CTNF 18/453,663 CTNF 100703 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 statement (IDS) submitted on December 29 th , 2023 is being considered by the examiner. Specification 07-44 AIA The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: Claims 8-9 speak to the composition of claim 1, further comprising an odorant, such as a citrus-based odorant. The specification makes no mention of odorants (in general) to be incorporated in the wound healing composition. The specification also doesn’t reference citrus-based odorants. Status of the Claims Claims 1-11 are pending in this application. See claim Objections . Claim Objections Two claims numbered as “Claim 7” are objected: The first claim 7 recites: “The therapeutic composition of claim 1, comprising ( . . . ) . Other useful ( . . . ).” Per MPEP § 608.01(m), each claim begins with a capital letter and ends with a period. Periods may not be used elsewhere in the claims except for abbreviations. See Fressola v. Manbeck, 36 USPQe2d 1211 (D.D.C. 1995). Further regarding claim 7 , the acronym PCCP-SA in poly(PCCP-SA anhydride) is not defined in the claim or in the specification. The second claim 7 , see below, needs to be renumbered. This claim will be referenced as claim 11 in this office action. PNG media_image1.png 55 637 media_image1.png Greyscale Appropriate correction is required. Claim Rejections - 35 USC § 101 07-04-01 AIA 07-04 35 U.S.C. 101 reads as follows: Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title. Claims 1-2, 4-9, and 11 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim does not fall within at least one of the four categories of patent eligible subject matter. Claims 1-2 and 4, are drawn to a composition comprising a wound healing agent (such as keratin – as disclosed by Kelly vide infra ) and a bitterant. Barron et al. (Obtained from wholisticmatters.com [retrieved on 12/10/2025]<URL: https://wholisticmatters.com/andrographis-for-immune-health/#:~:text=Andrographis%20(Andrographis%20paniculata)%2C%20an,in%20Southern%20and%20Southeastern%20Asia.&text=It%20is%20commonly%20referred%20to,to%20its%20ext remely%20bitter%20taste.> - Pub. Date: July 23, 2022) discloses the Andrographis plant as the “king of all bitters” and teaches its many medicinal properties. Thus, the claims read on a mixture of two natural products, namely keratin and the Andrographis plant, without significantly more. Regarding claims 5-6 , hydrogels derived, for example, from chitosan and/or honey, both of which are natural products. Regarding claim 7 , keratin is a natural polyamide, and thus the instant claim reads on a mixture of natural products comprising keratin, the Andrographis plant. Regarding claim 11, vinegar (acetic acid) is a natural product, and thus the instant claim reads on a mixture of natural products comprising keratin and vinegar. Regarding claims 8-9 , citrus oils are natural products, thus the claims are drawn to a mixture of natural products without significantly more. Claim Rejections - 35 USC § 112 07-30-02 AIA 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. The following is a quotation of 35 U.S.C. 112 (pre-AIA), second paragraph: The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention. 07-34-01 Claim 7 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Regarding claim 7 , the phrase "Other useful bioresorbable materials include" 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). This part of the claim is preceded by a period which adds to the confusion. 07-34-08 Regarding claim 7 , the term "i.e" renders the claim indefinite because it is unclear whether the limitation(s) 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. 07-15 AIA Claim s 1, 3, and 10-11 are rejected under 35 U.S.C. 102( a)(1 ) as being anticipated by Pinnaclife Animal Health (Retrieved from prnewswire.com [retrieved on 11/21/2025] <URL: https://www.prnewswire.com/news-releases/pinnaclife-animal-health-features-seal-n-heal-wound-shield-in-new-veterinary-dermatologist-tested-and-approved-product-line-179352931.html#:~:text=(Logo:%20http://photos.,tasks%20traditionally%20 requiring%20four%20products.>) (“PAH”) . Regarding claim 1, PAH discloses “Seal N’ Heal Wound Shield” as an effective composition for treating high-bioburden wounds in pets ( para. 1, lines 1-2 ). PAH teaches their composition comprises an Olivamine 10TM (a blend of molecules proven to improve healing rates - wound healing agents) and denatonium benzoate (bitterant) ( para. 3-4 ). Regarding claims 3 and 11 (second claim numbered as 7 – see claim objection) , PAH discloses denatonium benzoate as the bitterant of their product ( para. 3 ). Regarding claim 10, PAH discloses their composition for treating wounds in pets . 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. 07-21-aia AIA Claim s 2, 4, and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Pinnaclife Animal Health (Retrieved from prnewswire.com [retrieved on 11/21/2025 <URL: https://www.prnewswire.com/news-releases/pinnaclife-animal-health-features-seal-n-heal-wound-shield-in-new-veterinary-dermatologist-tested-and-approved-product-line-179352931.html#:~:text=(Logo:%20http://photos.,tasks%20traditionally%20requiring%20four%20products.