Providing a Detailed Explanation of the Evidence

by Dennis Crouch

The decision in Parus Holdings, Inc. v. Google LLC, — F.4th — (Fed. Cir. 2023), underscores the importance of adhering to the PTAB procedural requirements, particularly the prohibition against incorporating arguments by reference from one document into another during an IPR, as stipulated in 37 C.F.R. § 42.6(a)(3). The court’s affirmation of the PTAB’s decision not to consider arguments and evidence that violated this rule sends a clear message to future litigants: all arguments must be explicitly presented in the briefs, and the PTAB is not obligated to consider evidence or arguments that are not properly presented.

During the IPR the patentee (Parus Holdings) made a number of arguments  supporting the validity of the challenged claims.  Relevant for this appeal was its attempt to provide evidence showing it was the first to make the claimed invention, antedating the prior art. However, the PTAB declined to consider Parus’s arguments and evidence because of the procedural approach taken by the patentee. the substance of those arguments were made within several declarations, but not actually within the briefs. Rather, the briefs merely incorporated those arguments by-reference into its Response and Sur-reply briefs.  The problem, PTAB practice rules prohibit incorporation by reference. 37 C.F.R. § 42.6(a)(3).

(3) Incorporation by reference; combined documents. Arguments must not be incorporated by reference from one document into another document. Combined motions, oppositions, replies, or other combined documents are not permitted.

Id.

On appeal, the Court of Appeals for the Federal Circuit affirmed the PTAB’s decision. The court agreed that the PTAB was correct in disregarding Parus’s arguments that were in violation of the rule (no abuse of discretion).  The court also disagreed with Parus’s argument that the PTAB should have considered all record evidence, regardless of how it was presented. The justification here is that the PTAB is restricted to deciding cases on arguments that advanced by a party and to which the opposing party was given a chance to respond. Allowing subtle incorporation by reference raises potential confusion on these issues.  The court further noted that Parus had almost 3,000 unused words in its Patent Owner Response and could have sought leave to exceed its word count under 37 C.F.R. § 42.24(a)(2) or reallocated more of its briefs to that argument, but chose not to use the avenues available to it.  The result then is that the reference qualifies prior art and the obviousness holding stands.

In the case, the court noted that the patentee had an increased burden in this instance because it was not simply rebuffing claims from a patent challenger, but affirmatively asserting a pre-filing priority date.

When I look at the briefs, it looks awfully close to sufficient arguments.  The following comes from the briefs by the patentee:

The inventors conceived of the claimed subject matter before Kovatch’s January 4, 2000 U.S. priority filing date. . . .

Here, the source code, documents, and testimony show that at least by July 12, 1999, Alexander Kurganov, and Valery Zhukov conceived of and invented the claimed subject matter while working on the web-based upgrades to the Webley Assistant. Kurganov Decl. at ¶ 13. . . .

As shown through Alexander Kurganov’s testimony, which is corroborated by the time-stamped source code, emails documents, and the testimony of Paul Mulka and Benedict Occhiogrosso, the inventors conceived of the subject matter no later than July 12, 1999. Following conception, the inventors were reasonably and continuously diligent as the Webley Assistant enhancements was the only project they were working on at Webley and they were employed full-time. The evidence produced in Mr. Kurganov’s declaration, along with the accompanying exhibits, demonstrate that the enhancements to the Webley Assistant reduced the ’431 and ’084 inventions to practice in a prototype no later than December 31, 1999, five days before Kovatch’s earliest filing date of January 4, 2000.

To the extent that it is argued that the ’431 and ’084 inventions were not reduced to a prototype until January 7, 2000, the date the last source code file was added to the source code revision system, the inventors worked diligently to reduce the invention to practice from the critical date of January 4, 2000, until the grammar file was entered into the source code revision system on January 7, 2000. See Ex. 2059, Occhiogrosso Dec. at ¶¶ 44-91; Ex. 2060, Mulka Dec. at ¶¶ 1-6; Ex. 2020, Kurganov Dec. at ¶¶ 103-119.

. . . To show diligence during this short period, Patent Owner relies on the source code revision logs and emails, as well as the testimony of Paul Mulka. The source code revision logs and Paul Mulka’s testimony shows that from December 1999 to early January 2000, the inventors were employed full-time on the Webley Assistant project, and every file, or file modification they committed to the source code revision system, was for the Webley Assistant project. Accordingly, the activity represented by these source code revision logs exceeds the reasonable diligence required.

On appeal, the court apparently concluded that the citations here were not specific enough.

The burden of production cannot be met simply by throwing mountains of evidence at the Board without explanation or identification of the relevant portions of that evidence. One cannot reasonably expect the Board to sift through hundreds of documents, thousands of pages, to find the relevant facts.

Slip Op.  The court explained that a “detailed explanation of the evidence” is required under the rule, and this does not suffice.

===

NOTE – the court cites to 37 C.F.R. § 42.44, as requiring a “detailed explanation of the evidence.” However, that provision does not appear to be part of the Federal Regulation.  The court has not previously required this level of explanation within the briefing.

= = =

U.S. Patent 7,076,431 and U.S. Patent 9,451,084.

The Supreme Court to Decide if Trump is Too Small

Guest Post by Samuel F. Ernst[1]

As Dennis reported, the Supreme Court has granted certiorari in the case of Vidal v. Elster to determine if the PTO violated Steve Elster’s First Amendment right to free speech when it declined to federally register his trademark TRUMP TOO SMALL in connection with T-shirts. The PTO had denied registration under 15 U.S.C. § 1052(c), which provides that a mark cannot be registered if it “[c]onsists of or comprises a name, portrait, or signature identifying a particular living individual except by his written consent.” In February, the Federal Circuit held that this provision is unconstitutional as applied to TRUMP TOO SMALL, a mark intended to criticize defeated former president Donald Trump’s failed policies and certain diminutive physical features.[2] The Federal Circuit held that, as applied to marks commenting on a public figure, “section 2(c) involves content-based discrimination that is not justified by either a compelling or substantial government interest.”[3] The question presented before the Supreme Court is “[w]hether the refusal to register a mark under Section 1052(c) violates the Free Speech Clause of the First Amendment when the mark contains criticism of a government official or public figure.”

Under the Supreme Court’s precedent in Matal v. Tam and Iancu v. Brunetti, the Federal Circuit’s decision was almost certainly correct.[4] Unlike the provisions at issue in those cases, which barred the registration of disparaging, immoral, and scandalous marks, section 1052(c) does not discriminate based on the viewpoint expressed; it bars registration of a famous person’s name whether the mark criticizes praises or is neutral about that person. But the provision does discriminate based on content, because it bars registration of marks based on their subject matter. The Supreme Court has held that “a speech regulation targeted at specific subject matter is content based even if it does not discriminate among viewpoints within that subject matter.”[5] Even though viewpoint discrimination “is a more blatant and egregious form of content discrimination,” both viewpoint discrimination and content-based discrimination are subject to strict scrutiny.[6] Even if we view trademarks as purely commercial speech – an issue the Supreme Court has never decided – laws burdening such speech are subject to at least the intermediate scrutiny of Central Hudson, which is the level of scrutiny the Federal Circuit applied in finding section 1052(c) unconstitutional as applied to TRUMP TOO SMALL.

To survive the Central Hudson test, section 1052(c) must advance a substantial government interest and be narrowly tailored to serve that interest.[7] The government argues that the provision advances a government interest in protecting the right of publicity of public figures from having their names used in trademarks without their consent. However, even if the government has a substantial interest in protecting the state right of publicity, the provision is not narrowly tailored to serve that interest. This is because every state’s right of publicity law incorporates some sort of defense to protect First Amendment interests,[8] and “recogniz[es] that the right of publicity cannot shield public figures from criticism.”[9] But the PTO takes no countervailing interests into account before denying registration to a mark under Section 1052(c). The PTO merely inquires into whether “the public would recognize and understand the mark as identifying a particular living individual” and whether the record contains the famous person’s consent to register the mark.[10] Accordingly, section 1052(c) is unconstitutionally overbroad because it burdens speech that the right of publicity would not burden. The provision is therefore far more extensive than necessary to serve the government’s purported interest and is facially unconstitutional.

A peculiar aspect of the Supreme Court’s First Amendment jurisprudence in the context of trademark registration is that a trademark registrant is not only asserting a right to free speech, but also to obtain an exclusionary right to prevent others from using the same speech in commerce (at least to the extent it would cause consumer confusion). In other words, if we are concerned with burdening Elster’s right to proclaim that Trump is too small, it is odd to remedy that concern by giving him a right to prevent others from saying the same thing. Section 1052(c) is not equipped to deal with this larger concern with marks containing political commentary because it only prevents the registration of marks by persons other than the named political figure, and only if they contain the name of that political figure. Outside of this narrow context, the Lanham Act can do great harm to free political speech because it allows for the federal registration of all manner of marks containing pollical commentary. Anyone can register a mark containing political commentary so long as it does not name the political figure without her consent. And politicians are free to register marks making political commentary whether or not they contain their own names. For example, the Trump Organization has a federal registration for the mark MAKE AMERICA GREAT AGAIN.[11] This grant of a federal registration does more harm to free speech than the denial of any registration would, because it allows the trademark holder to prevent others from making the same political comment in commerce to the extent it would result in a likelihood of confusion (or to the extent they are unwilling to incur the expense of defending against a federal lawsuit).

