`571.272.7822
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`Paper 25
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` Date: August 20, 2020
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`KOHN & ASSOCIATES PLLC,
`Petitioner,
`v.
`COMPASS PATHWAYS LIMITED,
`Patent Owner.
`
`
`
`PGR2020-00030
`Patent 10,519,175 B2
`
`
`Before SHERIDAN K. SNEDDEN, TINA E. HULSE, and
`RICHARD J. SMITH, Administrative Patent Judges.
`
`HULSE, Administrative Patent Judge.
`
`
`
`DECISION
`Denying Institution of Post-Grant Review
`35 U.S.C. § 324
`
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`PGR2020-00030
`Patent 10,519,175 B2
`
` INTRODUCTION
`Kohn & Associates PLLC (“Petitioner”) filed a Corrected Petition
`requesting a post-grant review of claims 1–21 of U.S. Patent No.
`10,519,175 B2 (Ex. 2003, “the ’175 patent”). Paper 13 (“Pet.”). COMPASS
`Pathways Limited (“Patent Owner”) filed a Preliminary Response. Paper 15
`(“Prelim. Resp.”). With our authorization, Petitioner filed a Reply to Patent
`Owner’s Preliminary Response (Paper 17, “Reply”), and Patent Owner filed
`a Sur-Reply (Paper 23).
`We have authority under 35 U.S.C. § 324(a), which provides that a
`post-grant review may not be instituted “unless . . . the information
`presented in the petition . . ., if such information is not rebutted, would
`demonstrate that it is more likely than not that at least 1 of the claims
`challenged in the petition is unpatentable.” Upon considering the arguments
`and evidence presented by the parties, we determine Petitioner has not
`demonstrated that it is more likely than not that any of the claims challenged
`in the Petition are unpatentable.
`Real Parties-in-Interest
`A.
`In the Petition, Petitioner identifies only itself as the real party-in-
`interest to this proceeding.1 Pet. 2. Patent Owner also identifies itself as the
`real party-in-interest. Paper 8, 1.
`
`
`1 In its Reply, Petitioner requests leave to file an Amended Mandatory
`Notice to identify Freedom to Operate, Inc. (“FTO”), B. More Incorporated,
`and Carey Turnbull as the real parties-in-interest. Reply 1. Petitioner also
`requests leave to file a motion to change the identity of the Petition to
`replace Kohn & Associates PLLC with FTO. Id. at 2. Without prior
`authorization, Petitioner filed an Amended Mandatory Notice identifying the
`additional real parties-in-interest. Paper 21, 1. Because we deny the Petition
`on other grounds, we need not reach these requests (or the propriety of filing
`2
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`PGR2020-00030
`Patent 10,519,175 B2
`
`Related Proceedings
`B.
`Petitioner identifies U.S. Application No. 16/679,009 as related to the
`’175 patent. Pet. 2–3.
`
`The ’175 Patent
`C.
`The ’175 patent relates to the “large-scale production of psilocybin for
`use in medicine.” Ex. 2003, 1:6–7. According to the Specification,
`psilocybin is a plant-based psychedelic that has been used to treat mood
`disorders and alcoholic disorders, including three clinical trials for treating
`depressive symptoms. Id. at 1:26–29. The ’175 patent states an object of
`the invention is to provide chemically pure psilocybin of consistent
`polymorphic form for administration to humans. Id. at 3:21–23.
`The ’175 patent describes different psilocybin embodiments,
`including Polymorph A, Polymorph A′, Hydrate A, and Polymorph B. Each
`embodiment displays different peak positions at varying relative intensities
`on an X-Ray Powder Diffraction (“XRPD”) diffractogram. Id. at Table 1
`(XRPD for Polymorph A), Table 2 (XRPD for Polymorph A′), Table 3
`(XRPD for Hydrate A), Table 4 (XRPD for Polymorph B). For example, a
`peak at about 17.5°2θ ±0.1°2θ distinguishes Polymorph A from Polymorph
`A′, in which the peak is absent or substantially absent. Id. at 4:32–37; see
`also id. at 6:21–24 (stating a peak at 17.5°2θ ±0.1°2θ is absent or
`substantially absent in Polymorph A′). Moreover, Polymorph A′ is
`distinguishable from Polymorph A by the presence of a peak appearing at
`10.1°2θ ±0.1°2θ. Id. at 7:43–46; see also id. at 5:14–19 (stating a peak at
`10.1°2θ is absent or substantially absent in Polymorph A).
