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PTO Continues to Wave Wands in Assessing Enablement

In light of the 2023 Supreme Court of the United States decision in Amgen Inc. v. Sanofi, the US Patent & Trademark Office (PTO) published guidelines for PTO employees to use, regardless of technology, to ascertain compliance with the enablement requirement under 35 U.S.C. § 112. (89 Fed. Reg. 1563 (Jan. 10, 2024).) Unsurprising to those familiar with the Amgen decision, the PTO hewed closely to existing practice.

The PTO collected the Supreme Court’s clarifications regarding the relationship between the enablement requirement and an amount of experimentation, namely that although particular disclosure of all embodiments is not required, claims are not enabled if they require more than reasonable experimentation. Regarding the “reasonable experimentation” requirement, the PTO explained that consistent with several post-Amgen US Court of Appeals for the Federal Circuit opinions, it would continue to apply the factors that the Federal Circuit announced in its 1988 In re Wands decision.

Although the PTO intends to continue to rely on pre-Amgen Federal Circuit Wands analyses as instructive, it found particular persuasive force since the Federal Circuit’s decision was affirmed by the Supreme Court in Amgen. There, according to the guidance, the Federal Circuit concluded that the genus claims were not enabled because of the amount of experimentation required to test whether antibodies satisfied certain functional limitations. Thus, because “the scope of the claims was far broader in functional diversity than the disclosed examples, … [and] the invention was in an unpredictable field of science with respect to satisfying the full scope of the functional limitations, … there was not adequate guidance in the specification.”

The PTO also noted that the Federal Circuit’s 2023 Baxalta v. Genentech decision, like Amgen, found claims directed to antibodies that contained certain functional limitations to be invalid. There, the Court, like the PTO, detected no appreciable difference between the reasonable experimentation standard as articulated in Wands and the standard as set forth in Amgen. The guidance canvassed other post-Amgen enablement decisions, all of which the PTO read to support continued reliance on Wands.

Practice Note: Although the PTO says that it will continue to apply the Wands factors as it has before, the Amgen decision may, as a practical matter, make establishing enablement of functional limitations more difficult. Whether examiners—especially those in life sciences technology areas—change the course of their review post-Amgen remains to be seen.




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Ordinary Meaning: “Identifying” Doesn’t Mean Detecting; It Means Identifying

The US Court of Appeals for the Federal Circuit affirmed the Patent Trial & Appeal Board’s decisions finding one set of challenged claims patentable and another set of challenged claims in the same patent unpatentable. The Court determined that the Board properly construed a disputed claim term and made factual findings regarding prior art that were supported by substantial evidence. Pacific Biosciences of California, Inc. v. Personal Genomics Taiwan, Inc., Case Nos. 22-1410; -1554 (Fed. Cir. Jan. 9, 2024) (Prost, Taranto, Hughes, JJ.)

Pacific Biosciences of California (PacBio) filed two petitions seeking inter partes review (IPR) of different claim groups in a patent owned by Personal Genomics Taiwan (PGI). The challenged patent is directed to an apparatus for “identifying a single biomolecule” and methods of using or making that apparatus. The petitions overlapped in terms of the challenged claims but differed in terms of the invoked prior art. PacBio’s challenge (on both anticipation and obviousness) was based principally on the Hassibi reference in one IPR and on the Choumane reference in the other.

The Board rejected PacBio’s challenge to certain claims of the patent in its decision on the first IPR, but it agreed with PacBio’s challenge to certain claims of the patent in its decision in the other. In reaching its decisions, the Board construed the term “identifying a single biomolecule” as requiring an apparatus capable of ascertaining the identity of one single individual biomolecule by examining only that biomolecule. In the first decision, the Board found that this limitation was not taught by the Hassibi reference. In contrast, in the other IPR, the Board found that this limitation was taught by the Choumane reference. Both parties appealed.

The Federal Circuit affirmed both Board decisions. First, the Court agreed with the Board’s construction that the disputed claim term (“single biomolecule”) was the ordinary meaning of the phrase in context, namely that there was no apparent reason for the inclusion of the word “single” in the claim term unless to indicate that the capability required was identification of a molecule with just that one molecule in view. The Court explained that the specification supported this understanding by repeatedly stressing that this “single biomolecule” capability was critical to the invention and by differentiating the examination of individual biomolecules from examination of an ensemble of copied biomolecules. The Court also pointed to dependent claims of the patent to provide support for the Board’s construction (in terms of claim differentiation), noting that those claims recited using the claimed apparatus for expressly described multiple-molecule examinations.