This raises a broader critique of the Supreme Court’s rigid approach to the First Amendment. The Court deals in inflexible categories of scrutiny that focus solely on the rights of the speaker (in these cases, the trademark registrant), without considering how the absolute protection of those rights might affect the speech rights of others. For example, in Boy Scouts of America v. Dale, the Court decided that the First Amendment rights of the Boy Scouts were violated by a New Jersey law requiring it to rehire a gay scoutmaster it had fired.[12] But the Court did not consider how the Boy Scouts’ assertion of their First Amendment rights affected the rights of the fired scoutmaster or of other New Jersey employees to publicly express their sexual orientation without fear of being fired. And in Citizens United, the Court vindicated the First Amendment rights of private corporations to support political candidates without considering how the resulting flood of corporate political propaganda could drown out the speech of less powerful private citizens.[13] The trademark registration cases put this issue in stark relief, because in protecting the rights of the trademark registrant to say scandalous, immoral, disparaging, or political things, the Court utterly fails to consider the ways in which the resulting rights of exclusion might prevent other people from saying the very same things. This was the point Justice Breyer made in his Brunetti concurrence, where he argued that “[t]he First Amendment is not the Tax Code.”[14] Rather than focusing on inflexible, outcome-determinative categories, he urged the Court to adopt a balancing test: “I would ask whether the regulation at issue works speech-related harm that is out of proportion to its justifications.”[15] Even under such a test, section 1052(c) would likely not survive, because it is far broader than its purported justification to protect the right of publicity. But such an approach would at least allow the Supreme Court to consider in these trademark registration cases that it is not only protecting a right to speak, but a right to exclude others from speaking.

Several prominent scholars have argued that the PTO could prevent the registration of political commentary marks under the “failure to function” doctrine.[16] The Lanham Act’s definition of a “trademark” requires that a trademark must be “used by a person to identify and distinguish that person’s goods from those of others and to indicate the source of the goods, even if that source is generally unknown.”[17] The argument is that political commentary marks are not perceived by the public as source indicators, but, rather, as political commentary. Under the failure to function doctrine, the PTO has denied registration to EVERYBODY VS RACISM and ONCE A MARINE, ALWAYS A MARINE.[18] Denying registration to political commentary marks under this doctrine might not violate the First Amendment because it is clearly a legitimate trademark policy to regulate interstate commerce. However, this issue is not before the Supreme Court in the Elster case because failure to function was not a basis for the denial of registration of TRUMP TOO SMALL in the PTO. In any event, the constitutionality of section 1052(c) cannot be saved by the failure to function doctrine because that has never been the government’s asserted justification for the provision, and because in that context too, the provision would be unconstitutionally overbroad insofar as it would bar the registration of marks containing the names of famous persons that do operate as source indicators.

While predicting the outcome of a Supreme Court case is always hazardous, it appears that if the Court is to follow its own First Amendment precedent, it must either declare section 1052(c) facially unconstitutional or formulate a test for the PTO to apply similar to the First Amendment defenses to the right of publicity, such that a substantial number of the statute’s applications do not violate free speech. (more…)

Apple v. Vidal: A Case for the Supreme Court on USPTO Discretionary Denial

Apple Inc. v. Vidal (Supreme Court. 2023)

Under former director Iancu, the USPTO created a set of guidelines allowing the PTAB to deny IPR institution even in situations where the challenger raises strong challenges.  These discretionary denials are known as Fintiv guidelines based upon the precedential case of Apple Inc. v. Fintiv, Inc., IPR2020-00019 (P.T.A.B. 2020).  The statute appears to provide the USPTO Director with discretion in at least two key ways: (1) The statute does not expressly require institution but rather sets the reasonable-likelihood of success as a minimum threshold for granting institution. (2) The statute also indicates that the decision of whether to issue is non-appealable, suggesting a discretionary approach.

A group of five large companies led by Apple then sued the USPTO in the N.D. Cal. — arguing that the discretionary denials were in violation of the Administrative Procedure Act (APA).  These five companies all regularly face patent infringement allegations and want a smoother path to invalidating the claims via IPR and PGR.

The district court dismissed the APA case and that was largely affirmed on appeal (although the Federal Circuit did ding the USPTO for failing to follow notice-and-comment procedure).  See, Jordan Duenckel, IPRs and the APA: Review of Director’s Discretion to Initiate IPRs, Patently-O (March 15, 2023).

In a recent filing, the plaintiffs have indicated that they are planning to petition the Supreme Court to hear the case.  The new filing is a request for extension of time until August to file the petition for writ of certiorari.

In the background, Dir Vidal has moved forward with her Advance Notice of Proposed Rulemaking (ANPRM) for potential PTAB reforms that place some limits on discretionary denials, but not to the extent Apple would like. The forthcoming brief is likely argue that the Federal Circuit’s ruling has led to the PTO signaling interest in adopting rules that would contradict the America Invents Act (AIA) and that fail to adequately address concerns.

Meanwhile, comments on the ANPRM are due June 20, 2023.

Has Trademark Law Become a Parody?

by Dennis Crouch

The Supreme Court recently issued its pro-trademark-owner opinion Jack Daniel’s Properties, Inc. v. VIP Products LLC and unanimously vacated the Ninth Circuit favoring the accused comedic copycat.  Justice Kagan delivered the opinion of the Court with concurring opinions from both Justice Sotomayor and Justice Gorsuch.  The holding is that the First Amendment does not require any special scrutiny in cases where the accused activity is “the use of trademarks as trademarks.” Rather in this use-as-a-mark situation, standard principles of trademark law apply.  The court offered the possibility (but did not decide) that a heightened situation could still apply in other situations such as use of another’s mark as artwork or for criticism, etc.

VIP’s dog toy resembles a Jack Daniel’s whiskey bottle, with several allegedly humorous alterations. Jack Daniel’s Properties, which owns the trademarks, demanded VIP stop selling the toy, leading to VIP seeking a declaratory judgment that their product neither infringed nor diluted Jack Daniel’s trademark rights. The District Court sided with the mark holder after concluding that VIP product used Jack Daniel’s features to identify the source of their own products. On appeal, the Ninth Circuit reversed, applying the Rogers test, which provides a heightened scrutiny in situations where a trademark is being wielded against “expressive elements” protectable under the First Amendment.  See Rogers v. Grimaldi, 875 F. 2d 994 (2nd Cir. 1989). After a bit more procedure, the case eventually reached the Supreme Court on a question focusing on the Rogers test.   The court attempted to issue a somewhat narrow holding:

Without deciding whether Rogers has merit in other contexts, we hold that it does not [require any threshold requirement] when an alleged infringer uses a trademark in the way the Lanham Act most cares about: as a designation of source for the infringer’s own goods.

Slip Op.  Here, the court found that VIP’s use of the mark was as a source identifier.  What this mean is that VIP does not have an extra special First Amendment excuse.  However, standard trademark law already has some free speech outlet valves, such as the exception for parody.  The Supreme Court remanded the case to the lower courts to consider whether VIP’s “effort to ridicule Jack Daniel’s” offer an excuse in the “standard trademark analysis.”

Trademark law includes a special cause of action for big players with “famous marks” under the doctrines of dilution and tarnishment.  The trademark statute includes a fair-use exception, but it only applies in situations where the accused dilution/tarnishment is a use “other than as a designation of source.” This is a narrower exception that that available based upon judge-made law in traditional  trademark infringement cases.  And, the Supreme Court decided to stick with the statute — with the holding here that the VIP cannot claim fair use for the dilution/tarnishment because its use of the JD mark was as its own source identifier.

Critically, the [statutory] fair-use exclusion [for dilution] has its own exclusion: It does not apply when the use is “as a designation of source for the person’s own goods or services.” §1125(c)(3)(A). In that event, no parody, criticism, or commentary will rescue the alleged dilutor. It will be subject to liability regardless.

Id.  This is a powerful boon to those already in power.

Justice Kagen’s opinion was for the unanimous court. However, 5 of the justices also signed one of the concurring opinions.

Justice Sotomayor, joined by Justice Alito, joined the majority opinion but wrote separately to emphasize the need for caution in the context of parodies and other uses implicating First Amendment concerns. She highlighted the potential risk in giving uncritical or undue weight to surveys in alleged trademark infringement cases involving parody. She argued that surveys should be understood as merely one piece of the multifaceted likelihood of confusion analysis and that courts should carefully assess the methodology and representativeness of surveys.

Justice Gorsuch, joined by Justices Thomas and Barrett, also joined with the majority opinion. Gorsuch wrote separately to underscore that lower courts should handle Rogers v. Grimaldi, with care. He noted that the Court’s decision leaves much about Rogers unaddressed, including where the Rogers test comes from and whether it is correct in all its particulars. He urged lower courts to be attuned to these unresolved issues.

