• Greene’S Energy Group, LLC v. Oil States Energy Services, LLCAll claims unpatentable
  PTAB · May 1, 2015 · IPR2014-00216 · APJ James A Tartal · IPR · Final written decision

  Claims 1 and 22 are unpatentable as anticipated by Dallas ’118; the motion to amend with substitute claims 28 and 29 is denied.

  RulingsFinal written decision

  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable

    “member for connection to a wellhead of the well, and a locking member for detachably engaging the base member. Claim 22 contains a similar requirement. We agree with Petitioner that bottom flange 22 of Dallas ’118 corresponds to the base member of a first lockdown mechanism, and that bolts through the bores in lower flange 22 correspond to a locking member, as claimed in the ’053 patent. See Pet. 42. Claim 1 further requires a second lockdown mechanism having a range of adjustment adequate to ensure that the mandrel can be moved into the operative position, and locked down in the operative position while the first lockdown mechanism is in the lockdown position. Claim 22 contains a similar requirement. We agree with Petitioner that the hydraulic cylinder mechanism of Dallas ’118, which ensures a fluid tight seal between annular seal 78 and bit guide 84 by maintaining a pressure of about 1000 psi in upper chamber 36, corresponds to the recited second lockdown mechanism. See Pet. 36, 44.” slip op. at 18

  • 112 supportMotion to amend, deniedDenied

    “The determination of whether there is written description support turns on whether the original disclosure of the application relied upon reasonably conveys to a person of ordinary skill in the art that the inventor had possession of the claimed subject matter as of the filing date. Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc). The proposed substitute claims introduce the term “wellhead assembly,” a term that does not appear in the ’418 application or the ’053 patent. Patent Owner’s string citation to various disclosures, none of which identify a “wellhead assembly,” is insufficient to demonstrate written description support absent some explanation. The same is true with regard to the proposed addition of language requiring both an apparatus for securing the mandrel “within a tubing head spool of a wellhead assembly” and a setting tool “arranged to insert a bottom end of the mandrel through the wellhead.” A string citation does not explain how the original disclosure of the application relied upon reasonably conveys to a person the features intended to be encompassed by the proposed substitute claims. In particular, we cannot discern from Patent Owner’s conclusory discussion how the original disclosure describes both securing the mandrel within the wellhead assembly and inserting the mandrel through the wellhead, particularly where Patent Owner further argues a distinction between inserting a mandrel “into” a wellhead as opposed to “through” a wellhead. See PO Reply. 1–2. Accordingly, we conclude Patent Owner has not satisfied its burden of showing written description support for the proposed substitute claims 28 and 29.” slip op. at 26

  • PTAB / AIA Trials › Motions to amend / substitute claimsMotion to amend, deniedDenied

    “patentable distinction of each proposed substitute claim over the prior art. See 37 C.F.R. § 42.20(c). This includes providing a construction of new claim terms sufficient to support the distinction of the proposed substitute claim over the prior art. Patent Owner introduces the new claim terms “wellhead assembly” and “setting tool” in the proposed substitute claims, but provides no express construction of either term. Absent any discussion of what is encompassed by the recited “wellhead assembly,” it is unclear how the term differs from the use of “wellhead,” alone, elsewhere in the claim. This is particularly problematic, as discussed above, when attempting to discern what is claimed as a setting tool “arranged to insert a bottom end of the mandrel through the wellhead,” relative to the claimed apparatus for securing a mandrel “above the casing of the well and within a tubing head spool of a wellhead assembly.” In its Motion to Amend, Patent Owner also does not provide a construction for “setting tool.” We note that Patent Owner was aware that the district court had previously suggested the term “setting tool” was “ambiguous.” District Court Markman Order, Ex. 2008, 15. In reply to Petitioner’s opposition to the Motion, Patent Owner argues that “the defining characteristics of the ‘setting tool’” are set out in the claim language as: (1) “arranged to insert a bottom end of the mandrel through the wellhead,” and, (2) “separate from” the first and second lockdown mechanisms and thus “removable.” PO Reply 1. Patent Owner proceeds to dispute the construction of “setting tool” proposed by Petitioner’s Declarant, Mr. Perkin, but fails to offer any express construction of the term itself. Petitioner’s Declarant, Mr. Perkin, defined “setting tool” as “any device that is used to align the mandrel with the wellhead so that the mandrel can be inserted without interference.” Perkin Decl., Ex. 1014 ¶ 44. Patent Owner’s Declarant, Mr. Wooley, testified that “setting tool” is “usually the name given to a device for inserting some sort of tool.” Ex. 1011, 61:17–21. Absent a clear explanation of what is claimed, Patent Owner’s assertion that a particular reference does not teach “any kind of setting tool” is conclusory and not persuasive. See Mot. 9. Patent Owner has not provided a sufficient construction of the term “setting tool” by merely pointing to other claim language or by disputing Petitioner’s proposed construction. By failing to articulate adequately a construction of “setting tool” or “wellhead assembly,” Patent Owner has not satisfied its burden of showing a patentable distinction of each proposed substitute claim over the prior art. 3. Conclusion We conclude Patent Owner has not come forward with sufficient evidence to establish proposed substitute claims 28 and 29 have adequate written description support. We further conclude Patent Owner has not supported sufficiently the distinction of the proposed substitute claims 28 and 29 over the prior art by failing to provide adequately the necessary construction of the proposed amendments to claims 1 and 22. For these reasons, we deny Patent Owner’s Motion to Amend.” slip op. at 27

  Patent outcomesUS 6,179,053 unpatentable
  § 102 anticipation
  Patents in suitUS 6,179,053
• Medtronic, Inc. / Medtronic Vascular, Inc. v. Lifeport Sciences LLCNo claims unpatentable
  PTAB · Apr 21, 2015 · IPR2014-00288 · APJ Robert A Pollock · IPR · Final written decision

  Claims 1–5, 7–13, 15, and 16 were not shown unpatentable because the cited references did not establish the claimed permanent curve.

  RulingsFinal written decision

  • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownOther

    “Considering the teachings of the Specification, we conclude that the curve element must be permanent, as recited in the claims, rather than “resiliently flexible.” The Specification teaches that in some embodiments, the hook or protrusion “is resiliently flexible so as to form a substantially straight profile when compressed,” (Ex. 1001, Abstract) but “may be permanently-deformed into the curved configuration by heat setting the material” (id. at 6:1–4). As emphasized by Lifeport, the Specification teaches that a permanently deformed hook and frame—and, thus, a permanent curve—can be produced by heating Nitinol hook and frame combinations “at 550° for ten minutes.” Resp. 25–26 (citing Ex. 1001, 6:3– 4); see Ex. 2001 ¶ 77. When thus “permanently deformed,” “hook 20 may still be compressed into alignment with the frame 22 without losing the preset curve,” and subsequently “deployed in the curved configuration by releasing.” Ex. 1001, 6:7–9 (emphases added). We further note that the Specification makes clear that the disclosed hooks are incorporated into a variety of devices deployed in the veins of living bodies (see, e.g., Ex. 1001, 3:60–4:8), and subject to various physical forces therein. The ’662 patent, thus, discloses an embodiment having “a plurality of hooks 20 from the same incisions 40,” which “could form hooks 20 which project in opposing directions” and “provide superior resistance to radial and axial loads from the corporeal lumen and blood flow.” Ex. 1001, 5:33–37. In light of the foregoing, we refine our construction of “permanent curve” to be “a preset curve that maintains a fixed arc throughout normal use regardless of what configuration the device is in.” Insofar as Petitioners, and/or Petitioners’ expert, argue that the challenged claims are unpatentable under multiple constructions of this term, we address only those arguments relevant to this construction below.” slip op. at 10

