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 .
Priority
This application is a national stage application under 35 U.S.C. § 371 of International Application No. PCT/US2022/011262, filed 01/05/2022, which claims the priority benefit of PRO Application No. 63/134,414, filed 01/06/2021.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 01/13/2025 was filed in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Status of the Application
Claims 1-18 are pending and currently under examination.
Claim Rejections - 35 USC § 112
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.
Claim 6 is 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The term “associated” in claim 6, line 2 is a relative term which renders the claim indefinite. The term “associated” 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. It is unclear what degree of association is necessary to be considered a condition associated with bone loss, for example it is unclear if back pain in a care taker induced by physically assisting a patient with severe bone loss would be a condition encompassed by the claims. Accordingly, the claims are indefinite. Removing the term "associated" from the claims would overcome this rejection.
Allowable Subject Matter
Claim 7 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.
The following is a statement of reasons for the indication of allowable subject matter: The instant claims are drawn to a method for treating bone loss, wherein said method comprises the steps of (a) identifying a mammal as having bone loss, and (b) administering a composition comprising 4-AP or one or more derivatives of 4-AP to said mammal and makes a contribution over the prior art of Kaye (US 2014/0017226 Al) who teaches a method of treating a subject afflicted with multiple sclerosis or presenting a clinically isolated syndrome comprising administering to the subject fampridine (4-AP) (Abstract). Neither Kaye individually or in combination with the next closest prior art of Li (WO 2010/053584), who discloses compositions use in preventing and/or treating various diseases or disorders including bone loss, does not teach or fairly teach or suggest a method for treating bone loss or improving the microarchitecture of a bone, wherein said method comprises (a) identifying a mammal as having bone loss, and (b) administering a composition comprising 4-AP or one or more derivatives of 4-AP to said mammal. Though Li does teach compositions of treating bone loss and does disclose 4-AP, Li teaches 4-AP as a KATP channel blocker and does not provide any explicit teaching sufficient to satisfy the limitations of the instant claims.
Conclusion
Claims 1-5 and 8-18 are allowable, claims 6 is rejected. Claim 7 is objected to.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERNESTO VALLE JR whose telephone number is (703)756-5356. The examiner can normally be reached 0730-1700 M-F EST, 1st Friday off.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Adam C Milligan can be reached at 571-270-7674. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/E.V./Examiner, Art Unit 1623
/ADAM C MILLIGAN/Supervisory Patent Examiner, Art Unit 1623
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