The One Year Deadline for a PTAB Final Written Decision is more of a Guideline than a Rule (Oh, and the Written Description is more of a Rule than a Guideline)

In Purdue Pharma L.P., v. Collegium Pharmaceutical, Inc., [2022-1482] (November 21, 2023), the Federal Circuit affirmed the Final Written Decision of the PTAB that claims 1–17 of U.S. Patent No. 9,693,961 were unpatentable for lack of written description and anticipation.  The patent is titled “Pharmaceutical Formulation Containing Gelling Agent” and is meant to prevent or deter the abuse of opioid analgesics by the inclusion of at least one aversive agent.

Deadline for Final Written Decision

At the outset, the Federal Circuit rejected Purdue’s argument that the Board lacked authority to issue a Final Written Decision once the deadline established by 35 U.S.C. § 326(a)(11) and 37 C.F.R. § 42.200(c) (one year plus the six-month extension) passed.

Written Description

On written description, the test for sufficiency is whether the disclosure of the application relied upon reasonably conveys to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date.  The Federal Circuit said it has required that the specification provide sufficient blaze marks to “guide a reader through the forest of disclosed possibilities toward the claimed compound.”  The issue was whether the ’961 specification adequately disclosed the claimed polyglycolyzed glycerides (“PGGs”) as an aversive agent. The Board found the claimed formulation was not disclosed, and the Federal Circuit concluded that substantial evidence supported the Board’s finding.

Although the ’961 claims on their face do not require an aversive agent, the specification makes clear that the claims require “inclusion of at least one aversive agent” and the parties agree that the claims require the use of an aversive agent.  PGGs are identified as a possible surfactant “useful in accordance with the present invention.”  While the specification discloses that some surfactants can be gelling agents and that gelling agents can satisfy the aversive agent requirement, the parties agree that not all surfactants are gelling agents.  The specification does not say that PGGs are gelling agents.  The only time PGGs are mentioned in the specification, they are described as a surfactant, and not as a gelling agent, and surfactants generally are described as “useful in accordance with the present invention.”  In other parts of the specification, the patent recognizes that surfactants can be used completely separate from and in addition to the gelling agent.

The Federal Circuit said that “[j]ust because the specification states PGGs are useful for the invention does not suggest how PGGs are gelling agents. The disclosure of the application does not reasonably convey to those skilled in the art that the inventor had possession of the claimed drug formula containing PGGs as a gelling agent (aversive agent). In other words, there are insufficient blaze marks.” Because the anticipation finding flowed from the lack of written description in the claimed priority application, the finding of anticipation was affirmed.

Blast from the Past: In Vivo Testing is Not Required for an Actual Reduction to Practice

In Medtronic, Inc., Medtronic Vascular, Inc., v. Teleflex Life Sciences Limited, [2022-1721, 2022-1722] (November 16, 2023) the Federal Circuit affirmed two Final Written Decisions of the PTAB that the challenged claims of U.S. Patent RE46,116 had not been shown to be unpatenable.  The patent was directed to a method for using a guide extension catheter with a guide catheter.

Medtronic alleged invalidity of the claims based upon the Itou reference.  Teleflex argued that Itou was not prior art because the claimed invention was (1) conceived prior to Itou’s filing date of September 23, 2005 (i.e., the critical date), and (2) was either (a) actually reduced to practice before the critical date or (b) diligently pursued until its constructive reduction to practice through its effective filing in May 2006.  The Federal Circuit found that the invention was constructively reduced to practice.

Unique to this case was the question whether or not in vivo testing was required for actual reduction to practice because the claims at issue are method claims reciting “advancing . . . a guide catheter . . . through a main blood vessel to an ostium of a coronary artery.” The Board found that such testing was not required, noting Medtronic “was unable to identify any legal precedent requiring in vivo performance of a claimed in vivo method to show actual reduction to practice.” The Board found that the viability of the claimed method could be verified using a physical model that replicates the anatomy in which the method would likewise be performed in vivo.”

The Board also found that the Teleflex patent was entitled to an early priority date that removed Root as a prior art reference.  This issue was eliminated by prior decisions involving related patents.

