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.
