The Testimony of an Expert Without the Requisite Experience Would Be Discounted in the Obviousness Determination
| October 21, 2022
Best Medical International, Inc., v. Elekta Inc.
Before HUGHES, LINN, and STOLL, Circuit Judges. STOLL, Circuit Judge.
Summary
The Federal Circuit affirmed the Patent Trial and Appeal Board’s determination that challenged claims are unpatentable as obvious over the prior art.
Background
Best Medical International, Inc (BMI) owns the patent at issue, U.S. Patent No. 6,393,096 (‘096). Patent ‘096 is directed to a medical device and method for applying conformal radiation therapy to tumors using a pre-determined radiation dose. The device and the method are intended to improve radiation therapy by computing an optimal radiation beam arrangement that maximizes radiation of a tumor while minimizing radiation of healthy tissue. Claim 43 is listed below as representative of the claims:
43. A method of determining an optimized radiation beam arrangement for applying radiation to at least one tumor target volume while minimizing radiation to at least one structure volume in a patient, comprising the steps of:
distinguishing each of the at least one tumor target volume and each of the at least one structure volume by target or structure type;
determining desired partial volume data for each of the at least one target volume and structure volume associated with a desired dose prescription;
entering the desired partial volume data into a computer;
providing a user with a range of values to indicate the importance of objects to be irradiated;
providing the user with a range of conformality control factors; and
using the computer to computationally calculate an optimized radiation beam arrangement.
Varian Medical Systems, Inc. filed two IPR petitions challenging some claims of the ’096 patent. Soon after the Board instituted both IPRs, Elekta Inc. filed petitions to join Varian’s instituted IPR proceedings. The Board issued the final written decisions that determined the challenged claims 1, 43, 44, and 46 were unpatentable as obvious.
Prior to the Board’s final decisions, BMI canceled claim 1 in an ex parte reexamination where the Examiner rejected claim 1 based on the finding of statutory and obviousness-type double patenting. Although BMI had canceled claim 1, the Board still considered the merits of Elekta’s patentability challenge for claim 1 and concluded that claim 1 was unpatentable in its final decision. The Board explained that claim 1 had not been canceled by final action as BMI had “not filed a statutory disclaimer.” BMI appealed the Board’s final written decisions. Varian later withdrew from the appeal.
Discussion
The Federal Circuit first addressed the threshold question of jurisdiction. BMI asked for a vacatur of the Board’s patentability determination by arguing “the Board lacked authority to consider claim 1’s patentability because that claim was canceled before the Board issued its final written decision, rendering the patentability question moot.” The Federal Circuit found that it was proper for the Board to address every challenged claim during the IPR under the Supreme Court’s decision in SAS Institute Inc. v. Iancu in which the Supreme Court held that the Board in its final written decision “must address every claim the petitioner has challenged.” 138 S. Ct. 1348, 1354 (2018) (citing 35 U.S.C. § 318(a)). Furthermore, the Federal Circuit supported Elekta’s argument that BMI lacked standing to appeal the Board’s unpatentability determination. The Federal Circuit explained that BMI admitted during oral argument that claim 1 was canceled prior to filing its notice of appeal without challenging the rejections. Thus, the Federal Circuit found that there was no longer a case or controversy regarding claim 1’s patentability at that time. Accordingly, the Federal Circuit dismissed BMI’s appeal regarding claim 1 for lack of standing.
The Federal Circuit later moved to consider BMI’s challenges to the Board’s findings regarding the level of skill in the art, motivation to combine, and reasonable expectation of success. The Board’s finding put a requirement on the level of skill in the art that a person of ordinary skill in the art would have had “formal computer programming experience, i.e., designing and writing underlying computer code.” BMI’s expert did not have such requisite computer programming experience. Thus, BMI’s expert testimony was discounted in the Board’s obviousness analysis.
The Federal Circuit stated that there is a non-exhaustive list of factors in finding the appropriate level of skill in the art, these factoring including: “(1) the educational level of the inventor; (2) type of problems encountered in the art; (3) prior art solutions to those
problems; (4) rapidity with which innovations are made; (5) sophistication of the technology; and (6) educational level of active workers in the field.” The Federal Circuit found that both parties did not provide sufficient evidence relating to these factors. Elekta principally relied on its expert Dr. Kenneth Gall’s declaration, whereas BMI relied on Mr. Chase’s declaration. In Dr. Gall opinion, a person of ordinary skill in the art would have had “two or more years of experience in . . . computer programming associated with treatment plan optimization.” Mr. Chase only disagreed with “the requirement,” but did not provide any explanation as to why “the requirement of ‘two or more years of . . . computer programming associated with treatment plan optimization’” was “inappropriate.”
Despite competing expert testimony on a person of ordinary skill, the Federal Circuit took the Board’s side and held that the Board relied on “the entire trial record,” including the patent’s teachings as a whole, to conclude the level of skill in the art. The Federal Circuit cited several sentences from the specification of the ‘096 patent to explain why the Board was reasonable to conclude that a skilled artisan would have had formal computer programming experience. For example, representative claim 43 was cited, which recites “using the computer to computationally calculate an optimized radiation beam arrangement.” The written description in ‘096 patent also recites “optimization method may be carried out using . . . a conventional computer or set of computers, and plan optimization software, which utilizes the optimization method of the present invention.”
The Federal Circuit found that BMI’s additional arguments were unpersuasive. BMI argued that the claims require that one specific step must be accomplished using a single computer and the claimed “conformality control factors” are “mathematically defined parameter[s].” The Federal Circuit concluded that there is no error in the Board’s determination based on the plain claim language and written description. BMI also argued that the Board’s finding that the prior teaches “providing a user with a range of values to indicate the importance of objects to be irradiated” is unsupported by substantial evidence. The Federal Circuit was not persuaded, because Dr. Gall’s testimony provide the support that a skilled artisan would have found the feature obvious.
BMI also challenged the Board’s findings as to whether there would have been a motivation to combine the prior art of Carol-1995 with Viggars and whether a skilled artisan would have had a reasonable expectation of success. But the Federal Circuit found that the Board relied on the teachings of the references themselves to support both findings. Thus, it was concluded that the Board’s well-reasoned analysis was supported by substantial evidence.
Takeaway
- The level of skill in the art could be defined in the specification for determining obviousness.
- The testimony of an expert without the requisite experience would be discounted in the obviousness arguments.
Recapture Applies under 35 U.S.C. 101
| October 17, 2022
In re: John Bradley McDonald
Decided: August 10, 2022
NEWMAN, STOLL, and CUNNINGHAM[1]. Opinion by CUNNINGHAM
Summary
This precedential opinion serves as a warning for applicants seeking a broadening reissue application, namely, that amendments made in a parent application can trigger recapture in a child continuation application, even if the amendment in the parent application was made in response to a rejection under 35 U.S.C. 101. As a further warning, the recapture issue did not arise until a decision by the Patent Trial and Appeal Board (the Board) when two new grounds of rejection were made (with respect to recapture and based on a defective reissue declaration as lacking an error correctable by reissue).
Background
A parent application was filed in 2008 naming John Bradley McDonald as the inventor. In response to a rejection under 35 U.S.C. 101, the claims were amended to add a “processor” to certain claim limitations. The application was eventually allowed and issued as U.S. Patent No. 8,280,901 (the ‘901 patent). Prior to issuing, a continuation application was filed. The claims of the continuation application, while different from the claims in the parent application, also contained “processor” limitations. The claims in the continuation application were rejected based on nonstatutory double patenting over the parent application claims, and an obviousness rejection over prior art. A terminal disclaimer was filed to obviate the double patenting rejection, and the obviousness rejection was traversed without amendments. The continuation application was allowed and issued as U.S. Patent No. 8,572,111 (the ‘111 patent).
In 2015, McDonald filed a reissue application seeking to broaden the claims of the ‘111 patent. Claim 1 of the reissue application was amended as follows:
1. (Amended) A computer-implemented method of displaying search results in a search and display window, the method comprising:
a) receiving a primary search query from a user;
b) determining a primary search result comprising a first plurality of search results [using a processor executing] by executing the primary search query;
c) displaying a plurality of primary electronic representations representing at least a subset of [data] search results in the primary search result, the plurality of primary electronic representations being displayed in a primary search results portion of the search and display window, wherein each primary electronic representation represents a single respective corresponding [data item] search result in the primary search result;
d) receiving a secondary search query, wherein the secondary search query comprises a user selection of one of the primary electronic representations;
e) determining a secondary search result [using the processor executing] comprising a second plurality of search results by executing the secondary search query, wherein at least a portion of the [data] search results in the primary search result is different from the [data] search results in the secondary search result, wherein the secondary search result is determined by at least one of: (i) a visual similarity search on the [data item] search result represented by the selected primary electronic representation, and (ii) a metadata similarity search based on metadata associated with the [data item] search result represented by the selected primary electronic representation; and
f) displaying a plurality of secondary electronic representations representing at least a subset of [data] the search results in the secondary search result, the plurality of secondary electronic representations being displayed in a secondary search results portion of the search and display window, wherein each secondary electronic representation represents a single respective corresponding [data item] search result in the secondary search result;
wherein when the plurality of secondary electronic representations are displayed, at least a portion of the plurality of primary electronic representations [and the plurality of secondary electronic representations] are visible at the same time; and wherein [the data in] the primary search result is unchanged by display of the plurality of secondary electronic representations [secondary search result].
