Stay on Target: Proper Obviousness Analysis Requires Focus on Claimed Invention

by Dennis Crouch

If you break it down far enough, every invention is simply a combination of known materials or steps. In that frame, the obviousness inquiry fundamentally becomes a question of whether the combination of known elements was within the toolkit of an ordinary artisan. This is a flexible analysis (KSR) with the PTO and courts typically looking for a “motivation to combine” the prior art teachings that would have a “reasonable expectation of success.”

The Federal Circuit’s recent decision in Axonics, Inc. v. Medtronic, Inc., No. 2022-1451 (Fed. Cir. July 10, 2023) zeroes in on the motivation-to-combine analysis. In Axonics, the court ruled that the obviousness analysis must focus on the motivation to combine references to reach the claimed invention, not motivation to combine for some other purpose described in the prior art. The basic outcome is that it will prevent overly narrow framing of the motivation inquiry by the PTAB.

Medtronic has two patents that cover medical leads for nerve stimulation. Importantly for the case, although the claims appear broad enough to cover trigeminal nerve stimulation, they are not limited to that type of stimulation. Axonics IPR challenged the claims as obvious based upon two key prior art references: Young and Gerber. The Young patent relates to a lead for stimulating the trigeminal nerve, while the Gerber patent relates to a lead with a plurality of electrodes. Together, the two references taught all of the limitations found in the Medtronic claims. However, the PTAB concluded that an artisan would not have been motivated to combine the references. The PTAB started with Young’s focus on the trigeminal nerve stimulator, and found that the proposed addition of Gerber would fail to work for trigeminal nerve stimulation based on the anatomy of that area.

On appeal, the Federal Circuit found that the PTAB improperly limited the Young-Gerber combination analysis to what would work in the trigeminal-nerve area, which is a requirement of the Medtronic patents’ claims. The proper inquiry should have been whether the relevant artisan would be motivated to make the combination to arrive at the claims’ actual limitations, which are not limited to the trigeminal-nerve context. The Federal Circuit also found that the PTAB erred in its definition of “the relevant art” as limited to medical leads for sacral-nerve stimulation, as the Medtronic patent claims make no reference to sacral anatomy or sacral neuromodulation, and they cannot be properly construed as so limited.

This holding indicates that the PTAB cannot improperly narrow its view of the relevant art based on specification details not reflected in the claims. Rather, the relevant art must align with the scope of the claimed invention. The decision also underscores that the motivation analysis must focus on combining prior art to reach the claimed invention, not suitability for a specific context described in one reference.

I’ll note here that Judge Taranto justifies the decision with a statement about how the patent is not directed to sacral nerfes:

No claim of the two patents either mentions or is limited to sacral nerves. The same is true of the titles of the two patents.

I’ll note here that the rest of the patent is ripe with a focus on sacral nerves.  As an example, the  following comes from the background section:

This invention relates generally to a method and apparatus that allows for stimulation of body tissue, particularly sacral nerves. More specifically, this invention relates to an implantable medical electrical lead having at least one stimulation electrode adapted to be implanted near the sacral nerves for stimulation of a bundle of sacral nerve fibers and a fixation mechanism for providing chronic stability of the stimulation electrode and lead. Moreover, this invention relates to the method of implantation and anchoring of the medical electrical lead electrodes in operative relation to a selected sacral nerve to allow for stimulation.

Id.

On remand, the Board will need to take a fresh look at the Young-Gerber combination. But, it isn’t clear that the result will be obviousness since we still need to know whether someone of skill in the art would have some reason to believe they could to take the trigeminal nerve stimulator disclosed in Young; and combine it with plurality of electrodes disclosed in Gerber to make a non-trigeminal version covered by the claims.

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What is the invention? Traditionally, an invention requires reduction to practice; an actual embodiment.  And, although we have long permitted patent filings as an alternative, the law sees that as merely a constructive stand-in for the real thing.  At the same time, we have all heard the patent law maxim that an invention is defined be the scope of the claims. And, in 2011 the patent laws were finally amended to reflect that paper-focused framework by focusing attention on “the claimed invention” rather than just “the invention.”   The amended law now requires an analysis of the “the differences between the claimed invention and the prior art” and whether “the claimed invention as a whole would have been obvious.”   This was a subtle change, but one that fundamentally shifted focus from the historic framework of an invention that required reduction to practice toward the paper version that defines the invention in terms of what is claimed.

The difficulty for Medtronic in this case is that they took the original invention that focused on sacral nerves and decided to expand out the scope beyond that reach. (The company holds other patents in the family that do focus on sacral nerve stimulation).

Guest Post by Prof. Koffi: A Gender Gap in Commercializing Scientific Discoveries

Guest post by Marlene Koffi, Assistant Professor of Economics, University of Toronto and NBER Faculty Research Fellow. 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.

Diversity and inclusion in science and commercialization are integral to innovation, societal and economic growth. While progress has been made in increasing representation and inclusivity in STEM, there are complex factors at play that hinder a comprehensive understanding of the barriers faced by underrepresented groups in these fields. Today, I will focus on a challenging point later in the invention process: commercializing a scientific discovery. In a research study with Matt Marx, we characterize the gender dynamics of scientific commercialization in the full canon of scientific inquiry.

One of the highlights of our study is to show that, as a society, we have made lots of progress regarding gender balance in the early steps of the scientific production process. Analyzing 70 million scientific articles, we observe meaningful growth in female participation in scientific production. In 1980, barely one in five published papers included a female author. By 2020, that figure exceeded 50%. This increase represents a significant cultural shift in the scientific community. Diversity in science has been shown to stimulate innovation and promote higher recognition within the academic community. This is a win not just for the women involved but for the whole of society.

However, these gains for women early in scientific production hide potential pitfalls later. Namely, the key takeaway of our study is that a significant gender gap remains for commercializing scientific discoveries. Given that we find the gender gap in commercialization is the largest among discoveries that are more highly cited and with higher commercial potential, we title our study and refer to these uncommercialized discoveries as “Cassatts in the Attic” after the renowned female painter and printmaker Mary Cassatt.

What are the underlying reasons behind this gap? For instance, it could be that the investors financing early commercialization efforts are biased against women or that women have limited social networks to help move their scientific discovery to the next stage. While we explored several potential explanations, we found limited evidence that these supply-side factors alone could explain the gap. Instead, our findings indicate that the gender gap predominantly emerges in commercialization efforts conducted in collaboration with existing firms, pointing towards a potential bias from the firm side.

Now, let us consider the relevance of these findings to society.

At its core, the underrepresentation of women in the commercialization of scientific discoveries represents an enormous loss of potential. Women are leading innovative research projects, producing highly cited scientific papers, and making substantial contributions to the research community. Yet, their discoveries are often left “in the attic,” uncommercialized and underutilized, suggesting a possible waste of human and intellectual resources. These “Cassatts in the Attic,” represents missed opportunities to enhance societal welfare and economic prosperity.

This research also shows that the gender gap in commercialization is not just a women’s issue; it is an issue that affects all of us. In fact, it might stifle innovation, limit economic growth, and prevent society from fully benefiting from the contributions of half its population. So, it is essential to remember to promote inclusivity and diversity in all stages of the invention process and extend our efforts beyond the early stages of recruiting and training new STEM talent. We also must help those diverse voices in the critical process of commercializing scientific discoveries. This collective effort should involve all stakeholders, including government, firms, investors, universities, and scientists themselves.

Brilliant minds surround us from all types of backgrounds (gender, race, socio-demographic,…), possibly holding valuable insights that have the potential to shape our world. However, it is our responsibility to ensure that these ideas are not confined and hidden away but brought into the light where they can truly make a difference.

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Guest Post: “Design Patent Exceptionalism” Isn’t

By Sarah Burstein, Professor of Law at Suffolk University Law School

LKQ Corp. v. GM Global Tech., 21-2348 (Fed. Cir. 2023) (docket).

