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 request for continued examination under 37 CFR 1.114, amendment and remarks filed 06/11/2026.
Claims 13-15 are canceled.
Claim 10 is amended. Claims 10-12 are pending.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 06/11/2026 has been entered.
Response to Arguments
Applicant's arguments filed 06/11/2026 have been fully considered but they are not persuasive.
First, applicant argues that Choi does not suggest conjugating fluorophore to carboxyl group of the polymer. Secondly, on pages 6 to 10, applicant argues that Choi is directed to chemotherapy and not to treating gout and that Choi’s nanocarrier is specifically designed for cancer treatment, that Wei Feng discloses that quercetin alleviates rheumatoid arthritis and effectively exerts anti-inflammatory and analgesic action in gout mice, promoting apoptosis. Therefore, applicant argues that the office has not met its burden to establish that a person of ordinary skill in the art would have been motivated to combine Choi’s oncology optimized nanocarrier with Wei Feng’s teaching that quercetin treats gout with reasonable expectation; that the office failed to articulate rational underpinning why a person of ordinary skill in the art would have been motivated to repurpose a nano carrier specifically designed for tumor-targeted drug delivery; and that without the benefit of applicant’s disclosure, the ordinary skilled would have no reason to take Choi’s cancer targeted nanocarrier and apply it to gout treatment simply because one of the many therapeutic agents listed in Choi, quercetin, has anti-gout properties.
Response: The examiner disagrees because Choi discloses nanocarriers 6, 7 , 8 and 9 where the cyclodextrin moiety is attached to the polylysine at the amino group and fluorophore conjugated carboxyl group --- see at least paragraphs [0089] --- nanocarrier 6 is represented below:
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For the second argument, 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 nanocarrier composition and it is the administered composition that effects the treating. The current amendment has removed gout therapeutic agent form the claims. However, the comprising language of the claim is open and since the composition administered treats gout, the composition of Choi comprising quercetin or other medicaments when administered would predictably produce the effect of the drug carried by the nanocarrier. Choi teaches administration of the composition administered in claim 10 to treat gout. 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). The examiner disagrees with applicant that the office action is based on applicant’s disclosure because the rejection is based on what is known in the art. Specifically, quercetin is known to treat gout according to at least the title and abstract, right column of the introduction on page 1, lines 6-11 of Wei Feng. The unexpected results in applicant’s specification is not evidence that the administration of the composition in Choi where the active agent is Quercetin does not treat gout. The specification has not contrasted the composition disclosed in Choi comprising quercetin with the composition in claim 10 to show that Choi’s composition fails to 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 as currently amended does not contain any drugs/medicaments. Choi teaches the composition that is administered in claim 10. Thus, administration of the composition of Choi would also be expected to predictably treat gout.
Further also, with regards to applicant’s statement about uric acid/tophi reduction, Quercetin is known to lower uric acid (see Yuanlu Shi et al., “Quercetin lowers plasma uric acid in pre-hyperuricaemic males: a randomized, double-blinded, placebo-controlled, cross-over trial” in British Journal of Nutrition (2016), 115, 800-806, cited to address applicant’s argument. Parisa et al., “The Inflammation process of gout arthritis and its treatment” in Journal of Advanced Pharmaceutcal Technology & Research, 2023, pp 166-170 teaches that gouty arthritis is a significant case commonly associated with inflammatory arthritis (see the whole document, cited to address applicant’s argument).
Regarding claim 15, applicant’s argument on pages 10 -12 is moot in light of the cancelation of claim 15. Colchicine is one of the drugs listed in canceled claim 15.
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) 10-12 are 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 comprising cyclodextrin conjugated to amino group of polymer and fluorophore conjugated to the carboxyl moiety of the polymer; the polymer being selected from e-poly-L-lysine, L-polylysine, polylactic acid, poly(lactic-co-glycolic acid), polyaspartic acid, polyglutamic acid, or polyglutamic acid-poly(ethylene glycol) copolymers.
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; 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 10; and the contrast agent is conjugated to the carboxyl group of the polymer (see paragraph [0087] and the carrier 6, 7, 8, 9), Compound 6 below shows cyclodextrin and the contrast agent attached
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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]). Quercetin is a gout therapeutic agent. 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. The comprising language is open.
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 10-12 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.
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).
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/BLESSING M FUBARA/Primary Examiner, Art Unit 1613
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