Trials@uspto.gov
`571-272-7822
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`
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`Paper 9
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`Entered: July 15, 2019
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`OCULAR THERAPEUTIX,
`Petitioner,
`
`v.
`
`MATI THERAPEUTICS, INC.,
`Patent Owner.
`____________
`
`Case IPR2019-00442
`Patent 9,463,114 B2
`____________
`
`
`Before ERICA A. FRANKLIN, J. JOHN LEE, and RYAN H. FLAX,
`Administrative Patent Judges.
`
`LEE, Administrative Patent Judge.
`
`
`
`
`DECISION
`Denying Institution of Inter Partes Review
`35 U.S.C. § 314(a)
`
`
`
`
`
`
`
`
`
`
`571-272-7822
`
`
`
`
`
`
`Paper 9
`
`Entered: July 15, 2019
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`OCULAR THERAPEUTIX,
`Petitioner,
`
`v.
`
`MATI THERAPEUTICS, INC.,
`Patent Owner.
`____________
`
`Case IPR2019-00442
`Patent 9,463,114 B2
`____________
`
`
`Before ERICA A. FRANKLIN, J. JOHN LEE, and RYAN H. FLAX,
`Administrative Patent Judges.
`
`LEE, Administrative Patent Judge.
`
`
`
`
`DECISION
`Denying Institution of Inter Partes Review
`35 U.S.C. § 314(a)
`
`
`
`
`
`
`
`
`
`
`
`IPR2019-00442
`Patent 9,463,114 B2
`
`
`INTRODUCTION
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`Ocular Therapeutix (“Petitioner”) filed a Petition (Paper 8, “Pet.”)1
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`requesting an inter partes review of claims 1, 3, 5–8, 10, and 12–14 (“the
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`challenged claims”) of U.S. Patent No. 9,463,114 B2 (Ex. 1001, “the ’114
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`Patent”). Mati Therapeutics, Inc. (“Patent Owner”) timely filed a
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`Preliminary Response (Paper 7, “Prelim. Resp.”).
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`We have authority to institute an inter partes review only if the
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`information presented in the Petition shows “there is a reasonable likelihood
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`that the petitioner would prevail with respect to at least 1 of the claims
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`challenged in the petition.” 35 U.S.C. § 314(a). Upon consideration of the
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`Petition and the Preliminary Response, we conclude the information
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`presented fails to show a reasonable likelihood that Petitioner would prevail
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`in establishing the unpatentability of the challenged claims. Accordingly,
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`the Petition is denied.
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`A.
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`Related Cases
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`The parties identify a petition requesting inter partes review of
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`U.S. Patent 9,849,082 (IPR2019-00448), which relates to the technology of
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`the ’114 Patent, but is not in the same patent family. Pet. 3; Paper 5, 2.
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`B.
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`The ’114 Patent
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`The ’114 Patent relates to punctal plugs that are removably inserted
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`into the punctal apertures of the eye to block the openings and prevent
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`
`
`1 Petitioner filed the original Petition on December 14, 2018 (Paper 1), and
`subsequently filed a Corrected Petition on May 13, 2019 (Paper 8), to
`address a typographical error in the original Petition. All references to
`“Petition” herein refer to the Corrected Petition (Paper 8).
`
`2
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`IPR2019-00442
`Patent 9,463,114 B2
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`drainage of lacrimal fluid (tears). Ex. 1001, 1:13–18. In particular, the ’114
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`Patent is directed to a method for administering an active agent in the eye of
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`a subject by implanting a punctal plug to which the active agent is applied.
