2021001448 (P.T.A.B. Oct. 4, 2021)

University of Pittsburgh - Of the Commonwealth System of Higher Education

Patent Trials and Appeals BoardOct 4, 2021

2021001448 (P.T.A.B. Oct. 4, 2021)

UNITED STATES PATENT AND TRADEMARK OFFICE UNITED STATES DEPARTMENT OF COMMERCE United States Patent and Trademark Office Address: COMMISSIONER FOR PATENTS P.O. Box 1450 Alexandria, Virginia 22313-1450 www.uspto.gov APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO. 15/839,712 12/12/2017 Stephen Weber 8123-90676-02 4185 24197 7590 10/04/2021 KLARQUIST SPARKMAN, LLP 121 SW SALMON STREET SUITE 1600 PORTLAND, OR 97204 EXAMINER SHAH, NILAY J ART UNIT PAPER NUMBER 3783 NOTIFICATION DATE DELIVERY MODE 10/04/2021 ELECTRONIC Please find below and/or attached an Office communication concerning this application or proceeding. The time period for reply, if any, is set in the attached communication. Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the following e-mail address(es): docketing@klarquist.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________ Ex parte STEPHEN WEBER, AMIR H. FARAJI, YIFAT GUY, ANDREA JAQUINS-GERSTL, and ALEC C. VALENTA ____________ Appeal 2021-001448 Application 15/839,712 Technology Center 3700 ____________ Before MICHAEL C. ASTORINO, BRADLEY B. BAYAT, and AMEE A. SHAH, Administrative Patent Judges. BAYAT, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Appellant appeals under 35 U.S.C. § 134(a) from the Examiner’s decision rejecting claims 2, 3, 5–16, and 20–22, which constitute all pending claims before us for review.1,2 We have jurisdiction under 35 U.S.C. § 6(b). A video hearing was held on September 28, 2021. We REVERSE and enter a NEW GROUND OF REJECTION pursuant to our authority under 37 C.F.R. § 41.50(b). 1 “Appellant” refers to “applicant” as defined in 37 C.F.R. § 1.42. Appellant identifies the real party in interest as “University of Pittsburgh - Of the Commonwealth System of Higher Education.” Appeal Br. 3. 2 Claims 1, 4, and 17–19 are canceled. Id. at 10–12. Appeal 2021-001448 Application 15/839,712 2 Claimed Subject Matter “The present invention relates generally to the field of delivery of fluids and/or drugs to tissue, particularly to the electroosmotic delivery of fluid and/or drugs or other solutes to brain tissue.” Spec. para. 3. Apparatus claims 12 and 21, reproduced below, are the only independent claims on appeal. 12. An apparatus, comprising: a hollow fiber defining a fluid passage and terminating at a blunt end that is insertable into target tissue; a fluid reservoir; an electrode compartment adapted to accept a terminus of an electrode; a barrier situated to separate the electrode compartment and the fluid reservoir to inhibit mixing or solution exchange between the electrode compartment and the fluid reservoir, wherein the barrier is a frit; a catheter fluidically coupled to a second end of the hollow fiber opposite the blunt end and to the fluid reservoir so that the fluid passage defined by the hollow fiber is fluidically coupled by the catheter to the fluid reservoir; and a support rod situated in lumens of at least one of the hollow fiber and the catheter. 21. An apparatus, comprising: a vial; a frit situated within the vial and defining a reservoir and an electrode compartment, wherein: a first end of the reservoir is configured to permit solution in the reservoir to leave the reservoir and a second end of the reservoir is coupled to the frit, the electrode compartment is adapted to accept a terminus of an electrode, the frit inhibits mixing or solution exchange between the electrode compartment and the reservoir; and a fluid opening defined in the first end of the reservoir. Appeal 2021-001448 Application 15/839,712 3 Rejections3 Claims 3, 5–8, and 21 are rejected under 35 U.S.C. § 102(b) as being anticipated by Battista (US 3,115,280, iss. Dec. 24, 1963). Claims 12, 13, 15, and 20 are rejected under 35 U.S.C. § 103(a) as being unpatentable over Pang et al. (US 2009/0306594 A1, pub. Dec. 10, 2009) (Pang) and Deniega et al. (US 6,350,253 B1, iss. Feb. 26, 2002) (Deniega). Claim 14 is rejected under 35 U.S.C. § 103(a) as being unpatentable over Pang, Deniega, and Savastano et al. (US 5,681,584, iss. Oct. 28, 1997) (Savastano). Claim 16 is rejected under 35 U.S.C. § 103(a) as being unpatentable over Pang, Deniega, and Van Antwerp (US 6,461,331 B1, iss. Oct. 8, 2002). Claims 2 and 10 are rejected under 35 U.S.C. § 103(a) as being unpatentable over Battista and Deniega. Claims 9 and 11 are rejected under 35 U.S.C. § 103(a) as being unpatentable over Battista and Pang. 3 The Examiner rejects claims 12–16 and 20 under 35 U.S.C. § 112, second paragraph as being indefinite because “it is unclear . . . how the fluid reservoir is coupled to a second end of the hollow fiber opposite the blunt end.” Final Act. 2. Appellant does not address this rejection in the their Briefs, but we note that Appellant amended the claims after the Final Action “for clarification and withdrawal of th[e] rejection.” Amendment 5 (filed Apr. 6, 2020). The Examiner entered the amendment in the Advisory Action mailed April 13, 2020. However, there is no affirmative statement on the record that this rejection was maintained or withdrawn. In this case, we understand the silence on this matter to equate to the Examiner’s tacit agreement that the entered claims address the rejection. As such, we consider the Examiner’s rejection under 35 U.S.C. § 112, second paragraph of claims 12–16 and 20 to be withdrawn. Appeal 2021-001448 Application 15/839,712 4 Claim 22 is rejected under 35 U.S.C. § 103(a) as being unpatentable over Battista and Oh et al. (Improved Distribution of Small Molecules and Viral Vectors in the Murine Brain using a Hollow Fiber Catheter, 107 J. Neurosurg. 568–577 (Sept. 2007)) (Oh). OPINION As set forth below, pursuant to our authority under 37 C.F.R. § 41.50(b), we enter a new ground of rejection of claims 2, 3, 5–16, and 20–22 under pre-AIA 35 U.S.C. § 112, second paragraph, as being indefinite. In light of this new rejection, it would be premature to reach the merits of the rejections under 35 U.S.C. §§ 102(b) and 103(a) at this time. Before a proper review of the prior art rejections can be made, the subject matter encompassed by the claims on appeal must be reasonably understood without resort to speculation. Because the claims fail to satisfy the requirements under 35 U.S.C. § 112, second paragraph, we are constrained to reverse, pro forma, the Examiner’s rejections under 35 U.S.C. §§ 102(b) and 103(a). See In re Steele, 305 F.2d 859, 862 (CCPA 1962) (A prior art rejection cannot be sustained if the hypothetical person of ordinary skill in the art would have to make speculative assumptions concerning the meaning of claim language). It should be understood that our decision to reverse those rejections is based solely on the indefiniteness of the claims, and does not reflect on the merits of the underlying rejections. New Ground of Rejection––Indefiniteness In determining whether a claim is definite under 35 U.S.C. § 112, second paragraph, “[t]he USPTO, in examining an application, is obliged to test the claims for reasonable precision.” In re Packard, 751 F.3d 1307, Appeal 2021-001448 Application 15/839,712 5 1313 (Fed. Cir. 2014). “[A] claim is indefinite when it contains words or phrases whose meaning is unclear.” Id. at 1322; Ex parte McAward, No. 2015-006416, 2017 WL 3669566, at *5 (PTAB Aug. 25, 2017) (precedential) (quoting Packard, 751 F.3d at 1314). The USPTO “determines the scope of claims . . . not solely on the basis of the claim language, but upon giving claims their broadest reasonable construction ‘in light of the specification as it would be interpreted by one of ordinary skill in the art.’” Phillips v. A WH Corp., 415 F.3d 1303, 1316 (Fed. Cir. 2005) (en banc) (quoting In re Am. Acad. of Sci. Tech Ctr., 367 F.3d 1359, 1364 (Fed. Cir. 2004)). During examination, an applicant must “clearly and precisely set out the metes and bounds of the claimed [subject matter].” See Ex parte Miyazaki, 89 USPQ2d 1207, 1211–13 (BPAI 2008) (precedential) (holding that “if a claim is amenable to two or more plausible claim constructions, the USPTO is justified in requiring the applicant to more precisely define the metes and bounds of the claimed invention by holding the claim unpatentable under 35 U.S.C. § 112, second paragraph, as indefinite.”). Central to Appellant’s arguments against the prior art rejections is that the Examiner has misconstrued the claim term “frit.” Appeal Br. 5–8. According to Appellant, one of “ordinary skill in the art would understand that a frit is: a rigid or semi-rigid filter of any composition that is substituted where a granulated ceramic composition may otherwise have been used.” Id. at 6 (citing Declaration of Stephen Gregory Weber under 37 C.F.R. § 1.132, filed April 6, 2020) (Weber Decl.). Appellant provides Exhibits A–G (filed April 6, 2020), which purportedly “illustrate commercial products referred to as ‘frits’ or otherwise illustrate the use of the term ‘frit’ as it would be understood to one of ordinary skill in the art.” Id. at 7. For Appeal 2021-001448 Application 15/839,712 6 example, Exhibit B describes “a porous (fritted) glass disk in the middle that allows filtrate to drain,” “Exhibit C describes porous metal frits that are used to ‘filter microbial and inorganic contaminants’” and “Exhibit D pertains