IP UPDATE
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Specially Convened Rehearing Panel Vacates IPR Institution Denial

by | Mar 21, 2024 | ,

In a rehearing decision issued by a Delegated Rehearing Panel specially convened by the US Patent & Trademark Office (PTO) Director, the Patent Trial & Appeal Board vacated a prior panel decision denying institution, modified the claim construction to account for a “clear and unmistakable” prosecution history disclaimer, and remanded for further proceedings consistent with the modified claim construction. SynAffix B.V. v. Hangzhou DAC Biotech Co., Ltd., No. IPR2022-01531, Paper 23 (PTAB Mar. 4, 2024) (Kim, Acting Deputy Chief APJ; Gongola, Vice Chief APJ; Worth, Acting Senior Lead APJ).

SynAffix filed a petition for inter partes review (IPR) of certain patent claims owned by Hangzhou DAC Biotech. The claims at issue are directed to a hydrophilic linker of formula (I), reproduced below.

A Board panel issued a prior decision denying institution. In the prior decision, the Board noted that it was undisputed that moieties Y or Z enable connection of the linker to a cell-binding agent (Y) or a cytotoxic drug (Z), and that Q and T are one sulfone, sulfoxide or phosphinate. That said, the central issue was whether Y or Z must act independently or whether they can act in concert with an adjoined Q or T compound. The Board concluded that Y and Z must act independently to enable their respective chemical reactions without assistance from an adjoining Q or T compound, because during prosecution the patent owner disclaimed embodiments in which Y or Z was adjoined to a sulfone compound with no additional adjacent sulfone, sulfoxide or phosphinate to overcome a rejection based on a prior art reference (Lees). Thus, the Board denied institution.

SynAffix subsequently sought review by the Director. The Director issued an order delegating director review to a rehearing panel. The rehearing panel reviewed whether the prior decision misapprehended or overlooked any issue raised in the request for director review. In particular, the rehearing panel considered whether, when the hydrophilic linker contains a vinylsulfone group, one of Y and Z may be understood to be a vinyl group with one of Q and T as a sulfone group (i.e., the vinyl group and the sulfone group mapped to separate letters), or instead whether one of Y and Z must be a vinylsulfone group (i.e., the vinyl group and the sulfone group mapped to the same letter).

While the rehearing panel agreed with the first version of the prosecution history disclaimer in the prior decision, it rejected a second under which two sulfone groups would not fall within the scope of the claim. First, the rehearing panel accepted the Board’s prior finding that the patent owner disclaimed embodiments in which Y or Z was adjoined to a sulfone compound with no additional sulfone, sulfoxide or phosphinate. However, the conclusion (in the prior decision) that the challenged independent claim excludes compounds in which the sole terminal group is vinyl sulfone without one or more adjacent Q and [...]

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Be Cool: Don’t Construe the Construction

by | Mar 21, 2024 |

The US Court of Appeals for the Federal Circuit vacated and remanded a Patent Trial & Appeal Board decision after concluding that the patent owner’s proposed construction would require the parties to construe the construction. CoolIT Systems, Inc. v. Katherine Vidal, Director of the United States Patent & Trademark Office, Case No. 22-1221 (Fed. Cir. March 7, 2024) (Lourie, Bryson, Stark, JJ.) (nonprecedential).

CoolIT Systems owns a patent directed to a system for fluid heat transfer to cool electronic devices. The patent focuses on a heat exchange system comprising various components including a heat sink, a housing member and a compliant member. The patent claims priority from two provisional applications. Asetek Danmark petitioned for inter partes review (IPR) of the patent based on anticipation and obviousness. During the IPR proceeding, the parties disputed the meaning of the term “matingly engaged,” a term introduced in the later provisional application. To preserve validity, CoolIT argued that the term should be construed narrowly to mean “mechanically joined or fitted together to interlock.” Asetek sought a broader construction of “joined or fitted together to make contact,” which would encompass all methods of joining two surfaces.

The Board found both interpretations extreme and partially construed the term as being satisfied when at least a portion of the compliant member fits within the recessed region of the housing member. Despite agreement on the term “mate” to mean “join or fit together,” there was disagreement on the term “engage.” However, the Board did not determine whether “matingly engaged” could encompass forms of engagement beyond fitting.

The Board found that the cited prior art suggested a compliant member fitting the housing, thus rendering the claims obvious. CoolIT appealed. The US Patent & Trademark Office (PTO) intervened after Asetek withdrew from the appeal based on settlement.