As Professor Crouch has noted, the Federal Circuit has granted rehearing en banc in the design patent case of LKQ v. GM. The main question raised in the petition for rehearing—and in the court’s order granting that petition—is the continuing viability of the Rosen primary reference requirement for evaluating whether a design is obvious under § 103.

The court has ordered briefing on the issue of whether Rosen and Durling (the Federal Circuit case that expanded upon the Rosen approach) were overruled, abrogated, or otherwise affected by the Supreme Court’s decision in KSR and, if so, what the test should look like going forward. For my own thoughts on those issues, see this article and this post. (Tl;dr: The primary reference requirement is good but the Federal Circuit has applied it too strictly.)

In this post, however, I wanted to discuss another issue raised by the court. In granting LKQ’s petition for rehearing, the court asked:

To the extent not addressed in the responses to the questions above, what differences, if any, between design patents and utility patents are relevant to the obviousness inquiry, and what role should these differences play in the test for obviousness of design patents?

These are good questions and well worth discussing. They also stood out to me in light of some of the arguments that were made at the petition stage.

In support of LKQ’s petition for rehearing, some of my friends and colleagues submitted an amicus brief wherein they argued against what they called “design patent doctrinal exceptionalism.” According to these amici, “except where Congress has explicitly specified otherwise, there should be no ‘exceptional’ approach to design patent law doctrines that render them different from utility patent law doctrines. Congress, not the Supreme Court, has imposed this requirement of consistency.” I respectfully disagree.

Section § 171(b) provides: “The provisions of this title relating to patents for inventions shall apply to patents for designs, except as otherwise provided.” But the statute says nothing about legal “doctrines.” It refers only to the statutory “provisions.” Saying that a statutory provision applies to design patents is very different than saying that judicial decisions about how to apply that provision to utility patents also apply to design patents.

Indeed, due to the differences between utility patent and design patent claims, neither courts nor the USPTO could directly import those rules anyway.  Design patents cover different things (ornamental designs as opposed to useful inventions). They are claimed differently (using central as opposed to peripheral claiming). They are fundamentally different types of patents. General principles may be transferrable but the actual tests are generally not.

Consider novelty. Section 102 says a patentable invention must be novel. Section 171(b) says that this requirement of novelty applies to designs. But that doesn’t mean that the judicially-created tests for determining when a useful invention is novel also must be used to determine when a design is novel.

A useful invention is deemed not to be novel if all of its elements can be found in a single prior art reference. But design patent claims don’t have elements in the same way that utility patent claims have elements. (A design patent claim consists of a  pro forma verbal portion that incorporates by reference drawings that show the claimed design.) So courts can’t simply apply the “all elements” rule to design patents. Instead, courts have, quite rationally and fully consistent with § 171, developed a different anticipation test for design patents (for more on that test, see this short piece). That’s not “design patent exceptionalism,” it’s a thoughtful and appropriate application of a generally-applicable statutory requirement to a fundamentally different type of patent.

A similar problem occurs with § 103. Because design patent claims don’t have “elements” in the way utility patent claims do, we can’t just apply the utility patent mix-and-match approach to design patents.

Some might argue that we could just let litigants chop up design patent claims into “elements” in litigation and let them fight it out utility-patent style. But that would be inconsistent with longstanding case law emphasizing that the thing protected by a design patent is the design as a whole. It would also be inconsistent with design theory. Not to mention the significant litigation and uncertainty costs such an approach would entail.

A visual design isn’t simply a collection of visual pieces. It is, as a group of amici explained during Apple v. Samsung, a “cohesive and integrated whole.” While it might be technically obvious to take existing visual pieces and recombine them into new shapes or surface designs, that doesn’t mean that doing so always (or even often) creates a visually obvious result.

It’s true that actual designers don’t (often and definitely not always) start designing by taking a primary reference and modifying it. But the question of what we should deem obvious is ultimately a policy question, not a factual question about the actual processes of invention. Cf. The “Winslow tableau.” There’s nothing irrational about saying that, as a policy matter, we don’t think a design should be deemed visually obvious when there’s nothing that looks “basically the same” in the prior art.

This, of course, means that we need a concept of what looks “basically the same.” In particular, there needs to be a meaningful difference between what is deemed “basically the same” (i.e., similar enough to be a primary reference) and “the same” (i.e., similar enough to anticipate/infringe). The way the Federal Circuit has been applying Rosen doesn’t seem to leave much blue sky between those two concepts. But that is a problem with the application of Rosen, not a problem with Rosen itself.

One more thing: It’s true that it’s difficult to invalidate design patents. (If you’re tempted to ask about those old studies, read this.) It’s also true that the Rosen approach leaves some plainly uncreative designs immune from § 103 attacks—or at least, from successful ones. But maybe § 103 isn’t the best way to address that issue. Maybe, as I argue in this forthcoming article, courts should start taking the originality requirement of § 171(a) seriously.

Claim Preclusion Across Infringement Types

by Dennis Crouch

Inguran, LLC v. ABS Global, Inc., No. 22-1385 (Fed. Cir. July 5, 2023)

The court’s decision here makes two important res judicata holdings that favor patent holders: (1) a final judgment as to claims of literal infringement do not preclude the patentee from later suing the same party for inducing infringement since “an induced infringement claim rests on evidence and elements beyond those required by direct infringement;” (2) res judicata cannot bar a patentee from filing a lawsuit against  a defendant’s actions occurred after the first lawsuit began. This is true even (as here) when the original lawsuit was largely declaratory in nature; the later actions involved the same set of operative facts; and the patentee arguably had notice of the upcoming actions during the first lawsuit.

Both parties here sell gendered bovine sperm straws used for artificial insemination.  (Sorry, I’m not including images for this post).  Inguran (known as ST) sued ABS for infringement a decade ago and won the case. At the time of the lawsuit, ABS was just entering the market both in terms of selling straws and also licensing its technology so that others could make the straws.  But, the case focused on ABS direct infringement with ABS stipulating infringement and the patentee winning an award of $750k past damages (for internal field testing) and an ongoing royalty of $1.25 per straw.  Although it was discussed before the jury and in the litigation, no decision was made as to the infringement by ABS licensees resulting from the tech transfer.

Although the case included an ongoing royalty, those cause real monitoring and enforcement problems.  The parties privately agreed to a lump sum payment to satisfy the entire original judgment. (Undisclosed amount).

Now, ST is suing again, this time arguing that ABS is liable for inducing infringement by licensing/transferring its technology to others who are then making the straws.  ABS argued that ST already had its opportunity to prove ABS infringement, and that resulted in an award that is now fully paid. The district court agreed with ABS and concluded that the licensing/transfers are included within the original judgment and further arguments are precluded. On appeal though, the Federal Circuit concluded otherwise, finding (1) that inducement is a different cause of action than direct infringement and therefore is not automatically precluded; and (2) inducement itself had not been raised in the original case .

Lets backtrack a minute: Claim preclusion, also known as res judicata, prevents a party from bringing a lawsuit on a claim that has already been decided by a court in a previous lawsuit between the same parties or their privies. It aims to prevent repetitive litigation, save resources, and ensure consistent and final decisions.  The rules of res judicata are mostly  made-up by the courts and there is some variation among the states and circuits, but the standard approach requires:

  1. Final, valid judgment on the merits in the initial action;
  2. Same parties in both actions (privies may be included);
  3. Same “cause of action” or “claim” in both actions.

The third prong – same cause of action – is the one that causes the most consternation.  The quirk is that in the context of claim preclusion, “cause of action” is much broader than you might think and as a consequence claim preclusion regularly bars particular causes of action that were never actually raised in the initial lawsuit.  Here is how it works – In order to encourage parties to litigate all their related claims at once, the rules of procedure adopt a broad understanding off same-cause-of-action to include all claims that are based upon the “same set of transactional facts.”  For patent infringement, these “facts” are found within the asserted patent and the infringement accusations.  Some rules of thumb in the patent context:

  • Accusing one product in a first case; and a different product in a second case — different causes of action.
  • Asserting one patent in a first case, and an entirely different patent in a second case — different causes of action.
  • Asserting claim 1 of a patent in one case, and claim 2 of the same patent in a second case — same causes of action.

