Trials@uspto.gov
`571-272-7822
`
`
`Paper 27
`Date: March 10, 2020
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`LIFESCAN GLOBAL CORPORATION,
`Petitioner,
`v.
`IKEDA FOOD RESEARCH, LTD. and PHC CORPORATION,
`Patent Owner.
`____________
`
`PGR2019-00032
`Patent 9,976,125 B2
`____________
`
`
`Before ERICA A. FRANKLIN, ROBERT A. POLLOCK, and
`DAVID COTTA, Administrative Patent Judges.
`
`COTTA, Administrative Patent Judge.
`
`
`PRELIMINARY GUIDANCE
`PATENT OWNER’S MOTION TO AMEND
`
`
`
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`

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`PGR2019-00032
`Patent 9,976,125 B2
`
`INTRODUCTION
`I.
`On August 15, 2019, we instituted trial as to claim 8 of U.S. Patent
`
`No. 9,976,125 B2 (“’125 patent”).1 Paper 11 (“Decision” or “Dec.”). After
`institution, Patent Owner filed a Motion to Amend. Paper 18 (“Motion” or
`“Mot.”). Patent Owner moves to cancel claim 8 on a non-contingent basis
`and to substitute proposed claim 11. Id. at 1. Patent Owner requests that we
`provide Preliminary Guidance in accordance with the Board’s pilot program
`concerning motion to amend practice and procedures. Id. at 2; see also
`Notice Regarding a New Pilot Program Concerning Motion to Amend
`Practice and Procedures in Trial Proceedings Under the America Invents Act
`Before the Patent Trial and Appeal Board, 84 Fed. Reg. 9,497 (Mar. 15,
`2019) (providing a patent owner with the option to receive preliminary
`guidance from the Board on its motion to amend) (“Notice”). Petitioner
`filed an Opposition to the Motion. Paper 26 (“Opposition” or “Opp.”).
`We have considered Patent Owner’s Motion and Petitioner’s
`Opposition to the Motion. In this Preliminary Guidance, we provide
`information indicating the panel’s initial preliminary, non-binding views on
`whether Patent Owner has shown a reasonable likelihood that it has satisfied
`the statutory and regulatory requirements associated with filing a motion to
`amend in a post-grant review, and whether Petitioner (or the record)
`establishes a reasonable likelihood that the substitute claims are
`unpatentable. See 35 U.S.C. § 324(a) (2018); 37 C.F.R. § 42.221 (2018);
`
`
`1 Petitioner challenged claims 1–10 in the Petition. Prior to our decision,
`Patent Owner filed a statutory disclaimer under 35 U.S.C. § 253(a)
`disclaiming claims 1–7, 9, and 10 of the ’125 patent. Accordingly, we
`declined to institute post-grant review with respect to disclaimed claims 1–7,
`9, and 10. See Dec. 6–7.
`
`2
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`PGR2019-00032
`Patent 9,976,125 B2
`Lectrosonics, Inc. v Zaxcom, Inc., IPR2018-01129, Paper 15 (PTAB
`February 25, 2019) (precedential).
`For purposes of this Preliminary Guidance, we focus on the proposed
`substitute claim. See Notice, 84 Fed. Reg. at 9,497. Thus, we focus on the
`limitations added in Patent Owner’s Motion to Amend, and do not address
`the patentability of the originally challenged claims. Id. Moreover, in
`formulating our preliminary views on the Motion and Opposition, we have
`not considered the parties’ other substantive papers on the underlying merits
`of Petitioner’s challenges. We emphasize that the views expressed herein
`are subject to change upon consideration of the complete record, including
`any revision to the Motion filed by Patent Owner. Thus, this Preliminary
`Guidance will not be binding on the Board, for example, when it renders a
`final written decision. See id. at 9,500.
`
`
`PRELIMINARY GUIDANCE
`II.
`Statutory and Regulatory Requirements
`A.
`For the reasons discussed below, at this stage of the proceeding, and
`based on the current record, it appears that Patent Owner has not shown a
`reasonable likelihood that it has satisfied the statutory and regulatory
`requirements associated with filing a motion to amend.
