Size Matters: Element-by-Element Analysis in Obviousness

by Dennis Crouch

In re Universal Electronics, Inc., No. 2022-1716 (Fed. Cir. Aug. 15, 2023) (non-precedential)

This was a consolidated appeal from two Patent Trial and Appeal Board (PTAB) decisions affirming the rejection of claims from Universal Electronics, Inc.’s (UEI) U.S. Patent Application Nos. 12/645,037 and 16/279,095 as obvious under 35 U.S.C. § 103.  On appeal, the Federal Circuit has affirmed.

The typical approach to obviousness determination is for the examiner to mentally divide the claimed invention into a number of individual elements, and then search for the individual elements within the prior art.  If the examiner finds all of the limitations, then the only key question that remains is whether the combination would have been obvious. Under KSR, that outcome does not necessarily require further evidence, but typically focuses on questions of whether PHOSITA would have been motivated to combine the references to create the invention, and have a reasonable expectation of success of that endeavor.  On the other hand, based upon my experience, examiners are much more uncomfortable finding claims obvious where particular elements are not found in the prior art. This difference is reflected in KSR and other older cases where the Supreme Court has been most critical of patents merely claiming a combination of known elements.

As a prosecution strategy, patentees have some control over the “size” of each element through their organization of claim language.  Here though, the patentee attempted to do this via argument, but ultimately failed. Lets look at the rejection and the arguments here:

The claims at issue relate to a system and method for providing improved user input functionality on a controlling device, such as a universal remote control. Representative claim 1 of the ‘037 application recites determining and then using a particular “touch location” on a touch sensitive surface to retrieve command data from a library stored in the controlling device’s memory. The Examiner rejected the claims as obvious over two prior published patent applications, Fisher and Dresti. Fisher discloses determining a touch location and using it to control an appliance. Dresti discloses retrieving command data from a library in the remote control’s memory.

The patentee argued that a key component of the invention was not found in the prior art. In particular, UEI argued that neither reference individually taught the limitation of a “controlling device that uses a determined touch location to retrieve command data from a library of command data stored in a memory of the controlling device.”  Admittedly, each individual bit of this limitation was found in one of the prior art references, but the patentee argued that this feature should be treated as an entire limitation.

On appeal, the Federal Circuit found the argument unpersuasive, concluding that the rejection properly relied upon a combination of prior art to teach all of the claim limitations.  As the patentee here attempted, attorneys can argue against dividing the claims into smaller pieces. However, it is an uphill battle once the examiner and PTAB have defined the elements narrowly and found them in separate references.

The takeaway may be that attorneys should advocate for the broader, unified view of the invention during early prosecution to avoid being boxed into a narrow element-by-element approach. Carefully crafted claims and thorough responses emphasizing the integrated advance can help shape the analysis in the desired direction. But as this case shows, it can be difficult to overcome once piecemeal elements are embedded in the record.

Unfortunately, the non-precedential opinion does not provide any detail analysis for when a tribunal be satisfied with micro vs macro elements. But, I can imagine that we’ll look to the claim language, specification disclosure, and PHOSITA knowledge.

This is the same issue that arises during infringement analysis with application of the doctrine of equivalents.

Thus, the PTAB’s conclusions that the claims would have been obvious over the cited references.

Judges: Circuit Judges Reyna, Taranto, and Stoll

DC District Court: AI-Created Works Ineligible for Copyright 

By Dennis Crouch

Thaler v. Perlmutter, No. 22-1564 (D.D.C. Aug. 18, 2023). 

A federal court has dealt a blow to the prospect of granting copyright protections to works created entirely by artificial intelligence systems. In their recent decision, Judge Howell ruled that because AI systems lack human authorship, their output is ineligible for copyright.

The case centers around an image generated by an AI system called the Creativity Machine, which the system’s owner Stephen Thaler attempted to register with the U.S. Copyright Office. Dr. Thaler is the same individual who unsuccessfully attempted to protect and invention created by a separate machine that he had titled DABUS.

In this case, Thaler listed the Creativity Machine as the author and designated the work as created autonomously by the AI, with ownership transferring to himself as the owner and creator of the machine. The Copyright Office denied the registration application on the grounds that copyright law requires human authorship. Thaler challenged the rejection in court, but Judge Howell upheld the Copyright Office’s decision.

In her ruling, Howell emphasized that human authorship has underpinned copyright law since its Constitutional inception, which enables Congress to grant exclusive rights to “authors.” While copyright has adapted over time to cover new technologies like photography and film, Howell wrote, it has never extended so far as to protect works created without any human involvement. The court does not discuss in any detail the work made for hire doctrine that does permit non-human authorship. However, even in that situation a human underlies the creation.

Judge Howell also noted that machine learning systems like the Creativity Machine do not require copyright incentives, since they operate algorithmically rather than responding to legal rights and protections. The opinion concludes unambiguously that “in the absence of any human involvement in the creation of the work, the clear and straightforward answer is the one given by the [Copyright Office]: No.”