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`Id., Abstract. Figure 1 of the ’114 Patent is reproduced below:
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`Figure 1 illustrates punctal plug 10 with stem 12, which has been inserted
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`into punctal aperture 20 of eye 24 to seal canaliculus 22 against the flow of
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`tears onto the surface of eye 24. Id. at 1:65–67, 2:7–14. Figure 2 of the ’114
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`Patent is reproduced below:
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`3
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`IPR2019-00442
`Patent 9,463,114 B2
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`Figure 2 depicts two versions of plug 10 as implants 10a and 10b. Id. at
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`2:1–2, 15–18. Implant 10a is a substantially-cylindrical solid collagen plug
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`inserted into the upper punctum or tear duct 20a. Id. at 2:18–20. Implant
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`10b, which is inserted in lower punctum 20b, is hollow and includes a
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`tapered stem 12a having flared open end 12b. Id. at 2:22–24. Plug 10 may
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`be made entirely of a porous or absorbent material that is saturated with an
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`active agent. Id. at 2:38–40. A “[p]olymer that is absorbent to the agent is
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`preferable so that sufficient [active] agent is present and available for
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`discharge into the surrounding tissues.” Id. at 2:35–38. Appropriate active
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`agents include a variety of medications for treating conditions, such as
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`glaucoma, corneal infections, chronic diseases, allergic conjunctivitis and
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`rhinitis, and dry eye. See id. at 2:51–64, 3:3–8.
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`4
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`IPR2019-00442
`Patent 9,463,114 B2
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`C.
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`Challenged Claims
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`Petitioner challenges claims 1, 3, 5–8, 10, and 12–14 of the ’114
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`Patent. Claims 1, 8, and 14 are the independent claims. Claim 1 is
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`illustrative and is reproduced below:
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`A method for administering an active agent to a subject
`1.
`using a punctal plug, the method comprising:
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`inserting the punctal plug into a punctal aperture of the subject,
`wherein the composition of the punctal plug comprises:
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`a) an active agent selected from the group consisting of
`topical
`prostaglandin;
`latanoprost;
`travoprost;
`bimatoprost; a medication for treatment of a corneal
`infection; ciprofloxacin; moxifloxacin; gatifloxacin; a
`systemic medication;
`a medication
`for
`treating
`hypertension; atenolol; nifedipine; hydrochlorothiazide;
`and a medication for treating allergic conjunctivitis, and
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`b) a porous or absorbent material, and
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`wherein the shape of the punctal plug consists of a constant
`diameter cylinder configured to be inserted into a canalicular
`puncta of the subject.
`
`Ex. 1001, 3:31–47.
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`D.
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`Asserted Grounds of Unpatentability and Asserted Prior Art
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`Petitioner challenges the patentability of claims 1, 3, 5–8, 10, and 12–
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`14 of the ’114 Patent on the following grounds (Pet. 27–28):
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`
`
`
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`5
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`Patent 9,463,114 B2
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`Reference(s)
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`Basis
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`Claims Challenged
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`Schmitt2
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`§ 102(b)
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`1, 3, 6–8, 10, 13
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`Schmitt and Higuchi3
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`§ 103(a)
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`1, 3, 6–8, 10, 13, 14
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`Schmitt and PDR4
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`§ 103(a)
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`1, 3, 6–8, 10, 13, 14
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`Schmitt and Cagle5
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`§ 103(a)
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`1, 3, 5–8, 10, 12–146
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`In addition, Petitioner relies on the Declaration of Dr. Reza Dana (Ex. 1002)
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`in support of the asserted grounds of unpatentability.
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`ANALYSIS
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`A.
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`Claim Construction
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`As the original Petition was filed on December 14, 2018, we apply the
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`claim construction standard set forth in Phillips v. AWH Corp., 415 F.3d
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`1303 (Fed. Cir. 2005). See Changes to the Claim Construction Standard for
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`Interpreting Claims in Trial Proceedings Before the Patent Trial and Appeal
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`Board, 83 Fed. Reg. 51,340 (Oct. 11, 2018). Under the Phillips standard,
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`claim terms must be given “the meaning that the term would have to a
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`
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`2 U.S. Patent No. 5,469,867, issued Nov. 28, 1995 (Ex. 1004, “Schmitt”).
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`3 U.S. Patent No. 3,993,071, issued Nov. 23, 1976 (Ex. 1005, “Higuchi”).
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`4 PHYSICIAN’S DESK REFERENCE FOR OPHTHALMIC MEDICINES (Douglas J.
`Rhee et al. eds., 31st ed. 2003) (Ex. 1006, “PDR”).
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`5 U.S. Patent No. 6,509,327 B1, issued Jan. 21, 2003 (Ex. 1007, “Cagle”).
`
`6 The Summary of Grounds in the Petition does not include claim 5
`(Pet. 28), but the detailed discussion of the ground based on Schmitt and
`Cagle includes claim 5 (id. at 61, 65). Thus, we understand this asserted
`ground to include claim 5.
