Supreme Court Patent Law Outlook 2022

by Dennis Crouch

For the first time since 2008, the Supreme Court’s October 2021 term will come to a close without any patent decisions.  I have included a chart below, but should note that there is some debate around the edges about what constitutes a “patent decision.” Here is my list: SCTPatentCases.

In addition, the Court has also not granted writ of certiorari in any pending cases. Thus, it is entirely possible that the October 2022 term will come and go without any patent decisions.  The only IP centric case that has been granted certiorari is Andy Warhol Foundation for the Visual Arts, Inc. v. Goldsmith, reviewing a Second Circuit copyright decision on the issue of transformative fair use.

Still, there are a number of important pending petitions that could also be transformative in the patent law construct, including four cases with outstanding calls for the views of the Solicitor General (CVSG).  I have divided the pending cases into three general categories:

Patentability:

  • Eligibility under Section 101American Axle & Manufacturing, Inc. v. Neapco Holdings LLC, et al., No. 20-891 (CVSG requested May 3, 2021); Also, Universal Secure Registry LLC v. Apple Inc., et al., No. 21-1056; Interactive Wearables, LLC v. Polar Electro Oy, et al., No. 21-1281.; and Ameranth, Inc. v. Olo, Inc., No. 21-1228.
  • Scope and Procedure for the Enablement Requirement: Amgen Inc., et al. v. Sanofi, et al., No. 21-757 (CVSG requested April 18, 2022);

Infringement and Damages:

  • Do Enhanced Damages Require “Egregious Behavior”Cisco Systems, Inc. v. SRI International, Inc., No. 21-1267.

Procedure:

  • Prior art in Inter Partes Review: Baxter Corporation Englewood v. Becton, Dickinson and Company, No. 21-819 (use of expert testimony to fill gaps in the prior art).
  • Using Claim Construction to Undermine Jury DecisionsOlaf Sööt Design, LLC v. Daktronics, Inc., et al., No. 21-438 (CVSG requested October 4, 2021).
  • Appellate Standing for IPR Challenger & LicenseeApple Inc. v. Qualcomm Incorporated, No. 21-746 (CVSG requested February 22, 2022); also Apple Inc. v. Qualcomm Incorporated, No. 21-1327.
  • Res Judicata and the Patent-Specific Kessler DoctrinePersonalWeb Technologies, LLC v. Patreon, Inc., et al., No. 20-1394 (CVSG submitted, agreeding that Federal Circuit erred, but suggesting that this is not an appropriate case).

Most of these petitions will be decided by the end of June 2022, although the cases awaiting Gov’t amicus brief will likely be delayed until the Fall 2022.

SCIENTIFIC STUDY OF GOD

In re Glascoe (Fed. Cir. 2022)

The USPTO refused to register Glascoe’s mark SCIENTIFIC STUDY OF GOD for use as a service mark when “analyzing the process of creating a human being, the earth, the universe and its environment.” I know what you are thinking–deceptively misdescriptive.  The TTAB did not go there, but instead refused registration after concluding that the mark was “merely descriptive.”

“A term is merely descriptive if it immediately conveys knowledge of a quality, feature, function, or characteristic of the goods or services with which it is used.” In re Bayer Aktiengesellschaft, 488 F.3d 960, 963 (Fed. Cir. 2007)

Here. Glascoe’s purported services are related to the scientific study of god, which is the exact mark that is being claimed.  Glascoe appealed pro se. Her brief begins:

Pro Se Appellant DEIRDRE C. GLASCOE is an Extra-Terrestrial Life Form—The Alien Entity known As GOD. GOD Is A Brand Name®, as are “I AM,” “YHWH,”  “Yahweh,” “Jesus Christ™”, “Allah”, “Lord GOD of Israel,” “EL”, “Human Beings.” GOD’s Kingdom is a foreign state within the meaning of the Foreign Sovereign Immunities Act.

GlascoeBrief.  As you might guess from this excerpt, I did not find anything within Glascoe’s briefing that suggests ‘scientific study’ in a form that I would recognize. That makes me think that the misdescriptive refusal might be more appropriate.  For its part, the Federal Circuit provided a one sentence summary denial:  “Ms. Glascoe has failed to make any cogent, non-frivolous argument as to why the Board’s determinations were incorrect.”  In briefing, Glascoe noted that the TTAB had erred by failing “to recognize GOD as a legal person.”  On appeal, the Federal Circuit did not address that issue.

One thing that Glascoe does is use Anagrams as decoding keys to understand underlying meaning. I’ve provided a couple of examples from the briefing. 

Getting the Public Involved: Third Party PreIssuance Submissions

by Dennis Crouch

If you have never tried a third-party pre-issuance submission with the USPTO or UKIPO Observation. Give it a whirl.

[https://efs.uspto.gov/EFSWebUIUnregistered/EFSWebUnregistered]

The UK Intellectual Property Office recently announced its plans to provide the public with a bit more access to the patent examination system—making it easier for third parties to provide pre-grant observations that can be used by examiners and seen by others.[1]  UK law already allows any person to offer observations “on the question whether the invention is a patentable invention” that must be considered during examination.[2]  The UK law requires that any observations be in-writing and also provide reasoning.   In the recent accessibility pilot project, over half of submitted observations were identified as useful by the examiner.  The UK accessibility proposal is simple—the UKIPO will add an “OBSERVATIONS” button to its new Ipsum service that already provides docketing information.

The USPTO has an online submission form in-place that is a bit clunky, but remains somewhat user friendly. The largest problems with the system: (1) it requires someone to find the “Confirmation Number” from either PAIR or the Patent Center in order to provide a submission; (2) it is limited only to the submission of printed publication material under 35 U.S.C. 122(e); and (3) has a fairly tight timeline — i.e., after publication but before to the first OA rejection.  The result here is that the submissions will be easy for patent professionals, but tricky for the laity.

Button - File a third party preissuance submission

The system might be improved by adding a button directly to the Patent Center search results; easing the timing; and allowing for observations unrelated to printed publications. A simplistic mock-up is offered below: 

I looked for third-party submissions within the dockets of a set of recently issued patents.  I found submissions in about 0.14% of cases (14 out of every 10,000).  The number should be larger. Dennis Crouch, USPTO Third Party Submissions, Patently-O (Feb. 2, 2022).

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Judicial Estoppel and Changing Claim Construction

by Dennis Crouch

Intel Corp. v. XMTT, Inc. (Fed. Cir. 2022)

Chief Judge Moore is known (1) for her keen ability to identify logical flaws in appellate arguments and (2) her willingness to use those flaws to quickly dispose of the appeal.  In this case, the court only needed a few lines to reject Intel’s appeal:

The Board adopted the claim construction for which Intel advocated. Yet, Intel now changes its position and advocates for a claim construction that is clearly inconsistent with its position before the Board. Intel is judicially estopped from raising this argument.

[21-2127.OPINION.4-19-2022_1938320].

Although I don’t disagree with this holding, The court here does not walk through the principles of judicial estoppel in its decision.  Under the Supreme Court’s New Hampshire v. Maine precedent, we look for three markers:

  1. A party taking a position that is clearly inconsistent with its earlier position;
  2. The earlier position was accepted by the prior tribunal.
  3. The change in position would create some unfair advantage or detriment unless estopped.