Tune In Next Term for More on TM/Speech: The Supreme Court recently agreed to hear the case of In re Elster, which involves a California lawyer, Steve Elster, is seeking to trademark the phrase “Trump too small,” a reference to a taunt from Senator Rubio during the 2016 presidential campaign. Elster’s intent was to use the phrase on T-shirts to convey a message that he believed some aspects of President Trump (as well as his policies) were diminutive. However, the USPTO rejected the application, citing the prohibition on registering marks that identify a particular living individual without their written consent. The Federal Circuit ruled in favor of Elster — effectively following the Supreme Court’s prior cases of Tam and Brunetti and holding denial of registration as a free-speech violation. The Gov’t’s petition to the Supreme Court argued that Elster is different than Tam or Brunetti for a couple of important reasons: (1) the prohibition on registering another person’s name is an effective protection of competing rights of privacy / publicity held by the other person; and (2) the prohibition is viewpoint-neutral and therefore should be reviewed with less scrutiny.

Court Finds that it would be Inconvenient for Major Multinational Corporation (Microsoft) to Litigate in Texas

by Dennis Crouch

In the recent case of In re Microsoft, 23-128 (Fed. Cir. 2023), the Federal Circuit once again granted a writ of mandamus, ordering a patent infringement case to be transferred out of Judge Albright’s courtroom in the Western District of Texas (WDTX). This decision was made under the provisions of 28 U.S.C. § 1404(a), which allows for the transfer of cases for the convenience of the parties and in the interest of justice.

Microsoft, a multinational corporation with a significant presence in many U.S. states, including Texas, is no stranger to litigation in the Lone Star state. The company’s substantial business activities in Texas, which include marketing, selling, and servicing the accused products, did not significantly impact the 1404(a) jurisprudence in this case.

In 2022, Virtru Corporation sued Microsoft for infringing three of its data privacy patents: US8589673, US8874902, and US9578021. Microsoft sought to transfer the case to the Western District of Washington (WDWA) under § 1404(a), citing its incorporation and headquarters in Washington, the location of the accused technology’s development, and the absence of relevant operations by either party in WDTX.

The Judge Albright denied the motion, concluding that while access to sources of proof and local interest slightly favored transfer, administrative difficulties due to court congestion disfavored it. The district court found 27 Microsoft employees in WDWA who were potential witnesses, but it deemed the willing witness factor neutral because Virtru had identified eight potential party witnesses more conveniently located near (but not in) WDTX.

In the § 1404(a) mandamus context, the appellate court reviews only for clear abuses of discretion that produce patently erroneous results. The decision of whether to transfer a case is committed to the district court’s discretion, but the district court should transfer when a movant demonstrates that the transferee forum is clearly more convenient.

The appellate panel concluded that Judge Albright’s denial of transfer was patently erroneous. It noted a clear abuse of discretion in the district court’s assessment of the convenience of potential witnesses. The appellate court concluded that the center of gravity of the action was clearly in the WDWA, where the majority of potential witnesses with relevant and material information resided, where accused product features were researched, designed, and developed, and where physical evidence was located. The court granted the petition, vacated the district court’s order denying transfer, and directed the district court to grant the transfer motion.

Nike’s Patent Saga Highlights Controversial PTAB Practices

by Dennis Crouch

The pending petition in Nike v. Adidas asks the Supreme Court whether it is proper for the Patent Trial & Appeal Board (PTAB) to raise sua sponte new grounds of unpatentability against a substitute claim added during an inter partes review proceeding. The government, as a respondent in this case, argues that the PTAB can create its own reasons for rejecting newly-added claims so long as the patent owner is given sufficient notice and a chance to respond.

However, the case intrigue has recently heightened due to a somewhat chaotic saga involving the PTAB. Key figures involved include former PTAB Chief Judge Ruschke, current Chief Judge Boalick, and Judge Michael Fitzpatrick, who was recently justified as a wronged-whistleblower.

nike shoe

The Supreme Court petition was submitted amidst revelations of secretive maneuvers within the Board. These questionable practices include an abrupt panel expansions and judge replacement without notifying involved parties. Specifically, in the Nike v. Adidas IPR, the Board panel was first expanded to include Chief Judge Ruschke and then Deputy Chief Judge Boalick after all parties had finished their arguments and opinion writing had begun. The process also witnessed the replacement of Judge Fitzpatrick after he expressed discontent over the panel’s expansion, prompting his removal from all America Invents Act (AIA) cases.

Judge Fitzpatrick’s ousting ignited a legal battle against the USPTO, which recently concluded with a victory for Fitzpatrick at the Merit Systems Protection Board (MSPB). Fitzpatrick alleged that the USPTO had manipulated the inter partes review process in the Nike v. Adidas case, inappropriately expanding the PTAB review panel and delaying the final decision. Furthermore, Fitzpatrick’s whistleblowing disclosures extended beyond the PTAB, unearthing a misrepresentation by the Solicitor General to the Supreme Court regarding the frequency of expanded panels during the Oil States proceedings. In briefing in the case, the Solicitor General recently apologized to the Supreme Court, expressing regret for the unintended misinformation.  The SG’s brief indicates that they only recently learned of the underlying drama.

In light of these troubling revelations, the Solicitor General suggests the Supreme Court grant, vacate, and remand Nike v. Adidas, offering the petitioner a chance to present arguments based on this new information to the Federal Circuit, and allowing the Federal Circuit to consider these points in the first instance.

Interestingly, this practice of unannounced judge replacements parallels the Federal Circuit’s tactics in the infamous Novartis case. Although the Adidas name is still on the case, the company has formally requested not to be involved in the appeal, citing a settlement reached with Nike.

 

Judge Newman on Saving Patent Law

by Dennis Crouch

Washington Post has published a long article titled, “Colleagues want a 95-year-old judge to retire. She’s suing them instead,” by Rachel Weiner.  Judge Pauline Newman, the oldest active federal judge in the country, has been embroiled in controversy as she resists her colleagues attempts to urge/force her to retire. The article ends with a noteworthy quote from Newman that rings true to her characteristic resilience and dedication: “I want to spend my last five years correcting my colleagues’ mistakes.” In a career spanning four decades and more than 300 dissenting opinions, Newman’s resolve is clear.

My own quote in the Washington Post article outlines the complexity of the situation: “Moore’s order says other judges are concerned about Judge Newman’s health; I think that’s real.” I genuinely believe the concerns are rooted in care for Judge Newman, but the issue at hand extends beyond personal sentiments. As a former  Naval engineer, Chief Judge Kimberly Moore is seeking to run a disciplined court.

Weiner reports the details of her in-person interview with Judge Newman in her Lafayette Square office overlooking the White House.

The article cites to my 2022 study of Federal Circuit decisions showing that Judge Newman is the most patentee-friendly judge, with Chief Judge Moore a close 2nd.   Dennis Crouch, Judging Patent Cases, Patently-O (May 4, 2022).

Patently-O Bits and Bytes by Juvan Bonni

Recent Headlines in the IP World:

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Guest Post: Jillian Grennan, Charting New Paths in Innovation: Reflections from Harvard’s Innovation Economics Conference

(Editor’s note: (This post is part of a series by the Diversity Pilots Initiative, which advances inclusive innovation through rigorous research. The first blog in the series is here, and resources from the first conference of the initiative are available here. -Jason)

By: Jillian Grennan, Associate Professor of Finance and Principal, Diversity Pilots Initiative

Recently, I had the privilege of being part of the Junior Innovation Economics Conference at Harvard Business School. This diverse gathering of scholars from fields as varied as management, technology, economics, finance, and public policy delved headlong into the intricate dynamics of invention and innovation policy. Several researchers spoke about issues relevant for better understanding diversity and inclusion in the inventive process and how to improve it. These included: documenting gender disparities in attribution for innovative output, understanding how “opt-in” organizational processes can unlock the innovative potential of engineers from underrepresented groups, and measuring how broader representation can help bring more valuable innovations to market.

Britta Glennon, a researcher exploring the interaction between diversity and corporate strategy, shed new light on the well-documented fact that women publish and patent less than men. The reasons behind these gender disparities remain largely unknown. Could it be an unsupportive work environment, family obligations that take precedence, or simply less productive time use? Britta and her team propose a different angle: that women’s work is often undervalued; hence, female inventors are being deprived of rightful recognition.

Backed by terrific data collection, ranging from large-scale administrative data to surveys and qualitative responses, Britta made a compelling case that this alternative perspective merits our attention.

The evidence shows women are less frequently credited as authors on articles and patents, a pattern echoing historical instances like Rosalind Franklin’s unacknowledged work on the DNA structure and Jennifer Doudna’s worries about diminished recognition in the CRISPR development. It’s important to recognize that such biases might have inadvertently hidden countless female contributions over the years, possibly deterring many from pursuing a scientific career.  In fact, the crux of this research is that women, across nearly all scientific fields and career stages, are significantly under-credited compared to their male counterparts, indicating an attribution bias.  This discovery is especially important because it tells us that overcoming any female productivity deficit requires both the removal of barriers to accomplishment as well as proper attribution.

