Tag Archives: motivation to combine

USPTO Adapts to CAFC’s New Guidelines: What Design Patent Examiners Need to Know

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by Dennis Crouch

On May 22, 2024, the day after the Federal Circuit’s en banc LKQ v. GM decision, the USPTO issued a memorandum to its examiners providing updated guidance and examination instructions in light of the court’s overturning of the long-standing Rosen-Durling test for determining obviousness of design patents. The memo, signed by USPTO Director Kathi Vidal, aims to immediately align USPTO practices with the more flexible approach outlined by the Federal Circuit, which eliminated the rigid requirements that: (1) a primary reference be “basically the same” as the claimed design, and (2) secondary references be “so related” to the primary reference that features in one would suggest application to the other.  This is a major shift in examination practice for design patents so it will be important to watch the developments to see whether the office ramps up design examination. (more…)

Discerning Signal from Noise: Navigating the Flood of AI-Generated Prior Art

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by Dennis Crouch

This article explores the impact of Generative AI on prior art and potential revisions to patent examination standards to address the rising tidal wave of AI-generated, often speculative, disclosures that could undermine the patent system’s integrity.


The core task of patent examination is identifying quality prior art.  References must be sufficiently accessible, clear, and enabling to serve as legitimate evidence of what was previously known.  Although documents are widely available today via our vast network of digital communications, there is also increasing junk in the system — documents making unsubstantiated claims that are effectively science fiction.  Patent offices prefer patent documents as prior art because they are drafted to meet the strict enablement standards and filed with sworn veracity statements. Issued patents take this a step further with their imprimatur of issuance via successful examination.  Many of us learned a mantra that “a prior art reference is only good for what it discloses” — but in our expanding world of deep fakes, intentional and otherwise, is face value still worth much?

In a new request for comments (RFC), the USPTO has asked the public to weigh in on these issues — particularly focusing on the impact of generative artificial intelligence (GenAI) on prior art. (more…)

Munsingwear Mootness in Sumitomo Pharma v. Vidal

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by Dennis Crouch

Although non-precedential, the Federal Circuit’s new decision in Sumitomo Pharma v. Vidal offers the important conclusion that a patentee has no standing to appeal an invalidity holding once the patent expires, absent some showing of likely infringement during the prior six years.  Sumitomo Pharma Co. v. Vidal, No. 22-2276 (Fed. Cir. April 5, 2024).  The case is not so bad for the patentee because (more…)

Obviousness and Pharmaceutical Method of Treatment Claims

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by Dennis Crouch

In April 2024, the Federal Circuit issued a significant decision vacating a district court’s judgment that Janssen Pharmaceuticals’ dosing regimen patent claims were nonobvious. Janssen Pharms., Inc. v. Teva Pharms. USA, Inc., No. 2022-1258 (Fed. Cir. Apr. 1, 2024). The case involved Janson’s U.S. Patent No. 9,439,906, which claims methods of treating schizophrenia by administering specific doses of the long-acting injectable antipsychotic paliperidone palmitate.

Teva filed an Abbreviated New Drug Application (ANDA) seeking approval to market a generic version of Janssen’s Invega Sustenna product, which embodies the claimed methods. In the ensuing Hatch-Waxman litigation, Teva stipulated to infringement but challenged the patent on obviousness and indefiniteness grounds. Following a bench trial Judge Cecchi (D.N.J.) rejected Teva’s invalidity defenses, and Teva appealed.

On appeal, Judge Prost authored a unanimous opinion affirming the district court’s indefiniteness determination but vacating and remanding on obviousness.  Overall, this is a bad case for pharmaceutical formulary patents.

This post focuses on the court’s obviousness holding and its potential implications for pharmaceutical method of treatment claims more broadly. I make three key claims. . .

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Today’s Obviousness Key: Motivation to Combine

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by Dennis Crouch

The Federal Circuit’s recent decision in Virtek Vision International ULC v. Assembly Guidance Systems, Inc. focuses on the motivation to combine aspect of the obviousness analysis. The court’s ruling emphasizes that the mere existence of prior art elements is not sufficient to render a claimed invention obvious; rather, there must be a clear reason or rationale for a person of ordinary skill in the art to combine those elements in the claimed manner.  In the case, the IPR petitioner failed to articulate that reasoning and thus the PTAB’s obviousness finding was improper.

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More on Reasonable Expectation of Success from the Federal Circuit

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by Dennis Crouch

In Sisvel v. TCT Mobile and Honeywell, the Federal Circuit has affirmed the PTAB’s IPR findings that the claims are obvious.  The non-precedential decision provides further insight into the Federal Circuit’s reasonable expectation of success test.

Sisvel’s U.S. Patent 8,971,279 covers a method of sending Semi-Persistent Scheduling (SPS) deactivation signals that essentially “piggyback” on existing messages. SPS is a technique used in LTE networks to more efficiently allocate radio resources to user equipment (UE) for periodic transmissions, such as Voice over IP (VoIP). In SPS, the base station pre-allocates resources to the UE for a set period of time, reducing the need for frequent scheduling requests and grants. SPS deactivation signals are messages sent by the base station to the UE to indicate that the pre-allocated resources are being released and are no longer available for the UE’s periodic transmissions. These signals are necessary to free up the resources when they are no longer needed, allowing them to be reassigned to other UEs or used for other purposes.

In the context of Sisvel’s ‘279 patent, the invention was directed to a specific method of sending SPS deactivation signals by filling a preexisting binary field (the resource indication value or “RIV”) with all “1”s. This 111111111 technique was intended to provide a more efficient way of signaling SPS deactivation while still ensuring that the deactivation message would not be mistaken for a valid resource allocation message.  In the patented system, the string of ones would always be processed as an invalid value and never mistaken for a valid resource allocation message, providing stability to the network, regardless of size.

TCT Mobile and others petitioned for IPR, asserting that the challenged claims were obvious based on various combinations of prior art, including Samsung and Dahlman. The PTAB found the claims unpatentable as obvious, and Sisvel appealed. (more…)

Making a Proper Determination of Obviousness

Patent,

by Dennis Crouch

Earlier this week, the USPTO published updated examination guidelines regarding obviousness determinations under 35 U.S.C. §103. While these new guidelines are not legally binding, they offer important insight into how the Office plans to apply an even more flexible approach to obviousness — something Director Vidal sees as mandated by the Supreme Court’s 2007 decision in KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398 (2007). (2500 words).

Read the Guidance Here.

Overall the guidance here suggests that the office is looking to make non-obviousness a larger hurdle via increased flexibility.  Still, the guidelines spend some time on the requirements of a prima facie case; the necessity of both evidence and reasoning to support any obviousness rejection; and consideration of all evidence before the examiner.  Obviousness is already the most common rejection – with the vast majority of applications being initially rejected as obvious.  It will be interesting to see whether the rates go up even further following this new guidance. 

This post breaks down the guidelines and walks through some potential strategies for patent applicants. 

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Don’t Judge a Range by its Cover: Federal Circuit Sides with Patentee on Written Description Support

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by Dennis Crouch

In a recent decision, the Federal Circuit held that a claimed range reciting narrower values than those described in the patent specification can still satisfy the written description requirement under 35 U.S.C. § 112(a). RAI Strategic Holdings, Inc. v. Philip Morris Prods. S.A., No. 22-1862 (Fed. Cir. Feb 9, 2024). Reversing a PTAB post-grant review decision, the court ruled that claims reciting a heating element with having a length of 75-85% of the disposable aerosol-forming substance had adequate written description support even though the specification only described broader ranges, such as “about 75% to about 125%.” Id.