Here, the court addresses the first two points, but not the third.  I wonder if a different waiver or forfeiture argument might have been more appropriate.

What was Intel thinking.  Its appellate strategy here appears strategic.  Intel’s real problem was in how the PTAB used the construction in determining whether the claimed elements were disclosed in the prior art.  A direct appeal of that issue is given deference on appeal based upon a substantial evidence standard; instead it took the route of seeking de novo review.

Note that this decision is in some tension with Egenera, Inc. v. Cisco Systems, Inc. (Fed. Cir. 2020)

 

The Alexandria Backwaters

by Dennis Crouch

This week, the New York Times published a lengthy staff editorial negatively focusing on the U.S. patent office as a “backwater” used for corporate gamesmanship, won-over by “legal trickery,” and undermining innovation whenever possible.  It appears primarily a hit piece designed to destabilize and direct Dir. Kathi Vidal’s initial weeks as USPTO Director.  She will be having to defend and explain any pro-patentee stance to her White House colleagues.

Despite musty rhetoric, the high level suggestions have merit – especially the first: “Enforce existing standards.”  At its heart, the USPTO is a bureaucratic construct that needs constant attention to ensure that every examiner plays their role, and that none are lulled into complacency.  “The best way to ensure that patents spur innovation instead of thwarting it is to set a high standard for what deserves patent protection in the first place and then to honor it.” Dir. Vidal’s primary role in managing a 10,000+ person agency is to ensure that her examiners have the tools , the training, and the time needed to ensure the highest quality examination.  Although primary examiners have more training and experience, there is some evidence that they do a poorer job of ensuring that each allowed claim is patentable.  This may be an issue of time, oversight, or something else.

The editorial’s second suggestion is to “improve the process for challenging bad patents.”  In particular, the editorial calls for eliminating the FINTIV discretionary denials of IPRs implemented under Dir. Andrei Iancu. The bigger suggestions though are as follows: (1) Make it easier to challenge bad patents before they are granted. (2) Force secondary pharmaceutical patents to undergo an automatic review by the appeal board. (3) Rethink the legal structure for patent challenges. As part of this third point—restructuring the legal system—the essay attacks the Federal Circuit as merely an “echo chamber” of the pro patent lobby.  For this point, the editorial quotes Matthew Lane of CAPA.

The third suggestion calls for calling for elimination of potential conflicts of interest. This seems to be primarily (and expressly) a pot-shot at Dir. Iancu who rejoined his old law firm after leaving the Office last year.  The essay implies that Iancu acted unethically and improperly, but without presenting any evidence and in a way that feels gross. The PTO does not have the same revolving-door tradition that is seen in other major regulatory agencies, and so this complaint would not have made my top-three.

Four: Collaborate with other agencies.  Most particularly, the USPTO and FDA need to get together and ensure consistency across the board.  To get PTO approval, you need to show your invention is a major change, but for FDA or EPA approval, you want to show that your product is pretty much the same as what we already know and trust.  These are all good points here made by Charles Duan who is a member of PPAC.

The final suggestion in the essay – “let the public participate.” Yes!

Amgen v. Sanofi – Next Steps

In Amgen v. Sanofi, the Supreme Court has been asked to review Federal Circuit precedent on the enablement doctrine found in 35 U.S.C. § 112(a).   Although still uncertain, the case has a strong chance of being granted certiorari.  Most recently, the Supreme Court requested that the US Solicitor General file a brief in the case indicating the views of the U.S. Gov’t. That filing will likely come in December 2022.

The statute requires the patentee to provide “a written description of the invention, and of the manner and process of making and using it [sufficient] to enable any person skilled in the art … to make and use the same.”  The petition asks two particular questions:

  1. Whether enablement is “a question of fact to be determined by the jury” Wood v. Underhill, 46 U.S. (5 How.) 1, 4 (1846), as this Court has held, or “a question of law that [the court] review[s] without deference,” as the Federal Circuit holds.
  2. Whether enablement is governed by the statutory requirement that the specification teach those skilled in the art to “make and use” the claimed invention, 35 U.S.C. § 112, or whether it must instead enable those skilled in the art “to reach the full scope of claimed embodiments” without undue experimentation—i.e., to cumulatively identify and make all or nearly all embodiments of the invention without substantial “ ‘time and effort.’ ”

The invalidated patents here are likely worth >$100 million.

 

Is the Advance Meaningful?

by Dennis Crouch

The text of the Patent Act suggests that obviousness is a straightforward inquiry: find how the claimed invention differs from the prior art and ask whether, based upon those differences, an objective artisan would deem the invention obvious. 35 U.S.C. § 103. In reality, the analysis is not easy or straightforward. At the end of the day, tribunals are often left guessing whether the invention went far enough—are the differences from the prior art meaningful in some way or are they merely points of distinction. There are myriad ways that patentees endeavor to show results that are important, surprising, or synergistic—all terms that connote non-obviousness. One way to show meaning is through the use of what the Supreme Court has termed “secondary considerations” and others term “objective indicia.”

Such secondary considerations as commercial success, long felt but unsolved needs, failure of others, etc., might be utilized to give light to the circumstances surrounding the origin of the subject matter sought to be patented. As indicia of obviousness or nonobviousness, these inquiries may have relevancy. See Note, Subtests of “Nonobviousness”: A Nontechnical Approach to Patent Validity, 112 U. Pa. L. Rev. 1169 (1964).

Graham v. John Deere Co., 383 U.S. 1 (1966). When courts ask about the importance of the advance, they must take care to ensure a nexus between the advance and its import. Focusing on the importance of the advance incentivizes advances that are important. Nexus is always relevant when considering if an advance is meaningful, but in recent years the Federal Circuit has aggressively used nexus particularly to limit the use of objective indicia such as industry praise or commercial success. Rather than permitting a fact to weigh the evidence, the court requires a proven nexus before any consideration of the objective indicia and its impact. Often industry praise and commercial success are tied to a commercial product rather than “the invention.” In this situation—where a product has been successful and praised—courts have permitted the patentee to prove a nexus linking the praise to the invention by pointing to the product and showing the product is an embodiment of the patent claim and the claimed invention is not merely a small component of the invention. In various formulations, the court has seen this as requiring the product to be “commensurate in scope” or “coextensive” with the claimed features. See Polaris Industries, Inc. v. Arctic Cat, Inc., 882 F.3d 1056, 1072 (Fed. Cir. 2018); Asyst Techs., Inc. v. Emtrak, Inc., 544 F.3d 1310, 1316 (Fed. Cir. 2008); In re Grasselli, 713 F.2d 731, 743 (Fed. Cir. 1983); Brown & Williamson Tobacco Corp. v. Philip Morris Inc., 229 F.3d 1120, 1130 (Fed. Cir. 2000); Demaco Corp. v. F. Von Langsdorff Licensing Ltd., 851 F.2d 1387, 1392 (Fed. Cir. 1988). A difficulty with this formulary is that there are always unclaimed features found in any product, and so it is difficult to know when the two are “coextensive.” In its important 2019 Fox Factory decision, the Federal Circuit drew a hard line, requiring the product and claim be “essentially” identical:

Although we do not require the patentee to prove perfect correspondence to meet the coextensiveness requirement, what we do require is that the patentee demonstrate that the product is essentially the claimed invention. While coextensiveness is an issue of fact that should ordinarily be decided by the fact finder in the first instance, no reasonable fact finder could conclude, under the proper standard, that the X-Sync chainrings are coextensive with the patent claims.

