DETAILED ACTION
This action is in response to Applicant’s submission dated April 24, 2026, in which Applicant canceled claims 19-20, added new claims 21-26, amended claim 17, withdrew claims 1-16, and elected the invention of Group V.
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 .
Election/Restriction
Applicant’s election of Group V in the reply filed on April 24, 2026 is acknowledged. 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)).
Claims 1-16 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a non-elected Groups I-IV, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on April 24, 2026.
The requirement is still deemed proper and is therefore made FINAL.
Claims 17-18 and 21-26 are examined. A complete reply to the final rejection must include cancellation of non-elected claims or other appropriate action (37 CFR 1.144) See MPEP § 821.01.
Applicant is reminded that upon the cancellation of claims to a non-elected invention, the inventorship must be amended in compliance with 37 CFR 1.48(b) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. Any amendment of inventorship must be accompanied by a request under 37 CFR 1.48(b) and by the fee required under 37 CFR 1.17(i).
Information Disclosure Statement
The references contained in the IDS dated November 8, 2023 are made of record.
Claim Rejections - 35 USC § 103
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 non-obviousness.
Determining the scope and contents of the prior art.
Claims 17-18, 21, and 23-26 are rejected under 35 U.S.C. § 103 as being unpatentable over Saunders, et al., J. of Cellular Biochemistry, Vol. 100, No. 3, pp. 703-715 (2007).
Saunders, et al. discloses that Ca2+ and Pi ion pairs induce osteoblast apoptosis, but osteoblasts pretreated with 5-10 µM bongkrekic acid maintain the viability osteoblasts treated with 3 mM Pi and 1.9 mM Ca2+ (see p. 704, left column; p. 707, left column; and figure 2C).
Ascertaining the difference between the prior art and the claims at issue.
Claim 17 differs from Saunders, et al. with respect to a pharmaceutical composition for promoting bone formation or preventing or treating bone diseases as compared to methods with the same function. Said differences are matters which a person of ordinary skill in the art could easily derive through application of bongkrekic acid to methods of promoting bone formation or preventing or treating a bone disease in a subject in need thereof, in consideration of the feature disclosed in Saunders, et al. wherein bongkrekic acid inhibits osteoblast apoptosis (see p. 704, left column; p. 707, left column; and figure 2C).
Claim 23 pertains to the feature wherein an agent increases the proportion of osteoblast-derived mitochondria, claim 25 pertains to the feature wherein the expression of at least one selected from the group consisting of Alp1 and Ibsp increases. The limitations of these mechanisms amount to matters which a person skilled int eh art could derive through specific identification of the intrinsic mechanisms of bongkrekic acid or a pharmaceutically acceptable salt thereof for promoting bone formation or preventing or treating bone diseases, and the effects thereof are also recognized within ranges which could be predicted from the effects disclosed in Saunders, et al.
In relation to claim 24, the optimal content could be easily derived by a person skilled in the art through simple repeated experiments, from the feature disclosed in Saunders, et al. of pretreatment with 5-10 µM bongkrekic acid (see p. 707, left column), and the effect thus achieved could also be predicted.
Claims 18 and 26 are matters which a person skilled in the art could easily select.
Resolving the level of skill in the art.
The Court has addressed this obviousness issue: “The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 12 (2007). “When there is a design need or market pressure to solve a problem and there are finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, … the fact that a combination was obvious to try might show that it was obvious”. Id. at 17. That is exactly the case here for the reasons, supra.
Determining the scope and contents of the prior art.
Claims 17-18 and 23-26 are rejected under 35 U.S.C. § 103 as being unpatentable over Mao, et al., Cell Death and Disease, Vol. 9, Article No. 674, pp. 1-14 (2018).
Mao, et al. discloses that, after administration of silibinin, the level of S-Opa1 is reduced, showing antioxidant and mitochondrial protective effects against the death of AGE-induced osteoblasts (see p. 5 and figures 4j and 4k).
Ascertaining the difference between the prior art and the claims at issue.
Claim 17 differs from Mao, et al. with respect to a pharmaceutical composition for promoting bone formation or preventing or treating bone diseases as compared to methods with the same function. Said differences are matters which a person of ordinary skill in the art could easily derive through application of an Opa11 to a pharmaceutical composition for promoting bone formation or for preventing tor treating bone diseases, in consideration of the feature disclosed in Mao, et al. wherein a reduced level of S-Opa1 exhibits antioxidant and mitochondrial protective effects against the death of AGE-induced osteoblasts (see p. 5, and figures 4j and 4k).
Claim 21 is matters which a person skilled in the art could easily derive via selection, in consideration of the feature disclosed in Mao, et al. wherein a reduced level of S-Opa1 exhibits antioxidant and mitochondrial protective effects against the death of AGE-induced osteoblasts (see p. 5; and figures 4j and 4k).
Claim 23 pertains to the feature wherein an agent increases the proportion of osteoblast-derived mitochondria, claim 25 pertains to the feature wherein the expression of at least one selected from the group consisting of Alp1 and Ibsp increases. The limitations of these mechanisms amount to matters which a person skilled in the art could derive through specific identification of the intrinsic mechanisms of an S-Opa1 inhibitor for promoting bone formation or preventing or treating bone diseases, and the effects thereof are also recognized within ranges which could be predicted from the effects disclosed in Mao, et al.
Claims 18 and 26 are matters which a person skilled in the art could easily select.
Resolving the level of skill in the art.
The Court has addressed this obviousness issue: “The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 12 (2007). “When there is a design need or market pressure to solve a problem and there are finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, … the fact that a combination was obvious to try might show that it was obvious”. Id. at 17. That is exactly the case here for the reasons, supra.
Claim Objections
Claim 22 is objected to as being dependent upon rejected independent claim 17, but would be allowable if rewritten in independent form including all of the limitations of the base claims and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to ERICH A LEESER whose telephone number is (571) 272-9932. The Examiner can normally be reached Monday through Friday from 10-6 PST, M-F. PST.
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s supervisor, Mr. James Alstrum-Acevedo can be reached at (571) 272-5548. The fax number for the organization where this application is assigned is 571-273-8300.
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/ERICH A LEESER/Primary Examiner, Art Unit 1622
United States Patent and Trademark Office
Tel. No.: (571) 272-9932
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