Regarding the prior issues on appeal, the Federal Circuit concluded that the Board’s factual findings were supported by substantial evidence. Turning to the Hassibi reference, the Court stated that the Board reasonably credited the testimony of PGI’s expert and the Hassibi reference itself in finding that Hassibi only disclosed the capability to ascertain the identity of a single biomolecule using a BRC assay or different assay. With respect to the Choumane reference, the Court found that the Board reasonably [...]

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Don’t Assume Sweet Success: Forum Selection Clause Doesn’t Preclude IPR

The US Court of Appeals for the Federal Circuit affirmed a district court’s denial of a preliminary injunction seeking to bar a petitioner from challenging certain patents at the US Patent & Trademark Office (PTO) because of a forum selection clause in a settlement agreement. The Court found that the patent owner was unlikely to succeed on the merits based on the likelihood of success factor. DexCom, Inc. v. Abbott Diabetes Care, Inc., Case No. 23-1795 (Fed. Cir. Jan. 3, 2024) (Dyk, Hughes, Stoll, JJ.)

DexCom and Abbott are competing manufacturers of continuous glucose monitoring systems. In 2014, the parties entered into a settlement agreement that included a cross-license to certain patents, covenants not to sue or challenge the patents for a “Covenant Period,” and a forum selection clause identifying the US District Court for the District of Delaware as the exclusive jurisdiction “over any dispute arising from or under or relating to [the] Agreement, to the extent permitted by law.” After expiration of the Covenant Period, DexCom sued Abbott in the Western District of Texas. Abbott moved to transfer the case to the District of Delaware and added a breach of contract counterclaim, citing the settlement agreement’s forum selection clause. The case was transferred to Delaware, after which Abbott filed eight petitions for inter partes review (IPR) at the PTO. DexCom responded to the breach of contract counterclaim by alleging that Abbott had breached the forum selection clause by filing the IPR petitions. Until this point, DexCom had consistently taken the position that the asserted claims were not subject to the cross-license, rendering the forum selection clause inapplicable.

Six months after Abbott filed the IPR petitions, DexCom moved for a preliminary injunction prohibiting the IPRs from proceeding. The district court denied the preliminary injunction. In evaluating the four injunctive relief factors (i.e., likelihood of success on the merits, irreparable harm, balance of hardships and public interest), the district court simply assumed the likelihood of success in favor of DexCom. It nevertheless denied the injunction because DexCom waited six months to file the motion (suggesting there was no irreparable harm) and because DexCom had taken inconsistent legal positions with respect to whether the challenged patents were licensed, thus weighing against DexCom in the balance of hardships factor. DexCom sought interlocutory appeal of the district court’s order.

The Federal Circuit focused on the first factor, likelihood of success on the merits. While the district court assumed that this factor favored DexCom, the Federal Circuit disagreed. The Court noted that the agreement required that DexCom and Abbott “shall not Challenge” each other’s patents during the Covenant Period, with the exception that “each Party reserves its rights and is permitted to Challenge any of the patents of the other Party if there is a statute, regulation, or rule that sets a deadline to make the Challenge,” assuming certain conditions were met. The Court first explained that “challenge” includes IPRs of the patents and that nothing in the forum selection clause differentiated between the [...]

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Espresso Yourself: When Prosecution History as a Whole Doesn’t Demonstrate Clear, Unmistakable Disclaimer

The US Court of Appeals for the Federal Circuit reversed and remanded a district court’s claim construction and related summary judgment rulings after determining that the district court erred in construing a claim term by improperly limiting the plain and ordinary meaning of the term. K-fee System GmbH v. Nespresso USA, Inc., Case No. 22-2042 (Fed. Cir. Dec. 26, 2023) (Taranto, Clevenger, Stoll, JJ.)

K-fee filed a lawsuit against Nespresso alleging infringement of three K-fee patents directed toward coffee machine portion capsules that use a barcode. The district court issued a claim construction order construing the term “barcode,” which was present in every asserted claim. In the claim construction order, the district court characterized the dispute as “whether statements made by K-fee System GmbH . . . before the EPO [European Patent Office] concerning the meaning of ‘barcode’ should influence the plain and ordinary meaning of that limitation in these proceedings.”

