Trials@uspto.gov
`571-272-7822
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`
`
`Paper 54
`Entered: December 28, 2016
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`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`US ENDODONTICS, LLC,
`Petitioner,
`
`v.
`
`GOLD STANDARD INSTRUMENTS, LLC,
`Patent Owner.
`____________
`
`Case PGR2015-00019
`Patent 8,876,991 B2
`____________
`
`
`
`Before JOSIAH C. COCKS, HYUN J. JUNG, and
`TIMOTHY J. GOODSON, Administrative Patent Judges.
`
`GOODSON, Administrative Patent Judge.
`
`FINAL WRITTEN DECISION
`35 U.S.C. § 328(a) and 37 C.F.R. § 42.208
`
` 1
`
`USAA 1061
`USAA v Asghari-Kamrani
`CBM2016-00063
`CBM2016-00064
`
`
`571-272-7822
`
`
`
`
`Paper 54
`Entered: December 28, 2016
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`US ENDODONTICS, LLC,
`Petitioner,
`
`v.
`
`GOLD STANDARD INSTRUMENTS, LLC,
`Patent Owner.
`____________
`
`Case PGR2015-00019
`Patent 8,876,991 B2
`____________
`
`
`
`Before JOSIAH C. COCKS, HYUN J. JUNG, and
`TIMOTHY J. GOODSON, Administrative Patent Judges.
`
`GOODSON, Administrative Patent Judge.
`
`FINAL WRITTEN DECISION
`35 U.S.C. § 328(a) and 37 C.F.R. § 42.208
`
` 1
`
`USAA 1061
`USAA v Asghari-Kamrani
`CBM2016-00063
`CBM2016-00064
`
`
`
`PGR2015-00019
`Patent 8,876,991 B2
`
`INTRODUCTION
`I.
`US Endodontics, LLC (“Petitioner”) filed a Petition (Paper 1, “Pet.”)
`requesting post-grant review of claims 12–16 of U.S. Patent No.
`8,876,991 B2 (Ex. 1001, “the ’991 patent”). Gold Standard Instruments,
`LLC (“Patent Owner”) filed a Preliminary Response (Paper 14, “Prelim.
`Resp.”) to the Petition. On January 29, 2016, we instituted a post-grant
`review of claims 12–16 on certain grounds of unpatentability alleged in the
`Petition. See Paper 17 (“Dec. on Inst.”).
`After institution of trial, Patent Owner filed a Patent Owner Response
`(Paper 27, “PO Resp.”), and Petitioner filed a Reply (Paper 31, “Pet.
`Reply”). In addition, Patent Owner filed Observations on Cross
`Examination (Paper 37), to which Petitioner filed a Response (Paper 45).
`Both parties also filed motions to exclude evidence, and the briefing on
`those motions included oppositions and replies. See Papers 36, 40, 43, 44,
`46, 47. The parties presented oral argument at a hearing held on October 19,
`2016. Paper 53 (“Tr.”).
`For the reasons explained below, upon consideration of the evidence
`and arguments of both parties, we determine that Petitioner has shown by a
`preponderance of the evidence that claims 12–16 of the ’991 patent are
`unpatentable. See 35 U.S.C. § 326(e).
`A. Related Matters
`Petitioner has filed two petitions for inter partes review challenging
`U.S. Patent No. 8,727,773 (“the ’773 patent”), which is related to the ’991
`patent. We instituted review on several of the grounds presented in the first
`petition, and issued a Final Written Decision holding all of the challenged
`claims unpatentable. US Endodontics, LLC v. Gold Standard Instruments,
`LLC, Case IPR2015-00632 (PTAB Aug. 1, 2016) (Paper 78). We denied
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`institution on any of the grounds presented in the second petition. US
`Endodontics, LLC v. Gold Standard Instruments, LLC, Case IPR2015-01476
`(PTAB Oct. 26, 2015) (Paper 13).