CoolIT argued that the Board’s interpretation was flawed, and that the prior art did not meet the requirements of the “matingly engaged” limitation irrespective of the interpretation adopted. CoolIT contended that its proposed construction aligned with the invention’s purpose and properly distinguished between the 2007 and 2011 provisional applications. CoolIT also argued that the compliant member must partition features to control coolant flow, necessitating a specific type of joining or fitting.

In response, the PTO argued that CoolIT’s proposed construction read limitations from the specification into the claim. The PTO contended that neither the claims nor the specification required “interlock” and disputed CoolIT’s interpretation of the 2007 provisional application. The PTO did not propose an alternative construction, however.

The Federal Circuit concluded that “matingly engaged” should properly be construed as “mechanically joined or fitted together,” as that construction accurately reflected the term’s meaning and aligned with arguments presented by both parties. The Court rejected CoolIT’s proposal to add the word “interlock” because it would cause more confusion than clarity, noting that even CoolIT and the PTO still disagreed over what the term “interlock” meant and thus adding that term to the construction would provide little guidance.

The Federal Circuit found that the Board [...]

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Read the Fine Print: Covenant Not to Sue “At Any Time” Terminated Upon License Expiration

by | Mar 14, 2024 |

Illustrating the importance of carefully drafting and reviewing language in a covenant not to sue, the US Court of Appeals for the Federal Circuit found that the plain language of a covenant permitted a licensor to sue a licensee for breach of contract only after termination of the contract. AlexSam, Inc. v. MasterCard Int’l., Inc., Case No. 22-2046 (Fed. Cir. Feb. 28, 2024) (Lourie, Chen, Stoll, JJ.) (non-precedential).

In 2005, AlexSam and MasterCard entered into a patent licensing agreement that guaranteed AlexSam ongoing royalties under two of its patents that involved pre-paid cards used with point-of-sale devices. The agreement included a covenant not to sue, in which AlexSam agreed to “not at any time initiate, assert, or bring any claim . . . against MasterCard . . . relating to Licensed Transactions arising or occurring before or during the term of this Agreement.” The agreement also included a Term and Termination provision, which recited that the agreement would remain in full force for the life of the licensed patents unless a party breached, at which time, if the party failed to cure, the non-breaching party would have the right to terminate the agreement. The patents expired on July 10, 2017.

In May 2015, two years before the licensed patents expired, AlexSam sued MasterCard for breach of contract in the district court, claiming that MasterCard had not properly paid the royalties per transaction under the agreement. Separately, in March 2017, MasterCard filed a petition for Covered Business Method (CBM) Review, asking the Patent Trial & Appeal Board to review the patentability of the licensed patents. AlexSam argued that MasterCard lacked standing under 37 C.F.R. § 42.302(a), which required that MasterCard first be sued or charged with infringement of the patent on which it sought review. The Board determined that MasterCard lacked standing to bring the review. The Board also noted that it “need not, and do[es] not, address the question of whether [AlexSam’s] breach of contract claim in the New York Action itself violates the covenant not to sue.”

MasterCard moved for and was granted summary judgment in the district court on the grounds that AlexSam’s arguments before the Board regarding the covenant not to sue judicially estopped it from asserting its breach of contract claims. AlexSam filed its first appeal, and the Federal Circuit reversed the district court’s ruling, finding that it had abused its discretion in crediting AlexSam with a position it never actually took before the Board. The Court remanded the case for the district court to determine whether the covenant not to sue prohibited a claim for royalties. MasterCard again moved for summary judgment. The district court granted the motion, finding that the covenant not to sue barred AlexSam’s claim for unpaid royalties. AlexSam again appealed.

In this second appeal, AlexSam argued that the covenant not to sue in the 2005 License Agreement did not bar suit for breach of nonpayment of royalties since AlexSam would then have no remedy against a failure by MasterCard to pay [...]

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Optimizing Obviousness: Routine Optimization Can Fill in Prior Art Gaps

by | Mar 14, 2024 | ,

In an appeal from a Patent Trial & Appeal Board finding of invalidity, the US Court of Appeals for the Federal Circuit held that the result-effective variable doctrine can apply even when there is no overlap between a claimed range and a prior art range. The Court also held that before denying a motion to amend, the Board must address every element of proposed claims, and that a party cannot challenge the US Patent & Trademark Office (PTO) Director Review procedure if it cannot show prejudice. Pfizer Inc. v. Sanofi Pasteur, Inc., Case No. 19-1871 (Fed. Cir. Mar. 5, 2024), (Lourie, Bryson, Stark, JJ.)