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Federal Circuit Upholds PTAB’s Obviousness Finding and Joinder Decision in CyWee v. ZTE Smartphone Patent Case

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The Federal Circuit recently affirmed a ruling by the Patent Trial and Appeal Board (PTAB) in an inter partes review (IPR) filed by ZTE and joined by LG, finding claims of CyWee Group’s U.S. Patent No. 8,441,438 unpatentable as obvious. CyWee Group v. ZTE, No. 21-1855 (Fed. Cir. Jan. 18, 2024). The ’438 patent claims 3D motion-tracking technology for handheld devices like smartphones. The appeal included both IPR procedural issues and substantive patent law issues.  In siding with the PTAB, the Federal Circuit rejected CyWee’s argument that the Board should not have allowed LG to oppose CyWee’s motion to amend its claims. The court also affirmed the Board’s finding that the proposed amended claims would have been obvious over the prior art. (more…)

Seeing Clearly: Article III Standing of IPR Judicial Review

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

Article III standing remains a hot topic at all levels of federal litigation and across many different areas of law. Inter partes review is not unique. In Allgenesis Biotherapeutics Inc. v. Cloudbreak Therapeutics, LLC, Case No. 22-1706 (Fed. Cir. Nov. 7, 2023), the Federal Circuit dismissed, in a unanimous opinion by Chief Judge Moore, an appeal of a PTAB final IPR decision before reaching the merits by finding that the IPR challenger did not allege sufficient “injury in fact” to confer standing necessary for Article III judicial review.  

Pterygium is the result of cellular expression of kinase in the cornea that expands beyond control and creates tumors. With surgery as the only viable course of treatment, Cloudbreak Therapeutics created a topical application of multikinase inhibitors to provide a non-surgical treatment to prevent recurring tumors, which is recognized in U.S. Patent No. 10,149,820 (the ‘820 patent). Specifically, nintedanib is one of the most powerful multikinase inhibitors for reducing corneal neovascularization, a principal cause of pterygium.

Pterygium - Eye Doctors

Allgenesis petitioned for IPR of all eleven claims of the ’820 patent.  After the Board instituted, Cloudbreak disclaimed the genus claims, i.e., claims 1–3 and 6–11, leaving only claims 4 and 5, which more narrowly claim the use of nintedanib.  The Patent Trial & Appeal Board issued a final written decision finding that Allgenesis failed to show that the remaining two claims were unpatentable overcoming prior art and motivation to combine asserts. As part of its decision, the Board made a priority decision that a Patent Cooperation Treaty (PCT) application belonging to Allgenesis was not prior art to Cloudbreak’s patent.  While standing was not necessary to file an IPR because of the administrative nature of the PTAB, standing is a constitutional requirement for appeal to the federal courts. 

The Federal Circuit dismissed Allgenesis’s appeal because Allgenesis failed to establish Article III standing to appeal. Article III standing stems from the Constitutional requirement that federal courts only decide actual “cases” and “controversies” and avoid speculative advice administration. Lujan v. Defs. of Wildlife, 504 U.S. 555 (1992) is the seminal Supreme Court case that set forth the requirements for establishing Article III standing – namely that a party must show: 

  1. An “injury in fact” that is concrete, particularized, and actual or imminent (not hypothetical) 
  1. Causation between the injury and the challenged conduct 
  1. Redressability (a favorable court decision would likely redress the injury) 

In Lujan, the Court found the plaintiffs failed to show an imminent, concrete injury since their professed intentions to return to project sites at some indefinite time were insufficient. The Court also held that plaintiffs could not establish standing based solely on a “procedural injury” from violation of the consultation procedure, absent showing impairment of a separate concrete interest. Compare to Allgenesis. Specifically, Allgenesis did not show: 

  • An injury-in-fact based on potential infringement liability from its plans to develop a nintedanib product, because its plans were not sufficiently concrete. 
  • An injury-in-fact from the PTAB’s priority date determination, because any preclusive effect was speculative and Allgenesis did not sufficiently articulate how it impaired its own patent rights. 

Allgenesis argued it had standing based on potential infringement liability from developing nintedanib treatments for pterygium. The court found Allgenesis failed to show concrete plans creating a substantial risk of future infringement as Allgenesis’ VP of Finance declaration did not identify specific plans beyond a Phase II trial years ago, nor any current plans for Phase III trials or any efforts to seek FDA approval for their own nintedanib product. Likewise, settlement talks related to the IPR petition were insufficient to show its activities would likely cause Cloudbreak to assert infringement. 

Allgenesis also argued injury because the Board found the ‘820 patent claims were entitled to a June 2015 priority date, making Allgenesis’ PCT with a June 2015 filing date not prior art. Allgenesis asserted this would have a preclusive effect on its pending application claiming priority to its PCT. However, the court found Allgenesis did not establish any preclusive effect. Importantly, collateral estoppel will not attach to a non-appealable determination like the Board’s determination of priority. Therefore, if an examiner would find that Cloudbreak’s application served as prior art to Allgenesis’ pending application, Allgenesis would be able to challenge that on a separate appeal. For standing, any potential injury that may result from a future examiner’s action is too speculative.  

The precise line for what consists of “concrete plans” seems to be especially uncertain in a highly uncertain business like the life sciences and pharmaceutical business here. Prospectively applying the Court’s position, to even reach the merits, drug development companies that act as challengers in IPR proceedings will need to develop more factual support for standing, including clinical trials, timelines for future events, pending information regarding company target dates with regulatory agencies, economic data, or even sensitive company business data. These disclosure requirements may face resistance for business, competitive advantage, or any number of reasons but should be a relevant factor in determining whether to proceed with IPR petitions. 

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Note from Crouch: One key importance here is that the Federal Circuit demanded evidence of concrete injury.  At oral arguments, Allgenesis attorney Don Mizerk stated plainly that its client was practicing the invention, but that attorney statement was insufficient.

  • Court: I was curious as to what do you think is your best argument for why you have Article III standing?
  • Mizerk: Well, Your Honor, I think it’s a pretty clear case that we have standing. We are practicing the method that is claimed.
  • Court: Where is the evidence? … [W]here’s the proof that you’re doing that?

Although the court did not get into this issue, the Phase II trials conducted by Allgenesis would not likely create infringement liability because of the 271(e) safe harbor.

The Complex Fact/Law Divide in Obviousness Analysis

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by Dennis Crouch

The intersection between factual inquiries and legal conclusions in patent law is a complex and ever-evolving area, this is especially true in obviousness doctrine. A recent Federal Circuit decision highlights the tricky analysis required in assessing obviousness and damages in patent cases. In Cyntec Co. v. Chilisin Electronics Corp., the appellate court examined whether the lower court’s directed verdict (JMOL) of nonobviousness improperly removed factual questions from the jury.  This case provides an important reminder of the care required in delineating the fact finding and legal determinations in patent trials.  As is common, I think both the District Court and the Federal Circuit got it wrong.

Note, the court’s decision includes an interesting analysis of damages, finding that the plaintiff’s damages expert should have been excluded. It also includes a useful claim construction decision on when to give a term its plain and ordinary meaning.

A molded choke is a device used in electronic devices to filter undesirable signals.  The device contains a coiled conducting wire encapsulated in a molded mixture of magnetic powder. The powder is heated to a sufficiently high temperature to allow it all to bond together.  The patentee, Cyntec, had experienced some difficulties in creating the devices — with the high heat causing various problems such as melting the conducting wire or its insulative layer.  The solution that they hit upon was using a mixture of magnetic powders with different hardness and particle sizes.  This permitted a lowering of the required molding temperature and thus avoided wire damage during molding.  See U.S. Patent Nos. 8,922,312 and 9,481,037.