  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable

    “Lifeport has the more persuasive position. First, we note that endoprostheses such as those disclosed in the ’662 patent are deployed and function in a living body (see, e.g., Ex. 1001, 3:60–4:8). Accordingly, our construction of permanent curve as a preset curve that maintains a fixed arc throughout normal use regardless of the configuration of the device, is not limited to sheathed and unsheathed configurations taken in isolation. Thus, whereas Dr. Loomis’s analysis of Lefebvre focuses on the force applied by a catheter sheath impinging on a single tooth of the Lefebvre device, “throughout normal use” more broadly encompasses the deployed configuration of Lefebvre Figure 3 in which teeth 6, 7 penetrate into the vein wall “one in the direction of flow of the blood and the other in the opposite direction.” See Ex. 1003, 1:64–66. Dr. Loomis addressed the compressive effects during the application of a catheter sheath. We find no evidence that Dr. Loomis addressed compressive, hemodynamic, or other forces on the Lefebvre teeth when the device is deployed and functioning in normal use.9 9 Although an analysis of the forces applied to the Lefebvre device when it is deployed in a vein is among the issues raised in Medtronic’s Motion to Exclude Evidence, we need not resort to Dr. Loomis’s contested testimony as the omission is self-evident. We also are not persuaded by Medtronic’s assertion that Figure 3 and column 3, lines 34–42, of Lefebvre demonstrate The evidence of record is, therefore, insufficient to demonstrate that Lefebvre maintains a permanent curve as properly construed.” slip op. at 18

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successNot shown unpatentableNot shown unpatentable

    “Lazarus specifically teaches that by modifying hooks like those of Lefebvre to make them sharper, or to configure them as barbs or arrowheads, more secure anchoring of the device can be achieved. . . . Thus, a person of skill in the art dealing with the problem of intraluminal device migration would have been motivated to combine the teaching of Lazarus with that of Lefebvre to achieve even stronger anchoring of the device to the lumen wall. For the reasons discussed above, we find that Lefebvre fails to disclose or suggest the “permanent curve” set forth in independent claims 1 and 10, from which claims 7, 8, and 15 depend. As there is no assertion of record that the missing element is provided in Lazarus, we conclude that Petitioners have not proven by a preponderance of the evidence that the combination of Lefebvre and Lazarus renders claims 7, 8, and 15 unpatentable under 35 U.S.C. § 103(a).” slip op. at 22

  • Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Not shown unpatentableNot shown unpatentable

    “We do not discern, nor does Dr. Loomis adequately explain, how the angular relationship of White’s engagement members, whether in an expanded, flat, or inwardly-projection configuration, comports with our construction of permanent curve. At best, Dr. Loomis identifies changes in the shape of White’s engagement members in response to temperature or compressive forces. On their face, such changes are incompatible with a permanent curve that is a preset curve that maintains a fixed arc throughout normal use regardless of what configuration the device is in. Dr. Loomis has not convinced us of a contrary interpretation of the White reference. Accordingly, we credit Ms. Gold’s testimony that “[n]othing in the disclosure of White indicates that the engagement members 21 have a permanent curve.” Ex. 2001 ¶ 59.” slip op. at 27

  Patent outcomesUS 7,147,662 not shown unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR
  Patents in suitUS 7,147,662
• Medtronic, Inc. v. Nuvasive, Inc.All claims unpatentable
  PTAB · Apr 3, 2015 · IPR2014-00073 · APJ Francisco C Prats · IPR · Final written decision

  Claims 21, 22, 24, 30, and 33–37 are unpatentable under four § 103 grounds; the two grounds relying on Branch and Blewett fail because Blewett is not prior art.

  RulingsFinal written decision

  • BurdenDecided for petitioner

    “We conclude that Petitioner has proved by a preponderance of the evidence that claims 21, 22, 24, 30, and 33–37 of the ʼ356 patent are unpatentable, based on some, but not all, of the grounds upon which trial was instituted.” slip op. at 4

  • Skill levelOther

    “As to the level of ordinary skill in the pertinent art, the parties, as discussed below, challenge their opposing experts’ conclusions and qualifications. Nonetheless, neither party asserts specifically that the ultimate conclusion of obviousness turns on adoption of a particular level of ordinary skill. In that regard, the parties’ experts advance slightly different opinions as to the level of ordinary skill in the pertinent art. See Ex. 1015 ¶ 11 (Watkins Decl.)); Ex. 2020 ¶ 17 (Phillips Decl.). Both experts, nonetheless, generally agree that an ordinarily skilled artisan at the critical time would have been either an experienced spinal surgeon, or an experienced engineer or professional involved in the implementation or design of surgical instruments for use in spinal surgery, with significant access to orthopedic or neurosurgeons. See id. When evaluating the parties’ contentions regarding the scope and content of the prior art, and the differences between the prior art and the challenged claims, we take into consideration both parties’ assertions regarding the level of ordinary skill. We note also that the level of ordinary skill in the art may be evidenced by the cited references. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 14

  • Expert testimonyPatent owner expert creditedPetitioner expert discountedOther

    “Having reviewed the ’214 application, including the cited figures, in light of Patent Owner’s contentions and Dr. Phillips’s testimony, we find that the evidence supports Patent Owner’s assertion that an ordinarily skilled artisan would have understood that the ’214 application described a system for accessing a spinal disc of a lumbar spine, the system including a blade holder apparatus configured to releasably lock with a plurality of retractor blades, as claim 21 of the ’356 patent requires. Because that element is the sole feature of claim 21 urged by Petitioner as being absent from the ’214 application, we find also that the evidence does not support Petitioner’s assertion that claim 21 of the ’356 patent is not entitled to the benefit of the ’214 application’s filing date. Petitioner’s arguments do not persuade us to the contrary. It might be true, as Petitioner argues (Reply 15 (citing Ex. 1024 ¶¶ 29–30 (Watkins Reply Decl.))), that the cited figures of the ’214 application do not depict a hexagonal shape or threading that would have indicated the locking elements were nuts or bolts. Petitioner does not adequately explain, however, why the absence of such depictions demonstrates that Dr. Phillips erroneously characterized those elements. As to Dr. Phillips’s testimony on cross examination that he did not see a nut in Figure 28 of the ’214 application (Reply 15 (citing Ex. 1038, 206:9–207:9 (Phillips Deposition)), we note that on redirect examination he stated that he actually did see a nut-and-bolt structure in Figure 28A. Ex. 1038, 208. Moreover, the fact that Dr. Phillips might have misinterpreted one structure in one figure does not persuade us that he erroneously characterized the overall disclosure of the ’214 application, including the several other figures which he referred to in his testimony.” slip op. at 11

  • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITAPlain and ordinary meaningDecided for patent owner

    “A. Claim Construction The Board interprets claims using the “broadest reasonable construction in light of the specification of the patent in which [they] appear[].” 37 C.F.R. § 42.100(b); In re Cuozzo Speed Techs., LLC, No. 2014-1301, 2015 WL 448667, at *5–*7 (Fed. Cir. Feb. 4, 2015). Under that standard, claim terms are 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. See In re Translogic Tech. Inc., 504 F.3d 1249, 1257 (Fed. Cir. 2007). In the Decision to Institute we concluded that the recitations in claim 21 regarding the “lateral trans-psoas path to the lumbar spine” relate to an intended use of the claimed apparatus. Dec. 8. Accordingly, we attributed to those intended use recitations no particular structural limitations, beyond an ability to be used in, or follow, a trans-psoas path in the manner recited in the claim. Id. Neither party disputes that claim construction and we maintain it in light of the record developed during trial. No other terms require express construction for purposes of this Decision.” slip op. at 7

  Patent outcomesUS 8,192,356 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites KSR · Graham
  Patents in suitUS 8,192,356
• Baxter Healthcare Corp. / Apatech, Inc. et al. v. Millenium Biologix, LLCAll claims unpatentable
  PTAB · Mar 18, 2015 · IPR2013-00582 · APJ Brian P Murphy · IPR · Final written decision

  Claims 1 and 8–13 are unpatentable as anticipated by Ruys ’93a; claim 6 is unpatentable as obvious over Ruys ’93a and Bioceramics.

