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
Status of Application, Amendments, and/or Claims
The Information Disclosure Statement (IDS) filed 17 October 2022 has been entered. Applicant’s amendment of the specification filed 22 December 2022 has been entered. Applicant’s amendment of the claims filed 27 October 2025 has been entered.
Election/Restriction
In the response received in 27 October 2025, Applicant elected the species of: A-a) wherein the first amount of abaloparatide is 80 mcg daily administered subcutaneously; and B-a) wherein the abaloparatide is concomitantly administered with denosumab.
Claims 1-21, 23, 25-26, 32 and 35-38 are cancelled. Claims 22, 24, 27-31, 33-34 and 39-42 are pending and under examination to the extent they read on the elected species. Claims 22, 24, 28-30, 33-34 and 39-42 read on the elected species, and claims 27 and 31 are withdrawn as being drawn to nonelected species.
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Claim Objections
Claims 28-29 and 41 are objected to because of the following informalities:
In claims 28-29, the phrase “in subjects” should be “in the subject”.
In claim 41, the phrase “wherein the subject is a subject at high risk for a fracture …” should be “wherein the subject is at high risk of a fracture …”.
Appropriate correction is required.
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.
Claims 28-29 and 40-42 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.
Claims 28-29 and 40 recite: “wherein a total hip BMD is increased at least 10% in subjects where abaloparatide is administered with ongoing treatment with denosumab for 18 months” (claim 28); “wherein a total spine BMD is increased at least 15% in subjects where abaloparatide is administered with ongoing treatment with denosumab for 18 months” (claim 29); and “wherein a total hip BMD is increased at least 10% after 18 months of administration of abaloparatide” (claim 40). The claims are unclear whether a treatment period of 18 months is required for the claimed method.
Claim 41 recites “as indicated by declining or persistently low bone mass density”. The metes and bounds of the phrase “as indicated by” are unclear (e.g., is a declining or persistently low bone mass density a required limitation?)
Claim 42 recites “wherein the subject has had denosumab therapy, followed by teriparatide therapy, and has a total hip BMD below baseline at the start of teriparatide therapy”. The specification does not define the baseline of a total hip BMD; further, this parameter refers to the criteria prior to the teriparatide therapy. It is unclear how the claim limits the patient to be treated in the method as recited in claim 34.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 22, 24, 28-30, 33-34 and 39-42 are rejected under 35 U.S.C. 103 as being unpatentable over Tsai et al. (J. Clin. Endocrinol. Metab., 2016, Vol. 101(5):2023–2030), in view of Leder et al. (J. Clin. Endocrinol. Metab., 2015, Vol. 100(2):697–706).
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Tsai teaches treating osteoporosis in postmenopausal women using the combination of denosumab and teriparatide (see abstract). Tsai teaches that the patients received teriparatide at a dose of 20 mg sc daily and denosumab at a dose of 60 mg sc every 6 months for a treatment period of 2 years (ibid.). Tsai teaches that two years of combined teriparatide and denosumab improved bone microarchitecture and strength more than the individual treatments, particularly in cortical bone; and Tsai suggests that this regimen may be beneficial in postmenopausal osteoporosis (ibid.).
Tsai teaches as set for above. Tsai, however, does not teach combining denosumab with abaloparatide for the treatment.
Leder compared the effects of abaloparatide (a parathyroid hormone-related protein or PTHrP) and teriparatide (hPTH 1-34) on bone mineral density (BMD) in postmenopausal women with osteoporosis. Leder teaches that 24 weeks of daily sc abaloparatide at a dose of 20, 40 or 80 mg increased BMD of the lumbar spine, femoral neck, and total hip in a dose-dependent fashion; moreover, the total hip BMD increase in the 80 mg group of abaloparatide was greater than with the marketed dose of teriparatide (20 mg daily sc) (see Abstract).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the combination of denosumab and abaloparatide for treating osteoporosis in postmenopausal women. One of ordinary skill in the art would have been motivated to do so, because Tsai teaches treating osteoporosis in postmenopausal women using the combination of denosumab and teriparatide, and Leder further teaches that abaloparatide, particularly at a dose of 80 mg daily sc, is more effective than the marketed dose of teriparatide (20 mg daily sc) in increasing BMD in the postmenopausal women with osteoporosis. Therefore, the combined teachings provide a reasonable expectation of success in treating the patients.
Regarding claim 42, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the combination of denosumab and abaloparatide to treat the patients in Tsai that had inadequate response after the treatment with denosumab and teriparatide. One of ordinary skill in the art would have been motivated to do so, because Leder teaches that abaloparatide, particularly at a dose of 80 mg daily sc, is more effective than teriparatide in increasing BMD in the postmenopausal women with osteoporosis. Therefore, a person skilled int eh art would have a reasonable expectation of success in treating the patients.
Conclusion
NO CLAIM IS ALLOWED.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Xiaozhen Xie, whose telephone number is 571-272-5569. The examiner can normally be reached on M-F, 8:30-5.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Vanessa L. Ford, can be reached on 571-272-0857. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/XIAOZHEN XIE/Primary Examiner, Art Unit 1674 November 12, 2025