This gets tougher when the second case involves small changes to the product, or two different patents that are part of the same family. In those situations, the court will need to dig into the details and answer the functional question about whether the two claims involve the “same set of transactional facts.”  The court has also made clear that claim preclusion doesn’t attach to claims that could not have been raised in the first action. This could include situations where the infringement had not yet occurred or the patent had not yet issued.

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  1. Aside: Although the court pays lip service to its notion that it follows regional circuit law of preclusion (here, 7th Circuit), the decision goes on to repeatedly cite and rely upon Federal Circuit precedent without reference to the 7th circuit doctrine.

= = =

 

Building a Better BOTOX®? PGR and Enablement

Guest Post by Jordan Duenckel.  Jordan is a third-year law student at the University of Missouri, head of our IP student association, and a registered patent agent.  He has an extensive background in chemistry and food science.

Medytox, Inc. has appealed a decision made by the Patent Trial and Appeal Board regarding a post-grant review proceeding under the new Pilot Program. Medytox’s motion to amend the claim language, which aimed to substitute claims 19–27 of U.S. Patent No. 10,143,728 (‘728 patent), was denied by the Board for lack of enablement. Additionally, Medytox questions the Board’s Pilot Program regarding motion to amend practice and procedures under the Administrative Procedure Act. In Medytox v. Galderma, 2022-1165, — F.4th — (Fed. Cir. Jun. 27, 2023), Judge Reyna (joined by Judges Dyk and Stark) affirmed the Board’s determinations involving claim construction, enablement, arbitrary and capricious behavior under the Administrative Procedure Act (APA).

The ’728 patent is directed to the use of an animal-protein-free botulinum toxin composition that exhibits a longer-lasting effect in the patient compared to an animal protein-containing botulinum toxin composition. ’728 Patent, col. 2 ll. 57–62. Used to treat glabellar wrinkle lines and possibly chronic migraines, this botulinum toxin is claimed to have a greater length of efficacy than BOTOX®. While a deadly foodborne pathogen that can be present in canned food, modified botulinum toxin can be used as a cosmetic treatment in reducing wrinkling as well as other aesthetic applications.

Galderma S.A. submitted a petition for post-grant review of claims 1–10 of the ‘728 patent. Following the PTAB granting review, Medytox filed a motion to amend that sought to cancel claims 1–10 and introduce claims 11–18 instead. Medytox also requested the Board to provide Preliminary Guidance based on the Pilot Program, which relates to the practice and procedures for motions to amend. The Pilot Program allows a patent owner to receive Preliminary Guidance from the Board regarding its motion or to file a revised motion to amend. The Preliminary Guidance is an initial nonbinding discussion about whether there is a reasonable likelihood that the motion to amend meets the statutory and regulatory requirements. Read more about the Pilot Program here, 84 Fed. Reg. 9,497.

Galderma S.A. objects to the new claims claiming that they introduce new matter that is not disclosed in the specification. The new claim language claims that the responder rate at sixteen weeks is a range between 50% and 100%. The responder rate, in the context of the ’728 patent, is the proportion of patients who responded favorably to the animal protein-free botulinum composition expressed as a percentage. Galderma asserts that the original specification only discloses a responder rate up to 62% so anything above that is a range that is not fully enabled. The preliminary guidance was issued by the Board and stated that Medytox did not show a reasonable likelihood that the requirements of 35 U.S.C. § 326(d) and 37 C.F.R. § 42.221(a) were met to file a motion to amend. Significantly, the Board also gave its “preliminary view” that Medytox’s proposed responder-rate limitation did not add new matter. In order to comply with statutory and regulatory requirements, Medytox filed a revised motion to amend which was denied due to the introduction of new matter.

The responder rate substitute claim language was determined to have a scope of 50% to 100% based on the claim construction. Medytox relies on multiple clinical trials in their specification to show the actual responder rate that they attained. However, the highest rate achieved was 62% leaving a significant portion of the range unenabled with no clear direction on how to enable the rest of the claims. Relying on the Wands factors to conclude that the full scope of the claim was not enabled without undue experimentation.

Judge Reyna also references the recent Amgen v. Sanofi to require that the full scope of the claims must be enabled. Not enabling such a large range of the scope of the claims makes the lack of enablement seem more clear-cut in light of Amgen. While a different factual background from Amgen, not providing clear instructions to enable 76% of the claimed range is a more clear example of not enabling the full scope than the monoclonal antibodies of Amgen.

Medytox also challenges that the Board’s revision of its claim construction of the responder rate limitation made between its Preliminary Guidance and final written decision violated the Administrative Procedure Act (“APA”) because it was arbitrary and capricious and deprived it of a full and fair opportunity to litigate. Citing 5 U.S.C. § 706(2)(A), Medytox specifically asserts that the Board reversed its decision based on a nearly identical record rending the reversal arbitrary and capricious. The USPTO Director intervened to explain that the Board’s Preliminary Guidance was “initial, preliminary, and nonbinding.”

Likewise, the significant extrinsic evidence that warranted the reversal of the determination was developed after the Preliminary Guidance was issued. The claim construction regarding the responder rate limitation, expert testimony, briefing regarding written description, and subsequent oral argument on the limitation were all developed after the Preliminary Guidance. Based on the totality of the record, the reversal of the claim construction was not arbitrary and capricious. The guidance program is meant to be an effort to provide some direction to the patent owner and not be a binding decision. At oral arguments, the Board expressed multiple concerns about the responder rate limitation and Medytox did not adequately remedy the issue. As such, the Board had plenty of evidence to base their reversal.

Stumbling in the Dark: Regional Circuit Law at the Federal Circuit

Guest post by Paul R. Gugliuzza & Joshua L. Sohn

One of the oddest things about the Federal Circuit is that, in the court’s view, it’s powerless to decide many issues of federal law that arise in the appeals presented to it.

Sure, on matters of patent law, what the Federal Circuit says binds district courts, the Patent Office, and future panels of the Federal Circuit itself. Ditto for nonpatent matters the Federal Circuit considers “unique” to patent disputes.

But, on pretty much every other issue in a Federal Circuit patent appeal—whether it be transfer of venue, the permissible scope of discovery, co-pending antitrust or copyright claims, or anything else—the Federal Circuit asserts no “law-saying” power. Instead, the Federal Circuit—and district courts in cases that will be appealed to the Federal Circuit—apply the precedent of the regional circuit from which the case arose.

Recent Federal Circuit venue disputes spotlight the need for a better approach to questions of nonpatent law in patent cases.

As readers of this blog surely know, the Federal Circuit decides venue questions all the time, usually through petitions for writs of mandamus by defendants seeking to escape the Eastern or Western Districts of Texas. As a nonpatent issue, however, a court deciding a transfer-of-venue fight in a patent case must apply regional circuit law.

Yet, at the regional circuits, transfer disputes are vanishingly rare: the Federal Circuit in a single year decides as many transfer cases as the regional circuits decide in a decade. Moreover, the regional circuit cases that do exist usually involve fact patterns wildly dissimilar from patent litigation, making that precedent unhelpful in the patent context.

The paucity of relevant binding precedent has led both district judges and Federal Circuit judges to essentially guess about what “what the law is.” Judge Albright, for instance, has complained about having to choose between what he characterized as “traditional Fifth Circuit transfer law” or “the Federal Circuit’s”—erroneous, in his view—“interpretations of Fifth Circuit transfer law.”

And, in one of the Federal Circuit’s most high-profile venue mandamus grants, In re Apple, Judge Moore castigated the majority on the ground that “[n]either [the Federal Circuit] nor the Fifth Circuit has held that an accused infringer’s general presence in a district is irrelevant” to the transfer analysis. Well, of course the Fifth Circuit has never held that! With the Federal Circuit’s exclusive jurisdiction over patent cases, how could it?