  RulingsFinal written decision

  • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for petitioner

    “The word “isolated” in claim 1 is used in accordance with its plain and ordinary meaning to those skilled in the art—separated from all other substances. See Ex. 1005, 4 (right-hand column, “1isolate,” definition “2”).12 The isolated compounds disclosed in the ’251 patent are stabilized calcium phosphates synthesized and isolated as calcium phosphate “phases” or as a calcium phosphate “phase.” Therefore, we determine that the broadest reasonable interpretation of “isolated . . . compound” in the context of the claimed invention, consistent with the ’251 Specification, is “a stabilized 11 Patent Owner does not contest our construction of “isolated . . . compound” in its Response to the Petition. PO Resp. 22–23. 12 “to separate (as a chemical compound) from all other substances: obtain pure or in a free state” single phase or multi-phase calcium phosphate compound separated from all other substances.”” slip op. at 10

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed board ownDecided for petitioner

    “do not describe interconnected microporosity as critical or necessary to the microporous structure of the claimed compound. Id. at 5:37–38 (“compound having a microporous morphology based on inter-connected particles”); 11:50–52 (“the surface morphology is that of an interconnected set of rounded particles with a high degree of porosity”); 13:61–64 (“The ceramic comprises rounded, inter-connected particles . . . with a large degree of localized porosity.”); 22:3–6 (“A characteristic microporous morphology that arises from the agglomeration of particles . . . and the sintering of the material to produce a network of interconnected particles.”); Ex. 1134 ¶ 146. Patent Owner does not explain how interconnected microporosity results necessarily from interconnected particles. Interconnected microporosity may be preferred for supporting percolation of physiological fluids and bone cell activity,14 but interconnected microporosity is neither recited in claim 1 nor required for a functional biomaterial. As established by Dr. Mikos’s testimony and Dr. Ong’s testimony, dense HA (without interconnected microporosity) is suitable for implantation at load bearing sites in patients. Ex. 1003 ¶¶ 68, 69; Ex. 1134 ¶ 149 (citing Dr. Ong’s deposition testimony, Ex. 1133, 150:18–151:1). Therefore, we decline to read “interconnected microporosity” into the construction of “microporous structure.”” slip op. at 15

  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element) › Inherent disclosureNot shown unpatentableNot shown unpatentable

    “’93a must inherently disclose “interconnected microporosity” in order to satisfy the wherein clause recitation of “a microporous structure” in claim 1 of the ’251 patent. See section II A.2. above. Further, there is no dispute that Ruys ’93a discloses a silicon-substituted CaP compound having a porous structure, graphically demonstrated by the “apparent porosity” curve in Figure 2 of Ruys ’93a. Ex. 1011, 4 (left column); Pet. 44 (citing Ex. 1003 ¶¶ 388–391); Pet. Reply (citing Ex. 1003 ¶ 631; Ex. 2026 ¶¶ 38–39; Ex. 1133, 59:14–18, 242:12–15). The silicon-substituted CaP compound analyzed in Ruys ’93a demonstrates an apparent porosity as high as 50% of the material tested. Ex. 1011, 4 (Fig. 2); Tr. 20:7–15. Petitioner and Patent Owner both recognize, however, that Ruys ’93a does not report pore size. Pet. Reply 4; Tr. 52:22–24. Therefore, the dispute boils down to whether the porous structure of the silicon-substituted CaP compound disclosed in Ruys ’93a is inherently “microporous,” i.e. whether the method disclosed in Ruys ’93a would necessarily result in “pore sizes of about 2 microns or less in diameter,” in accordance with our claim construction. See In re Robertson, 169 F.3d 743, 745 (Fed. Cir. 1999)(“the extrinsic evidence ‘must make clear that the missing descriptive matter is necessarily present in the thing described in the reference’”(citation omitted)).” slip op. at 30

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundUnpatentable

    “2. Analysis Petitioner acknowledges Ruys ’93a does not teach the formation of a macroporous, open-cell structure, but Petitioner argues that formation of such a structure using Ruys ’93a’s silicon-substituted CaP material would have been an “obvious design choice” for one skilled in the art in view of the Bioceramics reference. Pet. 45 (citing Ex. 1003 ¶ 683). Petitioner, relying on the Declaration of Dr. Mikos, asserts that methods of making a biomaterial compound having a macroporous structure were conventional and well known. Id. at 48 (citing Ex. 1003 ¶¶ 147–164, 690); Tr. 34:14–20. Petitioner notes that Bioceramics was not considered during examination of the application resulting in the ’251 patent. Id. at 46 (citing Ex. 1003 ¶ 523). Petitioner emphasizes the Bioceramics disclosure that “[a]n ideal cancellous bone graft substitute would mimic osteon-evacuated cancellous bone and have a thin lattice interconnected by pores of 500–600 µm” (Ex. 1021, 110) and that “[p]orosity and interconnectivity are key determinants of amount and type of ingrowth” of CaP bone implant material (id. at 116–17). Pet. 46–47 (citing Ex. 1003 ¶¶ 155, 528–530, 685–87). Petitioner asserts that one of ordinary skill in the art would have been motivated by the teachings of Bioceramics to form the silicon-substituted CaP compound disclosed in Ruys ’93a into a macroporous open cell structure with interconnected voids having pore sizes within the claimed range of 50 to 1000 microns. Id. at 47– 48 (citing Ex. 1003 ¶¶ 689–90). Patent Owner argues that, even though techniques for forming CaP compounds into a macroporous structure were well known prior to the ’251 patent’s August 1996 priority date, there was no prior publication of forming elementally-substituted CaP compounds into a macroporous structure. PO Resp. 36–37. Patent Owner further argues Petitioner has failed to prove one of ordinary skill in the art would have had a reasonable expectation of success in forming the silicon-substituted CaP powder disclosed in Ruys ’93a into the macroporous structure recited in claim 6. Id. at 37–39. Patent Owner further relies on asserted secondary considerations in support of Patent Owner’s argument for the nonobviousness of claim 6. Id. at 27–36, 40–54. Dr. Ong agreed with Dr. Mikos that interconnected macroporosity was known to be “critical” to vascularization, bone cell differentiation, and bone implantation, as stated in the 1993 Bioceramics textbook. Pet. Reply 9 (citing Ex. 1133, 159:16–160:3). Figure 4 in chapter 10 of Bioceramics illustrates an “[i]dealized microstructure for cancellous bone regeneration” having “a thin lattice interconnected by pores of 500–600 [microns]” in diameter. Id.; Ex. 1021, 110–111. Bioceramics, therefore, expressly discloses the claim 6 recitation of a “macroporous structure” of “interconnected voids having a pore size of approximately 50 to 1000 microns,” and Bioceramics provides sound physiological reasons for forming a CaP biomaterial compound into a macroporous structure.” slip op. at 37

  Patent outcomesUS RE41,251 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips
• Cyanotech Corporation v. The Board Of Trustees Of The University Of IllinoisSome claims unpatentable
  PTAB · Dec 12, 2014 · IPR2013-00404 · APJ Sheridan K Snedden · IPR · Final written decision

  Claims 1–14 and 26 are unpatentable over Grangaud and/or Grangaud with Dowling; claims 15, 21, and 22 were not shown unpatentable.