Sanofi filed five inter partes review (IPR) petitions targeting a patent owned by Pfizer and directed to immunogenic glycoconjugates of Streptococcus antigens (i.e., combinations of sugar molecules found on the surface of Streptococcus bacteria capable of provoking an immune response). The challenged independent claim recited conjugates having a sugar from the 22F Streptococcus serotype and a molecular weight falling within a claimed range. Dependent claims further limited the independent claim by requiring combinations of specific sugars.

Sanofi challenged the claims based on a combination of two references: GSK-711 and Merck-086. GSK-711 described vaccines using sugars from 22F, and Merck-086 described immunogenic compositions using Streptococcus sugar conjugates. While neither reference disclosed the molecular weight of a 22F conjugate, the Board found that the molecular weight of a conjugate was a “result-effective variable” – i.e., a variable that affected the efficacy of the result – and thus it would have been obvious for a person of ordinary skill in the art (POSITA) to optimize the molecular weight of a 22F-based conjugate to achieve the claimed molecular weight range. The Board also found that the dependent claims would have been obvious, as GSK-711 disclosed the additionally claimed sugars. Pfizer filed a motion to amend to add new claims, but the Board denied the motion. Pfizer also requested Director Review of the Board’s decision, but the Director denied the request.

Pfizer appealed to the Federal Circuit alleging that the Board improperly applied the result-effective variable doctrine, that the Board improperly denied Pfizer’s request to amend the claims, and that the Director’s denial of review violated the Administrative Procedure Act (APA). The Federal Circuit affirmed the Board’s finding of invalidity, affirmed in part and remanded in part the issue of the proposed claim amendment, and finally held that any violation of the APA was harmless.

The Federal Circuit started with an analysis of the result-effective variable doctrine. Pfizer argued that the result-effective variable doctrine could not apply when there was no disclosure of an effective range in the prior art. Therefore, because neither GSK-711 nor Merck-086 disclosed an effective molecular weight range for a 22F conjugate, and because the relationship between molecular weight and efficacy was unpredictable, the independent claim was not obvious. The Court disagreed.

The Federal Circuit explained that, when there is a gap between the prior art and the claims, the relevant [...]

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PTO Seeks Permanent Rules Regarding Motion to Amend Practice Before Board

by | Mar 14, 2024 |

On March 4, 2024, the US Patent & Trademark Office published a Notice of Proposed Rulemaking seeking to revise its Motion to Amend (MTA) pilot program practice in connection with certain America Invents Act (AIA) proceedings. 89 Fed. Reg. 15531 (Mar. 4, 2024). The PTO set a May 3, 2024, deadline for stakeholders to submit written comments in response to the proposed rules.

The MTA pilot program has evolved since its inception nearly five years ago and has been extended to September 16, 2024. The proposal seeks to make permanent certain provisions of the pilot program in response to the PTO’s May 2023 request for comments. The rules would apply to the existing consolidated set of rules relating to trial practice for inter partes review (IPR), post-grant review (PGR) and derivation proceedings in trial proceedings under the AIA.

Under the existing MTA pilot program, patent claims challenged during an AIA trial proceeding provide the patent owner with two options when proposing substitute claims in response to a petitioner’s opposition. The first option gives the patent owner the ability to file an MTA so that the Patent Trial & Appeal Board can issue preliminary non-binding guidance regarding the likelihood of an invalidation decision. The PTO proposes to revise its rules of practice to provide for the issuance of preliminary guidance in response to an MTA and to provide a patent owner with the option of filing one additional revised MTA.

The Board’s preliminary guidance typically would come in the form of a short paper issued after a petitioner files its opposition to the MTA and typically would provide the Board’s preliminary views on the MTA, specifically whether the MTA meets the statutory and regulatory requirements for an MTA, whether the parties have met their respective burdens of proof and whether the substitute claims are likely to be found unpatentable. However, the preliminary guidance would not be binding on the Board.

The proposed provisions would also provide the Board with greater authority to raise new grounds of unpatentability based on a preponderance of evidence standard. The new grounds of unpatentability could rely on the entirety of the record, including all prior art of record. The guidance would be accompanied by citations to the evidence in support of these new grounds. Further, where no opposition is filed or other circumstances constitute a lack of opposition, the prior art of record may further include references obtained from the PTO (i.e., examiners) in response to a request from the Board.

