Federal Circuit’s Sleepy Obviousness Decision and Vanda’s En Banc Rehearing Petition

by Dennis Crouch

Documents: FedCir Vanda DecisionVanda EnBanc Brief

The Federal Circuit recently sided with the accused infringers Teva and Apotex, affirming the invalidation claims from four Vanda patents covering methods of using tasimelteon to treat circadian rhythm disorders. However, the patent owner has petitioned the court for en banc rehearing, arguing the panel improperly disregarded evidence of nonobviousness.  Responsive briefing from the generics are due on August 1.

This case provides an interesting look at the application of the obviousness standard to pharmaceutical treatment methods.

Background: Vanda Pharmaceuticals owns patents covering use of the drug tasimelteon to treat Non-24-Hour Sleep-Wake Disorder (Non-24), a condition caused by lack of synchronization between a person’s circadian rhythm and the 24-hour day. Tasimelteon is sold under the brand name Hetlioz and has over $100m in annual sales. Several generic drug makers, including Teva and Apotex, filed Abbreviated New Drug Applications (ANDAs) with the FDA seeking to market generic versions of tasimelteon and with allegations. Vanda sued, alleging infringement of four patents that were listed in the Orange Book. RE46604 (Claim 3); US10149829 (Claim 14); US9730910 (Claim 4); US10376487 (Claim 5). The district court found all asserted claims obvious based on prior art teachings about tasimelteon and related drugs. Vanda appealed.

In a May 2023 decision, the Federal Circuit affirmed the invalidity ruling. The panel found no error in the district court’s determination that the prior art would have provided a reasonable expectation of success for the claimed inventions.

Key Aspects of the Federal Circuit’s Obviousness Analysis

The inventions here involved fairly narrow differences, and the Federal Circuit concluded that a PHOSITA would have seen a reasonable expectation of success:

  • Administering without food: There was a motivation to try and a reasonable expectation of success here since FDA guidance recommended food studies, and there are just two potential options (with or without food).  There result here is close to a per-se obviousness ruling.
  • 20 mg dose to “entrain patients”: The prior art disclosed 20 mg dose and suggested entrainment.  Still obvious even though the prior study results (Rajaratnam) were not statistically significant.  In a different patent application, Vanda had characterized Rajaratnam as showing that an oral dose of 20 mg was effective.  The court also noted that an ongoing clinical trial at the time was testing 20 mg — further contributed to the expectation of success.
  • Avoiding Co-administration with CYP enzyme inhibitors: A similar drug (ramelton) had shown problems with co-administration with these CYP enzyme inhibitors, creating a reasonable expectation that tasimelteon would also show similar results. On this point, the testimony was that PHOSITA would not have “ruled out an interaction.”

The key with all of these is reliance on KSR‘s flexible approach and expanded use of the reasonable expectation of success standard.  Although Vanda argued objective indicia, it was given very little consideration by the appellate panel.

Vanda’s Petition for Rehearing En Banc

Vanda’s en banc brief asks three questions:

  1. With or Without Food: Whether method-of-treatment patents directed to the effect of food on a particular drug are per se obvious because of FDA Guidance acknowledging that food may affect the bioavailability of drugs and should be studied.
  2. Clinical Trial as Evidence of Reasonable Expectation of Success: Whether a disclosure showing existence of an ongoing clinical trial is evidence of a reasonable expectation of success as to the result of the trial.  See OSI Pharms v. Apotex (Fed. Cir. 2019) (clinical trial provides only hope, not expectation of success).
  3. Results from Similar Drug: Whether a drug-drug interaction patent is obvious when a POSA could not “rule out” the interaction because another compound in the same general category has shown such an interaction.

The petition urges the full Federal Circuit court to take the case en banc to maintain uniformity of obviousness precedents. I’m sure that companies in the life sciences sector will be closely watching this case as it continues to unfold.

Enablement, Written Description, and Anticipation: Takeaways from United Therapeutics v. Liquidia

by Dennis Crouch

The Federal Circuit recently affirmed a district court decision in United Therapeutics Corp. v. Liquidia Technologies, Inc., providing guidance on enablement, written description, and claim construction for method claims. The case involved patents covering treating pulmonary hypertension with treprostinil.

United Therapeutics Corp. v. Liquidia Technologies, Inc., 2022-2217, 2023-1021 (Fed. Cir. July 24, 2023)

United Therapeutics sued Liquidia for infringing two patents  covering the treatment of pulmonary hypertension using the drug treprostinil (US10716793) and a purified form of the drug itself (US9593066).  The patentee won on the treatment patent but lost on composition patent, with the district court holding that the broader composition claims were anticipated while the narrower claims were not infringed.  Both sides appealed, and the Federal Circuit affirmed on all grounds.