In that sense, Britta’s work on attribution related to my own research with Colleen Chien, examining engineers’ views on patenting. We discovered that while women are less likely to self-identify as inventors, both genders equally identify as problem-solvers. Could this imply traditional invention disclosure processes that require proactive inventor identification deter women? To probe this further, we implemented three pilot studies within firms, focusing on the impact of opt-out (default participation) vs. opt-in (active selection) systems on patenting disparities. Our findings suggest that, even when accounting for the inventive idea’s quality, altering the invention disclosure process to emphasize default participation can make a significant difference in participation rates for women and first-time inventors.

Another compelling presentation was delivered by Tamar Oostrom, who, alongside Jennifer Kao, is exploring innovation in healthcare markets. They reveal the glaring disparities between clinical trial enrollees and actual disease sufferers in terms of demographic characteristics. For instance, clinical trials for melanoma – a disease predominantly affecting older adults – often enroll much younger patients. By examining expansions in public insurance coverage for clinical trials, they demonstrate how reducing the financial frictions that inhibit enrollment leads to more representative enrollments in terms of age, race, and gender. More importantly, their work raises the question: Can more representative enrollments in clinical trials enhance drug effectiveness and medication adherence? If reducing the costs and hurdles associated with clinical trial enrollment can improve health outcomes, the case for expanding insurance coverage for such trials becomes stronger.

As the conference drew to a close, I was deeply inspired by my fellow scholars’ dedication and the important implications of our collective work. The key takeaways from this event for business and public policy are clear: We need to recognize and value women’s contributions to scientific innovation, ensure clinical trials are representative to avoid distorting health outcomes and consider opt-out mechanisms, where the default expectation is participation, to bridge the innovation gap for underrepresented groups.

The challenges tied to racial and gender equality in intellectual property development are substantial, but the insights from the conference reiterate the power of our collective effort to better understand the mechanisms at work and suggest how business and society can better gain from the innovative potential of everyone.  I left feeling thankful for all the support that the other young scholars and I had received to make our own research possible.

The dialogue at the conference also affirmed that academic-practitioner collaborations work and hold great promise for the future. I encourage those who can to consider initiating their own diversity pilots – it’s a win-win situation. Researchers from the Diversity Pilots Initiative are happy to help you with this. We have expertise in econometric, observational, survey, and other empirical methods and are well-versed in topics from mentoring to inequality in innovation to government policy. And please stay tuned for further updates by emailing us and signing up for DPI research updates.

Questioning Conventionality and Redefining Process in Patent Eligibility Law

by Dennis Crouch

In CareDx v. Natera, an intriguing amicus brief was recently filed by the Honorable Paul Michel (Ret.) and Professor John Duffy in support of the patentee petitioners Stanford and CareDx. The brief advocates for the clarification of patent-eligibility law, and criticizes the Federal Circuit’s handling of the case. The filing of the brief has seemingly prompted the Supreme Court to request a response from the accused infringers, after they initially waived their right to do so. This move reflects some significance of the arguments presented in the brief.  [Read the Brief]

According to Michel and Duffy, the Federal Circuit’s decision in the case overlooked the text of the Patent Act and conflicts with Supreme Court precedent such as Diehr and Cochran v. Deener. They argue that the decision fails to recognize the difference between patent eligibility (under § 101) and patentability (under §§ 102, 103, and 112). They further criticize the decision for an unduly simplified description of the invention that leaves out important details and for improper emphasis on “conventionality.”  The concept of “conventionality” is more appropriately associated with issues of novelty and nonobviousness, as regulated by §§ 102 and 103 respectively, rather than being a key criterion for patent eligibility under § 101.

The brief spends some amount of time focusing on landmark patent cases such as Diehr and Cochrane v. Deener (while rejecting Flook) to illustrate how a process can be patent eligible despite encompassing conventional elements.  And, throughout this argues that the Federal Circuit misunderstood the definition of “process,” which under 35 U.S.C. § 100(b) is defined to include “a new use of a known process.” The brief contends that this definition permits patents on new applications or improvements of known technologies, and that such improvements should be presumed to be patent eligible.  But, the Federal Circuit’s eligibility criteria of “conventionality” prohibits this interpretation even though not rooted in the Patent Act’s text or the Supreme Court’s precedent.

As with other recent eligibility briefs, this one also underscores a need to address confusion and uncertainty surrounding patent eligibility, particularly in relation to biomedical and diagnostic patents.

Now that we’re almost to June, the petition is unlikely to be decided before the recess and instead will be held-over until the fall 2023 before we get a decision on whether the court will grant certiorari.

See, A. Sasha Hoyt, The Impact of Uncertainty Regarding Patent Eligible Subject Matter for Investment in U.S. Medical Diagnostic Technologies, 79 Wash. & L. Rev. 397 (2022)

 

 

 

The Silent Echo: Supreme Court’s Non-Engagement with the Federal Circuit in Amgen v. Sanofi

by Dennis Crouch

Prof. Chris Holman recently characterized Amgen v. Sanofi as an “endorsement of the Federal Circuit’s current interpretation and application of the enablement requirement, and maintenance of the status quo.”  Although I largely align with Holman’s views, I note that the Supreme Court did not explicitly engage with Federal Circuit precedent. More specifically, the Court neither cited nor discussed any Federal Circuit or CCPA decision outside of case-specific historical documents.

The most recent enablement case invoked by the Supreme Court in Amgen is Holland Furniture Co. v. Perkins Glue Co., 277 U. S. 245 (1928). The Court also referenced several other historically significant enablement cases, including Wood v. Underhill, 5 How. 1 (1846); The Incandescent Lamp Patent, 159 U. S. 465 (1895); and Minerals Separation, Ltd. v. Hyde, 242 U. S. 261 (1916). The Court went to lengths to present O’Reilly v. Morse, 15 How. 62 (1854), as an enablement decision, even though in both Alice and Mayo, the court had labeled O’Reilly as an eligibility decision. The approach of Amgen echoes that of the Supreme Court’s 2010 Bilski decision, which advised a simple adherence to established precedents. The only non-Supreme Court decision that Amgen cites is Whittemore v. Cutter, 29 F. Cas. 1120 (C.C.D. Mass. 1813). Notably, Whittemore was adjudicated by Supreme Court Justice Joseph Story while on circuit duty.

In looking at the leading Supreme Court precedent case of Holland Furniture, it is telling that the Federal Circuit has invoked this case only twice – in both instances, for discussions regarding means-plus-function claim interpretation, not enablement. Nevertheless, Holland Furniture remains a crucial decision that precludes (a) genus claims built upon on the disclosure of a single species, as well as (b) genus claims that encompass inoperable species.  The case involved a patent covering starch-based glue.  The Supreme Court explained “an inventor may not describe a particular starch glue which will perform the function of animal glue and then claim all starch glues which have those functions, or even all starch glues made with three parts of water and alkali, since starch glues may be made with three parts of water and alkali that do not have those properties.”  Id.  The Federal Circuit’s failure to rely upon Holland Furniture likely stems from the fact that the case served as the foundation for Walker v. Halliburton that was later rejected by the 1952 Patent Act.

Elephants in the Room: The Federal Circuit has adjudicated numerous biotech enablement cases, providing nuanced analysis, none of which was cited or dissected by the Supreme Court.  Perhaps the simply have a tit-for-tat since the Federal Circuit so rarely cites the Supreme Court in enablement cases. The appellate court’s Amgen decision, for instance, cited many Federal Circuit opinions, but nothing from the Supreme Court.  In many ways, the two courts are simply talking past one another without disagreeing.

A critical case absent from the Supreme Court’s Amgen analysis is In re Wands, 858 F.2d 731 (Fed. Cir. 1988). In Wands, the Federal Circuit introduced a set of factual considerations to assess whether a claim is sufficiently enabled or would necessitate undue experimentation – a key factor is the amount of experimentation required.  In Amgen, these elements were handed to the jury for adjudication as mandated by the 7th Amendment. The jury in Amgen sided with the patentee, deeming the claims enabled. However, this pro-patentee verdict was overturned by the district court on JMOL, a decision subsequently affirmed by both the Federal Circuit and the Supreme Court. In its deliberation, the Supreme Court seems to reassess the Wands factors de novo without acknowledging the jury’s verdict. Intriguingly, the Supreme Court’s opinion finds substantial experimentation necessary, but does not even acknowledge the existence of a jury verdict, simply stating that “both the district court and Federal Circuit sided with Sanofi.” This omission marks a significant oversight by the Court.

While the Supreme Court’s decision in Amgen v. Sanofi seems to generally affirm the current approach of the Federal Circuit to enablement, it lacks any depth of engagement with the nuanced analysis often conducted by the Federal Circuit. In particular, the absence of reference to In re Wands and its eight-factor test, is a surprising omission. Even more disconcerting is the Court’s disregard for the jury’s verdict in the original Amgen trial, reflecting a potential underappreciation of the complexities of patent law and the factual determinations involved. It remains to be seen how this lack of engagement with Federal Circuit precedent may influence future patent law decisions.  Most likely, the Federal Circuit will continue its historic approach implicitly suggested by Prof Holman and continue to ignore the Supreme Court precedent on point.

