Bald Girls Do Lunch (“BDGL”) is a nonprofit organization dedicated to improving the quality of life for females living with alopecia areata (“AA”). AA has been described as “an autoimmune skin disease resulting in partial to complete hair loss on all hair-bearing areas of the body, including, for example, on the face, resulting in loss of eyebrows and eyelashes.” According to BDGL, “AA is not a simple cosmetic problem—it is a chronic, often devastating condition that has substantial and wideranging implications, affecting patient’s physical, mental, and emotional health. Indeed, in severe cases, AA can lead to chronic depression.” (more…)
In a recent tax appeal, the Third Circuit court of appeals afformed that legal expenses incurred by generic drug makers to defend against patent infringement suits brought under the Hatch-Waxman Act are deductible as ordinary and necessary business expenses. This aligns with longstanding precedent treating patent litigation defense costs as deductible for the alleged infringer. (more…)
The nexus requirement serves as a threshold that must be met before secondary indicia will be even considered as relevant to the obviousness inquiry. In its recent Volva Penta decision, the Federal Circuit found that the PTAB had (1) created too high of a burden to prove nexus and (2) been unduly dismissive of the patentee’s evidence of commercial success and copying. The case reinforces the notion that patentees should attempt to include some claims that are largely coexistive with its product line, especially in today’s world of likely copying. The case also serves as a reminder that product copying still caries significant weight in the obviousness analysis. Volvo Penta of the Americas, LLC v. Brunswick Corp., 22-1765, — F.4th — (Fed. Cir. August 24, 2022). (more…)
By: Suzanne Harrison, Chair of the Patent Public Advisory Committee (PPAC) at the USPTO. This post is part of a series by the Diversity Pilots Initiative, which advances inclusive innovation through rigorous research. The first blog in the series is here and resources from the first conference of the initiative are available here.(more…)
By: Abhay Aneja, Assistant Professor of Law, University of California, Berkeley, Diversity Pilots Initiative Researcher, Gauri Subramani, Assistant Professor in the Department of Management, College of Business, Lehigh University and Diversity Pilots Initiative Researcher, and Oren Reshef, Assistant Professor of Strategy, Washington University in St. Louis. This post is part of a series by the Diversity Pilots Initiative, which advances inclusive innovation through rigorous research. The first blog in the series is here, and resources from the first conference of the initiative are available here.(more…)
Steuben Food recently lost its infringement case against Shibuya Hoppmann with the district court holding (1) the doctrine of equivalents (DOE) cannot extend to cover the accused aseptic bottle filling technique and further (2) the reverse doctrine of equivalents shields the defendant against charges of literal infringement. Steuben Foods, Inc. v. Shibuya Hoppmann Corp., No. 1:19-cv-02181-CFC, 2023 WL 2498810 (D. Del. Mar. 14, 2023) (U.S. Patent Nos. 6,209,591; 6,536,188; and 6,702,985) (Chief Judge Connolly). The case is now pending on appeal at the Federal Circuit with the successful defendant’s responsive brief due in mid-September. (more…)
The Supreme Court’s landmark 1950 decision in Graver Tank & Mfg. Co. v. Linde Air Products Co., 339 U.S. 605 (1950) is one of the court’s most cited patent cases. The decision established important guideposts for applying the doctrine of equivalents (“DOE”), including consideration of the prior art and a focus on the substantiality of differences. While courts today emphasize evaluating equivalence on an element-by-element basis, Graver Tank‘s substantive analysis remains highly influential. (more…)
I’m getting ready to teach my Fall 2023 Patent Law class, and that means updating the granted utility patents graph that I do every few years. This year’s version shows U.S. utility patents granted per year from 1840-2022:
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. (more…)
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. (more…)
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. (more…)
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). (more…)
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. (more…)
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. (more…)
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.
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 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.”).
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.
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.
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.
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.”
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.
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.”