`1. Reasonable Number of Substitute Claims
`
`Does Patent Owner propose a reasonable number of substitute
`claims? (35 U.S.C. § 326(d)(1)(B))
`Yes. Patent Owner proposes replacing the single original claim 8 with a
`single amended claim (proposed claim 11). Mot. 1–3.
`
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`PGR2019-00032
`Patent 9,976,125 B2
`2. Respond to Ground of Unpatentability
`
`Does the Motion respond to a ground of unpatentability involved in
`the trial? (37 C.F.R. § 42.221(a)(2)(i))
`Yes. Patent Owner responds to the grounds of unpatentability at Motion
`3–4. Petitioner argues that in “new substitute claim 11, P[atent] O[wner]
`proposes nothing more than dependent claim 8 rewritten in independent
`form with two proposed additional limitations, neither of which . . .
`address the reasons why the Board instituted this proceeding.” Opp. 1.
`
`We have reviewed Petitioner’s argument and find it unpersuasive. In the
`Petition, Petitioner argued that claim 8 failed to comply with the
`enablement requirement because the Specification identified a six amino
`acid sequence — AGVPWV — as critical, but claim 8 does not require
`this sequence to be present. Pet. 37–38. Patent Owner explains that
`“[c]laim 11 includes all of the limitations of cancelled claim 8 and also
`includes the six amino acid sequence AGVPWV.” Mot. 3. Patent
`Owner’s amendment thus responds to a ground of unpatentability involved
`in the trial.
`
`
`3. Scope of Amended Claims
`
`Does the amendment seek to enlarge the scope of the claims? (35
`U.S.C. § 326(d)(3); 37 C.F.R. § 42.221(a)(2)(ii))
`No. Patent Owner’s amendment adds language to original claim 8
`requiring the claimed polypeptide contain the amino acid sequence
`AGVPWV.2 Mot. at App. Patent Owner’s amendment also reduces the
`required enzymatic activity of the FAD-conjugated glucose dehydrogenase
`for maltose from 10% or less to 5% or less. Id. Patent Owner argues that
`because it has only added limitations, it has not enlarged the scope of the
`claims. Id. at 3.
`
`Petitioner argues that Patent Owner’s amendment expands the scope of the
`claim because the added language requiring the six amino acid sequence
`
`2 Petitioner notes that Patent Owner does not refer to the claimed sequence
`by SEQ ID NO as required by 37 C.F.R. § 1.821. Opp. at 2, 6. We agree
`with Petitioner that the claim should comply with 37 C.F.R. § 1.821. Patent
`Owner may wish to address this issue in a revised motion to amend.
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`PGR2019-00032
`Patent 9,976,125 B2
`AGVPWV does not require the AGVPWV sequence to be encompassed
`within the originally claimed sequence. Opp. 1, 4–5. Put another way,
`Petitioner argues that the new claim encompasses a polypeptide having
`two amino acid sequences, one of indefinite length containing the
`sequence AGVPWV, and another separate sequence having 90%
`homology to amino acid sequence (a).
`
`On the current record, we tend to agree with Petitioner that the substitute
`claim encompasses a polypeptide having two separate amino acid
`sequences, one containing the sequence AGVPWV and a second, separate
`sequence having 90% homology to amino acid sequence (a). We
`recognize that the Specification does not disclose the use of the sequence
`AGVPWV in a sequence separate from amino acid sequence (a) and, thus,
`it may not have been Patent Owner’s intent for the substitute claim to
`encompass two separate sequences. However, the language of the
`substitute claim, on its face, is not limited to a single sequence having both
`AGVPWV and 90% homology to amino acid sequence (a).
`
`While we tend to agree with Petitioner on the scope of substitute claim 11,
`we tend not to agree that Patent Owner’s proposed amendment enlarges
`the scope beyond what was recited in original claim 8. In this regard, we
`note that original claim 8 uses the transitional term “comprises,” and thus
`original claim 8 also encompasses a polypeptide having a second amino
`acid sequence separate from amino acid sequence (a). We emphasize that
`our construction is preliminary, and invite the parties to address this issue,
`as well as issues that depend on this preliminary construction (discussed
`below), in further briefing and/or in a revised motion to amend.