Fox Factory, Inc. v. SRAM, LLC, 944 F.3d 1366 (Fed. Cir. 2019) (citing to Demaco Corp. v. F. Von Langsdorff Licensing Ltd., 851 F.2d 1387, 1392 (Fed. Cir. 1988)). I wrote about Fox Factory back in 2019 and explained:

The court here again raised the “nexus” hurdle by holding that a presumption of nexus can only be achieved by proving that the product being sold by the patentee is “essentially the claimed invention.” This is a situation where SRAM owned two patents in the same patent family — both of which covered aspects of its X-Sync bicycle chainring (gear). Each patent included elements not claimed in the other — for the court that was enough evidence to disprove coexistence.

Dennis Crouch, Nexus: Product must be “Essentially the Claimed Invention”, Patently-O (December 18, 2019). Since the product in Fox Factory included multiple inventions—each covered by its own patent—the patentee was unable to show that any one of the inventions had nexus with the product. (Note here in Fox Factory, we are not talking about some complex invention – it was only a chain ring, i.e. a gear, that sold well).

An important en banc petition is pending before the Federal Circuit in Zaxcom, Inc. v. Lectrosonics, Inc., 20-1921 (Fed. Cir. 2022) involving that nexus and asking the Federal Circuit to reconsider its Fox Factory precedent. The setup in the case is fairly typical: Zaxcom sued Lectrosonics for patent infringement back in 2019 (D.New Mexico); Lectrosonics responded with two inter partes review petitions. The PTAB granted both IPR petitions and then cancelled the challenged claims as obvious. On appeal the Federal Circuit affirmed, and Zaxcom has now petitioned for en banc rehearing.

The Zaxcom inventions relate to a wireless method for multi-track video recording. The problem with wireless was always timing, and the inventions here solve that with very particular time-codes. The invention here was said to change the industry, and the inventors were awarded both an Emmy and an Oscar. Here is the deal, the invention is embodied in the product, and the praise was tied to the new functionality offered. But, the invention also includes features claimed in a different patent. Because of that, the Board found no nexus and refused to consider the Emmy/Oscar results based upon Fox Factory. On appeal, the Federal Circuit affirmed. The petition now asks for reconsideration of Fox Factory and its progeny:

By deviating from established law, the Fox Factory panel precedent has triggered a need for en banc review. This Court has warned against unduly “strict requirements” in evaluating nexus. Rambus. Nowhere is the wisdom of this warning more apparent than in the present case. Here, it is undisputed that products embodying the claimed invention (Zaxcom’s wireless audio recording system) received industry praise, including a technical Oscar and an Emmy. Lectrosonics did not contend that the claimed invention is just a “small component” of this system. Under this pre-Fox Factory standard, this entitles Zaxcom to a presumption of nexus. Yet the Board and the panel not only rejected this presumption but quixotically failed to find that the claimed invention received any industry praise, because they found that another feature contributed to the praise but was not required by the claims. Put another way, the decisions below disregarded the fact that products embodying the claimed invention undisputedly received the equivalent of not just one Nobel Prize in its field, but two.

Zaxcom En Banc Petition. Retired Chief Judge Paul Michel added amicus support:

What started as a relatively straightforward evidentiary presumption to facilitate the obviousness analysis under 35 U.S.C. § 103 has now morphed into a complex analysis “requir[ing] the fact finder to consider the unclaimed features of the stated products to determine their level of significance and their impact on the correspondence between the claim and the products.” Teva Pharms. Int’l GmbH v. Eli Lilly & Co., 8 F.4th 1349 (Fed. Cir. 2021) (citing Fox Factory, Inc. v. SRAM, LLC, 944 F.3d 1366, 1375 (Fed. Cir. 2019)). In addition to the new “level of significance” factor, recent cases have imposed an “essentially claimed” factor in the presumption analysis. See, e.g., Quanergy Sys., Inc. v. Velodyne Lidar USA, Inc., 24 F.4th 1406, 1418 (Fed. Cir. 2022). These new “requirements” of the presumption-of-nexus analysis conflict with this Court’s precedent.

Judge Michel brief.  I expect responsive briefs from both the USPTO and the patent challenger Lectrosonics in late April 2022.

Standing in Trademark Opposition and Cancellation Proceedings

by Dennis Crouch

In a recent filing, Brooklyn Brewery (Brewery) indicated plans to take its trademark opposition/cancellation case to the US Supreme Court.  The key constitutional question involves when a TM challenger has Article III standing to appeal an adverse TTAB decision. The issues are parallel to those faced on the patent side by unsuccessful Inter Partes Review (IPR) petitioners who attempt to appeal that loss.

There is a lot going on in Brewery v. Brew Shop, but the question before the Supreme Court focuses on Brewery’s opposition to Brew Shop’s multi-class trademark registration application.  The application covers beer & beer-making-kits (both in Class 32) and also sanitizing products (Class 5).  Brewery challenged registration in both classes (and lost).  On appeal, the Federal Circuit divided up its opinion between the three types of goods.  It ruled on the merits for the beer and beer-making-kits. Brooklyn Brewery Corp. v. Brooklyn Brew Shop, 17 F.4th 129 (Fed. Cir. 2021). But, refused to hear the portion of the appeal relating to the sanitizing products.

Lack of Standing: With respect to use of the mark on sanitizing products, the appellate court dismissed Brewery’s appeal because the company did not show any concrete injury since Brewery does not compete in the sanitizing product market. “To be clear, an opposer cannot show standing by merely showing the registrant competes with the opposer and receives a benefit from an unlawful trademark.” The parties also do not compete in the beer-making-kit market. However, the court found standing there since “beer-making kits are related to beer and to some extent compete with beer since they are sold in many of the same stores.” And,  according to the court folks who brew beer also drink beer.  (Note that in this video, one of the BBS founders says that she didn’t like beer). It is important to note that the court’s holding here is on Constitutional grounds. The U.S. Constitution prevents the appellate court from hearing an appeal on this particular aspect of the case.

Brewery has not yet filed its petition for writ of certiorari, but it did recently petition the Surpeme Court for an extension of time and that document included the following:

This case presents a substantial and important question of federal law: what must a party show to have Article III standing to appeal an adverse judgment from the Trademark Trial and Appeal Board to the United States Court of Appeals for the Federal Circuit? Below, the Federal Circuit for the first time held that such appellants must show that (1) it competes in the same line of business as the appellee, and (2) failure to cancel or refuse registration of a mark would likely cause the appellant competitive injury. The Federal Circuit’s unprecedented decision contravenes this Court’s decisions, including Lexmark Int’l, Inc. v. Static Components, Inc., 572 U.S. 118 (2014), and, for many litigants, forecloses appellate review of adverse TTAB decisions.

