DETAILED ACTION
Status of Application
Receipt of the response to the restriction/election requirement, the amendments to the claims and applicant arguments/remarks, filed 03/05/2023, is acknowledged.
Applicant has 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 Claims 1-7 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species and inventions, there being no allowable generic or linking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. Claim 9 has 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:
The specification comprises references on publications (e.g., Para. 0001-0003, 0026-0027, 0029, 0031, 0033, 0037, 0042-0045, 0048, 0059, 0061-0062, 0068, 0073). The incorporation of essential material in the specification by reference to an unpublished U.S. application, foreign application or patent, or to a publication is improper. Applicant is required to amend the disclosure to include the material incorporated by reference, if the material is relied upon to overcome any objection, rejection, or other requirement imposed by the Office. The amendment must be accompanied by a statement executed by the applicant, or a practitioner representing the applicant, stating that the material being inserted is the material previously incorporated by reference and that the amendment contains no new matter. 37 CFR 1.57(g).
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.
The specification comprises acronyms without proper definition, “SD” (e.g., Para. 0048-0049). The acronym should be given once in parenthesis after the first use of the full term, and then the acronym used alone thereafter if needed. Appropriate correction is required.
List of cited references (Pages 22-26) should be removed from the specification. MPEP 608.01. If the applicant wants these references 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.
Information Disclosure Statement
The information disclosure statement, filed 01/12/2024, is acknowledged and has been considered. Please see the attached initialed PTO-1449. The information disclosure statement does not include/have a signature of the applicant or representative that is required in accordance with CFR 1.33.
Claim Objections
Claims 8-13, 16, 18-23 are objected to because of the following informalities:
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.
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” for clarity. 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).
Claim 16 comprises acronyms “SD”. The acronym should be given once in parenthesis after the first use of the full term, and then the acronym is used alone thereafter if needed. Further, regarding the limitation “0.40 (SD)” it is noted that parenthetical expressions are not permissible, which do not contribute to clearness or exactness in stating applicant’s invention (Ex parte Cahill, 1893 C. D., 78; 63 O. G., 2125).
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.
Claim 8 discloses the method of orally administering to a female subject claimed compounds (i.e., creatine, leucine, zinc, calcium, magnesium) in claimed amounts. Claims 10-13 (dependent on claim 1) disclose the use of creatine monohydrate, zinc sulfate, calcium citrate, magnesium citrate. In the present case, it is unclear what amounts/dosages of creatine monohydrate, zinc sulfate, calcium citrate, magnesium citrate should be used in the claimed method. 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 claim amounts, OR compositions that may include other additives (i.e., comprising). Similar is applied to claim 18.
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.
Claim 16 recites the limitation “the subject's BI score is improved by at least 0.40 (SD) compared to the subject's baseline BI score” that is unclear and indefinite. To this point, it is noted that where a claimed value (i.e., biomechanical integrity) varies with its method of measurement and several alternative methods of measurement are available (e.g., vaginal tactile imaging, digital palpation, perineometry, electromyography, etc.) the value is indefinite when the claim fails to concurrently recite the method of measurement used to obtain it. See Honeywell Intl. v. Intl. Trade Commn., 341 F.3d 1332, 1340 (Fed. Cir. 2003). Similar is applied to claim 17. Clarification is required.
Claims 9, 15, 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.
Conclusion
Claims 8-26 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.
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 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