`In addition, the ’773 patent and U.S. Patent No. 8,562,341, another
`patent related to the ’991 patent, are being asserted against Petitioner in an
`ongoing lawsuit in the U.S. District Court for the Eastern District of
`Tennessee, Dentsply International, Inc. v. US Endodontics, LLC, Case No.
`2:14-cv-00196-JRG-DHI. Pet. 1; Paper 52, 3. The parties list a number of
`pending patent applications owned by Patent Owner that may be affected by
`this proceeding. See Pet. 1; Paper 52, 3–4.
`B. The ’991 Patent
`The ’991 patent is titled “Dental and Medical Instruments Comprising
`Titanium.” Ex. 1001, Title. The invention is described as serving to
`“overcome[] the problems encountered when cleaning and enlarging a
`curved root canal.” Id. at 2:59–60. The ’991 patent explains that flexibility
`is a desirable attribute for endodontic files, but that in the prior art, the shank
`portions of files of larger sizes are relatively inflexible, which impedes the
`therapy of a root canal. Id. at 2:4–26.
`The ’991 patent also describes that it is known in the art that
`endodontic files may be formed of “superelastic alloys such as nickel-
`titanium that can withstand several times more strain than conventional
`materials without becoming plastically deformed.” Id. at 2:43–46. The ’991
`patent further explains that a property termed “shape memory . . . allows the
`superelastic alloy to revert back to a straight configuration even after clinical
`use, testing or fracture (separation).” Id. at 2:46–49. According to the ’991
`patent, there remained a need for endodontic instruments that “have high
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`flexibility, have high resistance to torsion breakage, maintain shape upon
`fracture, can withstand increased strain, and can hold sharp cutting edges.”
`Id. at 2:50–55.
`Figures 1a and 1b, reproduced below, illustrate “a side elevational
`view of an endodontic instrument” (Fig. 1a), and “a partial detailed view of
`the shank of the endodontic instrument shown in FIG. 1a” (Fig. 1b). Id. at
`3:26–29.
`
`
`The ’991 patent describes that the “endodontic instrument . . . shown
`in FIG. 1a . . . includes an elongate shank 42 mounted at its proximate end
`47 to a handle 43.” Id. at 4:5–8. The ’991 patent also explains that
`fabricating a medical instrument in accordance with the invention involves
`selecting a superelastic titanium alloy for the shank and subjecting the
`instrument to “heat-treatment” so as to “relieve stress in the instrument to
`allow it to withstand more torque, rotate through a larger angle of deflection,
`change the handling properties, or visually exhibit a near failure of the
`instrument.” Id. at 6:2–5.
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`C. Illustrative Claim
`Claim 12, reproduced below, is the only independent claim among the
`challenged claims:
`12. A method for manufacturing or modifying an
`endodontic instrument for use in performing root canal therapy
`on a tooth, the method comprising:
`(a) providing an elongate shank having a cutting edge
`extending from a distal end of the shank along an axial length of
`the shank, the shank comprising a superelastic nickel titanium
`alloy, and
`(b) after step (a), heat-treating the entire shank at a
`temperature above 25° C. up to but not equal to the melting point
`of the superelastic nickel titanium alloy,
`wherein the heat treated shank has an angle greater than
`10 degrees of permanent deformation after torque at 45 degrees
`of flexion when tested in accordance with ISO Standard 3630-1.
`D. Instituted Grounds of Unpatentability
`We instituted trial as to claims 12–16 of the ’991 on the following
`grounds:
`1. Whether claims 12–16 are unpatentable under 35 U.S.C. § 112(a)
`for lack of enablement;
`2. Whether claims 12–16 are unpatentable under 35 U.S.C. § 112(a)
`for lack of written description;
`3. Whether claims 12–16 are unpatentable under 35 U.S.C. § 102 as
`being anticipated by Luebke 2008;1
`
`
`1 U.S. Patent App. Pub. No. 2008/0032260 A1, published Feb. 7, 2008 (Ex.
`1022).
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`4. Whether claim 15 is unpatentable under 35 U.S.C. § 103 as
`obvious over Luebke 2008 alone or in view of Heath2 or ISO
`3630-1;3
`5. Whether claims 12–14 and 16 are unpatentable under 35 U.S.C.
