CTNF 18/801,052 CTNF 100157 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. Information Disclosure Statement The information disclosure statements (IDS) submitted on October 29, 2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner. Claim Status Claims 1 – 19 are examined here-in. Claim Objections 07-29-01 AIA Claim s 4 and 11 are objected to because of the following informalities: In claim 4 “denpol” is capitalized. Based on the instant specification, it appears that “denpol” is an abbreviation for “dendronized polymer” which is not a proper noun. Accordingly, “denpol” should not be capitalized. In claim 11, “nintedanib” is capitalized. Nintedanib is not a proper noun and should not be capitalized. If the terms “denpol” and “nintedanib” are intended to refer to commercial products, these claims may be rejected under 35 U.S.C. 112(b). See MPEP 608.01(v) and 2173.05(u) . Appropriate correction is required. 07-30-03-h AIA Claim Interpretation The phrase “enhances visceral fat distribution” in claims 13 and 17 is interpreted to mean that the method leads to enhanced distribution of visceral fat within the body, which is believed to be the broadest reasonable interpretation for one of ordinary skill in the art. However, fat distribution is described in two different ways in the specification: 1) “the metabolic risks of obesity depend largely on body fat distribution…” and 2) “this visceral fat distribution of PG-3” (page 2 line 2, page 4 lines 11 – 12). Applicant may wish to amend the claims if one of the descriptions cited above is more accurate to what Applicant intends to claim. For example, if the first description is desired, Applicant might consider amending to “wherein the method enhances visceral fat distribution in the body”. Alternatively, if the second option is desired, Applicant might consider amending to “wherein the method results enhances the distribution of polycationic polymer within visceral fat”. Claim Rejections - 35 USC § 112(a) 07-30-01 The following is a quotation of the first paragraph of 35 U.S.C. 112(a): (a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention. 07-31-01 Claims 15 and 19 are rejected under 35 U.S.C. 112(a) as failing to comply with the written description requirement. The claims contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, at the time the application was filed, had possession of the claimed invention. Claims 15 and 19 recite “wherein the method promotes adipogenesis” which appears to be a desired result of the active method steps of administering a polycationic polymer. The instant specification does not provide any description for “promotes adipogenesis” with only a reference to “Extended Data Figure 7c” which is not present in the specification or drawings (specification page 16 line 3). According to MPEP2163.03(v), a claim lacks written description support when the claim specifies a desired result but the disclosure fails to sufficiently identify how the result is achieved. In the instant case, claims 15 and 19 specify a desired result of the method, however, the instant specification fails to provide any guidance to a person of ordinary skill in the art as to how that result is achieved. Claim Rejections - 35 USC § 112(b) The following is a quotation of 35 U.S.C. 112(b): (b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention. Claims 1 – 19 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention. The term “derivatives” in claims 1, 8, and 10 is a relative term which renders the claim indefinite. The term “derivative” is indefinite because it is unclear how far one can deviate from the parent compound without the “derivative” being so far removed therefrom as to be a completely different compound. See MPEP 2173.05(b). The term “suitable” in claim 8 is a relative (and subjective) term which renders the claim indefinite. The term “suitable” is not defined by the claims, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. While the specification does provide possible examples for “suitable treating agents” there is no definition or description for “suitable polycationic polymer”. 07-34-10 AIA Regarding claim 11 , the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP 2173.05(d). Claim Rejections - 35 USC § 102 07-07-aia AIA 07-07 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 – 07-08-aia AIA (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. 07-12-aia AIA (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. 07-15 AIA Claim s 1, 7, and 16 are rejected under 35 U.S.C. 102( a)(1 ) as being anticipated by Liu (Liu, X. et al. “Effect of chitosan, o-carboxymethyl chitosan, and N-[(2-hydroxy-3-N,N-dimethylhexadecyl ammonium)propyl] chitosan chloride on overweight and insulin resistance in a murine diet-induced obesity” Journal of Agricultural and Food Chemistry , 2012, 60:13, p. 3471 – 3476) . Liu teaches N-[(2-hydroxy-3-N,N-dimethylhexadecyl ammonium)propyl] chitosan chloride, also known as N-CQ-chitosan, is a chitosan polysaccharide derivative with a positive surface charge (p. 3471 columns 1 and 2). Liu teaches N-CQ-chitosan was administered to rats fed on a high-fat diet to evaluate the therapeutic effects of the positively-charged polymer derivative on insulin resistance (abstract). Liu teaches that rats fed N-CQ-chitosan with a high-fat diet had reduction in fat to body weight ratio as compared to rats fed only a high-fat diet (page 3473 column 2, Table 2). Liu’s teaching that the administration N-CQ-chitosan to rats fed on a high-fat diet reduced fat to body weight ratio (a metric for