DETAILED ACTION
Status of Application
Receipt of the response to the non-final office action, the amendments to the specification and claims as well as applicant arguments/remarks, filed 06/22/2026, is acknowledged. Amendments to the specification have been entered.
Applicant has previously elected without traverse the invention of Group II, claims 8-26, drawn to a method of improving biomechanical integrity of the pelvic floor of a female subject by orally administering to the female subject a pharmaceutical composition comprising creatine, leucine, zinc, calcium, and magnesium.
Claims 1-26 are pending in this action. Claims 1-7 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species and inventions, there being no allowable generic or linking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 16 and 17 have been amended. Claims 8-26 are currently under consideration.
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 claims benefit of provisional U.S. Application No.63/438,705, filed January 12, 2023.
Specification
The specification is objected to because of the following informalities:
As stated previously, the specification comprises typographic errors, e.g., “2-4 g creatine” (Para. 0006) that need to be corrected to “2-4 g of creatine” (see Para. 0026). Similar is applied to other constituents recited in the instant specification (e.g., Para. 0011, 0028, 0030, 0032, 0034-0035, 0050, 0053). Appropriate correction is required.
As stated previously, the list of cited references (Pages 22-26) should be removed from the specification. MPEP 608.01. If the applicant wants these references to be printed in the patent, the applicant should submit them in the form of information disclosure statement to be considered by examiner. MPEP § 609.04(a) states "the list may not be incorporated into the specification but must be submitted in a separate paper." Further, it is noted that the publications recited in the instant application should be identified by publisher, author (if any), title, relevant pages of the publication, date, and place of publication. MPEP 609.05(a). Appropriate correction is required.
Claim Objections
Claims 8-13, 18-23 are objected to because of the following informalities:
As stated previously, claim 8 comprises the typographic error “2-4 g/day creatine” that needs to be corrected to “2-4 g/day of creatine”. Similar is applied to other constituents recited in claim 8, as well to claims 9, 18, 19.
As stated previously, claim 10 comprises the typographic error “the creatine is creatine monohydrate” that needs to be corrected to “creatine is in the form if creatine monohydrate” or clarified. Similar is applied to claim 20, as well as to claims 11-13 and 21-23 regarding the limitations “the zinc is zinc sulfate” (claims 11, 21), “the calcium is calcium citrate” (claims 12, 22), “the magnesium is magnesium citrate” (claims 13, 23).
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 8-26 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.
The main purpose of definiteness of claim language is to ensure that the scope of the claims is clear so the public is informed of the boundaries of what constitutes infringement of the patent; and to provide a clear measure of what the applicant regards as the invention so that it can be determined whether the claimed invention meets all the criteria for patentability. MPEP 2173. In the present case:
Claim 8 discloses the method of orally administering to a female subject claimed compounds, i.e., creatine/C4H9N3O2, leucine, zinc/Zn, calcium/Ca, magnesium/Mg in claimed amounts. Claims 10-13 (dependent on claim 8) disclose the use of creatine monohydrate/C4H11N3O3 (C4H9N3O2.H2O), zinc sulfate/ZnSO4, calcium citrate/Ca₃(C₆H₅O₇)₂, magnesium citrate/C₆H₆MgO₇. Therefore, it is unclear how claims 10-13 narrow the scope of claim 8 upon which they depend. Similar is applied to claims 18 and 20-23 (dependent on claim 18). Clarification is required.
Claim 8 discloses the method of orally administering to a female subject claimed compounds (i.e., creatine, leucine, zinc, calcium, magnesium) in claimed amounts. In the present case it is not clear what should be used in the claimed method – composition consisting of claimed compounds present in claimed amounts, OR compositions that may include other additives (i.e., comprising). Similar is applied to claim 18. Clarification is required.
Claim 14 (dependent on claim 8) recites the limitation “administration is once daily”. In the present case, it is not reasonably clear how claim 14 narrows the scope of the claim upon which it depends, given that claim 8 recites the limitation “administration continues daily”. Similar is applied to claims 18 and 24. Clarification is required.
Claims 9, 15-17, 19, 25, 26 are rejected as being dependent on rejected independent claims 8 and 18 and failing to cure the defect.
Allowable Subject Matter
The following is a statement of reasons for the indication of allowable subject matter: The prior art teaches a large variety of compositions that may include compounds as instantly claimed and can be used for improving muscle functioning. The prior art does not teach a method of improving pelvic floor muscle functioning in a female by orally administering to the female claimed compounds in claimed amounts daily for at least 6 weeks. Applicant teaches that said approach provides significant improvement in pelvic floor muscle strength and biomechanical integrity of the pelvic floor and leads to better urinary control after only six weeks of treatment.
Response to Arguments
Applicant's arguments, filed 06/22/2026, have been fully considered, but they were not found to be persuasive for the reasons set forth above. Applicant is advised to clarify the claimed language and scope, the structure of the claimed formulation to be used in the claimed method and clearly point out the patentable novelty of the claimed invention to place the application in condition for allowance.
Conclusion
Claims 8-26 are rejected but would be allowable if rewritten or amended to overcome the objections and 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.
THIS ACTION IS MADE FINAL. 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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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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/OLGA V. TCHERKASSKAYA/
Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615
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