While this ruling provides clarity for now, the accelerating development of AI systems means the issue is unlikely to disappear. As AI grows more advanced and autonomous in generating creative works, questions around copyright protections will likely resurface. Lawmakers may eventually need to reconsider whether AI-created works should be eligible for copyright, especially if human direction becomes minimal or nonexistent. With the current copyright regime requiring human authorship, however, true machine-created art remains in the public domain.

While this case dealt with a work claimed to be created entirely autonomously by an AI system, a more common scenario today sees individuals using AI tools in tandem with their own creativity and direction. In these situations where both human and machine contribute, questions arise around how much and what kind of human input is necessary to meet the originality and authorship requirements for copyright protection. If an artist uses a generative AI tool to create a work but provides extensive creative guidance and selection, there would seem to be a strong argument for human authorship. However, as AI grows more advanced and autonomous, that human contribution may become limited to little more than prompting the system. In these cases, courts will need to draw difficult lines around what amounts to human authorship. If AI progress continues apace, the fundamental question of whether true machine-created works should be eligible for copyright will require legislative attention.

What are your thoughts?

Three issues: Law/Fact Distinction in Obviousness; Envisaging the Invention; and Newman in Dissent

by Dennis Crouch

Incept LLC v. Palette Life Sciences, Inc., No. 21-2063 (Fed. Cir. Aug. 16, 2023) (Majority by Judges Schall and Taranto; Dissent-in-part by Judge Newman)

The most interesting line in the case for appellate attorneys (and legal scholars) is probably the court’s law/fact distinction in the context of obviousness analysis.  The majority wrote: “We see no reversible error … whether viewed as a factual one about the level of [commercial] success or a legal one about the weight of any such success in the overall obviousness analysis.”  The law/fact divide is important because of the evidentiary requirements in the first instance and the standard for review on appeal. Here, the court makes clear that the weight given to any objective indicia of non-obviousness is a question of law rather than a question of fact.  The result then is that its analysis can generally be based upon reason rather than evidence, and that issue is one that will be heard de novo on appeal.

The second issue of importance is as another data point in the forest-trees  anticipation analysis in situations where the prior art discloses thousands of potential embodiments.  The court has repeatedly held that such a reference is only anticipatory if a person of skill would have immediately envisaged the invention now being claimed.  In this case, the court took a relatively broad view of what constitutes anticipation — focusing on the level of specificity in the claims and guideposts such as the purpose of various elements in the claim.  In the end, the patentee lost and the claims were found invalid.

Finally, the case includes another dissent from Judge Newman.

= = =

Incept’s patents cover a method for treating cancer that involves injecting a biodegradable filler gel prior to radiation treatment in order to increase space between the the tissue being treated and the closest body organs.  Afterwards, the gel biodegrades and so does not need to be removed. U.S. Patent Nos. 8,257,723 and 7,744,913.  Palette Life Sciences initiated IPR proceedings and the PTAB eventually found the challenged claims unpatentable as anticipated/obvious.  On appeal, the Federal Circuit has affirmed with Judge Newman offering a partial dissent. The dependent claims include various forms of the filler, such as thixotropic polymer, collagen, a polysaccharide, or hyaluronic acid.

Wallace discloses millions of possible compositions, and the patentee argued that the Board engaged in improper retrospective construction of the invention by picking and choosing various elements from the disclosure.  The idea then is that one skilled in the art could not have “at once envisaged” the various species claimed by Incept.  On appeal, the majority sided with the Board, holding that “Wallace expressly describes compositions that have the claimed characteristics of, and are used for the same displacement purpose as, the compositions referred to in the ’723 patent claims challenged as anticipated.”

Incept cannot use the fact that Wallace describes multiple compositions to evade an anticipation finding where Wallace provides “as complete detail as is contained in the patent claim,” such that a skilled artisan would have understood that Wallace’s compositions had the same generic properties as those in the ’723 patent claims.

In her opinion, Judge Newman took the majority to task for ignoring limitations in narrower dependent claims.

The majority appears to hold that, when the broader claim is anticipated, the dependent claims are automatically anticipated. That is not the law. Each claim must be considered as a whole, including all its limitations. . . . A generic prior disclosure does not anticipate all of its embodiments, including novel specific embodiments, whether or not the facts are such that the generic disclosure may render the embodiment obvious.

The problem with Judge Newman’s arguments here is that the patentee only barely argued the dependent claims, and the majority recognizes this at least to most of the dependent claims – noting that Incept had failed to provide specific arguments directed to those claims.

Other claims were found obvious by the PTAB and the majority again affirmed that holding. The patentee had provided evidence of commercial success — showing that most prostate cancer treatments in the US used an injectable  known as “SpaceOar” exclusively licensed from the patentee.  The Board refused to give any weight to the commercial success because the sales numbers provided included free and replacement versions, without accounting for those numbers.   In addition, the Board found the patentee’s expert testimony not credible and not supported by evidence.