obesity) (page 3473 column 2, Table 2) anticipates instant claim 1. Liu’s report for reduced fat to body weight ratio reads on “treating or preventing obesity” and N-CQ-chitosan reads on “polycationic polymer and derivatives” as recited in claim 1 . Liu’s teaching that the rats are fed a high-fat diet (abstract, page 3473 column 2, Table 2) anticipates instant claim 7 . Liu teaches that the administration of N-CQ-chitosan to rats fed on a high-fat diet led to decreased insulin resistance (page 3473 column 2, page 3474 columns 1 -2, Table 3, Figure 5), anticipating instant claim 16 . Insulin resistance is an obesity-associated metabolic dysfunction according to the instant specification (page 11 lines 18 – 19), therefore Liu’s teaching for decreased insulin resistance reads on “alleviates associated metabolic dysfunctions” as recited in claim 16 . Claim Rejections - 35 USC § 103 07-20-aia AIA 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. 07-23-aia AIA 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 non-obviousness. 07-21-aia AIA Claim s 1 – 4 are rejected under 35 U.S.C. 103 as being unpatentable over Leong (US 2020/0171167 A1) . Leong teaches a method for treating an inflammatory or immune response (abstract, paragraph 0013, claim 1). Leong teaches administering a cationic polymer, cationic nanoparticle, or cationic microparticle (abstract, paragraph 0014). Leong teaches the administration of cationic agent results in a reduction in acute inflammatory response and can be used to treat patients suffering from a variety of diseases, including obesity (paragraph 0018). Leong teaches PAMAM and PCL-g-PAMAM as water-soluble cationic polymers (paragraphs 0046 – 0047). Leong teaches PAMAM polymer dendrimers can have a generation number from 1 to 3 (paragraph 0046). Leong teaches grafting polycationic polymers to nanoparticles, and that the cationic nanoparticles have large surface area, high charge density, and high binding affinity which leads to increased anti-inflammatory effects (paragraphs 0035, 0048). Leong teaches the cationic particles can be administered via intraperitoneal injection (paragraph 0036). Leong does not teach a specific embodiment having each of the claimed elements, however, claims 1 – 4 are rendered prima facie obvious over the teachings of Leong, because it is prima facie obvious to combine prior art elements according to known methods, in order to yield predictable results (MPEP 2143(i)(a)). In the instant case, all the claimed elements (e.g., polycationic polymers, polycationic nanoparticles) were known in the prior art (e.g., treatments for inflammatory and immune diseases) and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results (e.g., a method for administering polycationic polymers to treat obesity) to one of ordinary skill in the art. Leong’s teaching to administering a cationic polymer to treat patients suffering from obesity (paragraphs 0014, 0018) reads on instant claim 1 . Leong’s teaching that the cationic particles can be administered via intraperitoneal injection (paragraph 0036) reads on instant claim 2 . Leong’s teaching that the cationic polymer can be PAMAM with a generation number from 1 to 3 (paragraph 0046), and that the polycationic polymers are grafted to nanoparticles (paragraphs 0035, 0048) reads on instant claim 3 . A person of ordinary skill would be motivated to graft the polycationic polymers to nanoparticles because Leong teaches that polymer-grafted cationic nanoparticles have large surface area, high charge density, and high binding affinity which leads to increased anti-inflammatory effects (paragraphs 0035, 0048). Leong’s teaching for PCL-g-PAMAM as a water-soluble cationic dendronized polymer (paragraphs 0046 – 0047) reads on instant claim 4 . 07-21-aia AIA Claim s 5 and 7 – 19 are rejected under 35 U.S.C. 103 as being unpatentable over Leong (as cited above) in view of Fourney (US 2004/0235082 A1) . Leong’s teachings are discussed above. Leong does not teach the obesity is diet-induced obesity or a method of targeting adipose tissue. Fourney teaches the missing elements of Leong. Fourney teaches methods and compounds for regulating body weight, reducing body fat, and inducing weight loss (abstract). Fourney teaches multiple compounds for decreasing adipose, fat deposition, and regulating fat metabolism (paragraphs 0062 – 0066). Fourney teaches compound may be paired with a formulatory agent, such as biocompatible polymers (paragraph 0010). Fourney teaches that polymers serve as controlled/sustained release matrices or depot delivery systems (paragraph 0110). Fourney teaches the compounds can be administered in a variety of ways well-known in the art, including intraperitoneal administration (paragraph 0110). In Example 6, Fourney teaches high-fat diet mice with severe obesity were administered an active compound and had significantly less weight gain than untreated high-fat diet mice (paragraph 0163). The combination of Leong and Fourney’s teachings renders claims 5 and 7 – 19 prima facie obvious as combining prior art elements according to known methods to yield predictable results (MPEP 2143(i)(a)). A person of ordinary skill in the art would be motivated to utilize Leong’s delivery system of cationic polymers to deliver compounds according to Fourney’s teachings to treat or prevent obesity because Fourney teaches compounds for decreasing adipose, decreasing fat deposition, and regulating fat metabolism (paragraphs 0062 – 0066) Further, a person of ordinary skill in the art would have a reasonable expectation of