  RulingsFinal written decision

  • Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed board ownDecided for petitioner

    “treating damage caused by injury or disease (Resp. 14–15), however, the specification does not contain any indication that the patentee intended to act as his own lexicographer clearly defining “disease” and “damage” in the same manner. For example, the specification does not clearly convey the patentee’s intent to appoint a special meaning to the phrase “retinal damage or retinal disease.” We must determine, therefore, the ordinary meaning of “disease” and “damage” as used in these claims to one of skill in the art in light of the specification and prosecution history. In re Paulsen, 30 F.3d at 1480. In this regard, the term “damage,” as used in the specification, refers to damage resulting from injury or disease. Ex. 1001, 1:14–19. The specification does not equate damage and disease, but provides that damage may be caused by disease. Id. The meaning of the term disease, however, refers to conditions that may cause damage (such as degenerative eye disease), and are treatable themselves. Id. at 15:36–40. That is, the underlying cause of the damage is treatable, not just the damage alone. The University does not direct our attention to anything in the specification or prosecution that would clearly alter the ordinary meaning of “disease” and “damage.” Resp. 14–16. In view of the above, we do not construe “retinal damage” and “retinal disease” as a single concept. The evidence of record does not support a finding that the patentee acted as his own lexicographer by clearly defining the claim terms “damage” and “disease” in the same manner. In our Decision to Institute, we adopted the dictionary definition of “disease” and construed the term as “[a] morbid entity ordinarily characterized by two or more of the following criteria: recognized etiologic agent(s), identifiable group of signs and symptoms, or consistent anatomic alterations.” Dec. 8–9; see, Pet. ’401 (citing Ex. 1040). We adopted the dictionary definition of “damage” and construed the term as “[h]arm, diminution, or destruction of an organ, body part, system, or function.” Id. We maintain these constructions for “disease” and “damage” as they are consistent with the use of these terms in the Specification. “Retinal damage” refers to damage to the retina and “retinal disease” refers to disease of the retina. The phrase “retinal damage or retinal disease” refers to either retinal damage or retinal disease.” slip op. at 7

  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element) › Inherent disclosureUnpatentableNot shown unpatentableMixed

    “To establish inherent disclosure, the evidence must show that a feature necessarily is described in the reference, and that it would be recognized by persons of ordinary skill. In re Robertson, 169 F.3d 743, 745 (Fed. Cir. 1999); cf. EMI Grp. N. Am., Inc. v. Cypress Semiconductor Corp., 268 F.3d 1342, 1351 (Fed. Cir. 2001) (“Theoretical mechanisms or rules of natural law that are recited in a claim, that themselves are not patentable, however, do not need to be recognized by one of ordinary skill in the art for a finding of inherency.”). The mere fact that a certain thing may result from a given set of circumstances is not sufficient to establish inherency. In re Rijckaert, 9 F.3d 1531, 1534 (Fed. Cir. 1993). Inherency may not be established by probabilities or possibilities. In re Oelrich, 666 F.2d 578, 581 (CCPA 1981).” slip op. at 10

  • Obviousness (§103) › Objective indicia / secondary considerations › NexusObjective indicia no nexusDecided for petitioner

    “As to secondary considerations, we note that factual inquiries for an obviousness determination include secondary considerations based on evaluation and crediting of objective evidence of nonobviousness. Graham v. John Deere Co., 383 U.S. 1, 17 (1966). Notwithstanding what the teachings of the prior art would have suggested to one with ordinary skill in the art at the time of the University’s invention, the totality of the evidence submitted, including objective evidence of nonobviousness, may lead to a conclusion that the claimed invention would not have been obvious to one with ordinary skill in the art. In re Piasecki, 745 F.2d 1468, 1471-1472 (Fed. Cir. 1984). However, such a conclusion requires the finding of a nexus to establish that the evidence relied upon traces its basis to a novel element in the claim and not to something in the prior art. Institut Pasteur & Universite Pierre Et Marie Curie v. Focarino, 738 F.3d 1337, 1347 (Fed. Cir. 2013). All types of objective evidence of nonobviousness must be shown to have nexus. In re GPAC Inc., 57 F.3d at 1580 (nexus generally); In re Huang, 100 F.3d 135, 140 (Fed. Cir. 1996) (commercial success); In re Antor Media Corp., 689 F.3d 1282, 1293 (Fed. Cir. 2012) (licensing); Wm. Wrigley Jr. Co. v. Cadbury Adams USA LLC, 683 F.3d 1356, 1364 (Fed. Cir. 2012) (copying); Rambus Inc. v. Rea, 731 F.3d 1248, 1256 (Fed. Cir. 2013) (long-felt need); and In re Kao, 639 F.3d 1057, 1069 (Fed. Cir. 2011) (unexpected results). As discussed above, we conclude that claims 1, 3, and 8–12 are anticipated by Grangaud, as evidenced by Dowling. Because anticipation is the epitome of obviousness, a disclosure that anticipates under 35 U.S.C. § 102 also renders the claim unpatentable under 35 U.S.C. § 103. See In re Fracalossi, 681 F.2d 792, 794 (CCPA 1982) (“[E]vidence establishing lack of all novelty in the claimed invention necessarily evidences obviousness.”); In re Meyer, 599 F.2d 1026, 1031 (CCPA 1979); In re Pearson, 494 F.2d 1399, 1402 (CCPA 1974). Here, Cyanotech presents substantially the same evidence for both their anticipation and obviousness challenges of claims 1, 3, 8–14, and 26. As such, and for the same reasons set forth in our anticipation analysis above, we hold that claims 1, 3, 8–14, and 26 are rendered obvious by Grangaud, alone or in combination with Dowling. Because we have determined that claims 1, 3, and 8–12 lack a novel feature with which to establish a nexus with secondary considerations, Cyanotech, as a matter of law, cannot establish a nexus. In re Kao, 639 F.3d at 1068 (Objective evidence that results from something that is not “both claimed and novel in the claim” lacks a nexus to the merits of the invention.). As to claims 2 and 4–7, the University has not directed any arguments to these claims specifically and has not made any attempts to establish a nexus between the presented objective evidence of nonobviousness and these claims. Thus, we maintain our unopposed determination that the specific doses and routes of administration recited in these claims are predictable variations within the technical grasp of a person of ordinary skill in the art, and are not persuaded by the objective evidence that claims 2 and 4–7 are nonobvious.” slip op. at 23

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successUnpatentableNot shown unpatentableMixed

    “of all novelty in the claimed invention necessarily evidences obviousness.”); In re Meyer, 599 F.2d 1026, 1031 (CCPA 1979); In re Pearson, 494 F.2d 1399, 1402 (CCPA 1974). Here, Cyanotech presents substantially the same evidence for both their anticipation and obviousness challenges of claims 1, 3, 8–14, and 26. As such, and for the same reasons set forth in our anticipation analysis above, we hold that claims 1, 3, 8–14, and 26 are rendered obvious by Grangaud, alone or in combination with Dowling. Because we have determined that claims 1, 3, and 8–12 lack a novel feature with which to establish a nexus with secondary considerations, Cyanotech, as a matter of law, cannot establish a nexus. In re Kao, 639 F.3d at 1068 (Objective evidence that results from something that is not “both claimed and novel in the claim” lacks a nexus to the merits of the invention.). As to claims 2 and 4–7, the University has not directed any arguments to these claims specifically and has not made any attempts to establish a nexus between the presented objective evidence of nonobviousness and these claims. Thus, we maintain our unopposed determination that the specific doses and routes of administration recited in these claims are predictable variations within the technical grasp of a person of ordinary skill in the art, and are not persuaded by the objective evidence that claims 2 and 4–7 are nonobvious. In view of the above, we conclude that Cyanotech has demonstrated the unpatentability of claims 1–14 and 26 by a preponderance of the evidence. (2) Claim 15 Claim 15 depends from claim 14. As discussed above, we conclude that the preponderance of evidence of record demonstrates that neuronal damage to a retina is inherent to the condition of vitamin A deficiency-induced xerophthalmia. The question before us with regard to claim 15, however, is whether” slip op. at 24