`
`
`the Amended Mandatory Notice and amending the real parties-in-interest
`without prior authorization).
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`3
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`PGR2020-00030
`Patent 10,519,175 B2
`According to the ’175 patent, psilocybin is a “difficult active to
`formulate” because it has poor flow characteristics and is used in relatively
`low doses, which makes it difficult to ensure content uniformity and
`tableting. Id. at 19:44–48. Accordingly, the inventors found that in
`formulating psilocybin tablets, a non-standard filler—specifically a silicified
`microcrystalline cellulose—was preferred to achieve a satisfactory product.
`Id. at 19:56–62.
`
`Illustrative Claim
`D.
`Petitioner challenges claims 1–21 of the ’175 patent, of which claim 1
`is the only independent claim. Claim 1 is illustrative and is reproduced
`below:
`
`1. A method of treating drug resistant depression comprising
`orally administering to a subject in need thereof a therapeutically
`effective amount of an oral dosage form, wherein, the oral dosage
`form comprises:
`crystalline psilocybin in the form Polymorph A characterized
`by peaks in an XRPD diffractogram at 11.5, 12.0, 14.5,
`17.5, and 19.7°2θ±0.1°2θ, wherein
`the crystalline
`psilocybin has a chemical purity of greater than 97% by
`HPLC, and no single impurity of greater than 1%; and
`silicified microcrystalline cellulose.
`Ex. 2003, 69:47–58.
`
`4
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`PGR2020-00030
`Patent 10,519,175 B2
`The Asserted Ground of Unpatentability
`E.
`Petitioner asserts that claims 1–21 are unpatentable as obvious over
`Folen,2,3 Nichols4 or Carhart-Harris,5 and Guo.6
`Petitioner also relies on the Declarations of Drs. Poncho Mosenheimer
`and Alex Sherwood (Ex. 10087), Dr. Jordan Sloshower (Ex. 10178), and Dr.
`Charles Raison (Ex. 10189).
`
`
`2 We note Petitioner refers to its exhibits by letter. Because our rules state
`that Petitioner’s exhibits must be uniquely numbered sequentially in the
`range of 1001–1999, we cite to the exhibits by their exhibit number, as filed.
`See 37 C.F.R. § 42.63(c).
`3 V.A. Folen, X-Ray Powder Diffraction Data for Some Drugs, Excipients,
`and Adulterants in Illicit Samples, 20 J. FORENSIC SCI. 348–72 (1975)
`(“Folen,” Ex. 1001). Referred to by Petitioner as “Exhibit A.”
`4 D.E. Nichols, Psychedelics, 68 PHARMACOL. REV. 264–355 (2016)
`(“Nichols,” Ex. 1002). Referred to by Petitioner as “Exhibit B.”
`5 R. Carhart-Harris et al., Psilocybin with Psychological Support for
`Treatment-Resistant Depression: an Open-Label Feasibility Study, LANCET
`PSYCHIATRY, available at http://dx.doi.org/10.1016/S2215-0366(16)30065-7
`(published online May 17, 2016) (“Carhart-Harris,” Ex. 1003). Referred to
`by Petitioner as “Exhibit C.”
`6 M. Guo et al., Potential Application of Silicified Microcrystalline Cellulose
`in Direct-Fit Formulations for Automatic Capsule-Filling Machines,
`8 PHARM. DEV. AND TECH. 47–59 (2003) (“Guo,” Ex. 1004). Referred to by
`Petitioner as “Exhibit D.”
`7 Referred to by Petitioner as “Exhibit H.”
`8 Referred to by Petitioner as “Exhibit Q.”
`9 Referred to by Petitioner as “Exhibit R.”
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`5
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`PGR2020-00030
`Patent 10,519,175 B2
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` ANALYSIS
`Post-Grant Eligibility
`A.