`§ 102 as being anticipated by Kuhn;4 and
`6. Whether claim 15 is unpatentable under 35 U.S.C. § 103 as
`obvious over Kuhn alone or in view of Heath or ISO 3630-1.
`See Dec. on Inst. 37.
`
`II. ANALYSIS
`A. Post-Grant Review Eligibility
`1. Legal Standards for Post-Grant Review Eligibility
`The post-grant review provisions set forth in Section 6(d) of the AIA5
`apply only to patents subject to the first-inventor-to-file provisions of the
`AIA. See AIA § 6(f)(2)(A) (“The amendments made by subsection (d) . . .
`shall apply only to patents described in section 3(n)(1).”). The first-
`inventor-to-file provisions apply to any application for patent, and to any
`patent issuing thereon, that contains or contained at any time a claim to a
`claimed invention that has an effective filing date on or after March 16,
`2013. See AIA § 3(n)(1). The relevant statute defines the “effective filing
`date” as:
`
`
`2 U.S. Patent No. 5,628,674, issued May 13, 1997 (Ex. 1024).
`3 International Standard ISO 3630-1, 1st ed. (1992) (Ex. 1023).
`4 Grégoire Kuhn & Laurence Jordan, Fatigue and Mechanical
`Properties of Nickel-Titanium Endodontic Instruments, 28 J.
`ENDODONTICS 716 (2002) (Ex. 1030).
`5 Leahy-Smith America Invents Act, Pub. L. No. 112-29, 125 Stat. 284
`(2011) (“AIA”).
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`(A) if subparagraph (B) does not apply, the actual filing date of
`the patent or the application for the patent containing a claim to
`the invention; or
`(B) the filing date of the earliest application for which the patent
`or application is entitled, as to such invention, to a right of
`priority under section 119, 365(a), 365(b), 386(a), or 386(b) or
`to the benefit of an earlier filing date under section 120, 121,
`365(c), or 386(c).
`35 U.S.C. § 100(i)(1). Entitlement to the benefit of an earlier date under
`§§ 119, 120, 121, and 365 is premised on disclosure of the claimed invention
`“in the manner provided by § 112(a) (other than the requirement to disclose
`the best mode)” in the earlier application. See 35 U.S.C. §§ 119(e), 120.6
`Applying these statutes to determine whether a patent is subject to the
`first-inventor-to-file provisions of the AIA, and therefore eligible for post-
`grant review, is straightforward when the application from which the patent
`issued was filed before March 16, 2013, or when the application was filed on
`or after March 16, 2013 without any priority claim. The determination is
`more complex, however, for a patent that issues from a “transition
`application,” which is an application filed on or after March 16, 2013 that
`claims the benefit of an earlier filing date prior to March 16, 2013. See
`MPEP § 2159.04. As a consequence of the statutes discussed above, a
`patent that issues from a transition application is available for post-grant
`review “if the patent contains . . . at least one claim that was not disclosed in
`compliance with the written description and enablement requirements of
`§ 112(a) in the earlier application for which the benefit of an earlier filing
`date prior to March 16, 2013 was sought.” Inguran, LLC v. Premium
`
`
`6 Section 386 is irrelevant here because it concerns the right of priority for
`international design applications. See 35 U.S.C. §§ 381–390.
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`Genetics (UK) Ltd., Case PGR2015-00017, slip op. at 11 (PTAB Dec. 22,
`2015) (Paper 8).
`Separate from the requirement that the patent is subject to the AIA’s
`first-inventor-to-file provisions, an additional requirement for post-grant
`review eligibility is that “[a] petition for a post-grant review may only be
`filed not later than the date that is 9 months after the date of the grant of the
`patent.” 35 U.S.C. § 321(c); see 37 C.F.R. § 42.202(a). Here, Patent Owner
`does not dispute that the Petition was filed within the nine month filing
`deadline.7 See Pet. 11. Nor does Patent Owner dispute Petitioner’s
`representation that it is not barred or estopped from requesting post-grant
`review of the ’991 Patent. See id.