The Examiner rejected claims 1-7, 10, 12-16, and 18-38 as obvious. On appeal, the Board affirmed the obviousness rejection of claims 35-38 and entered two new grounds of rejection: (1) rejecting the reissue claims as based on a defective reissue application lacking an error correctable by reissue, and (2) rejecting claims 1-7, 10, 12-14 and 29-38 as impermissibly attempting to recapture subject matter that the patentee intentionally surrendered during prosecution to overcome a §101 rejection. A request for rehearing was filed and denied. McDonald then appealed to the CAFC arguing that the Board erred in making the rejection under 35 U.S.C. 251 as being an improper recapture of surrendered subject matter, and being based on a defective reissue declaration.
Discussion
The CAFC began its opinion with a discussion of the reissue statute and the recapture rule, noting that the Supreme Court had recognized over a century ago that a patentee could seek reissue if erroneously claiming less than the right to claim in the original patent (Leggett v. Avery, 101 U.S. 256 (1879)). Stemming from the reissue statute, the recapture rule provides that a reissue will not be granted to “recapture” claimed subject matter that was surrendered during prosecution to obtain the original claims. The reissue statute is “based on fundamental principles of equity and fairness.” In re Weiler, 790 F.2d 1576, 1579 (Fed. Cir. 1986).
The opinion then applied the three-step recapture analysis by considering (1) whether and in what aspect the reissue claims are broader than the patent claims; (2) if broader, whether those broader aspects of the reissue claim relate to the surrendered subject matter; and (3) if so, whether the surrendered subject matter has crept into the reissue claim.
Against this backdrop, the opinion summarizes the facts of the appeal as “simple”:
“By first adding the “processor” limitations during prosecution of the original claims, then removing the exact terms “using a processor executing” and “using the processor executing,” Mr. McDonald seeks to reclaim a broader claim scope related to the surrendered subject matter that has now crept back into the reissue claim.”
The opinion notes the reissue statute requirement of “inadvertence or mistake”, concluding that McDonald made no mistake but deliberately “amended the claim scope during prosecution of the parent application, explaining that the “processor” limitation overcame the §101 rejection by tying the methods to a particular machine. “He cannot now use the reissue application as a Trojan horse to recapture that which he deliberately gave up.”
The opinion states:
We have previously explained that “this court reviews a patent family’s entire prosecution history when applying both the rule against recapture and prosecution history estoppel.” MBO Lab’ys, 602 F.3d at 1318. “Because the rule against recapture and prosecution history estoppel both protect the public’s interest in relying on a patent’s prosecution history, we think equity requires a review of a patent family’s prosecution history to protect against recapture in a reissue patent.” Id. We have also rejected the erroneous theory that the recapture rule “does not contemplate surrenders made while prosecuting the original application or any precedent divisional, continuation, or continuation-in-part applications. . . . We have never limited our review of recapture only to the prosecution history for the patent corrected by reissue.” Id. at 1316.
McDonald had pointed out that prior decisions of the CAFC had been limited to amendments “to overcome a prior art rejection”. In response, the opinion stated “Although we previously addressed cases centered on prior art rejections, this does not mean that the recapture rule is limited to that context.”
McDonald also argued that a prior CAFC opinion held that § 112 amendments did not involve recapture because the rule “applies only if the patentee surrendered subject matter in the original prosecution in order to overcome a prior art rejection”. The opinion distinguished this stating “the outcome hinged on our determination that canceling the claim in response to the indefiniteness rejection did not constitute intentional surrender of claim scope.”
McDonald also pointed out that there was no surrender as the MPEP notes that surrender occurs when an amendment is made to overcome a prior art rejection. This argument was dismissed as the MPEP is merely informative and does not carry the weight of law.
With respect to the reissue declaration, the Board had held that “the statement of error in the Reissue Declaration relates to an error that is uncorrectable by reissue.” The error noted in the declaration was the existence of the “processor” limitations. This was not considered a correctable error because doing so would violate the recapture rule. McDonald had conceded that the defectiveness of the declaration rises or falls with the determination on recapture.
Comments and Observations
In the author’s opinion, the facts may not be as simple as stated. The claims of the continuation application, while appearing similar in some respects to the parent application, should have been considered directed to a different invention such that the “processor” limitation could have possibly been deemed unnecessary to those particular claims. For reference, the parent claim 1 is reproduced below highlighting some differences from the child continuation claims:
1. A computer-implemented method of displaying search results in a search and display window, the method comprising:
a) receiving a primary search termfrom a user;
b) determining a primary search result using a processor executing a primary search query, the primary search query comprising the primary search term;
c) displaying a plurality of primary electronic representations representing at least a subset of data in the primary search result, the plurality of primary electronic representations being displayed in a primary search results portion of the search and display window, wherein each primary electronic representation represents a corresponding datum in the primary search result;
d) receiving a secondary search query, wherein the secondary search query comprises a user selection of one of the primary electronic representations;
e) determining a secondary search result using the processor executing the secondary search query, wherein at least a portion of the data in the primary search result is different from the data in the secondary search result, wherein the secondary search result is determined by a visual similarity search on the secondary search query; and
f) displaying a plurality of secondary electronic representations representing at least a subset of data in the secondary search result, the plurality of secondary electronic representations being displayed in a secondary search results portion of the search and display window, wherein each secondary electronic representation represents a corresponding datum in the secondary search result;
wherein the plurality of primary electronic representations and the plurality of secondary electronic representations are visible at the same time; and
wherein the data in the primary search result is unchanged by display of the secondary search result; and
(g) receiving a subsequent secondary search term, and determining a subsequent secondary search result.
It is hard to fault the patentee or the Examiner for not raising the issues of recapture or a defective declaration as seen by the flow chart below from the MPEP which clearly sets forth amendments in response to prior art rejections.
Take Aways
- 35 U.S.C. §101 can trigger recapture.
- Look out at as this case could serve as opening the door to recapture based on 35 U.S.C. §112!
- When filing a continuation or divisional application, be aware that amendments made in the parent application could be used to invoke the recapture rule.
- When appealing a decision, be aware of the potential for the Board to raise new rejections. When new rejections are raised on appeal, addressing such rejections adequately can be difficult.
- Consider adding other possible errors in the reissue declaration.
- Could traversing the obviousness-type patenting rejection in the child application have avoided the recapture by making a stronger case of separately patentable claims or overlooked aspects? Or stating that the error was an overlooked aspect? MPEP 1412.01 states that overlooked aspects of the invention are not subject to recapture “because the claims are, by definition, unrelated to subject matter that was surrendered during the prosecution of the original application. In the decision of In re Youman, 679 F.3d 1335, 102 USPQ2d 1862 (Fed. Cir. 2012), the Federal Circuit explained:
Whereas the recapture rule applies when surrendered subject matter is being reclaimed, overlooked aspects by definition were never claimed and thus never surrendered. See Mostafazadeh, 643 F.3d at 1360 [98 USPQ2d at 1644]. Rather, as we explained in Mostafazadeh, “overlooked aspects” is a separate inquiry under reissue that is independent of whether or not the recapture rule applies. 679 F.3d at 1347, 102 USPQ2d at 1870.
- The patentee was asserted to have intentionally amended the parent claims to overcome the §101 rejection. Couldn’t be said that the claims of the child application were also intentionally “amended” in other respects to avoid §101?
- Unfortunately for the patentee, these issues would be difficult to foresee based on the guidance provided by the MPEP, and the fact that the Examiner never raised recapture during prosecution. It was only when the Board issued its decision with the new rejections based on recapture and a defective reissue declaration.
