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.

To Claim a Range, Make it Clear You are a Claiming a Range

In Indivior UK Limited v. Dr. Reddy’s Laboratories S.A., [2020-2073, 2020-2142] (November 24, 2021), the Federal Circuit affirmed the PTAB’s decision in an IPR that claims 1–5, 7, and 9–14 are unpatentable, and that DRL failed to demonstrate unpatentability of claim 8.

The ’454 patent, which generally describes orally dissolvable films containing therapeutic agents. The ’454 patent issued as the fifth continuation of U.S. Patent Application 12/537,571, which was filed on August 7, 2009. This appeal involves the question whether Indivior can get the benefit of that 2009 filing date for the claims of the ‘454 patent, and in particular support for the claimed ranges:

Claim 1about 40 wt % to about 60 wt %
Claim 7about 48.2 wt % to about 58.6 wt %
Claim 8about 48.2 wt %
Claim 12about 48.2 wt % to about 58.6 wt %

Invidior pointed out that Tables 1 and 5 of the ‘571 application disclose formulations with 48.2 wt % and 58.6 wt % polymer, and discloses that “the film composition contains a film forming polymer in an amount of at least 25%
by weight of the composition.” Indivior argued that the combination of these disclosures encompasses the claimed ranges, and therefore provides a written description of them. DRL contended that a skilled artisan would not have discerned the claimed ranges because the ’571 application does not disclose any bounded range, only a lower endpoint and some exemplary formulations. DRL contended that a skilled artisan would not have discerned any upper range endpoint.

Regarding claim 1, the Federal Circuit agreed with the Board that there was no written description support in the ’571 application for the range of “about 40 wt % to about 60 wt %,” noting that the range was not expressly claimed in the ’571 application; and that the values of “40 wt %” and “60 wt %” are not stated in the ’571 application.

Regarding claims 7 and 12, the Federal Circuit also agreed with the Board that there is no written description support for the range of “about 48.2 wt % to about 58.6 wt %” in the ’571 application, noting that this range also does not appear in the ’571 application. While the endpoints of this “range” could be discerned from the Tables, the Federal Circuit said that constructing a range from this data “amounts to cobbling together numbers after the fact.” The Federal Circuit said that Indivior failed to provide persuasive evidence demonstrating that a person of ordinary skill would have understood from reading the ’571 application that it disclosed an invention with a range of 48.2 wt % to 58.6 wt %.

Because Indivior did not contest that the claims would be anticipated without the benefit of the 2009 filing date the court affirmed the invaldity of the challenged claims, except claim 8, whose single data point was supported by the disclosure of the ‘571 patent.

This result is of course concerning to chemical practitioners who have or may one day fine the need to construct a range from disclosed datapoints. The Federal Circuit’s assurances that each case is fact specific is of little comfort if one find themselves in this predicament. The bottom line is if ranges are intended, ranges should be mentioned. It is unlikely that Invidior ever contemplated that the invention only worked at selected points, and not in between, Invidior apparently needed to make explicit what it thought was implicit. The issue in Invidior is not a problem in claiming ranges, but a problem in making clear that you are claiming ranges.

Patent Owner Could Not Claim Priority to Provisional Application That Only Disclosed Species of Claimed Genus

D Three Enterprises, LLC v. Sunmodo Corporation, [2017-1909, 2017-1910](May 21, 2018), the Federal Circuit affirmed the district court’s grant of summary judgment of invalidity of U.S. Patent Nos. 8,689,517, 9,068,339, and 8,707,655, based upon a determination that they could not claim priority to provisional application no. 61/150,301.

The patents-in-suit are directed to roof mount sealing assemblies, which allow users to mount objects on a roof and seal the mounting location against water.  The District Court determined that the patents-in-suit could not claim priority from the provisional application because the claims were broader than the invention disclosed in the provisional application, and thus the written description requirement pursuant to 35 U.S.C. §112(a).

The Federal Circuit noted that to claim a genus, a patentee must disclose a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that a PHOSITA can visualize or recognize the members of the genus.  All of the asserted claims save one recite washerless assemblies.  The provisional application disclosed one washerless assembly, depicted in Figures 27−33 and 41, showing an an attachment bracket with W-shaped prongs.  The district court noted that all of the applications disclosed this attachment bracket, such that a PHOSITA would not understand the attachment bracket to be an “optional feature.”  However, the claims to the washerless version were not limited to attachment brackets with the W-shaped prongs.

The Federal Circuit first considered with summary judgement on the issue was appropriate, finding that the patent owner had sufficient notice, so that it was.   The Federal Circuit then turned to the merits, agreeing with the district court that washerless assemblies using attachments other than attachment bracket with the W-shaped prongs were not adequately disclosed in the provisional application, which in no way contemplated the use of other types of attachment brackets in a washerless assembly.  The Federal Circuit added that it was not sufficient for purposes of the written description requirement of § 112
that the disclosure, when combined with the knowledge in the art, would lead one to speculate as to the modifications that the inventor might have envisioned, but failed to disclose.

