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
This action is in response to Applicant’s amendment filed January 12, 2026 in reply to the First Office Action on the Merits mailed August 5, 2025. Claims 33, 35, and 39 have been amended; and claims 1-28 have been canceled. Claims 29-32 and 36-38 have been withdrawn. Claims 33-35 and 39 are under examination.
Withdrawal of Prior Objection - Drawings
The drawings have been satisfactorily amended on corrected drawing sheets in compliance with 37 CFR 1.121(d). Therefore, the objection to the drawings presented in the First Office Action on the Merits mailed August 5, 2025 is hereby withdrawn.
Claim Objections
Claims 33 and 35 have been satisfactorily amended. Therefore, the objections to these claims presented in the First Office Action on the Merits mailed August 5, 2025 are hereby withdrawn.
Withdrawal of Prior Claim Rejections - 35 USC § 112(b)
Claims 33 and 35 have been satisfactorily amended. Therefore, the 35 USC 112(b) rejection presented in the First Office Action on the Merits mailed August 5, 2025 is hereby withdrawn.
Abstract
The abstract of the disclosure is objected to because of the following:
1. The phrase about “aspects of the present disclosure relate to” should be deleted. Further, the phrase “aspects of the present disclosure generally relate to…some aspects of the present disclosure relate to” is awkward and redundant.
2. Applicant is advised to concisely summarize the key aspects of the invention which are new to the art to which the invention pertains. For example, “method of treating osteosarcoma”, via “administering a composition” having all of “hydroxyapatite nanoparticles”, “doxorubicin”, and “zoledronic acid” certainly appear to be some of the key aspects of the invention.
A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 33-35 and 39 are rejected under 35 U.S.C. 103 as being unpatentable over Ghosh et al. (J Nanosci Nanotech. 2020; 20: 3994-4004; published July 1, 2020), in view of Chang et al. (Oncology Letters. 2012; 4: 299-304), and Lu et al. (Mat Sci Eng. 2018; 82: 225-233).
Applicant Claims
Applicant claims a method of treating e.g. osteosarcoma in a subject in need thereof comprising administering to the subject once every 7 days a composition comprising doxorubicin, zoledronic acid, and a particulate material; wherein the particulate material is hydroxyapatite with particle size of 20-200 nm.
Determination of the Scope and Content of the Prior Art (MPEP §2141.01)
Ghosh et al. disclose a method of treating osteosarcoma in a subject in need thereof comprising administering to the subject a composition comprising doxorubicin and hydroxyapatite nanoparticles with size of 11-13 nm in diameter.
Chang et al. disclose that zoledronic acid directly inhibits growth and induces apoptosis of osteosarcoma cancer cells.
Lu et al. disclose a method of treating bone tumor and promoting bone repair comprising administering to the subject in need thereof a composition comprising zoledronic acid and hydroxyapatite nanoparticles with size of about 10-50 nm.
Ascertainment of the Difference Between the Scope of the Prior Art and the Claims (MPEP §2141.02)
Ghosh et al. do not explicitly disclose that the composition being administered further contains zoledronic acid. This deficiency is cured by the teachings of Chang et al. and Lu et al.
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
It would have been prima facie obvious for one of ordinary skill in the art at the time the present application was filed to combine the respective teachings of Ghosh et al., Chang et al., and Lu et al., outlined supra, to devise Applicant’s presently claimed method.
Ghosh et al. disclose a method of treating osteosarcoma in a subject in need thereof comprising administering to the subject a composition comprising doxorubicin and hydroxyapatite nanoparticles. Since Chang et al. disclose that zoledronic acid directly inhibits growth and induces apoptosis of osteosarcoma cancer cells; and since Lu et al. disclose that zoledronic acid can be administered with hydroxyapatite nanoparticles, and that a composition comprising zoledronic acid and hydroxyapatite nanoparticles not only exhibits a potent antitumor effect but also promotes bone repair; one of ordinary skill in the art would thus be motivated to further include zoledronic acid in the Ghosh et al. composition, with the reasonable expectation that the resulting composition, when administered to a subject in need thereof, will successfully treat osteosarcoma and also promote bone repair.
Moreover, since Ghosh et al. disclose that their composition provides sustained-release of doxorubicin, and that the cumulative release of doxorubicin from the composition shows a significant plateauing after about 5-6 days (see e.g. Figure 6), one of ordinary skill in the art would thus be motivated to administer the composition about once every 7 days, with the reasonable expectation that this dosage regimen will ensure an adequate supply of doxorubicin for successful treatment of bone cancer.
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(a).
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.
Response to Arguments
Applicant's arguments filed January 12, 2026 have been fully considered but they are not persuasive.
i) Applicant contends that “Ghosh…concludes that a sustained release of doxorubicin is observed due to the presence of the PLGA polymer”; that “Chang does not mention any ceramic material, let alone hydroxyapatite” and “also does not mention doxorubicin”; that “Lu is completely silent with respect to any combination of zoledronic acid and doxorubicin” and “makes it very clear to a person of skill in the art that the presence of chitosan offers superior capabilities to nHA”; and that “neither Ghosh nor Lu teach or suggest dispensing with the organic polymer”.
The Examiner, however, would like to point out the following:
1. Neither Ghosh, Chang, nor Lu has been cited for individually anticipating the presently claimed subject matter under 35 USC 102. On the contrary, the prior art rejection is under 35 USC 103 based on the combination of the cited references, and what these references expressly teach and reasonably suggest to one of ordinary skill in the art, who is one of ordinary creativity and not an automaton.
2. In view of the cited prior art, one of ordinary skill in the art would have been able to arrive at the presently claimed subject matter with a reasonable expectation of success. Applicant has provided no evidence at all to the contrary.
3. The present claims do not necessarily exclude organic polymers generally, or PLGA and chitosan specifically. Hence, neither Ghosh nor Lu need teach or suggest dispensing with the organic polymer at all.
For the foregoing reasons, the 35 USC 103 rejection is hereby maintained.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Inquiries
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID BROWE whose telephone number is (571)270-1320. The examiner can normally be reached Monday - Friday, 9:30 AM to 6 PM EST.
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/DAVID BROWE/Primary Examiner, Art Unit 1617