[1] TIFFANY P. CUNNINGHAM was appointed by President Joseph R. Biden in 2021 and assumed duties of her office on September 1, 2021. Prior to her appointment, she served as trial and appellate counsel for companies and individuals in complex patent and trade secret disputes. From 2014 to 2021, Judge Cunningham served as a partner at Perkins Coie LLP in Chicago, Illinois. She also was a member of the Executive Committee of Perkins Coie LLP from 2020 to 2021. She served as a partner at the Chicago office of Kirkland & Ellis LLP from 2007 to 2014 and as an associate at the same office from 2002 to 2007. During her time in private practice, she was recognized on The Best Lawyers in America, Super Lawyers, and Leading Lawyers lists. Judge Cunningham clerked from 2001 to 2002 for the Honorable Timothy B. Dyk, Circuit Judge of the United States Court of Appeals for the Federal Circuit. Judge Cunningham received her S.B. in Chemical Engineering from the Massachusetts Institute of Technology in 1998 and her J.D. from Harvard Law School in 2001. She is a member of the Phi Beta Kappa and Tau Beta Pi honor societies. (Source: U.S. CAFC website)
Artificial Intelligence Systems Cannot be Inventors on a Patent Application
| October 5, 2022
Thaler v. Vidal
Decided: August 5, 2022
Moore, Taranto and Stark. Opinion by Stark
Summary:
This case decided the issue of whether an artificial intelligence (AI) software system can be an inventor on a patent application. The USPTO concluded that an inventor is limited to natural persons. The U.S. District Court for the Eastern District of Virginia agreed and granted the USPTO summary judgment. The CAFC affirmed the District Court concluding that an inventor must be a natural person.
Details:
Thaler developed the Device for the Autonomous Bootstrapping of Unified Science which is referred to as “DABUS.” DABUS is described as “a collection of source code or programming and a software program.” Thaler filed two patent applications at the USPTO listing DABUS as the sole inventor. Thaler stated that he did not contribute to the conception of the inventions and that any person having skill in the art could have taken DABUS’ output and reduced the ideas in the applications to practice.
For the inventor’s last name, Thaler wrote that “the invention was generated by artificial intelligence.” For the oath/declaration requirement, Thaler submitted a statement on behalf of DABUS. In a Statement on Inventorship, Thaler explained that DABUS was “a particular type of connectionist artificial intelligence” called a “Creativity Machine.” Thaler also filed an assignment assigning all of DABUS’ rights to himself.
The PTO mailed a Notice to File Missing Parts for each application requiring that Thaler identify valid inventors. Thaler petitioned the PTO to vacate the notices. However, the PTO denied the petitions on the ground that “a machine does not qualify as an inventor.” Thaler then challenged the petition decision in District Court. The District Court granted the PTO’s motion for summary judgment concluding that “an ‘inventor’ under the Patent Act must be an ‘individual’ and the plain meaning of ‘individual’ as used in the statute is a natural person.”
Thaler appealed the District Court’s decision to the CAFC. The CAFC stated that “[t]he sole issue on appeal is whether an AI software system can be an ‘inventor’ under the Patent Act. The CAFC first looked to the plain meaning of the Patent Act. The Patent Act defines an “inventor” as “the individual or, if a joint invention, the individuals collectively who invented or discovered the subject matter of the invention.” 35 U.S.C. 100(f). Citing § 115, the CAFC stated that the Patent Act also consistently refers to inventors as “individuals,” and uses personal pronouns “himself” and “herself” to refer to an “individual.” The Patent Act does not define “individuals,” but the CAFC looked to Supreme Court precedent and stated that “as the Supreme Court has explained, when used as a noun, ‘individual’ ordinarily means a human being, a person.
The CAFC also looked to dictionary definitions of “individual” which is defined as a human being. The CAFC also referred to the Dictionary Act which states that “person” and “whoever” broadly include “unless the context dictates otherwise,” “corporations, companies, associations, firms, partnerships, societies, and joint stock companies, as well as individuals.” 1 U.S.C. § 1. The CAFC interprets the Dictionary Act as meaning that Congress understands “individual” to mean natural persons unless otherwise noted.
Thaler argued that the Patent Act uses “whoever” in §§ 101 and 271. With regard to § 101, the CAFC stated that this section uses “whoever,” but § 101 also states that patents must satisfy the “conditions and requirements” of Title 35 of the U.S. Code, including the definition of inventor. Regarding § 271, the CAFC stated that this section refers to infringement, however, “That non-humans may infringe patents does not tell us anything about whether non-humans may also be inventors of patents.”
Thaler also argued that AI software must qualify as inventors because otherwise patentability would depend on “the manner in which the invention was made,” in contravention of 35 U.S.C. § 103. However, the CAFC stated that § 103 is not about inventorship. The cited provision of § 103 refers to how an invention is made, and does not outweigh the statutory provision addressing who may be an inventor.
The CAFC also referred to its own precedent stating that inventors must be natural persons and cannot be corporations or sovereigns. Univ. of Utah v. Max-Planck-Gesellschaft zur Forderung der Wissenschaften E.V., 734 F.3d 1315, 1323 (Fed. Cir. 2013); Beech Aircraft Corp. v. EDO Corp., 990 F.2d 1237, 1248 (Fed. Cir. 1993).
Thaler also raised some policy arguments stating that “inventions generated by AI should be patentable in order to encourage innovation and public disclosure.” However, the CAFC stated that this is speculative and lacks a basis in the text of the Patent Act and in the record, and anyway, the text in the statue is unambiguous.
The CAFC concluded that the Patent Act unambiguously and directly answers the question regarding whether AI can be an inventor and stated that “Congress has determined that only a natural person can be an inventor, so AI cannot be.”
Comments
According to Thaler, South Africa has granted patents with DABUS as an inventor. However, this will not be possible in the US unless the Supreme Court steps in (which does not seem likely) or Congress amends the Patent Act.
Detecting Natural Phenomena Using Conventional Techniques Found “Directed to” Natural Phenomena at Alice/Mayo Step One
| September 16, 2022
CAREDX, INC. v. NATERA, INC.
Lourie, Bryson, and Hughes. Opinion by Lourie.
Summary
The CAFC held that genetic diagnostic method claims are ineligible for patent, finding that the claims reciting conventional laboratory techniques to perform diagnosis using a naturally occurring correlation are directed to natural phenomena under Alice/Mayo step one, and also lack additional elements to constitute enough inventive concept under Alice/Mayo step two.
Details
CareDx sued Natera and Eurofins in the U.S. District Court for the District of Delaware, asserting that their products infringed one or more patents licensed to CareDx. The district court awarded summary judgment for the defendants, holding that the patents are ineligible for patent under 35 U.S.C. §101. CareDx appealed the district court’s grant of the summary judgment motions of ineligibility.
The patents at issue, U.S. Patents 8,703,652, 9,845,497, and 10,329,607, relate to diagnosis of organ transplant status by detecting a donor’s cell-free DNA (“cfDNA”) circulating in a recipient’s body. The specification, common to all three patents, depicts prior findings that the existence of cfDNA in blood is mostly attributed to dead cells, and had been used for various diagnostic purposes, such as cancer diagnostics and prenatal testing. The specification notes that the cfDNA-based diagnostic scheme is applicable to organ transplant situations, where the recipient’s immune system kills incompatible donor’s cells which in turn release their nucleic acids into the recipient’s stream, such that an increased level of the donor-derived cfDNA may allow for detection of the transplant rejection.
Claim 1 of ‘652 patent recites:
1. A method for detecting transplant rejection, graft dysfunction, or organ failure, the method comprising:
(a) providing a sample comprising cell-free nucleic acids from a subject who has received a transplant from a donor;
(b) obtaining a genotype of donor-specific polymorphisms or a genotype of subject-specific polymorphisms, or obtaining both a genotype of donor-specific polymorphisms and subject-specific polymorphisms, to establish a polymorphism profile for detecting donor cell-free nucleic acids, wherein at least one single nucleotide polymorphism (SNP) is homozygous for the subject if the genotype comprises subject-specific polymorphisms comprising SNPs;
(c) multiplex sequencing of the cell-free nucleic acids in the sample followed by analysis of the sequencing results using the polymorphism profile to detect donor cell-free nucleic acids and subject cell-free nucleic acids; and
(d) diagnosing, predicting, or monitoring a transplant status or outcome of the subject who has received the transplant by determining a quantity of the donor cell-free nucleic acids based on the detection of the donor cell-free nucleic acids and subject cell-free nucleic acids by the multiplexed sequencing, wherein an increase in the quantity of the donor cell-free nucleic acids over time is indicative of transplant rejection, graft dysfunction or organ failure, and wherein sensitivity of the method is greater than 56% compared to sensitivity of current surveillance methods for cardiac allograft vasculopathy (CAV).
The representative claims of the three patents recite somewhat similar procedures, which may be summarized as:
- collecting a bodily sample from the recipient,
- “genotyping” or identifying genetic features that allow for distinction between the donor and recipient,
- “sequencing” or determining the makeup of cfDNA included in the sample, and
- determining, using the genetic features, the amount of cfDNA originating from the donor in the sample.