Have a Seat Over There — Petitioner Has No Standing to Appeal PTAB Decision

In Allgenesis Biotherapeutics Inc., v. Cloudbreak Therapeutics, LLC, [2022-1706] (November 7, 2023), the Federal Circuit dismissed the appeal of the PTAB’s final written decision that claims 4 and 5 of U.S. Patent No. 10,149,820 had not been shown to be unpatentable, because Allgenesis has failed to establish an injury in fact sufficient to confer standing to appeal.

Although a party does not need Article III standing to file an IPR petition or to obtain a Board decision, the party must establish Article III standing once it seeks review of the Board’s decision in this Court.  To meet the Article III standing requirements, an appellant must have (1) suffered an injury in fact, (2) that is fairly traceable to the challenged conduct of the defendant, and (3) that is likely to be redressed by a favorable judicial decision.”  To establish an injury in fact, an appellant must show it has suffered an invasion of a legally protected interest that is concrete and particularized and actual or imminent, not conjectural or hypothetical.

Allgenesis first argued it has suffered an injury in fact based on the potential infringement liability stemming from its development of nintedanib treatments for pterygium.  Where an appellant relies on potential infringement liability as a basis for injury in fact, it must establish that it has concrete plans for future activity that creates a substantial risk of future infringement or likely cause the patentee to assert a claim of infringement.  The Federal Circuit found that Allgenesis failed to identify any specific, concrete plans for Allgenesis to develop a nintedanib product that might implicate claims 4 and 5 of the ’820 patent.

Allgenesis also argued it has suffered an injury in fact based on the Board’s priority determination. Specifically, the Board found that Allgenesis’ PCT, which has a later effective filing date of June 22, 2015, is not prior art to Cloudbreak’s application.  The Federal Circuit found that Allgenesis has not established that the Board’s decision will have preclusive effect, noting that collateral estoppel will not attach to the Board’s non-appealable priority determination.

Extrinsic Evidence Needed to Construe Numerical Limitation in the Claims

Actelion Pharmaceuticals Ltd, v. Mylan Pharmaceuticals Inc., [2022-1889] (November 6, 2023), the Federal Circuit vacated the district court’s claim construction order with respect to the term “a pH of 13 or higher” in U.S. Patent Nos. 8,318,802 and 8,598,227 and the judgment of infringement, and remand for the district court to consider the extrinsic evidence and its impact on claim construction.  The patents in suit were directed to improved epoprostenol formulations.

The claim required “the bulk solution has a pH of 13 or higher.”  Both parties proposed the plain and ordinary meaning of the term but disagreed on what that means.  Actelion argued that “a pH of 13” in the context of the asserted claims is “a value of acidity that is given as an order of magnitude that is subject to rounding.”  More specifically, Actelion’s proposal would allow a pH of 12.5, which rounds to 13, to read on the claim limitation of “a pH of 13 or higher.” By contrast, Mylan argued that the proper construction cannot cover any pH values less than 13.

The Federal Circuit said that there was no blanket rule that ranges, or specifically open-ended ranges, must foreclose rounding.  Unlike other claim terms, the disputed claim term lacks approximation language like “about.”  Mylan argued, “13” and “about 13” would both imply rounding, making the approximation language superfluous.  Actelion argued that rounding is required because approximation language like “about” signals different variations than those of rounding. Actelion also argued that “it is not practically possible to measure exact pH values” because to get an “exact” measurement “one would have to count every hydrogen ion in solution, which is not scientifically possible.”  Ultimately, the Federal Circuit did not find the absence of approximation language dispositive here, and rejected any invitation to create a bright-line rule.

The specification revealed that the inventor inconsistently described the level of specificity for a pH of 13.  The specification explains that “[t]he pH of the bulk solution is preferably adjusted to about 12.5-13.5, most preferably 13.”  Mylan argues that this shows that the inventor (1) knew how to use approximation language when it wanted (“about 12.5-13.5”) and chose not to for a pH of 13; (2) distinguished a pH value of “12.5” from that of “13”; and (3) distinguished a range (“12.5-13.5”) from a definite value (“13”).  Actelion countered that “13” should allow rounding or else a preferred embodiment of the invention, meaning a pH of about 12.5 to 13.5, would be excluded from the claim scope.