`Patent Owner does contend, however, that the ’991 patent is ineligible
`for post-grant review because its claims are entitled to an effective filing
`date of June 7, 2005. See PO Resp. 40. Thus, with respect to post-grant
`review eligibility, the only dispute is whether the ’991 patent is subject to
`the first-inventor-to-file provisions of the AIA.
`2. Facts Relevant to Post-Grant Review Eligibility
`The application that issued as the ’991 patent was filed on January 29,
`2014, and was assigned Application No. 14/167, 311 (“the ’311
`application”). Ex. 1001, at [21], [22]. The ’991 patent claims priority to a
`series of continuation and divisional applications reaching back to June 7,
`2005, as well as a provisional application filed on June 8, 2004. Id. at [60].
`Consistent with the characterization of the earlier applications in the ’991
`patent’s priority claim, Petitioner agrees that “[t]he descriptions in the
`
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`7 The ’991 patent issued on November 4, 2014. Ex. 1001, at [45]. The
`Petition was filed on August 3, 2015. See Paper 3, 1.
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`priority applications are substantively the same except for their claims; the
`entire family comprises continuation and divisional applications (but not
`continuation-in-part applications).” Pet. 32. Thus, it is undisputed that the
`Specification of the ’991 patent is substantively identical to the
`specifications of the applications to which it claims priority. See Prelim.
`Resp. 25; PO Resp. 40. It is also undisputed that the claims in the ’311
`application, as filed on January 29, 2014, are identical to the claims as issued
`in the ’991 patent. See Pet. 6; Ex. 1003, 23–25.
`3. Burden of Proof on Post-Grant Review Eligibility
`In this case, eligibility hinges on whether the ’991 patent is subject to
`the first-inventor-to-file provisions of the AIA. That analysis, in turn,
`depends on whether the patent contains any claims having an effective filing
`date on or after March 16, 2013. In the Petition, Petitioner argued that
`“Patent Owner bears the ultimate burden of demonstrating entitlement to an
`earlier application’s filing date.” Pet. 22 (citing In re NTP, Inc., 654 F.3d
`1268, 1276–77 (Fed. Cir. 2011)). Petitioner argued that the ’991 patent is
`eligible for post-grant review because “Patent Owner will not be able to
`meet its burden of proving that the claims at issue are entitled to a filing date
`earlier than the . . . January 29, 2014 filing date.” Id. at 23. In our Decision
`on Institution, we determined that it is Petitioner, not Patent Owner, that
`bears the burden to prove that the ’991 patent is subject to the first-inventor-
`to-file provisions of the AIA and, therefore, eligible for post-grant review.
`Dec. on Inst. 9–12 (citing Research Corp. Technologies, Inc. v. Microsoft
`Corp., 627 F.3d 859, 870–71 (Fed. Cir. 2010); Tech. Licensing Corp. v.
`Videotek, Inc., 545 F.3d 1316, 1327–29 (Fed. Cir. 2008); PowerOasis, Inc.
`v. T-Mobile USA, Inc., 522 F.3d 1299, 1305–06 (Fed. Cir. 2008)). In the
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`briefing following our Decision on Institution, neither party has contested
`this assignment of the burden of proof on eligibility for post-grant review.
`Accordingly, for the same reasons explained in our Decision on Institution,
`we maintain our determination that Petitioner bears the burden to show that
`the ’991 patent is eligible for post-grant review.
`4. Analysis of Post-Grant Review Eligibility
`Petitioner presents several arguments for why the ’991 patent includes
`claims with an effective filing date of January 29, 2014, which is the actual
`filing date of the ’311 application. See Pet. 23–32. Among these arguments
`is Petitioner’s contention that the disclosure of the ’991 patent does not
`satisfy the written description and enablement requirements of 35 U.S.C.
`§ 112 for claims 12–16. See Pet. 31–45. Because the disclosure of the
`priority applications is the same as that of the ’991 patent’s Specification,
`Petitioner argues, the priority applications also fail to provide adequate
`support for the subject matter of claims 12–16. Id. at 31–32. Thus,
`according to Petitioner, claims 12–16 are not entitled to an effective filing
`date earlier than January 29, 2014. Id.