Competitor Chilisin began selling its own molded chokes and Cyntec sued for infringement.  At trial, Chilisin presented invalidity arguments that the claims were obvious based on two prior art references – Shafer and Nakamura. However, the district court granted JMOL of nonobviousness in favor of Cyntec before the case went to the jury (i.e., directed verdict). The jury subsequently found infringement and awarded full lost profits damages based on Cyntec’s expert calculations.

Although obviousness is ultimately a question of law, it depends upon upon substantial factual finding.  The particular threshold of where factual findings end and legal conclusions begin is quite tricky in this area.  In KSR, the Supreme Court appeared quick to determine as a matter of law that it PHOSITA would have been motivated to combine the references in a way rendering the claims obvious.  In subsequent cases, however, the Federal Circuit took pains to tease out motivation to combine from the ultimate conclusion of obviousness.

“Before KSR, we had also consistently treated the question of motivation to combine prior art references as a question of fact… KSR did not change this rule ….” Wyers v. Master Lock Co., 616 F.3d 1231, 1238–39 (Fed. Cir. 2010) (as quoted in Apple Inc. v. Samsung Elecs. Co., Ltd., 839 F.3d 1034, 1051 (Fed. Cir. 2016) (en banc)).

But, the fact/law divide is a bit more complicated in Cyntec because it involves a Judgment as a Matter of Law (JMOL).  We typically have two distinct types of legal questions at the JMOL stage:

  1. Regular questions of law, such as the meaning of a statute or the ultimate conclusion of a patent claim’s obviousness; and
  2. Lopsided questions of fact, where the evidence so favors one-side that no reasonable jury could find otherwise.

At JMOL, the district court is empowered to make these two types of legal conclusions, but cannot otherwise invade the jury’s factfinding role.

Adding to the difficulty is the reality that determination of the Graham factors rarely lead directly to the obviousness/nonobvious determination.  In Graham, the Supreme Court indicated that courts should work through the following for step fact-finding process and then rely upon the results to make the ultimate legal conclusion of obviousness.

These factual questions include: “(1) the scope and content of the prior art, (2) differences between the prior art and the claims at issue, (3) the level of ordinary skill in the pertinent art, and (4) [if presented,] the presence of objective indicia of nonobviousness such as commercial success, long felt but unsolved needs, failure of others, and unexpected results.”

Cyntec Co. v. Chilisin Electronics Corp., No. 22-1873 (Fed. Cir. Oct. 16, 2023) (quoting Elbit Sys. of Am., LLC v. Thales Visionix, Inc., 881 F.3d 1354, 1357 (Fed. Cir. 2018)).   The point here is that even after the fact-finder has made all the factual findings, there is still quite a bit of work for a the law-decider to do.  That said, quite a bit of the work is occupied by the motivation-to-combine factual finding.

Here, the patentee presented prior art and testimony regarding a motivation to combine. The district court found the evidence insufficient and awarded JMOL for the patentee.  On appeal, the Federal Circuit vacated that decision and instead concluded that “Chilisin presented the jury with evidence that would have allowed it to reasonably find the asserted claims obvious in view of Shafer and Nakamura. . . . Taken together and drawing all reasonable inferences in Chilisin’s favor, this evidence is enough for a reasonable jury to have found that the asserted claims would have been obvious.”

I have an important nitpick with the appellate court’s decision that goes back to the complexity of the law-fact divide in obviousness analysis.  The court skipped an important step by simply concluding that a reasonable jury could have found the claims obvious. Recall that obviousness is a question of law, and at JMOL we are only concerned taking disputed facts away from the jury.  The appellate court should have instead explained something like the following: “that the defendant presented evidence sufficient to put the factual question of motivation-to-combine into dispute in a way that, if taken as true, would lead to a legal conclusion of obviousness.”

The distinction here is important, the Federal Circuit’s rule here makes it harder to award summary judgment of non-infringement because it places an additional layer of reasonableness on the ultimate legal conclusion of obviousness. But that is a question of law, and with questions of law we don’t account for reasonable fact finders but instead ask only whether the question was decided rightly or wrongly. This distinction is why legal determinations are reviewed de novo on appeal and factual findings are given deference. This analysis also reveals the dirty secret that, although the law does not permit reasonable deference into legal questions, reasonable minds regularly do disagree upon the conclusion of obviousness even after making all the underlying factual findings.

On remand, the district court must ensure that the jury is tasked only with resolving the factual disputes, while reserving the ultimate legal question for itself. Carefully delineating the fact finding and legal conclusions will be critical to applying the proper review on any subsequent appeal.

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Regarding damages, the Federal Circuit found the district court abused its discretion in admitting Cyntec’s expert testimony on alleged lost profits. Cyntec’s expert used total revenue from customer SEC filings to estimate what percentage of products containing the accused chokes were imported into the U.S. However, the appellate court found his methodology “speculative” because the filings included revenue from products that did not contain accused chokes, without distinguishing between them. Citing precedent like Power Integrations, Inc. v. Fairchild Semiconductor Int’l, Inc., 711 F.3d 1348 (Fed. Cir. 2013), the Federal Circuit held the expert “assumed that (1) the sales revenue reported in the customers’ Form 10-K reflected sales of products with molded chokes; and (2) each third-party product shipped into the United States contained an infringing choke.” This “speculative” testimony should have been excluded under Daubert. The appellate panel thus vacated the lost profits award.  On remand, the damages calculation will need to be reevaluated without the flawed expert testimony, likely with a new trial focusing on obviousness and damages.

 

Sisvel v. Sierra Wireless – Useful Guidance for Prosecutors on Motivation to Combine and Means-Plus-Function Claims

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by Dennis Crouch

Today’s post introduces the new decision in Sisvel International S. A. v. Sierra Wireless, Inc., No. 22-1493 (Fed. Cir. Oct. 6, 2023).  Here, I focus on two distinct issues. The first part has to do with motivation-to-combine, with the decision offering some good language for patent prosecutors attempting to overcome weakly worded office actions.  The second part focuses on means-plus-function language and concludes with my rant about the court’s unduly complicated layers of tests.  The case also upholds a single-reference obviousness holding, but I didn’t write about that portion of the decision.

Justifying a Motivation to Combine

In the IPR, the PTAB cancelled some claims of Sisvel’s U.S. Patent No. 6,529,561 based upon a single-reference obviousness determination (Chen; WO 99/26371), but sided with the patentee as to other claims. The Board particularly found no motivation to combine One of the key reasons was because of a lack of motivation to combine Chen with other GSM references.

On appeal, the Federal Circuit affirmed these findings.  US patent law has a long history of debate with regard to combination claims, with the Supreme Court’s most recent pronouncement in KSR reaffirming its old pronouncement that a combination of known elements is likely obvious absent some justification for deciding otherwise.  KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398 (2007).

[I]f a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond his or her skill. . . . The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.

Id.  Referencing Sakraida v. Ag Pro, Inc., 425 U.S. 273 (1976); Anderson’s-Black Rock, Inc. v. Pavement Salvage Co., 396 U.S. 57 (1969); and Great Atlantic & Pacific Tea Co. v. Supermarket Equipment Corp., 340 U.S. 147 (1950).

Despite this lower bar, IPR petitioners still have the burden of at least explaining why a skilled artisan would have been be motivated to combine various references to form the claimed invention.  This is so, even if that explanation is simply a showing of how its case fits the model set out in KSR.