Transfer isn’t the only area where we see the Federal Circuit’s choice-of-law rule leaving judges and litigants in the dark. In a forthcoming article, we provide examples from areas as varied as copyright, antitrust, and attorney-client privilege.

And we propose a simple solution: much like federal courts certify unsettled questions of state law to state supreme courts, the Federal Circuit should certify unsettled questions of nonpatent law to the regional circuits.

At this point, you hopefully have lots of questions: Wouldn’t we need Congress to pass a statute to make this happen? What about Article III’s case-or-controversy requirement? Wouldn’t certifying questions just add more cost and delay? And wouldn’t it be easier to simply change the choice-of-law rule?

To see how we respond, download the article!

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Paul R. Gugliuzza is Professor of Law at Temple University Beasley School of Law.

Joshua L. Sohn is a Trial Attorney at the U.S. Department of Justice and former law clerk to Judge Jerome Farris, U.S. Court of Appeals for the Ninth Circuit. J.D., Harvard Law School; A.B., Stanford University.

The views expressed in this piece are those of the authors and should not be taken to represent those of the U.S. Department of Justice. 

Reevaluating Design Patent Obviousness

by Dennis Crouch

Design patents continue to rise in importance, but the underlying law full of eccentricities.  The crux of the issue lies in the manner patent law decisions are typically written. Most of precedential patent decisions are penned with a strong focus on utility patent doctrine, yet, surprisingly, the same patent doctrines of novelty, obviousness, definiteness, enablement, and written description are also applicable in the realm of design patents.

The Federal Circuit has decided to reevaluate this dichotomous situation specifically in relation to the question of obviousness. The case under scrutiny is LKQ Corp. v. GM Global Tech, 21-2348 (Fed. Cir. 2023). The court has set forth six key questions for the parties to consider:

A. Does KSR International Co. v. Teleflex Inc., 550 U.S. 398 (2007), overrule or abrogate In re Rosen, 673 F.2d 388 (CCPA 1982), and Durling v. Spectrum Furniture Co., Inc., 101 F.3d 100 (Fed. Cir. 1996)?

B. Assuming that KSR neither overrules nor abrogates Rosen and Durling, does KSR nonetheless apply to design patents and suggest the court should eliminate or modify the Rosen-Durling test? In particular, please address whether KSR’s statements faulting “a rigid rule that limits the obviousness in-quiry,” 550 U.S. at 419, and adopting “an ex-pansive and flexible approach,” id. at 415, should cause us to eliminate or modify: (a) Durling’s requirement that “[b]efore one can begin to combine prior art designs . . . one must find a single reference, ‘a something in existence, the design characteristics of which are basically the same as the claimed design,’” 101 F.3dat 103 (quoting Rosen, 673 F.2d at 391); and/or (b) Durling’s require-ment that secondary references “may only be used to modify the primary reference if they are ‘so related to the primary reference that the appearance of certain ornamental fea-tures in one would suggest the application of those features to the other,’” id. at 103 (quot-ing In re Borden, 90 F.3d 1570, 1575 (Fed. Cir. 1996)) (internal alterations omitted).

C. If the court were to eliminate or modify the Rosen-Durling test, what should the test be for evaluating design patent obviousness challenges?

D. Has any precedent from this court already taken steps to clarify the Rosen-Durling test? If so, please identify whether those cases resolve any relevant issues.

E. Given the length of time in which the Rosen-Durling test has been applied, would eliminat-ing or modifying the design patent obviousness test cause uncertainty in an otherwise settled area of law?

F. To the extent not addressed in the responses to the questions above, what differences, if any, between design patents and utility patents are relevant to the obviousness inquiry, and what role should these differences play in the test for obviousness of design patents?

En Banc Order.

The case itself involves design patents covering GM parts, such as front fenders.  See D797,625.  The existence of the design patent means that repair parts must come from authorized manufacturers and channels.  For years, auto insurance companies and others have argued that this improperly raises costs.

The original appellate decision was non-precedential and supported the PTAB IPR decision that the patent challenger failed to demonstrate obviousness. The court relied on the tests delineated in Rosen & Durling, putting a spotlight on a primary reference that ought to be “basically the same” as the claimed design. Notably, this is a substantially different approach than the one employed in utility patent obviousness doctrine.

The original panel was composed of Judges Lourie, Clevenger, and Stark. Though the panel released a per curium opinion, separate opinions were also issued by Judges Lourie and Stark. Judge Lourie expressed his conclusion that it is totally acceptable for the design patent obviousness test to be different from that in utility patents. “Obviousness of an ornamental design thus requires different considerations from those of a utility invention.”  Judge Stark disagreed with the majority opinion on a procedural grounds (forfeiture of certain arguments).

Barry Irwin teamed up with Profs Mark Lemley and Mark McKenna for the en banc petition. Joseph Herriges and John Dragseth from Fish & Richardson represent GM.

The court specifically invited the US Gov’t to file an amicus brief and also welcomed additional briefs of amicus curiae — noting that they “may be filed without consent and leave of the court.”  If you support LKQ (making it easier to invalidate design patents), amicus briefs will be due in late August.  If you support GM, briefs will be due in late September.

Guest Post by Kevin Ahlstrom: Closing the Gender Innovation Gap with Guided Inventor Sessions

(Guest Post by Kevin Ahlstrom, Associate General Counsel, Patents, Meta. 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)

Kevin Ahlstrom headshot

Guided invention sessions not only increase idea submission rates but also transform individuals’ perception of themselves as inventors. By creating a supportive environment and equipping participants with the necessary tools, these sessions pave the way for gender equality in patenting.

Women submit ideas for patenting at a lower rate than men

In 2021, I noticed that most of the ideas I received for patenting came from men. At Meta, employees are encouraged to submit patent ideas through an inventor portal. Women submitted less than 10% of the ideas I received, despite making up more than 30% of the technical and design roles in the organizations I supported. I was chatting with a research scientist about this, and I asked her why she didn’t submit more of her ideas for patenting. She said, “I tend to minimize my contributions compared to others on my team. I sometimes think that the big patentable ideas are for people above my paygrade.”

Another female UI designer said, “We are all often working on things with many other people, and so it can feel presumptuous to claim ‘ownership’ over an idea. Vying for credit can bring up yucky shame feelings in me when I have been trained by our culture to make people happy, to support others, to help.”

I realized there were stark differences between the way that I, a male patent attorney, and many of my female coworkers view the invention process and related work. There are likely many causes for this engagement gap:

  • differences in social expectations between men and women;
  • fewer historical female inventor role models;
  • women may be implicitly penalized for claiming ownership and credit;
  • women often take on the unpaid labor of home and childcare responsibilities, leaving less time or energy for patent activities.

Regardless of the cause, it was clear that I could not rely solely on our inventor portal to capture women-generated innovation.

As my team and I searched for solutions, I initially wanted to hold training sessions for women on how to submit and advocate for their ideas. That’s what the men did – they submitted frequently and argued with me frequently; consequently, I approved more of their ideas for patenting. But why should we train women to act more like men? It didn’t make sense to ask women to change their behavior to fit inside a system that wasn’t designed for them. Instead of more training, we needed a change in our system to meet innovators where they were.

The Patent Team at Meta has been working on this issue for years. Together, we have made large strides in creating a patent program that is equitable and accessible to everyone. We’ve surveyed employees to better understand their needs, we’ve revamped our inventor portal to be more inclusive, we’ve held conferences and forums to spotlight diverse inventors and encourage other companies to improve, and much more.

Our Pilot: how to double women’s idea submission rate with guided invention sessions

A main component of our efforts has been implementing guided invention sessions for underrepresented inventors. Before I explain how to run one, I just want to say that guided invention sessions work. During the months in which we initially implemented these sessions, I saw the invention submission rate from women more than double: among orgs I support, ideas coming from women rose from less than 10% to 22%. Not quite the 30% needed for gender parity, but this is significant progress.