The specification depicts that the methods are performed using specific techniques that are “standard,” “well-established” and/or reported in prior patents and scientific articles, including sophisticated polymerase chain reaction (“PCR”), such as digital PCR and selective amplification, and next-generation sequencing (“NGS”), all of which are advanced, but already known, techniques in the field.
The district court held that that the asserted claims were patent ineligible as they were “directed to the detection of natural phenomena, specifically, the presence of donor cfDNA in a transplant recipient and the correlation between donor cfDNA and transplant rejection” and also, “recited only conventional techniques.”
On appeal, the CAFC performed the two-step Alice/Mayo analysis to determine patent-eligibility.
- Are the claims “directed to” laws of nature or natural phenomena? – Yes.
CareDx sought to characterize the claimed invention as directed to “improved measurement methods,” in particular, patent-eligible “use of digital PCR, NGS, and selective amplification” allowing for improved accuracy in cfDNA measurement, as opposed to “discovery of a natural correlation between organ rejection and the donor’s cfDNA levels in the recipient’s blood.” CareDx also asserted that the district court improperly considered conventionality of the claimed techniques at step one, essentially merging the two steps into a single-step analysis centered on conventionality.
The CAFC found that the claims satisfy the step one. Two contrasting precedents are notable: Illumina, Inc. v. Ariosa Diagnostics, Inc., 952 F.3d 1367, opinion modified by 967 F.3d 1319, 1327 (Fed. Cir. 2020), and Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371 (Fed. Cir. 2015). The CAFC noted that this case is different from Illumina, where the claimed improvement was a patent-eligible “method for preparing” a cfDNA fraction that would not occur naturally without manipulation of a starting sample; rather, the asserted claims are akin to those in Ariosa, wherein the claimed diagnostic methods, including the steps of “amplifying” (i.e., making many copies of) a cfDNA sample using PCR and “detecting” a certain type of cfDNA, so as to perform diagnosis using a natural correlation between certain conditions and the level of cfDNA, were found to be “directed to a natural phenomenon.”
The CAFC noted that the conventionally considerations are not limited to step two, and precedents have routinely performed overlapping conventionality inquiry at both stages of Alice/Mayo. The CAFC found that the use of specific laboratory techniques relied on by CareDx only amounts to “conventional use of existing techniques to detect naturally occurring cfDNA.” The CAFC added that the conventionality is supported by the specification’s numerous remarks characterizing the claimed techniques as “any suitable method known in the art” and similar boilerplate language.
- Do the claims recite additional elements, aside from the natural phenomena, which transform the nature of the claim’ into a patent-eligible application? – No.
CareDx’s main argument at step two was that the inventive concept resides in the use of the specific advanced techniques to identify and measure donor-derived cfDNA.
The CAFC disagreed, concluding that the claimed methods lack requisite inventive concept. In reaching the conclusion, the CAFC again pointed to the specification’s admissions of the conventionality of the individual techniques recited in the claims. The CAFC went on to state that “[t]he specification confirms that the claimed combination of steps … was a straightforward, logical, and conventional method for detecting cfDNA previously used in other contexts,” which adds nothing inventive to the detection of natural phenomena.
Takeaway
This case provides a reminder that conventionality of claimed elements may affect both steps of Alice/Mayo test. At step one, the effort to characterize the claim as being “directed to” a patent-eligible subject matter can be thwarted where the claimed elements are undisputedly conventional, in the absence of an unconventional element that is not a judicial exception to eligibility. And at step two, the conventionality of the individual elements and their combination prohibits finding of inventive concept.
When does the absence of evidence turn into evidence of absence? The CAFC vacate their prior decision to now hold that there must be evidence that a skilled artisan would understand silence regarding a limitation to necessarily exclude said limitation.
| September 9, 2022
Novartis Pharmaceuticals v. HEC Pharms Co, Ltd, & Accord Health Care et al.
Summary:
HEC petitioned for rehearing of a CAFC prior decision in this case, (21 F 4th 1362 – Fed. Cir. 2022) in which the CAFC affirmed a final judgement of the Delaware district court determining that claims 1 to 6 of US Patent 9,187,405 are not invalid and that HEC infringes them. The CAFC Panel in the prior case was Judges, Moore (dissent) with Linn and O’Malley. Here, Chief Judge Moore with Circuit Judge Hughes (majority herein after) vacate the CAFC’s prior decision holding that the Novartis claims are invalid for inadequate written description pertaining to a negative limitation.
- Background
Novartis owns the ‘405 patents and markets a drug for treating relapsing remitting multiple sclerosis that purportedly practices the patent. HEC filed an ANDA with the FDA seeking approval to market a generic version of the drug. Novartis sued. The Delaware district count found that the claims were not invalid either as anticipated or for inadequate written description of the no-loading-dose or daily dosage limitations. HEC appeals as to the written description issue of the no-loading dose.
Claim 1 at issue recites in part “a daily dosage of 0.5 mg, absent an immediately preceding loading dose regime.” The appeal at hand being related to the underlined negative limitation. A loading dose is a higher-than-normal daily dose.
The Majority go into detail regarding what is required to satisfy the written description, stating that “[F]or negative claim limitations…. there is adequate written description when., for example, “the specification described a reason to exclude the relevant [element]… A reason to exclude an element could be found in ‘statements in the specification expressly listing the disadvantages of using’ that element and alternatives to it…. Silence is generally not disclosure.” The Majority further noted that the negative limitation may not be recited verbatim in the specification, but there “generally must be something in the specification that conveys to a skilled artisan that the inventor intended the exclusion, such as a discussion of disadvantages or alternatives.” However, the Majority further noted that while “a written descriptions silence about a negative claim limitation is a useful and important clue and may often be dispositive, it is possible that the written description requirement may be satisfied when a skilled artisan would understand the specification as inherently disclaiming the negative limitation.”
The district count had found that the negative limitation was supported because the prophetic trial described therein states “initially” giving a daily dose, thus this would inform the skilled artisan that there was no loading dose. The Majority found this interpretation erroneous arguing that because the specification says “Initially patients receive treatment for 2 to 6 months” it is clear this sentence speaks to the initial length of treatment and not the dosage. The Majority believed that one of the two Novartis experts admitted this, and that the contrary testimony by the second Novartis experts was inconsistent with the plain text of the specification and therefore carried no weight.
Next, the Majority discussed the district courts finding that the specifications disclosure of a daily dosage combined with its silence regarding a loading dose would tell a person of skill that loading doses are excluded. However, the Majority countered that a patent is not presumed complete such that things not mentioned are necessarily excluded. The Majority noted that the applicants added the limitation during prosecution to address a prior art rejection arguing that the limitation was “to specify that the [daily dosage] cannot immediately follow a loading dose regiment” and “to further distinguish their claims.” The Majority argued that if reciting “daily dosage” without mentioning a loading dose necessarily excludes said loading dose, there would have been no reason for the applicants to add the limitation.
The Majority noted that the expert testimony focused on where in the specification the patentee would have mentioned a loading dose if they intended a loading dose to be included, but that is not the issue at hand, rather the question is whether the patentee precluded the use of a loading dose. The Majority concluded that there is no evidence that a skilled artisan would understand silence regarding a loading artisan to necessarily exclude a loading dose.
Thus, the Majority vacated their prior decision and reversed the distinct courts judgement that the claims of the ‘405 patent are not invalid.
- Dissent:
Circuit Judge Linn dissented, her opinion being very reminiscent of her opinion in the prior judgment, for which she penned the Majority. CJ Linn stated that the “majority in its analysis employs the heightened standard of “necessary exclusion” against which to assess the district court’s fact findings in this case and uses that standard to conclude that the district court clearly erred.” CJ Linn argued that the central tenet of the written description jurisprudence is that the disclosure must be read from the perspective of a person of skill in the art. Here, CJ Lin argued that the district conducted an objective inquiry into the four corners of the specification and found sufficient written description, while also crediting the expert testimony. In particular, the testimony that one skilled in the art would understand the loading dose to be excluded, and that loading dose regiments have been used in the prior art for treating MS. CJ Linn concluded this is sufficient to show that claim language that precludes the administration of a loading dose is supported.
Take-away:
- When express support for a negative limitation is absent, look for evidence that a skilled artisan would understand the silence regarding the limitation to necessarily exclude said limitation.
- Be mindful of statements made during prosecution as to why an amendment is being made.
CAFC HOLDS THAT A SIMPLE ERROR IS STILL SIMPLE EVEN IF IT IS HARD TO FIND
| August 23, 2022
LG Electronics Inc. v. Immervision, Inc.
NEWMAN, STOLL, and CUNNINGHAM. Opinion by Stroll. Dissent by Newman.
