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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.
`
`13/518,038
`
`06/21/2012
`
`Siva Rama Krishna Nutalapati
`
`AI0025US.NP
`
`5329
`
`7590
`26259
`LICATA & TYRRELL P.C.
`66 E. MAIN STREET
`MARLTON, NJ 08053
`
`07/29/2019
`
`EXAMINER
`
`YOUNG, MICAH PAUL
`
`ART UNIT
`
`PAPER NUMBER
`
`1618
`
`NOTIFICATION DATE
`
`DELIVERY MODE
`
`07/29/2019
`
`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):
`PTOactions@licataandtyrrell.com
`
`PTOL-90A (Rev. 04/07)
`
`1
`
`1/6
`
`

`

`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`Ex parte SIVA RAMA KRISHNA NUTALAPATI1
`____________
`
`Appeal 2018-004192
`Application 13/518,038
`Technology Center 1600
`____________
`
`
`Before RYAN H. FLAX, RACHEL H. TOWNSEND,
`and CYNTHIA M. HARDMAN, Administrative Patent Judges.
`
`FLAX, Administrative Patent Judge.
`
`
`
`
`DECISION ON APPEAL
`This is a decision on appeal under 35 U.S.C. § 134(a) involving
`claims to a functionally coated multilayer tablet for oral administration and a
`method of formulating the same. The Examiner’s rejection of claims 1, 3–5,
`7, 8, and 10 under 35 U.S.C. § 103(a) is appealed. We have jurisdiction
`under 35 U.S.C. § 6(b).
`We reverse.
`
`
`
`
`
`
`1 The Real Party in Interest is identified as “AptaPharma, Inc.” Appeal
`Br. 1.
`
`2/6
`
`

`

`Appeal 2018-004192
`Application 13/518,038
`
`
`
`STATEMENT OF THE CASE
`The Specification states:
`The present invention relates to multilayer functionally
`coated tablets for oral administration of one or more active
`pharmaceutical ingredients (API). The multilayer functionally
`coated tablets contain one or more quick release API containing
`layers and one or more modified release API containing layers
`separated by an inert layer. Methods for formulation and use of
`these tablets are also provided.
`Spec. 1:8–15. The Specification describes the quick release API-containing
`layer or layers as providing “a dissolution profile relatively faster than the
`modified release layer. In one embodiment, the dissolution profile of the
`quick release layer ranges from 0 to 120 minutes.” Id. at 6:29–32. The
`Specification further describes the modified release API-containing layer or
`layers as providing “a dissolution profile which is extended, delayed or
`controlled as compared to the in vitro dissolution of the quick release layer.
`In one embodiment, the modified release layer has a release profile of 4
`hours or greater,” although it could be shorter than 4 hours. Id. at 7:13–24.
`Independent claim 1, reproduced below, is representative:
`1.
`A functionally coated multilayer tablet for oral
`administration comprising:
`(a) a core tablet comprising
`(i) a quick release layer or layers comprising one or
`more active pharmaceutical ingredients (APIs);
`(ii) a modified release layer or layers comprising
`one or more APIs and a release retarding excipient; and
`(iii) an inert layer separating said quick release layer
`or layers and said modified release layer or layers, wherein
`said inert layer is insoluble and impermeable;
`
`2
`
`3/6
`
`