D Three argued that boilerplate language in the provisional application disclosed alternative attachment brackets:

[PHOSITAs] will recognize certain modifications, permutations, additions and sub-combinations therefore. It is therefore intended that the following appended claims hereinafter introduced are interpreted to include all such modifications, permutations, additions and subcombinations are within their true sprit [sic] and scope.

But the Federal Circuit found that this boilerplate language at the end of the provisional application was not sufficient to show adequate
disclosure of the actual combinations and attachments used in the Washerless Claims. The Federal Circuit noted that adequate written description does not ask what is permissible in view of the disclosure, rather, it asks what is disclosed.

The Federal affirmed that the provisional application lacked adequate written description of what was claimed, and thus did not support a claim of priority.


There is no Transitive Property of Priority Claims; a Patent Must Contain a Specific Reference to Each Prior-Filed Application

In Droplets, Inc., v. E*Trade Bank, [2016-2504, 2016-2602] (April 19, 2018), the Federal Circuit affirmed the Board’s decision finding all claims of U.S. Patent No.
8,402,115 invalid as obvious over a published grandparent application due to an improper priority claim.

This application claimed priority to it’s immediate parent application, and to its ultimate  great grand parent application, but failed to mention a priority claim between the parent application the grand parent application, or between the grand parent application and the great grand parent application:

One might think that if B claims priority to A, C claims priority to B, and D claims priority to C, that this is sufficient for D to get credit for the filing date of A. D After all should D be entitled to priority of C, C should get the priority of B and B should get the priority of A.  However, that is not how the Federal Circuit interpreted Sections 119 and 120 in this case, nor how it has interpreted these statutes in the past.

The Federal Circuit noted that consistent with 35 U.S.C. § 120 and 37 C.F.R. § 1.78,
MPEP § 201.11 III.C. provides detailed guidance on how to claim priority from multiple prior-filed applications. It states that the reference to the prior applications must identify
all of the prior applications and indicate the relationship (i.e., continuation, divisional, or continuation-in-part) between each nonprovisional application in order to establish copendency throughout the entire chain of prior applications.

The Federal Circuit rejected Droplets’ characterization of the issue as “hypertechnical.”  The Federal Circuit also rejected Droplets’ more creative argument that the priority claim was incorporated by reference from the application whose priority was properly claimed, finding §120’s “specific reference” requirement does not contemplate incorporation by reference.

The Federal Circuit reiterated that a patent must contain a specific reference to each prior-filed application to be entitled to those applications’ earlier filing dates, and added that incorporation by reference cannot satisfy this statutorily mandated specific reference requirement. Because the patent at issued contained only a reference to its immediate parent, and not its grand parent, or great grand parent, the Federal Circuit affirmed the Board’s decision finding all claims of the patent invalid as obvious.

Rule of Reason Applies to Priority

In Perfect Surgical Techniques, Inc., v. Olympus America, Inc., [2015-2043] (November 15, 2016), the Federal Circuit reversed the PTAB decision in an IPR invalidating claims 1, 4–6, 8, 9, 11, 12, 38, 41–44, 46, 47, and 49 of U.S. Patent No. 6,030,384.

The Board determined that PST failed to antedate the prior art because it had not proven that the inventor of the ’384 patent was reasonably diligent in reducing his invention to practice, and that the invention was anticipated or rendered obvious from the prior art.

The Federal Circuit found that the Board erroneously applied a heightened burden of proof which “infected” its analysis. The Federal Circuit said that the Board should have weighed evidence of priority of inventorship under a rule of reason.   Instead, the Board fixated on the portions of the critical period where PST did not provide evidence of the inventor’s specific activities to conclude the exercise of diligence was not “continuous.” The Federal Circuit said that under a rule of reason analysis, an inventor is not required to corroborate every day or what was done.

The Federal Circuit found that the Board compounded its error by summarily dismissing the activities of the inventor’s attorney.  An attorney’s work in preparing a patent application is evidence of an inventor’s diligence.  The Federal Circuit further found that the Board’s focus on gaps of inactivity also led it to make fact findings unsupported by substantial evidence.

The Federal Circuit instructed that on remand, the question before the Board is whether all of patent owner’s evidence, considered as a whole and under a rule of reason, collectively corroborates the inventor’s testimony that he worked reasonably continuously within the confines of his and his attorney’s occupations to diligently finalize the patent application during the critical period.

