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 .
DETAILED ACTION
Response to Amendment
1. Claims 1 and 11 have been amended and claim 4 canceled as requested in the amendment filed on January 07, 2026. Following the amendment, claims 1-3 and 5-85 are pending in the instant application.
2. Claims 6, 8 and 15-85 stand withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention(s), there being no allowable generic or linking claim. Election was made without traverse in the reply filed on October 10, 2025.
3. Claims 1-3, 5, 7 and 9-14 are under examination.
4. Any objection or rejection of record, which is not expressly repeated in this action has been overcome by Applicant’s response and withdrawn.
5. Applicant’s arguments filed on July 06, 2026 have been fully considered but found to be not persuasive for reasons set forth below. New grounds of rejection necessitated by Applicant’s amendment are set forth below as well.
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.
6. Claims 1-3, 5, 7 and 9-14, as amended, 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
7. Claim 1, as currently presented, makes no sense. First, the claim recites limitation “administering to a subject […] agonizing agent increasing the level of” BMP. It is not obvious what stands for an “agonizing agent increasing the level.” Second, the claim recites “the level or Bone Morphogenic Protein (BMP) binding activity,” which is indecipherable. Third, it is not clear what comparison point is made by reciting limitation “relative to their normal activities,” such as what activities are intended by the claim? Applicant is advised to rewrite the claim to better express claimed subject matter.
8. Claims 2 and 3 stand indefinite for reasons of record in section 6 of Paper mailed on January 07, 2026.
9. Claims 1-3 stand vague and indefinite for reasons of record in section 7 and 8 of Paper mailed on January 07, 2026. Applicant is advised that amendment to claim 1 did not overcome the rejection of claims 2 and 3.
10. Claims 5, 7 and 9-14, as amended, are rejected under 35 U.S.C. 112, second paragraph, as being incomplete for being dependent from a cancelled claim. See MPEP § 608.01(n), V.
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
11. Claims 1-3 stand rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement for reasons of record in section 11 of Paper mailed on January 07, 2026.
At pp. 11-12 of the Response, Applicant traverses the rejection by first citing Teva Pharmaceuticals V. Eli Lilly & Co. case law, and arguing that “because preparation of antibodies is now considered routine, and preparation of any suitable antibody will allow the method to be carried out, it is unreasonable to require that the structure-function relationship be satisfied for antibodies in a method of treatment claim.” Applicant’s arguments have been fully considered but found to be not persuasive because they appear misplaced since the instant claims 1-3 do not recite any antibodies, including “MuSK muscle regeneration agonizing antibodies.”
For reasons of record fully explained earlier and reasons above, the rejection is maintained.
Conclusion
12. No claim is allowed.
13. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OLGA N CHERNYSHEV whose telephone number is (571)272-0870. The examiner can normally be reached 9AM to 5:30PM, Monday to 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, Jeffrey Stucker can be reached at (571)272-0911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/OLGA N CHERNYSHEV/Primary Examiner, Art Unit 1675
July 29, 2026
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