Guest Post: Piers Blewett, Bridging the Gap: IP Education for All with SLW Academy

Editor’s note: this post is part of a series by the Diversity Pilots Initiative, which advances inclusive innovation through rigorous research. The first blog in the series is here and resources from the first conference of the initiative are available here. – Jason

By: Piers Blewett, Principal at Schwegman Lundberg & Woessner (SLW)

(This post is part of a series by the Diversity Pilots Initiative, which advances inclusive innovation through rigorous research. The first blog in the series is here and resources from the first conference of the initiative are available here.)

Hello! I’m Piers Blewett, a principal at Schwegman Lundberg & Woessner (SLW), and a patent attorney who started in a place once known as Rhodesia, now Zimbabwe. My personal journey exposed me to the nuances of systemic change and the gap that can often exist when it comes to universal access to opportunities.

During the transitional period in Zimbabwe and later South Africa, I witnessed firsthand that systemic change does not always include broad availability of opportunities. Elements like knowledge transfer and mentorship can often seem out of reach, particularly for those at the beginning of these transitions.

This personal perspective was tragically echoed nearly three years ago. On May 25th, 2020, the world witnessed the heartbreaking tragedy of George Floyd’s murder at the intersection of 38th and Chicago Ave in Minneapolis, a location not far from our offices. The events etched George Floyd’s name into our collective memory, catalyzing a global outcry against systemic racism and underscoring the persistent racial disparities afflicting our communities.

This tragedy led my team and me to ponder deeply on the systemic disparities that exist in our own professional sphere in Intellectual Property (IP), and to listen carefully to those impacted by the effects of injustice. I recalled what one of my mentors taught me year ago: “if you endow people with skills and mentors, they will succeed.” With this background, we decided to act, and the SLW Academy was born.

The SLW Academy is a platform designed to democratize access to IP education and mentorship, especially for underrepresented communities. Our objective isn’t just to impart skills, but to genuinely care for our students, nurturing them in their pursuit of an IP career. We hope to empower students and help them become dynamic, proficient members of the intellectual property community by offering practical advice, useful real-world skills, and a certification to assist in resume building. The SLW Academy’s courses are free, online, and available to stream at the student’s convenience.

At the heart of the SLW Academy’s mission is the aspiration to engage students from various fields of interest and at different stages in their education.  Our focus extends to three key groups, each with distinct needs and potential:

  1. High School Students: Recognizing the importance of early exposure, we extend an invitation to high school students interested in law, science, or engineering to embark on a career path in Intellectual Property. By providing them with practical instruction and mentorship, the SLW Academy helps them explore their passions and develop a strong foundation.
  2. Undergraduate Students, Graduate Students, and Professional Engineers: The SLW Academy tailors programs for students pursuing or holding degrees in engineering, science, or mathematics. Students at this level are introduced to the intersection of law and science.
  3. Law Students and Graduates: The SLW Academy provides a bridge between legal theory and practice for both practicing lawyers and law students, empowering these individuals to enter the field of Intellectual Property law with confidence.

Historical barriers such as availability of IP-centric education or availability of mentors can be overcome at least in part through the SLW Academy. In acknowledging the individuality of each student’s journey, the SLW Academy facilitates mentorship opportunities between students interested in Intellectual Property and practitioners in the field by inviting students to engage with the material and the presenters. Guidance on a variety of careers is provided from presenters who work throughout the field.

We urge other law firms and engineering departments to join us in promoting inclusivity. The benefits of diversity are manifold, and it is crucial that we work together to ensure every voice contributes to our collective progress.

Watch Piers’ presentation on the SLW Academy during the Diversity in the Profession and Pipeline session at the fall 2022 Diversity Pilots Conference hosted at Santa Clara University (slides) or sign up for the SLW Academy webinar taking place on June 20, 2023.

Please visit the SLW Academy website to learn more about our mission. We encourage you to share the SLW Academy with others. Together, we can make a difference.

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Challenges of Proving Inventorship: Corroboration of All Inventive Facts

by Dennis Crouch

Medtronic, Inc. v. Teleflex Innovations S.A.R.L., — F.4th — (Fed. Cir. 2023)

The case involving Medtronic and Teleflex centered on five patents related to a coaxial guide catheter used in interventional cardiology procedures. These patents, US Patents 8,048,032, RE45,380, RE45,776, RE45,760, and RE47,379, cover inventions devised to offer an “enhanced backup support” in contrast to using a guide catheter individually.

In an attempt to invalidate these patents, Medtronic launched a succession of Inter Partes Review (IPR) petitions. Despite the initial approval of the petitions, the Board eventually ruled in favor of Teleflex, the patent holder. The pivotal question on appeal was whether U.S. Patent 7,736,355 (“Itou”) could be regarded as prior art.

In a split decision, the Federal Circuit confirmed the Board’s decision, establishing that the first-to-invent law from before the America Invents Act (AIA) allowed Teleflex to antedate the prior art by demonstrating prior invention. The case underlines a situation where the transition to the AIA has resulted in the loss of certain rights for patent holders. Under the AIA’s provisions, Itou would have been considered prior art, therefore preventing Teleflex’s patenting. The also case stands out as Itou was clearly the first inventor, but this evidence was not taken into account due both to arcane pre-AIA rules and due to the IPR process focusing only on the published patent documents.

Teleflex’s patents claim a priority filing date of May 3, 2006, based on a purported conception date in early 2005. Itou’s priority application was filed in Japan in September 2004, and a year later, the US application was filed on September 23, 2005. Despite Itou pioneering the invention in Japan and filing the Japanese patent application prior to Teleflex’s invention, Teleflex arguably demonstrated an invention date that preceded Itou’s US filing date, which was critical for the court’s decision.

A crucial regulation in this context is pre-AIA 102(e), which introduces a form of ‘secret prior art’ for patent applications that are unpublished as of the patentee’s invention date. Under this regulation, a third party’s US or PCT patent application becomes prior art once published. However, the quirk of 102(e) as compared to pre-AIA 102(a) lies in the fact that these applications are treated as prior art from their filing date, not their publication date. An important subtlety is that a foreign patent filings, like Itou’s Japanese application, do not qualify as prior art under 102(e). In re Hilmer, 149 USPQ 480 (CCPA 1966).

Proving Prior Invention: The concept of ‘invention date’ is crucial in pre-AIA patent cases, and typically, this date is assumed to be the filing date of the patent application. The patentee can then furnish evidence to establish an earlier date of invention, which usually involves a sworn declaration from the inventor, corroborated by additional evidence. Perfect Surgical Techs., Inc. v. Olympus Am., Inc., 841 F.3d 1004 (Fed. Cir. 2016).

Both the Patent Trial and Appeal Board (PTAB) and the majority judges (Judge Lourie and Chief Judge Moore) concurred that Teleflex had provided adequate evidence to substantiate an earlier invention date. Judge Dyk, however, wrote in dissent.

It’s important to understand that the process of invention involves two steps – conception and reduction to practice. The majority and dissent agreed that Teleflex had provided evidence sufficient to proven both conception and the creation of a prototype before the critical date. However, reduction to practice also necessitates evidence demonstrating the suitability of the invention for its intended purpose. For complex inventions like the one in this case, the courts can require testing to establish this suitability prong. Steinberg v. Seitz, 517 F.2d 1359 (C.C.P.A. 1975). While the majority deemed the evidence of testing adequate, the dissent argued it was insufficient — with the debate focusing on the extent of corroboration required.

The majority observed, “[B]oth inventors Howard Root and Gregg Sutton testified regarding testing performed on a prototype of the claimed invention. These tests, although more qualitative than quantitative, were sufficient to confirm that the prototype would work for its intended purpose — providing increased backup support as compared with a guide catheter alone.” The judges concurred with the Board’s view that the tests did not require a direct comparison or a quantitative analysis to prove improvement in function. They also noted expert testimony suggesting “qualitative testing would have been sufficient.”

However, Judge Dyk, dissenting, questioned the lack of corroborative evidence supporting the prior testing. He cited to Cooper v. Goldfarb, 154 F.3d 1321 (Fed. Cir. 1998), to assert that “[i]n order to establish an actual reduction to practice, an inventor’s testimony must be corroborated by independent evidence.” Judge Dyk particularly concluded that every “inventive fact” should be corroborated with evidence beyond the inventors’ testimonies.

The corroborating evidence in this case included a sales presentation and two non-inventors’ testimonies. However, Judge Dyk believed that this evidence did not provide any information regarding proof of operation for the intended purpose. Specifically, there was “no specific description of what tests were performed or the results of the tests … [or] when the tests were performed and whether they were performed before the critical date.” Dissent.

The majority responded that not every detail of reduction-to-practice needs to be independently corroborated, advocating for a rule of reason. Despite agreeing with this general principle, Judge Dyk insisted that the lack of corroboratory evidence regarding testing for the intended use couldn’t be overlooked.