The claim construction issues revolved around the construction of “perforated,” in the claim language “wherein at least one of the jaws is perforated to permit the release of steam during use.” The Board reasoned that the specification, which states “the jaws may be perforated or otherwise provided with passages,”  described passages as another form of perforations and did not distinguish between these terms.” Because of this equivalence between perforations and passages, the prior art disclosure of passages anticipated the claims, which required perforations.  The Federal Circuit found that the Board used extrinsic evidence (a dictionary) to establish the equivalence of that perforations included passages.  The Federal Circuit agreed with the patent owner  that the description in the specification that the device “may be perforated or otherwise provided with passages” evidences a difference in meaning between passages and perforations. The Federal Circuit said that the specification’s separation of the terms perforated and passages with the disjunctive phrase “or otherwise” makes clear that the patentee intended that the term “perforated” is not the same as “passages.” The patentee claimed only jaws that are “perforated”; this claim does not extend to passages. In light of the intrinsic record, we conclude that the term “perforated” is not coextensive with or the same as “passages.”

Thus the Board’s finding that JP ’551 disclosed at least one “perforated” jaw because JP ‘551 referenced “a passage” cannot be supported. The Federal Circuit  vacate the Board’s decision invalidating claims 11, 38, 41–44, 46, 47, and 49 over JP ’551 and remanded for proceedings consistent with this construction.


Corroboration of the Inventor is Necessary, but Evaluated Under a Rule of Reason, Considering the Totality of the Circumstances

In NFC Technology, LLC v. Matal, [2016-1808] (September 20, 2017), the Federal Circuit reversed the PTAB’s final written decision that claims of U.S. Patent 6,700,551 we obvious, and remanded for the board to determine whether NFC presented sufficient evidence that the prototype embodied the claimed invention

The Board rejected NFC’s attempt to antedate the prior art with a prototype embodying the claimed invention before the priority date of the prior art.  The Board held that even assuming that the prototype embodied the invention, NFC had not adequately established that a third party’s fabrication of the prototype inured to NFC’s benefit.

The Federal Circuit said that an inventor’s testimony, standing alone, is insufficient to prove conception—some form of corroboration must be shown.  However, there is no particular formula that an inventor must follow in providing corroboration of conception.  Corroboration is determined by a “rule of reason” analysis, in which an evaluation of all pertinent evidence must be made so that a sound determination of the credibility of the inventor’s story may be reached.

The Federal Circuit found that when taken as a whole, the documents corroborate Charrat’s account of conception.  While the Board was unpersuaded that the NFC had provided sufficient evidence to demonstrate that the prototype was produced according to the inventor’s design, the Federal Circuit Federal Circuit found that dorroboration of
every factual issue contested by the parties is not a requirement
of the law.  The Federal Circuit concluded that on the fact, particularly considering the amount of time that has passed, the inventor’s account was adequately corroborated.

The Federal Circuit noted that the Board’s analysis raised the question of who, if not the inventor, designed the prototype — the named inventor is the only source identified by the evidence for the design
of the prototype. There was no record evidence of any other employee communicating with the fabricator.  The Federal Circuit concluded that under the rule of reason, the totality of the evidence establishes the credibility of the inventor’s account.  Thus, the Board erred in concluding that NFC had not submitted adequate evidence of conception, and in finding that the inventor’s account was not adequately corroborated.
was not supported by substantial evidence.

The Federal Circuit remanded, however, so that the Board could determine whether the prototype embodied the claimed invention.


Lack of Enablement in Provisional Application Results in Loss of Priority

In Storer v. Clark, [2015-1802] (June 21, 2017) the Federal Circuit affirmed PTAB’s decision awarding priority in an interference to Clark, on the grounds that Storer’s provisional application did not enable the interference subject matter.

The subject matter in dispute involved methods of treating hepatitis C by administering compounds having a specific chemical and stereochemical structure.  Storer was issued U.S. Patent No. 7,608,600, and Clark challenged priority of invention and moved to deny Storer the priority date of its provisional application.  Clark argued that the application did not enable the claimed compound, while Storer argued that the compounds were readily obtained based on the provisional application and the prior art.

Enablement was relevant for validity and to the issue of whether the provisional application was a constructive reduction to practice.  It is a question of law, and is reviewed without deference, although the factual underpinnings of enablement are reviewed for substantial evidence.

Analyzing the disclosure under the factors set forth in In re Wands, the Board determined that undue experimentation would be required to produced the claim compounds from the provisional application’s disclosure.

The Federal Circuit began its analysis noting that the boundary between a teaching sufficient to enable a person of ordinary skill in the field, and the need for undue experimentation, varies with the complexity of the
science.   While the specification need not recite textbook science, it must be more than an invitation for further research.  Further, while the application need not disclose what is well-known in the art, it is the specification, not the knowledge of one skilled in the art, that must supply the novel aspects of an invention in order to constitute adequate enablement.

The Federal Circuit concluded that substantial evidence supported the Board’s findings that the synthetic schemes in Storer’s provisional application did not enable a person of ordinary skill to produce the target compounds without undue experimentation.