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
Continued Examination Under 37 CFR 1.114
1. A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on March 09, 2026 has been entered.
Response to Amendment
2. Claim 1 has been amended, claims 6-9 canceled and claim 47 added as requested in the amendment filed on October 17, 2025. Following the amendment, claims 1-5, 12, 15, 19-27 and 47 are pending in the instant application.
3. Claims 1-5, 12, 15, 19-27 and 47 are under examination in the instant office action.
4. Any objection or rejection of record, which is not expressly repeated in this action has been overcome by Applicant’s response and withdrawn.
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.
5. Claims 1-5, 12, 15, 19-27 and 47 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.
6. Claims 1 and 47 are vague and indefinite for failing to clearly articulate the critical dose of GDF11 polypeptide intended for treatment of “a larger mammalian species.” Specifically, the claims currently recite a dose of 0.8 mg/kg (body weight) for administration to a rodent species, “and the same such dose in a larger mammalian species, normalized to the molecular weight of GDF11 polypeptide molecule relative to the body weight of the subject per day,” emphasis added. Thus, to obtain the dose intended for clinical administration, the starting point is the same dose as 0.8 mg/kg (body weight), which is normalized to the molecular weight of GDF11 polypeptide molecule, which is vague and ambiguous by definition as related to gram equivalents per liter of solution expressed in molar concentration. Next, the normalized dose is calculated relative to the body weight, wherein it is not clear what units are used for “…/kg.” Finally, the dose is expressed as a daily dose, which makes this limitation in conflict—not “the same”— with the dose used in rodent species. Applicant is advised to rewrite the claims so that every element, especially the critical distinguishing property of the instant invention, the dose of GDF11, is set forth in positive, exact, intelligible language, so that there is no uncertainty about what it meant (means).
7. Applicant is advised that one of the purposes of the 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph is to provide a clear warning to others as to what constitutes infringement of the patent (see, e.g., Solomon v. Kimberly-Clark Corp., 216 F.3d 1372, 1379, 55 USPQ2d 1279, 1283 (Fed. Cir. 2000). The test for definiteness under 35 U.S.C. § 112, second paragraph, is whether “those skilled in the art would understand what is claimed when the claim is read in light of the specification.” Orthokinetics, Inc. v. Safety Travel Chairs, Inc., 806 F .2d 1565 (Fed. Cir. 1986) (citations omitted).
In precedential decision Ex parte Kenichi Miyazaki, Appeal 2007-330, BPAI stated “In particular, rather than requiring that the claims are insolubly ambiguous, we hold that if a claim is amendable to two or more plausible claim constructions, the USPTO is justified in requiring the applicant to more precisely define the metes and bounds of the claimed invention by holding the claim unpatentable under 35 U.S.C. § 112, second paragraph.”
Further, the federal Circuit stated in Halliburton Energy Servs.:
When a claim limitation is defined in purely functional terms, the task of determining whether that limitation is sufficiently definite is a difficult one that is highly dependent on context (e.g., the disclosure in the specification and the knowledge of a person of ordinary skill in the relevant art area). We note that the patent drafter is in the best position to resolve the ambiguity in the patent claims, and it is highly desirable that patent examiner demand that applicants do so in appropriate circumstances so that the patent can be amended during prosecution rather than attempting to resolve the ambiguity in litigation.
Halliburton Energy Servs. V. M-ILLC 514 F .3d 1244, 1255 (Fed. Cir. 2008) (emphasis added).
8. Claim 12 recites the limitation "substitutions or deletions relative to the amino acid sequence of SEQ ID NO: 1" in claim 1. There is insufficient antecedent basis for this limitation in the claim because claim 1 is limited to the amino acid sequence of SEQ ID NO: 1 only.
9. Claims 2-5, 15 and 19-27are indefinite for being dependent from indefinite claim.
Conclusion
10. No claim is allowed.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/OLGA N CHERNYSHEV/Primary Examiner, Art Unit 1675
April 21, 2026
Prosecution Insights