Judge Dyk, in his dissent, noted the lack of internal documents from Teleflex corroborating any testing during the crucial period in 2005. “Common sense, and Teleflex’s own testimony [showing record keeping in this area], suggest that these documents would exist if testing had occurred.” Dissent. He argued requiring such documents did not created an unreasonable standard for inventors seeking to enforce a patent claim. Judge Dyk’s dissent concludes that “I think that Itou has been shown to be prior art to the patents at issue and therefore could support a determination of anticipation or obviousness.”

However, the majority, led by Judge Lourie, disagreed with the dissent and upheld the PTAB’s decision in favor of Teleflex.

The attorneys for the appellants (Medtronic) were led by Tasha Bahal from Wilmer Cutler. Representing Teleflex were attorneys from Carlson Caspers, led by Derek Vandenburg.

Devil’s Dictionary of Patent Law

Longtime patent attorney Martin Abramson just sent me a copy of his short 153 page book titled The Devil’s Dictionary of Patent Law & Beyond: Tapping the Funny Bone of Patent Law.  I just spent 10 minutes flipping through and did actually laugh out loud at one of the squibs.

The Devil’s Dictionary of Patent Law and Beyond by Martin Abramson fills a long-standing humor gap in patent law. It contains diabolical definitions, hilarious cartoons, and amusing anecdotes on patent law and the general law environment in which it exists. Where there’s satire, clarity follows, and as in the original Devil’s Dictionary by Ambrose Bierce, the droll definitions in the present book have the “ring of truth.” The author has more than 40 years of IP experience and a deep knowledge of its history, so along with the patent law are showcased the little known gems of patent lore.

Also a great gift for those fortunate enough to have a patent attorney in your life.

Guest Post: Margo Bagley, The Diversity Pilots Initiative

Editor’s note: This post is the first in a series relating to the Diversity Pilots Initiative, a project co-organized by Professors Margo Bagley & Colleen Chien along with Professor Jillian Grennan that seeks to advance inclusive innovation through rigorous research. The preview blog in the series is here and resources from the first conference of the initiative, co-organized with the USPTO are available here. Below, Professor Bagley introduces herself, the project, and the series. – Jason Rantanen

By: Margo A. Bagley, Asa Griggs Candler Professor of Law, Emory University School of Law, co-inventor, and Principal, Diversity Pilots Initiative. Watch her video for Invent Together, entitled Challenges Encountered as a Diverse Inventor.

In addition to being Associate Dean for Research and Asa Griggs Candler Professor of Law at Emory University School of Law, I am an African-American woman, co-inventor on two patents, patent attorney and law professor, author of numerous articles, chapters, and books on patent law, and advisor on patent issues to governments and international organizations. And yet, it is my firsthand experience, as a member of groups that have been systematically underrepresented and overlooked in the innovation ecosystem, that gives me a deep understanding and resolve to champion diversity and inclusion in innovation and led me to co-organize, with Professor Colleen Chien and personnel from the USPTO, the first Innovator Diversity Pilots conference held at Santa Clara Law School on November 18, 2022. (video recordings and slides available here.) This blog post, and others to follow in the series, will highlight practices that have been or will be tried, tested and evaluated to increase diversity in innovation.

According to the USPTO, women represent over 50% of the workforce and 27% of STEM workers, but  comprise only 13% of inventors on patents. Moreover, while black inventors have made profound contributions to technological advances in America, it is estimated that from 1970 to 2006, black American inventors received six patents per million people, compared to 235 patents per million for all U.S. inventors.  These statistics provided part of the impetus for the conference, which was co-organized by the USPTO and co-sponsored by the law schools of Santa Clara University and Emory University, the Intellectual Property Owners Association, the US Intellectual Property Alliance, the National Academy of Inventors, the Institute for Progress, the Association of University Technology Managers, Meta, the Institute for IP and Social Justice, Finnegan, and Schwegman Lundberg & Woessner.

The conference focused on piloting: temporarily introducing new practices to learn from, combined with rigorous research methods to evaluate their effectiveness.  The day comprised a lively mixture of “Firestarter” presentations describing pilots already completed or underway, along with academic “pitches” — proposals for new pilots across a range of entities and at a variety of points along the innovation timeline. It also included a thought-provoking keynote address by Professor John List (author of the Voltage Effect) (video), exploring the importance of successful scaling of pilots to achieve measurable results, and a fireside chat with dynamic USPTO Director Kathi Vidal whose unparalleled commitment to increasing the participation of members of underrepresented groups in the patenting process is already well underway and bearing fruit. (video)

An underlying theme of the conference was the important realization that growing the percentage of Americans of all backgrounds participating in the innovation system is not only the right thing to do, it is also critical to global economic competitiveness for the United States. For many who are aware of the dismal statistics cited above but are unsure of how to impact them, the conference provided (and through its preserved recordings still provides) an empowering opportunity to identify measurable, deployable ways to pilot low risk interventions.  It also facilitated the fostering of a community of practice, the bolstering of an evidence base for what works (and, importantly, what does not), all of which can inform policy and regulatory efforts to promote diversity and inclusion in innovation and invention.

Segments explored the why and how of diversity piloting, including the case for diversity in innovation and for rigorously piloting ways of advancing it.  Firestarters described, inter alia, diversity nudges and ways of addressing organizational barriers to diversity in the innovation ecosystem such as the measurable success of opt-out vs. opt-in invention disclosure systems; affinity group creation and support in the USPTO; the PTAB LEAP program (granting 15 additional minutes of argument to a party that allows a junior associate to participate in oral advocacy); and a “moneyball”-like fellowship program successful in bringing back into the legal profession more than 200 women who left it to raise children. Pitches covered attribution practices at the Office, mentorship, and adapting the diversity pledge to the legal academy. (video)

An intrinsic feature of the conference was its effectiveness in lifting up several successful initiatives already underway, as well as resources available to stakeholders seeking where or how to begin.  It built on and featured important early efforts like the USIPA Increasing Diversity in Innovation Pledge, signed by over 50 leading companies, the USPTO Council for Inclusive Innovation (CI2)IPO Diversity in IP Toolkit, and the Santa Clara Diversity in Innovation Best Practices Guide.

Important law firm and corporate initiatives highlighted at the conference during Session 5 include Adapt.legal’s mentorship and DEI program resources, Schwegman Lundberg & Woessner’s SLW Academy providing a comprehensive set of free patent training videos, as well as Harrity & Harrity’s multi-pronged approach to increasing innovator and patent practitioner diversity and capacity, including the Harrity Academy and Patent Pathways programs (volunteer here).  We hope at future conferences to feature even more of the work that these and other firms are doing that often is insufficiently publicized and lauded.

The conference also provided opportunities for sharing personal reflections.  Colleen Chien (the mastermind of the conference and diversity piloting approach) and I together shared ways that technical fields have provided opportunities for the advancement of women and people of color in our own families and journeys, but also stereotypes and roadblocks that may stymie progress.  We both found encouraging the variety of approaches presented during the day that bode well for the patent system’s ability to facilitate personal advancement for more Americans from all walks of life, while advancing our national interest in technological progress. (video presentation, slides)

Students in a Patent Law course I taught at Harvard Law School were assigned to watch a 1.5-hour conference segment of their choosing and write a short reaction paper on their impressions.  Their reactions were fascinating, featuring words like “shocking”, surprising”, “moving”, “jarring”, “heartening”, “wonderful”, “compelling”, “hopeful”, and “amazing”, and often linking what they heard in the conference pitches to their own lived experiences in research ecosystems prior to law school.

The second Innovator Diversity Pilots conference being planned for 2024 at Emory University School of Law, will build on the success and momentum of this first conference and will provide an opportunity to report learnings from pilots launched and/or continued in the interim.  Please check out the conference recordings and resources, stay tuned for future blog posts, and drop us a line to let us know how we can uplift your effective practices for increasing diversity in innovation too! (diversitypilots@gmail.com)

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PTAB Finds Patentee Breached Duty of Candor During IPR But in Doing So Conflates Rule 56 and IPR Candor Rules

By David Hricik, Mercer Law School

In a single decision issued by several panels, the Board held that the patentee had failed to act in good faith by, boiled down, intentionally withholding material test data that was inconsistent with the arguments it was making in favor of patentability of both original and proposed substitute claims. The case is Spectrum Solutions LLC v. Longhorn Vaccines & Diagnostics LLC, IPR2021-00847 (Patent 8,084,443 B2), IPR2021-00850 (Patent 8,293,467 B2), IPR2021-00854 (Patent 8,669,240 B2), IPR2021-00857 (Patent 9,212,399 B2), IPR2021-00860 (Patent 9,683,256 B2) (May 3, 2023).

Basically, the claims were directed to a composition that would kill certain pathogens and the test data showed it didn’t.  If so, then of course the Board’s conclusion that intentionally withholding that information violates the duty of candor is itself no news.

What is worth discussing is the Board’s statement that Rule 56 applied to an IPR. It cited and quoted Rule 56 in several spots, though it also cited and quoted the IPR rules in other spots.

Why does this matter?   Citing Rule 56 is wrong. By its terms it applies only to “the filing and prosecution of a patent application…”  IPRs are not “patent prosecution.”  (Nor are ex parte re-examinations, which are subject to a different rule from both Rule 56 and the IPR rules, but I digress.). But, the Board did rely also on the IPR rules, which are the applicable ones, so what’s the problem?