[Petition]

This result is what my old Brooklyn butcher might have termed “slicing the bologna a bit too thin.”  In my view, if a party has Constitutional standing to challenge one aspect of a trademark registration, the Constitution should permit a challenge of all aspects of that application.  You could think of this like having standing to challenge claim 1 of the patent, but not claims 2-4.  That result can happen, but ordinarily requires an affirmative act by the patentee to show that there is no way that any liability would ever flow from those extra claims.

Facts: This was not raised by Brewery’s attorneys, but I’ll also note that my 2 minute internet search revealed the Brooklyn Brewery napkin below–showing that in-fact the company may compete in the sanitizing product marketplace.

In its opposition, the Brewery had argued that Brew Shop’s mark – as used on sanitation products – lacked acquired distinctiveness.  However, the Board did not actually render a decision on that issue.  In some of its briefing, Brewery argues that this situation calls for an automatic remand under the “ordinary remand rule;” and that such a remand does not require the full standing analysis. Brewery En Banc Petition.

= = =

As mentioned, the trademark oppositions and cancellation proceedings have a number of parallels to IPR challengers, including the issue of appellate standing for unsuccessful petitioners.  A patent case on the point is pending before the Supreme Court, and we are awaiting the views of the Solicitor General. Apple Inc. v. Qualcomm Incorporated, No. 21-746 (CVSG requested February 22, 2022).

One difference between the Trademark and Patent cases is that the TM opposition statute limits the availability of oppositions to folks who “who believe[] that [they] would be damaged by the registration of a mark upon the principal register” 15 U.S.C. § 1063(a).  What that means is that we already have a decision by the TTAB that Brewery had standing to make these challenges.  The Federal Circuit did not appear to provide any deference to the TTAB’s factual conclusions regarding that issue.  In addition, the court took the unusual stance of avoiding the question of statutory standing in favor of deciding Constitutional standing in violation of the common principle of Constitutional avoidance.

Trademark Registration No. 4,034,439; U.S. Trademark Application Serial No. 86,280,776; Brooklyn Brewery Corp. v. Brooklyn Brew Shop, 17 F.4th 129 (Fed. Cir. 2021).

Dir. Vidal’s First Steps

Kathi Vidal is now the USPTO Director after being sworn-in by Federal Circuit Chief Judge Kimberly Moore.  Congratulations!

Dir. Vidal’s first press release is a call for dialogue on what needs to happen to advance the patent office and “to expand, protect, and commercialize U.S. innovation.”  In addition to IP expansionist statements, the announcement also repeatedly adds caveats: “minimizing inappropriate opportunistic behavior … deterring abuses and gamesmanship.”  The other key theme taking steps to ensure that the innovation incentive reaches broadly to all Americans “especially those who have historically lacked access to, and opportunities for equitable participation in, our intellectual property (IP) economy . . . from every region of the Country and across gender, race, identity, socioeconomic class, and veteran status, as well as among all other groups that have been underserved and overlooked.”  This is exactly right – for our world to remain viable, we need to allow space for each person’s individual genius.   Vidal proposes reaching out to actually teach innovation “in our schools, universities, and communities and encourage the emergence of additional innovation hubs.”

Read more here.

The Corporation as an Inventive Artificial Intelligence

Prof. Ryan Abbott has gathered an amazing group of scholars for his new book on AI and IP that is forthcoming later this year. Research Handbook on Intellectual Property and Artificial Intelligence (Edward Elgar Press, Forthcoming 2022) (R. Abbott, ed.).

In general, the various chapters focus on various aspects of machine-based AI. My contribution takes a different tack and instead consider idea that modern corporations and other non-human entities are also a form of artificial intelligence.  But, unlike their computer-bound AI cousins, corporations have already been granted the legal fiction of personhood status and many accompanying civil rights.[1]

I write:

An item still lacking from the corporate arsenal is inventorship rights. Yes, a corporation may own or license an invention and its resulting patents. And in fact, most patents are owned by non-human persons. But, the law persists in most nations as it has for more than 200 years that patentable inventions must begin with a human person, the inventor. In that sense, there is no “corporate invention” because corporate ownership of patent rights are derived rather than original—they stem from a transfer of property rights from human inventors who begins the chain of title.

This chapter considers the competing legal fictions of corporate personhood and corporate invention and how those factions operate in the transformed legal regime that places less emphasis on the role of human inventors and their inventive acts.

I would love to get your suggestions and feedback. [Read mine here]. You’ll be able to read the whole book soon, but meanwhile here are a few chapters that are available in draft form:

= = = =

[1] Dennis D. Crouch, Legal Fictions and the Corporation as an Inventive Artificial Intelligence, Forthcoming Chapter in Research Handbook on Intellectual Property and Artificial Intelligence (R. Abbott, ed), https://ssrn.com/abstract=4081569.

Preparing for Christmas and Shifting Arguments at the PTAB

by Dennis Crouch

The Federal Circuit’s April 12, 2022 decision in Everstar Merchandise narrowly focuses on PTAB trial procedure.[1] And, as a non-precedential opinion, it lacks weight.  Still, the case is important because of the fabulous Christmas Theme drawings found in the patent-at-issue.[2]

Willis Electric and Everstar compete in the decorative lighting marketplace.  In 2019, Everstar petitioned for post-grant review (PGR) of a Willis patent covering a “strength-enhanced, net-like decorative lighting structure.”[3]

These nets need to be strong enough so that they do not fall apart.  The prior art solutions of twisted-pair, thicker wires, and extra support wires solved the problem but had drawbacks of cost, bulk, and weight.  Willis improved upon the prior art with a single wire with internally reinforced strands and an outer insulating layer.  The obviousness case presented two references whose combination taught all of the claim elements: Kumada disclosed a net design; Debladis disclosed the internally reinforced wire.[4]  Although the PTAB initially granted the PGR petition, it eventually sided with the patentee—holding that a person of skill in the art would not have been motivated to combine the references.

During briefing, the patent challenger argued that cost reduction provided a motivation to combine the references.  This seemed like a natural argument because cost reduction is a stated reason for the Willis invention at issue as well as a stated concern in both prior art references. In response, the patentee got technical and provided evidence that the proffered combination would not necessarily reduce cost.  A cost reduction might come from reducing copper content, but the original petition did not particularly make the reduced-copper argument. In a reply brief, the challenger then made the link—arguing that the combination “would reduce the amount of total copper [and therefore] would reduce the cost of the system.”

The Board eventually refused to consider the particularized cost-reduction argument since it was not raised in the initial petition.  The result then was a holding that the challenger had not met its burden of proving the claims obvious.  On appeal, the Federal Circuit has vacated and remanded.