Here, however, the Board concluded that the IPR petitioner had failed that low burden.  In particular, in this case the petitioner offered “reasons to combine [that] were merely assertions that the references were analogous art, which, without more, is an insufficient articulation for motivation to combine.”  Rather, as KSR suggests, the known elements need to be combined “according to known methods” and yield only “predictable results.”  Although the petitioner might have recited these legal conclusions in its petition, the Board found them too conclusory and lacking in clarity.  Rather, the Board indicated that a proper motivation to combine analysis would explain how the primary reference is modified by the GSM reference.  As I mentioned above, this is a fairly low standard under KSR, but the Board explained that the petition failed to explain: “what reference is the primary versus secondary reference, what elements are missing from the primary reference, what elements should be added from the secondary reference to reach the claimed invention, or why those particular elements would be obvious to add.”

On appeal, the Federal Circuit affirmed the lack of motivation to combine – holding that “we cannot fault the Board for being at a loss in trying to decipher Cross-Appellants kitchen-sink of unclear and confusing motivation-to-combine arguments.”

Sisvel’s ’561 patent, owned by Sisvel, relates to improving channel coding techniques in transmitting data for radio systems. Channel coding adds redundant data bits to a data block before transmission to allow a receiver to better detect and correct errors caused by noise or other interference. The invention particularly employs “link adaptation” and “incremental redundancy” to optimize channel coding. Link adaptation allows the transmitter to adjust the code rate between data block transmissions by changing the number of redundant bits. Incremental redundancy allows the receiver to combine original and retransmitted data blocks to improve decoding.

The Federal Circuit’s affirmance on motivation to combine could be useful for patent prosecutors facing obviousness rejections. While the explanatory burden on an IPR petitioner is higher on the IPR petitioner than on a patent examiner, prosecutors may find Sisvel helpful in arguing an examiner provided inadequate rationale for combining references. Patent applicants could cite Sisvel in contending an office action improperly combines references without particularly explaining: (1) the primary and secondary references; (2) missing elements supplied by the secondary reference; (3) why a skilled artisan would have looked to the secondary reference to fill gaps in the primary reference; (4) why adding the secondary reference’s teaching would yield predictable results; etc. Although Sisvel arose in the context of invalidity allegations by an IPR petitioner, the motivation to combine principles apply equally during prosecution. By requiring examiner explanations meet KSR’s standards, applicants may succeed in overcoming some obviousness rejections.

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The Noah Test as One Layer of Means Plus Function Analysis

The case also includes an interesting discussion about a means-plus-function limitation found in some of the claims, and the question of whether the claim is indefinite.  As you know, a claimed means plus function limitation is interpreted as covering the corresponding structures disclosed within the specification along with their equivalents.  35 U.S.C. 112(f).  But we have a special null case — if no such structures are disclosed then the Federal Circuit has ruled that the associated claim is automatically invalid as indefinite.  This gets a bit trickier for inter partes review proceedings since the petitioner is not permitted to challenge claims based upon indefiniteness. In Intel Corp. v. Qualcomm Inc., 21 F.4th 801 (Fed. Cir. 2021), the Federal Circuit instructed the PTAB to take the following approach to potentially indefinite MPF claims:

  1. Impossibility: Determine that the claim is indefinite and then decide whether the indefiniteness prevents a prior art analysis (the “impossibility” conclusion); or
  2. Possibility: Explain why it is able to construe the claim and resolve the prior art issues despite potential indefiniteness.

In either case, the PTAB needs to make some moves toward determining whether the limitation includes sufficient structural support in the specification.

Here, Claim 5 of the ’561 patent requires a “means for detecting a need for retransmission.”  The specification does not specify a particular algorithm to accomplish this goal, but does disclose protocols like “ARQ” and “hybrid ARQ.”  In situations like this, the Federal Circuit has created an unduly complicated framework  to determine whether expert testimony can be used to fill gaps in the structural explanation of algorithmic MPF claims. Noah Systems, Inc. v. Intuit Inc., 675 F.3d 1302 (Fed. Cir. 2012). At step one, the Noah framework specifically asks whether any algorithm is disclosed.  If no algorithm then no expert. In Noah step two, where an algorithm is disclosed but arguably inadequate, its sufficiency is judged based on a skilled artisan’s perspective and expert testimony is permitted to support the conclusions. Id.

Here, the PTAB found that references to “ARQ” and “Hybrid ARQ” were not algorithms.  On appeal the Federal Circuit found error in that conclusion. In particular, the court held the PTAB erred by not evaluating the protocol names under the step two framework. The court explained that even “brief disclosures” may warrant assessing expert views on their import to a skilled artisan. Because the specification explicitly referenced protocols, it was not wholly devoid of structure. The court vacated and remanded for the PTAB to conduct a step two analysis, including evaluating expert testimony.

This holding provides useful guidance for assessing computer-implemented means-plus-function claims. The Federal Circuit appropriately avoided rigid formalism, recognizing algorithm disclosures need not detail every step and by recognizing that  reference to commercially available tools can satisfy the structural requirement of 112(f).  Still, I would have simplified this approach and simply held that the claim covered the disclosed protocols. After Sisvel, courts evaluating software means-plus-function limitations must carefully walk the line between Noah’s step one and two.

Conclusions: The means-plus-function doctrine was originally designed to allow patent applicants to claim an element by the functions it performs rather than reciting structure, with the goal of providing a simple and flexible claiming technique. However, as evidenced by the complicated Noah framework sitting atop Williamson and Donaldson, Sisvel’s nuanced analysis of whether disclosed protocols qualify as algorithms, means-plus-function claims have become one of the more complex and controversial doctrines in patent law. The current morass of rules, exceptions, and expert testimony required to assess even basic computer-implemented means-plus-function claims suggests the doctrine has veered far from its original purpose. In my view, courts should seek to simplify the rules and refocus on whether the specification provides sufficient information to allow a skilled artisan to understand the boundaries of the functional claim element.

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  • Sisvel International S.A.: Represented by Robert Gajarsa, Timothy Devlin, and Neil Benchell of Devlin Law Firm.
  • Sierra Wireless, Inc.: Represented by Kourtney Merrill of Perkins Coie LLP and Amanda Tessar.
  • Telit Cinterion: Represented by Guy Yonay of Pearl Cohen and Kyle Auteri.
  • Opinion: Authored by Judge Chen and joined by Chief Judge Moore and Judge Clevenger.

How Prosecution History Can Support a Motivation to Combine

Patent

by Dennis Crouch

Elekta Ltd. v. Zap Surgical Systems, Inc., — F.4th — (Fed. Cir. Sept 21, 2023)

The recent Federal Circuit decision in Elekta v. ZAP Surgical provides an interesting case study and also warning on how prosecution history can be used to support a finding of a motivation to combine prior art references, even when those references come from different fields.  Here, the patentee claimed a radiation therapy invention, but included references to imaging devices in its IDS.  That inclusion (along with some other evidence) led to an inference that PHOSITA would generally be motivated to combine art across these two fields.

Background on the Elekta Case

In Elekta, the patent-at-issue claimed a device for treating patients with ionizing radiation using a radiation source mounted on concentric rings. U.S. Patent No. 7,295,648. During an inter partes review (IPR) proceeding, the Patent Trial and Appeal Board (PTAB or Board) found the claims obvious based on a combination of two prior art references:

  • Grady, which disclosed an X-ray imaging device with the X-ray tube mounted on a sliding arm connected to rotating support rings. This was an imaging device.
  • Ruchala, which disclosed a radiation therapy device using a linear accelerator (linac) as the radiation source, where the linac rotates around the patient to deliver the radiation dose. This was a therapy device.

