DETAILED ACTION
Status of Application
Receipt of the amendments to the claims and applicant arguments/remarks, filed 06/23/2026, 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 Claims 19-36, 38-40 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species and inventions, there being no allowable generic or linking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. 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Any rejection or objection not reiterated in this action is withdrawn.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 1 is objected to because of the following informalities: Claim 1 comprises the typographic error “molecular weight of 400 to” that needs to be corrected to “molecular weight of from 400 to” (see claim 37). 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.
Claim 1 recites the limitations: (i) “at least one polymerizable monomer”, and “the polymerizable monomer is methacrylic acid”; and (ii) “at least one solvent” and “the at least one solvent comprises polyethylene glycol” that is not reasonably clear. First, it is unclear what polymerizable monomer should be used in the claimed fluid fill mass – a mixture (i.e., “at least one”), or methacrylic acid. Second, it is unclear what solvent should be used in the claimed fluid fill mass. Is it a mixture (i.e., “at least one solvent”) comprising a solvent, polyethylene glycol having molecular weight of 400-600 Da that may include other compounds/liquids even in large amounts (i.e., comprising)? Therefore, the scope of the claim is not reasonably clear. Clarification is required.
Claim 13 (dependent on claims 1, 7) discloses the fluid fill mass consisting of naproxen sodium/active ingredient, methacrylic acid/monomer, polyethylene glycol, and 2,2-dimethoxy-2- phenylacetophenone/polymerization initiator. First, it is unclear what is used/disclosed herein as “at least one solvent”. Second, it is unclear which PEG should be used. Therefore, it is unclear how claim 13 narrows the scope of the claim upon which it depends. Similar is applied to claim 14 regarding the limitation “polyethylene glycol”. Clarification is required.
Claim 15 (dependent on claims 1, 11) discloses the fluid fill mass consisting of ibuprofen/active ingredient, methacrylic acid/monomer, ethanol/solvent, and 2,2-dimethoxy-2-phenylacetophenone/polymerization initiator. In the present case, it is noted that said fluid fill mass does not include PEG having molecular weight of 400-600 Da. Therefore, it is unclear how claim 15 narrows the scope of the claim upon which it depends. Clarification is required.
Claim 37 recites the limitation "polyethylene glycol 400" that is unclear. As stated previously, it is unclear what the term "400" does imply. This limitation was interpreted as best understood as "polyethylene glycol having molecular weight of 400 Da". Clarification is required.
Claim 41 recites the limitation “polymerizable monomers comprises a mixture of methacrylic acid and a salt of methacrylic acid”. As stated previously, said limitation is not reasonably clear, because polymerizable monomers (i.e., molecules) are defined as a mixture (i.e., comprising). Clarification is required.
Claim 43 recites the limitation “a dissolution test conducted in accordance with Real Farmacopea Espanola 2008 Monograph 2.9.1”. To this point, it is noted that citations of prior art under 35 U.S.C. § 301 and 37 CFR § 1.501 are not part of the patent claims; they are separate submissions that may be filed to help define claim meaning, but they do not become claim language. In the present case, the claimed dissolution test is not clearly delineated. It is unclear to what solutions at pH 1.2 and /or pH 6.8 the claimed “composition comprising at least one solvent” should be exposed. 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 06/23/2026, have been fully considered, but they were not found to be persuasive. New arguments and/or rejections have been added to the record to clarify the position of the examiner and/or to address newly introduced amendments. Applicant is advised to clarify the compounds to be included into the claimed fluid fill mass composition/product, the structure of the claimed fluid fill mass 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. As stated previously, 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).
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.
Conclusion
No claim is allowed at this time.
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.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert A. Wax can be reached on (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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/OLGA V. TCHERKASSKAYA/
Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615
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