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`6
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`Patent 9,463,114 B2
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`person of ordinary skill in the art in question at the time of the invention.”
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`Phillips, 415 F.3d at 1313.
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`Petitioner proposes a construction for the term “a medication for
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`treatment of a corneal infection,” as recited in claims 1 and 8, and a similar
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`term recited in claims 6 and 13. Pet. 19–22. Patent Owner contends this
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`term does not require express construction. Prelim. Resp. 13–14. We agree
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`with Patent Owner and conclude that no claim terms require express
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`construction for purposes of this Decision. See Vivid Techs., Inc. v. Am. Sci.
`
`& Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999).
`
`B.
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`The Level of Ordinary Skill in the Art
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`Petitioner asserts that the “[t]he person of ordinary skill in the relevant
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`art is an ophthalmologist with several years of experience in the design,
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`development, or use of drug delivery devices and/or ocular inserts,” relying
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`on Dr. Dana’s testimony in support. Pet. 18 (citing Ex. 1002 ¶ 28). Patent
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`Owner disputes Petitioner’s proposed level of skill, contending that a person
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`of ordinary skill “is a medical doctor specializing in ophthalmology or a
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`person having a doctorate degree in chemistry having at least 5 years of
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`experience in designing and developing drug delivery ocular inserts.”
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`Prelim. Resp. 12–13.
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`Based on the current record, Patent Owner’s contention is supported
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`only by attorney argument. Petitioner’s proposed formulation of the level of
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`ordinary skill is supported by record evidence, i.e., Dr. Dana’s testimony.
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`Therefore, we accept and use Petitioner’s proposed definition of the skilled
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`artisan, taking into account the level of skill in the art reflected in the prior
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`art of record. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir.
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`2001). Our conclusions in this Decision, however, do not turn on which
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`7
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`party’s definition is used, and our determinations would be unchanged if we
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`applied Patent Owner’s definition.
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`C.
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`Alleged Anticipation Under 35 U.S.C. § 102(b)
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`A claim is anticipated only if each and every element is disclosed and
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`arranged as in the claim, either expressly or inherently, in a single prior art
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`reference. Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1369 (Fed.
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`Cir. 2008); Verdegaal Bros., Inc. v. Union Oil Co. of Cal., 814 F.2d 628,
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`631 (Fed. Cir. 1987). Petitioner contends that claims 1, 3, 6–8, 10, and 13
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`are unpatentable as anticipated by Schmitt. Pet. 29–42. As explained
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`below, we conclude Petitioner has not demonstrated a reasonable likelihood
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`of prevailing on this asserted ground of unpatentability.
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`1.
`
`Overview of Schmitt
`
`Schmitt relates to medical devices and methods of treatment involving
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`the occlusion of channels in living mammals using thermoplastic polymeric
`
`or composite channel occluders formed in situ. Id. at 1:6–11, 4:59–61. The
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`thermoplastic polymeric material or composite “exhibits the special
`
`characteristic of being a flowable viscous liquid between the average
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`temperature of the site and 50° C[] and a rheologically stable solid at or
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`below the average temperature of the site is used.” Id. at 4:66–5:2; see also
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`id. at 13:65–67 (“[T]he polymers must be designed such that they are solid
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`and non-flowable at body temperature and below.”). The polymer is heated
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`to create a flowable material or “preplug,” which is loaded into an injecting
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`device. Id. at 5:6–8. The flowable material (preplug) is injected into a
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`mammalian channel, such as a canalicular canal, and the material cools and
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`solidifies in place, forming a plug that blocks the channel. Id. at 5:16–19,
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`29–30; see also id. at 9:58–61 (“The polymer can be formed into a thin rod
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`8
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`IPR2019-00442
`Patent 9,463,114 B2
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`or cylinder and inserted in a channel as it is undergoing a transition to a fluid
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`form but is preferably injected into the channel.”).
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`Figure 2 of Schmitt is reproduced below:
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`
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`Figure 2 of Schmitt depicts injecting device nozzle 6 inserted through lower
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`punctum 1 to inject flowable polymeric material 7 into canalicular canal 2.