Enablement/Written Description of Unclaimed Variants

A key issue is whether the claims lack enablement and written description. The  treatment claims are directed to “treating pulmonary hypertension,” and the defendant argued that the claim was unduly broad in its swath. In particular, the specification provides guidance only for certain types of pulmonary hypertension.  No disclosure is given for how to treat Group 2 Pulmonary Venous Hypertension.

The Federal Circuit rejected this argument:

Liquidia essentially asks us to treat Group 2 PH as a claimed species within a larger genus (i.e., all five groups of pulmonary hypertension). But analogizing a subset of patients having a variant of a particular disease to traditional genus and species claims is inapt. It would be incorrect to fractionate a disease or condition that a method of treatment claim is directed to, and to require a separate disclosure in the specification for each individual variant of the condition (here, an individual group of pulmonary hypertension patients) in order to satisfy the enablement and written description provisions of 35 U.S.C. § 112, unless these variants are specified in the claims.

Slip Op. This decision provides important guidance for drafting and prosecuting method claims, making clear that the specification does not need to address every possible disease subtype or non-responsive patient population to satisfy 35 USC 112, as long as those limitations are not captured in the claims.  Specifications need not address every disease subtype or patient population, as long as not expressly captured in the claims.  It will be interesting though to see how this precedent sits along side the recent focus on “full scope” disclosure.

The court also dug into the details to find that the treatment improved Group 2 PH hemodynamics (the studied marker of improvement) even if it also increased mortality of those patients.  That death problem “may be an issue for the FDA. But our focus is on the claimed invention. And on this record, with the district court’s claim construction, the claims are adequately enabled.”

Claim Construction and Safety/Efficacy Limitations

As mentioned, the claims are directed to “[a] method of treating pulmonary  hypertension comprising administering … a therapeutically effective single event dose …”  The accused infringer argued that this language should be construed to require a showing of both safety and efficacy. On appeal though the appellate panel agreed with the district court that “therapeutically effective” had been particularly defined in the specification is improving hemodynamic values and the preamble language of treating PH “does not import any additional efficacy limitations or any safety limitations.”  Again, the court washed its hands of any safety or efficacy concerns: “Questions of safety and efficacy in patent law have long fallen under the purview of the FDA. . . We decline to insert the FDA’s responsibilities into claims by importing requirements where they do not recite such limitations.”

Product-by-Process Claims

Some of the composition claims were directed to a product (treprostinil) prepared  by a particular process (alkylation and hydrolysis). When judging this type of product-by-process claim for anticipation purposes, courts ignore the process limitation.  The question becomes simply whether the prior art discloses the claimed product even if created by some different or not disclosed process. “As these claims are product claims, they are anticipated by a disclosure of the same product irrespective of the processes by which they are made.” Slip Op.  Here, the defendant had provided such a references.


Registering Product Design and the Functional Limitation

by Dennis Crouch

TBL Licensing v. Vidal (4th Cir. 2023)

The Timberland Boot trade dress case is pending before the Fourth Circuit, raising some interesting questions about the role of product trade dress vs design patents vs copyright vs utility patents.

Timberland boots were first sold in the 1970s with a unique design that quickly resonated with consumers. The company has now sold more than $1.3 billion of the boots in the US, with more than $100 million in sales most years.  The boot design is well recognized as an icon.  The image above is not an actual boot sold by the company, but one created by an AI with the prompt “timberland boot.”

In 2015 Timberland began the process of registering the boot design as a trademark.  The proposed registration filings focused on iconic elements of the boot, including the silhouette features shown above. But, the USPTO refused to register the mark.  The examiner found that the design lacks secondary meaning and is also too functional.  The TTAB affirmed, but only focused on the lack of secondary meaning. At that point Timberland filed a civil action under 15 U.S.C. § 1071(b) seeking a court order to register the design mark.  The district court sided with the USPTO, holding that Timberland had failed to prove (1) that the design was nonfunctional; and (2) that consumers recognize the design as a unique source identifier.  The case is now pending appeal before the Fourth Circuit.

One of the USPTO’s key arguments in the case focuses on timing.  Timberland boots have been on the market for 50 years, and according to the record the company has “never has demanded that competitors cease and desist from
selling look-alike boots.”  And, although lots of folks recognize the look of Timberland boots, it turns out that the marketplace is flooded with look-alike alternatives.