Judge Newman’s dissent noted that “It is undisputed that the Incept product
experienced regular increases in annual commercial sales, and at the time of trial Incept had obtained 55% of the market for comparable products. Palette’s only criticism of Incept’s commercial information was that Incept also gave free samples. The majority now holds that Incept’s commercial sales cannot be considered as a measure of commercial success because some product was provided free of charge.”

= = =

Independent claim 1 of the ’723 patent recites:

1. A method of delivering a therapeutic dose of radiation to a patient comprising

introducing a biocompatible, biodegradable filler between an organ and a nearby tissue to increase a distance between the organ and the tissue, and

treating the tissue with the therapeutic dose of radiation so that the presence of the filler causes the organ to receive less of the dose of radiation compared to the amount of the dose of radiation the organ would receive in the absence of the filler,

wherein the filler is introduced as an injectable material and is a gel in the patient, and

wherein the filler is removable by biodegradation in the patient.

 

New Amendment to FRCP Could Help Streamline Privilege Management in Patent Cases

by Dennis Crouch

On August 15, 2023, the Judicial Conference Advisory Committee on Civil Rules published proposed amendments to Rules 16 and 26 of the Federal Rules of Civil Procedure. One of the goals of these amendments is to encourage parties to address issues relating to claims of privilege and work product protection early in litigation. This could be particularly impactful for patent cases, which frequently involve extensive disputes over these very issues.  The proposal would also retitle Rule 16(b) to include both scheduling and case management (the current version just focuses on scheduling).

Rule 26(b)(5)(A) focuses on the the procedure for “claiming privilege” as an reason for refusing to comply with an otherwise valid discovery request or disclosure requirement.  A party generally has to:

(i) expressly make a claim of privilege; and

(ii) create a privilege log that describes the nature of the thing withheld.

The privilege log will be disclosed to the other side and it is something of an art to describe the items without putting the other side on the trail of the protected information. Note – I use privilege here as an overarching term. The rule applies to items/information protected by both privilege and work product rules.

The proposed amendment to Rule 26 requires parties to discuss and include in their discovery plan the method they will use to comply with Rule 26(b)(5)(A).  This will likely include some information about the contents of the privilege log; manner and timing of the exchange; etc.  Similarly, the change to Rule 16 make discussion of this plan an optional aspect of the Judge’s 16(b) scheduling order.

Patent cases often involve the assertion of attorney-client privilege and work product protection over large volumes of technical, financial, and legal documents. At times, litigation between competitors centers on highly confidential corporate information that parties often seek to protect as privileged.  Producing privilege logs describing all of these documents can be extremely burdensome and costly.  The amendment encourages parties to agree upfront on efficient ways to approach this task, such as through categorical designations or date ranges rather than document-by-document listings.

The proposed amendment to Rule 16 allows the court to include provisions about privilege issues in its scheduling and case management orders. With an early understanding of the volume and type of potentially privileged materials involved, the judge can build in procedures for timely resolution of any disputes. For example, the order could provide for rolling productions of privilege logs on a regular schedule.

Getting ahead of privilege disputes will be especially useful in patent cases, where objections often arise late in discovery — and key documents are often hidden behind that privilege wall. Last-minute disagreements can derail case schedules. An orderly process set forth in the case management order will allow privilege issues to be dealt with efficiently as they arise, without disrupting the rest of the litigation.  To be clear though, the new rule is quite incremental and is subject to substantial abuse by parties who seek to hide documents using weak privilege arguments.

While application will depend on the specifics of each case, these amendments represent a step in the right direction. Patent litigators should be prepared to have detailed discussions about privilege during the Rule 26(f) conference and seek early guidance from the court.

The Rule 16/26 proposals begin on page 120 of the following PDF document released by the Judicial Center: https://www.uscourts.gov/sites/default/files/2023_preliminary_draft_final_0.pdf.

Meta Claim Construction: Finding Meaning in the Meaning

by Dennis Crouch

One-E-Way, Inc. v. Apple Inc., 22-2020 (Fed. Cir. Aug. 14, 2023) (nonprecedential) (Opinion by Chief Judge Moore, joined by Judges Lourie and Stoll).

The district court sided with Apple on summary judgment, finding no infringement. On appeal, the Federal Circuit has affirmed, holding that Apple’s accused Bluetooth products do not infringe One-E-Way’s patents.  Although the parties had agreed to the construction of the “unique user code” term, they disagreed over the construction-of-the-construction.  On appeal, the court treated this meta-construction effectively as a form of claim construction — looking for the ordinary meaning rather than a contract-like interpretation that would have looked more toward discerning the intent of the parties.

One-E-Way sued Apple for infringing the claims of two patents related to a wireless digital audio system that allows private listening without interference. The system uses a transmitter connected to an audio source and a receiver connected to headphones. The transmitter contains a code generator that generates a “unique user code” associated with a specific user to allow pairing between the transmitter and receiver.

During the infringement litigation, the parties agreed to construe “unique user code” as a “fixed code (bit sequence) specifically associated with one user of a device(s).” Although Apple’s Bluetooth products do transmit a unique code to establish the connection, the code is not unique to the user, but rather it is unique to the Bluetooth device.  The district court agreed with Apple’s assessment and granted summary judgment of non-infringement.