  Patent outcomesUS 5,527,533 mixed
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 5,527,533
• Cyanotech Corporation v. The Board Of Trustees Of The University Of IllinoisSome claims unpatentable
  PTAB · Dec 12, 2014 · IPR2013-00401 · APJ Sheridan K Snedden · IPR · Final written decision

  Claims 1–14 and 26 are unpatentable as anticipated by Grangaud and obvious over Grangaud alone or with Dowling; claims 15, 21, and 22 were not shown unpatentable.

  RulingsFinal written decision

  • Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed board ownDecided for petitioner

    “treating damage caused by injury or disease (Resp. 14–15), however, the specification does not contain any indication that the patentee intended to act as his own lexicographer clearly defining “disease” and “damage” in the same manner. For example, the specification does not clearly convey the patentee’s intent to appoint a special meaning to the phrase “retinal damage or retinal disease.” We must determine, therefore, the ordinary meaning of “disease” and “damage” as used in these claims to one of skill in the art in light of the specification and prosecution history. In re Paulsen, 30 F.3d at 1480. In this regard, the term “damage,” as used in the specification, refers to damage resulting from injury or disease. Ex. 1001, 1:14–19. The specification does not equate damage and disease, but provides that damage may be caused by disease. Id. The meaning of the term disease, however, refers to conditions that may cause damage (such as degenerative eye disease), and are treatable themselves. Id. at 15:36–40. That is, the underlying cause of the damage is treatable, not just the damage alone. The University does not direct our attention to anything in the specification or prosecution that would clearly alter the ordinary meaning of “disease” and “damage.” Resp. 14–16. In view of the above, we do not construe “retinal damage” and “retinal disease” as a single concept. The evidence of record does not support a finding that the patentee acted as his own lexicographer by clearly defining the claim terms “damage” and “disease” in the same manner. In our Decision to Institute, we adopted the dictionary definition of “disease” and construed the term as “[a] morbid entity ordinarily characterized by two or more of the following criteria: recognized etiologic agent(s), identifiable group of signs and symptoms, or consistent anatomic alterations.” Dec. 8–9; see, Pet. ’401 (citing Ex. 1040). We adopted the dictionary definition of “damage” and construed the term as “[h]arm, diminution, or destruction of an organ, body part, system, or function.” Id. We maintain these constructions for “disease” and “damage” as they are consistent with the use of these terms in the Specification. “Retinal damage” refers to damage to the retina and “retinal disease” refers to disease of the retina. The phrase “retinal damage or retinal disease” refers to either retinal damage or retinal disease.” slip op. at 7

  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableNot shown unpatentableMixed

    “In view of the above, we conclude that the preponderance of the evidence presented by Cyanotech demonstrates that retinal damage is inherent to the condition of vitamin A deficiency-induced xerophthalmia. Grangaud’s animals were kept on a vitamin A-deficient diet for about 2 months (Ex. 1002, 43), and Dowling supports a conclusion that animals kept on such a diet would have suffered retinal damage. Ex. 1026, 88–89. Dowling also supports a finding that restoration of vitamin A to the diet could reverse the damage caused by a vitamin A deficiency. Id. at 94–96. Grangaud did not administer vitamin A itself, but rather administered astaxanthin. Astaxanthin, however, is capable of being converted to vitamin A in rats, which then would be available to correct the retinal damage caused by a vitamin A-deficient diet, as well as treat ocular lesions resulting from xerophthalmia, thereby improving the vision of the rats. Pet., 14-16; Ex. 1002, 44; Ex. 1033 ¶¶ 42–43 and 51; Ex. 1045, 60 and 160. As such, the inherent action of astaxanthin would have resulted in improved vision in Grangaud’s animal model.” slip op. at 13

  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element) › Inherent disclosureInherency foundInherency not foundMixed

    “In view of the above, we conclude that the preponderance of the evidence presented by Cyanotech demonstrates that retinal damage is inherent to the condition of vitamin A deficiency-induced xerophthalmia. Grangaud’s animals were kept on a vitamin A-deficient diet for about 2 months (Ex. 1002, 43), and Dowling supports a conclusion that animals kept on such a diet would have suffered retinal damage. Ex. 1026, 88–89. Dowling also supports a finding that restoration of vitamin A to the diet could reverse the damage caused by a vitamin A deficiency. Id. at 94–96. Grangaud did not administer vitamin A itself, but rather administered astaxanthin. Astaxanthin, however, is capable of being converted to vitamin A in rats, which then would be available to correct the retinal damage caused by a vitamin A-deficient diet, as well as treat ocular lesions resulting from xerophthalmia, thereby improving the vision of the rats. Pet., 14-16; Ex. 1002, 44; Ex. 1033 ¶¶ 42–43 and 51; Ex. 1045, 60 and 160. As such, the inherent action of astaxanthin would have resulted in improved vision in Grangaud’s animal model.” slip op. at 13

  • Obviousness (§103) › Graham factors (scope of art, differences, level of skill)UnpatentableNot shown unpatentableMixed

    “of all novelty in the claimed invention necessarily evidences obviousness.”); In re Meyer, 599 F.2d 1026, 1031 (CCPA 1979); In re Pearson, 494 F.2d 1399, 1402 (CCPA 1974). Here, Cyanotech presents substantially the same evidence for both their anticipation and obviousness challenges of claims 1, 3, 8–14, and 26. As such, and for the same reasons set forth in our anticipation analysis above, we hold that claims 1, 3, 8–14, and 26 are rendered obvious by Grangaud, alone or in combination with Dowling. Because we have determined that claims 1, 3, and 8–12 lack a novel feature with which to establish a nexus with secondary considerations, Cyanotech, as a matter of law, cannot establish a nexus. In re Kao, 639 F.3d at 1068 (Objective evidence that results from something that is not “both claimed and novel in the claim” lacks a nexus to the merits of the invention.). As to claims 2 and 4–7, the University has not directed any arguments to these claims specifically and has not made any attempts to establish a nexus between the presented objective evidence of nonobviousness and these claims. Thus, we maintain our unopposed determination that the specific doses and routes of administration recited in these claims are predictable variations within the technical grasp of a person of ordinary skill in the art, and are not persuaded by the objective evidence that claims 2 and 4–7 are nonobvious. In view of the above, we conclude that Cyanotech has demonstrated the unpatentability of claims 1–14 and 26 by a preponderance of the evidence. (2) Claim 15 Claim 15 depends from claim 14. As discussed above, we conclude that the preponderance of evidence of record demonstrates that neuronal damage to a retina is inherent to the condition of vitamin A deficiency-induced xerophthalmia. The question before us with regard to claim 15, however, is whether” slip op. at 24

  Patent outcomesUS 5,527,533 mixed
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 5,527,533
• Sequenom, Inc. v. The Board Of Trustees Of The Leland Stanford Junior UniversityNo claims unpatentable
  PTAB · Nov 25, 2014 · IPR2013-00390 · APJ Francisco C Prats · IPR · Final written decision

  Claims 1–17 were not shown unpatentable because the Board found they were reduced to practice before Lo II’s filing date, so Lo II was not prior art.