In the EPO, Nespresso’s foreign affiliate had challenged the validity of K-fee’s related European patent, and K-fee had responded seeking to distinguish a particular piece of prior art (Jarisch/D1). Because the statements made to the EPO were submitted to the US Patent & Trademark Office during prosecution of the asserted patents, the district court analyzed the statements as part of the intrinsic record. The district court concluded that K-fee had “argued strenuously before the EPO for a particular ‘plain and ordinary meaning,’ which excluded ‘bit codes’—codes made up of two binary symbols.” Based on the EPO submissions, the district court construed the claim term “barcode” to:

its plain and ordinary meaning (i.e., a code having bars of variable width, which includes the lines and gaps), the scope of which is understood by the clear and unequivocal statements K-fee made to the EPO (i.e., the scope of barcode does not include the type of bit code disclosed in Jarisch/D1).

Based on that construction of “barcode,” Nespresso moved for summary judgment of noninfringement. It argued that its accused products operated identically to Jarisch capsules, which K-fee distinguished before the EPO, since both use a machine-readable code with only two binary symbols. The district court agreed. When applying its construction at summary judgment, the district court clarified that using “the type of bit code disclosed in Jarisch” … means “a binary code containing only ‘0s’ and ‘1s.’” Thus, the district court read K-fee’s EPO statements “to mean that a barcode must ‘contain more than only two binary symbols’ and, by extension, that any code that contains only two binary symbols could not be a barcode.” Because the court found that “there was no dispute that Nespresso’s accused products used a code having only two symbols,” it granted Nespresso’s motion for summary judgment of noninfringement. K-fee appealed.

Considering the issue de novo, the Federal Circuit reviewed K-fee’s statements to the EPO in context and disagreed “that the ordinary meaning of ‘barcode’ excludes ‘bit codes’ (in some sense, two-value codes) or even bit codes of ‘the type . . . disclosed in Jarisch’ to [...]

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Same Applicant, Similar Claims Support Obviousness-Type Double Patenting Rejection

The US Court of Appeals for the Federal Circuit affirmed a Patent Trial & Appeal Board obviousness-type double patenting rejection, finding that an unexpected mechanism of action does not render the known use of a known compound nonobvious. In re: Institut Pasteur, Case No. 22-1896 (Fed. Cir. Dec. 13, 2023) (Taranto, Clevenger, Stoll, JJ.) (nonprecedential).

Institut Pasteur filed a patent application directed to peptides derived from human basic proline-rich lacrimal protein and claimed, among other things, a method for treating pain comprising of administering 10 to 300 mg/day of the peptide for seven days. The examiner rejected the claims for obviousness-type double patenting over another patent application filed by Pasteur, which was directed to diagnostic and therapeutic uses of human basic proline-rich lacrimal protein and peptides derived therefrom.

Pasteur appealed to the Board, which affirmed the examiner’s rejection. Rather than appeal the Board’s decision to the Federal Circuit, Pasteur sought continued examination of the application and modified the claims to specify that the method of treatment was for human patients, was in a dose of 1 mg/kg to 2 mg/kg at 10 to 300 mg/day, and should not induce pharmacodependence or tolerance in the patient. The examiner rejected the amended claims for obviousness-type double patenting over the same application. On appeal, the Board issued another decision agreeing with the examiner. Pasteur appealed this decision.

Pasteur argued that the Board’s second decision was unsupported by substantial evidence because the Board applied a legally flawed prima facie obviousness analysis and disregarded the secondary indicia of nonobviousness presented in a declaration submitted by Catherine Rougeot, the named inventor of the application.

The Federal Circuit disagreed with Pasteur and affirmed the Board’s rejection. As for Pasteur’s argument that the Board disregarded the differences between the claims of the patent application and the claims of the other application, the Court noted that the Board “explained why each claim limitation was obvious in light of the [other application].” With respect to Pasteur’s argument that the Board improperly relied on inherency when finding one limitation of the filed application to be satisfied, the Court concluded that “[i]t is settled that inherency may supply a missing claim limitation in an obviousness analysis.”