Here’s how it works. We model the guided invention sessions after the 6-3-5 Brainwriting Method, which is a proven way to come up with lots of ideas in an hour or less. Here’s a quick breakdown of the process:

  • 5-7 participants gather to ideate around a single problem. The problem can be anything, but ideally should encourage patentable ideas that align with company goals.
  • The sessions consist of two meetings, each lasting one hour. At the first meeting, participants brainstorm using the 6-3-5 method. This can be done in-person on sheets of paper or virtually using a remote collaboration tool like Google Sheets, Slides, or Figma.
  • The first meeting is broken up into multiple 5-8 minute segments where participants use the collaboration tool to write solutions to the problem.
  • At the end of each 5-8 minute segment, papers are passed and a new segment begins. Each participant can either write down new ideas or build on the existing ones from previous segments.
  • At the end of this first 60-minute meeting, the group will have generated 40-60 solutions to the problem.

Between the first and second meeting, a patent attorney reviews the ideas and selects the most patentable ideas for further discussion. At the second meeting, the group discusses 2-4 of the selected ideas to build on. I encourage as much detail as possible in this meeting, so that by the end we have enough detail to begin drafting one or more patent applications.

In terms of cadence, we have found that doing guided invention sessions once per half produces strong patents, gives inventors something to look forward to, and avoids putting too much burden on patent counsel.

Conclusion: help people become confident and comfortable with patents

In my opinion, the most remarkable result of these sessions has been the inventor transformation. Session participants realize what it takes to generate a patentable idea, and after participating in the process, they are much more likely to become repeat inventors. After attending her first guided inventor session, the research scientist who thought patents were above her paygrade has since submitted 16 ideas for patenting and has 6 patent applications to her name.

Another participant said, “I didn’t know I was an inventor until I attended this workshop.”

Just to drive the point home: guided invention sessions immediately boost the idea rate coming from underrepresented inventors. Participants find the sessions fulfilling and leave confident and excited to patent their innovations.

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Three main takeaways:

  1. A variety of societal expectations and gender norms has resulted in a significant disparity in patent idea submissions between men and women.
  2. Guided invention sessions have proven to be a game-changer in boosting idea submissions from underrepresented inventors. By providing a structured and inclusive platform for brainstorming, these sessions empower women and other underrepresented inventor groups to participate confidently in the patenting process.
  3. Guided invention sessions not only increase idea submission rates but also transform individuals’ perception of themselves as inventors. By creating a supportive environment and equipping participants with the necessary tools, these sessions pave the way for gender equality in patenting.

What is in the Final Rejections: Eligibility

by Dennis Crouch

Though there have been some improvements, initial office actions regularly require a fair amount clean-up and fine-tuning. This process often includes rectifying typographical errors and clarifying loose claim language. It’s also common for the examiner to misconstrue aspects of the invention.  However, by the time the final rejection stage is reached, these issues are usually addressed, and the lines of difference are more clearly drawn.  So, for my study here, I decided to look solely at final office actions and ask the question of what percentage of these involve eligibility rejections.

The chart above reports the percentage of final office actions that include an eligibility rejection.  The uppermost (orange dashed) line on the chart represents applications examined by the eCommerce art units (specifically the 3620s, 3680s, and 3690s). Notably, in 2023 more than 90% of the final rejections for the 3690s (finance, banking, insurance) included an eligibility rejection.  The middle (grey) line in the chart pertains to non-financial data processing inventions (2120s). The main focus of 2120s examination has now shifted predominantly to issues related to AI  simulation and modeling. The third and last (double blue) line in the chart represents all applications. This totals line illustrates that around 9% of all final rejections include an eligibility focus. This is an increase from the 2% rate in 2012.  Notably, about half of the USPTO art units have an eligibility rejection rate of around 0%.

One issue with my study here approach is the time factor. The majority of cases that receive a final rejection are at least three years removed from their effective filing date, and so more recent filings might be doing a better job.  This study was conducted based on a sample size of 100,000 final rejections and is limited only to publicly available files.

Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act

The second major new Senate patent bill focuses on reconstructing AIA trials — particularly by reducing availability and power of inter partes review and post grant proceedings.  The bipartisan Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act was introduced by Senators Chris Coons (D-Del.),Thom Tillis (R-N.C.), Dick Durbin (D-Ill.), and Mazie Hirono (D-Hawaii).

  1. Limiting Standing: Parties could only file IPR petitions if they would have standing to bring a declaratory judgment action in Federal Court.
  2. Clear and Convincing Evidence: Invalidating a patent before the PTAB would require proving unpatentability of a previously issued claim by clear and convincing evidence.  This is a substantially higher standard than the current requirement of preponderance of the evidence.
  3. Separating Institution from Trial: Judges who participate in the institution will would be forbidden from then serving on the trial team.  The idea here is to avoid holdover bias against the patent that may have been established during the institution stage.
  4. Drop Invalidity Defenses: If an IPR is established, the petitioner must drop any invalidity defenses from pending litigation that could have been raised in an IPR.
  5. No Interference: Although the Director still has power of Director Review, the law would forbid the Director from interfering or influencing PTAB IPR decision-making.

The press release also notes the following provisions:

  • Require standing for PTAB challengers and limit repeated petitions challenging the same patent;
  • Harmonize PTAB claim construction and burden of proof with federal district court;
  • End duplicative patent challenges by requiring a party to choose between making its validity challenges before the PTAB or in district court; and
  • Increase transparency by prohibiting the USPTO director from influencing PTAB panel decisions.

IPRs would remain valuable if this bill became law, but their scope would be substantially limited.

Read the bill here.

 

An Overview of Proposed Changes in the ‘Patent Eligibility Restoration Act of 2023’

by Dennis Crouch

Senators Tillis and Coons have released their “Patent Eligibility Restoration Act of 2023” designed to overturn the Supreme Court case of Mayo and Alice Corp.  The impact here is to return eligibility doctrine back to the mid 2000s when almost any useful advance was likely patent eligible.

Here are some key points:

1. Elimination of Judicial Exceptions: The Act proposes to eliminate all judicial exceptions to patent eligibility. “Under this Act, and the amendments made by this Act, the state of the law shall be as follows: (A) All judicial exceptions to patent eligibility are eliminated.”

2. Statutory Ineligibility Categories: The Act specifies that that the following are not eligible: (A) mathematical formulas that are not part of an invention; (B) processes that a human could practically perform that are “substantially economic, financial, business, social, cultural, or artistic” even if the process itself requires a machine; (C)  mental processes performed solely in the human mind or processes that occur in nature wholly independent and prior to any human activity; (D) unmodified human genes (“as that gene exists in the human body”); and (E) unmodified natural material (“as that material exists in nature”)

3. Claims as a Whole: When determining eligibility, the tribunal must consider the claims as a whole without discounting or disregarding any claim element and without regard to its novelty or conventionality.

Read the proposal here.

Claim Construction and the Power of Preferred Embodiments

by Dennis Crouch

The Federal Circuit’s decision in Broadcom v. Netflix revolves around the construction of the claim term “drive server” found in Broadcom’s U.S. Patent No. 6,341,375.  The decision reaffirms the significance of preferred embodiments in claim construction and their potential to shape the validity of patent claims.

The basic question in the case is whether a “drive server” requires computing capabilities, or is storage capacity enough.  Although the plain language of “server” suggests computing capacity, the court agreed with the PTAB that the intrinsic evidence, including the claim language and the specification, supported the broader interpretation.  In the IPR, Broadcom was seeking the narrower construction in order to avoid prior art.  Under the broader construction, the claims were found invalid as obvious.