Summary:
CAFC affirms PTAB that LG failed to demonstrate obviousness in its IPR petitions relying on a “copy-and-paste” error which took an expert detailed analysis to locate. The Court and Board both found the error to be within the Yale standard that an obvious error of a typographical or similar nature that would be apparent to one of ordinary skill in the art who would mentally disregard the errant information as a misprint or mentally substitute it for the correct information, the errant information cannot be said to disclose subject matter.
Background:
LG Electronics Inc. appealed from the United States Patent Trial and Appeal Board’s final written decisions in a pair of inter partes review proceedings challenging claims 5 and 21 of U.S. Patent No. 6,844,990 asserted by Immervision.
The ’990 patent specification describes capturing an initial digital panoramic image using an objective lens having a non-linear image point distribution function that “expands certain zones of the image and compresses other zones of the image.” Id. at col. 3 l. 62–col. 4 l. 38. The “non-linearity of the initial image” can then be corrected to produce a final panoramic image for display. Id. at col. 4 ll. 47–53. “[T]he expanded zones of the image cover” a higher “number of pixels of the image sensor” than they would with a lens having linear image point distribution. Id. at col. 3 l. 62–col. 4 l. 10. The exemplary claim used by the Court was claim 5:
5. The method according to claim 1, wherein the objective lens compresses the center of the image and the edges of the image and expands an intermediate zone of the image located between the center and the edges of the image.
LG filed two petitions for inter partes review, each challenging a dependent claim of the ’990 patent. J.A. 322–66 (IPR2020-00179 challenging claim 5); J.A. 3338–87 (IPR2020-00195 challenging claim 21). In the petitions LG argued that U.S. Patent No. 5,861,999 (“Tada”), directed to a “Super Wide Angle Lens System Using an Aspherical Lens.”2 Tada describes four embodiments that share a general system structure and differ in aspects such as lens element thick-ness, separation distance, and lens shape. The embodiment relevant to the appeal, Embodiment 3, described by a prescription—or set of optical parameters—set forth in Table 5 of its specification.
LG argued that Tada discloses, as recited in the challenged claims, a panoramic objective lens having a non-linear image point distribution that compresses the center and edges of an image and expands an intermediate zone of the image between the center and the edges of the image. Tada, however, does not explicitly discuss the image point distribution functions of its lenses. Instead, LG relied on its expert Dr. Chipman’s declaration for the proposition that Tada’s third embodiment has a distribution function producing “a compressed center and edges of the image and an expanded intermediate zone of the image between the center and the edges of the image” as recited in challenged claims 5 and 21.
Dr. Chipman “reconstruct[ed] the lens of Figure 11 [of Tada] using the information in Table 5 of Tada” by inputting certain “information from Table 5 [as published] . . . into an optical design program.” J.A. 1486–87. LG relied exclusively on Dr. Chipman’s calculations and plots using the prescription in Table 5 to show that Tada’s third embodiment meets the compression and expansion zone limitation of the challenged claims.
In its patent owner response, ImmerVision, relied on its expert witness Mr. Aikens’ declaration, arguing that Tada’s Table 5 includes a readily apparent error that cannot form the basis of any obviousness ground. Specifically, Mr. Aikens first noticed that the physical surface of his lens model based on Tada’s Table 5 and the example lens depicted in Tada’s Figure 11 did not match. Because of this discrepancy, Mr. Aikens compared the sag table—a table of heights of a lens surface with respect to the optical axis—generated for his lens model with the sag table provided in Tada’s Table 6 corresponding to Embodiment 3. They also did not match. After Mr. Aiken’s extensive review which included comparing the ‘990 patent with its priority Japanese application, it became apparent that there was a transcription, or copy-and-paste, error in Tada. The disclosures in Tada’s Table 5, which were intended to correspond to its Embodiment 3, were actually identical to those in Table 3, which corresponded to Embodiment 2.
Based on Mr. Aiken’s Declarations, the Board found that the “disclosure of aspheric[] coefficients in Table 5 of Tada is an obvious error” that a person of ordinary skill in the art would have recognized and corrected. Further, the Board found that because the correct aspheric coefficients in Table 5 of the Japanese Priority Application do not satisfy the language of the challenged claims, LG had not met its burden to prove the challenged claims unpatentable as obvious. The Board concluded that LG did not meet its burden to prove the challenged claims would have been obvious by a preponderance of evidence.
LG appealed.
Decision:
First, the Court noted that it is undisputed that the aspheric coefficients in Tada’s Table 5 were erroneous. Therefore, their decision focused on whether substantial evidence supports the Board’s fact finding that the error would have been apparent to a person of ordinary skill in the art such that the person would have disregarded the disclosure or corrected the error.
Second, the Court set forth the legal standard for such a review, citing to In re Yale, 434 F.2d 666 (C.C.P.A. 1970), as the controlling case law. They noted that Yale held that where a prior art reference includes an obvious error of a typographical or similar nature that would be apparent to one of ordinary skill in the art who would mentally disregard the errant information as a misprint or mentally substitute it for the correct information, the errant information cannot be said to disclose subject matter. Id. at 669.
Next, the Court reviewed the Board’s fact finding. They affirmed that the Board correctly identified several aspects of the disclosure in Table 5 that would alert the ordinarily skilled artisan that the disclosure was an obvious error of a typographical or similar nature. Specifically, they noted that it was undisputed that Tada’s Tables 5 and 9 are inconsistent: the aspheric coefficients A4, A6, and A8 in Tada’s Table 5 should match the values for conditions (2)–(4) in Table 9 but do not. They contrasted this to the facts in Yale, finding precedent (describing the internal inconsistency within a reference as a signal that a person of ordinary skill “would readily recognize” as portending error). Yale, 434 F.2d at 667. Based thereon, the Court concluded that
Table 5 cannot be said to disclose a lens that compresses the center of the image and the edges of the image and expands an intermediate zone of the image located between the center and the edges of the image as required by claim 5 of the ‘990 patent.
The CAFC also reviewed LG’s arguments attempting to distinguish the current fact pattern from Yale. First, LG contended that Yale sets forth an “Immediately Disregard or Correct” standard that imposes a temporal urgency on the discovery of the error before the error can be considered “obvious” to a skilled artisan. Applying this reading of Yale, LG argued that Mr. Aikens’ “convoluted process” that took “ten to twelve hours” to complete clearly weighed against the obviousness of the error. LG asserted that because Tada remained uncorrected in the public domain for over 20 years, LG should have been able to rely on the aspheric coefficients in Tada’s Table 5 as published.
In response, the Court held that LG’s suggestion that Yale requires a person of ordinary skill in the art to immediately recognize the apparent error is incorrect. The Court affirmed the PTAB’s holding that the length of time and the “particular manner” in which the error was actually discovered “does not diminish that there is an obvious error in Tada within the meaning of Yale.”
Contrary to LG’s assertions, Yale does not impose a temporal requirement. Nor does LG cite any other authority requiring that the error be discovered within a specified amount of time. Certainly, the amount of time it takes a skilled artisan to detect an error may be relevant to whether an error is, in fact, an apparent error under Yale. But this is just one factor for the fact finder to consider as part of the overall analysis. Here, the Board considered the totality of circumstances and found that Tada’s disclosure of aspheric coefficients in Table 5 is an obvious error of a typographical or similar nature, notwithstanding the amount of time that preceded detection of the obvious error.
Second, LG argued that Yale is limited to instances in which the error is a typographical error, and therefore should be narrowly limited to errors such as spelling mistakes and similar minor, easily detectable errors. The CAFC disagreed, finding instead that while the error in Yale was typographical, the error at issue here was not so far afield as to warrant a different outcome.
The distinction between the typographical error in Yale and the copy-and-paste error here is a distinction without a difference.
Based thereon, the Court affirmed the PTAB’s ruling that LG failed to demonstrate obviousness based on the erroneous calculations set forth in the Tada reference.
Dissent
Judge Newman dissented, asserting that she could not agree that the error in the Tada Tables was typographical or similar in nature, because its existence was not discovered until an expert witness conducted a dozen hours of experimentation and calculation.
She asserted that the appearance of a few of the same numbers in two different tables in the Tada reference provides no information as to which numbers and tables are correct and which may be in error. Contrary, she considers a typographical or similar error needs to be apparent to the reader and may conveniently be ignored without impeaching the content of the information.
Judge Newman outlines the extensive history of the ‘990 patent, noting that no one detected the error until Immervision’s expert spent significant time ascertaining that an error was in fact present in the ‘990 patent. She asserts that these events that preceded the expert’s discovery of the error in the Tada reference cannot be ignored.