On appeal, Elekta argued that a person having ordinary skill in the art would not have been motivated to combine an imaging device like Grady with a therapy device like Ruchala. The Federal Circuit affirmed the Board, finding substantial evidence supported a motivation to combine, including the prosecution history.

Using the Prosecution History to Find an Implicit Motivation to Combine

A key dispute in Elekta was whether a person having ordinary skill would have been motivated to combine references from different fields – here, imaging and therapy.  Elekta argued that a key difference made the imaging art inapplicable to therapy. In particular, the linear accelerator used for therapy is quite heavy and so support systems designed for imaging are typically will not work.

The Board disagreed with the patentee and found a motivation to combine the imaging reference with the therapy reference. A key factor for the Board was that the patentee had cited imaging references in its information disclosure statement.

The Board supported this conclusion by reviewing “the prosecution of the ’648 patent, [which demonstrated that] patents directed to imaging devices were cited, and were not distinguished based on an argument that imaging devices were not relevant art.”

Slip Op.   Digging into the case history, I found that the patentee had cited an imaging device in its IDS filing and the examiner had cited the reference in an office action rejection.  The patentee distinguished the reference based upon its particular mounting configuration. But, the patentee did not raise any written objection to the reference being an imaging system rather than a treatment system.   Later, in the notice of allowance the examiner cited a different imaging system as state of the art for mounting radiation sources.  Again, the patentee did not raise any express objection to that characterization and its applicability to the claimed therapy system.

On appeal, the Federal Circuit affirmed that it was proper for the Board to infer a motivation to combine based (in part) on this citation history:

We hold that the Board’s finding that a skilled artisan would have been motivated to combine the [imaging] device with Ruchala’s linac [therapy device] is supported by substantial evidence, including the prosecution history of the ’648 patent … Specifically, as explained above, during prosecution, the patentee notably did not argue that prior art references directed to imaging devices were not relevant art.

Id.  The court found this prosecution history suggested an implied admission that both imaging and therapy references were relevant to the claimed invention, and thus established an implied motivation to combine the references.

I want to be clear on the holding here. The imaging references cited during prosecution are different from those relied upon in the IPR.  But, citing those imaging references created an inference that PHOSITA would consider other imaging references and even have a motivation to combine them with the therapy prior art.

One note – neither the Board nor the FedCir distinguished the particular prosecution history acts that were sufficient to create the inference.  When I first read the case, I assumed it was simply IDS citations, but learned of the rejection/NOA citations as I dug into the briefing.  In the briefing, the challenger noted that the imaging patent was the first-cited-reference and therefore was important – but the tribunals did not appear to give credence to that particular statement.  Bottom line, it appears that an IDS statement could be sufficient to trigger the inference, but the actual threshold is is unclear.

Takeaways from Elekta — Disclaimers

This case demonstrates the need for patent prosecutors to be very thoughtful and strategic when citing references, responding to rejections, and notices of allowance in order to avoid creating an unintended prosecution history record that could imply motivation to combine disparate references. The following are some specific steps prosecutors could take include:

  • When citing a reference in an IDS, drafting an explicit statement that the citation should not be construed as an admission that the cited reference comes from an area that is analogous or directly applicable to the invention, and rather that the reference is being cited out of an abundance of caution.
  • If an examiner cites a reference in a rejection from a separate area of technology, not remaining silent and instead actively responding on the record with an explanation of why the particular area of technology is not applicable or combinable due to key differences.
  • Even if rejections are eventually overcome on other grounds, reiterating for the record (and especially in the face of a contrary reason-for-allowance) that no admission is made regarding the applicability of art.
  • Drafting tailored disclaimers and statements to avoid implications of compatibility between disparate references, while balancing the need to prevent unintended admissions.

While it is important to avoid unnecessary concessions, applicants must be deliberate and strategic in crafting the intrinsic record, while also recognizing that these additional statements are contrary to substantial conventional wisdom advising applicants to avoid unnecessary statements in the prosecution history.

ApoA1-Fc Fusion Proteins: Federal Circuit keeps Patent Hopes Alive, Holding that the USPTO Must Explain its Decisions

Patent

In re Theripion, Inc., 2022-1346 (Fed. Cir. Aug. 10, 2023) (nonprecedential) (Opinion by Judge Stark, joined by Judges Hughes and Cunningham).

ApoA1 is a key component of HDL, also known as “good cholesterol.” The founders of Therapin created a synthetic “fusion protean” of ApoA1 linked to the Fc portion of an antibody (the stem).  That fusion extends the half-life of injected HDL and allows it to be a better potential drug treatment. The claims require a specific linker protein of 10-40 amino acids between the ApoA1 and Fc portions. Theripion discovered that this longer linker improved cholesterol efflux activity compared to fusion proteins having shorter 2 amino acid linkers or no linker.  So the essence of the invention as claimed is an ApoA1-Fc fusion protein with an optimized 10-40 amino acid linker that enhances the fusion protein’s ability to remove cholesterol from cells as compared to a much shorter or absent amino acid linker.  To be clear, the prior art (including some work by the inventors here) had created ApoA1-Fc fusions, but with a short linkage. And, various types of connectors of the claimed length were also known.

The crux of the obviousness case then is whether a person of skill in the art would expect that the use of a longer peptide linker in this situation would increase cholesterol efflux activity. The patent examiner rejected the claims as obvious and the PTAB affirmed despite evidence of unexpected results presented by Theripion.

On appeal, the Federal Circuit has vacated and remanded — holding that the PTAB did not sufficiently explain its decision.

It appears the Board was not persuaded by Theripion’s evidence of unexpected results. However, we cannot discern from its opinion the reasons for such a conclusion. Nor can we determine whether the Board adequately considered the totality of Theripion’s evidence.

Slip Op.

When making an obviousness determination, the Board must first articulate all necessary underlying findings, including establishing “an adequate evidentiary basis”  and “a rational connection between the facts found and the [legal determination] made.”  A written explanation is required, although the permits brief explanations in cases that are “simple and familiar” and where “the prior art is clear in its language and easily understood.”  In re Nuvasive, Inc., 842 F.3d 1376, 1382 (Fed. Cir.
2016).  Here, the PTAB failed to walk through its justification for finding no unexpected results — and for rejecting Theripion’s evidence. The court also found the Board’s explanation for motivation to combine references to be conclusory and lacking articulation of why a skilled artisan would have been motivated to combine the teachings.

PTAB Decision: 10780_1590931411-12-2021APDA
CAFC Decision: 22-1346.OPINION.8-10-2023_2171709

I should note the irony of this decision with the Federal Circuit requiring a clear explanation from the PTAB even though the Federal Circuit does not require the same of itself, despite statutory guidance to the contrary.

= = =

In this case, the Board first found the invention prima facie obvious before addressing any objective indicia of non-obviousness. On appeal, the Federal Circuit gave that approach a pass “So long as the Board considers all evidence before reaching an ultimate conclusion as to obviousness, there is nothing inherently wrong with proceeding in the order the Board did here.” See Adapt Pharma Ops. Ltd. v. Teva Pharms. USA, Inc., 25 F.4th 1354 (Fed. Cir. 2022).

Shifting Arguments at the PTAB

Patent

by Dennis Crouch

The Federal Circuit’s new decision in Rembrandt Diagnostics, LP v. Alere, Inc., 2021-1796 (Fed. Cir. Aug 11, 2023) complements the court’s recent decision in Axonics, Inc. v. Medtronic, Inc., 2022-1532 (Fed. Cir. Aug. 7, 2023). Ordinarily, an IPR petitioner must stick to the arguments and reasoning that it sets forth in the original petition.  These two cases take a contrary position and permit the petitioner to shift as late as the  final reply brief. The court permits these changes only if responsive to new arguments by the patentee and sufficiently linked to previously raised arguments.

