Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
This application is a 371 of PCT/IN2022/050207 (03/08/2022)
and claims foreign priority to INDIA 202141009765 (03/09/2021).
Claim Interpretation - BRI
The claim preamble of “[A]n oral film” requires interpretation as to the limiting effect on the product claim. As per MPEP 2111.02:
The claim preamble must be read in the context of the entire claim. The determination of whether preamble recitations are structural limitations or mere statements of purpose or use “can be resolved only on review of the entirety of the [record] to gain an understanding of what the inventors actually invented and intended to encompass by the claim” as drafted without importing “‘extraneous’ limitations from the specification.” Corning Glass Works, 868 F.2d at 1257, 9 USPQ2d at 1966. If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Shoes by Firebug LLC v. Stride Rite Children’s Grp., LLC, 962 F.3d 1362, 2020 USPQ2d 10701 (Fed. Cir. 2020) (The court found that the preamble in one patent’s claim is limiting but is not in a related patent); Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See also Rowe v. Dror, 112 F.3d 473, 478, 42 USPQ2d 1550, 1553 (Fed. Cir. 1997) (“where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention, the preamble is not a claim limitation”); Kropa v. Robie, 187 F.2d at 152, 88 USPQ2d at 480-81 (preamble is not a limitation where claim is directed to a product and the preamble merely recites a property inherent in an old product defined by the remainder of the claim); STX LLC. v. Brine, 211 F.3d 588, 591, 54 USPQ2d 1347, 1350 (Fed. Cir. 2000)
Thus, giving the instant claims their broadest reasonable interpretation of “[A]n oral film” in view of the specification’s broad definition of the phrase results in a claim interpretation that requires a solid form of any shape or size able to disintegrate in the oral cavity (Specification p. 8, i.e. “An oral film according to the present invention … provides a non-mucoadhesive orally disintegrating film …, able to disintegrate upon contact with aqueous media or saliva in oral cavity”, “The term ‘film’ … includes films, sheets, and wafers, in any size and shape”), and comprising the recited elements in the body of the claim.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 5-8 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The claims include the language “selected from the group comprising …” which is indefinite as per MPEP 2173.05(h) - If a Markush grouping requires a material selected from an open list of alternatives (e.g., selected from the group “comprising” or “consisting essentially of” the recited alternatives), the claim should generally be rejected under 35 U.S.C. 112(b) as indefinite because it is unclear what other alternatives are intended to be encompassed by the claim. See In re Kiely, 2022 USPQ2d 532 at 2* (Fed. Cir. 2022) (each independent claim recites "a selection from the group comprising a person, an animal, an animated character, a creature, an alien, a toy, a structure, a vegetable, and a fruit.” … (emphasis added).
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Verwijs et al. (US20140163068).
Verwijs teaches pharmaceutical compositions comprising a CFTR modulator, 3-(6-(1-(2,2-difluorobenzo[d][1,3]dioxol-5-yl)cyclopropanecarboxamido)-3-methylpyridin-2-yl)benzoic acid (“Lumacaftor”), formulated in a solid dispersion form for oral administration (Abstract, [0249], [0259] HCl salt) with hydroxypropylmethylcellulose (HPMC) ([0023]-[0024], [0281] – form filming polymer), polyethyleneglycol ([0281] – plasticizer), polyvinylpyrrolidone ([0026] – “povidone” / carrier), pharmaceutical excipients ([0114]-[0120]: disintegrant, filler, surfactant, binder, colorant).
Thus, Verwijs meets all of the limitations of claims 1-8 under the BRI.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-10 are rejected under 35 U.S.C. 103 as being unpatentable over Verwijs et al. (US20140163068).
Regarding claims 1-8, Verwijs teaches as detailed in the 35 USC 102 rejection supra and incorporated herein. Verwijs also renders these claims obvious as anticipation is the epitome of obviousness and because one of ordinary skill in the art following the prior art teaching would have readily formed the same composition as claimed with a reasonable expectation of success.
Regarding claims 9-10, Verwijs teaches i) the CFTR modulator at 30-55% by weight (claim 3), ii) film forming polymer is HPMC at 10-20% ([0023]), iii) plasticizer of PEG, iv) carrier at 0-5% ([0026] – polyvinylpyrrolidone / “povidone”; claim 4), excipients at 0.5-2 % ([0025] surfactant). However, Verwijs does not specify the particular amount of plasticizer equivalents of PEG or sorbitol ([0146]) in the composition. One of ordinary skill in the art would consider routine the optimization of components such as PEG and sorbitol in a formulation, particularly in view of Verwijs’ teaching of optimization of the hardness of the composition ([0146]).
With each of the claims, the level of skill in the art is very high such that one of ordinary skill in the art would consider routine the combination of elements from the teaching of the art. One of ordinary skill in the art would have recognized that the results of the combination would be predictable due to the well-known nature and optimizations routinely performed in the art. Thus, one of ordinary skill in the art would have arrived at the invention as claimed before the effective filing date with a reasonable expectation of success.
Conclusion
No claims allowed.
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/ROBERT H HAVLIN/Primary Patent Examiner, Art Unit 1626