That gets to the second point:  the Board’s decision masks the extraordinary breadth of the disclosure rules in IPR. Specifically, in an IPR who is subject to a duty to disclose is much broader — ridiculously broad — compared to Rule 56.

Specifically, Rule 56 only applies to inventors, practitioners, and those “substantively involved” in prosecution. 37 C.F.R. § 1.56(c) In contrast, the main rule that applies to original claims in an IPR proceeding, 37 C.F.R. § 42.11(a), applies to “parties and individuals involved” in the proceeding. Re-read that: not only is it not limited to “substantively involved,” it says “parties.”  No such language appears in Rule 56.

Another IPR rule applies when a party files a paper, and it has a different scope of “who” is subject to disclosure. Specifically, there’s an obligation to disclose inconsistent information, but it is both broader and narrower than both Rule 56 and 42.11(a): that obligation applies to “inventors, corporate officers, and persons involved in the preparation or filing of the documents or things” where the inconsistency exists.  37 C.F.R. § 42.51(b)(1)(iii)

A decade or so ago I was speaking at the Office and pointed out that the word “party” in 42.11(a) is ridiculously broad as is including inventors and corporate officers in 42.51(b)(iii) since it is not limited to those inventors and corporate officers who are at least involved in the proceeding (do you really have to call Tim Cook to see if he knows something when Apple is in an IPR? Inventors who left the company and aren’t involved?).

Would this have mattered here? Doesn’t look like it as the data that was withheld was seemingly known to the lawyers representing the patentee, but it is important in IPR proceedings to watch this trap about the scope of disclosure (and it’s also more important that the USPTO fix it…).

Some Thoughts on Amgen v. Sanofi

By Chris Holman

Much has been already been written about the Supreme Court’s recent decision in Amgen v. Sanofi, including Dennis’s prompt response. Speaking for myself, I read Amgen as an endorsement of the Federal Circuit’s current interpretation and application of the enablement requirement, and maintenance of the status quo. The enablement requirement is an important (and I would argue the primary) non-prior art-based doctrinal tool for policing claim scope, and as such it plays an important role in preventing inventors of pioneering inventions from laying too much claim to subsequent innovation.

As the Supreme Court observed in Amgen, although Sawyer and Man might have been the first to invent an electric lamp filament of “carbonized fibrous or textile material,” this achievement did not necessarily entitle them to a patent encompassing all electric lamps filaments constructed of this broadly defined class of material, including Edison’s subsequent, but apparently vastly superior, bamboo-based filament. Similarly, Samuel Morse’s invention of the telegraph did not mean he was allowed a patent encompassing any use of electricity “for marking or printing intelligible characters, signs, or letters, at any distance” (sounds like the internet). And in the realm of biopharmaceuticals, the discovery of an antibody capable of specifically binding a particular epitope does not necessarily justify a patent claim encompassing all antibodies specific for that epitope, including antibodies having different (or even superior) pharmaceutical function, a point raised by Sanofi in its briefing of Amgen.

For years, this has been Federal Circuit’s interpretation of the enablement requirement, which requires the scope of the patent’s disclosure to be “commensurate” with the scope of the claims. In Amgen the Supreme Court essentially paraphrased this long-standing standard, stating that “we understand [the Federal Circuit] to have recognized only that the more a party claims for itself the more it must enable. [T]hat much is entirely consistent with Congress’s directive and this Court’s precedents.”

At the same time, it has also long been understood that a patentee is not required to literally enable a person of skill in the art to make and use every embodiment falling within the scope of a patent claim in order to satisfy the enablement requirement. For example, it is uncontroversial that a patent claim broadly directed towards pharmaceutical compositions comprising a specified active ingredient is not invalid for lack of enablement simply because the claim encompasses improved formulations of that active ingredient (e.g., timed release or combination products) that are not literally enabled by the original patent.  In many cases, such formulations are sufficiently innovative to justify their own patent, sometimes referred to as an “improvement patent.”  I do not think that anything in Amgen should be interpreted as altering this fundamental understanding of the enablement requirement.

Over the last few years I have written quite a bit about the enablement requirement, particularly in the context of therapeutic antibodies and other pharmaceuticals. For those who might be interested, here are some links to those articles, along with a brief description of some of the points raised in those articles.

I will begin with two articles I co-authored with Professor S. Sean Tu, entitled Antibody Patents: Use of the Written Description and Enablement Requirements at the Patent & Trademark Office and Antibody Claims and the Evolution of the Written Description / Enablement Requirement.  These articles report the results of an empirical study wherein we found that over the last couple of decades patent examiners faced with antibody claims have steadily increased the use of enablement and written description rejections, and have shifted from the issuance of broad, functionally-defined antibody claims (such as the claims struck down in Amgen) to narrower, structurally-defined claims (such as the sequence-based patent claims Amgen and Sanofi have obtained on their respective products, which the Federal Circuit and Supreme Court both pointed to with seeming approval).

In another article, Amgen v. Sanofi: The Supreme Court Takes up the Enablement Requirement in the Context of Therapeutic Monoclonal Antibodies, I offered some thoughts on Amgen prior to the Supreme Court deciding the case.   The article summarizes some of the main arguments that were raised in Amgen’s successful petition for certiorari, as well as Sanofi’s brief in opposition and a number of amici curiae briefs filed by various interested parties, including the U. S. government’s brief recommending that the Court not grant certiorari.

Amgen’s petition for certiorari relied heavily upon a 2020 law review article entitled The Death of the Genus Claim (“Death”), which purports to document a dramatic shift in the Federal Circuit’s interpretation of the enablement and written description requirements that has rendered it nearly impossible to obtain a chemical genus claim that will withstand judicial scrutiny.  Perhaps Death played some role in the Court’s decision to grant certiorari.  In any event, I responded to Death with my own two-part article, entitled Is the Chemical Genus Claim Really “Dead” at the Federal Circuit?, Parts I and II.

In Part I, I analyzed the judicial decisions upon which Death bases its claim, and explain why, in my view, the article does not substantiate its claim of a marked shift in the Federal Circuit’s interpretation and application of 112(a).  In Part II, I push back against one particular assertion made in Death, i.e., the suggestion that patentees can circumvent the Federal Circuit’s purported heightened application of 112(a) to chemical genus claims by drafting broader claims that define chemical genuses solely in structural terms, without the inclusion of any functional limitations. Part II then reviews a substantial number of judicial decisions involving chemical genus claims, and finds little evidence of a pronounced change in the application of 112(a) to chemical genus claims over the time span which Death identifies as corresponding to a purported dramatic shift in the law.

In another article, The Enablement and Written Description Requirements Through the Lens of the Federal Circuit’s Actions (As Opposed to Its Words), I observe that, when applying patent law’s enablement and written description requirements to police the scope of chemical genus claims, there can at times be a marked divergence between what the Federal Circuit says the law is and what the court actually does. For example, although the Federal Circuit has repeatedly stated that a patentee must enable the “full scope” of a patent claim in order to comply with 112(a), that is clearly not literally true – rarely if ever does a patent enable every conceivable embodiment that would fall within the scope of a patent claim, a task that would be impossible in most (if not all) cases, given the open-ended nature of most patent claims.  In Amgen, the Supreme Court expressly observed that “we review judgments of the lower courts, not statements in their opinions,” which I interpret as tacit recognition of the importance of focusing more on the actions of the Federal Circuit, as opposed to statements in the opinions that can sometimes be misleading when divorced from context.

Summary Judgment Denial and Its Ramifications for Attorney Fee Motions

by Dennis Crouch

In OneSubsea IP v. FMC Tech (Fed. Cir. 2023), the court has affirmed a district court denial of attorney fees for the successful defendant. A key holding in the case is that denial of summary judgment serves as a big flashing sign that the case is not exceptional.

OSS sued FMC back in 2015 for infringing claims found in ten different patents all relating to subsea processing of hydrocarbons (oil and gas). This includes: adding chemicals, separating water and sand from the hydrocarbons; increasing pressure; etc. The patents required a “flow diverter assembly” to “divert fluids” to and from a processing area. The parties argued about the word “divert.” In the context of the invention, the district court concluded that it required two different potential flowpaths, and that fluid flow must be forced to follow one instead of the other. And simply changing directions is not a diversion.

The two-flowpath requirement was a problem for the patentee. FMC’s accused structure just had one flowpath that passed through the processor as shown in the figure below.

The Proceedings: The district court issued its claim construction back in 2016, but rather than quickly granting summary judgment of non-infringement, it stayed the case pending outcome of parallel inter partes reviews challenging the patents’ validity. Those IPRs resulted in many of the claims being found invalid as obvious, with that determination affirmed by the Federal Circuit without opinion. In 2019, the district court lifted the stay and the case moved toward trial. The district court again refused to grant summary judgment of non-infringement. According to the transcripts, FMC’s counsel presented 3,200 pages of documents illustrating the differences between the patented claims and the accused products. Judge Bennett (S.D.Tex.) thought that depth of factual record was a bit too much for a summary judgment. “And you really think I’m going to be able to grant summary judgment on that?” Judge Bennett asked. Eventually, Judge Bennett excluded OSS’s expert testimony for misapplying its prior claim construction and granted the summary judgment of non-infringement. OSS did not appeal the dismissal.