`
`
`
`
`4. New Matter
`
`Does the amendment seek to add new subject matter? (35 U.S.C.
`§ 326(d)(3); 37 C.F.R. § 42.221(a)(2)(ii))
`Yes. Petitioner argues that Patent Owner’s amendment “allows for the six
`amino acid sequence [AGVPWV] to extend outside SEQ ID NO:1,[3]
`thereby enlarging the amino acid sequence to at least 599, which is . . .
`
`
`3 “SEQ ID NO:1” is the same sequence as the claimed “amino acid sequence
`(a).”
`
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`PGR2019-00032
`Patent 9,976,125 B2
`new matter.” Opp. 5. On this record, and in accord with our preliminary
`construction of substitute claim 11, we tend to agree with Petitioner that
`by allowing the AGVPWV amino acid sequence to extend outside of SEQ
`ID NO:1, the claim encompasses new matter. See Ex. 1005, 4:8–12 (“[I]n
`order to significantly express an FAD-conjugated glucose dehydrogenase
`in an Aspergillus oryzae strain, it was necessary that an amino acid
`sequence (AGVPWV) be contained in a polypeptide encoding a gene of
`the enzyme.”).
`
`Petitioner also argues that substitute claim 11 encompasses new matter
`because the “proposed claim amendment allows for the six amino acid
`sequence [AGVPWV] to appear anywhere within the 593 amino acids of
`SEQ ID NO:1.” Opp. 5 According to Petitioner, this creates new matter
`because “the ’125 Patent makes it clear that the six amino acid sequence
`must appear at location 202-207 of SEQ ID NO:1.” Id.
`
`On the current record, we tend to agree with Petitioner that substitute
`claim 11, on its face, does not limit the position of the AGVPWV
`sequence. We emphasize that our construction is preliminary, and invite
`the parties to address this issue, as well as issues that depend on this
`preliminary construction (discussed below), in further briefing and/or in a
`revised motion.
`
`On the current record, we also tend to agree with Petitioner that the
`Specification teaches the importance of a specific location for the
`AGVPWV sequence. It does so in two ways. First, the Specification does
`not appear to exemplify the AGVPWV sequence in any position other than
`in the vicinity of positions 202 to 207. See Ex. 1005, 6:48–53 (“The
`amino acid sequence: AGVPWV is contained in the amino acid sequence
`of the enzyme in the vicinity of positions 202 to 207 (derived from NBRC
`5375 strain) (in the case of an enzyme derived from other strain, positions
`corresponding to the positions) with the initiator amino acid residue M in a
`signal sequence region counted as position 1.”); cf. id. at 6:20–23 (“The
`above-mentioned amino acid sequence comprising 6 amino acid residues
`is preferably located at positions 202 to 207”) (emphasis added). Second,
`the Specification suggests that the location of the AGVPWV sequence in
`the vicinity of position 202 may be important to its function. Id. at 21:10–
`14 (“The presence of the amino acid sequence: AGVPWV in the vicinity
`of position 202 with the initiator amino acid residue M counted as position
`1 is important for expressing the function.”). We emphasize that our
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`PGR2019-00032
`Patent 9,976,125 B2
`position on the importance of the location of the AGVPWV sequence is
`preliminary, and invite the parties to address this issue in further briefing
`and/or in a revised motion to amend.
`
`
`
`Patentability
`B.
`For the reasons discussed below, based on the current record, it
`appears that Petitioner (or the record) has shown a reasonable likelihood that
`proposed substitute claim 11 is unpatentable.
`
`Does the record establish a reasonable likelihood that the proposed
`substitute claims are unpatentable?
`Yes.
`1. Obviousness
`Petitioner contends that Tsuji discloses all of the elements of substitute
`claim 11, including a sequence identical to the claimed “amino acid
`sequence (a),” except for the limitation requiring that the “biosensor is
`capable of detecting glucose by a pH change.” Opp. 13. With respect to
`this limitation, Petitioner relies on Omura’s teaching that “a biosensor can
`be constructed so that the chromogenic intensity or pH change is
`detected.” Id. (citing Ex. 1010, 19:3–4). Petitioner contends that it would
`have been obvious to “combine . . . the FAD-conjugated [GDH] of Tsuji
`with the glucose sensor structure described in Omura to measure glucose
`concentration using a pH change.” Id. at 14 (citing Ex. 1010, Abstr.; Ex.
