DETAILED ACTION
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 .
The examiner acknowledges receipt of amendment and remarks filed 01/07/2026.
Claims 1-9 are canceled.
No claim is amended. Original claims 10-15 are pending.
Response to Arguments
The cancelation of claims 1-9 overcomes the rejection under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Choi et al. (US 20190224341 A1, published July 25, 2019) and evidenced by Wei Feng et al. “Study on the effect and mechanism of quercetin in treating gout arthritis” in International Immunopharmacology, 111 (2022) 109112 (for claims 1-6 and 8-9) and Choi et al. (US 20190224341 A1, published July 25, 2019) in combination with Wei Feng et al. “Study on the effect and mechanism of quercetin in treating gout arthritis” in International Immunopharmacology, 111 (2022) 109112, in view of Ichim et al. (US 20160074489 A1), Rau et al. (US 20120058084 A1) and Luo et al. (US 20120040397 A1) (for claim 7).
Regarding the rejection under 35 U.S.C. 103, applicant argues on pages 5 to 7 of the remarks filed 01/07/2026 that a) Choi treats cancer and not gout; b) the polymers, fluorophores, and nanocarrier design are optimized for oncology application such that there will be no motivation to solve the problem of gout treatment by expecting that the anticancer agents can be used to treat gout even as evidenced by Wei Feng --- Wei Fent is concerned with the effect of free quercetin; c) the rejection is based on what was not known at the time the invention was made and thus not known to the person of skill and the Federal circuit in Innogenetics, N.V., v. Abbott Lab’ys, 512 F.3d 1363, 1374 n.3 (Fed. Cir. 2008), counsels against impermissible hindsight reconstruction of references to reach the claimed invention without explanation as how or why the references would be combined; d) the rejection uses applicant’s own disclosure as a roadmap for arriving at the claimed method for treating gout, the method comprising administering to a mammal in need thereof an effective amount of nano-drug containing a gout therapeutic agent and there is no motivation at the time of invention to select Choi’s specific nanocarrier and combine it with the knowledge from Wei Feng for the purpose of treating gout; e) Test example 1, Table 1 ZW800-CDPL+ prepared in Example 1 showed a 4x improvement in uric acid removal compared to PBS, Test Example 2, administration of cyclodextrin-conjugated EPL (ZW800-CDPL+) showed excellent tophi size reducing effect in FIGS 5 and 6, in a mouse model test for the cyclodextrin-conjugated EPL (ZW800-CDPL+) administration group of the present invention, no change in weight observed for 14 days which indicates no toxicity when compared with saline administration, and Choi fails to provide any guidance for selecting a compound with enhanced uric acid removal in vitro or tophi size reducing effect in vivo; g) on pages 7 and 8 of the remarks filed 01/07/2026, applicant argues that Ichim, Rau and Luo fail to remedy the deficiency of Choi and Wei Feng.
Response: For a), the examiner agrees that Choi does not teach treating gout and that is the reason for the rejection under 35 USC 103. Choi teaches administration of the composition administered in claim 10 to treat gout. For b), While polymers, fluorophores, and nanocarrier design are optimized for oncology application, the examiner disagrees that the administration of the same composition that is administered in the claims to treat gout could not treat gout when it is known that in the art that Quercetin is known to treat gout (see the abstract, right column of the introduction on page 1, lines 6-11 of Wei Feng). For c), the examiner disagrees with applicant because the rejection is based on what is known in the art in because Quercetin is known to treat gout according to at least the abstract, right column of the introduction on page 1, lines 6-11 of Wei Feng. Therefore, the findings in Innogenetics, N.V., v. Abbott Lab’ys, 512 F.3d 1363, 1374 n.3 (Fed. Cir. 2008) is not violated because the fact that Quercetin is known to treat gout is not a reconstruction of references to reach the claimed invention. For d), the rejection does not use applicant’s disclosure. For e), The unexpected results in applicant’s specification in examples 1 and 3, Table 1 is not evidence that the administration of the composition in Choi where the active agent is Quercetin does not treat gout. The prior art is also clear Quercetin treats gout and cancer (Wei Feng) so that administration of Quercetin containing composition would predictably treat gout and cancer. Claim 10 is directed to any drug for treating gout and not specific to any specific gout therapeutic agent. Claims 10-15 do not teach ZW800 conjugated to cyclodextrin and as such the Choi does not have to teach ZW800-CDPL in order to render claim 10 prima facie obvious. Further also, with regards to applicant’s statement about uric acid, Quercetin is known to lower uric acid (see Yuanlu Shi et al., “Quercetin lowers plasma uric acid in pre-hyperuricaemic males: a randomised, double-blinded, placebo-controlled, cross-over trial” in British Journal of Nutrition (2016), 115, 800-806, cited to address applicant’s argument.