`We must first determine whether the ’175 patent is eligible for post-
`grant review. Section 6(d) of the Leahy-Smith America Invents Act, Pub. L.
`No. 112-20, 125 Stat. 284 (2011) (“AIA”) sets forth the post-grant review
`provisions, which apply only to patents subject to the first-inventor-to-file
`provisions of the AIA. AIA § 6(f)(2)(A) (stating the provisions of Section
`6(d) “shall apply only to patents described in section 3(n)(1)”). Post-grant
`reviews are only available for patents that issue from applications “that
`contain[] or contained at any time . . . a claim to a claimed invention that has
`an effective filing date . . . on or after” March 16, 2013. AIA § 3(n)(1).
`Moreover, “[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 or of
`the issuance of a reissue patent (as the case may be).” 35 U.S.C. § 321(c).
`Other than certifying that the ’175 patent is available for post-grant
`review, Petitioner does not address post-grant review eligibility. See Pet. 2.
`Patent Owner, however, does not challenge eligibility in the Preliminary
`Response. See generally Prelim. Resp.
`The ’175 patent issued on December 31, 2019, from U.S. Application
`No. 16/155,386, which was filed on October 9, 2018. Ex. 2003, codes (45),
`(22). The ’175 patent does not expressly claim priority to any earlier
`applications. The earliest effective filing date for the ’175 patent claims is,
`therefore, October 9, 2018, which is after March 16, 2013. Moreover, the
`original Petition was filed February 21, 2020, which is within the nine-
`month statutory window after issuance to file a petition for post-grant
`review. See Paper 1; 35 U.S.C. § 321(c).
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`6
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`PGR2020-00030
`Patent 10,519,175 B2
`We, therefore, determine the ’175 patent is eligible for post-grant
`review and the Petition was timely filed.
`Person of Ordinary Skill in the Art
`B.
`Petitioner does not address the level of ordinary skill in the art in the
`Petition. See generally Pet. Nor does Patent Owner in the Preliminary
`Response. See generally Prelim. Resp.
`We note Petitioner’s experts Drs. Meisenheimer and Sherwood both
`have a Ph.D. in organic synthesis with experience in small molecule
`characterization. Ex. 1008 ¶ 1. Absent further guidance from the parties,
`we rely on the experience of the declarants and the prior art itself as
`sufficient to demonstrate the relatively high level of skill in the art at the
`time of the invention. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed.
`Cir. 2001) (explaining that specific findings regarding ordinary skill level
`are not required “where the prior art itself reflects an appropriate level and a
`need for testimony is not shown” (quoting Litton Indus. Prods., Inc. v. Solid
`State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985))).
`Claim Construction
`C.
`Where, as here, a Petition is filed on or after November 13, 2018, the
`Board applies the same claim construction standard that would be used to
`construe the claim in a civil action under 35 U.S.C. § 282(b). 37 C.F.R.
`§ 200(b) (2019); see Changes to the Claim Construction Standard for
`Interpreting Claims in Trial Proceedings Before the Patent Trial and Appeal
`Board, 83 Fed. Reg. 51,340 (Oct. 11, 2018). Under that standard, claim
`terms “are generally given their ordinary and customary meaning” as
`understood by a person of ordinary skill in the art at the time of the
`invention. Phillips v. AWH Corp., 415 F.3d 1303, 1312–13 (Fed. Cir. 2005)
`(en banc).
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`7
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`PGR2020-00030
`Patent 10,519,175 B2
`We determine that it is unnecessary to expressly construe any claim
`terms for purposes of rendering this Decision. See Wellman, Inc. v. Eastman
`Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (“[C]laim terms need only
`be construed ‘to the extent necessary to resolve the controversy.’” (quoting
`Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir.
`1999))).
`
`D. Obviousness of the Challenged Claims
`Petitioner asserts claims 1–21 of the ’175 patent are unpatentable as
`obvious over Folen in view of Nichols or Carhart-Harris, and further in view
`of Guo. Pet. 3–47. Patent Owner does not address the merits of Petitioner’s
`challenge in the Preliminary Response. See generally Prelim. Resp.
`Nevertheless, having considered the evidence and argument presented
`in the Petition, we determine Petitioner has not shown it is more likely than
`not that any of the challenged claims are unpatentable as obvious over the
`cited art.