On appeal, One-E-Way argued that the “unique user code” limitation is still met by Apple’s accused Bluetooth products. Specifically, One-E-Way contended that even though the Bluetooth address codes are associated with devices, the codes are still associated with individual users through operation of the device. In other words, One-E-Way argued that Bluetooth pairing to a particular device is equivalent to pairing with a specific user.  This argument makes the assumption that each device is limited to just “one user.” Although that assumption is not strictly true, I expect that it holds true in 99% of cases.  For a while, I shared Bluetooth headphones with one of my daughters–it did not work well at all.

The Federal Circuit rejected this argument, finding that it was inconsistent the claim construction which clearly states the code is associated with “one user.” rather than the device itself.  Even if the Bluetooth address code is associated with a user through use of the device, the code remains fundamentally associated with the device. The Federal Circuit found no evidence that the code itself becomes directly linked to the user, rather than the device, through pairing and use.

The arguments in this case are somewhat meta. The parties are not arguing about claim construction per se, but rather construction of the construction.  In the appeal, the Federal Circuit considered the “plain and ordinary meaning of the agreed-upon construction” and concluded that it required required a more direct link to a user.   As it would with ordinary claim construction, the court looked to the specification for support.  In particular, the court noted that the patent specifications “distinguish between users and devices when describing the purpose of the invention” and recognized the problem of conflict that I had with sharing Bluetooth accessories. “The patents’ consistent reference to ‘user’ and ‘device’ as distinct entities and association of the unique user code with ‘user’ supports the district court’s conclusion that ‘one user of a device’ does not mean the device itself.” Slip Op.

Non-infringement affirmed.

= = =

The patents at issue are:

– U.S. Patent No. 10,129,627
– U.S. Patent No. 10,468,047

The ‘627 and ‘047 patents share the same specification. The court treated Claim 1 of the ‘627 patent as representative.

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

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

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.

Shamoon v. Resideo: Obviousness affirmed

by Dennis Crouch

Shamoon v. Resideo Technologies, Inc., No. 2021-1813 (Fed. Cir. Aug. 8, 2023) (opinion by Judge Newman; joined by Judges Reyna, and Cunningham) (non-precedential)

Charles Shamoon is the inventor and owner of U.S. Patent No. 8,064,935. The patent relates to a remote access system that allows users to monitor and control “environmental devices” like alarm and HVAC systems in their home using a base control unit and a remote unit.  Resideo challenged the patent in a pair of IPR petitions, and the PTAB eventually found the challenged  claims unpatentable as obvious over a combination of two/three prior art references.

On appeal, the Federal Circuit affirmed and rejected Shamoon’s three challenges.

The claims require a microcontroller, and Shamoon argued that the term should be construed as requiring a particular type of microcontroller that included certain memory elements. That narrowed definition might have helped Shamoon avoid the prior art.  But, the Federal Circuit upheld the PTAB’s broad claim construction of “microcontroller” — finding that it was broadly used both in the claims and the specification.

Some of the claims required a confirmation message be sent once an instruction had been executed, and Shamoon argued that the prior art failed to teach a confirmation message related to an environmental device command.  On appeal though, the court found that it was proper to combine the teaching of a confirmation message from a reference not related to environmental devices.  “Because Oinonen and Whitley disclose the environmental devices and  commands, it does not avail Mr. Shamoon to complain that Menard does not.” Slip Opinion.  Shamoon’s argument here

Finally, Shamoon argued that applying AIA proceedings to his pre-AIA patent was impermissible taking by the United States without just compensation, in violation of the Fifth Amendment.  The court quickly rejected this argument based upon its prior precedent in Celgene Corp. v. Peter, 931 F.3d 1342 (Fed. Cir. 2019) (“retroactive application of IPR proceedings to pre-AIA patents is not an unconstitutional taking under the Fifth Amendment.”).

PTAB Strategy: Balancing the Sandbagging

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.

Special Committee: Newman Should be Suspended for 1 Year based upon Refusal to Undergo Medical Examinations

by Dennis Crouch

The Federal Circuit Special Committee has released a 100+ page report that recommends Judge Pauline Newman be suspended for her refusal to comply with the committee’s order that would permit an independent doctor conduct a mental or physical examination.   The proposed suspension for “one year or until she complies.”  This report will be delivered to the Judicial Council that will make its own decision.  I expect that the Judicial Council will agree with the sanction.

The committee consisting of Chief Judge Moore, former Chief Judge Prost, and Judge Taranto concluded that it had authority and a reasonable basis to order medical examinations and records from Judge Newman.  And, her refusal to cooperate constitutes misconduct with no good cause shown. Her arguments attempting to justify her refusal were each addressed and rejected by the committee.