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`Id. at 6:54–56, 12:10–14. The injected polymeric material fills canalicular
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`canal 2 and solidifies to form a plug that conforms to the size and shape of
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`canalicular canal 2, acting as a blocking dam. Id. at 12:15–22.
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`Figure 3 of Schmitt is reproduced below:
`
`Figure 3 of Schmitt depicts plugs of polymeric material 7 that conform to,
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`and block, canalicular channels 2 and 4. Id. at 6:58–60, 12:22–24. The
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`polymer material can be combined with biologically active substances, such
`
`as antibiotics, to produce a composite that leaches the biologically active
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`substance from the plug in the channel. Id. at 8:34–36.
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`2.
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`Independent Claims 1 and 8
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`Claims 1 and 8 recite, “wherein the shape of the punctal plug consists
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`of a constant diameter cylinder configured to be inserted into a canalicular
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`puncta of the subject.” Based on the information presented in the Petition,
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`we are not persuaded Petitioner has made an adequate showing that Schmitt
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`discloses this “shape” limitation. Petitioner relies on two aspects of Schmitt
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`as allegedly disclosing the “shape” limitation. See Pet. 34–37, 41.
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`First, Petitioner cites Schmitt’s disclosure that “the polymer is
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`‘formed into a thin rod or cylinder and inserted in a channel . . . .’” Id. at 34
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`(quoting Ex. 1004, 9:57–61). Petitioner further cites Schmitt’s disclosure
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`that the “‘polymeric material may be included within the injecting device in
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`a solid form,’” (id. (quoting Ex. 1004, 10:9–11)), and that the injection may
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`be performed using, for example, hypodermic needles or pointed plastic tip
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`applicators (id. (citing Ex. 1004, 8:62–64)). Based on Dr. Dana’s testimony,
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`Petitioner’s contention is that Schmitt discloses including solid polymeric
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`material in an injection device in the form of a rod or cylinder, and injecting
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`it into a canalicular punctum such that the polymer is formed into a constant
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`diameter cylinder by the injection device.7 See Pet. 34, 36–37 (citing
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`Ex. 1002 ¶¶ 78, 83).
`
`
`
`7 To the extent Petitioner also contends that Schmitt discloses injecting solid
`rods/cylinders already having a constant diameter directly into the
`canalicular puncta, we are not persuaded because Schmitt explicitly states
`that the rod/cylinder is inserted “as it is undergoing a transition to a fluid
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`10
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`Patent 9,463,114 B2
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`Second, Petitioner contends Schmitt’s disclosures about injecting the
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`polymeric material “ensures that the punctal plug will have a cylindrical
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`shape before and during insertion into the canaliculus,” because the polymer
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`would be pushed through a cylindrical tube of a constant diameter. See
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`Pet. 34–37 (citing Ex. 1002 ¶¶ 79–83).
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`Thus, in summary, Petitioner contends Schmitt discloses the shape
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`limitation because (a) it discloses using solid rods or cylinders of polymeric
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`material for eventual injection into the canaliculus; and (b) whether using
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`solid or flowable polymer, the material is injected through a cylindrical
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`device (e.g., tube or needle) that would result in a constant diameter plug.
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`Id. We are not persuaded, however, that these aspects of Schmitt disclose
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`the “shape” limitation of claims 1 and 8.
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`As an initial matter, as Patent Owner notes (Prelim. Resp. 28),
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`Schmitt explicitly distinguishes between a “plug” and a “preplug.” A “plug”
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`is expressly defined as “the polymer . . . in its solid form . . . and in the
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`shape and dimensions of the channel which it fills.” Ex. 1004, 8:43–46
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`(emphasis added). A “preplug,” however, is defined as “the polymer . . . in
`
`its fluid form or state . . . and takes the shape and dimensions of the
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`container or injecting device which holds it.” Id. at 8:47–50 (emphasis
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`added). Petitioner’s contentions (and Dr. Dana’s opinion) focus on the
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`shape and dimensions of Schmitt’s polymer before injection, and the shape
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`and dimensions of the injecting device that allegedly causes the polymer to
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`form a constant diameter cylinder—i.e., disclosures relating to a preplug (or,
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`
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`form.” Ex. 1004, 9:58–61. Additionally, we note that Petitioner does not
`identify any evidence indicating that the disclosed rods/cylinders have a
`constant diameter before being used in the injection device.