INTA has filed an amicus brief in support of Timberland arguing that the district court erred in its functionality analysis. Rather than analyzing whether the boot design “as a whole” is functional, the District Court incorrectly disectected the overall appearance of the Icon Boot design into constituent elements, without addressing whether the combination of elements (even if individually functional) formed a whole that was more than just the sum of its parts.

Read the briefs here:


A National Right of Publicity: the Federal Anti-Impersonation Right (FAIR)

by Dennis Crouch

Intellectual property rights in the U.S. have long been a mix of state common law rights and federal statutory rights.  Patents and copyrights were established in the Constitution and enacted by the First Congress in 1790.  Those rights were fairly quickly established as exclusively federal, meaning that there is effectively no patents or copyrights offered by individual states.  Trademarks and trade secrets followed a different path – developing under state common law before later later gaining federal protections; with trade secrets moving federal most recently via the Defend Trade Secrets Act (DTSA) of 2016.  Unlike patent and copyright, trademarks and trade secrets continue to be concurrent and overlapping, meaning that state rights continue to exist and be enforceable alongside the federal right.  It is common for litigation to assert both.  With trademark law, the federal right has been around since 1870 and today occupies most of the space.  Because the federal trade secrecy right is so new (and no registration is available), it is still unclear whether we’ll see the same result.

The straggler here is the right of publicity, often termed Name Image & Likeness or NIL rights.  Although publicity rights initially emerged as a privacy interest, I find that students are quick to see its kinship to trademark law and unfair competition.  While typical privacy rights focus on personal interests and one’s peace of mind, the right of publicity is more economic and commercial in nature.  The basic idea here is that a person’s reputation is an asset — commercial goodwill.  And, that person’s brand is their name, image, and likeness.

The growth of the internet and influencer culture has raised the awareness and importance of publicity rights as the a key transferable with endorsement deals and celebrity advertising.  In the background, we also have the emergence of deep fake AI tools that allow digital impersonation of celebrities at a level never experienced (as exemplified by my AI created version of Swift above).

In a recent hearing on AI IP issues before the US Senate IP subcommittee, Adobe proposed creating a new federal right of publicity called the Federal Anti-Impersonation Right (FAIR). This would establish a minimum level of protection against the unauthorized commercial use of a person’s name, image, likeness, or other identifying aspects of their persona. Adobe argued this is needed to protect artists and creators from having their style or likeness copied by AI tools and used by others for commercial gain.  A national right of publicity could provide more consistent protections similar to those created for trademarks and trade secrets. It could also facilitate enforcement across state lines and could eventually serve as the basis for international treaties in this increasingly global space where persona rights are often exploited online and across multiple platforms.

Adobe’s proposal is largely in theory, and the terms have not yet been drawn-up. Obviously, key policy questions remain:

  • Should protections apply only to famous personalities or to anyone whose NIL is used for commercial gain?
  • How should we balance free speech, parody, and fair use concerns?
  • To what extent should online platforms be shielded from liability?
  • Should rights vest only for commercial exploitation or is there a privacy interest to protect?

The origins of publicity rights stem from privacy protections rather than commerce. This conceptual difference from trademark law is important, and I would suggest that any federal right should consider personal dignity and reputational interests, not just economic harms from impersonation.

What do you think? Are you ready for a national right of publicity?

Essential Elements Test for Reissues Patents

by Dennis Crouch

In re Float’N’Grill LLC, 2022-1438 (Fed. Cir. 2023)

Just in time for my early August floating trip down in the Ozarks, the Federal Circuit has affirmed the USPTO’s rejections of Float’N’Grill’s proposed reissue claims.  The problem: the reissue claims omit an “essential element” of the original invention in violation of 35 U.S.C. 251. The case here is quite similar to the maligned essential elements test of Gentry Gallery, but relies upon the reissue statute rather than the written description requirement of Section 112(a).

Float’N’Grill’s US 9,771,132 covers a floating grill. In patent lingo, we call this a “floating apparatus with grill supports” to allow grilling while floating in water. The disclosed embodiment uses magnets to removably secure the grill to the grill supports, and the original claims required a plurality of magnets.  After the patent issued, the patentee recognized that the magnet limitation was unduly narrow.  The broadening reissue was filed within the two-year 112(d) deadline and replaced the magnet limitation with one requiring the portions to be “removably securable.”