`As we noted in our Decision on Institution, Petitioner’s contention
`that January 29, 2014, is the effective filing date for claims 12–16 is not
`based on an argument that those claims are adequately supported in the ’311
`application but lack support in earlier applications to which priority is
`claimed. See Dec. on Inst. 12. Instead, Petitioner’s contention is that neither
`the ’311 application nor any of the earlier applications adequately supports
`claims 12–16, and therefore, the effective filing date for those claims is the
`actual filing date. See Pet. 31–32.
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`Petitioner’s argument accords with the definition of “effective filing
`date” set forth above, which provides in subparagraph (B) that the effective
`filing date is the filing date of the earliest application to which the patent is
`entitled to priority or to the benefit of an earlier filing date. 35 U.S.C.
`§ 100(i)(1)(B). Subparagraph (A) provides that “if subparagraph (B) does
`not apply,” the effective filing date is the actual filing date of the patent
`containing a claim to the invention. 35 U.S.C. § 100(i)(1)(A). Under this
`definition, if a claim in a patent application is not entitled to an earlier filing
`date, then subparagraph (B) does not apply and the effective filing date is the
`actual filing date of the application under subparagraph (A), regardless of
`whether the disclosure in the application is sufficient to support the claim.
`Consequently, we agree with Petitioner that if claims 12–16 are shown to
`lack adequate § 112 support in the ’311 application and all of the earlier
`applications to which priority is claimed, the effective filing date for those
`claims is the actual filing date of the ’311 application.8
`Our analysis of Petitioner’s enablement and written description
`challenges is set forth in Sections II.D.1. and II.D.2., respectively. For the
`reasons explained therein, we determine that Petitioner has shown that
`claims 12–16 are not adequately supported by the disclosure of the ’311
`application. Because it is undisputed that the ’311 application has the same
`disclosure as the earlier applications to which the ’991 patent claims priority,
`see Pet. 32; Prelim. Resp. 25; PO Resp. 40, we also determine that Petitioner
`has shown that claims 12–16 are not entitled to an effective filing date
`
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`8 We came to the same conclusion in our Decision on Institution. See Dec.
`on Inst. 13. The parties’ briefing after that Decision does not contest that
`determination.
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`earlier than January 29, 2014. Therefore, Petitioner has met its burden to
`show that the ’991 patent is eligible for post-grant review.
`B. Claim Construction
`Claims of an unexpired patent are interpreted using the broadest
`reasonable interpretation in light of the specification. 37 C.F.R. § 42.200(b);
`see Cuozzo Speed Techs. LLC v. Lee, 136 S. Ct. 2131, 2144–46 (2016)
`(upholding the use of the broadest reasonable interpretation standard).
`Under the broadest reasonable interpretation claim construction standard,
`claim terms are generally given their ordinary and customary meaning, as
`would be understood by one of ordinary skill in the art in the context of the
`entire disclosure. In re Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed.
`Cir. 2007).
`In our Decision on Institution, for the purposes of that decision, we
`adopted the parties’ agreed-upon construction that the phrase “heat-treating
`the entire shank” in claim 12 includes heat treatment in any environment.
`Dec. on Inst. 22. We also construed the clause in claim 12 that recites
`“wherein the heat treated shank has an angle greater than 10 degrees of
`permanent deformation after torque at 45 degrees of flexion when tested in
`accordance with ISO Standard 3630-1.” We disagreed with Petitioner’s
`argument that this “wherein” clause should not be considered limiting. See
`id. at 22. Instead, we construed the “wherein” clause as a limitation that lays
`out a metric for determining if a heat treatment process falls within the scope
`of the claim. See id. at 22–24.