Attorney Fees: After winning on the merits, FMC moved for attorney fees and non-taxable costs. The district court denied those costs, finding the case to be not exceptional. On appeal, the Federal Circuit affirmed, finding no abuse of discretion.

Section 35 U.S.C. § 285 permits a district court to award reasonable attorney fees to the prevailing party; with the caveat that it may only do so “in exceptional cases.” Under the 2014 decisions of Octane Fitness and Highmark, the Section 285 analysis is a flexible one with the district court having substantial discretion in its determination of whether a particular case is “exceptional” and whether fee shifting is appropriate. In this case, the court noted a “totality of the circumstances” approach should be taken on a “case-by-case” basis. The district court can consider whether the case is an outlier from others in terms of the “substantive strength of a party’s litigating position . . . or the unreasonable manner in which the case was litigated.” Octane Fitness.

Because district courts are given discretion in making these determinations, the decisions are given deference on appeal and only overturned based upon either: (1) clear error of judgment, (2) clear error in factual finding, or (3) a material error of law. (Note here, the error of law is reviewed de novo).

Deference and Successor Judges: Here, Judge Bennett stepped into the lawsuit at the very end of the case, replacing Judge Atlas who moved to senior status.  On appeal, FMC argued that no deference should be given to Judge Bennett’s decision because he had not “lived with the case.”  In Highmark, the Supreme Court grounded its decision to give deference to district court decisions upon the fact that district courts are much more into the weeds of the litigation and thus better positioned to judge exceptionally bad behavior.  Because Judge Bennett decided the case on written record without even a hearing, FMC suggested that his decision should not be given deference.   On appeal though the Federal Circuit rejected that analysis based upon caselaw from the other circuits consistently holding that deference is also given to successor judges discretionary decisions.  “The successor judge receives the same deferential review on appeal as the original judge would have received.” Slip Op.  Further, “FMC had ample notice that a successor judge would decide its § 285 motion and did not object.”

Exceptional Case: In looking at the exceptional case question, the appellate court concluded that FMC’s failure to achieve an early summary judgment was its own fault. Basically, the original motion for summary judgment was deemed “unpersuasive.”  The appellate court then explained the importance of summary judgment denial:

When a district court, fully aware of the competing contentions of the parties, declines to end the case on summary judgment and allows a plaintiff’s case to proceed, the district court may have effectively determined that the position of the party opposing summary judgment is not objectively baseless, making it nearly impossible for the plaintiff’s case (on the issue that was the subject of the summary judgment motion) to “stand out” as lacking substance at that time.

Denial of fees affirmed.

US Patent Nos. 6,637,514, 7,111,687, 8,066,076, 8,122,948, 8,272,435, 8,281,864, 8,540,018, 8,573,306, 8,746,332, and 8,776,893.

Connect & Collaborate: Unpacking the NAPP 2023 Annual Meeting & Conference

by Dennis Crouch

As a member and supporter of the National Association of Patent Practitioners (NAPP), I am looking forward to the NAPP Annual Meeting and Conference scheduled for July 19-21 in Alexandria, Virginia at the USPTO Headquarters. I invite all those invested in protecting intellectual property rights to attend, especially folks who are deep in the day-to-day business of protecting patent rights. We have a remarkable line-up of speakers this year, including the USPTO Director, Kathi Vidal.

Delving deeper into the conference agenda, we kick off on July 19th with an optional tour of Old Town Alexandria, followed by expert-led discussions on a broad range of topics from the current USPTO Pilot Programs to how to protect your practice from cyber-attacks. Thursday, July 20th, will offer another full day of sessions covering everything from responding to prior art rejections, to cultivating diversity in patent law, and best practices for PTAB appeals.  My patent law update is Thursday morning.  Finally, on Friday, July 21st, we’ll wrap up with in-depth sessions on nonce words and means plus function, invention in the corporate environment, and patent term adjustment calculation, among other nerdy patent topics.

I particularly encourage law students to attend and take advantage of the steeply discounted rate for students and academics. It’s worth noting that attendance is free for the Judiciary and Federal Government employees such as PTAB Judges and Patent Examiners. Organizers have made arrangements for discounted accommodation at the Embassy Suites Alexandria Old Town for those who book early.

If you have not been part of NAPP, this is a wonderful opportunity to join a great organization for patent practitioners, network with industry professionals, and gain practical insights into the world of patent law. I hope to see you there!

For more information and registration, click here.

Shaping the Future of Patent Law: The Amgen v. Sanofi Decision and Bite-Sized Monopolies

by Dennis Crouch

“The more one claims, the more one must enable.”

In a unanimous opinion delivered by Justice Gorsuch, the Supreme Court has affirmed the Federal Circuit’s decision invalidating Amgen’s functionally claimed genus of monoclonal antibodies. The Court held that Amgen’s patent claims were invalid due to a lack of enablement, as they failed to provide adequate guidance for making and using the claimed antibodies.

The case in question is Amgen Inc. v. Sanofi, 22-157, — U.S. — (2023) (21-757_k5g1).

Amgen’s patents cover monoclonal antibodies created by Amgen researchers which aid in reducing blood levels of low-density lipoprotein (LDL), also known as “bad cholesterol.” These antibodies inhibit the operation of a naturally occurring protein known as PCSK9, which degrades LDL receptors and contributes to high cholesterol levels. Amgen’s original patent covered antibodies having particular amino acid sequences, but later its competitor Sanofi patented another antibody with a different sequence from those disclosed and began competing.   Amgen was then able to obtain the broader patents at issue here that are not tied to any particular antibody structure or amino acid sequence. Rather, the claims cover an “entire genus” of antibodies capable of binding to specific amino acid residues on PCSK9 and consequently inhibit PCSK9 activity. Amgen subsequently sued Sanofi for infringement, prompting a defense from Sanofi challenging whether these broader claims were sufficiently enabled.

The Patent Act requires that patent applicant describes the invention in explicit terms to enable any person skilled in the art to make and use the invention. 35 U.S.C. 112. Sanofi characterized the methods Amgen provided for generating additional antibodies as merely a trial-and-error process, claiming that Amgen’s patents failed the enablement requirement as they sought exclusive use over potentially millions more antibodies than the company had taught how to produce. Although a jury sided with the patentee Amgen, the district court and the Federal Circuit agreed with Sanofi’s contention, ruling that Amgen did not meet the enablement requirement as a matter of law.

The enablement requirement is a crucial aspect of the patent “bargain”: an inventor is granted limited protection from competition in exchange for publicly disclosing their new technology. The Supreme Court, in its decision, referenced previous cases such as Morse, Incandescent Lamp, and Holland Furniture, as establishing the requirement that if a patent claims an entire class or genus of processes, machines, or compositions of matter, the specification must enable a person skilled in the field to make and use the entire class. In simpler terms, it follows the elementary school principle: If you bring cookies to share, bring enough for everyone.

If a patent claims an entire class of processes, machines, manufactures, or compositions of matter, the patent’s specification must enable a person skilled in the art to make and use the entire class. In other words, the specification must enable the full scope of the invention as defined by its claims.

The more one claims, the more one must enable. See §112(a); see also Continental Paper Bag Co. v. Eastern Paper Bag Co., 210 U. S. 405 (1908) (“[T]he claims measure the invention.”).

Amgen v. Sanofi.

In this case, Amgen sought exclusivity for the entire class of functional antibodies, not just the 26 antibodies expressly disclosed.  Although Amgen also provided a “roadmap” for discovering more antibodies, the court found that those approaches were insufficient “research assignments” rather than a clear process for creating the additional antibodies. The Supreme Court ruled that these disclosures did not fulfill the enablement requirement as per the Patent Act, as they simply described Amgen’s trial-and-error method without providing sufficient information for skilled scientists to make the entire class of claimed antibodies.

The Supreme Court did agree with Amgen that functional/genus claims should not be held to a stricter standard of enablement. In other words, there is “one statutory enablement standard.” Nonetheless, the general principle remains that broader claims necessitate more enablement, and all claims must be enabled to their “full scope.”

The outcome of the Amgen v. Sanofi case, while significant, may not come as a surprise to those familiar with the evolution of patent law. In recent years, there has been a growing emphasis on promoting innovation and competition by limiting the scope of patent monopolies. This approach recognizes that patents should strike a balance between incentivizing inventors to disclose their inventions and ensuring that the public can freely build upon existing knowledge. Rather than granting broad and far-reaching patent rights, the trend has been towards encouraging more focused and narrowly tailored claims. This shift reflects a recognition that patents are more palatable when they offer bite-sized protection rather than providing a singular and overpowering monopoly. The ruling in the Amgen v. Sanofi case aligns with this approach, reinforcing the notion that patents should enable the creation and use of the claimed inventions while still allowing for competition and further advancements in the field.