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`11
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`Patent 9,463,114 B2
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`perhaps, even pre-preplug material), not a plug. See Pet. 34–37; Ex. 1002
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`¶¶ 79–84. Neither Petitioner nor the cited testimony from Dr. Dana address
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`this distinction or explain why a person of ordinary skill would consider
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`Schmitt’s descriptions regarding a “preplug” as disclosing the “plug” recited
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`in claims 1 and 8.
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`Moreover, we are not persuaded that Schmitt discloses that the
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`polymer to be injected into the channel (i.e., the “preplug”) necessarily
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`“consists of a constant diameter cylinder configured to be inserted into a
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`canalicular puncta of the subject” as recited in claim 1. Schmitt discloses
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`that the polymer “can be formed into a thin rod or cylinder and inserted in a
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`channel as it is undergoing a transition to a fluid form.” Ex. 1004, 9:58–61
`
`(emphasis added). This transition is accomplished, for example, by heating
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`the entire injection device (and polymer within), passing the polymer
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`through a heated catheter as it is injected, or heating the polymer with a laser
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`beam as it is injected. Id. at 10:14–23. Thus, whether the polymer is in a
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`solid or flowable form when inserted into the injection device, it is
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`“configured to be inserted” into the canalicular puncta in flowable form.
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`Schmitt discloses doing so because the polymer is intended to form a “plug”
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`by taking on the “shape and dimensions of the channel which it fills” (id. at
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`8:43–46) such that “a perfect fit is achieved between the plug and the
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`[channel] wall thus assuring that no passage of any biological fluids or
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`substance will be allowed” (id. at 5:58–62). Patent Owner reasonably
`
`asserts, and the record indicates, that ordinary artisans would understand that
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`such a plug would not be a constant diameter cylinder. See Prelim. Resp.
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`23–25 (citing Ex. 1012, 3:43–65).
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`12
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`We agree with Patent Owner (id. at 22–23, 26) that Schmitt’s
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`disclosure of a flowable polymer injected into a canalicular punctum to take
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`on the shape and dimensions of the canaliculus does not disclose, expressly
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`or inherently, a plug consisting of a constant diameter cylinder configured to
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`be inserted into a canalicular puncta of the subject. Even to the extent the
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`flowable polymer “preplug” could be said to take on a cylindrical shape
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`temporarily as it is extruded into the canaliculus through a cylindrical tube
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`or needle (see Pet. 34–37), Petitioner has not presented sufficient evidence to
`
`support a finding that this meets the limitation of a punctal “plug” that
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`“consists of a constant diameter cylinder configured to be inserted into a
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`canalicular puncta of the subject,” as recited in claims 1 and 8.
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`For the above reasons and based on the evidence presented in the
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`Petition, Petitioner has not demonstrated a reasonable likelihood of
`
`prevailing on its asserted ground of unpatentability that claims 1 and 8 are
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`anticipated by Schmitt.
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`3.
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`Dependent Claims 3, 6, 7, 10, and 13
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`Claims 3, 6, and 7 depend from claim 1, and claims 10 and 13 depend
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`from claim 8; thus, each of these claims recites the same “shape” limitation
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`by virtue of their associated independent claims. As a result, the
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`deficiencies discussed above with respect to the independent claims also
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`indicate Petitioner has not shown a reasonable likelihood of prevailing on its
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`anticipation ground against these dependent claims.
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`D.
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`Alleged Unpatentability Under § 103(a)
`
`A claim is unpatentable under § 103(a) if the differences between the
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`claimed subject matter and the prior art are “such that the subject matter as a
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`whole would have been obvious at the time the invention was made to a
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`13
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`person having ordinary skill in the art to which said subject matter pertains.”
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`KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 406 (2007). The question of
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`obviousness is resolved on the basis of underlying factual determinations,
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`including: (1) the scope and content of the prior art; (2) any differences
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`between the claimed subject matter and the prior art; (3) the level of skill in
`
`the art; and (4) objective evidence of nonobviousness, i.e., secondary
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`considerations.8 Graham v. John Deere Co., 383 U.S. 1, 17–18 (1966).