  RulingsFinal written decision

  • Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportPriority date awardedDecided for patent owner

    “when it is successfully performed.” Shurie v. Richmond, 699 F.2d 1156, 1159 (Fed. Cir. 1983). “In order to establish an actual reduction to practice, an inventor’s testimony must be corroborated by independent evidence. . . . [A] ‘rule of reason’ analysis is applied to determine whether an inventor’s testimony regarding reduction to practice has been sufficiently corroborated.” Cooper v. Goldfarb, 154 F.3d 1321, 1330 (Fed. Cir. 1998) (citation omitted). This “rule of reason” analysis “requires an evaluation of all pertinent evidence when determining the credibility of an inventor’s testimony.” Id. Under that analysis, “to corroborate a reduction to practice, it is not necessary to produce an actual over-the-shoulder observer. Rather, sufficient circumstantial evidence of an independent nature can satisfy the corroboration requirement.” Id. Corroborating evidence may be “testimony of a witness, other than an inventor, to the actual reduction to practice or it may consist of evidence of surrounding facts and circumstances independent of information received from the inventor.” Hahn v. Wong, 892 F.2d 1028, 1032–33 (Fed. Cir. 1989). Corroboration, however, “is not necessary to establish what a physical exhibit before the [B]oard includes. Only the inventor’s testimony requires corroboration before it can be considered.” Price v. Symsek, 988 F.2d 1187, 1195 (Fed. Cir. 1993) (citation omitted).” slip op. at 8

  • Novelty / Anticipation (§102) › Prior-art status of a reference › Patents / published applications (effective date, provisional support)Reference not prior artNot shown unpatentable

    “In sum, for the reasons discussed, non-inventor corroborating evidence reasonably supports Patent Owner’s assertion that, on June 19, 2008, inventor Dr. Fan sent to Dr. Blumenfeld the draft of the PNAS paper appearing in Exhibits 2111 and 2113. As also discussed above, the evidence reasonably supports Patent Owner’s assertion that that document describes an actual reduction to practice of the processes recited in claims 1–17 of the ’415 patent. We are persuaded, therefore, that Patent Owner has shown that the subject matter of the challenged claims was reduced to practice before Lo II’s July 23, 2008 filing date. Accordingly, because the evidence does not support Petitioner’s position that Lo II constitutes prior art to the challenged claims under 35 U.S.C. § 102(e), and because Lo II is relied upon in every ground on which trial was instituted, Petitioner has not shown by a preponderance of the evidence that any of the challenged claims is unpatentable, based on any of the asserted grounds of unpatentability. III. CONCLUSION” slip op. at 14

  • Expert testimonyPatent owner expert creditedDecided for patent owner

  Patent outcomesUS 8,195,415 not shown unpatentable
  § 102 anticipation
  Patents in suitUS 8,195,415
• Ariosa Diagnostics v. The Board Of Trustees Of The Leland Stanford Junior UniversityAll claims unpatentable
  PTAB · Nov 19, 2014 · IPR2013-00308 · APJ Lora M Green · IPR · Final written decision

  Claims 1–13 are unpatentable: claims 1–5, 7–9, 12, and 13 as anticipated by Lo; claims 10–11 and 6 as obvious over Lo with Brenner and Li, respectively.

  RulingsFinal written decision

  • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for petitioner

    “recites (emphasis added) “sequencing predefined subsequences of the maternal and fetal DNA to obtain a plurality of sequence tags aligning to the predefined subsequences.” Thus, the claim language associates “sequencing predefined sequences” with obtaining “sequence tags.” The Specification of the ’076 patent discusses sequence tags in the context of shotgun sequencing. See, e.g., Ex. 1001, col. 14, ll. 56–66. As Petitioner notes, there is no discussion in the Specification of the term “targeted sequencing.” Reply 1. Instead, the ’076 patent also discloses the use of a large number of windows of defined length created along the chromosome, such that the windows cover each chromosome in question, except for the non-informative regions of the chromosome, such as centromere and repetitive regions, may be omitted. Id. at col. 4, ll. 56–62. Thus, “[v]arious average numbers, i.e., median values, are calculated for different windows and compared. By counting sequence tags within a series of predefined windows of equal lengths along different chromosomes, more robust and statistically significant results may be obtained.” Id. at col. 4, ll. 62–67 (emphasis added). As taught by the ’076 patent, “[e]ach autosome (chr. 1–22) is computationally segmented into contiguous, non-overlapping windows,” although sliding windows could also be used. Id. at col. 5, ll. 4–9. In addition, as noted above, the ’076 patent also provides examples that describe “direct sequencing of cell-free DNA from plasma of pregnant women with high throughput shotgun sequencing technology,” wherein sequences were mapped to specific chromosomal regions, allowing for the measurement of over- and under-representation of chromosomes from an aneuploid fetus. Id. at col. 20, ll. 30–36. Thus, the Specification does not disclose sequencing only the defined sequences as Patent Owner would have us construe this phrase, but instead, it discloses sequencing the predefined sequences along with other sequences, and then using various techniques to locate the predefined sequences in the material that has been sequenced. Thus, we conclude that the broadest reasonable interpretation of the phrase “sequencing predefined subsequences” is that the subsequences may be predefined through comparison with the predefined windows that are created along the length of the chromosome. The predefined subsequences may walk along the entire length of the chromosome. Thus, although one predefined subsequence would not include the entire chromosomal sequence, two or more subsequences may include the entire length of the chromosomal sequence. That interpretation encompasses the preferred embodiment of the ’076 patent, whereas Patent Owner’s proffered construction limiting the method of claim 1 to “targeted” sequencing, as Patent Owner defines that term, would not” slip op. at 10

  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable

    “may then be sequenced, for example, by using massively parallel sequencing methods. Id. ¶¶ 55–56. As taught by Lo, sequence tags are generated, aligned to each chromosome, and tags identified as originating from a potentially aneuploid chromosome are compared quantitatively to tags originating from a reference chromosome, to allow for the identification of chromosomal gains or losses. Id. ¶ 70. That falls within the scope of the limitation of step (b) of claim 1 of “sequencing predefined subsequences of the maternal and fetal DNA to obtain a plurality of sequence tags aligning to the predefined subsequences, wherein said sequence tags are of sufficient length to be assigned to a specific predefined subsequence.” That is, as construed above, the sequencing step is not limited to sequencing only the predefined subsequences, but encompasses sequencing other portions of the genome. And, as Lo teaches that the sequence tags are aligned to a chromosome to allow for the identification of chromosomal gains or losses (id. ¶ 70), the tags generated must necessarily be of sufficient length to be assigned to a specific predefined subsequence. See, e.g., Ex. 1008 ¶ 60 (noting that although Lo “does not describe specifically that the sequence tags were of sufficient length to be assigned to a specific region of the genome, one skilled in the art would understand this to be the case, because the sequence tags used to identify chromosomal origin must have been of sufficient length to allow assignment to a particular genomic region”).” slip op. at 20

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot shown unpatentableNot shown unpatentable

