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/Election/Restrictions
Applicant’s election of Gemcitabine for species of second composition, SN-38 for species of hydrophobic camptothecin-based compound, Irinotecan for species of hydrophilic camptothecin-based compound, Bevacizumab for species of VEGF inhibitor and pancreatic cancer for species of cancer in the reply filed on February 4, 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 1-8 canceled. Claims 9-18 are pending in this application. Upon reconsideration, the species election on second composition, hydrophobic camptothecin-based compound, hydrophilic camptothecin-based compound, VEGF inhibitor and cancer is withdrawn because the subject matter can be found in the same prior art reference. Election was treated as without traverse in the reply filed on February 4, 2026.
Claims 9-18 are under examination in this office action.
Claim Objections
Claim 15 is objected to because of the following informalities: the recitation “oneselected” should be “one selected”. Appropriate correction is required.
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 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.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 9-14 and 17-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Park et al. (US20180369231, priority Jun 22, 2017, as in IDS)
Claims 9-14 and 17-18 are drawn to a method for treating cancer, the method comprising a step of administering, to a subject in need of administration, (a) a first pharmaceutical composition comprising particles comprising a hydrophobic camptothecin-based compound, a hydrophilic camptothecin-based compound, and an amphiphilic block copolymer composed of a hydrophobic block and a hydrophilic block in combination with (b) antitumor therapy or a second pharmaceutical composition comprising at least one antitumor agent as an active ingredient selected from the group consisting of a taxane- based anticancer agent, an albumin-bound taxane-based anticancer agent, a vascular endothelial growth factor (VEGF) inhibitor, and gemcitabine.
Park et al. (US20180369231) teach a method for treating cancer (see para.[00-9]; [0036]), the method comprising administering to a subject in need thereof (see para. [00103]), a pharmaceutical composition comprising particles comprising a hydrophobic camptothecin-based compound, a hydrophilic camptothecin-based compound, and an amphiphilic block copolymer composed of a hydrophobic block and a hydrophilic block (see para. [0008]; [0014]-[0037]; [0113]; [0119]) in combination with a second pharmaceutical composition comprising at least one antitumor agent as an active ingredient including a taxane-based anticancer agent, such as paclitaxel or docetaxel (see para. [0034];[0098]-[0099]). Park teaches that the first pharmaceutical composition and the second pharmaceutical composition are administered as simultaneously or separately as in claim 10 or a composite formulation or a single formulation as in claim 11 (see para. [0098]-[0099]).
Park teaches that the hydrophobic camptothecin-based compound is selected from SN-38, camptothecin or 10-hydroxycamptothecin as in claim 12 (see para. [0018]; [0051];[0071];[0073]; [0115])). Park teaches that the hydrophilic camptothecin-based compound is selected from irinotecan, topotecan, belotecan, exatecan, lurtotecan, sinotecan, rubitecan, 9-nitrocamptothecin, 9- aminocamptothecin, gimatecan, karenitecin, silatecan, diflomotecan, elomotecan, a pharmaceutically acceptable salt thereof, a glucuronide metabolite thereof, and a glucuronide metabolite of the hydrophobic camptothecin-based compound as in claim 13 (see para [0019]; [0052];[0072]; [0073]). Park teaches that the amphiphilic block copolymer is composed of A-B blocks or A-B-A blocks, wherein (a) A is a hydrophilic polymer, which is monomethoxy polyethylene glycol, dimethoxy polyethylene glycol, polyethylene glycol, polypropylene glycol, monomethoxy polypropylene glycol, polyethylene oxide, polyacrylic acid, or a polymer thereof; and (b) B is a hydrophobic polymer, which is polylactic acid, poly-L-lactide, poly-D-lactide, poly-D, L-lactide, poly(lactide-co-glycolide), polyglycolic acid, polyglycolide, a polylactic acid-glycolic acid copolymer, polymandelic acid, polycaprolactone, polydioxan-2-one, polyglutamic acid, polyaspartic acid, polyornithine, polyorthoester, or a derivative thereof as in claim 14 (see para.[0020]-[0022]; [0053]-[0056]; [0074]-[0076]).
Park teaches that the particles have an average diameter of 10-500nm (para.[0027]; [0089]) or 20-200nm, which is within the claimed range of 2-200nm as in claim 17 (see para.[0077]; [0089]; [0109]).
