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 .
Status of Application
Receipt of Applicant’s remarks, amended claims, and the amendment to the specification filed on March 30, 2026 is acknowledged.
Claims 1-2, 5-6, 8-9, 12-15, 27-33, and 45-47 are pending in this application.
Claims 3-4, 7, 10-11, 16-26, and 34-44 have been cancelled.
Claims 1, 5-6, 12-15, and 27 have been amended.
Claims 45-47 are new. All pending claims are under examination in this application.
Withdrawn Objections/Rejections
Specification
The objection to the disclosure because the recitation and use of acronyms should be consistent throughout the specification, for example, poly(vinyl alcohol) is also known as PVA, poly(ethylene oxide) is also known as PEO has been withdrawn in view of the amendment to the specification, such as poly(vinyl alcohol) (PVA).
Claim Objections
The objection to claims 1 and 5-6 because:
claims 1 and 27 it is suggested the claims be amended to include a colon (:) after “comprising” in line 1 has been withdrawn in view of the amendment to the claims to include a colon (:);
claim 5 recites polyacrylic acid (PAA), gelatin-modified dopamine (DOPA), carboxymethyl cellulose, (CMC), and PEG (polyethylene glycol) and it is suggested one format be adopted for such designation; for example, the name followed by the acronym, such as polyacrylic acid (PAA), or vice versa instead of a combination of the two, and recitation and use of acronyms should be consistent throughout the claims has been withdrawn in view of the amendment to the claims as suggested by the Examiner;
claim 6 the component name and acronym have been previously identified in claim 5, therefore, their recitation is unnecessary in dependent claims and it is suggested that for already defined acronyms, the component name be deleted has been withdrawn in view of the amendment to the claim as suggested by the Examiner.
Claim Rejections - 35 USC § 112
The rejection of claims 14-15 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 because, for example the claims recite “the first layer comprises the first active ingredient and the second active ingredient, wherein the first active ingredient and the second active ingredient are present at a first amount equal to the amount of the first active ingredient plus the amount of the second active ingredient in the first layer” has been withdrawn in view of the clarifying language of the first and second active agents in the first layer and second layer.
Claim Rejections - 35 USC § 102
The rejection of claims 1, 5-6, 9-10, 12, and 27-33 under 35 U.S.C. 102(a)(1) as being anticipated by Eisen et al. (US 2019/0201417), as evidenced by Desai et al. (Is Oral Lichen Planus a potential malignant disorder?: A critical appraisal, Journal of Oral and Maxillofacial Pathology, 2022) and Odukoya et al. (A Histologic Study of Epithelial Dysplasia in Oral Lichen Planus, Arch Dermatol-Vol 121, Sept 1985) has been withdrawn in view of the amendment to claim 1 to incorporate the limitations of claim 7 (wherein the first active ingredient if oxaliplatin (OXP).
Claim Rejections - 35 USC § 103
The rejection of claims 1-2, 5-8, 10, 27, and 33 under 35 U.S.C. 103 as being unpatentable over Matheny (US 2013/0338700) has been withdrawn in view of the amendment to claim 1 to incorporate claim 11 (wherein the first layer is interposed between the support frame and the second layer).
The rejection of claims 1, 5-6, 9-13, and 27-33 under 35 U.S.C. 103 as being unpatentable over Eisen et al. (US 2019/0201417) in view of Rupprecht et al. (US 2002/0142036) has been withdrawn in view of the amendment to claim 1 to incorporate the limitations of claim 7 (wherein the first active ingredient if oxaliplatin (OXP).
Newly Applied Rejections
Claim Objections
Claim 9 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Regarding claim 9, oxaliplatin is a chemotherapy agent, whereas mycophenolate is an immunosuppressant for transplant patients. There is no motivation within the art to combine the two actives in a single composition.
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.
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 1-2, 5-6, 8-9, 12-15, 27-33, and 45-47 are rejected under 35 U.S.C. 103 as being unpatentable over Obeid et al. (US 10,272,038) in view of Gao (Pharmacokinetic Evaluation of Novel Mycophenolic Acid and Oxaliplatin Patches for Supralingual Administration, Texas Southern University ProQuest Dissertations and Thesis, 2020).
Obeid discloses a film dosage form with extended release mucoadhesive particles (abstract).
The dosage forms can comprise at least 2 layers (column 2, lines 22-23).
The mucoadhesive particles, sweetener, flavor, and a pore former are combined and stirred into a homogenous dispersion (wet blend). Polyethylene oxide is then added into the wet blend. The wet blend is then coated on a support liner (column 14, lines 58-65).
The Examiner has interpreted the support liner to the support frame of the instant claims.
Examples of mucoadhesive materials that can be used to prepare the mucoadhesive particles include poly(ethylene oxide), polyvinyl pyrrolidone, poly(acrylic acid) derivatives, sodium carboxymethylcellulose, cellulose derivatives, alginate, and pectin, (column 7, lines 4-25).
A wide variety of active agents can be used in the dosage form. Obeid disclose the recited active agents as well as others can be used alone or in combination (column 7, lines 32-62). The use of two active agents is discloses and exemplified (column 8, lines 60-62).
Regarding claim 2, the claim recitation of “configured as a three dimensional printed composition” is interpreted as a product by process limitation. Applicants attention is directed to MPEP 2113 which discloses [E]ven though product by process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product by process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).
Regarding claims 5-6, as noted above, examples of mucoadhesive materials that can be used to prepare the mucoadhesive particles include poly(ethylene oxide)(PEO), polyvinyl pyrrolidone(PVP), poly(acrylic acid) (PAA) derivatives, sodium carboxymethylcellulose (CMC), cellulose derivatives, alginate, and pectin, (column 7, lines 4-25).
Claims 12-13, Obeid discloses more than 1 active agent can be included in the layers and there can be multiple layers in the dosage form.
Regarding claim 27, the dosage form can be administered to treat gingivitis, buccal ulcers, canker sores, Sjogren’s syndrome, oral mucositis, and behcet disease (column 3, lines 45-48).
Regarding claim 33, the dosage form is administered orally (column 3, line 39).
Obeid does not disclose the combination of oxaliplatin and mycophenolic acid (MPA) or mycophenolate (MPS).
Gao discloses mucoadhesive formulations containing mycophenolic acid (MPA) and oxaliplatin (OXP).
Claim 8, as noted above, MPA is disclosed.
Regarding claims 14-15 and 45-47, Gao discloses the MPA is in a concentration of 0.5-1000ng/mL and the OXP is in a concentration of 10-5000 ng/mL. Therefore, the instant claims differ from the references only in the specific ratios of OXP and MPA selected for the compositions. However, It would have been deemed prima Facie obvious to one having ordinary skill in the art at the time of the invention to optimize the ratios to dosage form for the topical treatment of oral lesions because the determination of a specific percentage having the optimum therapeutic effect is well within the level of one having ordinary skill in the art, and the artisan would be motivated to determine optimum amounts to get the maximum effect of the active compounds. Therefore, the invention as Whole has been prima face obvious to one of ordinary skill in the art at the time the invention was made.
Regarding claims 28-32, treatment of oral premalignant lesions is disclosed. It is noted that leukoplakia and oral lichen planus as premalignant lesions
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the invention to have used the combination disclosed by Gao in the formulation of Obeid since it is disclosed the combination achieves high local concentration on target oral premalignant lesions.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MELISSA S MERCIER whose telephone number is (571)272-9039. The examiner can normally be reached M-F 6:30 am to 4 pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert A Wax can be reached at 571-272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MELISSA S MERCIER/ Primary Examiner, Art Unit 1615
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