    “us, Petitioner has not demonstrated that the ordinary artisan would have combined Quake and Kapur as set forth in the Petition (29–39) to arrive at the method of challenged claim 1. In particular, Petitioner relies on Figures 6 and 7 of Kapur as teaching “a method for sequence determination of randomly generated DNA fragments using arrays having oligonucleotides of known sequence. Sequencing of a randomly generated genomic fragment via binding to a predefined sequence on an array aligns a random sequence to a probe indicative of a specific genomic region.” Pet. 31. The evidence relied upon by Petitioner does not explain, however, why one would have a used a method for detecting SNPs as taught by Kapur to perform the sequencing of Quake. That is, what is lacking in the Petition and accompanying Declarations is an “articulated reason[] with some rational underpinning to support the legal conclusion of obviousness.” Kahn, 441 F.3d at 988. Petitioner responds that the “sequencing by array technology of Balasubramanian (US 2003/0022207 A1, published Jan. 30, 2003, Ex. 1040) is cited in all of Kapur (Ex. 1005 ¶ 163), Quake (Ex. 1006 ¶ 120), and the ‘076 patent (Ex. 1001 at col. 10, lines 50–56).” Paper 34 ¶ 19. Figures 6 and 7 relied upon by Petitioner, however, are drawn to methods of detecting SNPs, and not to the sequencing array technology of Balasubramanian. In fact, Petitioner first relies on paragraph 163 of Kapur, which it contends cites the sequencing array technology of Balasubramanian, in its challenge of claim 3, which is drawn to the use of massively parallel sequencing. Petitioner cannot rely upon Balasubramanian in its Reply to make up for the deficiencies in its Petition. See, e.g., 37 C.F.R. § 42.23(b) (noting that “[a]ll arguments for the relief requested in a motion must be made in the motion,” and that a “reply may only respond to arguments raised in the corresponding opposition or patent owner response”).” slip op. at 32

  • ExcludeMotion to exclude, deniedDenied

    “Patent Owner’s objections go more to the weight that paragraph 15 of Exhibit 1043 should be afforded, rather than to its admissibility. It is within our discretion to assign the appropriate weight to be accorded to Dr. Morton’s testimonial evidence. The Board, sitting as a non-jury tribunal with administrative expertise, is well-positioned to determine and assign appropriate weight to evidence presented. Gnosis S.P.A. v. S. Alabama Medical Science Foundation, IPR2013-00118, slip op. at 43 (PTAB June 20, 2014) (Paper 64). See also Donnelly Garment Co. v. NLRB, 123 F.2d 215, 224 (8th Cir. 1941) (“One who is capable of ruling accurately upon the admissibility of evidence is equally capable of sifting it accurately after it has been received.”). We thus decline to exclude paragraph 15 of Exhibit 1043.” slip op. at 36

  Patent outcomesUS 8,296,076 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 8,296,076
• Respironics, Inc. v. Zoll Medical CorporationSome claims unpatentable
  PTAB · Sep 17, 2014 · IPR2013-00322 · APJ Scott E Kamholz · IPR · Final written decision

  Claim 1 is unpatentable as anticipated by Owen; claims 2, 4, 5, 8, 9, 16, 19, and 20 were not shown unpatentable. The contingent motion to amend was denied.

  RulingsFinal written decision

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed petitioner constructionDecided for petitioner

    “A limitation using the term “means for” creates a rebuttable presumption that the drafter intended to invoke 35 U.S.C. § 112 ¶ 6.1 Personalized Media Commc’ns. LLC v. Int’l Trade Comm’n, 161 F.3d 696, 703-04 (Fed. Cir. 1998). When construing a means-plus-function limitation under 35 U.S.C. § 112 ¶ 6, we first must identify the claimed function, and then we look to the specification to identify the corresponding structure that performs the claimed function. Medical Instrumentation & Diagnostics Corp. v. Elekta AB, 344 F.3d 1205, 1210 (Fed. Cir. 2003); Cardiac Pacemakers, Inc. v. St. Jude Med., Inc., 296 F.3d 1106, 1119 (Fed. Cir. 2002). With respect to the second step, “structure disclosed in the specification is ‘corresponding’ structure only if the specification or prosecution history clearly links or associates that structure to the function recited in the claim.” Golight, Inc. v. Wal-Mart Stores Inc., 355 F.3d 1327, 1334 (Fed. Cir. 2004) (citations and quotation marks omitted).” slip op. at 6

  • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for patent owner

    “cite numerous passages in the ’003 patent, none of these passages serves to define “patient compliance [and use] data” in a manner that justifies disregarding that term. Although the ’003 patent does describe patient compliance data as relating to whether the patient is using the device improperly, or at all (Ex. 1001, 5:49-52), it is used within the context of assessing whether the patient is following (i.e., complying with) instructions. To construe the terms as encompassing any data related to patient use is, therefore, unreasonably broad.” slip op. at 7

  • Claim Construction › Functional claiming / §112(f) means-plus-function › Whether §112(f) applies (Williamson, nonce words)§112(f) appliesDecided for petitioner

    “A limitation using the term “means for” creates a rebuttable presumption that the drafter intended to invoke 35 U.S.C. § 112 ¶ 6.1 Personalized Media Commc’ns. LLC v. Int’l Trade Comm’n, 161 F.3d 696, 703-04 (Fed. Cir. 1998). When construing a means-plus-function limitation under 35 U.S.C. § 112 ¶ 6, we first must identify the claimed function, and then we look to the specification to identify the corresponding structure that performs the claimed function. Medical Instrumentation & Diagnostics Corp. v. Elekta AB, 344 F.3d 1205, 1210 (Fed. Cir. 2003); Cardiac Pacemakers, Inc. v. St. Jude Med., Inc., 296 F.3d 1106, 1119 (Fed. Cir. 2002). With respect to the second step, “structure disclosed in the specification is ‘corresponding’ structure only if the specification or prosecution history clearly links or associates that structure to the function recited in the claim.” Golight, Inc. v. Wal-Mart Stores Inc., 355 F.3d 1327, 1334 (Fed. Cir. 2004) (citations and quotation marks omitted).” slip op. at 6

  • Claim Construction › Functional claiming / §112(f) means-plus-function › Corresponding structure / algorithm (indefinite if none)Decided for petitioner

    “We focus our analysis on the “means for monitoring and storing” limitation in claims 4 and 19. Claim 4 recites: “means for monitoring and storing operations information of the medical device and patient compliance and use data.” Claim 19 recites: “means for monitoring and storing patient medical parameters, device performance data and patient compliance data.” Respironics argues that the structures disclosed in the ’003 patent as performing the “monitoring” and “storing” functions are a medical device and a memory. Pet. 8. Zoll does not contest this structural correspondence. We maintain our determination that these limitations invoke 35 U.S.C. § 112 ¶ 6, and that the structures corresponding to each of these limitations are a medical device and a memory. We have considered the parties’ arguments and evidence concerning” slip op. at 8

  Patent outcomesUS 6,681,003 mixed
  Claim construction§ 102 anticipation
  Patents in suitUS 6,681,003
• Gnosis S.P.A. / Gnosis Bioresearch S.A. et al. v. Merck & CieAll claims unpatentable
  PTAB · Jun 20, 2014 · IPR2013-00117 · APJ Jacqueline Wright Bonilla · IPR · Final written decision

  Claims 8, 9, 11, 12, 14, 15, and 19-22 are unpatentable under §102 over Serfontein and/or §103 over Serfontein with Marazza, and for claims 11, 12, 14, 15, 21, and 22 with Ubbink.