`The parties’ briefing after institution does not contest those
`constructions, nor do the parties propose that any other term should be
`construed. At the hearing, Petitioner confirmed that it does not challenge the
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`construction of the “wherein” clause that we adopted in the Decision on
`Institution. See Tr. 7:18–23. Patent Owner agrees that our construction of
`the “wherein” clause was correct, but argues that the analysis in our
`Decision on Institution did not faithfully apply the construction that we
`adopted. See id. at 34:3–16. Patent Owner’s argument concerning the
`relevance of the “wherein” clause to the enablement analysis is discussed
`below. Accordingly, we maintain the constructions set forth in our Decision
`on Institution.
`C. Level of Ordinary Skill in the Art
`In determining the level of ordinary skill in the art, relevant factors
`include the type of problems encountered in the art, the prior art solutions to
`those problems, the rapidity with which innovations are made, the
`sophistication of the technology, and the educational level of active workers
`in the field. Custom Accessories, Inc. v. Jeffrey-Allan Indus. Inc., 807 F.2d
`955, 962 (Fed. Cir. 1986).
`Petitioner argues, with support from the testimony of Dr. Goldberg,
`that a person of ordinary skill in the art at the time of the invention of the
`’991 patent would have:
`(i) a bachelor’s degree or master’s degree in materials science,
`metallurgy, or a related field and at least two years of experience
`so as to understand the structural, chemical, and mechanical
`properties that can be manipulated in Ni-Ti alloy materials used
`in dental applications, or (ii) a Ph.D. or equivalent degree in
`materials science, metallurgy, or a related field and at least one
`year of experience so as to understand the structural, chemical,
`and mechanical properties that can be manipulated in Ni-Ti alloy
`materials used in dental applications.
`Pet. 32–33 (citing Ex. 1002 ¶ 75). Patent Owner did not contest this
`proposal or present a competing definition in its briefing, and stated at the
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`hearing that it does not object to Petitioner’s proposed definition of the level
`of ordinary skill in the art. Tr. 34:18–35:3. We adopt the parties’ agreed-
`upon definition of the level of ordinary skill in the art.
`D. Asserted Grounds of Unpatentability
`1. Enablement
`a. Legal Principles
`“Section 112 requires that the patent specification enable those skilled
`in the art to make and use the full scope of the claimed invention without
`undue experimentation.” Invitrogen Corp. v. Clontech Labs. Inc., 429 F.3d
`1052, 1070–71 (Fed. Cir. 2005). The Federal Circuit has explained that an
`enabling disclosure is “part of the quid pro quo of the patent bargain.” AK
`Steel Corp. v. Sollac & Ugine, 344 F.3d 1234, 1244 (Fed. Cir. 2003).
`Specifically, the enablement requirement under § 112
`ensures that the public knowledge is enriched by the patent
`specification to a degree at least commensurate with the scope of
`the claims. The scope of the claims must be less than or equal to
`the scope of the enablement. The scope of enablement, in turn,
`is that which is disclosed in the specification plus the scope of
`what would be known to one of ordinary skill without undue
`experimentation.
`National Recovery Techs. Inc. v. Magnetic Separation Sys., Inc., 166 F.3d
`1190, 1195–96 (Fed Cir. 1999). “Whether undue experimentation is needed
`is not a single, simple factual determination, but rather is a conclusion
`reached by weighing many factual considerations.” In re Wands, 858 F.2d
`731, 737 (Fed. Cir. 1988). Factors to be considered include
`(1) the quantity of experimentation necessary, (2) the amount of
`direction or guidance presented, (3) the presence or absence of
`working examples, (4) the nature of the invention, (5) the state
`of the prior art, (6) the relative skill of those in the art, (7) the
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`predictability or unpredictability of the art, and (8) the breadth of
`the claims.
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`Id.
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`b. Summary of the Parties’ Contentions Regarding Enablement
`Petitioner’s enablement arguments focus on the range of temperatures
`at which the claimed heat treatment occurs. Claim 12 recites
`heat-treating the entire shank at a temperature above 25° C. up
`to but not equal to the melting point of the superelastic nickel
`titanium alloy, wherein the heat treated shank has an angle
`greater than 10 degrees of permanent deformation after torque at
`45 degrees of flexion when tested in accordance with ISO
`Standard 3630-1.