`1021 ¶ 44 (Cass Declaration); Ex. 1008 ¶ 48 (La Belle Declaration)).
`
`Based on the information presented at this stage of the proceeding, the
`evidence tends to suggest that the combination of Tsuji and Omura would
`have rendered the biosensor of substitute claim 11 obvious for the reasons
`set forth in Petitioner’s Opposition and the accompanying declarations.
`See Opp. 12–15; Ex. 1008 ¶¶ 34, 48; Ex. 1021 ¶¶ 32, 44; see also Dec. 37–
`41 (analyzing Petitioner’s assertion that the combination of Tsuji and
`Omura would have rendered original claim 8 obvious, concluding that “the
`current record tends to suggest that claim 8 would have been obvious over
`the combination of Tsuji and Omura”).
`
`Patent Owner argues that Petitioner has not met its burden to establish that
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`PGR2019-00032
`Patent 9,976,125 B2
`Tsuji is prior art under 35 U.S.C. § 102(e). Mot. 10–12. Tsuji is a patent
`application that was filed on March 28, 2007. Ex. 1007, code (22). It
`claims priority to two provisional patent applications, the earliest of which
`was filed on March 31, 2006. Id. at code (60). Patent Owner contends
`that substitute claim 11 is supported by, and can claim priority to, Japanese
`Application No. 2006-247535, which was filed on September 13, 2006.
`Mot. 10; see also id. at 6–7 (identifying support for substitute claim 11 in
`priority applications). Assuming substitute claim 11 can claim priority to
`the Japanese priority application, Tsuji would qualify as prior art under 35
`U.S.C. § 102(e) only if it can claim priority to its earliest filed provisional
`application.4 Patent Owner argues that “[n]owhere does Petitioner
`demonstrate support in the earlier Tsuji provisional applications for the
`claims of the Published Tsuji patent application,” and thus Petitioner did
`not carry its burden to establish that Tsuji is entitled to the filing date of its
`earliest provisional application. Mot. 12.
`
`Patent Owner’s argument is not persuasive because Petitioner’s
`Opposition provides a table identifying where support for the two claims
`in Tsuji’s published application can be found in Tsuji’s earliest filed
`priority application. Opp. 11. We acknowledge that Patent Owner has not
`yet had the opportunity to address this evidence. Patent Owner will have
`the opportunity to do so in its Reply to Petitioner’s Opposition (or in a
`revised motion to amend) in this proceeding.
`
`2. Indefiniteness
`Petitioner argues that “[a]ccording to the disclosure of the ’125 Patent,
`without the location of the six amino acid sequence AGVPWV in position
`202-207 of SEQ ID NO:1, the polypeptide will not function as a glucose
`dehydrogenase.” Opp. 16. Petitioner thus contends that substitute claim
`11 is indefinite because it “includ[es] numerous inoperative polypeptides
`that P[atent] O[wner] was not in possession of at the time of the
`invention.” Id.
`
`
`4 Petitioner contends that the Japanese priority application does not support
`claim 11. Opp. 8–10. We need not resolve this issue because, for the
`reasons discussed below, we conclude that Petitioner is reasonably likely to
`establish that Tsuji is entitled to the benefit of its earliest filed provisional
`application.
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`PGR2019-00032
`Patent 9,976,125 B2
`As discussed above in our discussion of whether the amendment
`encompasses new matter, we tend to agree with Petitioner that claim 11
`does not limit the position of the AGVPWV sequence and that the
`Specification teaches the importance of having the AGVPWV sequence in
`the vicinity of positions 202-207 of SEQ ID NO:1. Accordingly, claim 11
`would appear to encompass a substantial number of inoperative
`embodiments, suggesting that claim 11 may be indefinite. In re Corkill,
`771 F.2d 1496, 1501 (Fed. Cir. 1985). We emphasize that our positions
`on claim construction and on the importance of the location of the
`AGVPWV sequence are preliminary, and invite the parties to address this
`issue in further briefing and/or in a revised motion to amend.