`

`Appeal 2018-004192
`Application 13/518,038
`
`
`
`(b) a functional coating or film surrounding the core tablet,
`wherein said coating or film comprises a pore-forming agent
`which permits quick release of the API from the quick release
`layer regardless of the functional coating or film being present
`while providing release of the API from the modified release
`layer controlled by [ ] the release retarding excipient, inert layer
`and functional coating or film.
`Appeal Br. 14 (Claims Appendix). Independent claim 8 is directed to a
`method of producing a tablet as defined by claim 1. Id. at 15.
`The following rejection is on appeal:
`Claims 1, 3–5, 7, 8, and 10 stand rejected under 35 U.S.C. § 103(a)
`over Seroff2 and Dharmadhikari.3 Final Action 2.
`DISCUSSION
`“[T]he examiner bears the initial burden, on review of the prior art or
`on any other ground, of presenting a prima facie case of unpatentability.
`[Only once] that burden is met, [does] the burden of coming forward with
`evidence or argument shift[] to the applicant.” In re Oetiker, 977 F.2d 1443,
`1445 (Fed. Cir. 1992). “[O]bviousness requires a suggestion of all
`limitations in a claim.” CFMT, Inc. v. Yieldup Int’l Corp., 349 F.3d 1333,
`1342 (Fed. Cir. 2003) (citing In re Royka, 490 F.2d 981, 985 (CCPA 1974)).
`The Examiner determined the claims would have been obvious over
`Seroff and Dharmadhikari. Final Action 2–3; see also Answer 5–7. The
`Examiner points to Seroff’s Figure 3 as illustrating a tablet as claimed and
`determined the figure shows the claimed quick release layer as feature 16,
`the claimed modified release layer as feature 17, the claimed inert layer as
`
`
`2 US 6,387,403 B1 (issued May 14, 2002) (“Seroff”).
`3 US 8,470,367 B2 (issued June 25, 2013) (“Dharmadhikari”).
`
`3
`
`4/6
`
`

`

`Appeal 2018-004192
`Application 13/518,038
`
`
`feature 18, and the claimed coating as feature 19. Final Action 2–3 (citing
`Seroff columns 12 and 13). In response to Appellant’s argument that Seroff
`states layer 17 “does not contain drug,” the Examiner asserted that Seroff’s
`disclosed layer 17 is a drug layer because Seroff says as much at column 13,
`which the Examiner determined refers to “a lesser preferred embodiment[].”
`Answer 5.
`Appellant presents several arguments, the first of which is that the
`prior art combination does not teach or suggest the claimed modified release
`API layer because Seroff’s layer 17, identified by the Examiner as this claim
`element, is not a drug-containing layer, but is a push layer that facilitates
`drug release by swelling adjacent to Seroff’s drug-containing layer 16.
`Appeal Br. 5. We find this argument persuasive.
`Reading Seroff in its entirety, it is apparent that the portions of
`column 13 cited by the Examiner to support his determination that Seroff’s
`layer 17 is a drug-containing modified release layer are errors within the
`reference. The Examiner is correct that Seroff’s column 13 states twice,
`“drug layer 17.” See Seroff 13:33 and 13:45–46. However, within the
`context of Seroff’s disclosure as a whole, it is apparent that a person of
`ordinary skill in the art would have understood Seroff intends to discuss
`layer 16 at these portions, and we conclude that the identification of layer
`“17” instead is an apparent typographical error. See In re Yale, 434 F.2d
`666, 668–69 (Fed. Cir. 1970) (when a prior art reference’s typographical
`error, e.g., as exemplified by internal inconsistencies in the reference, would
`lead the skilled artisan to disregard the related disclosure, reliance on that
`
`4
`
`5/6
`
`

`

`Appeal 2018-004192
`Application 13/518,038
`
`
`express disclosure to establish the obviousness of what it expressly states is
`error).
`In particular, nothing in the column 13 portions of Seroff relates to the
`push layer 17 elsewhere discussed in the reference, but the cited portions
`relate to materials for the drug-containing layer 16. Moreover, Seroff
`describes the push layer 17 as “compris[ing] osmotically active
`component(s) but does not contain drug.” Seroff 8:17–20, 8:56–58. Seroff
`also describes providing the inert layer 18 to prevent drug from migrating
`from layer 16 to layer 17. Seroff 8:58–63. Thus, we find the balance of
`evidence supports Appellant’s position on this issue.
`Because we conclude the Examiner’s cited prior art combination fails
`to teach or suggest the claimed invention, we reverse the obviousness
`rejection.
`
`SUMMARY
`The obviousness rejection of claims 1, 3–5, 7, 8, and 10 under
`35 U.S.C. § 103(a) is reversed.
`
`
`REVERSED
`
`
`
`5
`
`6/6
`
`

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