Detailed Action
The present office action is in response to the response filed on 30 Mar 2026.
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 .
Status
Claims 1-9 of the pending application have been examined on the merits. Acknowledgement is made of the amendments filed 30 Mar 2026. Acknowledgement is made of the cancellation of claims 10-11.
Priority
Applicants identify the instant application, Serial #: 18/257,261, filed 13 Jun 2023, as a National Stage Entry of International Application #: PCT/US2021/063832, filed 16 Dec 2021, which claims priority from Provisional Application #: 63/127,578, filed 16 Dec 2020.
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on 09 May 2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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.
Response to Applicant Election
Applicant’s election of Group I, claims 1-9, in the reply filed on 30 Mar 2026 is acknowledged. Applicant has further elected sirolimus as the species of PI3K/Akt/mTOR inhibitor in the reply filed 30 Mar 2026. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). Prior art was returned after a search for the elected species.
Claim Rejections - 35 USC § 112(b)
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 1-9 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.
Claim 1 is drawn to a “method of treating, preventing, and/or reducing glucocorticoid-induced osteoporosis in a subject comprising administering to the subject a PI3K/Akt/mTOR inhibitor.” It is unclear, however, what the patient population is that the method is drawn to. Claims 2-9 are rejected for failing to remedy the deficiencies of claim 1. Applicant may overcome this rejection by amending the claims to read, “A method of treating, preventing and/or reducing glucocorticoid-induced osteoporosis in a subject in need thereof…”
Claims 2-3 recites the limitation "the glucocorticoid." There is insufficient antecedent basis for this limitation in the claim. Applicant may overcome this rejection by amending to give sufficient antecedent basis for “the glucocorticoid.”
Claim 5 recites the limitation "wherein the subject has not yet exhibited glucocorticoid-induced side-effects." Claim 1, however, does not claim glucocorticoid-induced side-effects and there is insufficient antecedent basis for this limitation in the claim. Applicant may overcome this rejection by amending to give sufficient antecedent basis for “glucocorticoid-induced side-effects.”
Claim 5 recites the limitation “wherein the subject has not yet exhibited glucocorticoid-induce side effects.” It is unclear how a person having skill in the art would treat glucocorticoid-induced osteoporosis in a subject in need when the subject has not yet exhibited the effects of glucocorticoid induced osteoporosis. Applicant may overcome this rejection by amending claim 5 to clarify how the artisan would treat a side-effect that has not presented itself yet.
Claim 6 recites the limitation, “wherein the subject exhibits glucocorticoid-induced osteoporosis.” It is unclear how a person having skill in the art would prevent glucocorticoid-induced osteoporosis in a subject in need when the subject has already exhibited the side-effects the artisan was attempting to prevent. Applicant may overcome this rejection by amending claim 6 to clarify how the artisan would prevent a side-effect that has already presented itself.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 9 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 9 states “wherein the PI3K/Akt/mTOR inhibitor is a PI3K inhibitor, an Akt inhibitor, or an mTOR inhibitor.” However, the term “PI3K/Akt/mTOR inhibitor” is a PI3K inhibitor, an Akt inhibitor, or an mTOR inhibitor and the claim therefore does not narrow claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 5, and 7-9 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lesovaya et al. (Mol Cancer Ther, 2020, 19:1898-1908; provided in IDS 05/09/25), hereinafter Lesovaya.
The instantly elected claims are drawn to a method of treating, preventing, or reducing glucocorticoid-induced osteoporosis by administering a PI3K/Akt/mTOR inhibitor. Applicant has elected sirolimus as the species of PI3K/Akt/mTOR inhibitor. Applicant has identified that sirolimus is also known as rapamycin in the remarks filed 30 Mar 2026. The claims narrow the sequence of administration of the PI3K/Akt/mTOR inhibitor to co-administration with (claim 2) or prior to (claim 3) a glucocorticoid. Applicant has further narrowed the claims to include when a subject exhibits glucocorticoid induced side effects selected from osteoporosis, skin atrophy, muscle atrophy, metabolic disorder, and endocrine disorder (claim 4) or when the subject has not exhibited any side effects (claim 5).