As for Pasteur’s challenge to the Board’s consideration of the secondary indicia of nonobviousness presented in the Rougeot declaration, the Federal Circuit found that the Board’s analysis was supported by substantial evidence. The Court made clear that Pasteur failed to prove that the benefits claimed by the application were unexpected compared to the closest prior art since unexpected mechanisms of action do not ipso facto make the known use of known compounds nonobvious. The Court also noted that Federal Circuit precedent did not demand a finding of nonobviousness simply because one limitation was found to be satisfied through inherency. The Court was similarly unpersuaded by the long-felt need described in the Rougeot declaration because any need for the subject matter claimed by the patent application was already satisfied by the subject matter claimed by the other [...]

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TikTok: Federal Circuit Follows Fifth Circuit, Transfers Case for Witness Convenience

In the first mandamus decision applying the US Court of Appeals for the Fifth Circuit’s new transfer motion guidelines under 28 U.S.C. 1404(a), the Federal Circuit followed suit and transferred a case for witness convenience. In re Samsung Elecs. Co., Ltd., Case No. 2023-146 (Fed. Cir. Dec. 14, 2023) (nonprecedential) (Prost, Hughes, Stoll, JJ.) (per curiam).

DoDots Licensing sued Samsung in the US District Court for the Western District of Texas (WDTX), alleging that Samsung phones and tablets infringed three DoDots patents. Samsung moved to transfer the case to the Northern District of California (NDCA). The applicable Fifth Circuit law allows for transfer only when the movant shows that the transferee forum is “clearly more convenient” than the transferor forum, which is determined by assessing a series of private and public interest factors. Echoing three of those factors, Samsung argued the following:

  • The teams that developed the allegedly infringing functionalities resided in NDCA and Korea.
  • Important third-party witnesses could be compelled to testify in NDCA but not in WDTX.
  • There was no meaningful connection between WDTX and the events giving rise to the suit.

Judge Albright denied the motion to transfer. He found that two factors weighed in favor of transfer: the ability to compel witness testimony and NDCA’s local interest in the case. However, Judge Albright also found that two factors weighed against transfer: WDTX was more convenient for certain witnesses, and DoDots’ co-pending and related lawsuits in WDTX meant that practical problems would arise if this case was transferred. The district court further determined that any remaining factors were neutral. Weighing all factors, the district court denied Samsung’s transfer motion, finding that Samsung had not shown that NDCA would be “clearly more convenient.”

Samsung filed a petition for writ of mandamus to the Federal Circuit, seeking to have the Court direct WDTX to transfer the case to NDCA. The sole question presented was whether, under Fifth Circuit law, the district court erred in refusing to transfer the case.

The Federal Circuit determined that the district court had clearly abused its discretion and that failing to transfer the case to NDCA had led to a “patently erroneous result.” The Federal Circuit found that the two factors that the district court determined weighed against transfer instead weighed in favor of transfer.

First, the Federal Circuit explained that the district court erred in finding that the “willing witness” factor weighed against transfer. Various Samsung entities had 10 relevant employees in NDCA and 20 in Korea. DoDots, in contrast, pointed to no potential technical or key witnesses in WDTX, although there were some Samsung marketing employees in Eastern Texas. The district court found that this weighed against transfer because any added travel from California to Texas for these technical witnesses was only a “slight” inconvenience. This argument echoed the argument that the Fifth Circuit rejected in its recent ruling in In re TikTok. In that case, the Fifth Circuit found on very similar facts that it was [...]

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Store This Element: Lexicography Controls Claim Term Definition Over Plain and Ordinary Meaning

The US Court of Appeals for the Federal Circuit affirmed a Patent Trial & Appeal Board obviousness finding, determining that the Board properly applied the patentee’s lexicography in construing a disputed claim term and properly treated arguments raised by the parties in the reply and sur-reply briefings. ParkerVision, Inc. v. Vidal, Case No. 22-1548 (Fed. Cir. Dec. 15, 2023) (Prost, Wallach, Chen, JJ.)

Intel filed a petition for inter partes review of a patent owned by ParkerVision. The challenged patent is directed to wireless local area networks (WLANs) that use frequency translation technology and incorporate another patent that describes down-conversion utilizing down-converter modules. The challenged claim is directed to apparatuses for down-converting electromagnetic (EM) signals. Among other things, the claim recites “wherein said first and said second frequency down-conversion modules each comprise a switch and a storage element.” The Board found the challenged claim unpatentable and in doing so, construed the term “storage element” to mean “an element of a system that stores non-negligible energy from an input signal.” The Board based its construction on the description of “storage modules” in a patent incorporated by reference into the challenged patent. ParkerVision appealed.

