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
RESPONSE TO AMENDMENT
Status of Application/Amendments/claims
Applicant’s amendment filed July 7, 2026 is acknowledged. Claims 1-8, 12-16 and 18 canceled. Claim 9 is amended. Claims 19-21 are newly added. Claims 9-11, 17 and new claims 19-21 are pending in this application. Election was treated as without traverse in the reply filed on February 4, 2026.
Claims 9-11, 17 and 19-21 are under examination in this office action.
4. Applicant’s arguments filed on July 7, 2026 have been fully considered but they are not deemed to be persuasive for the reasons set forth below.
Claim Rejections/Objections Withdrawn
5. The objection to claim 15 is moot because the claim is canceled.
The rejection of claims 9-14 and 17-18 under 35 U.S.C. 102(a)(1) as being anticipated by Park et al. (US20180369231) is withdrawn in response to Applicant’s amendment to the claims and cancelation of claims 12-14 and 18.
The rejection of claims 9 and 15-16 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 (US11801240) is withdrawn in response to Applicant’s amendment to the claims and cancelation of claims 15-16.
New Grounds of Rejection Necessitated by the Amendment
The following rejections are new grounds of rejections necessitated by the amendment filed on July 7, 2026.
Claim Rejections - 35 USC § 103
6. 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 9-11 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Park et al. (US20180369231) in view of Von Hoff et al. (New Engl. J. Med. 2013; 369:1691-1703. DOI:10.1056/NEJMoa1304369).
Park teaches a method for treating pancreatic cancer (see para.[0033]; [0091], Examples 10-11, claims 13), the method comprising a step of administering, to a subject in need of administration, (a) a first pharmaceutical composition comprising particles comprising SN-38 (see para. [0113]; [0115]; [0119]; [0123];[0138]; table 1; Example 2; claim 2), Irinotecan (see para. [0123]; [0138]; table 1; Example 2; claim 3; ) and an amphiphilic block copolymer composed of a hydrophobic block and a hydrophilic block (see para. [0008]; [0014]-[0037]; [0113]; [0119]) in combination with (b) a second pharmaceutical composition comprising at least one antitumor agent as an active ingredient paclitaxel or docetaxel (see para. [0034];[0098]-[0099]), wherein the amphiphilic block polymer 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-coglycolide), 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 (see para. [0020]-[0022]; [0053]-[0055];[0074]-[0087]; [0149]; table 5; claim 4; claims 1-12), which relate to the limitations recited in claims 9-11 and 17. 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 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 treating different types of cancer including gastric cancer, pancreatic cancer and colorectal cancer (see para.[0033]; [0091]).
But Park does not explicitly teach that the second pharmaceutical composition comprises at least one antitumor agent selected from the group consisting of nab-paclitaxel and gemcitabine.
Von Hoff et al. teach that in a phase1-2 trial of albumin-bound paclitaxel (nab-paclitaxel) plus gemcitabine for pancreatic cancer, patients with pancreatic cancer treated with nab-paclitaxel plus gemcitabine have increased survival compared to the patients treated with gemcitabine alone (see p. 1691; p. 1694-1699).
A person of ordinary skill in the art would have recognized that selecting and applying the known pharmaceutical composition comprising nab-paclitaxel and/or gemcitabine for treatment of pancreatic cancer and the known technique disclosed by Von Hoff to the Park’s method would have yielded the predictable result of treating pancreatic cancers, and resulted in an improved method.
Using and including the known pharmaceutical composition comprising nab-paclitaxel and/or gemcitabine for treatment of pancreatic cancer 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 pancreatic cancer because a combination therapy including a combination of a SN-38 and Irinotecan in an amphiphilic block copolymer composed of a hydrophobic block and a hydrophilic block with a second anti-tumor agent including paclitaxel has been used for treatment of pancreatic cancer as taught by Park and a pharmaceutical composition comprising nab-paclitaxel and/or gemcitabine has been used for treatment of pancreatic cancer as taught by Von Hoff.