This post focuses on Rembrandt.  A prior post looked at Axonics.

Rembrandt was previously before the Federal Circuit on the full-institution issue that the Supreme Court addressed in SAS Institute.  The PTAB had originally instituted Alere’s IPR petition on some but not all grounds presented.  In its 2019 decision, the Federal Circuit affirmed the PTAB’s claim construction but remanded for the PTAB to consider non-instituted grounds.   On remand, the PTAB instituted on all grounds and eventually concluded that additional claims were also unpatentable as obvious. On appeal this time, the Federal Circuit has affirmed — finding that the PTAB had properly found the claims obvious.

Rembrandt owns U.S. Patent No. 6,548,019 related to assay test strip devices for testing biological fluids.  As the figure shows, the setup is quite simple and allows for multiple strips to be tested at once.

One of the key issues raised on appeal was the presentation of new theories mid-stream by the petitioner Alere.  In particular, Rembrandt pointed to Alere’s reply brief as offering new theories.

Rembrandt argued Alere raised new theories about cost/time savings as a motivation to modify the MacKay reference to hold multiple test strips. However, the Federal Circuit found this was responsive to Rembrandt’s argument that there was no motivation to modify MacKay. Further, the cost/time savings was viewed as properly expanding on Alere’s previous “efficiency” argument.

Alere’s reply argument discussing cost and time savings has a nexus to Rembrandt’s prior argument and is responsive. It refutes Rembrandt’s assertions that there is no motivation to add multiple test strips or an expectation of success. And by discussing time and cost savings as a form of efficiency, it also properly expands on and is a fair extension of its previously raised efficiency argument.

Slip Op.

The Federal Circuit found an alternative reason to affirm — holding that forfeited its argument.  Before the PTAB, Rembrandt had generally objected to new theories presented by Alere.  However, the Federal Circuit concluded that generic objection was insufficient to timely assert its right. The Federal Circuit’s position was bolstered by the fact that Rembrandt had made a very specific objection regarding another new-theory issue that is not on appeal. “We hold that Rembrandt’s generic objection is insufficient to constitute a proper objection—especially because Rembrandt expressly objected to other allegedly new theories without doing so here.”

In addition to these procedural issue, the court also concluded that the Board’s conclusions were supported by substantial evidence. A key here is that Rembrandt did not provide expert testimony to rebut Alere’s expert. The prior art and expert testimony provide substantial evidence to support the PTAB’s findings on the teachings of the prior art and motivation to combine.

PTAB Strategy: Balancing the Sandbagging

Patent

by Dennis Crouch

The Federal Circuit’s recent Axonics decision reflects an ongoing tension between IPR petitioners and patent owners concerning litigation strategies and procedural fairness. A prevalent patentee strategy aims to force the petitioner to lock in specific arguments, only to provide a game-changing response later on.

In Axonics, the patentee offered a new claim construction proposal in its post-institution response. On appeal, the Federal Circuit determined that it was only just, and mandated by the APA, for the petitioner to present new responsive arguments and evidence in its reply briefing. Additionally, the court suggested that the patentee should then have the opportunity to submit further evidence in a sur-reply. The PTAB had adopted the patentee’s claim construction proposal and refused to consider Axonics reply arguments and evidence — finding them to represent improper new arguments.  The Federal Circuit vacated that decision and sent the case back down for reconsideration.

Sandbagging Risk and the Need for Balance

In his opinion for the court, Judge Dyk quotes from the oral argument transcript after getting an admission from Medtronic’s attorney (Naveen Modi from Paul Hastings) that the PTAB approach risks sandbagging by the patentee:

The Court: “But isn’t there a risk here of sandbagging, that you realize there’s a good claim construction argument, [and] you leave it out of your preliminary response. If you argued it in your preliminary response, then maybe institution would be denied and there would
be no estoppel. But if you hold back on the argument and wait to make it until the response, then you get the estoppel. Isn’t there a risk of that?”

Medtronic’s counsel: “Certainly, your honor, there is a risk of that . . . .”

Oral Arg. at 14:24–51.  Modi went on to explain that the risk could also affect the petitioner. The new rule permits the petitioner to provide an unreasonable initial claim construction, then present new evidence later if challenged. Here, the court explicitly concluded that petitioners are not bound to preemptively address all potential reasonable claim interpretations.

Important Caveats and Ongoing Questions

The case has some important caveats regarding what argument/evidence can be provided in reply.  The court made clear that a petitioner cannot raise entirely new prior art references in a reply to a patent owner’s response: “a petitioner may not in reply rely on new prior art to teach a claim limitation.”  And, the court refused to decide an intermediary question of whether the petitioner can rely upon “new embodiments” from the already presented prior art in order to counter a new claim construction proposal. “We leave for another day the question of whether, when presented with a new claim construction, a petitioner can rely in its reply on new embodiments from the prior art references that were relied on in the petition.”  That particular situation was not at issue because “Axonics, in the reply, relied on the same embodiments as it relied on in the petition.”

In essence, while a petitioner cannot introduce entirely new prior art references in a reply, it remains an open question whether new portions or embodiments from the same preexisting references can be cited to address a new claim construction proposed post-institution.

Striking a Middle Course

In this frame, the decision shows the Federal Circuit steering a middle course – allowing petitioners to respond to changed claim constructions with arguments tied to the same prior art, while prohibiting entirely new prior art in replies. Ongoing cases will likely continue to shape the precise boundaries between fair response and improper new arguments in this contentious field.

Citation: Axonics, Inc. v. Medtronic, Inc., 2022-1532 (Fed. Cir. Aug. 7, 2023) (opinion by Judge Dyk, joined by Judges Lourie and Taranto).

In July 2023, the same panel released a separate decision involving the same parties and also siding with the petitioner Axonics in holding that Board erred in its obviousness analysis by improperly framing the motivation-to-combine inquiry. [LINK]

The result: Although the Board sided with the patentee on the four challenged patents, the Federal Circuit vacated those holdings and given the petitioner another chance to prove its case. and See U.S. Patent Nos. 8,036,756, 8,457,758, 8,626,314, and 8,738,148.  As with most Medtronic patents, the inventions are super interesting. One set relates to implanting a neurostimulation lead and the second set relates to transcutaneous charging of implanted medical devices.

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

Patent, ,

by Dennis Crouch

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

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

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

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

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

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

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

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

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

Id.

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

= = =

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. Hrdy & Dan Brean: The Patent Law Origins of Science Fiction

Patent,

Guest post by Camilla A. Hrdy, Professor of Intellectual Property Law at University of Akron School of Law, and Daniel H. Brean, Senior In-House Intellectual Property Counsel, Respiratory Care, Philips.

Are inventions described in works of science fiction patentable? The answer is usually no, and for good reason. Some of the most beloved fixtures of the genre—time machines, faster-than-light space travel, teleportation, downloading memories, copying a consciousness, etcetera—are impossible or not yet possible when described by the author. This sort of science fiction is not patentable because it cannot logically be enabled or have credible utility when the patent is filed.