to chromatography frits that are inert filtration devices.” Id. The Examiner construes the claim term “frit” as any element “capable of keeping solutions separate without mixing them” based on Appellant’s disclosure that “[a] frit 708 or other separator may split the vial into two compartments of the probe to avoid electrochemical reactions from altering the solution to be delivered.” Ans. 3–4 (citing Spec. para. 57). According to the Examiner, in the absence of a description of the structure of a frit in the Specification, “the ‘frit’ can be construed to be any element that is capable to separate the vial into a reservoir and an electrode compartment while inhibiting mixing or solution exchange between the electrode compartment and the reservoir.” Id. at 5. The Examiner finds that the plain meaning of “the word ‘frit’ is defined as ‘the calcined or part[l]y fused material of which glass is made’” and states that it is unclear “how ‘the calcined or part[l]y fused material of which glass is made’ is capable to keep two solutions separate without being mixed into one another.” Id. at 4 (citing Merriam- Webster’s online dictionary). The Examiner also takes issue with the definition provided by Appellant because “the definition is coming from an expert.” Id. We initially note that the term “frit” is neither defined nor discussed in detail in the Specification. The only mention of “frit” in the written disclosure is in paragraph 57. Appellant asserts paragraph “57 clearly states that either a frit or something else that is not a frit can be used. A frit is merely one type of separator.” Appeal Br. 6. Appellant disagrees with the Appeal 2021-001448 Application 15/839,712 7 Examiner’s dictionary definition of “frit” as the ordinary and customary meaning to those skilled in the art and, instead, submits a definition by inventor Dr. Weber “[b]ased on [his] experience and knowledge of this technical area” (Weber Decl. 2) as an expert in the field. The accompanying exhibits discussed above do not fully support the definition provided by Dr. Weber such that one of ordinary skill would understand a frit as a rigid or semi-rigid filter of any composition for substituting a granulated ceramic composition. As such, we are not persuaded that the broadest reasonable interpretation of “frit” as understood by a person of ordinary skill in light of the Specification is “a rigid or semi-rigid filter of any composition that is substituted where a granulated ceramic composition may otherwise have been used” (Reply Br. 2) as defined by Dr. Weber. Section 112 places the burden of precise claim drafting on applicants. See Packard, 751 F.3d at 1313 (“Given the role of the applicant in the process, it is a reasonable implementation of the examination responsibility, as applied to § 112[, second paragraph], for the USPTO, upon providing the applicant a well- grounded identification of clarity problems, to demand persuasive responses on pain of rejection.”). Accordingly, we issue a new ground of rejection as to claims 2, 3, 5–16, and 20–22 under 35 U.S.C. § 112, second paragraph as indefinite. CONCLUSION The Examiner’s rejections under 35 U.S.C. §§ 102(b) and103(a) are reversed pro forma. A NEW GROUND OF REJECTION is entered for claims 2, 3, 5–16, and 20–22 as indefinite under 35 U.S.C. § 112, second paragraph. Appeal 2021-001448 Application 15/839,712 8 Section 41.50(b) provides that “[a] new ground of rejection pursuant to this paragraph shall not be considered final for judicial review.” Thus, WITHIN TWO MONTHS FROM THE DATE OF THE DECISION, Appellant must exercise one of the following two options with respect to the new ground of rejection to avoid termination of the appeal as to the newly rejected claims: (1) Reopen prosecution. Submit an appropriate amendment of the claims so rejected or new Evidence relating to the claims so rejected, or both, and have the matter reconsidered by the examiner, in which event the prosecution will be remanded to the examiner[; or] (2) Request rehearing. Request that the proceeding be reheard under § 41.52 by the Board upon the same [r]ecord. DECISION SUMMARY Claim(s) Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed New Ground 3, 5–8, 21 102(b) Battista 3, 5–8, 21 12, 13, 15, 20 103(a) Pang, Deniega 12, 13, 15, 20 14 103(a) Pang, Deniega, Savastano 14 16 103(a) Pang, Deniega, Van Antwerp 16 2, 10 103(a) Battista, Deniega 2, 10 9, 11 103(a) Battista, Pang 9, 11 22 103(a) Battista, Oh 22 2, 3, 5–16, 20–22 112 Indefiniteness 2, 3, 5–16, 20–22 Overall Outcome 2, 3, 5–16, 20–22 2, 3, 5–16, 20–22 Appeal 2021-001448 Application 15/839,712 9 No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a)(1)(iv). REVERSED; 37 C.F.R. § 41.50(b)