`Ex. 1001, 10:42–48 (emphasis added). Dependent claim 14 narrows the
`temperature range somewhat, reciting that “the temperature is from 300° C.
`up to but not equal to the melting point of the superelastic nickel titanium
`alloy.” Id. at 10:53–54.
`Petitioner argues that “‘heat-treating’ a superelastic, nickel-titanium
`endodontic instrument at as low as 25°C, or at mouth temperature (37°C),
`will not result in a file that exhibits the recited level of permanent
`deformation.” Pet. 36 (citing Ex. 1002 ¶¶ 101–102). Petitioner’s declarant,
`Dr. Goldberg, testifies that “[i]n order to transform a Ni-Ti endodontic
`instrument from one which would not satisfy the ‘wherein’ clause into one
`that would satisfy it, one must process the alloy so as to change its
`transformation temperatures.” Ex. 1002 ¶ 101. Yet, according to Dr.
`Goldberg:
`[S]ubjecting a Ni-Ti instrument to 25–37°C will not alter its
`transformation temperatures. Effective heat-treatment requires
`enough thermal energy for the individual atoms to move to
`different positions within the solid material. Heat-treatment at
`25–37°C does not provide this energy. Significantly higher
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`temperatures are required: one paper explained that, with respect
`to one Ni-Ti alloy, the transformation temperature did not change
`significantly with a treatment temperature of 300°C.
`Id. ¶ 102 (citing Ex. 1006, 113).
`To show that the method of the ’991 patent is inoperative within the
`claimed temperature ranges, Petitioner describes testing in which the shanks
`of ten ProFile brand Ni-Ti endodontic files were heat-treated at 25°C for
`durations between 75 minutes and twelve hours. Pet. 36–37 (citing Ex. 1015
`¶¶ 4–5). The heat-treated shanks were then subjected to flexion testing in
`accordance with ISO Standard 3630-1, and their permanent deformation was
`measured to be between 0.04 and 2.19 degrees, averaging 0.87 degrees.
`Pet. 37 (citing Ex. 1018, 10; Ex. 1002 ¶ 105). Similar testing was conducted
`with a heat-treatment at 300°C, and the results of that testing showed
`permanent deformation in the 300°C-treated shanks between 0.07 and 2.73
`degrees, averaging 1.17 degrees. Pet. 39 (citing Ex. 1015 ¶¶ 3–5; Ex. 1018,
`10; Ex. 1002 ¶ 107). Thus, none of the 25°C-treated shanks or the 300°C-
`treated shanks exhibited permanent deformation of greater than 10 degrees
`as required by the “wherein” clause of claim 12. Pet. 39.
`Petitioner further argues that claims 12–16 are not enabled because
`undue experimentation would be required to practice the full scope of the
`claimed invention. Pet. 40–45. Petitioner asserts, with reference to Dr.
`Goldberg’s testimony, that “the results of heat treatment depend on several
`variables, including temperature, time, alloy composition and alloy treatment
`history.” Pet. 41 (citing Ex. 1002 ¶ 111). Petitioner argues that the
`Specification provides insufficient guidance regarding how to achieve the
`claimed permanent deformation result using the claimed heat treatment
`parameters. Pet. 45. Example 4 in the ’991 patent is the only description
`
`16
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`PGR2015-00019
`Patent 8,876,991 B2
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`provided in the Specification for achieving the claimed permanent
`deformation. Id. at 41; see also Ex. 1001, 8:35–62 (describing heat-
`treatment at 500˚C for 75 minutes of files comprising 54–57 weight percent
`nickel and 43–46 weight percent titanium). According to Petitioner, “the
`specification does not provide any guidance as to how variations in time and
`temperature, or alloy composition, may affect the results one way or
`another.” Pet. 45. Thus, the example disclosed in the Specification is
`insufficient to enable claims 12–16, which encompass a broad range of
`possible combinations of these variables. Id. at 44–45 (citing Ex. 1002
`¶ 125). In particular, the claims do not specify a duration for heat-treating,
`encompass temperature ranges from above 25°C (claims 12, 13, 15, 16) or
`300°C (claim 14) up to but not equal to the melting point of the alloy, and
`either do not specify a composition for the nickel titanium alloy (claims 12–
`15) or include a range of 54–57 weight percent nickel (claim 16). See Ex.