Most pointedly, Judge Newman had provided her own medical report purporting to show her competence. The committee rejected that report as inadequate — giving it “no weight”:

  • Source of Expert: The neurologist was chosen and engaged by Judge Newman herself, rather than being an independent expert selected by the Committee. This raised concerns about impartiality.
  • Limited Scope: The report indicates only a limited examination was performed, not the comprehensive medical and mental health evaluations ordered by the Committee.
  • No Opportunity to Question: The Committee and its experts had no ability to question the doctor, assess credibility, or probe his evaluation methods.
  • Incomplete Conclusion: The report concludes there is no disability, but does not seem to thoroughly evaluate Judge Newman’s mental fitness to fulfill her judicial duties.
  • Contrary Evidence: The report appears to ignore or downplay the contrary evidence of cognitive issues cited by the Committee.

In essence, the Committee found the report lacked credibility and thoroughness. Judge Newman had raised additional issues:

  • Due Process and Recusal: Judge Newman argued the proceedings violate due process and required judicial recusal. The committee found they follow appropriate procedures and do not violate any of Judge Newman’s rights.
  • Bias Arguments: Judge Newman alleged bias by the Judicial Council and Committee. The committee found no evidence of bias in the Council’s actions to suspend case assignments or the Committee’s prior orders.
  • Staffing/Resources Arguments: Judge Newman claimed she was deprived of necessary staff and equipment. The committee found no merit to these arguments.
  • Transfer Request Arguments: Judge Newman requested the matter be transferred to another circuit. The committee found no basis for such transfer.
  • Cooperation Arguments: Judge Newman asserted she has cooperated and the orders were defective. The committee found she clearly refused to undergo medical exams and that the orders were proper.
  • No Reasonable Basis Arguments: Judge Newman argued the committee lacked reasonable basis for orders. The committee pointed to staff concerns, case delays, and expert recommendation as providing reasonable basis.

July 31, 2023 Report and Recommendation

Newman’s separate lawsuit in D.C.Circuit seeking a declaratory judgment has not really moved.  The Special Committee indicated the view that their process was the proper venue rather than district court.

* The image above comes from the Montreal Cognitive Assessment (MOCA) that was given to Judge Newman by her neurologist. MOCA-Test-English. It was only partially completed because she had a broken wrist at the time and so was not able to trace the dots, draw the cube, or draw the clock.

Claim Construction Order Sets Stage for Moderna v. Pfizer Vaccine Patent Showdown

by Dennis Crouch

Moderna filed a patent infringement lawsuit against Pfizer and BioNTech in August 2022, alleging that the defendants COVID-19 vaccine infringes three patents related to Moderna’s mRNA vaccine technology.  United States Patent Nos. 10,898,574, 10,702,600, and 10,933,127. The lawsuit centers around two key components of Moderna’s mRNA platform that it claims Pfizer copied – the use of modified nucleosides like 1-methylpseudouridine and the encoding of a full-length coronavirus spike protein. Moderna asserts that it pioneered these innovations years before the COVID-19 pandemic and patented them between 2011-2016. The complaint alleges Pfizer and BioNTech initially tested different vaccine designs but ultimately chose to copy Moderna’s approach, despite being aware of Moderna’s patents. In the lawsuit, Moderna is seeking monetary damages for patent infringement but not injunctive relief taht would remove the Pfizer vaccine from the market. Although Moderna pledged not to enforce its COVID-19 patents during the pandemic, it signaled in March 2022 that expected companies to respect its intellectual property rights going forward.

In its response, Pfizer denied Moderna’s allegations of patent infringement and explained that it independently developed its COVID-19 vaccine without copying Moderna’s technology. Pfizer argues that Moderna’s patents are invalid because of the way they reach beyond Moderna’s actual contributions to mRNA technology and improperly claim fundamental discoveries made by other scientists.  In this vein, Pfizer raises several affirmative defenses, including invalidity and non-infringement of the asserted patents. Pfizer also asserts defenses based on implied license, waiver, and acquiescence stemming from Moderna’s public pledge not to enforce its COVID-19 patents during the pandemic.  As is usual, the answer also includes counterclaims that mimic the affirmative defenses — seeking declarations that the patent claims are invalid, not infringed, and unenforceable against Pfizer.  Here, these particular pleadings are rather limited and, for the most part, generally assert “35 U.S.C. 101, 102, 103, and/or 112.”

Docs:

The case is slowly moving forward in before Judge Richard Stearns with a trial rougly set for Fall 2024. Most recently, Judge Stearns issued a claim construction order following a Markman hearing.  As is common, the patentee did not ask for any construction, the defendants asked the court to define several terms.  Some of the proposals ask for broad definitions of certain terms (that would help Pfizer prove invalidity); while others sought narrow definitions of other terms (that would help Pfizer avoid infringement).  I tried to note the impact of the various constructions below. As you can see, each party won and lost arguments, but in the whole this looks like a good decision for Moderna.