The Federal Circuit affirmed the Board’s construction, finding that ParkerVision had acted as its own lexicographer when it defined the term “storage element” in the incorporated-by-reference patent. The Court relied on a “critical” paragraph from the incorporated-by-reference patent that states: “[s]torage modules and storage capacitances, on the other hand, refer to systems that store a non-negligible amount of energy from an input EM signal.” The Court reasoned that the term “refer to,” together with the “as used herein” language from a preceding sentence, conveyed an intent for the sentence to be definitional and applicable to the whole patent rather than to a specific embodiment. To that end, the Court reiterated that a patentee may act as its own lexicographer by crafting a definition for a claim term rather than relying on the plain and ordinary meaning of that term, and that when a patentee does so, the definition may act as a disavowal of the full scope of the plain and ordinary meaning of the term.

ParkerVision also argued that the Board impermissibly relied on arguments allegedly raised for the first time in Intel’s reply brief, and that it erred in excluding certain arguments made by ParkerVision on sur-reply. The Federal Circuit rejected both arguments. The Court reasoned that because ParkerVision proposed a new claim construction in its patent owner response, Intel was permitted to argue and present evidence of obviousness under that new construction as long as such evidence relied on the same embodiments for each invalidity ground as were relied on in the petition.

The Federal Circuit also noted that ParkerVision’s arguments on sur-reply exceeded the scope of its patent owner response. While ParkerVision’s patent owner response proposed that the “storage element” be an element of the energy transfer system and store non-negligible amounts of energy from an input EM signal, ParkerVision only argued that the [...]

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If the Label Is Skinny Enough – No Inducement Under Hatch-Waxman

The US Court of Appeals for the Federal Circuit made explicit what has long been considered implicit based on Warner-Lambert and its progeny, namely, that plaintiffs asserting an induced infringement theory to bar the entry of generic drugs in a Hatch-Waxman suit are subject to higher scrutiny than plaintiffs asserting the same theories outside of the Hatch-Waxman context. H. Lundbeck A/S v. Lupin Ltd., Case No. 22-1194 (Fed. Cir. Dec. 7, 2023) (Dyk, Prost, Hughes, JJ.)

Lundbeck owns the approved new drug application (NDA) for Trintellix®, a drug indicated for the treatment of major depressive disorder (MDD), as well as an expired compound patent for the associated active ingredient vortioxetine. Lundbeck also owns a patent that claims the use of vortioxetine as an antidepressant that can be prescribed in place of a traditional antidepressant to alleviate a patient’s negative sexual side effects, and another patent that claims the use of vortioxetine to treat cognitive impairment symptoms in patients with MDD.

Generic pharmaceutical companies filed abbreviated new drug applications (ANDAs) seeking approval to market generic versions of Trintellix® and asserting that Lundbeck’s unexpired patents listed in its NDA were invalid and would not be infringed by the generic companies. As required by the Hatch-Waxman Act (to prevent the entry of a generic on the market), Lundbeck sued the generic companies. At the district court, the defendants prevailed on the finding of noninfringement but lost on invalidity. Lundbeck appealed.

Lundbeck pressed its induced infringement and contributory infringement theories on appeal. Lundbeck argued that the generics infringed under the plain text of Hatch-Waxman (35 USC 271(e)(2)(A)) because they filed ANDAs seeking approval to market vortioxetine, and that “some uses of vortioxetine—for the treatment of patients that have previously taken other drugs but had to cease or reduce use due to sexually related adverse events and for the treatment of cognitive impairment—are covered by [Lundbeck’s listed] patents; and the labels do not prohibit prescribing vortioxetine for those uses, even though the defendants do not propose to market the drug for those patented uses.” In other words, Lundbeck argued that in terms of its inducement allegation, it made no difference whether a drug would be sold for a use not covered by Lundberg’s NDA-listed patents because the drug could be prescribed for those patented uses.