The Federal Circuit agreed that the initial petition controls the AIA trial, and that initial petition must identify the particular evidence that supports the grounds for challenging each claim.  Here, though the court distinguished between an “entirely new rationale” (which is prohibited) and responsively elaborating on prior arguments (which is allowed).  Here, the court concluded that the petition had sufficiently raised the cost-reduction argument and tied it particularly to the prior art references.  In its conclusions though, the court referenced materials beyond the initial petition itself by further noting that cost reduction was discussed in the institution decision, was the subject of expert testimony, and was briefed on the merits.  Those actions together constituted a “developed record” that allows for a “fair extension” of the original arguments. Further, “[a]ny ambiguity as to whether a reply constitutes a new argument is eliminated when the reply is a legitimate reply to arguments introduced in a patent owner’s response or the Board’s institution determination.”[5]

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Definiteness: Federal Circuit’s Pliable Standard Results in Resilient Patent Claims

by Dennis Crouch

Although Nautilus made it easier for a court to find claim terms indefinite, the Federal Circuit continues indicate that the definiteness test strongly favors validity.

In Niazi Licensing Corp. v. St. Jude Medical S.C., Inc. (Fed. Cir. 2022), the court has sided with the patentee–rejecting the district court’s indefiniteness finding.

Niazi’s US6638268 covers a double lined catheter designed for placing an electrical lead in the coronary sinus vein. The outer catheter is a “resilient catheter having shape memory and a hook shaped distal end.”  The inner catheter is a “pliable catheter.”  In Figure 8 below, you can see that the larger outer catheter can get most of the way to the vein destination, but its less-pliable construction makes it difficult to follow all the twists.  The pliable inner catheter is then inserted and extended to reach the vein location.

D.Minn. Judge Wright found the terms “resilient” and “pliable” indefinite and therefore that the claims were invalid. On appeal, the Federal Circuit has reversed–holding that terms meet the requirement of “reasonable certainty.” Nautilus, Inc. v. Biosig Instruments, Inc., 572 U.S. 898 (2014).

Patent law’s definiteness requirement is derived from the requirement that patent claims “particularly pointing out and distinctly claiming the subject matter” of the invention.  35 U.S.C. 112.  The purpose of express claims is to provide public notice of the scope of exclusive rights so that competitors and potential copycats can arrange their affairs to avoid infringement.  (We could pause here to question whether competitors and potential copycats do this in the ordinary course or if it is instead merely legal fiction.)  But, the Supreme Court has also recognized that claims need not perfectly delineate claim scope — rather, the claims must provide “reasonable certainty” as to their scope. Nautilus.  In particular, the Federal Circuit has repeatedly found terms of relative degree to be definite so long as POSITA would have “enough certainty.”  Further, “a claim is not indefinite just because it is broad.” Slip Op.  On the other hand, “purely subjective” claim terms are indefinite — such as “aesthetically pleasing” as used in Datamize, LLC v. Plumtree Software, Inc., 417 F.3d 1342, 1345, 1349–56 (Fed. Cir. 2005) (there must be some “objective anchor”).

Here, according to the court, Niazi’s claims terms provide enough guidance to avoid being labelled indefinite.

  • Resilient: The claims require “an outer, resilient catheter having shape memory.”  In its decision, the court concluded that resilient is guided by the “shape memory” requirement.  The specification further explains that it may have a “braided design.” and may be made of “silastic or similar material” with the purpose of “return[ing] to its original shape” after being distorted.  The specification also categories resilience in terms of both torque control and stiffness.
  • Pliable: The claims require “an inner, pliable catheter slidably disposed in the outer catheter.”  The specification provides further explanation: “constructed
    of a more pliable, soft material such as silicone;” and without “longitudinal braiding, which makes it extremely flexible and able to conform to various shapes.”

In addition to each having some amount of support from the specification, the court also noted that the two terms can be read relative to one another– the pliable inner catheter must be “more flexible than the outer.”

Definiteness is ordinarily a question of law and so the Federal Circuit reviews the issue de novo on appeal. Here, the court found sufficient reasons to find the terms definite. Reversed.

Note: The court also considered dictionary definitions.  It did not discuss whether those definitions introduced extrinsic evidence requiring deference rather than de novo review.

= = = =

Niazi’s Claim 11 is a method-of-use claim that did not use the pliable/resilient terms.   Thus, it survived the district court indefiniteness attack.  The defendant here St. Jude supplied the accused catheter, and Niazi argued that St. Jude had induced doctors and hospitals to infringe.  The district court found no inducement.  On appeal, the Federal Circuit affirmed — holding that under the correct construction of the claim terms there was no underlying direct infringement.

= = = =

Exclusion as a Discovery Sanction: In his expert report, Dr. Niazi’s technical expert (Dr. Burke) stated that he had personally infringed the Niazi patent while using the accused products.  The problem: Dr. Burke had not been identified as a fact witness as required by R.26(a)/(e).  Dr. Niazi’s damages expert relied upon several license agreements to support his report. However, those agreements were not identified during fact discovery despite a specific request for documents.  Both expert reports were provided after the close of fact discovery (as is common).  As a sanction for the late disclosures, the District Court struck those facts from the expert reports and barred Dr. Burke from testifying as a factual witness.   On appeal, the Federal Circuit affirmed on a technical ground — finding that Niazi’s appeal on this question failed because he did not challenge the actual basis for the district court’s decision–whether the delay in disclosure was “substantially justified or harmless.”

Despite the exclusion order, Niazi still presented a declaration from Dr. Burke in support of summary judgment that included a number of factual claims based upon Burke’s personal experience.  The district court struck the statements and also awarded monetary sanctions under R. 37.  The Federal Circuit affirmed:

Here, the sanctions the court imposed were specifically keyed to St. Jude’s expenses in moving to strike the already-excluded evidence from consideration at summary judgment. We see no abuse of discretion in the district court’s decision to award monetary sanctions.

Slip Op.

= = = =

Finally, the district court also excluded Niazi’s damage expert report as unreliable.

The district court excluded Mr. Carlson’s expert opinion as legally insufficient because Mr. Carlson failed to “apportion” between infringing and noninfringing uses and because he could not properly include leads in the royalty base. We affirm the district court’s exclusion.

Slip Op.   Here, the idea was that St.Jude agued that some uses were non-infringing and the expert did not attempt to apportion-out the non-infringing uses but instead merely stated that apportionment would be “impractical in view of real-world considerations.”

Here, the claim was that sales by St. Jude (along with its instructions) were inducing infringement the method-of-use claims.  The patentee argued that apportionment does not apply to method claims.   But, the Federal Circuit disagreed with that broad statement. “Damages should be apportioned to separate out noninfringing uses, and patentees cannot recover damages based on sales of products with the mere capability to practice the claimed method. Rather, where the only asserted claim is a method claim, the damages base should be limited to products that were actually used to perform the claimed method.”

Induced Infringement and the Section 286 Statute of Limitations

By Chris Holman

Roche Diagnostics Corp. v. Meso Scale Diagnostics, LLC, 2022 WL 1052320, — 4th —  (Fed. Cir. Apr. 8, 2022)

Through its acquisition of BioVeris Corporation, Roche Diagnostics became the owner of various patents relating to immunoassays employing electrochemiluminescence (“ECL”). In spite of its ownership of the patents, however, a jury found that a predecessor of BioVeris (IGEN) had exclusively licensed the patents to Meso Scale Diagnostics, and that Roche was liable to Meso for directly infringing one of the patents, and for inducing infringement of two others. On appeal, a divided Federal Circuit affirmed the jury’s decision with respect to direct infringement, but reversed the judgment of induced infringement, remanding for a new trial on damages. Writing in dissent, Judge Newman would have found that Meso did not have an exclusive license in the patents, and therefore Roche was not liable for either direct or induced infringement. The decision raises interesting issues relating to induced patent infringement and the interpretation of a licensing provision.