Park teaches different types of cancer including gastric cancer, ovarian cancer, uterine cancer, small cell lung cancer, non-small cell lung cancer, pancreatic cancer, breast cancer, esophageal cancer, oral cancer, rectal cancer, colon cancer, large intestine cancer, kidney cancer, prostate cancer, melanoma, liver cancer, gall bladder, and other biliary tract cancer, thyroid cancer, bladder cancer, brain and central nervous system cancer, bone cancer, skin cancer, non-Hodgkin's and Hodgkin's lymphoma as in claim 18 (see para.[0033]; [0091]). Thus, claims 9-14 and 17-18 are anticipated by Park et al. (US20180369231).
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 of this title, 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 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 9 and 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Park et al. (US20180369231) in view of Kenmotsu et al. (Cancer, 2010; 116:4597-604, as in IDS) and Mikule et al. (US11801240, issued Oct 31, 2024, priority Oct 17, 2017).
Park is set forth above but does not teach a VEGF inhibitor including bevacizumab, ranibizumab, and aflibercept. or gemcitabine or surgery and/or radiotherapy as antitumor therapy recited in claims 9 and 15-16.
Kenmotsu et al. teach that a combination of NK012, a SN-38 incorporating polymeric micelle with an anti-VEGF inhibitor, bevacizumab, provides better anti-tumor activity for treating lung cancer (see abstract; p. 4598, 2nd col., last paragraph; p.4601, 1st col., 3rd paragraph; p.4602-4603).
Mikule et al. (US11801240) teach a method of treating different cancers, comprising administering to a combination therapy including an agent inhibiting PARP and an anti-VEGF inhibitor, wherein the cancer includes carcinoma, squamous carcinoma, adenocarcinoma, sarcomata, endometrial cancer, breast cancer, cervical cancer, fallopian tube cancer, primary peritoneal cancer, colon cancer, colorectal cancer, squamous cell carcinoma of the anogenital region, melanoma, renal cell carcinoma, lung cancer, non-small cell lung cancer, squamous cell carcinoma of the lung, stomach cancer, bladder cancer, gall bladder cancer, liver cancer, thyroid cancer, laryngeal cancer, salivary gland cancer, esophageal cancer, head and neck cancer, glioblastoma, glioma, squamous cell carcinoma of the head and neck, prostate cancer, pancreatic cancer, mesothelioma, sarcoma, hematological cancer, leukemia, lymphoma, and neuroma; wherein the anti-VEGF inhibitor includes bevacizumab, ranibizumab, and aflibercept, or further comprising administering a therapeutically effect amount of another agent or further treating the human with surgery or radiotherapy or a third agent that is a chemotherapeutic agent including gemcitabine as in claims 9 and 15-16 (see col.4, lines 7-col.5, line 3; col. 5, lines 40-54; col. 6, line 30; , claims 1, 3-31; 21-22, 26). .
A person of ordinary skill in the art would have recognized that selecting and applying the known combination therapy including a combination of a SN-38 incorporating polymeric micelle with an anti-VEGF inhibitor including bevacizumab, ranibizumab, and aflibercept, or further treating the human with surgery or radiotherapy or a third agent that is a chemotherapeutic agent including gemcitabine and the known technique disclosed by Kenmotsu and Mikule to the Park’s method would have yielded the predictable result of treating different cancers, and resulted in an improved method.
Using and including the known combination therapy including a combination of a SN-38 incorporating polymeric micelle with an anti-VEGF inhibitor including bevacizumab, ranibizumab, and aflibercept, or further treating the human with surgery or radiotherapy or a third agent that is a chemotherapeutic agent including gemcitabine in the Park’s method would provide better anti-tumor treatment, and expand application of the Park’s method, and would increase patient’s satisfaction with treatment of different cancers because a combination therapy including a combination of a SN-38 incorporating polymeric micelle with an anti-VEGF inhibitor including bevacizumab, ranibizumab, and aflibercept, or further treating the human with surgery or radiotherapy or a third agent that is a chemotherapeutic agent including gemcitabine has been used for better treatment of different cancers as taught by Kenmotsu and Mikule.
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select and apply the known combination therapy including a combination of a SN-38 incorporating polymeric micelle with an anti-VEGF inhibitor including bevacizumab, ranibizumab, and aflibercept, or further treating the human with surgery or radiotherapy or a third agent that is a chemotherapeutic agent including gemcitabine and the known technique disclosed by Kenmotsu and Mikule to the Park’s methodand yield the predictable result of treating different cancers.
Conclusion
NO CLAIM IS ALLOWED.
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Chang-Yu Wang
April 1, 2026
/CHANG-YU WANG/Primary Examiner, Art Unit 1675
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