This is a Shark Tank innovation that got investment (video below). Before getting an investor, these guys filed a low quality initial patent application that had unduly narrow claims that were exploited by knock-off versions and really just disclosed a single embodiment.  They got a notice of allowance within a year and paid the issue fee without a continuation.   In its decision, the Federal Circuit rejected their reissue patent claims on what is clearly a technicality and one that is extremely biased toward those who spend more on patent prosecution.  Patent holders with more money would drafted a more “lawyerly” initial patent application that included wiggle room boilerplate statements and additional prophetic embodiments; and would have kept a continuation application alive.  Either of those strategies would have saved the broader claims.

The Original Patent Requirement: Section 251 requires that the reissue claims be directed to “the invention disclosed in the original patent.”  And here, the problem, according to the PTO and Federal Circuit, is that the magnets was essential to the invention as originally disclosed.

The key precedent on point is U.S. Industrial Chemicals, Inc. v. Carbide & Carbon Chemicals, Corp., 315 U.S. 668 (1942). In that case, the Supreme Court rejected a  set of reissue claims on similar grounds.  The original specification highlighted the inclusion of water to improve the efficiency of a reaction. Later, in the reissue, the patentee removed the water requirement.  In its analysis, the Supreme Court concluded that water was “a necessary step” in the invented process “essential in the original patent.”  As such, the claim omitting water was improperly added in the reissue.

In US Industrial Chemicals, the court also remarked that the original patent requirement goes beyond the ordinary limits of Section 112.  The test is not passed simply by showing that the proposed invention “might have been claimed in the original patent because it was suggested or indicated in the specification.”

The Federal Circuit reaffirmed these principles in Forum US, Inc. v. Flow Valve, LLC, 926 F.3d 1346 (Fed. Cir. 2019).  In that case, the original patent document disclosed several different machining implements, each having multiple arbors. The patent  also described advantages of the multiple-arbor arrangement.  In the reissue though the patentee attempted to remove the multiple-arbor requirement in favor of a  more generic support. In its opinion, the Federal Circuit concluded the proposed claims were invalid for failure to satisfy the original patent requirement.  The court noted that the patent document failed to suggest anywhere “that arbors are an optional feature of the invention.”  See also Antares Pharma, Inc. v. Medac Pharma Inc., 771 F.3d 1354, 1358 (Fed. Cir. 2014).


User Matching Patent Fails 101 Test for Lacking Technical Improvement

by Dennis Crouch

Trinity Info Media, LLC v. Covalent, Inc., No. 2022-1308, — F.4th — (Fed. Cir. July 14, 2023).

Trinity Info Media sued Covalent for infringing two patents covering a process of connecting users based on polling question answers – US Patent Nos. 9,087,321 and 10,936,685. The patents describe a system where users answer polling questions and the system uses those answers to find a “likelihood of match” between users. Connections are suggested for high-likelihood matches. The system uses conventional computer components like processors, memory, servers, etc. The ‘685 patent adds limitations about performing operations on a handheld device, displaying results via swiping, and using a mobile app.

The district court granted Covalent’s motion to dismiss, finding the asserted claims ineligible under 35 U.S.C. 101. The Federal Circuit affirmed after analyzing the claims under the two-step Alice/Mayo framework:

Step 1 – Determine if the claims are directed to a patent ineligible concept like an abstract idea.

  • The court found the claims are directed to the abstract idea of “matching based on questioning”, which involves collecting user information, analyzing it, and displaying results.
  • This is a mental process that could be performed by humans without a computer. Using generic technical components does not change the character of the claims.

Step 2 – Determine if the claims recite an inventive concept, i.e. something significantly more than the abstract idea.

  • The court found the claims do not contain an inventive concept. The additional elements like processors, servers, mobile devices, etc. are generic and conventional.
  • They are used in a conventional way to apply the abstract idea, which is insufficient to qualify as significantly more.
  • The alleged advance of real-time matching based on polling does not make the claims patent eligible. That merely reflects use of generic computers to speed up the process.

At oral arguments, the patentee’s attorney (Gregory Hillyer) argued that a better framing of the invention was the requiring of a “unique identifier to the answer so that that answer can find its place in a new and novel array of match servers, rather than a single match server that would have to later be searched.”  Unfortunately for the patentee these features were not actually required by the claims. Judge Cunningham pressed the patentee to identify specific non-conclusory allegations in the complaint about inventiveness. The patentee had difficulty citing anything substantial.