The Federal Circuit disagreed, explaining that “‘the use’ in § 271(e)(2)(A) refers to the use for which the FDA has granted an NDA” and for which the ANDA was submitted.” The Court emphasized that it is not “an act of infringement under . . . § 271(e)(2)(A) to submit an ANDA for a drug if just any use of that drug were claimed in a patent.” If it were, a brand could “maintain its exclusivity merely by regularly filing a new patent application claiming a narrow method of use not covered by its NDA,” which “would confer substantial additional rights on pioneer drug patent owners that Congress quite clearly did not intend to confer.” As the Court then held, “actions for [...]

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Sound the Alarm: Reasonable Royalty Apportionment Analysis Overlooks “Sleep State”

After a jury found infringement of two patents and awarded almost $2.2 billion in damages, the US Court of Appeals for the Federal Circuit reversed the infringement finding for one asserted patent, vacated the damages award for the other asserted patent, and reversed the district court’s refusal to allow the alleged infringer to add a licensing defense. VLSI Technology LLC v. Intel Corporation, Case No. 22-1906 (Fed. Cir. Dec. 4, 2023) (Lourie, Dyk, Taranto, JJ.)

VLSI sued Intel for infringement of two patents. During the litigation, third party Finjan underwent a change in control after which it was controlled by the same parent entity as VLSI. Intel sought to amend its answer to add a licensing defense based on the broad definition of “affiliates” in its license agreement with Finjan, arguing that as a consequence of the change in control Intel was licensed to patents owned by VLSI. The district court denied the motion to amend.

At trial, the jury found literal infringement of one patent and infringement under the doctrine of equivalents (DoE) for the other patent. The jury awarded $2.2 billion in damages. Intel appealed.

The patent that the jury found infringed under the DoE was directed to devices, such as computer processors, having the ability to operate at a variety of frequencies. Depending on the operating conditions, a master device can provide a trigger input to a controller in response to a desired increase in device performance, and the controller can then adjust the clock frequency accordingly. Intel argued that the evidence of equivalents presented to the jury was legally insufficient to support a finding of infringement.

The Federal Circuit agreed and reversed the jury’s finding under the DoE. The Court stressed that for a patent owner to prevail under a DoE assertion, it must provide “particularized testimony and linking argument as to the insubstantiality of the differences between the claimed invention and the accused device.” While VLSI’s proof of equivalence was limitation specific, the testimony provided during the trial was insufficient to explain the “insubstantiality” of the differences between the claims and the Intel products. The Court specifically cited trial testimony by VLSI’s expert, who characterized the differences as “a difference of where an engineer draws the line . . . it’s a design choice.” In its explanation of why the analysis and testimony was insufficient, the Court explained that “[i]t is not enough [] to say that the different functionality-location placements were a ‘design choice.’ . . . VLSI had to prove—with particularized testimony and linking argument—that the elements of the Intel arrangement were substantially the same as the elements of the claimed arrangement. But VLSI offered no meaningful testimony doing so.”

Intel also appealed the damages award based on the patent that was found to be literally infringed. That patent was directed to certain features that provide separate scalable (as opposed to fixed) power supply voltages for both processors and memory devices, depending on the need of the device. VLSI’s expert presented a calculation of damages based [...]

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PTO Creates Separate Design Patent Bar

The US Patent & Trademark Office (PTO) published its final rule, creating a separate design patent bar where admitted design patent practitioners will practice in design patent proceedings only. (88 Fed. Reg. 78644 (Nov. 16, 2023).)

Prior to this rulemaking, there was a single patent bar for those who practice in patent matters before the PTO, including in utility, plant and design patent proceedings. PTO regulations previously required that all patent bar practitioners pass a registration exam and possess specific and stringent scientific and technical qualifications, such as an engineering degree or substantial course work in physics, biology, chemistry or the like.

The new rule creates a separate design patent bar that still requires members to pass the current registration exam but permits applicants to have a bachelor’s degree, master’s degree or PhD in any of the following areas from an accredited college or university:

  • Industrial design
  • Product design
  • Architecture
  • Applied arts
  • Graphic design
  • Fine/studio arts
  • Art teacher education.

The new rules expanding the patent bar admission criteria are intended to encourage broader participation and to keep up with the ever-evolving technology and related teachings that qualify someone to practice before the PTO. Practitioners currently admitted before the PTO will not be impacted by the change and can continue to prosecute utility, plant and design patents.

The rule will take effect on January 2, 2024.




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