`
`3. Written Description
`Petitioner argues that there is no written description support for the
`language “contains the sequence AGVPWV,” which Patent Owner
`proposes to add by amendment. Opp. 17. Petitioner contends that
`substitute claim 11, as written “does not require the six amino acid
`sequence AGVPWV to be within SEQ ID NO:1” and further “does not
`require that AGVPWV be at a particular location within SEQ ID NO:1.”
`Id. Petitioner contends that the Specification only discloses the AGVPWV
`sequence at positions 202–207 and teaches that this location is important
`to the function of the enzyme. Id. at 18, 19. Petitioner thus argues that
`substitute claim 11 fails to comply with the written description
`requirement because “[t]here is no supporting written description for the
`location of the six amino acid sequence in any other location other than
`position 202-207.” Id. at 19.
`
`As discussed above, we tend to agree with Petitioner that: 1) the claim
`encompasses a polypeptide having two amino acid sequences, one
`containing the sequence AGVPWV and another separate sequence having
`90% homology to SEQ ID NO:1, 2) the claim does not limit the position
`of the AGVPWV sequence, 3) the Specification does not exemplify the
`sequence AGVPWV in a sequence separate from SEQ ID NO:1, and
`4) the Specification suggests that the location of the AGVPWV sequence
`in the vicinity of position 202 may be important to its function.
`Accordingly, substitute claim 11 may encompass subject matter that is not
`described in the Specification. We emphasize that our positions on claim
`construction and on the importance of the location of the AGVPWV
`sequence are preliminary, and invite the parties to address this issue in
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`PGR2019-00032
`Patent 9,976,125 B2
`further briefing and/or in a revised motion to amend.
`
`4. Enablement
`Petitioner argues that substitute claim 11 fails to comply with the
`enablement requirement because it “fails to recite a critical element — the
`location of the ‘critical’ six amino acid sequence that is needed in order to
`achieve the claimed functionality.” Opp. 20–21. To illustrate the
`criticality of the claimed location, Petitioner points to language in the
`Specification teaching that it was “necessary that an amino acid sequence
`(AGVPWV) be contained in a polypeptide encoding a gene of the
`enzyme” and that “when the gene does not encode the peptide comprising
`the amino acid sequence, it does not express a protein having FAD-
`conjugated glucose dehydrogenase activity.” Id. at 21 (quoting Ex. 1005,
`4:6–16, 6:14–19). Petitioner also cites the passage in the Specification
`stating that “[t]he presence of the amino acid sequence: AGVPWV in the
`vicinity of position 202 . . . is important for expressing the function.” Id.
`at 22 (citing Ex. 1005, 21:10–14) (alteration in original).
`As discussed above, we tend to agree with Petitioner that the Specification
`suggests that the location of the AGVPWV sequence in the vicinity of
`position 202 may be important to its function. As also discussed above,
`we tend to agree with Petitioner that the claim does not limit the position
`of the AGVPWV sequence. Accordingly, it appears that substitute claim
`11 may not recite elements that are critical to the function of the claimed
`biosensor. We emphasize that our positions on claim construction and on
`the importance of the location of the AGVPWV sequence are preliminary,
`and invite the parties to address this issue in further briefing and/or in a
`revised motion to amend.
`
`Accordingly, it appears that Petitioner has shown a reasonable likelihood
`that proposed substitute claim 11 is unpatentable.
`
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`10
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`PGR2019-00032
`Patent 9,976,125 B2
`For PETITIONER:
`
`Aaron Eckenthal
`Brian Tomkins
`Alyssa D’Antonio
`LERNER, DAVID, LITTENBERG, KRUMHOLZ & MENTLIK, LLP
`aeckenthal.ipr@ldlkm.com
`btomkins.ipr@ldlkm.com
`adantonio@lernerdavid.com
`
`For PATENT OWNER:
`
`Kenneth George
`Brian Comack
`AMSTER, ROTHSTEIN & EBENSTEIN LLP
`kgeorge@arelaw.com
`bcomack@arelaw.com
`
`
`
`
`
`11
`
`