The specifics of what led the expert, Mr. Aikens, to discover the erroneous values in Table 5 also cast doubt on whether the error may be deemed “obvious and apparent.” Mr. Aikens testified that he had fully modeled Tada’s Embodiment 3—relying on data from Table 5—without noticing the error. … It was only after his model was completed that he noticed the lens created a distorted image, leading him to presume there was perhaps some error in Tada.
The Japanese application had the correct aspherical values in Table 5, as confirmed by a skilled expert in this technology, after many hours of corrective effort that included fully modeling three separate embodiments of the lens. In sum, the error was not of “typographical or similar nature.”
Judge Newman contrasts this to the evidence in Yale, noting that the error therein did not require calculations or experimentation, and that without the Japanese Priority Application, there is no source of the correct information in the current case.
She agreed with the panel majority that Yale establishes the correct standard to determine if an error would be obvious to a person of ordinary skill in the field, but maintains that an “obvious error” should be apparent on its face and should not require the conduct of experiments or a search for possibly conflicting information to determine whether error exists.
Take away:
Relying on an error in prior art as teaching aspects of a claim is less likely to be sufficient to establish that the subject matter was known even if the error is difficult to locate. Care needs to be taken in examining the prior art reference including contrasting to the disclosures of priority documents. The Yale standard of whether an error can be relied upon looks to the simplicity of the error not to the scrutiny necessary to locate it.
General industry skepticism may not be sufficient by itself to preclude a finding of motivation to combine
| August 2, 2022
Auris Health, Inc. v. Intuitive Surgical Operations, Inc.
Decided: April 29, 2022
Prost (author), Dyke, and Reyna (dissenting)
Summary:
The Federal Circuit rejected the PTAB’s obviousness decision by holding that general industry skepticism is not relevant to the question of obviousness.
Details:
In 2018, Intuitive Surgical sued Auris Health for patent infringement of U.S. Patent No. 8,142,447 (“the ’447 patent”).
The ’447 patent
This patent is directed to robotic surgery systems.
The ’447 patent describes “an improvement over Intuitive’s earlier robotic surgery systems, which allow surgeons to remotely manipulate surgical tools using a controller.”
The ’447 patent attempts to solve problems (doctors must swap out various surgical instruments and this step could be tricky in a robotic surgical system where space is limited, different ranges of motion must be calibrated for different surgical instruments, and time is need to interchange those instruments) in the surgery via a robotic system with a servo-pulley mechanism so that doctors could swap out surgical instruments and reduce surgery time, improve safety, and increase reliability of the system.
PTAB
The PTAB determined that the prior art references asserted by Aurie – Smith and Faraz – disclosed each limitation of the claims in the ’447 patent.
The only remaining issue is whether a skilled artisan would have motivated to combine these two references.
Smith discloses “a robotic surgical system that uses an exoskeleton controller, worn by a clinician, to remotely manipulate a pair of robotic arms, each of which holds a surgical instrument.” Smith discloses that the clinician may direct an assistant to relocate the arms as necessary.
Faraz is directed an adjustable support stand that holds surgical instruments. Faraz discloses that its stand “may enable a surgeon to perform surgery with fewer assistants” because its stand “can support multiple surgical implements while [they] are being moved” and “can also provide support for a surgeon’s arms during long or complicated surgery.”
Auris argued that a skilled artisan would be motivated to combine these references to decrease the number of assistants necessary for surgery.
Intuitive argued that a skilled artisan would not be motivated to combine these references because “surgeons were skeptical about performing robotic surgery in the first place, [so] there would have been no reason to further complicate Smith’s already complex robotic surgical system with [Faraz’s] roboticized surgical stand.”
The PTAB agreed with Intuitive that there is no motivation to combine these references because there is skepticism at the time of the invention for using robotic systems during surgery in the first place.
Federal Circuit
The Federal Circuit held that general industry skepticism cannot, by itself, preclude a finding of motivation to combine.
The Federal Circuit noted that the evidence of skepticism must be specific to the invention, not generic to the field and that Intuitive provided not case law to suggest that the PTAB can rely on generic industry skepticism to find a lack of motivation of combine.
The Federal Circuit held that the PTAB was wrong to exclusively rely on Intuitive’s expert testimony that “there was great skepticism for performing telesurgery” at the time of the invention and, as a result, a skilled artisan “would not have been compelled to complicate Smith’s system further.”
Therefore, the Federal Circuit remand for further consideration of the parties’ motivation-to-combine evidence.
Dissent
Judge Reyna noted that the PTAB’s determination that Auris failed to show a motivation to combine is adequately supported by substantial evidence and was not contrary to our law on obviousness.
While Judge Reyna agreed that skilled artisans’ general skepticism toward robotic surgery, by itself, could be insufficient to negate a motivation to combine, he disagreed that it could never support a finding of no motivation to combine.
Judge Reyna believes that the majority’s inflexible and rigid rule appears to be in tension with the central thrust of KSR (rejecting the “rigid approach of the Court of Appeals” and articulating an “expansive and flexible approach” of determining obviousness).
Takeaway:
- General industry skepticism may not be sufficient by itself to preclude a finding of motivation to combine.
- Specific evidence of industry skepticism related to a specific combination of references might contribute to finding a lack of motivation to combine.
The applicants’ statement during the prosecution may play a critical role for claim construction
| July 4, 2022
Sound View Innovations, LLC v. Hulu, LLC
Decided: May 11, 2022
Prost, Mayer (Sr.) and Taranto. Court opinion by Taranto.
Summary
On appeals from the district court for summary judgment of noninfringement of a patent, directed to a method of reducing latency in a network having a content server, the Federal Circuit affirmed the district court’s construction of the down-loading/retrieving limitation solely on the basis of prosecution history, but the Court rejected the district court’s determination that “buffer” cannot cover “a cache,” and vacated the district court’s grant of summary judgment and remanded for further proceedings.
Details
I. Background
(i) The Patent in Dispute
Sound View Innovations, LLC (“Sound View”) owns now-expired U.S. Patent No. 6,708,213 (“the ’213 patent”), which describes and claims “methods which improve the caching of streaming multimedia data (e.g., audio and video data) from a content provider over a network to a client’s computer.” Claim 16 of the ’213 patent provides as follows:
16. A method of reducing latency in a network having a content server which hosts streaming media (SM) objects which comprise a plurality of time-ordered segments for distribution over said network through a plurality of helpers (HSs) to a plurality of clients, said method comprising:
receiving a request for an SM object from one of said plurality of clients at one of said plurality of helper servers;
allocating a buffer at one of said plurality of HSs to cache at least a portion of said requested SM object;
downloading said portion of said requested SM object to said requesting client, while concurrently retrieving a remaining portion of said requested SM object from one of another HS and said content server (the “downloading/retrieving limitation”); and
adjusting a data transfer rate at said one of said plurality of HSs for transferring data from said one of said plurality of helper servers to said one of said plurality of clients (emphasis added).
During the prosecution, the examiner rejected original claim 16—which was identical to issued claim 16 except that it lacked the downloading/retrieving limitation—as anticipated over DeMoney (U.S. Patent No. 6,438,630). To overcome the rejection, the applicants amended the claim to add the downloading/retrieving limitation. The applicants explained that support for the added limitation is found in the applicants’ specification, pointing to the portion of the specification that shows concurrent downloading and retrieval involving a single buffer (emphasis added). In fact, the specification nowhere says that the invention includes use of separate buffers for the concurrent downloading and retrieving functions, and it nowhere illustrates or describes such an embodiment, in which different buffers are involved in con- current downloading of one portion and retrieving of a remaining portion of the same SM object in response to a given client’s request.
(ii) The District Court
Sound View sued Hulu, LLC (“Hulu”) for infringement of six Sound View patents including the ’213 patent in the United States District Court for the Central District of California (“the district court”). As the case proceeded, only claim 16 of the ’213 patent remained at issue.
It was undisputed that the accused edge servers— the edge servers Sound View identified as the “helper servers” for its infringement charge—do NOT download and retrieve subsequent portions of the same SM object in the same buffer (emphasis added).
Sound View alleged, among other things, that, under Hulu’s direction, when an edge server receives a client request for a video not already fully in the edge server’s possession, and obtains segments of the video seriatim from the content server (or another edge server), the edge server transmits to the Hulu client a segment it has obtained while concurrently retrieving a remaining segment.
The district court agreed with Hulu’s argument that the applicants’ statements accompanying the amendment in the prosecution disclaimed the full scope of the downloading/retrieving limitation, and that the downloading/retrieving limitation thus required that the same buffer in the helper server—the one allocated in the preceding step—host both the portion sent to the client and a remaining portion retrieved concurrently from the content server or other helper server (emphasis added).