  RulingsFinal written decision

  • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner

    “administering at least one tetrahydrofolate in natural stereoisomeric form to a human subject,” where the tetrahydrofolate is, for example, “5-methyl-(6S)- tetrahydrofolic acid” or a salt thereof. Ex. 1004, challenged claims. Nothing in the challenged claims themselves, nor the specification of the ’040 patent, indicates that the phrase “5-methyl-(6S)-tetrahydrofolic acid” refers to the natural isomer only when it is substantially free of its non-natural enantiomer, i.e., excludes the non-natural isomer present in a mixture of isomers. In fact, the claims and specification do not mention or define “substantially free” (a term proffered by Merck) in any context, and Merck does not suggest otherwise. Resp. 2-5. Even assuming, as Merck points out, that “examples of the ’040 patent describe compositions containing only the natural isomer,” such examples do not correspond to the entire disclosure in the specification, or otherwise dictate that we import a limitation into the claim that is not recited. Id. at 4; see Deere & Co. v. Bush Hog, LLC, 703 F.3d 1349, 1354 (Fed. Cir. 2012) (“While claim terms are understood in light of the specification, a claim construction must not import limitations from the specification into the claims”); Innova/Pure Water, Inc. v. Safari Water Filtration Sys., Inc., 381 F.3d 1111, 1117 (Fed. Cir. 2004) (“[E]ven where a patent describes only a single embodiment, claims will not be ‘read restrictively unless the patentee has demonstrated a clear intention to limit the claim scope using ‘words or expressions of manifest exclusion or restriction’” (quoting Liebel-Flarsheim Co. v. Medrad, Inc., 358 F.3d 898, 906 (Fed. Cir. 2004)). The claims and specification of the ’040 patent, as a whole, do not indicate that the recited methods comprising administering L-5-MTHF exclude administering a mixture comprising both L-5-MTHF (natural form) and D-5- MTHF (non-natural form). A broadest reasonable reading of the challenged claims as a whole, in the context of the entire disclosure in the ’040 patent, indicates that one may meet the challenged claims if, inter alia, one administers “5-methyl-(6S)- tetrahydrofolic acid” (L-5-MTHF), regardless of whether one administers it as part of a mixture with other things, such as the corresponding non-natural isomer. There is no requirement in any challenged claim that one must administer L-5- MTHF or its salt by itself, substantially free of its enantiomer, or otherwise separate from a mixture comprising both L-5-MTHF and D-5-MTHF.” slip op. at 9

  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable

    “The issue then becomes whether an ordinary artisan would have envisaged, at once, each member of a limited class of compounds encompassed by the phrase “suitable active metabolite of folate” in Serfontein. See Petering, 301 F.2d at 681. Merck does not dispute Gnosis’s position that one would have envisioned the eight reduced folate compounds, including 5-methyl-tetrahydrofolic acid (N5-methyl THFA or 5-MTHF), disclosed in Modern Nutrition (Ex. 1007, 391-392) in some form when reading the phrase “suitable active metabolite of folate” in Serfontein (Ex. 1009, 4). Accord Tr. 25:1 21. Rather, Merck essentially argues that one would have envisaged “thousands” of sub-species of compounds or preparations falling with the eight species of compounds falling within the genus of “suitable active metabolites of folate” disclosed in Serfontein. Resp. 7. The challenged claims at issue, however, recite compounds in terms of a “tetrahydrofolate in natural stereoisomeric form,” and more specifically, in terms of seven THF compounds, such as 5-methyl-(6S)-tetrahydrofolic acid (i.e., L-5-MTHF), or their salts generally. Thus, the claims do not recite, and are not limited to, any specific salt, polyglutamate and/or crystalline form or preparation type. Thus, even assuming one would have envisaged “thousands” of unclaimed salt, polyglutamate and/or crystalline forms or preparations, as Merck contends, such a fact does not undermine Gnosis’s contention, and evidence in support, indicating that one would have envisaged a small number of compounds, including 5-methyl-(6S)-tetrahydrofolic acid or its salt, i.e., the “natural” form of 5-MTHF, when reading the phrase “suitable active metabolite of folate” in Serfontein. On this record, we are persuaded by Dr. Miller’s testimony that an ordinary artisan reading the phrase “suitable active metabolite of folate” in Serfontein would have at once envisaged each of the compounds in the small number of compounds that Dr. Miller identifies, including 5-methyl-(6S)-tetrahydrofolic acid, as recited in challenged claims.6 Testimony by Dr. Gregory (Ex. 2001 ¶¶ 66-82), cited by” slip op. at 15

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundTeaching away not foundDecided for petitioner

    “knowledge of Serfontein and Marazza. Marazza expressly discloses salts of 5- MTHF and describes processes for separating the natural “6S” form of 5-MTHF from the “unnatural (6R)-diastereoisomer.” Ex. 1012, 1:10-19, 1:55-2:20. Because Marazza taught that “[t]here exists an increasing interest for the application of this natural metabolite [(L-5-MTHF)] as at least one active compound in a therapeutic agent, for example as vitamin in folate deficient states,” an ordinary artisan would have had reason to use L-5-MTHF as the “suitable active metabolite of folate” in Serfontein’s method. Id. at 1:25-28; Ex. 1009, 4:37-42.” slip op. at 19

  • Obviousness (§103) › Objective indicia / secondary considerations › NexusObjective indicia no nexusDecided for patent owner

    “It is not sufficient, however, that a product or its use merely falls within the scope of a claim in order for objective evidence of nonobviousness tied to that product to be given substantial weight. There must also be a causal relationship, termed a “nexus,” between the evidence and the claimed invention. Merck & Co., Inc. v. Teva Pharm. USA, Inc., 395 F.3d 1364, 1376 (Fed. Cir. 2005). A showing of sufficient nexus is required in order to establish that the evidence relied upon traces its basis to a novel element in the claim, not to something in the prior art. Institut Pasteur & Universite Pierre Et Marie Curie v. Focarino, 738 F.3d 1337, 1347 (Fed. Cir. 2013). Objective evidence that results from something that is not “both claimed and novel in the claim” lacks a nexus to the merits of the invention. In re Kao, 639 F.3d 1057, 1068 (Fed. Cir. 2011). Nexus must exist in relation to all types of objective evidence of nonobviousness. GPAC, 57 F.3d at 1580 (generally); In re Huang, 100 F.3d 135, 140 (Fed. Cir. 1996) (commercial success); In re Antor Media Corp., 689 F.3d 1282, 1293 (Fed. Cir. 2012) (licensing); Wm. Wrigley Jr. Co. v. Cadbury Adams USA LLC, 683 F.3d 1356, 1364 (Fed. Cir. 2012) (copying); Ormco Corp. v. Align Tech., Inc., 463 F.3d 1299, 1313 (Fed. Cir. 2006) (failure of others); Rambus Inc. v. Rea, 731 F.3d 1248, 1256 (Fed. Cir. 2013) (long-felt need); Kao, 639 F.3d at 1069 (unexpected results); Stamps.com Inc. v. Endicia, Inc., 437 F. App’x 897, 905 (Fed. Cir. 2011) (skepticism); Muniauction, Inc. v. Thomson Corp., 532 F.3d 1318, 1328 (Fed. Cir. 2008) (praise). Thus, for objective evidence to be accorded substantial weight, the record “must establish a nexus between the evidence and the merits of the claimed invention.” GPAC, 57 F.3d at 1580. Moreover, establishing nexus involves a showing that novel elements in the claim, not prior-art elements, account for the objective evidence of nonobviousness. See Kao, 639 F.3d at 1068. As the Federal Circuit explains, “[t]o the extent that the patentee demonstrates the required nexus, his objective evidence of nonobviousness will be accorded more or less weight.” GPAC, 57 F.3d at 1580. Thus, the stronger the showing of nexus, the greater the weight accorded the objective evidence of nonobviousness. See Ashland Oil, Inc. v. Delta Resins & Refractories, Inc., 776 F.2d 281, 306 (Fed. Cir. 1985).” slip op. at 31

  Patent outcomesUS 6,011,040 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR
  Patents in suitUS 6,011,040

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