  • The court adopted a broad definition of “unmodified mRNA” suggested by Pfizer that includes a statement that “Unmodified may, but does not always, refer to the wild type or native form of a biomolecule.”  (This will help Pfizer prove invalidity)
  • For the term “betacoronavirus,” the court rejected Pfizer’s argument that it is limited to betacoronaviruses in existence at the time of filing. The court found the intrinsic evidence indicates the term encompasses betacoronaviruses discovered after the filing date.  (This will help Moderna prove infringement)
  • The court construed “S protein” as simply “spike protein, a structural protein forming a spike.” It declined to include functional limitations proposed by Pfizer.  (This will help Moderna prove infringement)
  • The court construed “open reading frame” to apply to both DNA and mRNA. Pfizer had suggested limiting the term to just DNA contexts. (This helps Moderna prove infringement).
  • The court construed the term “mRNA” to mean “messenger RNA, i.e., a ribonucleic acid (RNA) that encodes a polypeptide and can be translated to produce the encoded polypeptide.” This roughly aligns with Moderna’s proposed construction.   Pfizer had asked that for a definition that included mRNA as a “template for encoding” a polypeptide.  (It is not clear to me the impact of this ruling, however it likely favors Pfizer’s invalidity arguments focusing on whether certain prior art references sufficiently disclose mRNA).

For those of you new to claim construction, the district court is charged with defining terms used in the patent claims when they are a bit too unclear, or when the parties are disputing over their meaning.  The basic approach is that the court should provide the meaning that would a person of ordinary skill in the art would give to the terms at the time of the invention, and after reviewing the claims, the specification, and the prosecution history. See Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005) (en banc). Extrinsic evidence such as dictionary definitions and expert opinion can play a role, but is usually secondary to the intrinsic evidence.  This ruling on claim construction is really setting of the stage, with the real action coming soon via summary judgment motions and eventually the trial.

In my analysis above, I noted some inference about the impact of the various claim construction rulings. Please note that the parties have not yet briefed these issues and so we’ll see what happens.  There may be an immediate summary judgment motion, but I don’t see that as likely until the close of discovery.  It is important to remember that claim construction is not a final determination on infringement or invalidity, but  simply provides interpretations of disputed terms that will be used in those later determinations. In addition, parties often ask a court to reconsider its claim construction.

Although Pfizer obviously does not want to be liable for patent infringement here, Pfizer also holds and is seeking numerous patents on its own related technology.  I expect that Pfizer’s invalidity arguments will be targeted toward specific concerns with the Moderna patents rather than attempting to substantially expand the law.  We might see a different strategy if a non-profit or consumer-focused group had filed. We saw the latter in the Supreme Court’s 2013 Myriad decision.

= = =

Claim 1 of the ‘600 Patent is directed to the mRNA composition designed to encode a betacoronavirus spike protein or subunit, formulated in a lipid nanoparticle.

1. A composition comprising: a messenger ribonucleic acid (mRNA) comprising an open reading frame encoding a betacoronavirus (BetaCoV) S protein or S protein subunit formulated in a lipid nanoparticle.

Note that the court broadly defined betacoronavirus to include later-invented forms.  This leaves the claim open to enablement and written description challenges.

The ‘574 patent claims methods of using modified messenger RNA (mmRNA) with reduced immune activation properties compared to unmodified mRNA and also a slightly different composition claim. Unlike the ‘600 patent, these do not focus on the spike protein but are more generic versions of using the mRNA technology.

1. A method of producing a polypeptide of interest in a cell in a subject in need thereof, comprising administering to the subject a pharmaceutical composition comprising a modified messenger RNA (mmRNA) such that the mmRNA is introduced into the cell, wherein the mmRNA comprises a translatable region encoding the polypeptide of interest and comprises the modified nucleoside 1-methyl-pseudouridine, and wherein the pharmaceutical composition comprises an effective amount of the mmRNA providing for increased polypeptide production and substantially reduced innate immune response in the cell, as compared to a composition comprising a corresponding unmodified mRNA.

2. A pharmaceutical composition comprising: a plurality of lipid nanoparticles comprising a cationic lipid, a sterol, and a PEG-lipid,

wherein the lipid nanoparticles comprise an mRNA encoding a polypeptide, where in the mRNA comprises one or more uridines, one or more cytidines, one or more adenosines, and one or more guanosines and wherein substantially all uridines are modified uridines.

Finally, the ‘127 patent claims methods of administering a composition comprising mRNA encoding a betacoronavirus spike protein formulated in a lipid nanoparticle.  These claims specify percent ranges for ionizable cationic lipid, neutral lipid, cholesterol, and PEG-modified lipid components in the lipid nanoparticle.

1. A method comprising administering to a subject a messenger ribonucleic acid (mRNA) comprising an open reading frame encoding a betacoronavirus (BetaCoV) S protein or S protein subunit formulated in a lipid nanoparticle in an effective amount to induce in the subject an immune response to the BetaCoV S protein or S protein subunit, wherein the lipid nanoparticle comprises 20-60 mol % ionizable cationic lipid, 5-25 mol % neutral lipid, 25-55 mol % cholesterol, and 0.5-15 mol % PEG-modified lipid.