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 pharmaceutical composition comprising nab-paclitaxel and/or gemcitabine for treatment of pancreatic cancer and the known technique disclosed by Von Hoff to the Park’s method yield the predictable result of treating pancreatic cancer.
Claim Rejections - 35 USC § 103
7. Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Park et al. (US20180369231) in view of Sym et al. (Cancer Chemother. Pharmacol. 2008; 63:1-8. DOI 10.1007/s00280-008-0701-2).
Claims 19 is drawn to a method for treating gastric cancer as in claim 9 above but using (b) docetaxel as in the second pharmaceutical composition.
Park is set forth above and also teaches treating gastric cancer (see [0032]; [0091]). But Park does not explicitly teach that docetaxel as the second pharmaceutical composition for treating gastric cancer.
Sym et al. teach treating gastric cancer using a combination therapy comprising Irinotecan and docetaxel (see abstract; p. 4; p. 5-7).
A person of ordinary skill in the art would have recognized that selecting and applying the known pharmaceutical composition comprising for Irinotecan and docetaxel treatment of gastric cancer and the known technique disclosed by Sym to the Park’s method would have yielded the predictable result of treating gastric cancers, and resulted in an improved method.
Using and including the known pharmaceutical composition comprising Irinotecan and docetaxel for treatment of gastric cancer 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 gastric cancer because a combination therapy including a combination of a SN-38 and Irinotecan in an amphiphilic block copolymer composed of a hydrophobic block and a hydrophilic block with a second anti-tumor agent including docetaxel has been used for treatment of different cancers including gastric cancer as taught by Park and a pharmaceutical composition comprising Irinotecan and docetaxel has been used for treatment of gastric cancer as taught by Sym.
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 pharmaceutical composition comprising Irinotecan and docetaxel for treatment of gastric cancer and the known technique disclosed by Sym to the Park’s method yield the predictable result of treating gastric cancer.
Claim Rejections - 35 USC § 103
8. Claims 20-21 are rejected under 35 U.S.C. 103 as being unpatentable over Park et al. (US20180369231) in view of Mikule et al. (US11801240).
Park is set forth above and also teaches treating colorectal cancer (see para. [0124]; Example 9, [0158]-[0162]). But Park does not explicitly teach bevacizumab as the second pharmaceutical composition in claim 20 or antitumor radiotherapy (RT) in claim 21.
Mikule et al. (US11801240) teach a method of treating different cancers including colorectal cancer, comprising administering to a combination therapy including an agent inhibiting PARP and an anti-VEGF inhibitor, wherein the anti-VEGF inhibitor includes bevacizumab, 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, or further treating the human with radiotherapy and the known technique disclosed by Mikule to the Park’s method would have yielded the predictable result of treating colorectal cancer, 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, or further treating the human with radiotherapy 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 colorectal cancer because a combination therapy including a combination of a SN-38 and Irinotecan in an amphiphilic block copolymer composed of a hydrophobic block and a hydrophilic block with a second anti-tumor agent has been used for treatment of colorectal cancer as taught by Park and a combination therapy including a combination of a SN-38 incorporating polymeric micelle with an anti-VEGF inhibitor including bevacizumab, or further treating the human with anti-tumor radiotherapy has been used for better treatment of different cancers including colorectal cancer as taught by 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, or further treating the human with radiotherapy and the known technique disclosed by Mikule to the Park’s method and yield the predictable result of treating colorectal cancer.
Conclusion
9. NO CLAIM IS ALLOWED.
10. Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
11. Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHANG-YU WANG whose telephone number is (571)272-4521. The examiner can normally be reached Monday-Thursday, 7:00am-5:00pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Stucker can be reached at 571-272-0911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Chang-Yu Wang
October 7, 2026
/CHANG-YU WANG/Primary Examiner, Art Unit 1675
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