The specification seems to equate a pH of “13.0” to that of “13.” Example 4 describes screening several “formulations with the pH of bulk solution . . . adjusted between 10.5 and 13.0.” ’802 patent col. 10 ll. 63–64. Tables 8 and 9 show the resulting stability data and display a bulk solution pH as “13” with no decimal point. Mylan argues that this shows that the inventor equated a pH of “13” with “13.0.”  The Federal Circuit noted that the specification uses both “13” and “13.0”—and various degrees of precision for pH values generally—throughout. In other words, the specification supplies the same clarity as to the desired level of precision as muddied water.

Turning to the prosecution history, the Federal Circuit note that the inventor amended the claim language at issue several times, and that the Examiner said that the inventor had demonstrated that for a pH of 13 “there is a significant difference.”

The Federal Circuit said that this case was one where the proper claim construction cannot be reached without the aid of extrinsic evidence, and that the district court should have considered, at minimum, the textbook excerpts offered and addressed by the parties. The Supreme Court has made clear that there are cases where the district court must “look beyond the patent’s intrinsic evidence and . . . consult extrinsic evidence in order to understand, for example, the background science or the meaning of a term in the relevant art during the relevant time period.” The Federal Circuit vacated the district court’s judgment of infringement, and remand for the district court to consider the extrinsic evidence and its impact on claim construction.

Deference Given to $5 Million Attorneys Fee Award by District Court that “Lived with [the] Case and its Counsel for Years”

In re: Personalweb Technologies LLC, [2021-1858, 2021-1859, 2021-1860] (November 3, 2023) the Federal Circuit affirmed a $5,187,203.99 award of attorneys’ fees against Personalweb.

In 2018, PersonalWeb asserted the True Name patents against eighty-five Amazon customers (the “customer cases”) across the country for their use of Amazon S3.  After summary judgment was granted against PersonalWeb on two different patents, the district court granted defendant’s motion for attorneys’ fees and costs under 35 U.S.C. § 285, determining that the case was exceptional.  Specifically, the district court found that:

  • PersonalWeb’s infringement claims related to the first product were objectively baseless and not reasonable when brought because they were barred due to a final judgment entered in the Texas Action.
  • PersonalWeb frequently changed its infringement positions to overcome the hurdle of the day;
  • PersonalWeb unnecessarily prolonged this litigation after claim construction foreclosed its infringement theories;
  • PersonalWeb’s conduct and positions regarding the customer cases were unreasonable; and
  • PersonalWeb submitted declarations that it should have known were not accurate.

“The court in exceptional cases may award reasonable attorney fees to the prevailing party.” 35 U.S.C. § 285. To determine whether a case is exceptional under § 285, courts consider “the totality of the circumstances.”  An exceptional case is “simply one that stands out from others with respect to the substantive strength of a party’s litigating position (considering both the governing law and the facts of the case) or the unreasonable manner in which the case was litigated.”

The Federal Circuit said that the district court lived with this case and its counsel for years. It thoroughly reviewed the totality of the circumstances to find that this case both lacked “substantive strength” and was litigated in an “unreasonable manner.”  The Court saw no clear error in law or fact by the district court in arriving at these conclusions.

The district court took steps to be fair. For early motion practice, such as the motion to stay and motion for preliminary injunction, the district court recognized the efficiency of these tactics, stating Amazon “would have undoubtedly incurred even more legal fees in actively defending the menagerie of customer cases.” The Federal Circuit noted that the district court reduced Amazon’s requested fees by 25% to account for “otherwise necessary activities” after explaining PersonalWeb’s “abandoned infringement theories serially dominated the case, leading to unnecessary work across multiple categories of litigation.”