`
`Folen (Ex. 1001)
`1.
`Folen is an article entitled, “X-Ray Powder Diffraction Data for Some
`Drugs, Excipients, and Adulterants in Illicit Samples,” published in the
`Journal of Forensic Science. Ex. 1001, 1. According to Folen, “[t]he
`development of new compounds with the potential for drug abuse
`necessitates a continuous accumulation of analytical data in the forensic
`laboratory.” Id. Moreover, identifying excipients and adulterants in drug
`samples provides a database that can be used for intelligence purposes. Id.
`Accordingly, Folen states that “[t]he purpose of the present paper is to
`present X-ray powder diffraction data not available in the literature.” Id.
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`8
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`Patent 10,519,175 B2
`Table 2 of Folen provides complete X-ray diffraction data and relative
`intensities of the peaks for 73 different compounds, including psilocybin (id.
`at 366). Id. at 353–69.
`
`Nichols (Ex. 1002)
`2.
`Nichols is a review article on psychedelics. Ex. 1002, 264. Nichols
`describes the use of psilocybin in several double-blind placebo-controlled
`phase 2 studies to treat anxiety and depression caused by cancer-related
`psychosocial distress. Id. at 266, 323.
`Carhart-Harris (Ex. 1003)
`3.
`Carhart-Harris describes an open-label feasibility trial of psilocybin to
`treat treatment-resistant depression. Ex. 1003, 1. The Carhart-Harris study
`included 12 patients with moderate-to-severe unipolar treatment-resistant
`major depression who received two oral doses of psilocybin. Id. The study
`found depressive symptoms were markedly reduced one week and three
`months after high-dose treatment. Id.
`Guo (Ex. 1004)
`4.
`Guo teaches that silicified microcrystalline cellulose (“SMCC”) has
`physico-mechanical properties that may be advantageous in hard gelatin
`capsule formulations. Ex. 1004, 47. Guo found that products formulated
`with SMCC exhibited relatively high compactibility under low compression
`force and faster dissolution rates than those formulated with pregelatinized
`starch and anyhydrous lactose when loaded with 5% piroxicam, 30%
`acetaminophen, and 50% acetaminophen. Id. at 58. The higher
`compactibility and fast dissolution rates “suggest that SMCC could be a
`suitable alternative excipient for direct-fill formulations for hard shell
`capsules.” Id.
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`9
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`Patent 10,519,175 B2
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`Analysis
`5.
`A patent claim is unpatentable under 35 U.S.C. § 103(a) if the
`differences between the claimed subject matter and the prior art are such that
`the subject matter, as a whole, would have been obvious at the time the
`invention was made to a person having ordinary skill in the art to which the
`subject matter pertains. KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 406
`(2007). The question of obviousness is resolved on the basis of underlying
`factual determinations, including: (1) the scope and content of the prior art;
`(2) any differences between the claimed subject matter and the prior art;
`(3) the level of skill in the art; and (4) objective evidence of nonobviousness.
`Graham v. John Deere Co., 383 U.S. 1, 17–18 (1966).
`“[A] patent composed of several elements is not proved obvious
`merely by demonstrating that each of its elements was, independently,
`known in the prior art.” KSR, 550 U.S. at 418. “[I]t can be important to
`identify a reason that would have prompted a person of ordinary skill in the
`relevant field to combine the elements in the way the claimed new invention
`does.” Id. Moreover, a person of ordinary skill in the art must have had a
`reasonable expectation of success of doing so. Par Pharm., Inc. v. TWi
`Pharms., Inc., 773 F.3d 1186, 1193 (Fed. Cir. 2014).
`Although Patent Owner does not address the substance of Petitioner’s
`challenge, after considering the arguments and evidence presented in the
`Petition, we find Petitioner has failed to show sufficiently that the
`combination of references teaches or suggests each limitation of claim 1.