The important part of the case serves as a reminder of the power of “preferred embodiment” language within the patent specification.  In this case, Qualcomm had included a preferred embodiment of a DVD drive server, also known as a disk library, that contained a number of DVD drives and associated disks.  Broadcom admitted that its proposed construction would exclude this preferred embodiment if the disk library contained no additional computer.  On appeal, the Federal Circuit quoted Vitrionics in its conclusion that: Claim constructions that exclude a preferred embodiment are “rarely, if ever, correct and would require highly persuasive evidentiary support.”  Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1583 (Fed. Cir. 1996) (opinion by Judge Michel). In this case, that evidentiary support was lacking.  Invalidity affirmed.

Since Vitrionics, the Federal Circuit has placed additional weight upon intrinsic evidence — something that seemingly should give the recited principle even more power.

Certiorari Petition: Wakefield v. Blackboard – Challenging Judge Newman’s Competency

by Dennis Crouch

This week, the Supreme Court is considering the re-filed certiorari petition of Franz Wakefield, dba CoolTVNetwork.com v. Blackboard, Inc., No. 22-819.  The petition’s basis stems from the debate over Judge Newman’s competency.  The appellate case was decided by a panel that included Judge Newman, and the petitioner relies heavily upon the public documents circulated in the ongoing disability hearing. Including the repeated statements suggesting that Judge Newman lacks competence and “may suffer from impairment of cognitive abilities (i.e., attention, focus, confusion and memory).”  The petition notes that Judge Newman’s colleagues acted unanimously  to remove her from being assigned new cases.  Wakefield is pursuing his case pro se and so it lacks some fine points, but the thrust of the claims here are quite clear.

Read the petition here: https://www.supremecourt.gov/DocketPDF/22/22-819/268013/20230531141520726_20230531-141242-95759941-00000772.pdf

On the 22nd of June, the court will also consider petitions in two additional IP cases that both focus on IPR procedure grounded in statutory interpretation:

  • Apple Inc. v. CalTech, No. 22-203: Scope of estoppel following IPR. After losing an IPR, when can defendant later raise similar issues in district court?
  • Nike v. Adidas, No. 22-927: Can the PTAB raise its own patentability objections to substitute claims that are different from those raised by the patent challenger?

As always, the odds are on denial, and we’ll know something by early July.

Judge Newman’s Standoff with the Federal Circuit: Refusal to Comply as Misconduct

by Dennis Crouch

The Federal Circuit’s special investigation committee recently released an order in focusing on next steps in its ongoing investigation into the conduct and capacity of Judge Newman.  Although the investigation generally centers on disability and misconduct in her role as judge — the most recent order narrows the focus to the question of whether Judge Newman’s refusal to submit to medical testing constitutes misconduct that could potentially lead to her removal from the bench. The committee’s next steps will be to hold a closed-door hearing on July 13 solely on this issue.  The committee appears to be tacitly admitting that its allegations of general misconduct are insufficient alone and that it cannot prove disability without a medical evaluation.  Still, the committee is moving forward methodically and the order indicates that the refusal-to-cooperate is one area that it could fairly efficiently review and reach a conclusion sufficient to make a final recommendation to the Judicial Council, despite Judge Newman’s lack of cooperation.

Confidentiality: The court’s decision to refuse Judge Newman’s request for a public hearing is another important aspect of this case. This decision raises questions about transparency and the public’s right to know about proceedings that could potentially impact the composition of the judiciary. The order explains the committee’s reasoning:

  • The court begins with a strong presumption that all proceedings that form part of the Committee’s investigation should be confidential, as mandated by the Judicial Conduct and Disability Act of 1980 and the Rules for Judicial-Conduct and Judicial-Disability Proceedings.
  • Confidentiality facilitates the investigative process and is almost universally accepted.
  • Opening the argument to the public carries a grave risk of inadvertent disclosure of both witnesses’ identities and confidential details of witness statements, which could impair the investigative process.
  • The court believes that a public hearing may include references to materials that have not been made public, and that discussion may disclose information that would identify witnesses or confidential details of witness statements.
  • The court believes that a better approach to permitting some public transparency would be to consider releasing a redacted transcript after the argument has been completed.
  • The court argues that the cases defining a right of access to trials are of limited usefulness in the context of the fundamentally different procedures of judicial disciplinary boards, which do not have a long history of openness.

Read the Order.

 

Reframing ITC’s Role: The Advancing America’s Interests Act

by Dennis Crouch

This essay focuses on proposed Advancing America’s Interests Act (H.R.3535) which aims to limit NPE access to the ITC by refining the economic prong of the domestic industry requirement and by adding a stronger public interest consideration prior to issuance of an exclusion order. 

The International Trade Commission (ITC) is a branch of the U.S. government focused on protecting domestic industry against undue foreign competition.  The ITC’s power extends in to several areas, but primarily by enforcing the laws of (1) intellectual property rights; (2) anti-dumping; and (3) countervailing duties.

  1. Intellectual Property Rights: Section 337 investigations constitute a significant portion of ITC’s enforcement activities. These investigations patent, trademark, or copyright violations caused by trade importation into the US. The ITC has the power to issue an exclusion order — much like an injunction — to bar infringing products from entering the US.
  2. Anti-dumping and Countervailing Duties: The ITC can impose anti-dumping duties on foreign manufacturers selling goods in the U.S. at less than fair value. The ITC can also impose countervailing duties to counter effects of foreign subsidies on products imported into the U.S.

Because the ITCs key role is protecting US industry, the agency can only act if there is a domestic industry to be protected.   In recent years, the ITC and Federal Circuit have expanded the scope of what counts for ITC domestic industry.  For instance, US investments in licensing of IP have been increasingly recognized as a major factor in establishing the economic prong of the domestic industry requirement.  And, patent holders have been able to rely upon uses of their technology licensees as evidence of a domestic industry.  Likewise, R&D may also satisfy the requirements. Changes like these have broadened the scope of the domestic industry requirement, making ITC action accessible to industries and companies that may not have traditional manufacturing facilities or significant capital investments in the United States. — i.e., non practicing entities.

H.R.3535 – Advancing America’s Interests Act (AAIA) This proposed legislation aims to amend Section 337 of the Tariff Act of 1930 to counteract some of these expansions by narrowing the definition of domestic industry.  This is the third time that Rep Schweikert has introduced the legislation. And, the basic thrust is that non-practicing patent holders would have real difficulty in bringing Section 337 complaints.

Key features of the proposed amendments include:

  1. Licensing Activities: The Bill seeks to refine the economic prong of the domestic industry requirement by requiring that complainants demonstrate their licensing activities have led to the development of a product. This change is intended to prevent Non-Practicing Entities (NPEs), which often license their patents under threat of patent infringement suits, from establishing a domestic industry. This adjustment is designed to still permit entities who license patents as part of a technology transfer leading to new products, to assert their intellectual property rights at the ITC.
  2. Unwilling Licensees: The Bill proposes changes regarding the use of “unwilling” licensees to establish a domestic industry. Currently, a third-party licensee can be subpoenaed for confidential information, regardless of their desire to participate in the investigation. The proposed Act stipulates that the patent owner can only rely on the licensee’s activities to establish a domestic industry if the licensee joins the complaint under oath.
  3. Public Interest and Exclusion Orders: The Act introduces a significant shift in how the ITC considers exclusion orders. It requires the ITC to affirmatively determine that any exclusion serves the public interest. This change effectively removes the current presumption in favor of exclusionary relief — making ITC action more akin to the eBay analysis in district court..
  4. Expedited Fact Finding: The Act would codify the ITC’s existing “100-day early disposition program,” directing the ITC to consider at the beginning of an investigation whether there are potentially dispositive issues appropriate for an early Initial Determination by the presiding administrative law judge.

ITC action became much more popular in the wake of eBay and the difficulty of obtaining injunctive relief in district court. The proposal here would shift that dynamic once again and would represent a significant shift — coupled with the limits on NPE filings.  If passed, this legislation would reshape the ITC’s approach and its effectiveness for many patent holders.