For similar reasons, science fiction is rarely cited as prior art against later patent filings. Science fiction can qualify as prior art under § 102(a) as a “printed publication” or as “otherwise available to the public.” It can be especially useful as “obviousness” prior art because, to quote the Federal Circuit, a “reference that does not provide an enabling disclosure for a particular claim limitation may nonetheless furnish the motivation to combine, and be combined with, another reference in which that limitation is enabled.” Raytheon Techs. Corp. v. General Electric Company, 993 F.3d 1374 (2021). However, science fiction is unlikely to be cited during examination.[1] Examiners lack the time and energy to search for on-point science fiction where there is so much more (and better catalogued) prior art among patents and scientific publications. Applicants, for their part, are not required to disclose prior art that is not material to patentability or that is cumulative of other prior art they’ve already provided. See https://www.uspto.gov/web/offices/pac/mpep/s2001.html.

It may surprise you, then, to learn that the genre of science fiction is deeply indebted to patent law and patent theory. In our new paper, The Patent Law Origins of Science Fiction, available at https://papers.ssrn.com/sol3/papers.cfm?abstract_id=4291271, we show that science fiction as a literary form was originally premised on the idea that works of science fiction are like patents. They disclose useful technical information that can give readers a “stimulus” to perfect the invention and figure out how to make it work.

The person responsible for this comparison was the so-called “father” of science fiction, Hugo Gernsback. He started the first exclusively-science fiction magazine, called Amazing Stories, in 1926. The Hugo awards, given to the best works of science fiction and fantasy writing, are named after him.

Gernsback was also an inventor and serious scientific thinker in his own right. He died with over thirty patents to his name. In the early 1900s, he started a radio and electronics equipment company in New York. To support his business, he initially published catalogs for mail-order electrical components, but the catalogs soon morphed into full-sized magazines with titles like “Modern Electrics,” marketed to inventors and amateur “tinkerers.” Hugo Gernsback, The Perversity of Things, Grant Wythoff ed. (University of Minnesota Press 2016). His magazines were full of information about patents and advice on patenting—which Gernsback deemed an essential step in the commercial success of any new invention.

At first, Gernsback started publishing science fiction stories—which he then called “scientifiction”—to fill space in his electrical magazines. These stories were sometimes little more than a few paragraphs of exposition about some speculative new device that might be used in the future, plugged into a generic adventure plot. For example, one story featured a genius from the future using (what we now call) “radar” to track down a Martian who had kidnapped the protagonist’s love interest in a Space Flyer. Despite the fictional elements, science and scientific plausibility were still all-important. Gernsback was fond of saying the recipe for good scientifiction was 25% science and 75% literature.

Readers loved it, and Amazing Stories was born. Gernsback knew he was on to something, and he frequently published editorials expounding on the virtues of scientifiction. These editorials, along with his unpublished manuscripts, reveal Gernsback’s theory that a good science fiction story is like a patent, but a much more “palatable” read. Although he did not articulate it in precisely the same terms, Gernsback’s justification for scientifiction echoes the language of patent law’s disclosure theory. Scientifiction, he wrote, provides both knowledge and “stimulus.”[2] It inspires “seriously-minded” readers to learn about science and technology, and it supplies the “inventor or inventor-to-be who reads the story” with “an incentive” to “realiz[e] the author’s ambition” by perfecting the author’s science fictional inventions in the real world. Gernsback often drew the analogy to patents quite explicitly. The science fiction author, in his framework, was “an original inventor,” like the named inventor on a patent. The readers who got the author’s invention to work were like “manufacturers” who buy patents and commercialize the inventions therein “with but a few changes.” They were just there to profit from the author’s grand ambitions.

Over time, Gernsback developed a crazy idea. If science fiction authors are “inventors” who inspire others to reduce their inventions to practice, then shouldn’t science fiction authors be able to get patents for their prescient descriptions of future inventions? And shouldn’t science fiction serve as prior art against other peoples’ patents? In 1952, just after Congress had modernized the Patent Act, Gernsback made these ideas public. In a speech he gave to the World Science Fiction Convention in Chicago, he proposed that Congress should reform patent law (again) to give science fiction authors the ability to apply for “Provisional Patents.”

Gernsback’s Provisional Patents were not at all like today’s provisional patent applications. Compare 35 U.S.C. § 111. His Provisional Patents would have given science fiction authors thirty extra years in which to demonstrate their science fictional inventions worked. If they could do so, the Provisional Patent would be converted into a normal patent, presumably in force for the full patent term (which at that time meant 17 years). Otherwise, it would be abandoned. This proposal was not adopted and, we presume, was never seriously considered.

In the same speech, Gernsback also proposed that authors and publishers should start identifying works of science fiction that contained “new and feasible” inventions, so that they could send these selected works to the patent office. Gernsback’s hope was that the patent office would be deluged with science fiction and have no choice but to start reviewing and citing science fiction more often as prior art. This idea had more grounding in current law than Gernsback’s Provisional Patents, but it was not adopted either. Mechanisms for getting prior art to the patent office have certainly improved since Gernsback’s time. But we still don’t send the patent office curated collections of science fiction.

Gernsback’s ideas were iconoclastic, and his proposal to make Provisional Patents available for inventions that are not yet reduced to practice is deeply troubling from a policy perspective. Science fiction authors who make reasonably accurate predictions about future technological developments would gain the ability to sue the very people who figure out how to make those technologies. Imagine the effect on the computer industry if a science fiction author had been able to reserve the right to patent a supercomputer in the early 1920s, and then converted this into a full patent in the 1950s…

But taking Gernsback’s ideas seriously generates some surprising insights. Science fiction—of the type that Gernsback and “hard sf” writers like Jules Verne and Isaac Asimov wrote—has more in common with patents than it might seem. Publishing a work of science fiction confers no exclusive rights on the inventions it contains. But, like patents, works of science fiction are documents that disclose potentially useful information about science and technology. Like patents, science fiction stories can describe inventions that have not literally been reduced to practice; they can leave many details to skilled artisans to figure out. Both science fiction readers and patent examiners are also supposed to suspend disbelief, presuming the inventions described on the page are based on plausible scientific principles. See, e.g. In re Cortright, 165 F.3d 1353 (1999). If we think patents are an important part of the innovation ecosystem because they disseminate useful technological teachings and insights, then science fiction might be too.

How often science fiction influences innovation is an extremely interesting question. Ironically, the patent record itself is a great source of data with which to test Gernsback’s theories. In fact, one of Gernsback’s more questionable assumptions was that profit-hungry readers are “continuously” filing patents on inventions they learned about in science fiction. They remember the idea, “lard it with a few of [their] own, patent it and start a new billion dollar industry on it.” Regardless of whether that is true, if someone is inspired by science fiction to make an invention in the real world, then we should sometimes see evidence of this in the patent record.

Formal prior art citations to science fiction are rare for the reasons we said above. But we can find circumstantial evidence of science fiction’s influence by searching patents. For example, specifications sometimes reference science fiction in the body, even if they don’t formally cite to science fiction as prior art. Search the patent record for “Asimov, “Three Laws of Robotics,” or “Star Trek,” and you’ll see what we mean. We can also find more direct evidence of influence—situations where inventors expressly state that they got their inspiration from science fiction. For this, though, we usually have to look outside the patent record. Inventors’ autobiographies, interviews, speeches, and marketing efforts can reveal clues. For example, Neil Stephenson’s 1992 book Snow Crash features a virtual world called the Metaverse. Facebook and other tech companies are making their own virtual worlds and calling them by the same name. That, along with direct statements from employees that Stephenson is “our inspiration,” helps support that there was some degree of influence. Steven Levy, Neal Stephenson Named the Metaverse. Now, He’s Building It, Wired (Sept. 16, 2022).