`Specifically, claim 1 recites “peaks in an XRPD diffractogram at 11.5, 12.0,
`14.5, 17.5, and 19.7°2θ ±0.1°2θ.” Ex. 2003, 69:52–53. Petitioner relies on
`
`10
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`PGR2020-00030
`Patent 10,519,175 B2
`the teachings of Folen for the recited XRPD peaks of Polymorph A.10
`Pet. 3–4, 30–41. Petitioner provides a side-by-side comparison of the
`psilocybin XRPD peaks taught by Table 2 of Folen and the XRPD peak
`positions for Polymorph A disclosed in Table 1 of the ’175 patent:
`
`
`
`
`10 As Petitioner notes, Folen provides d-spacing values for the XRPD peaks,
`which can be converted to their corresponding degrees 2θ values using
`Bragg’s Equation, which allows for direct comparison to the claims of the
`’175 patent. Pet. 31–32.
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`11
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`PGR2020-00030
`Patent 10,519,175 B2
`Pet. 34. Petitioner’s comparison highlights in green the peaks of Folen that
`correspond to the peaks of Table 1 of the ’175 patent within ±0.1°2θ. Id.
`Petitioner highlights in yellow the peaks of Folen that correspond to the
`peaks of Table 1 within ±0.2–0.25°2θ. Id. Thus, for the claimed peaks of
`11.5, 12.0, and 14.5°2θ ±0.1°2θ, Petitioner asserts that Folen teaches
`corresponding peaks at 11.4, 11.9, and 14.4°2θ, which are each within the
`±0.1°2θ range recited in claim 1.
`For the claimed peaks at 17.5 and 19.7°2θ ±0.1°2θ, however,
`Petitioner admits that Folen does not teach XRPD peaks within the ±0.1°2θ
`range. Id. at 37–38. Rather, Petitioner asserts that Folen teaches peaks at
`17.7 and 19.45°2θ, which are ±0.2°2θ and ±0.25°2θ of the claimed peak
`position, respectively. Ex. 1001, 366; see also Pet. 34 (converting d-spacing
`values to degrees 2θ).
`To satisfy the claim limitations, Petitioner asserts that Folen’s peaks
`are “equivalent” to the claimed peaks because the peaks of Folen are “within
`the expectations of instrumental precision as claimed in claim 1.” Pet. 4,
`37–38. According to Petitioner, “[i]rrespective of the attempt in [the ’175
`patent] to claim a narrow uncertainty of ±0.1° in measurement tolerance,
`USP standards reflect that even current conventions accept tolerances of
`±0.2° 2θ [citing Ex. 1005] let alone the tolerances found in instrumentation
`of 1975.” Id. at 30.
`We are not persuaded by Petitioner’s argument. Even assuming the
`USP standard supports Petitioner’s contention that “current conventions”
`accept tolerances of ±0.2°2θ, Folen’s peak at 19.45°2θ is outside that range
`
`12
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`PGR2020-00030
`Patent 10,519,175 B2
`at ±0.25°2θ of the claimed peak at 19.7°2θ.11 Thus, even assuming
`acceptable instrument tolerances of ±0.2°2θ, Petitioner has not shown
`sufficiently that a person of ordinary skill in the art would have considered a
`peak at 19.45°2θ (or 19.4°2θ) to be equivalent to 19.7°2θ ±0.1°2θ. Indeed,
`the lack of a peak at 19.7°2θ ±0.1°2θ in Folen was one of the reasons
`identified by the examiner in her Notice of Allowance: “The closest prior art
`of record, Folen, fails to teach or suggest Applicant’s instantly claimed
`invention as the psilocybin in Folen differs by having . . . a peak at 19.4
`instead of 19.7 +/- 0.1, see page 366 Table II and Bragg’s law.” Ex. 3001, 8.
`Moreover, to the extent Petitioner relies on the “tolerances found in
`instrumentation of 1975” as support for its argument, Petitioner provides no
`objective evidence for this statement other than the conclusory testimony of
`its experts, who also fail to provide objective evidence. See Pet. 30;
`Ex. 1008 ¶ 2. We give little to no weight to such unsupported expert
`testimony and therefore do not find this argument persuasive. See 37 C.F.R.
`§ 42.65(a) (stating opinion testimony that does not disclose underlying facts
`or data “is entitled to little or no weight”); see also Ashland Oil, Inc. v. Delta
`Resins & Refractories, Inc., 776 F.2d 281, 294 (Fed. Cir. 1985) (stating a
`lack of objective support for expert opinion “may render the testimony of
`little probative value in a validity determination”).