Proposing Locations for Southeast Regional Office

by Dennis Crouch

The USPTO began establishing satellite offices a decade ago to expand beyond the traditional Alexandria (Washington DC) headquarters.  We now have offices in Detroit, Dallas, Denver, and San Jose. Last year, Congress voted to further expand the decentralization by at least one more. The Unleashing American Innovators Act of 2022 (UAIA) mandates creation of a Southeast Regional Office (SERO).  The USPTO is now seeking comments on where the office should be located — and the methodology it should use in selecting a location.  [Fed Reg].

The statute requires that it be located in Virginia, North Carolina, South Carolina, Georgia, Florida, Tennessee, Alabama, Mississippi, Louisiana, or Arkansas.  I would automatically rule-out Virginia and North Carolina as too close to the PTO HQ; and also rule-out Arkansas as too close to the Dallas Office.  In my mind, I quickly narrowed things down to four potential cities: Atlanta, Jacksonville, Miami, and Nashville.

In my comments to the PTO, I will be including the results of this poll: LinkedIn Poll.  Voting is open for a few more days.  Atlanta is currently in the lead.

The core objective here is to is to deliver better services to citizens and inventors in the region; be more responsive to their needs; and drive positive changes in these regions.  Simultaneously, the Community Outreach Office aims to provide a platform for dialogue, bridging the gap between citizens and the government. The statute sets out five particular considerations:

  1. Strengthen connections between the Office and patent filers through enhanced outreach to a broad spectrum of innovators including underrepresented, rural, low-income, and student populations.
  2. Improve retention of diverse patent examiners and judges, taking into account economic, geographic, and demographic factors.
  3. Enhance the recruitment process to attract more high-quality patent examiners.
  4. Reduce the backlog of pending patent applications.
  5. Elevate the standards of patent examination to ensure greater accuracy and quality.

In addition to the new Southeast Regional Office, the PTO has also been tasked with opening a “Northern New England Community Outreach Office (NNECOO)” and the PTO is seeking comments on its location as well.  The USPTO will be also be conducting a study to identify whether more regional offices would benefit US innovation.

En Banc: Is Obviousness Law or Fact?

by Dennis Crouch

Roku’s recently filed en banc petition begins with an intriguing statement: “What should have been a garden-variety substantial-evidence appeal has produced a dangerous obviousness precedent—one as far-reaching as it is misguided.”  [Roku, Inc. v. Universal Electronics, Inc., Docket No. 22-01058 (Fed. Cir.) (en banc petition)]

An every day part of patent practice is arguing about whether a cited prior art reference teaches a particular claim limitation.  That analysis is not always an easy task because prior art is often quite cryptic as are the patent claims being evaluated.  One way to look at the process is an interpreting of the prior art to see if it teaches the claim.  In that form, the process is seen a question of fact that must be based upon substantial evidence and reviewed with deference on appeal.  Tribunals also often use an alternative approach that involves a question of law reviewed de novo on appeal.  In the alternative approach, the patent claim is interpreted to see whether it covers the the prior art in the process known as claim construction.  The difference between these two approaches is subtle, but often with huge results.

In its recent Roku decision, the Federal Circuit provides an example of these two approaches. Roku, Inc. v. Universal Electronics, 63 F.4th 1319 (Fed. Cir. 2023). The 2-1 majority decided to interpret the prior art to see whether it taught the claimed multiple “communication methods.”  The court found value in “both sides of this factual question,” but ultimately gave deference to the Board’s conclusions. In her dissenting opinion, Judge Newman contended that the majority overlooked the established principle that the obviousness is a question of law that should be reviewed afresh, or ‘de novo’.

Universal Remote: In its IPR petition, Roku presented the prior art (“Chardon”) that described a universal remote control that uses two different types of communications codes (CEC and IR) in order to control various devices. Chardon includes a table with CEC and IR codes for each different type of action that might be needed.  The patent at issue claims the use of “two different communication methods.”  The panel majority endorsed the Board’s factual finding that a “listing of command codes does not teach or suggest a listing of communication methods.”

In its rehearing petition, Roku argues that the panel majority’s analysis conflicts the Supreme Court’s repeated statement that obviousness is a question of law.  Rather, according to Roku, the majority’s treatment of obviousness as effectively a question of fact contravenes 150 years of precedent holding that obviousness is a question of law.  This shift could have far-reaching “pernicious consequences.”

Roku’s bad-consequences argument centers on two main points. First, they assert that the majority’s approach could undermine the uniformity of obviousness jurisprudence.  I.e., the Court is effectively deferring to lower tribunals on the question of obviousness. This, they contend, contradicts a key purpose of the Court’s exclusive patent jurisdiction, which is to ensure nationwide uniformity in patent law. It also undermines the requirement set out in KSR that the obviousness analysis must be made explicit.

Second, Roku suggests that the majority’s methodology could lead to undesirable substantive outcomes — allowing for patents on trivial distinctions from the prior art. Roku argues that such trivial advances should not warrant patent protection as they do not represent real innovation and can hinder progress. They also caution that the majority’s approach could lead to genuine inventions being deemed unpatentable if the Court simply affirms factual findings without conducting a de novo analysis of obviousness.  The argument here is that the appellate court is in a better position to judge obviousness than the PTAB or a Jury.

Recitation of a Previously Unappreciated Mechanism of Action Does Not Overcome Prima Facie Obviousness of Drug Combination

By Chris Holman

In re Couvaras, 2023 WL 3984753 (Fed. Cir. June 14, 2023)

A prima facie obvious combination of prior art chemical compounds can sometimes be deemed nonobvious if the result of the combination is sufficiently surprising, such as when a combination of pharmaceutical active ingredients results in an unexpected synergy. See, e.g., Sanofi-Aventis Deutschland GmbH v. Glenmark Pharms. Inc., USA, 748 F.3d 1354 (Fed. Cir. 2014).  In a recent Federal Circuit decision, In re Couvaras, Judge Lourie (writing for a unanimous panel) explains the important distinction between unexpected results in a pharmaceutical combination product as opposed to the mere recitation of an unexpected mechanism of action.

The case is an appeal of a Patent Trial and Appeal Board decision affirming an Examiner’s rejection of the claims at issue as obvious.  A representative claim recites:

11.  A method of increasing prostacyclin release in systemic blood vessels of a human individual with essential hypertension to improve vasodilation, the method comprising the steps of:

providing a human individual expressing GABA-a receptors in systemic blood vessels due to essential hypertension;

providing a composition of a dosage of a GABA-a agonist and a dosage of an ARB combined into a deliverable form, the ARB being an Angiotensin II, type 1 receptor antagonist;

delivering the composition to the human individual’s circulatory system by co-administering the dosage of a GABA-a agonist and the dosage of the ARB to the human individual orally or via IV;

synergistically promoting increased release of prostacyclin by blockading angiotensin II in the human individual through the action of the dosage of the ARB to reduce GABA-a receptor inhibition due to angiotensin II presence during a period of time, and

activating the uninhibited GABA-a receptors through the action of the GABA-a agonist during the period of time; and

relaxing smooth muscle of the systemic blood vessels as a result of increased prostacyclin release.

Judge Lourie leads off the decision by observing that, while the claims at issue “literally recite methods of increasing prostacyclin release … by co-administering two well-known types of antihypertensive agents[, i]n reality, the claims relate to combatting hypertension with known antihypertensive agents and claiming their previously unappreciated mechanism of action.”

He then affirms the Board’s conclusion that it “is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition which is to be used for the very same purpose.”  It was undisputed that the two types of active agents recited in the claims, GABA-a agonists and ARBs, were both known to be useful for alleviating hypertension.