 

Overlapping Patent Doctrines: Eligibility versus Enablement

by Dennis Crouch

As I was reading the Federal Circuit’s nonprecedential decision in Realtime Data v. Array Networks, I noted the court’s repeated statements about how the broad functional claims lacked support in the specification.   Although I knew this was an eligibility case, the language made me think enablement and written description.  Then I reached Judge Newman’s dissenting opinion that begins:

This is properly an enablement case. . . . § 101 was never intended to bar categories of invention in this way. This judicial exception to eligibility is an unnecessary and confusing creation of the courts. This case is an example, for the enablement requirement of § 112 is better suited to determining validity of these claims than is the distortion of § 101. I respectfully dissent, and would remand for determination of validity under § 112.

Slip Op. (Judge Newman in Dissent).

The seven patents here all relate to methods of selectively compressing files to improve speed/storage capacity.  The basic idea behind the inventions is to quickly figure out whether it would be faster to compress & store a data block rather than simply store the uncompressed block.  This generally appears to be a technical question whose solution should be patentable, but the district court all the claims ineligible as directed to one or more abstract ideas.  For  instance US10019458 was deemed directed to the abstract idea of “compressing data using two distinct lossless compression algorithms such that the time to compress and store the first data block is less than the time to store the uncompressed data block.”  On appeal, the Federal Circuit affirmed, finding the claims directed to abstract ideas and lacking any eligible inventive concept under Alice Step 2.

The majority opinion included substantial animus to functional claim limitations:

  • Ineligible if simply “claiming only a result.”
  • Ineligible if merely “stating a functional result.”
  • Ineligible if fail to “identify how the functional result is achieved by limiting the claim scope to structures specified at some level of concreteness.”

The policy debate over functional claiming is longstanding as was evident in the Supreme Court’s recent decision in Amgen v. Sanofi. This case continues that debate in the context of 101.

The majority opinion was written by Judge Reyna and joined by Judge Taranto.  The majority opinion does not reference enablement or Judge Newman’s dissent.

Newman’s dissent is only 3 pages and begins with the argument that the claims should be evaluated under 35 USC 112 for enablement, not 101 for eligibility.  Newman argues the enablement requirement of 112 already addresses overbroad functional claims by requiring the specification teach how to make and use the invention. Using 101 eligibility to target functional claims is therefore unnecessary.  Of course eligibility offers a short-cut for judges and accused infringers.

Judge Newman also makes the larger claim that section 101 was never intended to be a “limitation on patentable subject matter” but rather merely an introduction to the statute.  Expanding upon this, she criticized the judicial exceptions to 101 eligibility created by the courts as an “unnecessary and confusing creation” and identified the the current 101 law a “distortion” of the statute that creates “uncertainty” and “stifles innovation.”

Federal Circuit Jurisdiction over Permissive Counterclaims raising Patent Issues

by Dennis Crouch

The law of appellate jurisdiction routes almost every patent appeal to the Court of Appeals for the Federal Circuit.  This result is by design to ensure more national uniformity in application of the U.S. patent laws.  The court’s recent decision in Teradata Corp. v. SAP SE, 22-1286 (Fed. Cir. Aug. 1, 2023) provides an exception to the general rule.  In its decision, the Federal Circuit held it lacked jurisdiction over Teradata’s appeal because the patent infringement allegations only been raised in a permissive counterclaim.  Although the counterclaims might have been compulsory if compared against Teradata’s original complaint, during the litigation Teradata narrowed its claims in a way that caused separation from the counterclaims.

After a brief partnership pursued under an NDA, SAP began offering a product similar to that of Teradata.  Teradata then sued for trade secret misappropriation and antitrust violations.  SAP responded with denials and also added patent infringement counterclaims.

Counterclaims: The Federal Rules of Civil Procedure permit a defendant to file counterclaims against the plaintiff. The rules divide the counterclaims roughly into two categories: compulsory and permissive.  Although no one actually forces defendant to any counterclaims, failure to assert the compulsory counterclaims is seen as a forfeiture of those claims.  Permissive counterclaims are not lost and instead can be raised in a separate, subsequent lawsuit (so long as a statute of limitations has not run, etc.). The rules spell out the following test for compulsory counterclaims:

(A) arises out of the transaction or occurrence that is the subject matter of the opposing party’s claim; and (B) does not require adding another party over whom the court cannot acquire jurisdiction.

FRCP 13(a).   Compulsory Counterclaims are important for Federal Circuit jurisdiction because the court’s jurisdictional statute routes cases to the Federal Circuit if either (1) the plaintiff asserts a clam that arises under the US patent laws; or (2) a party asserts a compulsory counterclaim that arises under the US patent laws.  Note here the gap — The Federal Circuit does not get jurisdiction if only patent claim is filed as a permissive counterclaim (or a crossclaim or third-party claim).  A final quirk of the appellate jurisdiction is that the jurisdiction statute applies even if non-patent issues are the only ones being appealed.

