Office Action 2: Notice of Allowance (2025-01-06)

CLAIMS:
AMENDMENTS TO THE CLAIMS

This listing of claims will replace all prior versions and listings in the above-referenced patent application.

Listing of Claims:

1.- 23. (Canceled)222

24\. (Currently Amended) A method of controlling serum calcium levels in a subject in need thereof comprising administering to the subject an effective amount of a parathyroid hormone (PTH)-Fc fusion protein, wherein the PTH-Fc fusion protein is PTH-66 having the amino acid sequence of SEQ ID NO: 8.

25\. (Original) The method of claim 24, wherein the subject has hypoparathyroidism.

26\. (Previously Presented) The method of claim 24, wherein the PTH-Fc fusion protein is administered subcutaneously.

27\. (Previously Presented) The method of claim 24, wherein the PTH-Fc fusion protein is administered once daily.

28\. (Previously Presented) The method of claim 24, wherein the PTH-Fc fusion protein is administered once weekly.

29\. (Previously Presented) The method of claim 24, wherein the PTH-Fc fusion protein is provided to the subject in an amount from about 20 pg per day to about 100 pg per day of the PTH-Fc fusion protein.

30\. - 48. (Canceled)3147

49\. (Previously Presented) The method of claim 24, wherein the PTH-Fc fusion protein is glycosylated.

50\. (Previously Presented) A method of controlling serum calcium levels in a subject in need thereof comprising administering to the subject an effective amount of a pharmaceutical composition comprising a PTH-Fc fusion protein, wherein the PTH-Fc fusion protein is PTH-66 having the amino acid sequence of SEQ ID NO: 8.

51\. (Previously Presented) The method of claim 50, wherein the pharmaceutical composition is administered subcutaneously.

52\. (Previously Presented) The method of claim 50, wherein the pharmaceutical composition is administered once daily.

53\. (Previously Presented) The method of claim 50, wherein the pharmaceutical composition is administered once weekly.

54\. - 56. (Canceled)5555

57\. (Previously Presented) The method of claim 50, wherein the PTH-Fc fusion protein is glycosylated.

58\. (Currently Amended) A method of controlling serum calcium levels in a subject in need thereof comprising administering to the subject an effective amount of a pharmaceutical dosage form comprising a PTH-Fc fusion protein, wherein the PTH-Fc fusion protei

 is PTH-66 having the amino acid sequence of SEQ IDNO: 8.

59\. (Previously Presented) The method of claim 58, wherein the pharmaceutical dosage form is administered subcutaneously.

60\. (Previously Presented) The method of claim 58, wherein the pharmaceutical dosage form is administered once daily.

61\. (Previously Presented) The method of claim 58, wherein the pharmaceutical dosage form is administered once weekly.

62\. - 64. (Canceled)6363

65\. (Previously Presented) The method of claim 58, wherein the pharmaceutical dosage form is a liquid dosage form suitable for administration by injection or infusion.

OFFICE ACTION:
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 .
EXAMINER’S AMENDMENT
An examiner’s amendment to the record appears below. Should the changes and/or additions be unacceptable to applicant, an amendment may be filed as provided by 37 CFR 1.312. To ensure consideration of such an amendment, it MUST be submitted no later than the payment of the issue fee.
Authorization for this examiner’s amendment was given in an interview with Alina Khankin, applicant’s representative, on 12/6/24.
IN THE CLAIMS
In claims 50, 54, and 58, line 1, the term “controlling” has been deleted and the following term inserted: --increasing--.
REASONS FOR ALLOWANCE
The following is an examiner’s statement of reasons for allowance:
Allowable Subject Matter – Methods of Using Issued Peptide SEQ ID NO: 8
Peptide species SEQ ID NO: 8 was not found to be reasonably taught or suggested by the prior art of record – as issued in the parent, now U.S. Patent No. 11,634,468.  Such is now allowed with the previous indication that were the instant claims amended to the same issued product scope (peptide SEQ ID NO: 8) as in ‘468; the scope of the method claims 24, 50, and 58  preambles amended “A method of [controlling] --increasing—serum calcium levels . . . “,  thereto (approved here); and a Terminal Disclaimer filed and approved over parent ‘468 (filed/approved; since there is no 35 USC 121 bar as the claims here were not restricted out of the parent and would have been open to rejoinder upon finding of the allowable product thereof) – as such the claims are now in condition for allowance.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee.  Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion

APPLICANT REBUTTAL: REMARKS
Applicant has carefully studied the Non-Final Office Action dated September 10, 2024, which issued in connection with the above-identified application. The present response is intended to be fully responsive to all points raised by the Examiner and is believed to place the claims in condition for allowance. Favorable reconsideration and allowance of the present claims are respectfully requested.
I.    Status of the Claims
Claims 24-29 and 46-65 are pending and stand rejected.
Applicant acknowledges, with thanks, the Examiner's statement at p. 2 of the Office Action that the peptide species SEQ ID NO: 8 is free of art, and claims amended to the product scope of the peptide of SEQ ID NO:8 would be allowable.
Independent claims 24, 50, and 58 are amended herein to incorporate the allowable subject matter, i.e., to specify that the PTH-Fc fusion protein is the peptide species SEQ ID NO: 8. Claims 46-48, 54-56 and 62-64 are canceled herein without disclaimer or prejudice. Applicant reserves the right to pursue canceled subject-matter in a subsequent application.
No new matter is added by way of this amendment. Upon entry of this amendment, claims 24-29, 49-53, 57-61, and 65 will be pending and under consideration.
II. Claim rejection under 35 U.S.C. §112(a)
Claims 24-29 and 46-65 have been rejected under 35 U.S.C. § 112(a) or 35 U.S.C. 112 (pre- AIA), first paragraph, as allegedly failing to comply with the written description requirement. According to the Examiner, Applicant is not in 'possession' with the full breadth of the claims with respect to PTH "variants" and polypeptide "derivatives" because guidance as to the positions to be modified was allegedly not provided.
Without acquiescing in the rejection and solely to expedite prosecution, independent claims 24, 50 and 58 are amended herein to specify that the PTH-Fc fusion protein is the peptide species SEQ ID NO: 8. Applicant submits that, as this subject-matter is considered allowable by the Examiner, all claims dependent therefrom are likewise allowable.
Reconsideration and withdrawal of the § 112 rejection is respectfully requested.
III. Non-Statutory Double-Patenting Rejection
Claims 24-29 and 46-65 have been rejected on the ground of nonstatutory double patenting as allegedly being unpatentable over the claims of U.S. Pat. No. 11,634,468. Without acquiescing in the double patenting rejection and solely to expedite allowance of the application, applicant submits concurrently herewith an electronic Terminal Disclaimer over U.S. Pat. No. 11,634,468.
Applicant respectfully submits that the Terminal Disclaimer obviates the present rejection, and the application is now in condition for allowance.
CONCLUSION


CITED REFERENCE SUMMARIES: Ref US11634468: Claims:
1. A parathyroid hormone (PTH)-Fc fusion protein, wherein the PTH-Fc fusion protein is PTH-66 having the amino acid sequence of SEQ ID NO: 8.
2. The PTH-Fc fusion protein of claim 1, wherein the PTH-Fc fusion protein is glycosylated.
3. A pharmaceutical composition comprising the PTH-Fc fusion protein of claim 1 and a pharmaceutically acceptable carrier.
4. A pharmaceutical dosage form comprising the PTH-Fc fusion protein of claim 1.
5. The pharmaceutical dosage form of claim 4, wherein the dosage form is a liquid dosage form suitable for administration by injection or infusion.