This is surely sometimes independent invention, the result of multiple inventors responding to the same technological developments and contemporary trends. Mark A. Lemley, The Myth of the Sole Inventor, 110 Mich. L. Rev. 709 (2012). But sometimes it is not. Despite all the legal and practical barriers, science fiction appears in the patent record. It was important enough to play some small part in the journey that culminated in the invention. At the end of the day, there is only one explanation for this: Some inventors read science fiction, and some science fiction matters to those people. Its ideas inspire them in ways that traditional sources (including patents) do not. Gernsback put it best. Science fiction “fires the reader’s imagination more perhaps than anything else of which we know,” leaving readers “deeply thrilled[,]” as their “imagination is fired to the nth degree[.]” Few people would ever say that about reading patents.

Even if science fiction does not directly influence someone to make the precise inventions it discloses, it can impact peoples’ career choices, inspiring them to go into science or pursue a general line of inquiry. It can inspire them to go to space. Kristen Houser, Science fiction doesn’t predict the future. It inspires it, BigThink (Oct. 23, 2021). Arthur C. Clarke went so far as to say that “by writing about space flight we have brought its realization nearer by decades.” In Clarke’s view, science fiction both imparted useful technical information and acclimated readers to the possibility of space flight, priming them to support and accept the novel technology when it arrived.

Gernsback’s science fiction-as-patent theory also contains some wisdom for science fiction writers. A little more patent-style “enablement” in science fiction might do more for innovation than science fiction writers want to believe. There is nothing wrong with fantasy and so-called speculative fiction. It is often tremendously entertaining. But we call it science fiction (and thankfully not scientifiction) for a reason: it is based on kernels of real science. To quote Gernsback, what makes science fiction different from romance and adventure stories is that it is grounded in “scientific fact” and has the potential to be “prophetic.” It might one day come to pass. Science fiction authors who work to “enable” their stories, even just a bit, have a better chance to give a stimulus to readers to reduce their inventions to practice. There are many, many authors who already do this, and do so without compromising the quality of the narrative. They might literally affect the future in the way we imagine all inventors hope their patents will. See https://gamerant.com/best-hard-sci-fi-novels-newcomers/#the-three-body-problem-mdash-liu-cixin; https://upjourney.com/best-hard-science-fiction-novels.

For more about Gernsback’s ideas on patents and for more examples of science fiction’s impact on innovation, check out our paper here: https://papers.ssrn.com/sol3/papers.cfm?abstract_id=4291271

[1] This is not to say it does not happen. In litigation, defendants have stronger incentives to find science fiction prior art and use it to build a case for invalidity. For example, in 2011, during the “smart phone wars,” Samsung argued Apple’s iPad design patent was anticipated by what appear to be “tablet” computers in scenes from Stanley Kubrick’s 1968 film 2001: A Space Odyssey. http://www.fosspatents.com/2011/08/samsung-cites-stanley-kubricks-2001.html

[2] These quotes come from Gernsback’s editorials in Amazing Stories. The full quotes and citations can be found in the paper. https://papers.ssrn.com/sol3/papers.cfm?abstract_id=4291271

 

Reasonable Expectation of Success as the Post-KSR Nonobviousness Hook

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Tris Pharma v. Actavis Labs (Fed. Cir. 2022) (non-precedential opinion)

One quirk of the Patent Act is Section 271(e), which creates infringement liability for simply seeking FDA approval to market a generic version of an already approved drug. 35 USC 271(e).  Here, Actavis filed an Abbreviated New Drug Application (ANDA) seeking FDA approval to market a “liquid methylphenidate (MPH) oral suspension.”  This is the same drug found in Ritalin and used to treat ADHD and other neurological concerns.  This particular formulation is in liquid form and the active ingredient is designed for slow release. (Tris sells under the brand “Quillivant XR”).  Tris responded to the Actavis ANDA by suing under 271(e) and asserting three separate patents.

271(e) actions are seen as a form of declaratory action similar to those taken by courts of equity prior to the merger of law and equity.  As such, there is no Constitutional right to a jury trial in these cases and instead all issues of fact and law are typically determined by a federal district court judge.

The usual jury verdict just requires the ticking of an [X] invalidity box. Likewise, the Federal Circuit regularly decides its cases with by ticking the [X] affirmed without opinion box.  The trick with bench trials though, is that the judge is required to explain its factual and legal conclusions.  Fed. R. Civ. Pro. 52(a).

In an action tried on the facts without a jury or with an advisory jury, the court must find the facts specially and state its conclusions of law separately.

Id.  Here, Judge Connolly (D.Del.) held a bench trial and original sided with the generic manufacturer–finding the asserted claims obvious.  That original decision though was vacated by the Federal Circuit back in 2018 (the also panel slightly amended its decision in a 2019 rehearing order). In its decision, the Federal Circuit found that the district court had failed to explicitly and specifically consider a number of factual disputes and thus remanded for further findings:

[T]he district court failed to make the necessary factual findings and provide sufficient analysis of the parties’ arguments to permit effective appellate review. Specifically, the district court’s opinion merely recites the parties’ arguments but fails to explain or identify which arguments it credits or rejects. We thus cannot reach the merits of whether the Quillivant XR® formulation would have been obvious over the prior art. Rather, we identify gaps in the district court’s opinion and remand for the district court to conduct further factfindings and detailed analysis consistent with this opinion.

Tris Pharma, Inc. v. Actavis Lab’ys FL, Inc., 755 F. App’x 983 (Fed. Cir. 2018) (Tris I).

On remand, the district court accepted further briefing on the merits and then flipped the outcome–this time siding with the patentee.  In particular, the district court held that “Actavis failed to prove by clear and convincing evidence that a person of ordinary skill in the art would have been motivated to combine the prior art references with a reasonable expectation of success.”  On appeal here, the Federal Circuit has affirmed.

Claim 1 of Tris Pharma’s U.S. Patent Nos. 8,465,765 reads as follows:

1. A methylphenidate aqueous extended release oral suspension comprising (1) an immediate release methylphenidate component, (2) a sustained release methylphenidate component, and (3) water, said suspension having a pH of about 3.5 to about 5,

wherein said suspension provides a single mean average plasma concentration peak and a therapeutically effective plasma profile for about 12 hours for methylphenidate, and

wherein the suspension has a pharmacokinetic profile in which the single mean plasma concentration peak for methylphenidate has

  • an area under the curve (AUC)0->∞ of about 114 to about 180 ng-hr/mL,
  • Cmax of about 11 to about 17 ng/mL,
  • Tmax of about 4 to about 5.25 hours, and
  • T1/2 of about 5 to about 7 hours

following a single oral administration of said suspension at a dose equivalent to 60 mg racemic methylphenidate HCl in adults.

By the time Tris filed its patent application, several other methylphenidate oral formulations & extended release versions were already on the market, including Concerta, Daytrana, Focalin XR, Metadate CD, and Ritalin LA. As with most obviousness cases, the prior art taught all the claim limitations in various subsets, but no single reference disclosed an embodiment with all the limitations.  And, the Federal Circuit agreed with the district court that the patent challenger had failed to show that PHOSITA would have a reasonable expectation of success when attempting to make any of the proffered combinations.

Without delving into the merits here, I only want to note the court’s focus on motivation-to-combine that is now regularly coupled with the requirement that the combination be based upon a “reasonable expectation of success.”   The Federal Circuit (as well as lower courts and the USPTO) have increasingly used the “reasonable expectation of success” as a prong in the obviousness analysis.   The chart below shows the number of Precedential Federal Circuit decisions that discuss a the Reasonable Expectation of Success test as part in the context of an Obviousness determination. As you can see, there was a substantial rise in its use beginning in 2006 during the lead-up to KSR (2007).

I’ll note also that this appears to be a case where forcing the tribunal to fully explain its decision ended up shifting the ultimate result.