The appellant, citing Honeywell International Inc. v. Mexichem Amanco Holdings S.A., 865 F.3d 1348, 1355 (Fed. Cir. 2017), argued that the mechanism of action recited in the claims, i.e., the increased release of prostacyclin, was unexpected, and that the Board had erred in dismissing the limitation as having no patentable weight due to inherency.  But the Federal Circuit rejected this argument, noting that “Honeywell held that ‘unexpected properties may cause what may appear to be an obvious composition to be nonobvious,’ not that unexpected mechanisms of action must be found to make the known use of known compounds nonobvious.” The court agreed with the Board that the recitation of various mechanistic steps in the claims was insufficient to overcome the prima facie obviousness of the claimed methods, observing that:

While mechanisms of action may not always meet the most rigid standards for inherency, they are still simply results that naturally flow from the administration of a given compound or mixture of compounds. Reciting the mechanism for known compounds to yield a known result cannot overcome a prima facie case of obviousness, even if the nature of that mechanism is unexpected.

. . .

To establish unexpected results, Couvaras would have needed to show that the co-administration of a GABA-a agonist and an ARB provided an unexpected benefit, such as, e.g., better control of hypertension, less toxicity to patients, or the ability to use surprisingly low dosages. We agree with the Board that no such benefits have been shown, and therefore no evidence of unexpected results exist.

Guest post by Prof. Robinson: How We Can Bridge the Innovation Gap

Guest post by W. Keith Robinson, Professor of Law, Faculty Director for Intellectual Property, Technology, Business, and Innovation, Wake Forest University School of Law. Watch his video proposing a Law and Technology Pipeline Consortium. 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. Sign up for research updates.

The patent system is a foundational part of the United States’ innovation ecosystem. The country created a national patent system in 1789. While the patent system has evolved over 200 years, it has remained stagnant in one glaring way. The number of inventors and patent professionals that are women or belong to underrepresented racial and ethnic groups is alarmingly low as compared to white men. While this disparity raises concerns about inclusivity, it also raises the possibility that there are untapped reservoirs of creativity and innovation within our borders.

For example, a 2016 study by the Innovation Technology and Innovation Foundation revealed that 3.3% of U.S.-born innovators identified as Hispanic, and 0.4% of U.S.-born innovators identified as black or African American. The same study found that women represent just 12% of U.S.-born innovators. These numbers might seem staggering to some. Others might genuinely ask why these numbers should raise concerns.

One need look no further than the changing demographics of the U.S. Census data from 2020 indicate that the share of the U.S. population that identifies as White has declined for several decades. The U.S. is becoming more diverse, and it seems this trend will continue. In Peter F. Drucker’s book, Innovation and Entrepreneurship, Drucker argues that demographics are the clearest external source of innovative opportunity. Underrepresented innovators tend to address overlooked problems that are inherent to their communities. The country’s changing demographics could provide a wealth of untapped innovative opportunities.

The question then, is what is the cause of the demographic disparity in the patent system, and how can we address it?

In his book, Black Inventors in the Age of Segregation, Rayvon Fouché identifies three primary factors that historically hindered black innovation – (1) limited personal networks; (2) lack of access to legal information and advice; and (3) scarcity of capital. These factors remain challenges for underrepresented groups today. Addressing these challenges, particularly the second, could help increase the number of inventors from underrepresented groups.

As part of my educational and research mission, I am working to build partnerships with government agencies, undergraduate universities, law schools, and corporations to bridge the representation gap in patent-related careers. This proposed consortium seeks to accomplish three primary objectives:

  1. Increase the number of patent agents that identify as belonging to an underrepresented racial or ethnic group.
  2. Foster informed inventors that identify as belonging to an underrepresented racial or ethnic group.
  3. Increase the number of patent attorneys in the United States that identify as belonging to an underrepresented racial or ethnic group.

To accomplish these objectives, the consortium will need to build a robust and accessible IP curriculum. The consortium will work with selected universities, particularly Historically Black Colleges and Universities (HBCUs) with strong engineering and scientific programs. The program will also collaborate with law schools in areas near these universities. This strategy will create a robust pipeline for underrepresented students to gain valuable insight into intellectual property and the patent process early in their academic journey.

What will the U.S. innovation landscape look like if we can accomplish these objectives? Underrepresented populations may have greater access to legal assistance. With this access, more ideas can become viable inventions, furthering the collective innovative potential of the country. Further, employees from underrepresented groups will have a better understanding of how their innovative contributions can be exploited. This may lead to greater innovative activity within firms.

These goals may seem ambitious and costly. However, the costs and resources needed to increase diversity in the patent system should be seen as an investment that can yield significant dividends in the long run. There are potentially significant economic and societal gains that could be realized from a more diverse and inclusive patent system. Diverse teams have been shown to be more innovative and creative, bringing a wider range of perspectives and problem-solving approaches to the table. One law firm that has made significant investments in this area is Schwegman Lundberg & Woessner. Their SLW Academy is a free educational resource that provides “practical instruction and opportunities to students who are traditionally underrepresented in intellectual property.”

Another concern is that such initiatives will cause people to be hired or promoted based on their sex, racial or ethnic background rather than their qualifications and experience. This perspective fails to consider the systemic barriers (many of which Fouché discusses) that have prevented underrepresented groups from participating fully in the patent law profession. I am not advocating for the hiring of underqualified individuals for the sake of diversity. Instead, I seek to create opportunities for individuals who, due to systemic issues, might not have had the chance to fully demonstrate their potential.

Closing the disparity gap in patent law and innovation will not happen overnight, nor will it be an easy task. However, the consortium offers a feasible and promising roadmap. By providing underrepresented groups with the necessary resources and opportunities, we can stimulate innovation, increase economic productivity, and foster an innovation ecosystem that truly reflects the diversity of the United States. If we are to believe that innovation knows no gender or color; it is time our profession reflected the same.

Help us shape a more inclusive future in patent law and innovation. If you are a member of a government agency, a university, a law school, a corporation, a law firm, or an individual committed to bridging the representation gap in patent-related careers, we’d love to collaborate. Let’s work together to build a more robust pipeline for underrepresented students and unleash untapped innovative potential within our country.

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USPTO Advisory Committees: An Opportunity to Advocate for Beneficial Innovation

The U.S. Patent and Trademark Office (USPTO) has announced a call for nominations for membership in its esteemed Patent Public Advisory Committee (PPAC) and the Trademark Public Advisory Committee (TPAC).

These committees were established under the Patent and Trademark Office Efficiency Act in 1999 with the task of advising the Secretary of Commerce and the Under Secretary of Commerce for Intellectual Property on patent and trademark operations, including agency management, goals, performance, budgets, and user fees. Kathi Vidal, Under Secretary of Commerce for Intellectual Property and Director of the USPTO, has repeatedly highlighted the central role of these committees in helping her to guide the agency’s strategic actions and upholding the robust IP system that powers American innovation.

Each committee is composed of nine voting members who are chosen by the Secretary of Commerce to serve a three-year term. The USPTO is seeking nominations for up to three members for both the PPAC and the TPAC. The term for new members will begin on December 1, 2023. The deadline for nominations, which must be submitted electronically or postmarked, is July 3, 2023.  If you are a U.S. citizen with a strong background in finance, management, labor relations, science, technology, or office automation, this could be your opportunity to influence the landscape of IP and promote innovation on a significant platform.

Here are three key goals for the next PPAC that I would promote:

1. Persistently advocating for the highest quality patent examination and to ensure enforceable patent rights. Much like a constant gardener, this task requires ongoing attention to accommodate the continual emergence of new innovation.

2. Harnessing ‘born digital’ opportunities to enhance efficiencies in patent examination and technology dissemination. This involves embracing digital transformation to revolutionize our approach to patent processes.

3. Championing the potential of beneficial innovation and the critical task of acknowledging that each individual possesses innate genius and transformative potential. It’s inspiring to witness the astounding results that can spring from establishing an environment that fosters growth and exploration.

To apply for membership in the PPAC or TPAC, please find the application forms at the following links:

More Details: https://www.uspto.gov/about-us/news-updates/uspto-seeks-nominations-patent-and-trademark-public-advisory-committees-0

LinkedIn Post: https://www.linkedin.com/posts/patentlyo_you-can-help-shape-policies-that-support-activity-7074365933271617538-1mqU