The proposed provisions would allow a patent owner to file a revised MTA after receiving a petitioner’s opposition to the original MTA or after receiving the Board’s preliminary guidance. Under the current pilot program, a revised MTA must be preauthorized for “good cause.” Under the revised provisions, the patent owner would be able to file a revised MTA without preauthorization. A revised MTA would replace the original MTA and must include new proposed substitute claims in place of the originally proposed claims. [...]

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That’s So Metal: Narrow Limitation Doesn’t Contradict Broader One

by | Mar 14, 2024 |

The US Court of Appeals for the Federal Circuit reversed a district court’s indefiniteness determination, finding that two claim limitations – one broad and one narrow – were not contradictory since it was possible to meet the requirements of both. Maxell, Ltd. v. Amperex Technology Limited, Case No. 23-1194 (Fed. Cir. Mar. 6, 2024) (Prost, Taranto, Chen, JJ.)

Maxell owns a patent directed to a rechargeable lithium-ion battery. Maxell filed suit against Amperex alleging infringement. Following claim construction proceedings, the district court found the claims to be indefinite based on two limitations in the independent claim that recited the variable M1. The relevant claim limitations read:

1- wherein M1 represents at least one transition metal element selected from Co, Ni and Mn, [. . .]

2- wherein the content of Co in the transition metal M1 of the formulae (1) and (2) is from 30% by mole to 100% by mole[.]

The district court found that these two limitations contradicted each other because limitation 1 recited Co (cobalt) as an optional transition metal selected from a Markush group for M1, whereas limitation 2 recited a minimum Co content of 30% in M1. The district court reasoned that the claims were indefinite because limitation 1 did not require the presence of cobalt, whereas limitation 2 did. In its claim construction order, the district court stated that simultaneous recitation that a claim element is both optional and required is a “contradiction on its face.” Maxell appealed.

The Federal Circuit found no contradiction between the two limitations, explaining that “[i]t is perfectly possible for a selected [M1] to satisfy both of these limitations.” The Court reasoned that in the context of Maxell’s patent, it was of no import that the two requirements (i.e., that M1 must comprise cobalt, nickel (Ni) or manganese (Mn), and that M1 must comprise at least 30% cobalt) were recited in separate clauses. It was enough that both limitations could be simultaneously satisfied. The Court further reasoned that the inclusion of two requirements in a claim did not create an otherwise nonexistent contradiction because the claim language must be read as a whole and not merely on a limitation-by-limitation basis. The Court also looked to the prosecution history to provide context for the ordering of the claim limitations at issue and explained that limitation 2 was added during prosecution to overcome a prior art reference that primarily used nickel as a transition metal.

The Federal Circuit explained that contrary to the district court’s characterization, the subject claim limitations did not grant options. Instead, they stated requirements that must be met to fall within the scope of the claimed invention. The Court noted that, rather than contradicting limitation 1, limitation 2 narrowed it. If limitation 2 had been recited in a dependent claim, there would be no contradiction, notwithstanding that proper construction of a dependent claim requires importation of all limitations from the claims from which it depends. The same conclusion applied when both limitations were [...]

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I Hear Ya – No Intent to Deceive, No Inequitable Conduct

by | Mar 7, 2024 |

The US Court of Appeals for the Federal Circuit affirmed a district court’s finding that the asserted patents were not unenforceable for inequitable conduct, determining that statements made by counsel to the US Patent & Trademark Office (PTO) to revive an abandoned application were not shown to have been made with deceptive intent. Freshub, Inc. v. Amazon.com, Inc., Case No. 2022-1391 (Fed. Cir. Feb. 26, 2024) (Reyna, Taranto, Chen, JJ.)

Freshub sued Amazon for infringement of patents directed to voice processing technology. Amazon denied infringement and defended on the basis that the patents should be declared unenforceable based on inequitable conduct by Freshub’s parent company, Ikan Holdings, during prosecution of the application at the PTO. Amazon alleged that Ikan improperly revived an earlier-abandoned parent application from which the asserted patents descend.

The predicate facts are as follows: In June 2011, the PTO issued a final office action rejecting the claims of the parent application. Ikan failed to respond to the office action, rendering the application abandoned in January 2012. In January 2017, Ikan petitioned the PTO to revive the application. In support of its revival petition, Ikan’s counsel asserted that “[t]he entire [five-year] delay in filing the required reply . . . was unintentional.” “[R]elying on petitioner’s duty of candor and good faith,” the PTO granted the petition, eventually resulting in issuance of the three patents-in-suit.