Therefore, the rejection of claim(s) 10-14 under 35 U.S.C. 103 as being unpatentable over Choi et al. (US 20190224341 A1, published July 25, 2019) and evidenced by Wei Feng et al. “Study on the effect and mechanism of quercetin in treating gout arthritis” in International Immunopharmacology, 111 (2022)109112 is maintained/reiterated below --- no claim is amended. Also, the rejection of claim 15 under 35 U.S.C. 103 as being unpatentable over Choi et al. (US 20190224341 A1, published July 25, 2019) in combination with Wei Feng et al. “Study on the effect and mechanism of quercetin in treating gout arthritis” in International Immunopharmacology, 111 (2022) 109112, in view of Ichim et al. (US 20160074489 A1), Rau et al. (US 20120058084 A1) and Luo et al. (US 20120040397 A1) is maintained and reiterated herein below. Claims 10-15 are original claims.
Maintained Rejections
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.
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.
Claim(s) 10-14 remain rejected under 35 U.S.C. 103 as being unpatentable over Choi et al. (US 20190224341 A1, published July 25, 2019) and evidenced by Wei Feng et al. “Study on the effect and mechanism of quercetin in treating gout arthritis” in International Immunopharmacology, 111 (2022)109112 for reasons of record and reiterated below.
Claim 10 teaches a method of treating gout by administering to a mammal an effective amount of a nanodrug containing gout therapeutic agent.
Choi discloses composition that comprises nanocarriers comprising one or more cyclodextrin moieties conjugated to polymer comprising polyaspartic acid, polyglutamic acid, polylysine, polylactic acid, poly(lactic-co-glycolic acid) which meet the limitation of polymer of claims 10 and 13; the nanocarrier comprises contrast agent namely near-infrared fluorophore selected from the group consisting of ZW800-1C, ZW800-1, ZW800-3C, ZW700-l, indocyanine green (ICG), Cy5, Cy5. 5, Cy7, Cy7.5, IRDye800-CW (CW800), and ZWCC meeting claim 14; one of the therapeutic agents in Choi is quercetin (see the whole document with emphasis on paragraphs [0005]-[008], claims 1-8). In some embodiments, the nanocarrier comprises one or more positively charged moieties (paragraph [0016]), one or more negatively charged moieties (paragraph [0017]), see also paragraph [0018], meeting claim 11.
The nanocarrier comprises one or more therapeutic agents that form complex with the one or more cyclodextrin moieties (paragraph [0009]) and quercetin is one of the therapeutic agents named (paragraph [0010]). Thus, quercetin meets the limitation of gout therapeutic agent of claim 10. Cyclodextrin nanocarrier has molecular weight of from about 10,000 to about 22,000 g/mole and nanocarrier comprises from about 5 to about 14 cyclodextrin moieties (claims 42 and 45, paragraphs [0021], [0071]-[0072]) meeting claims 10 and 12.
Choi teaches administering its composition to treat cancer (at least paragraph [0003]). Choi fails to teach treating gout. However, the effect of the administered composition containing active agents such as quercetin (paragraph [0010]) is treating cancer. It is also known that quercetin is used to treat gout. For example, Wei Feng teaches that Quercetin is known to treat gout as (see the abstract, right column of the introduction on page 1, lines 6-11).
Therefore, before the effective date of the invention, the artisan would reasonably expect that administration of quercetin to a mammalian patient (column 39 of Choi) would predictably treat gout.
Choi in view of We Feng renders claims 10-14 prima facie obvious.
Claim(s) 10 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Choi et al. (US 20190224341 A1, published July 25, 2019) in combination with Wei Feng et al. “Study on the effect and mechanism of quercetin in treating gout arthritis” in International Immunopharmacology, 111 (2022) 109112, in view of Ichim et al. (US 20160074489 A1), Rau et al. (US 20120058084 A1) and Luo et al. (US 20120040397 A1) for reasons of record and modified to remove claims 1 and 7 from the rejection in light of the cancelation of claims 1 an-9.
Choi in view of Wei Feng renders claim 10 prima facie obvious. Claim 15 depends on claim 10.
Choi differs from claim 15 by not teaching the active agents of claim 15. Ichim teaches that allopurinol and quercetin are antioxidants (paragraph [0019]). Wei Feng teaches quercetin treats gout (abstract, right column of the introduction on page 1, lines 6-11). Rau teaches that allopurinol is an anticancer agent (paragraph [0296]) Luo teaches that allopurinol and Colchicine are drugs for gout (paragraph [0371]). Therefore, quercetin and allopurinol are functionally equivalent such that administration of allopurinol to a mammalian subject patient would effectively treat gout.
Thus, before the effective date of the invention it would have been reasonably expected that administration of a composition comprising cyclodextrin nanocarrier, polyaspartic acid, polyglutamic acid, polylysine, polylactic acid, poly(lactic-co-glycolic acid) polymer, and allopurinol found in claim 15, would predictably be effective to treat gout.
Therefore, Choi in combination with Wei Feng, and further in view of Ichim, Rau and Luo renders claim 15 prima facie obvious.
No claim is allowed.
The specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BLESSING M FUBARA whose telephone number is (571)272-0594. The examiner can normally be reached 7:30 am-6 pm (M-T).
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, Brian Yong Kwon can be reached at 5712720581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/BLESSING M FUBARA/Primary Examiner, Art Unit 1613