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 .
Claim 54, 60, 62 and 66 have been amended.
Claims 54-60, 62-64 and 66-73 are pending.
Claims 67-73 are withdrawn.
Note, rejections and objections not reiterated from previous office actions are hereby withdrawn. The following rejections or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 01/27/2026 has been entered.
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 54, 55, 60, 62, and 66 are rejected under 35 U.S.C. 103 as being unpatentable over KRYZA (Granulocyte-Colony Stimulating Factor Nanocarriers for Stimulation of the Immune System (Part II): Dose-Dependent Biodistribution and In Vivo Antitumor Efficacy in Combination with Rituximab. Bioconjugate Chemistry. 2018.) in view of LIMASALE (Epidermal growth factor receptor-targeted immunoliposomes for delivery of celecoxib to cancer cells. International Journal of Pharmaceutics. 2015.).
Regarding claim 54 and 66, KRYZA teaches a nanoparticle conjugated to a granulocyte-colony stimulating factor (G-CSF) (abstract and page 805, paragraph 6), which reads on a immunosuppressive myeloid cell (isMC) targeting moiety. The nanoparticle further comprises rituximab (abstract), which is an immunosuppressant drug. The composition is for cancer therapy (abstract).
KRYZA does not teach adding an isMC metabolism disrupting drug, such as celecoxib.
Regarding claims 54 and 66, LIMASALE teaches a nanoparticle composition comprising celecoxib, which is a isMC metabolism-disrupting drug, and a targeting agent, such as anti-epidermal growth factor receptor (EGFR) monoclonal antibody (abstract). The composition is for cancer therapy (abstract). LIMASALE teaches celecoxib (abstract), which is a isMC metabolism-disrupting drug, specifically nonsteroidal anti-inflammatory drug as taught by Applicant’s specification (Applicants specification, page 16, paragraph 1). Celecoxib is known to help in the treatment of cancer and have a high therapeutic effect in cancer cells lines (page 364, paragraph 1-2).
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate an isMC metabolism disrupting drug, such as celecoxib. The person of ordinary skill in the art would have been motivated to make those modifications, because celecoxib is used as a treatment for cancer that has high therapeutic effect in cancer cell lines, and reasonably would have expected success because the references are in the same field of endeavor, such as nanoparticles for use in cancer therapy that involve multiple components involving a drug and a targeting agent.
Regarding claim 55, KRYZA teaches the nanoparticle had a dimeter of 154 nm (page806, paragraph 1).
Regarding claim 60 and 62, KRYZA teaches a nanoparticle conjugated to a granulocyte-colony stimulating factor (G-CSF) (abstract and page 805, paragraph 6), which is a polypeptide.
Claims 54-60, 62-64, and 66 are rejected under 35 U.S.C. 103 as being unpatentable over KRYZA (Granulocyte-Colony Stimulating Factor Nanocarriers for Stimulation of the Immune System (Part II): Dose-Dependent Biodistribution and In Vivo Antitumor Efficacy in Combination with Rituximab. Bioconjugate Chemistry. 2018.) and LIMASALE (Epidermal growth factor receptor-targeted immunoliposomes for delivery of celecoxib to cancer cells. International Journal of Pharmaceutics. 2015.) in view of MARGEL (US 2013/0030282 A1).
KRYZA and LIMASALE teach Applicant’s invention as discussed above.
Regarding claim 56-59 and 63-64, KRYZA and LIMASALE do not teach using a protein nanoparticle, such as human serum albumin (HSA) nanoparticles or adding a near-infrared imaging agent.
Regarding claim 56-59, MARGEL teaches a nanoparticle for use in cancer therapy (abstract). The nanoparticle comprises albumin nanoparticles (abstract), specifically human serum albumin (HSA) nanoparticles (page 13, paragraph 0212). The nanoparticle can further comprise a drug (page 2, paragraph 0035) and a targeting agent (page 13 paragraph 0217). HSA nanoparticles are already commercially available (page 1, paragraph 0009), readily available, biodegradable, have a long half-life in vivo and lack toxicity and immunogenicity (page 1, paragraph 0005).
Regarding claim 63-64, MARGEL further teaches adding an Near-infrared (NIR) imaging agent (abstract), which allows the cancerous tissue to be identified in imaging (abstract image). NIR imaging achieves the highest tissue penetration due to minimal absorbency of the surface tissue in this spectral region (page 1, paragraph 0004).
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate HSA nanoparticles. The person of ordinary skill in the art would have been motivated to make those modifications, because HSA nanoparticles are already commercially available, biodegradable, have a long half-life in vivo and lack toxicity and immunogenicity, and reasonably would have expected success because the references are in the same field of endeavor, such as nanoparticles for use in cancer therapy that involve a drug and a targeting agent.
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate an NIR imaging agent. The person of ordinary skill in the art would have been motivated to make those modifications, because it allows the cancerous tissue to be imaged and NIR imaging achieves the highest tissue penetration due to minimal absorbency of the surface tissue in this spectral region, and reasonably would have expected success because the references are in the same field of endeavor, such as nanoparticles for use in cancer therapy that involve a drug and a targeting agent.
Response to Arguments
Applicant’s arguments with respect to claim(s) 54-60, 62-64, and 66-73 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
No claims are allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAMANTHA L. MEJIAS whose telephone number is (703)756-5666. The examiner can normally be reached M-F.
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/S.L.M./ Examiner, Art Unit 1618 /JAKE M VU/Primary Examiner, Art Unit 1618
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