At trial, a jury found that Amazon did not infringe the asserted patents. The district court subsequently conducted a bench trial on inequitable conduct and found that Amazon had failed to prove inequitable conduct by clear and convincing evidence. Freshub appealed, arguing that it was entitled to judgment as a matter of law that Amazon infringed. Amazon cross-appealed, seeking reversal of the district court’s inequitable conduct ruling.

The Federal Circuit affirmed the district court’s determination of failure to prove inequitable conduct, finding that Amazon had not shown by clear and convincing evidence that Ikan misrepresented or omitted material information with the specific intent to deceive the PTO. The Court focused its analysis on deceptive intent, finding that the district court did not commit clear error in rejecting Amazon’s inequitable conduct defense.

The Federal Circuit noted that the record was minimal due to the passage of time and the limited testimonial and documentary evidence available, as well as the many unchallenged claims of attorney-client privilege. Nevertheless, both parties presented evidence concerning Ikan’s intent between 2012 and 2017.

To support its position, Freshub relied on the 2017 statement by Ikan’s counsel asserting that Ikan’s delay in filing its reply to the PTO’s final office action was unintentional. The Federal Circuit found this evidence probative, even without the presentation of additional evidence to further explain why the period of non-response was so long. On the other hand, Amazon presented specific evidence that it contended demonstrated deceptive intent. For example:

  • The 2017 statement to revive the parent application was made by the same counsel that prosecuted the application at the time of its 2012 abandonment.
  • Ikan’s counsel [...]

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New PTO Guidance: Use KSR Flexible Approach to Obviousness

by | Mar 7, 2024 |

On February 27, 2024, the US Patent & Trademark Office (PTO) published updated guidance for examiners on how to make a proper determination of obviousness. The guidance expands upon and reinforces the legal framework for obviousness determinations discussed by the Supreme Court in KSR Int’l. v. Teleflex (2007) and Graham v. John Deere Co. (1966) through the lens of post-KSR precedential Federal Circuit cases. The guidance does not have the force and effect of law and is not intended by the PTO to convey any new practice or procedure.

Drawing from more than 30 Federal Circuit cases, the guidance addresses several themes. An overriding theme concerns the implementation of a flexible approach to obviousness and the need for a reasoned explanation when concluding that a claimed invention would have been obvious. In its discussion, the PTO characterizes the flexibility expressed by the KSR court and reiterated by subsequent Federal Circuit cases as mandating a proper understanding of the scope of the prior art and providing appropriate reasons to modify the prior art.

Regarding the scope and content of the prior art, the guidance draws attention to understanding the prior art and all that it may reasonably suggest to a person of ordinary skill in the art (POSITA) who would naturally apply common sense and glean suggestions from the art – even where such suggestions are not explicitly stated. Thus, the obviousness inquiry need not seek out precise teachings regarding a solution to a technological problem but can take account of the inferences, creative steps and common knowledge that a POSITA would employ. In one precedential example, the Federal Circuit held that a POSITA would have combined certain prior art elements based on common knowledge of an industry’s concern for rider stability when using water recreational devices. (Zup v. Nash Mfg. (2018).) The guidance also affirms the need for an evaluation of analogous prior art, which must be evaluated using a flexible approach when considering the “same field of endeavor” and “reasonably pertinent” tests in combination with evidence concerning the knowledge and perspective of a POSITA.

According to the guidance, a flexible approach to obviousness should provide a reasoned explanation with evidentiary support for modifying the prior art. To facilitate compact prosecution, the examiner should clearly articulate this explanation early in the prosecution. The PTO also cautions that wholesale use of “common sense” as a rationale is no substitute for reasoned analysis and evidentiary support. There should be an explanation of why common sense would have compelled a finding of obviousness, especially where limitations are not expressly disclosed in the prior art.

The guidance further emphasizes that decision-makers are not free to ignore relevant evidence before them, including Graham’s secondary considerations or other objective indicia of obviousness, to establish prima facie obviousness. At the same time, conclusory opinions by an expert in a declaration or attorney argument alone should not be accorded weight in the absence of factual support. The guidance notes that in keeping with the flexible approach to obviousness [...]

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Not Admitted to PTO Bar? No Problem.

by | Feb 29, 2024 |

On February 21, 2024, the US Patent & Trademark Office (PTO) issued a Notice of Proposed Rulemaking that would give parties the option to designate a non-registered practitioner as lead counsel in proceedings before the Patent Trial & Appeal Board. 89 Fed. Reg. 13017 (Feb. 21, 2024) (to be codified at 37 C.F.R. pt. 42).