Inducement:  In 2003, prior to acquiring BioVeris (and its ECL patents), Roche obtained a nonexclusive license to the patented ECL technology from IGEN in the field of “human patient diagnostics.”  This license required Roche to note this field restriction on its product packaging. Later, in 2007, a Roche affiliate acquired BioVeris (including over 100 patents) for approximately $600 million. Roche announced this acquisition in a press release stating it would now “own the complete patent estate of the [ECL] technology,” giving it “the opportunity to fully exploit the entire immunochemistry market” and ensuring its ability to “provide unrestricted access to all customers.” Roche also prepared a customer letter indicating that the field-restriction labels were “now obsolete” and would be “removed as soon as possible,” but that in the interim customers should “please ignore the restrictions.” Roche subsequently began selling the products without field restrictions.  Meso argued that these actions induced customers to use the patented technology outside of the licensed field of use, i.e., “human patient diagnostics.”

Writing for the majority, Judge Prost explained that the decision to reverse the district court’s judgment with respect to induced infringement rested on two independent grounds: (A) absence of intent, and (B) absence of an inducing act that could support liability during the six-year statute of limitations on collecting back-damages, as set forth in 35 U.S.C. § 286.  (In a 2019 post, Dennis explains why it is correct to refer to the Section 286 limitation on damages as a “statute of limitations.”  For the record, Judge Newman uses the term in her  Roche Diagnostics dissent.)

Regarding absence of intent, the court found that the district court had, in denying JMOL, “incorrectly applied a negligence standard rather than requiring specific intent for inducement.” Judge Prost explained that:

While it’s true that we previously applied a “knew or should have known” formulation, we’ve since made clear that, “to the extent our prior case law allowed the finding of induced infringement based on recklessness or negligence, such case law is inconsistent with Global-Tech and no longer good law.”  …  Under the proper standard, the jury’s inducement conclusion is unsupportable.

The majority went on to explain that a finding of induced infringement was fundamentally inconsistent with the district courts conclusion (made in the context of a JMOL of no willful infringement) that “at no time did Roche have a subjective intent to infringe (or induce infringement of) Meso’s patent rights.”  In particular, the district court found that Roche had reasonably (albeit ultimately incorrectly) concluded that Meso did not have an exclusive license in the patents, and thus that Roche had no liability to Meso for patent infringement. Judge Prost explained that:

In some respects, the intent standard for inducement is akin to the one for willfulness, as both rest on the subjective intent of the accused infringer. … Here, the jury’s verdict of inducement couldn’t have survived JMOL under the proper intent standard because it contradicts the court’s express findings regarding Roche’s subjective belief that it wasn’t infringing or inducing infringement.

The majority further found that Meso had not proven that Roche had committed inducing acts within the Section 286 patent-damages limitations period, which began in April 2011. In particular, Roche’s allegedly inducing acts, i.e., its press release, customer letter, and decision to stop affixing field-restriction labels, occurred solely in 2007.

In sustaining the jury’s verdict of induced infringement, the district court had posited that acts occurring before the damages period could support a finding of inducement if they “continued to have an impact and caused third parties to use the products-at-issue outside of the licensed patient-diagnostics field after April 2011.”  The majority rejected the district court’s “continuing-impact” standard, citing Standard Oil Co. v. Nippon Shokubai Kagaku Kogyo Co., 754 F.2d 345 (Fed. Cir. 1985), and finding that “Roche’s press release, customer letter, and removal of field restrictions cannot support the jury’s induced-infringement verdict because the evidence indicates—and Meso doesn’t dispute—that none of these acts occurred within the damages period.”

Meso argued that Roche had committed inducing acts during the damages period because Roche “sold the products without restrictive labels throughout the damages period.” But the majority found that “sales without restrictive labels are not acts of inducement where, as here, the products have both in-field (non-infringing) and out-of-field (infringing) applications.”

The court further found that:

Even if Standard Oil doesn’t foreclose the district court’s “continuing-impact” standard, we reach the same conclusion because Meso didn’t provide evidence of causation between the allegedly inducing acts (before the damages period) and the direct infringement (within the damages period). Specifically, Meso put forward no evidence that any customers purchasing Roche’s products during the damages period received the 2007 communication and, in reliance on it, used the products out-of-field. …  For similar reasons, Meso’s argument that Roche induced infringement because it “never withdrew” its 2007 guidance also fails, at least because Meso didn’t show that this omission caused customers to infringe.

Readers might find it interesting to compare Judge Prost’s opinion in this case with her dissent in the Federal Circuit’s recent “skinny label” decision, Glaxosmithkline v. Teva, 7 F.4th 1320 (Fed. Cir. 2021) wherein she discusses induced infringement, and particularly her interpretation of the causation element of inducement.

License Scope:  Meso’s exclusive license in the ECL patents arose out of a joint venture agreement between IGEN and Meso Scale Technologies, a company owned by Jacob Wohlstadter (son of IGEN CEO Samuel Wohlstadter).  The agreement specified a “Research Program” for Meso to perform and included the following license provision:

2.1. IGEN Technology. IGEN hereby grants to [Meso] an exclusive, worldwide, royalty-free license to practice the IGEN Technology to make, use and sell products or processes (A) developed in the course of the Research Program, or (B) utilizing or related to the Research Technologies; provided that IGEN shall not be required to grant [Meso] a license to any technology that is subject to exclusive licenses to third parties granted prior to the date hereof. In the event any such exclusive license terminates, or IGEN is otherwise no longer restricted by such license from licensing such technology to [Meso], such technology shall be, and hereby is, licensed to [Meso] pursuant thereto.

With respect to the directly infringed patent, the majority affirmed the district court’s determination that the patent was “developed in the course of the Research Program,” and therefore, under “prong A” of the provision, Meso had exclusive rights in the asserted claim.  The court noted that “the work that was done in this patent was part of the research program,” and that Roche had not provided any persuasive reason why the asserted claim wasn’t “developed in the course of the Research Program.”  According to the majority:

The most Roche offers on this score is a footnote arguing generally that “the evidence at trial was insufficient for the jury to find that Meso held exclusive rights to the entirety of the ‘939 patent claim” and citing further course-of-conduct evidence. But this argument, “made in passing only in a footnote, is not sufficient under our precedents to preserve an argument for review.”

The majority found it unnecessary to decide whether Meso had an exclusive license in the patent claims that were only infringed indirectly, given that the district court’s finding of induced infringement had been reversed.

Writing in dissent, Judge Newman argued that Roche was not liable for infringement of any of the patents, since, under her interpretation of the license provision, Meso did not have an exclusive license to any of them.  She found the jury’s verdict to be “contradicted by the activity of all parties at the time of the 1995 license and the ensuing twenty-two years (citing Old Colony Tr. Co. v. City of Omaha, 230 U.S. 100, 118 (1913) (The practical interpretation of a contract by the parties to it for any considerable period of time before it comes to be the subject of controversy is deemed of great, if not controlling, influence)).”