In reliance on the construction, Hulu then sought summary judgment of non-infringement of claim 16, arguing that it was undisputed that, in the edge servers of its content delivery networks, no single buffer hosts both the video portion downloaded to the client and the retrieved additional portion. Sound View countered that there remained a factual dispute about whether “caches” in the edge servers met the concurrency limitation as construed. The district court held, however, that a “cache” could not be the “buffer” that its construction of the down- loading/retrieving limitation required, and on that basis, it granted summary judgment of non-infringement. A final judgment followed.
Sound View timely appealed.
II. The Federal Circuit
The Federal Circuit (“the Court”) affirmed the district court’s construction of the down-loading/retrieving limitation. but the Court rejected the district court’s determination that “buffer” cannot cover “a cache,” and vacated the district court’s grant of summary judgment and remanded for further proceedings.
Claim Construction (the downloading/retrieving limitation)
The Court first noted that this is not a case in which the other intrinsic evidence—the claim language and specification—establish a truly plain meaning contrary to the meaning assertedly established by the prosecution history because the downloading/retrieving limitation, which does not expressly refer to “buffers,” contains no words affirmatively making clear that different buffers in the helper server may be used for the sending out to clients of one portion of the SM object and the receiving of a retrieved remaining portion.
The Court viewed the prosecution history as establishing that the applicants made clear that the applicants’ invention concurrently empties and fills the buffer, while the DeMoney reference teaches filling the buffer only after the buffer is empty,” citing column 12, lines 28–40 of DeMoney (emphasis added).
Based on the applicants’ statements, the Court agreed with the district court that the applicants limited claim 16 to using the same buffer for the required concurrent downloading and retrieval of portions of a requested SM object.
Summary Judgment of Non-Infringement
After the district court adopted its “buffer”-requiring claim construction of the downloading/retrieving limitation, it granted summary judgment of non-infringement, concluding that accused-system components called “caches”—on which Sound View relied for its allegation of infringement under the court’s claim construction—could not be the required “buffers.” The district court relied for its conclusion on the ’213 patent’s references to its described “buffers” and “caches” as distinct physical components. To support the conclusion, the district court noted that the ’213 patent describes buffers and caches in different locations: The patent defines “cache” as “a region on the computer disk that holds a subset of a larger collection of data,” and although the patent does not define “buffer,” it describes “ring buffers” located “in the memory” of the HS.
However, the Court stated that the district court’s construction here was inadequate for the second step of an infringement analysis (comparison to the accused products or methods) because it did not adopt an affirmative construction of what constitutes a “buffer” in this patent. More specifically, the Court stated that the district court did not decide, and the record does not establish, that “cache” is a term of such uniform meaning in the art that its meaning in the ’213 patent must be relevantly identical to its meaning when used by those who labeled the pertinent components of the accused edge servers. The Court thus concluded that, in the absence of such a uniformity-of-meaning determination, the district court’s conclusion that the ’213 patent distinguishes its buffers and caches is insufficient to support a determination that the accused-component “caches” are outside the “buffers” of the ’213 patent. What was needed was an affirmative construction of “buffer”— which could then be compared to the accused-component “caches” based on more than a mere name.
For an additional reason for the further affirmative construction, the Court pointed out that, even in the ’213 patent, the terms “buffer” and “cache” do not appear to be mutually exclusive, but instead seem to have at least some overlap in their coverage given that the disputed claim describes “allocating a buffer . . . to cache” a portion of the SM object, and that the specification explains that “the ring buffer . . . operates as a type of short term cache” because it is capable of servicing multiple client requests within a certain time interval (emphasis added).
Takeaway
· Claim construction: The applicants’ statement during the prosecution may play a critical role for claim construction if the claim language and specification do not establish a truly plain meaning of a disputed term contrary to the meaning assertedly established by the prosecution history.
· Summary Judgment: Portions of the specification may provide genuine issue of material fact for denial of summary judgment (in this case, the embodiment describes buffers and caches in different locations while the disputed claim provides “allocating a buffer . . . to cache”)
Inventor’s Own Provisional Application Can Be Prior Art Against Inventor’s Own US National Stage Application
| June 10, 2022
Konda v. Flex Logix Technologies, Inc.
Decided: May 6, 2022
per curiam: Taranto, Clevenger, Chen (May 6, 2020).
Summary:
In Flex Logic’s inter partes reviews (IPRs), the PTAB agreed with Flex Logic in that the ‘605 PCT and the ‘394 Provisional application did not support the challenged claims of the ‘523 patent, and therefore, the ‘523 patent could not benefit from the earlier filing dates of the ‘605 PCT and the ‘394 Provisional application and that the ‘523 patent benefited only from its filing date of November 22, 2009. The PTAB agreed that a prior art ‘756 PCT publication (another one of Konda’s earlier patent applications published on September 12, 2008) and the ‘394 provisional application (that was incorporated by reference into the ‘756 PCT) rendered all the challenged claims unpatentable. The only issue on appeal was whether the ‘394 Provisional is publicly available to qualify as prior art. The Federal Circuit held that Konda’s US ‘394 Provisional application that is incorporated by reference in a publicly available publication of a PCT application is “publicly available” as prior art under pre-AIA 35 USC §102(b).
Background:
Konda’s US Patent No. 8,269,523 issued from US patent application s/n 12/601,275 (the ‘275 application) filed November 22, 2009. The ‘275 application is the national phase entry of PCT application no. PCT/US2008/064605 (the ‘605 PCT) filed May 22, 2008. The ‘275 application also claimed priority back to Provisional application no. 60/940,394 (the ‘394 Provisional) filed May 25, 2007. Flex Logic’s IPRs relied upon WO 2008/109756 (the ‘756 PCT) and the ‘394 Provisional as prior art against the challenged claims of the ‘523 patent. The ‘756 PCT is another one of Konda’s earlier patent applications that incorporated by reference the ‘394 Provisional. The ‘756 PCT was published on September 12, 2008.
Procedural History:
Two inter partes reviews (IPRs) were filed by Flex Logic, addressing different sets of claims in Konda’s US Patent No. 8,269,523 (the ‘523 patent). The PTAB’s Final Decision in the consolidated IPRs found that the ‘605 PCT and the ‘394 Provisional applications did not have support for the claims of the ‘523 patent as required by 35 USC §112. Accordingly, the ‘523 patent only benefited from its filing date of November 22, 2009. The PTAB also found that all the challenged claims to be unpatentable as being anticipated or obvious over the ‘756 PCT published on September 12, 2008 and the ‘394 provisional application that was incorporated by reference into the ‘756 PCT. The only issue on appeal to the Federal Circuit was whether the ‘394 Provisional was publicly available to qualify as prior art under pre-AIA 35 USC §102(b).
Relevant Statute and Rules:
35 U.S.C. 122(a):
(a) CONFIDENTIALITY.— Except as provided in subsection (b), applications for patents shall be kept in confidence by the Patent and Trademark Office and no information concerning the same given without authority of the applicant or owner unless necessary to carry out the provisions of an Act of Congress or in such special circumstances as may be determined by the Director
37 CFR 1.14(a)(1)(vi):
(vi) Unpublished pending applications (including provisional applications) that are incorporated by reference or otherwise identified. A copy of the application as originally filed of an unpublished pending application may be provided to any person, upon written request and payment of the appropriate fee (§ 1.19(b)), if the application is incorporated by reference or otherwise identified in a U.S. patent, a statutory invention registration, a U.S. patent application publication, an international publication of an international application under PCT Article 21(2), or a publication of an international registration under Hague Agreement Article 10(3) of an international design application designating the United States. The Office will not provide access to the paper file of a pending application, except as provided in paragraph (c) or (i) of this section.
37 CFR 1.14(c):
(c) Power to inspect a pending or abandoned application. Access to an application may be provided to any person if the application file is available, and the application contains written authority (e.g., a power to inspect) granting access to such person. The written authority must be signed by:
(1) The applicant;
(2) A patent practitioner of record;
(3) The assignee or an assignee of an undivided part interest;
(4) The inventor or a joint inventor; or
(5) A registered attorney or agent named in the papers accompanying the application papers filed under § 1.53 or the national stage documents filed under § 1.495, if a power of attorney has not been appointed under § 1.32.
Decision:
There is no dispute that the ‘756 PCT is an international patent application that incorporated by reference the ‘394 Provisional application, thereby meeting the requirements of 37 CFR 1.14(a)(1)(vi) for public accessibility to the ‘394 Provisional application.
Konda relied on the last sentence of 37 CFR 1.14(a)(1)(vi) whereby “The Office will not provide access to the paper file of a pending application, except as provided in paragraph (c) or (i) of this section.” And, Konda did not provide any written authority pursuant to 37 CFR 1.14(c) to provide access the ‘394 Provisional application. Konda also relied on MPEP 103(VII) (8th ed., rev. July 7, 2008) stating that access to provisional applications “will only be given to parties with written authority from a named inventor, the assignee of record, or the attorney or agent of record.”