37 CFR 42.10(a) currently requires each party to designate a lead counsel and at least one back-up counsel. The lead counsel must be a registered practitioner. Non-registered practitioners can serve as back-up counsel pro hac vice, but only upon a showing that they are an experienced litigating lawyer serving as back-up counsel and that they possess significant familiarity with the subject matter at issue. Permission for back-up status requires grant of a pro hac vice motion filed by counsel presenting specific statements of fact showing good cause for admission, as well as an affidavit or declaration by counsel attesting to good standing before the courts, familiarity with the PTO’s Patent Trial Practice Guide and the Board’s Rules of Practice for Trial set forth in part 42 of 37 C.F.R., and familiarity with the subject matter at issue.

The proposed changes to 37 C.F.R. 42.10 would:

  • Permit non-registered practitioners to serve as lead counsel for a party in Board proceedings as long as at least one other counsel designated to appear on behalf of the party is a registered practitioner.
  • Permit parties to proceed without back-up counsel upon a showing of good cause. A party may show good cause by demonstrating that it lacks the financial resources to retain both lead and back-up counsel.
  • Create a new streamlined procedure for pro hac vice recognition of Board-recognized practitioners. This procedure applies to non-registered practitioners who have previously been admitted pro hac vice in a different Board proceeding and have not been subsequently denied pro hac vice recognition in a different Board proceeding.
  • Clarify that those recognized pro hac vice have a duty to inform the Board if the information presented in a request for pro hac vice recognition is no longer accurate or complete.

The PTO seeks public comments on the proposed rulemaking by May 21, 2024, through the Federal eRulemaking Portal. Enter docket number PTO-P-2023-00587 on the homepage and select “search.”

For further details, click here.



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Consider Invention When Assessing Support for Claimed Range

by | Feb 29, 2024 |

The US Court of Appeals for the Federal Circuit affirmed in part and vacated in part a Patent Trial & Appeal Board finding that the claims at issue were either invalid under 35 U.S.C. §112 as unsupported by written description or obvious under 35 U.S.C. §103. RAI Strategic Holdings, Inc. v. Philip Morris Products S.A., Case No. 22-1862 (Fed. Cir. Feb. 9, 2024) (Chen, Stoll, Cunningham, JJ.)

RAI owns a patent with claims directed to “electrically powered smoking devices that provide an inhalable vapor by heating tobacco or other substances without significant combustion.” Philip Morris challenged the patent in a post-grant review (PGR).

The Board issued a final written decision concluding that two dependent claims, which recited limitations requiring a heating member with “a length of about 75% to about 85% of a length of the disposable aerosol forming substance,” lacked § 112 written description support. The specification disclosed ranges of 75% – 125%, 80% – 120%, 85% – 115% and 90% – 110%. The Board explained that written description support was lacking because “the claimed range is different from and substantially narrower than the specific ranges disclosed in the specification.”

The Board found that the remaining claims were unpatentable as obvious based on a combination of prior art references where the heater found in one reference, Robinson, was replaced with the heater from another, Greim. Robinson explained that its heating element could be altered and acknowledged design choices, thus inviting skilled artisans to select an alternate appropriate heating element. Greim disclosed certain advantages to its heater. Thus, the Board found that a skilled artisan would have been motivated to replace Robinson’s heater with that of Greim, rendering the claims obvious. RAI appealed.

Citing its expert, RAI argued that the ranges disclosed in the specification all centered around 100%, so that a person of ordinary skill in the art (POSITA) would not “conclude that the inventors possessed a range that went no higher than 85%[.]” The Federal Circuit began by summarizing a line of numerical range cases, including:

  • In re Wertheim (CCPA 1976), which found that a described range of 25% – 60%, with examples of 36% and 50%, supported a claim directed to a range of 35% – 60%.
  • In re Blaser (CCPA 1977), which found that a described range of 60° – 200° C supported a claim reciting a range of 80° – 200° C.
  • Kolmes v. World Fibers Corp. (Fed. Cir. 1997), which found that a described range of 4 – 12 turns per inch, and preference for 8 turns per inch, supported claims directed to 8 – 12 turns per inch.
  • In re Baird (CCPA 1965), which found that a relatively unexplained disclosure of 32 – 176° F did not support claims directed to a range from 40° to “at least as low as” 60° F.
  • Indivior UK v. Dr. Reddy’s Laboratories (Fed. Cir. 2021), which found that:
    • Disclosure of ranges of at least 25%, at least 50% and “any” value [...]

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