DETAILED ACTION
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 .
Election/Restrictions
Applicant’s election without traverse of Group I claims 1-3, 5, 7-10 and 32-33 in the reply filed on 07/21/2026 is acknowledged. Claim 33 was mistakenly included in Group I in the restriction requirement mailed on 06/22/2026. However, since it depends on claim 22 it should belong in Group II. Therefore, claims 1-3, 5, 7-10 and 32 are being examined herein.
Claims 22-31 and 33 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 2, 5 and 7-8 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.
Claim 2 contains the limitations “the water-soluble organic solvent optionally selected from the group consisting of…”, “further optionally selected from the group consisting of isopropanol, ethanol and methanol” and “even further optionally wherein the water-soluble organic solvent is isopropyl alcohol”. It is unclear what how the solvents may “further optionally” and “even further optionally” selected from the species recited given that they are explicitly claimed in the first clause of “the water-soluble organic solvent optionally selected from the group consisting of…”. It is therefore unclear what the “further optionally” limitations are intended to refer to or what the difference between “optionally” and “further optionally” is.
Regarding claim 5, the limitation “optionally wherein the gum is guar gum” is indefinite because “guar gum” is already an optional limitation is the list of “water-soluble gum” species.
Regarding claim 7, A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 7 recites the broad recitation “no less than about 1:200 and no more than about 2:1”, and the claim also recites “no less than about 1:100 and no more than about 1:1” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Regarding claim 8, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 32 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 32 contains a limitation directed to a total coat weight of claim 1 which has the same range limitation as in claim 1. As such, claim 32 does not further limit claim 1.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-3, 5, 7-10 and 32 are rejected under 35 U.S.C. 103 as being unpatentable over Yadav et al. (U.S. App. Pub. No. 2016/0303038).
Regarding claims 1 and 32, Yadav et al. discloses an oral film composition including a copolymer of polyvinyl alcohol and polyethylene glycol (i.e. a water-soluble polymer) and at least one gum. (Abstract). The gum is present in the form of particles. (par. [0028]).
With respect to the coating weight of the film, the composition is applied in a film weight of 10 mg to around 200 mg onto a surface area of 0.5 to 15 cm2. (par. [0055] and [0060]). For a 1 cm2 surface area and a range of 10-200 mg, this would be equivalent to 1.55 mg/in2 to 31/inch2 (1 square inch = 6.45 cm2). Therefore, for a 24inch2 surface, the coating amount would be 24 x1.55 = 37 mg/24inch2 to 24x31 = 744 mg/24inch2, overlapping with the presently claimed range. As set forth in MPEP 2144.05, in the case where the claimed range “overlap or lie inside ranges disclosed by the prior art”, a prima facie case of obviousness exists, In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Regarding claims 2-3, the composition further includes film forming agents including PVP and PEO (par. [0041]) which are soluble in water and the list of organic solvents of claim 2.
Regarding claim 5, the gum may include locust bean gum, xantham gum and guar gum. (par. [0044]).
Regarding claim 7, the content of polyvinyl alcohol to gum in the film composition is in the range of 99:1 to 5:1, overlapping with the presently claimed range. (par. [0033]).
Regarding claims 8-10, the coating composition is applied onto the surface of a polypropylene petri dish (i.e. a thin film culture device) without an adhesive (par.[0072] and [0100]). The polypropylene petri dish would include a plastic material.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEXANDRE F FERRE whose telephone number is (571)270-5763. The examiner can normally be reached M-F: 8 am to 4 pm ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alicia Chevalier can be reached at 5712721490. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALEXANDRE F FERRE/Primary Examiner, Art Unit 1788 09/24/2026