Judge Newman also took issue with what she she saw as the majority’s decision to “disregard[] the undisputed evidence of [Meso]’s acceptance of Roche’s rights, because Roche mentioned that evidence in a footnote.” In her view:

Although presented in footnotes, these arguments were fully developed. The majority’s holding that Roche forfeited this issue defeats “the orderly administration of justice,” instead presenting a trap for the unwary. The judicial obligation is to seek truth and justice, even from footnotes.

Clearly, an attorney addressing the court should think twice before using a footnote to make a substantive point.

Prosecution Disclaimer – What is Clear from the Record

by Dennis Crouch

Courts continue to struggle with their use of evidence for claim construction.  The recent case of Genuine Enabling Tech. LLC v. Nintendo Co., Ltd., 2022 WL 982246, — F.4th — (Fed. Cir. Apr. 1, 2022), shows us subtle dividing lines between applicant statements (1) that create a disclaimer compared with those (2) that are merely helpful for interpretation.  The decision offers solace to careful patent prosecutors that the courts should not unduly extrapolate upon arguments distinguishing the prior art.

The normal rule of claim construction is that claim terms should be given “the meaning that the term[s] would have to a person of ordinary skill in the art in question at the time of the invention, i.e., as of the effective filing date of the patent application.” Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005)(en banc).  That rule is tempered by the requirement that courts consider the specification and prosecution history as relevant to shape our understanding.  At times a patentee will particularly define a claim term–and that definition will control its scope. Similarly, a patentee may disclaim or disavow claim scope. Disavowal generally requires  a clear statement that shows “unmistakable [and] unambiguous evidence of disclaimer.”  Omega Eng’g, Inc, v. Raytek Corp., 334 F.3d 1314, 1332 (Fed. Cir. 2003).  In litigated cases, the prosecution history rarely includes an express statement of disclaimer–“I hereby disclaim ….”–forcing courts to draw the lines in a murky field.

I see disclaimer as an examination failure.  When a patentee distinguishes the prior art based upon non-apparent limitations, the examiner should require the patentee to amend the claims by adding limitations rather than permitting the patentee to re-define claim terms on the fly.  If the specification would not support such an amendment, then the specification also would not support the disclaimer.  In Genuine Enabling Tech., the examiner accepted a distinguishing argument and issued the patent — leading to the case at hand.

Background on GET: Nguyen’s U.S. Patent No. 6,219,730 stems from his invention of a “voice mouse.”  The apparatus works like a regular computer mouse but also allows for sound input/output through the mouse.  The sound signal is then combined and synchronized with the mouse movement signal to be sent to and from the computer.   In the drawings sheet below, you can compare the prior art (Fig. 1A – sound connected to PC via sound-card) to Nguyen’s invention (Fig. 1B – sound connected through the mouse).

Although I described the two inputs as a mouse-movement signal and a sound signal, the patent claims actually use much broader terms: a “user input stream” (i.e., the mouse movement) and an “input signal”  (i.e., the audio signal). These two signals are encoded into a “combined data stream” for transfer across a communication means.  In its lawsuit against Nintendo, the patentee argues that Wii and Switch controllers embody the invention. In particular, the “user input stream” is “generated by the user pushing buttons” and the “input signal” comes from the accelerometer.  At the district court, Nintendo successfully argued that “input signal” should be narrowly construed to exclude the accelerometer.  In particular, the district court found that  the patentee’s prosecution disclaimer required the narrow construction.

1. A user input apparatus … comprising:

user input means for producing a user input  stream;

input means for producing [an] input signal;

converting means for receiving [the] input signal and producing therefrom an input stream; and

encoding means for synchronizing the user input stream with the input stream and encoding the same into a combined data stream transferable by the communication means.

US6219730, claim 1.

Input Signal. When interpreting the term “input signal,” the district court looked to the specification and also the prosecution history to limit “input signal” to signals at >500 Hz, and “excluding positional change, physiological response, or other “slow-varying information.”  Nintendo argued that this construction offered two reasons for non infringement, one of which was accepted by the district court.

  • Argument 1: Controller accelerometers signaled positional change and therefore cannot create the claimed ‘input signal.’ The district court rejected this argument–concluding that accelerometers measure acceleration, not position.
  • Argument 2: Controller accelerometers send signals at <500 Hz and therefore cannot create the claimed ‘input signal.’ The district court agreed with this argument and thus dismissed the case on summary judgment for lack of infringement.

On appeal, the Federal Circuit has rejected that construction as unduly limiting.

During prosecution, the examiner rejected the claims as obvious based upon a prior patent (Yollin).  Yollin disclosed a mouse/joystick that combined the mouse movement signal with a button-pushing signal as well as signals from potential biometric sensors (muscle tension, heart activity, brain activity, blood pressure, etc.).   Those all look like “input signals”–but the patentee argued  in its OA response that the “slow varying” signals were fundamentally different from the sound-related input signal he was claiming.  Rather, his claimed “input signal” was directed to “signals containing audio or higher frequencies.” He also showed that the Yollin approach would not work for high frequency signals because it did not account for signal collision.  The examiner accepted the distinguishing argument and allowed the case.

At the Markman hearing during litigation, Nintendo’s expert conducted an analysis of the ‘slow varying’ signals found in Yollin and concluded that they could operate at a range of up to 500 Hz.  The district court concluded that by arguing around Yollin, the patentee had effectively disclaimed all input frequencies below 500 Hz.

On appeal, the patentee admitted that its prosecution statements did create a disclaimer, but argued that the district court overreached. For its part, the Federal Circuit first noted that the expert testimony was not necessary and unduly stole attention from the intrinsic evidence.

Regarding the 500 Hz threshold, the district court erred by relying on expert testimony to limit the claim scope in a manner not contemplated by the intrinsic record. . . [T]he 500 Hz frequency threshold has no basis anywhere in the intrinsic record.

Slip  Op. Disclaimer must be clear, and so we look to the words of the applicant. The applicant here particularly stated that its claimed “input signal” was directed to “signals containing audio or higher frequencies.”  That is the disclaimer, nothing more.  “We conclude that the only disavowal of claim scope that is clear and unmistakable in the record before us is Mr. Nguyen’s disavowal of signals below the audio frequency spectrum.” Slip Op.

On remand the parties will take the next step of arguing about (1) what is the low point for the audio frequency and (2) whether the Nintendo controller signals operate above that frequency.  In its decision, the Federal Circuit appears to have fully construed the claim term: “We therefore conclude that the proper construction of ‘input signal’ is ‘a signal having an audio or higher frequency.'” Slip Op. That suggests to me that these arguments on remand will be part of the infringement case and thus factual questions for a jury to decide.  [Note here that Nintendo will also likely argue invalidity based upon the expanded claim scope].

= = = =

Note – the court’s rejection of expert testimony here contrasts with its demand for expert testimony in the Williamson v. Citrix line of cases where the court is asking whether a particular claim term inherently includes sufficient structure.