Lesovaya teaches that chronic treatment with glucocorticoids leads to adverse effects including skin and muscle atrophy and osteoporosis (Abstract). One such possibility of treatment is using PI3K/Akt/mTOR inhibitors to test whether dexamethasone-induced atrophy and osteoporosis decreased when the inhibitor is administered prior to the glucocorticoid. Lesovaya teaches that pre-treating an osteoporosis mouse model with the mTOR inhibitor rapamycin before administering dexamethasone prevents development of dexamethasone-induced osteoporosis (Abstract; pg. 1899, column 1; pg. 1899, column 2; pg. 1905, column 1; and pg. 1907, column 1).
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.
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.
Claim(s) 1-4 and 7-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent No. 9,980,976, hereinafter ‘976, further in view of Shen et al. (J Cell Physiol, 2018, 233:3929-3944), hereinafter Shen, and Canalis et al. (Osteopros Int, 2007, 18:1319-1328), hereinafter Canalis.
‘976 teaches a method for treating diseases, disorders, and conditions associated with glucocorticoid receptor expression and activity by administering a REDD1 inhibitors before, concurrently with, or after a glucocorticoid receptor agonist to a patient in need (pg. 1, Abstract; column 2, lines 54-62). ‘976 teaches that REDD1 inhibitors reduce or alleviate glucocorticoid-induced skin atrophy and glucocorticoid antrophogenic effects (column 2, lines 18-21). ‘976 teaches that suitable REDD1 inhibitors include rapamycin (column 3, line 7; column 7, lines 36-38). ‘976 also teaches that osteoporosis is a side effect of glucocorticoid receptor agonism (column 17, lines 1-5; column 33, lines 55-60). ‘976 teaches that an embodiment of the reference invention includes administering a REDD1 inhibitor to a patient when the patient was previously administered a glucocorticoid receptor agonist and is exhibiting negative side effects (column 13, lines 29-32). However, ‘976 does not teach treatment of glucocorticoid-induced osteoporosis by administering a PI3K/Akt/mTOR inhibitor.
Shen teaches that mTOR signaling has been suggested as a target in various diseases and that inhibition of mTOR signaling is suggested to have positive impact on bone growth (pg. 3932, column 2). Shen further teaches that inhibition of mTOR by rapamycin may be a feasible therapeutic approach for senile osteoporosis (pg. 3936, column 2).
Canalis teaches that glucocorticoid-induced osteoporosis is the most common form of secondary osteoporosis (Abstract). Further, Canalis teaches that glucocorticoids decrease the number and function of osteoblasts leading to a suppression of bone formation (pg. 1320).
Based on the teachings of ‘976, Shen, and Canalis, a person having ordinary skill in the art would treat glucocorticoid-induced osteoporosis, as taught by Shen and Canalis, with a PI3K/Akt/mTOR inhibitor such as rapamycin, as taught by ‘976. The artisan would be motivated to perform this treatment because inhibition of mTOR signaling has a positive impact on bone growth. The artisan would have a reasonable expectation of success that rapamycin would treat osteoporosis as taught by Canalis.
A reference is good not only for what it teaches by direct anticipation but also for what one of ordinary skill in the art might reasonably infer from the teachings (In re Opprecht 12 USPQ 2d 1235, 1236 (Fed Cir. 1989); In re Bode 193 USPQ 12 (CCPA) 1976). In light of the foregoing discussion, the examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103. From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Conclusion
No claim is allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jonathan D. Mahlum whose telephone number is (703)756-4691. The examiner can normally be reached 8:30 AM - 5:00 PM ET, M-F.
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/J.D.M./Examiner, Art Unit 1625
/Andrew D Kosar/Supervisory Patent Examiner, Art Unit 1625
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