success because Fourney teaches these compounds can be delivered with biocompatible polymer systems (paragraph 0110). Therefore, the combination of Leong and Fourney’s teachings is prima facie obvious according to MPEP 2143(i)(a), combining prior art elements according to known methods to yield predictable results. The combination of Leong’s teaching for a PAMAM cationic polymer with 1 to 3 generations grafted to nanoparticles (paragraphs 0035, 0046, 0048) with Fourney’s teachings to administer an active compound to mice fed a high-fat diet to treat obesity (paragraph 0163) reads on instant claim 5 . Fourney’s teachings that the mice were fed a high-fat diet and developed obesity reads on the recitation of “first determining that the patient is likely to become obese” because by feeding mice a high-fat diet Fourney determined the mice would become obese. Then, the administration of PAMAM cationic polymer with 1 to 3 generations grafted to nanoparticles (as taught by Leong) to deliver Fourney’s compound reads on “the administering of P-G3 is intended to slow or prevent the development of obesity in the patient”. Both Leong and Fourney are directed to methods for treating obesity, therefore, a person of ordinary skill in the art would have a reasonable expectation of success combining Leong’s carrier with Fourney’s active compound to treat obesity. Fourney’s teaching that mice were fed a high-fat diet reads on instant claim 7 . Fourney’s teaching that compounds may be targeted to adipose tissue by using a targeted drug delivery system (paragraphs 0079 and 0104) in combination with Leong’s teaching to administer a polycationic polymer to treat obesity (abstract, paragraphs 0014, 0018) reads on instant claims 8 and 9 . The combination of Leong’s polycationic polymers (abstract, paragraphs 0014, 0018) with Fourney’s active compounds (paragraphs 0062 – 0066) reads on claim 10 . Fourney’s teaching for compounds that decrease adipose, decrease fat deposition, and regulate fat metabolism (paragraphs 0062 – 0066) reads on “one or more fat-manipulating reagents” as recited in claim 11 . For claims 12 – 19, the recitations for “wherein the method inhibits visceral adiposity, increases energy expenditure, prevents obesity, and/or alleviates associated metabolic dysfunctions,” “wherein the method enhances visceral fat distribution,” “wherein the method impedes adipocyte hypertrophic growth and reduces the size of adipocytes,” and “wherein the method promotes adipogenesis ” do not further limit the active method steps defined by the claim, namely administering a polycationic polymer or derivative. According to MPEP 2111.04, “a whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited”. In this case, claims 12 – 19 use the term "wherein", rather than "whereby", however, the terms appear interchangeable because both refer to the intended result of the method step that is positively recited. The wherein clause does not inform the artisan of how the administration step is performed; rather, the wherein clause merely characterizes the desired results of those steps. For the sake of compact prosecution, the prior art teachings that read on the desired results recited in claims 12 – 14 and 16 – 18 are addressed below. Fourney’s teaching that high-fat diet mice with severe obesity were administered an active compound and had significantly less weight gain than untreated high-fat diet mice (paragraph 0163) reads on “inhibits visceral adiposity” as recited in claims 12 and 16 . Furthermore, although Fourney does not specific that adipocyte hypertrophic growth was impeded, thus resulting in reduced size of adipocytes, Fourney’s mice’s “significantly less weight gain” likely included adipocytes of reduced size as compared to adipocytes in the untreated control mice, reading on claims 14 and 18 Fourney teaches that the regulation of fat metabolism alters fat distribution within the body (paragraph 0042) reading on claims 13 and 17 . Potentially Allowable Subject Matter 12-151-08 AIA 07-43 12-51-08 Claim 6 appears to be free of prior art as Liu, Leong, and Fourney alone or in combination do not teach P-G3-chol(5) as a cationic polymer for treating or preventing obesity. Therefore, claim 6 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. Conclusion All claims are rejected. No claims are allowed. Correspondence Any inquiry concerning this communication or earlier communications from the examiner should be directed to Toriana N. Vigil whose telephone number is (571)270-7549. The examiner can normally be reached Monday - Friday 9:00 a.m. - 5:00 p.m. 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, Sahana Kaup can be reached at 571-272-6897. 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. /TORIANA N. VIGIL/Examiner, Art Unit 1612 /SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612 Application/Control Number: 18/801,052 Page 2 Art Unit: 1612 Application/Control Number: 18/801,052 Page 3 Art Unit: 1612 Application/Control Number: 18/801,052 Page 4 Art Unit: 1612 Application/Control Number: 18/801,052 Page 5 Art Unit: 1612 Application/Control Number: 18/801,052 Page 6 Art Unit: 1612 Application/Control Number: 18/801,052 Page 7 Art Unit: 1612 Application/Control Number: 18/801,052 Page 8 Art Unit: 1612 Application/Control Number: 18/801,052 Page 9 Art Unit: 1612 Application/Control Number: 18/801,052 Page 10 Art Unit: 1612 Application/Control Number: 18/801,052 Page 11 Art Unit: 1612 Application/Control Number: 18/801,052 Page 12 Art Unit: 1612
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