`1001, 10:35–60.
`Patent Owner presents several arguments in rebuttal. See PO Resp.
`17–33. Patent Owner argues that Petitioner’s testing does not show
`inoperative embodiments because “the ‘wherein’ clause limits the heat
`treatments encompassed by claims 12–16 to only those that result in a NiTi
`file that is capable of exhibiting the claimed degree of permanent
`deformation.” Id. at 17. Because none of Petitioner’s tests produced the
`deformation characteristic recited in the “wherein” clause, Patent Owner
`asserts that those tested files were outside the scope of claims 12–16. Id. at
`18–19. Further, Patent Owner argues that Petitioner’s showing of
`inoperative embodiments is insufficient because Petitioner tested at only two
`temperatures, and “[i]t is not necessary that every permutation within a
`
`17
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`PGR2015-00019
`Patent 8,876,991 B2
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`generally operable invention be effective in order for an inventor to obtain a
`generic claim, provided that the effect is sufficiently demonstrated to
`characterize a generic invention.” Id. at 20 (quoting Capon v. Eshhar, 418
`F.3d 1349, 1359 (Fed. Cir. 2005)).
`Patent Owner also criticizes Petitioner’s testing on the basis that it did
`not take into account what an ordinarily skilled artisan would have gleaned
`from the ’991 patent’s teaching that the time period selected for heat
`exposure was dependent on the temperature. Id. at 21–22 (citing Ex. 1001,
`4:16–29). “Despite the express teaching that other temperatures and times
`are suitable, Petitioner either intentionally did not test longer periods of time
`at 300°C (or other temperatures), or tested them and did not provide the
`results of that data.” Id. at 22. Finally, concerning the testing, Patent Owner
`points to the cross-examination testimony of Messrs. Zanes and Kozak,
`employees at the laboratories that carried out Petitioner’s testing, that the
`tested files had an initial bend before bend testing was conducted, and that
`the bend testing was carried out in the same direction as the initial bend. Id.
`at 22 (citing Ex. 2040, 45–48; Ex. 2041, 61–66). According to Patent
`Owner, conducting bend testing in the same direction as the initial bend
`minimized the amount of resulting deformation, which calls into question
`the accuracy of the data gathered. Id. at 22–23.
`Next, Patent Owner challenges Petitioner’s showing that any
`experimentation would be undue. Patent Owner argues that Petitioner’s
`undue experimentation analysis is premised on an incorrect interpretation of
`the “wherein” clause. PO Resp. 24–25. With respect to the Wands factors,
`Patent Owner contends that Petitioner failed to address the quantity of
`experimentation that would be needed to practice the claimed invention. Id.
`
`18
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`at 26–27. Patent Owner argues that Dr. Goldberg’s cross examination
`testimony shows that he was unsure whether the volume of testing would be
`undue. Id. at 27 (citing Ex. 2039, 182–83). Patent Owner asserts that
`“Petitioner has never stated that the experimentation would involve overly
`complex testing, testing beyond the skill of one in the art at the time of Dr.
`Luebke’s invention, or more testing than a person of skill in the art would be
`capable of performing.” Id. at 28. Patent Owner further argues that
`Petitioner does not address the guidance in the ’991 patent concerning
`examples for heat-treatment temperatures and durations. Id. at 29–31.
`“While Petitioner did make reference to Dr. Luebke’s Example 4, Petitioner
`did not analyze what a person of skill in the art would have gleaned from
`those heat treatment processes based on their knowledge of the art.” Id. at
`31. Patent Owner also asserts that Petitioner did not address the nature of
`the invention, the state of the prior art, or the relative skill of those in the art.
`Id. at 31–32. Finally, regarding the Wands factors, Patent Owner challenges
`the su
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