Co-owned, but Unrelated Application Cited in IDS Does not Inform the Meaning of the Claims

In Malvern Panalytical Inc., v. TA Instruments-Waters LLC, [2022-1439] (November 1, 2023), because the district court erred in construing “pipette guiding mechanism,” the Federal Circuit vacated the stipulated judgment of non-infringement of U.S. Patent Nos. 8,827,549 (“the ’549 patent”) and 8,449,175 and remanded for further proceedings.  These patents both disclose microcalorimeters, which are machines that measure the amount of energy absorbed or released during a chemical reaction between two compounds.

Malvern and Waters disputed whether the term “pipette guiding mechanism” encompasses only manual guiding mechanisms (Waters’s position) or covers both manual and automatic guiding mechanisms (Malvern’s position). The Federal Circuit agreed with Malvern that “pipette guiding mechanism” means a mechanism that guides the pipette assembly manually or automatically.

Starting with the claim language, the Federal Circuit concluded that “pipette guiding mechanism” has a plain and ordinary meaning—a mechanism that guides the pipette assembly.  It is appropriate to construe this term by looking to the words “pipette,” “guiding,” and “mechanism” individually.  Looking at the individual words in the claim, the immediately apparent meaning is that a “pipette guiding mechanism” is a mechanism that guides the pipette. The claim language contains no restrictions that would suggest that the “pipette guiding mechanism” is only manual. Instead, the broad claim language supports the conclusion that the “pipette guiding mechanism” encompasses both manual and automatic embodiments.

The specification confirms the broader understanding of the “pipette guiding mechanism.” It discloses two embodiments of the guiding mechanism. The first embodiment is a guide arm that can move only by way of a guide rod where permitted by guide grooves.  The second is a guide arm that can only move where permitted by a coaxial guide sleeve.  The specification contains no language describing the invention as limited to a manual guiding mechanism, stating that “the present invention ‘is,’ ‘includes,’ or ‘refers to’” a manual guiding mechanism, or “expressing the advantages, importance, or essentiality” of a manual guiding mechanism.

The district court took a different view, concluding that “pipette guiding mechanism” is a coined term with no commonly understood meaning in the art.  On this basis, the district court concluded that “pipette guiding mechanism” “cannot be construed broader than the disclosure in the specification.”  The Federal Circuit said that it has sparingly applied this principle of construction in other cases.  The district court’s analysis predominantly addressed whether “pipette guiding mechanism” has a plain and ordinary meaning broadly in the art. The Federal Circuit said that this analysis, however, did not answer the question of what plain and ordinary meaning a term has in the context of a patent, which is the focus of the Federal Circuit’s analysis.  The Federal Circuit said that it discerns plain and ordinary meaning by examining the claims themselves, the specification, and the prosecution history.

The district court relied heavily on the co-owned, but unrelated ’782 patent prosecution history to limit the guiding mechanism to manual embodiments.  The Federal Circuit concluded that merely listing the ’782 patent office actions in the IDS of the patent supplemental examination was insufficient to inform the meaning of “pipette guiding mechanism” in the unrelated ’175 and ’549 patents.  On this basis, the Federal Circuit concluded that the district court erred when it used the ’782 patent prosecution history statements to limit “pipette guiding mechanism” to manual guiding mechanisms.  The Federal Circuit said:

“In the absence of an incorporation into the intrinsic evidence, this court’s precedent takes a narrow view on when a related patent or its prosecution history is available to construe the claims of a patent at issue and draws a distinct line between patents that have a familial relationship and those that do not.”

The amount of characterization of that reference in the IDS impacts how informative we consider that reference when evaluating a patent. For example, listing of references in an IDS does no more than admit “that references in the disclosure may be material to prosecution of the pending claims,” but it does not admit materiality.  Likewise, a patentee has not necessarily admitted that a listed reference’s characterization or use of a claim term bears on the proper construction of that term in the patent.

The Federal Circuit noted that although the ’782 patent applicant argued that the ’968 application discloses only a manual guiding mechanism, the examiner clearly stated its rejection of this argument several times.  In these circumstances, where an applicant abandons its unsuccessful argument, the Federal Circuit concluded that the prosecution history lacks the clarity necessary to establish prosecution disclaimer.