Recapture Applies under 35 U.S.C. 101
Stephen G. Adrian | 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
Andrew Melick | 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
Fumika Ogawa | 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.
Adele Critchley | 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.