`Petitioner also argues that “Polymorph A as claimed in claim 1 would
`have been inherent in all historical isolations using the described method.”
`Pet. 31. According to Petitioner, the ’175 patent “discloses that Polymorph
`
`
`11 We further note that when solving for 2θ using Bragg’s equation where
`d=4.56, 2θ = 19.449. When rounded to the tenths place—as the rest of the
`peak positions are in Petitioner’s table (see Pet. 34)—19.449°2θ rounds
`down to 19.4°2θ, which is ±0.3°2θ of the claimed peak at 19.7°2θ.
`13
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`A is consistently yielded from their method of isolating the final crystalline
`material by recrystallization from water and drying under vacuum, and their
`method is a historically taught method.” Id. at 31 (citing Ex. 1002 (Nichols),
`Ex. 1006 (Shirota), and Ex. 1007 (Hofman)). Petitioner again cites its
`experts’ declaration, which parrots the language of the Petition. Ex. 1008
`¶ 2.
`
`To establish inherency in the context of obviousness, “the limitation at
`issue necessarily must be present, or the natural result of the combination of
`elements explicitly disclosed by the prior art.” Hospira, Inc. v. Fresenius
`Kabi USA, LLC, 946 F.3d 1322, 1329 (Fed. Cir. 2020). To the extent
`Petitioner argues that Polymorph A would have been inherent in the methods
`taught by Nichols, Shirota, or Hofman, Petitioner fails to provide any
`specific evidence or argument demonstrating that the claimed peak positions
`would have necessarily been present, or would have been the natural result
`of the methods taught by the cited references. Indeed, neither Petitioner nor
`its experts provide specific citations to the references identifying what
`methods are taught by the references or any explanation of how or why those
`methods necessarily result in the production of Polymorph A with the peaks
`disclosed by Folen. See id.; Ex. 1002 ¶ 2. That is, Petitioner fails to explain
`how the methods of Nichols, Shirota, or Hofman relate to the psilocybin
`analyzed by Folen, which Petitioner admits was “of undisclosed origin.”
`Pet. 31. Without knowing where the psilocybin came from or how the
`psilocybin in Folen was produced, it is unclear why or how the methods of
`Nichols, Shirota, or Hofman are relevant to Petitioner’s argument.
`Accordingly, we are not persuaded by Petitioner’s argument.
`Thus, having considered the arguments and evidence presented in the
`Petition, we find Petitioner has failed to demonstrate that Folen (or any of
`
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`Patent 10,519,175 B2
`the cited references) teaches or suggests the claimed peak at 19.7°2θ
`±0.1°2θ, as required by each of the challenged claims. Accordingly, we
`determine Petitioner has not shown that it is more likely than not that any of
`the challenged claims of the ’175 patent are unpatentable as obvious over the
`cited references.
`
`Remaining Arguments
`E.
`Patent Owner also argues we should deny the Petition under 35 U.S.C.
`§ 325(d) and for failure to identify all real parties-in-interest in the Petition.
`See generally Prelim. Resp. Because we determine that Petitioner has not
`sufficiently established that any of the challenged claims are unpatentable as
`obvious over the cited references, we need not address those issues in this
`Decision.
`
` CONCLUSION
`For the foregoing reasons, we determine that Petitioner has failed to
`show it is more likely than not that any of the challenged claims of the ’175
`patent are unpatentable.
`
` ORDER
`In consideration of the foregoing, it is hereby:
`ORDERED that the Petition is denied as to all challenged claims of
`the ’175 patent and no trial is instituted.
`
`
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`15
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`PGR2020-00030
`Patent 10,519,175 B2
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`PETITIONER:
`
`John Griem, Jr.
`griem@clm.com
`
`Kenneth Kohn
`s.fox@kohnandassociates.com
`
`
`PATENT OWNER:
`
`Sandhya Deo
`sdeo@cooley.com
`
`Michael Tuscan
`mtuscan@cooley.com
`
`Xiaozhen Yu
`syu@cooley.com
`
`
`
`16
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