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`Additionally, the obviousness inquiry typically requires an analysis of
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`“whether there was an apparent reason to combine the known elements in
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`the fashion claimed by the patent at issue.” KSR, 550 U.S. at 418 (citing
`
`In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006) (requiring “articulated
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`reasoning with some rational underpinning to support the legal conclusion of
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`obviousness”)); see In re Warsaw Orthopedic, Inc., 832 F.3d 1327, 1333
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`(Fed. Cir. 2016) (citing DyStar Textilfarben GmbH & Co. Deutschland KG
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`v. C. H. Patrick Co., 464 F.3d 1356, 1360 (Fed. Cir. 2006)).
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`Petitioner contends that claims 1, 3, 6–8, 10, 13, and 14 are
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`unpatentable as obvious in view of Schmitt and Higuchi. Pet. 44–53. In
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`addition, Petitioner contends that claims 1, 3, 6–8, 10, 13, and 14 are
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`unpatentable as obvious in view of Schmitt and PDR. Id. at 53–61. Finally,
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`Petitioner contends that claims 1, 3, 5–8, 10, and 12–14 are unpatentable as
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`obvious in view of Schmitt and Cagle. Id. at 61–69.
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`In each of the asserted obviousness grounds, Petitioner relies solely on
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`Schmitt as teaching the “shape” limitation—i.e., “wherein the shape of the
`
`
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`8 Neither party presented any evidence or argument regarding secondary
`considerations of non-obviousness at this stage of the case. Thus, we do not
`consider any such considerations in our analysis for this Decision.
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`14
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`punctal plug consists of a constant diameter cylinder configured to be
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`inserted into a canalicular puncta of the subject”—which is recited
`
`identically in each of independent claims 1, 8, and 14. See Pet. 47, 51–53,
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`55, 59–61, 63, 67, 69. Further, Petitioner cites and relies on the same
`
`arguments as it put forth for anticipation of claim 1 by Schmitt, and presents
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`no additional analysis or evidence for its obviousness grounds with respect
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`to Schmitt as it relates to the “shape” limitation. See id. For similar reasons
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`as discussed above with respect to the anticipation ground, we conclude that
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`Petitioner also has not shown sufficiently that Schmitt would have taught or
`
`suggested the “shape” limitation to an ordinary artisan. Thus, Petitioner has
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`not demonstrated a reasonable likelihood of prevailing on its obviousness
`
`grounds with respect to independent claims 1, 8, and 14, as well as their
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`challenged dependent claims.
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`E.
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`Denial Under 35 U.S.C. 325(d)
`
`Patent Owner contends that the Petition should be denied as an
`
`exercise of the Board’s discretion under § 325(d) because substantially the
`
`same prior art was previously presented to the Office. Prelim. Resp. 18, 55–
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`56. As explained above, we determine that Petitioner has not shown a
`
`reasonable likelihood of prevailing on any of its asserted grounds of
`
`unpatentability based on the merits of the substantive arguments and
`
`evidence presented in the Petition. Thus, we do not reach the question of
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`whether to exercise our discretion under § 325(d).
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`CONCLUSION
`
`For the foregoing reasons and on the present record, we determine that
`
`the information presented in the Petition does not demonstrate a reasonable
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`Patent 9,463,114 B2
`
`likelihood that Petitioner would prevail in establishing the unpatentability of
`
`claims 1, 3, 5–8, 10, and 12–14 of the ’114 Patent.
`
`ORDER
`
`In consideration of the foregoing, it is hereby:
`
`ORDERED that the Petition is denied and no trial is instituted.
`
`
`
`16
`
`
`
`IPR2019-00442
`Patent 9,463,114 B2
`
`PETITIONER:
`
`Brian Seeve
`Brian.seeve@wilmerhale.com
`
`Thomas Foley
`tfoley@mccarter.com
`
`Kia Freeman
`kfreeman@mccarter.com
`
`PATENT OWNER:
`
`Anitha Varma
`Anita.varma@whitecase.com
`
`David Tennant
`dtennant@whitecase.com
`
`Grace Wang
`Grace.wang@whitecase.com
`
`Yang Xu
`Yang.xu@whitecase.com
`
`
`
`17
`
`
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