DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission, filed 01/20/2026, has been entered.
Status of Application
Receipt of the amendments to the claims and applicant arguments/remarks, filed 01/20/2026, is acknowledged.
Applicant has previously elected without traverse the invention of Group I, claims 1-18, 37 drawn to a composition comprising a fluid fill mass comprising an active ingredient(s), a polymerizable monomer(s), a polymerization initiator(s).
Claims 1, 4, 7, 9, 11, 13-16, 19-43 are pending in this application. Claims 19-36, 38-40 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species and inventions, there being no allowable generic or linking claim. Claims 2-3, 5-6, 8, 10, 12, 17-18 have been cancelled previously. Claims 1, 37 have been amended. New claims 41-43 have been added. No new matter was added. Claims 1, 4, 7, 9, 11, 13-16, 37, 41-43 are currently under consideration.
Any rejection or objection not reiterated in this action is withdrawn. Applicant's amendments necessitated new ground(s) of rejection presented in this office action. 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/US2019/056481, filed October 16, 2019, which claims benefit of provisional U.S. Application No. 62/915,231, filed October 15, 2019, and U.S. Application No. 62/746,184, filed October 16, 2018.
Claim Objections
Claim 37 is objected to because of the following informalities: As stated previously, claim 37 comprises the typographic error “in an amount less than” that needs to be corrected to “in an amount of less than”. Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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 1, 4, 7, 9, 11, 13-16, 37, 41-43 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 pre-AIA the applicant regards as the invention.
Newly amended claim 1 recites the limitations “at least one solvent” and “the solvent is polyethylene glycol” that is not reasonably clear. First, it is unclear what solvent should be used in the claimed compositions – a mixture (i.e., “at least one”), or polyethylene glycol (PEG). Second, it is noted that the instant specification teaches the use of PEG as a polymer in a fluid mass (Page 8), low molecular PEG as a solvent constituent (Page 12), and/or PEG as an optional excipient (Page 17). Therefore, the scope of the claim is not reasonably clear. Similar is applied to claim 13, as well as to claims 14-15 regarding the use of PEG and ethanol, and to claim 37 regarding the use of PEG with ethanol and water. Clarification is required.
New claim 41 recites the limitation “polymerizable monomer comprises a mixture of methacrylic acid and a salt of methacrylic acid” that is not reasonably clear, because the molecule/monomer is defined as a mixture (i.e., comprising). Clarification is required.
New claim 43 recites the term "about” that is a relative term, which renders the claim indefinite. This term is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Clarification is required.
New claim 43 recites the limitation “composition releases at least 80% of the active ingredient” that is unclear and indefinite, given that said numerical limitation is shown with and without units of measurements. Therefore, the metes and bounds of the claim are not reasonably clear. Clarification is required.
Claims 4, 7, 9, 11, 16, 42 are rejected as being dependent on rejected independent claim 1 and failing to cure the defect.
Response to Arguments
Applicant's arguments, filed 01/20/2026, have been fully considered, and they were found to be persuasive. The 103-rejection of record has been withdrawn. The prior art does not teach a fluid fill mass composition comprising constituents/compounds as instantly claimed that does not comprise/include a cross-linking agent, and wherein activation of a polymerization initiator leads to production of a polymeric fill matrix in a form of a solid or gel-like polymeric fill that entraps active ingredients in a reversible polymer matrix, i.e., in a matrix that is in a collapse state at acidic pH (e.g., in stomach) preventing disintegration/dissolution of the filler in this medium, and wherein said matrix can dissolve/disintegrate in the gastrointestinal tract (e.g., at pH 6.8). Applicant is advised to clarify the compounds to be included into the claimed composition/product, the structure of the claimed compositions and clearly point out the patentable novelty, which the applicant thinks the claims present in view of the state of the art, to place the application in condition for allowance.
Conclusion
Claims 1, 4, 7, 9, 11, 13-16, 37, 41-43 are rejected, but would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
Regarding withdrawn claims 19-36, 38-40 nonelected without traverse (see Office Action, filed 11/13/2023), the applicant is advised to cancel or amend the withdrawn claims to clarify the special technical feature for rejoinder. MPEP 821. 04.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OLGA V. TCHERKASSKAYA whose telephone number is (571)270-3672. The examiner can normally be reached 9 am - 6 pm, Monday - Friday.
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/OLGA V. TCHERKASSKAYA/
Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615