However, the Federal Circuit noted the last sentence of 37 CFR 1.14(a)(1)(vi) pertains only to access to the “paper file” of the pending application, which the Federal Circuit interprets to mean the “whole file history,” which the regulation clearly distinguishes from the “application as originally filed.” It is the “application as originally filed” to which 37 CFR 1.14(a)(1)(vi) grants public accessibility when that “application as originally filed” was incorporated by reference in a PCT application. The last sentence of 37 CFR 1.14(a)(1)(vi) and 37 CFR 1.14(c) do not apply to the “application as originally filed.” There was no need for Konda’s written authorization to access that “application as originally filed.”
As for the MPEP, the court noted that the MPEP “does not have the force of law.” The court also noted that MPEP 103 further stated that provisional applications were “also available in the same manner as any other application” “thereby permitting the access authorized under 37 CFR 1.14(a)(1)(vi).”
Takeaways:
- If, following the inventor’s incorporation by reference preferences, the ‘605 PCT in the subject ‘523 patent family incorporated by reference the ‘756 PCT, perhaps 112 support could have been argued for the ‘523 claims. Nevertheless, as can be appreciated from the result of this case (an inventor’s own provisional application was used as prior art against his own national stage application!), applicants must be careful when incorporating by reference applications from a different patent application family.
- In the PTAB’s Final Decision, the entire 112 support discussion is premised on case law regarding entitlement to the benefit of the filing date of an earlier filed application only if the disclosure of the earlier filed application provides support for the claims of the later application. And, somehow, the national stage application of an international PCT application is only accorded the benefit of its “filing date” of the national stage ‘275 application. However, the international ‘605 PCT application is not “an earlier filed application” from the national stage application thereof. As noted in MPEP 1893.03(b):
An international application designating the U.S. has two stages (international and national) with the filing date being the same in both stages. Often the date of entry into the national stage is confused with the filing date. It should be borne in mind that the filing date of the international stage application is also the filing date for the national stage application.
Pursuant to 35 USC 363:
An international application designating the United States shall have the effect, from its international filing date under Article 11 of the treaty, of a national application for patent regularly filed in the Patent and Trademark Office.
Similarly, PCT Article 11(3) provides that…
an international filing date shall have the effect of a regular national application in each designated State as of the international filing date, which date shall be considered to be the actual filing date in each designated State.
Here, the ‘275 national stage application appears to be identical to the ‘605 PCT application. Nevertheless, this issue was never challenged before the PTAB nor the Federal Circuit.
Tags: Earliest effective date > Incorporation by reference > PCT application > Publicly available as prior art
TRANSACTIONS WITHOUT PRIMARY EXPERIMENTAL-USE PURPOSE DO NOT INSULATE FROM THE ON-SALE BAR
| June 3, 2022
Sunoco Partners Marketing & Terminals L.P., v. U.S. Venture, Inc., U.S. Oil Co., Inc.
Decided: April 29, 2022
Before PROST, REYNA, and STOLL, Circuit Judges.
Summary
The Federal Circuit affirmed in part, reversed in part, vacated in part, and remanded judgement of the United States District Court for the Northern District of Illinois regarding patent infringement. In one of the decisions, the Federal Circuit overturned a district court judgment on some of Sunoco’s claims insulating from the on-sale bar.
Background
Sunoco Partners Marketing & Terminals L.P. (“Sunoco”) sued U.S. Venture, Inc. and U.S. Oil Co., Inc. (collectively, “Venture”), alleging that Venture’s operation butane-blending systems infringed claims of U.S. Patent Nos. 7,032,629 (“the ’629 patent”), 6,679,302 (“the ’302 patent”), 9,494,948 (“the ’948 patent”), and 9,606,548 (“the ’548 patent”) owned by Sunoco.
The patents claimed systems and methods that are directed to blending butane into gasoline before the end chain of distribution. Butane blended with gasoline has some advantages: butane’s volatility helps cars start more easily at low temperatures, and butane is cheaper than gasoline. However, since butane causes air pollution when burned in warm climate, the Environmental Protection Agency (EPA) established regulations on butane blending. Sunoco’s patented technology seeks to maximize butane content while complying with EPA’s (U.S. Environmental Protection Agency) regulations.
The district court ruled on various summary judgment motions and sided with Sunoco in a bench trial to affirm the award of $2 million in damages, later trebled to $6 million.
Discussion
Venture appealed the district court’s decision on (I) rejection of its on-sale-bar defense, (II) determination that it infringed two patents, (III) construction of two claim terms, and (IV) decision to enhance damages. On cross-appeal, Sunoco challenged the district court’s decision not to grant lost-profits damages and its reasonable-royalty award.
The discussion is focused on the topic of on-sale-bar. Venture’s on-sale-bar defense, if successful, would invalidate some claims in two of Sunoco’s patents. The “on-sale-bar” provides the principle that “no person is entitled to patent an ‘invention’ that has been ‘on sale’ more than one year before filing a patent application” (i.e., before the critical date). “On sale” defined by the courts should meet two criteria that the invention is both “the subject of a commercial offer for sale” and “ready for patenting.” Pfaff v. Wells Elec’s., Inc., 525 U.S. 55 (1998). In addition, the on-sale bar can be negated if the patent owner demonstrates that the sale qualifies as “primarily for purposes of experimentation.”
The inventor’s company (MCE) offered to sell and install a butane-blending system to Equilon on February 9, 2000, two days before the critical date. The agreement indicated that Equilon would not pay anything for the machine, but would agree to purchase at least 500,000 barrels of butane from MCE over the next 5 years. The district court found that the equipment was being given away since “the contract did not require Equilon to pay MCE anything in exchange for the system in the normal course of events.” The district court later determined that Sunoco’s systems were sold for experimental-use purposes rather than commercial purposes. However, the Federal Circuit disagreed and opined that the sale “agreement bears ‘all the hallmarks of a commercial contract for sale.’”
The Federal Circuit states that “the agreement begins by expressly describing the transaction as a sale, without reference to any experimental purpose” as recited in the agreement:
MCE agrees to sell to Equilon, and Equilon agrees to purchase, the Equipment (as hereinafter defined) along with a license to use certain technology and software owned by MCE pertaining to the computerized blending of Butane and gasoline stocks, in consideration for the purchase and sale of Butane as set forth herein.
The section of the agreement characterized the sale’s commercial purpose and indicated that “MCE already ‘developed’ the relevant technology and equipment, that Equilon wanted to purchase it, and that MCE was willing to sell it, install it, and supply butane for it.”
Sunoco argued that a primarily experimental purpose is a section of the agreement entitled “Equipment Testing” including two sets of testing: pre-installation testing and post-installation testing. Sunoco drew an analogy to the Supreme Court’s seminal City of Elizabeth case. However, the Federal Circuit pointed out that “the nature of a street pavement,” the invention in the case of the City of Elizabeth, “is such that it cannot be experimented upon satisfactorily except on a highway, which is always public,” City of Elizabeth, 97 U.S. at 134. The Federal Circuit found that the testing was not done by Equilon but a third party. Sunoco also acknowledged that the test could have been done at any time prior to entering the deal with Equilon in January of 2000.
For the posit-installation testing, the section of the agreement states:
Upon completion of installation of the Equipment, MCE shall provide Equilon with written notice of such completion. Within three (3) days of said notice, Equilon shall (i) make all necessary arrangements within the Terminal to enable MCE to test the Equipment to determine whether the Equipment is properly blending butane, and (ii) provide notification to MCE that said arrangements have been made. MCE shall test the Equipment according
to parameters set forth in Schedule 1.10. MCE shall proceed with testing in a timely manner and have a period not to exceed ninety (90) days from the date of said notification by Equilon to complete its testing.
The Federal Circuit found that the post-installation tests were also not experiments, but are acceptance tests to confirm that the equipment “is properly blending butane”—that is, that it is working as promised. It further noted that there was no objective evidence that supported a conclusion that the “primary purpose” of the sale was “to conduct experimentation.”
The Federal Circuit further noted that the district court should have considered “whether the invention was under development, subject to testing, or otherwise still in its experimental stage at the time of the asserted sale.” But that consideration is not the question of Pfaff prong 1. The district court’s “still under development” observation would be better considered at Pfaff prong 2.
Therefore, the Federal Circuit reversed the district court’s experimental-use determination and remand the district court to assess whether the invention was “ready for patenting.”.
Takeaway
- Transactions without primary experimental-use purpose do not insulate from the on-sale bar.