In Teradata, the district court initially declined to sever SAP’s patent, finding they arose from the same transaction or occurrence as Teradata’s claims.  Eventually though the district court entered summary judgment on the antitrust and certain “technical” trade secret claims in SAP’s favor.  The court then entered partial final judgment under Rule 54(b) on those claims while staying remaining “business” trade secrets claim and the patent counterclaims.  R.54(b) partial final judgment is designed to sever aspects of the case and allow those to be immediately appealed.

Teradata appealed the antitrust and trade secret losses to the Federal Circuit. The court has rejected the appeal, holding that it lacks jurisdiction over Teradata’s appeal because SAP’s patent infringement counterclaims were not compulsory.  Rather, holding the appeal should be heard by the appropriate regional circuit court of appeals. For this case that is the 9th Circuit because the lower court is located in Northern California.

The Federal Circuit applies three tests in analyzing the same transaction test quoted above from R.13: (1) whether the legal and factual issues are largely the same; (2) whether substantially the same evidence supports or refutes the claims; and (3) whether there is a logical relationship between the claims.  In this analysis, the court looks to the complaints and counterclaims as filed. In addition, the Federal Circuit treats claims dismissed without prejudice as having never been filed.  Chamberlain Group, Inc. v. Skylink Technologies, Inc., 381 F.3d 1178, 1189 (Fed. Cir. 2004)

In its initial complaint Teradata had asserted a wide range of trade secret claims that would arguably overlap with the asserted patents.  However, the company narrowed the scope of its claims via amended complaint and later stipulated dismissal without prejudice.  On appeal, the Federal Circuit concluded that those actions narrowed the operative claim to only what was finally asserted by Teradata.  In the case, this was particularly the “batched merge” functionality.  But, the patents asserted by SAP focus on a different technology and different products than batched merge.  This weighed heavily in the Federal Circuit’s analysis, distinguishing this case from prior compulsory counterclaim precedents.  The court noted that the legal and factual issues, as well as the evidence required, are not largely the same or substantially similar between Teradata’s narrowed trade secret claims and SAP’s patent counterclaims.  As a result, there is not a sufficient logical relationship between the narrowed trade secret claims and the patent counterclaims to make the latter compulsory.

= = =

At the district court, Teradata was seeking to have the patent claims severed for a separate trial and, at that time, SAP provided evidence it claimed “demonstrates the substantial overlap between Teradata’s alleged trade secrets and SAP’s asserted patents.”  This statement on the record apparently occurred after the narrowing of the trade secrets claims.  On appeal the sides were reversed.  In particular, SAP stepped back from the argument because it preferred to have the 9th Circuit decide the case rather than the Federal Circuit.  When questioned about its prior statements, SAP responded that estoppel cannot be used to shift a court’s jurisdictional requirements.

= = =

A strange aspect of the case has to do with the trade secret claims that were dropped during litigation.  There does not appear to be an express statement in the record that they were dropped “without prejudice.” And, even if they were dropped without prejudice, res judicata likely still applies to block those trade secrecy claims from being raised in a subsequent lawsuit.  Res judicata would apply because they are clearly part of the same transaction-or-occurrence of the other trade secrecy claims that were litigated.  During oral arguments, Judge Taranto asked an astute question of SAP’s lawyers seeking an admission that Teradata would have a right to relitigate those claims.  SAP’s lawyers refused to make that admission.  The opinion itself offers nothing here and appears to simply assume that the dismissals were without prejudice.

Not a perfect triangle: Even though the dropped trade secret claims likely relate to the same transaction or occurrence as the remaining “batched merge” trade secret claims; AND the dropped trade secret claims likely relate to the same transaction or occurrence as SAP’s patent counterclaims; It does NOT necessarily follow that the remaining “batched merge” trade secret claims arise from the same transaction or occurrence as the patent counterclaims. The relationship between the claims is not transitive – each comparison must be made directly based on the elements and facts required to prove each claim.

= = =

The underlying appeal is interesting and relates to per se antitrust violations and market analysis.

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

by Dennis Crouch

Documents: FedCir Vanda DecisionVanda EnBanc Brief

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

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

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

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

Key Aspects of the Federal Circuit’s Obviousness Analysis

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

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

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

Vanda’s Petition for Rehearing En Banc

Vanda’s en banc brief asks three questions:

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

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

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

by Dennis Crouch

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

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

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

Enablement/Written Description of Unclaimed Variants

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

The Federal Circuit rejected this argument:

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

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

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

Claim Construction and Safety/Efficacy Limitations

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

Product-by-Process Claims

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

Affirmed.

Registering Product Design and the Functional Limitation

by Dennis Crouch

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

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

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

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

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

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

Read the briefs here:

 

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

by Dennis Crouch

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

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

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

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

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

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

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

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

Essential Elements Test for Reissues Patents

by Dennis Crouch

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

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

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

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

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

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

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

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

 

User Matching Patent Fails 101 Test for Lacking Technical Improvement

by Dennis Crouch

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

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

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

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

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

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

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

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

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

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

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

= = =

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

 

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

by Dennis Crouch

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

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

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

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

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

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

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