The patentee (Trinity) provided a number of arguments, but the court rejected each one in turn:

  • Trinity argued the claims recite specific improvements to computer capabilities, like using “multiple match servers” and a “match aggregator.” However, the court found these were simply generic computer components used in a conventional way to implement the abstract idea.
  • Trinity argued the claims recite a technical solution to a problem, like allowing “rapid real-time matching.” But the court found this merely uses computers to make the process faster, which is not enough for patent eligibility.
  • Trinity argued humans cannot perform mental matching as fast as the claimed system. However, the court noted the claims do not require the alleged improvements in speed or capability. Rather, the focus of the claims themselves was on the abstract idea.
  • Trinity argued the claims recite unconventional features like using a handheld device and swiping to review matches. However, the court found these limitations just apply the abstract idea using generic technology, and are not an inventive concept.  These were generic components by the time of the invention.
  • Trinity relied on allegations that some limitations were not in the prior art. However, the court discounted these conclusory statements, noting that an abstract idea remains abstract even if some computer limitations are novel.

In the end, the appellate panel affirmed the lower court’s obviousness finding.

= = =

Patent eligibility can sometimes involve underlying factual questions, but that this was not one of those cases. The quoted Berkheimer to explain that ‘not every § 101 determination contains genuine disputes over the underlying facts material to the § 101 inquiry.’  Here, the court also concluded that claim construction and discovery were not necessary precursors for the 101 analysis since the patentee failed to identify any proposed claim constructions or specific facts that would affect the 101 analysis.


SNIPR v. Rockefeller: A Final Nail in the Interference Coffin

by Dennis Crouch

The key benefit of the first-to-file patent regime, introduced by the Leahy-Smith America Invents Act (AIA), is the clarity that it provides. The filing date is an understandable, immutable, and reasonable priority claim marker. This is in contrast to the invention “date”, which requires evidence of the inventor’s mental state as shown by corroboratory evidence; spread across time from conception to invention completion accomplished at reduction to practice. Pre-AIA invention priority contests were decided through a process known as Interference Proceedings—mini trials before the Board (then known as the Board of Patent Appeals and Interferences or BPAI).

The transition from first-to-invent to first-to-file has involved a number of quirks, the latest is found in SNIPR Technologies Ltd. v. Rockefeller University, — F.4th — (Fed. Cir. July 14, 2023). The case focuses on situations where one party has a Pre-AIA filing date and the other was Post-AIA.

Both parties claim patent rights to certain methods of using CRISPR tools to edit bacterial genes for the purpose of creating antibiotic resistance. The idea then is that those “good” bacteria will not be impacted by the use of antibiotics to kill “bad” bacteria growing in the same pot.

After SNIPR’s patents issued, Rockefeller amended its pending claims to match those of the SNIPR patents for the purpose of prompting an interference.  The PTO took the bait, declared an interference, and invalidated the SNIPR patents.  On appeal though, the Federal Circuit has reversed — holding that the SNIPR patents are post-AIA patens and therefore should not have been subjected to an interference proceeding.

Rockefeller’s application claims priority to a provisional application filed on February 7, 2013 (before the March 2013 AIA date). The SNIPR patents claim priority back to a May 2016 filing. In interference lingo, Rockefeller is the “senior party” because of its earlier filing date and SNIPR was unable to provide an earlier date of conception.

On appeal, the Federal Circuit concluded this whole process was wrong and no longer permitted. In particular, the PTAB erred in subjecting SNIPR’s AIA patents to an interference proceeding. Only pre-AIA patents, not pure post-AIA patents like SNIPR’s, can be subjected to such a proceeding. The court reached this conclusion based upon its analysis of the text, purpose, and history of the AIA, concluding that first-to-file patents are exclusively governed by the new priority provisions found in the AIA and therefore cannot be subject to an interference. Under the AIA, we no longer question which party is the first inventor, but rather only ask if there is some prior art that renders the claimed invention obvious or anticipated.

The result then is that SNIPR’s patents have not been cancelled, and the PTO will also need to issue the Rockefeller patent. Some folks see this as a major metaphysical risk—that the existence of two patents covering the same invention could lead to the singularity. While having double patents is probably not the best outcome, industry will work through this possibility of blocking rights as it has many times in the past. The Federal Circuit considered this issue and noted that the Rockefeller filings could be raised in a variety of other ways—such as an AIA-trial proceeding, a process to challenge the validity of a patent—to challenge the SNIPR patents. Although there is a theoretical scenario where a pre-AIA application would not qualify as post-AIA prior art, that scenario is highly unlikely and remote. While a remote risk exists, the Court ultimately found it did not justify overriding Congress’ intent in the AIA statute to rid the system of interference proceedings and focus on filing date.

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.


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.

= = =

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.

= = =

  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!


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.