Justice Ketanji Brown Jackson

Congratulations to our newest member of the United States Supreme Court, Justice Ketanji Brown Jackson, confirmed today by by the US Senate.  Justice Brown Jackson will take office once Justice Breyer retires in June 2022.  She does not have substantial patent law experience, but does have extensive experience handling administrative law cases based upon her time as a Federal District Court Judge and Appellate Judge, both in the District of Columbia.

The Definiteness Implications of Using “Examples” to Define Claim Terms

by Chris Holman

ImmunoGen, Inc. v. Hirshfeld, 2022 WL 885774, (Fed. Cir. Mar. 25, 2022) (nonprecedential)

The patent application at issue in this case claims a method of treating a cancer patient by administering mirvetuximab (an immunoconjugate drug) “at a dose of 6 milligrams (mg) per kilogram (kg) of adjusted ideal body weight (AIBW) of the patient.” The purported invention arose out of the discovery that administration of mirvetuximab at the recited dosage significantly reduces the severe ocular side effects that were observed during Phase 1 clinical trials when the drug was administered at a dose of 7 mg per kg of the patient’s total body weight (“TBW”).  After the Patent Trial and Appeal Board (“Board”) affirmed the examiner’s rejection of the pending claims for obviousness and obviousness-type double patenting, the applicant (ImmunoGen) filed a § 145 suit in the Eastern District of Virginia challenging the rejections.  The district court determined on summary judgment that the claims are “fatally indefinite and fatally obvious” as a matter of law.  On appeal, the Federal Circuit vacated the grant of summary judgment and remanded for further proceedings.

The district court’s indefiniteness ruling was based on the claims’ recitation of “AIBW,” a term which the court found was not defined in the application in manner that would inform a skilled artisan, with reasonable certainty, as to the scope of the invention (the Nautilus standard).  The application defines AIBW as “a size descriptor that accounts for sex, total body weight, and height.” It further defines ideal body weight (“IBW”), which is used to calculate AIBW, as “an estimate of weight corrected for sex and height, and optionally frame size.”  The AIBW and IBW definitions each includes a specific formula, introduced by the phrase “for example,” for calculating the respective values.

The formulas are reproduced below in the form of equations:

AIBW = IBW + 0.4(Actual weight in kg – IBW)

IBW (male) = 0.9(Height in centimeters) – 88

IBW (female) = 0.9(Height in centimeters) – 92

These “example” formulas were also reproduced in Example 4 of the application, which relates to the dosing of mirvetuximab.

In support of its decision finding the claims indefinite, the district court relied primarily on the fact that the definitions section of the application preceded the AIBW formula with the language “for example,” which the court found “ma[de] clear that there are multiple ways to calculate AIBW,” thereby “leav[ing] a skilled artisan to wonder or to guess whether the formula provided is the only one covered by the ’809 Application.” This uncertainty was, in the view of the district court, compounded by: (1) similar “for example” language accompanying the IBW formula; (2) the disclosure that IBW corrects “for sex and height, and optionally frame size”; and the incorporation by reference in its entirety of “Green,” an article that discloses several methods for calculating IBW and lists correction factors, each specific to a different drug, that can be used to adjust IBW to AIBW.

On appeal, the Federal Circuit found that the material factual findings underlying the district court’s definiteness ruling were far from undisputed. In particular, ImmunoGen had identified other intrinsic evidence a skilled artisan would consider in determining the scope of the claims, including that: (1) the claims and specification are drawn to a specific dosing regimen for a specific immunoconjugate, which is significant in light of expert testimony that the correction factor used to calculate AIBW is drug-specific; (2) Example 4 describes dosing mirvetuximab in accordance with the claimed method and uses the same AIBW and IBW formulas disclosed in the definitions section; and (3) during the prosecution of the ’809 Application, the USPTO never disputed the definiteness, or gave any indication it failed to understand the meaning, of the now-allegedly indefinite term. ImmunoGen also presented extrinsic evidence regarding the knowledge of a skilled artisan. For instance, both parties’ experts testified that AIBW dosing involves drug-specific formulas and correction factors.

The Federal Circuit also found that the district court had erred in concluding that there was no disputed question of material fact with respect to obviousness.  It was undisputed that AIBW dosing had not previously been used for mirvetuximab, or for that matter any other immunoconjugate drug.

If on remand the court ultimately finds the claims indefinite for defining a critical claim limitation in terms of an “example,” it would not be the first time that the Federal Circuit has flagged this as an issue.  In Interval Licensing LLC v. AOL, Inc., 766 F.3d 1364 (Fed. Cir. 2014), the Federal Circuit held claims invalid for indefiniteness because the specification failed to adequately define the claim limitation “unobtrusive manner that does not distract a user.”  While “recognizing that a patent which defines a claim phrase through examples may satisfy the definiteness requirement,” the court “decline[d] to cull out a single “e.g.” phrase from a lengthy written description to serve as the exclusive definition of a facially subjective claim term.”  The court observed that “[h]ad the phrase been cast as a definition instead of as an example—if the phrase had been preceded by “i.e.” instead of “e.g.”—then it would help provide the clarity that the specification lacks.”

Still, I think that Interval Licensing can be readily distinguished over ImmunoGen, in that Interval Licensing’s “unobtrusive manner that does not distract the user” claim limitation seems much more “facially subjective” than ImmunoGen’s “adjusted ideal body weight.”

USPTO Leadership Updates

Longtime Commissioner of Patents Drew Hirshfeld announced today that he plans to leave the USPTO this summer.  Until that point, he will likely serve as Acting Deputy Director to help Kathi Vidal hit the ground running as she begins her tenure as USPTO Director.  Hirshfeld writes:

Kathi Vidal … is, without a doubt, the right person to lead the USPTO. Not only is she highly qualified, but she has also repeatedly shown me and so many others how thoughtful and steadfast she is in her determination to do the right things for this agency and our nation’s inventors and entrepreneurs. She will be a great leader. . . . I cannot think of a better way to conclude my time at the agency than by helping Kathi in any way I can before a permanent deputy director arrives.

In this structure, Andy Faile will stay on as acting Commissioner for Patents until a new Commissioner is appointed by the Secretary of Commerce. 35 U.S.C. 3 (“The Secretary of Commerce shall appoint a Commissioner for Patents . . . for a term of 5 years.”).  Dave Berdan has been serving in the role of deputy director under Hirshfeld.  Berdan will likely return to his role as General Counsel — pushing Will Covey back to his permanent role of Deputy General Counsel and Director for the Office of Enrollment and Discipline (OED).

Welcome Prof. Chris Holman

I want to welcome Prof. Chris Holman to Patently-O. He’ll be writing about biotech patent law issues as they arise from time to time. Holman is a fellow professor within the University of Missouri System, although we are at different schools.

Prof. Holman was a scientist before shifting to law.  He earned his PhD in Biochemistry and Molecular Biology from UC Davis and was a post-doc fellow at Syntex Research/Roche Bioscience. Holman worked as a patent law professional for a decade–both at law firms and in-house at start-up biotech firms.  Holman became a law professor in 2005 and has written extensively about biotech IP issues.