>) (“PAH”); as applied to claims 1, 3, and 10-11; in view of Kelly et al. ( Wound Healing Biomaterials , 2, 2016, 353-365) (“Kelly”) . The teachings of PAH are disclosed in the 102-section above and incorporated herein. While PAH does not teach their composition comprising: (i) keratin (claims 2, 4); the teachings of Kelly are relied upon for these disclosures. Kelly teaches keratins possess the required properties for use in wound healing, including biocompatibility, desirable biological or physical response in a wound environment, and practical process for isolation and manipulation to facilitate into usable wound healing products ( page 353, last para. ). Kelly discloses how keratin treated wounds healed faster when compared to untreated wounds ( Figure 17.1, page 357 ). Kelly teaches Keramatrix® as a pure keratin composition (reading on about 100% keratin) and teaches other trademarked compositions that come in liquid and gel form, comprising keratin ( page 358, Section 17.4, lines 4 ). Therefore, regarding instant claims 2 and 4 , it would have been prima facie obvious to one of ordinary skill prior to the effective filing date of the claimed invention to prepare a wound healing composition for pets comprising keratin and a bitterant, like denatonium benzoate, as taught by PAH in view of Kelly. One of ordinary skill would have been motivated to do so with a reasonable expectation of success because PAH teaches their pharmaceutical composition comprising denatonium benzoate and other components, which is effective in treating wounds in pets while discouraging them from licking and disturbing the treated area, due to the presence of a bitterant. Furthermore, one would have been motivated with a reasonable expectation of success because Kelly teaches keratins accelerated wound healing and possesses ideal properties, like biocompatibility, desirable biological or physical response in a wound environment, and practical process for isolation and manipulation to facilitate into usable wound healing products. Applicant is advised, the courts have found that “[i]t is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art ( In re Kerkhoven , 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).” See MPEP 2144.06. It is therefore obvious to provide a mixture of the two agents. Furthermore, the courts have held that an express suggestion to substitute one equivalent component or process for another is not necessary to render such substitution obvious. In re Fout, 675 F.2d 297, 213 USPQ 532 (CCPA 1982). Therefore, it is obvious to substitute one component of the composition for another functionally equivalent one. Further regarding claim 4, Kelly teaches Keramatrix® as a keratin composition (reading on about 0.1-100% keratin the claimed composition) and teaches other trademarked compositions that come in liquid and gel form, comprising keratin ( page 358, Section 17.4, lines 4 ). Thus, regarding the instantly claimed ranges of 0.1-100% keratin in the claimed composition, as recited in instant claim 4, Applicant is advised that the courts have stated where the claimed ranges overlap or lie inside the ranges disclosed by the prior art and even when the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have similar properties, a prima facie case of obviousness exists. See In re Wertheim , 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff , 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990); Titanium Metals Corp. of America v. Banner, 778 F2d 775. 227 USPQ 773 (Fed. Cir. 1985) (see MPEP 2144.05.01). The courts have also found that where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. See In re Aller , 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP 2144.05-II. Therefore, the claimed ranges merely represent an obvious variant and/or routine optimization of the values of the cited prior art. Regarding claim 10 , it would have been prima facie obvious to one of ordinary skill to treat a wound in a pet by administering a composition comprising keratin and denatonium benzoate, in view of PAH and Kelly. One of ordinary skill would have been motivated to do so with a reasonable expectation of success because PAH teaches their pharmaceutical composition comprising as effective in treating wounds in pets while discouraging them from licking and disturbing the treated area, due to the presence of a bitterant; and Kelly teaches keratins accelerate wound healing, thus minimizing discomfort in the afflicted pet . 07-21-aia AIA Claim s 5-7 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Pinnaclife Animal Health (Retrieved from prnewswire.com [retrieved on 11/21/2025 <URL: https://www.prnewswire.com/news-releases/pinnaclife-animal-health-features-seal-n-heal-wound-shield-in-new-veterinary-dermatologist-tested-and-approved-product-line-179352931.html#:~:text=(Logo:%20http://photos.,tasks%20traditionally%20requiring%20four%20products.>) (“PAH”); as applied to claims 1, 3, and 10-11; in view of Yar et al. (WO 2018/162900 A1) (“Yar”) . The teachings of PAH are disclosed above and incorporated herein. While PAH does not teach their composition comprising: (i) hydrogels, like gelatin, etc. (claims 5-6); (ii) a synthetic material like polycaprolactone etc. (claim 7); the teachings of Yar are relied upon for these disclosures. Yar teaches a composition for wound healing ( abstract ), wherein their treatment is administered in a biocompatible matrix material or hydrogel (reading on claim 5) ( page 4, para. 1, line 4 ), wherein the hydrogel may be a crosslinked hydrogel, like chitosan, gelatin, etc. (reading on claim 6) ( page 4, para. 4 ). Yar also teaches suitable biocompatible matrix materials for administration may be electro-spun nanofibers, such as polycaprolactone (reading on claim 7) ( page 22, last para. ). Therefore, regarding instant claims 5-7 , it would have been prima facie obvious to one of ordinary skill prior to the effective filing date of the claimed invention to prepare a wound healing composition for pets comprising a healing agent and a bitterant, in the form of hydrogels or biocompatible matrix material, further comprising gelatin or polycaprolactone, etc. as taught by PAH in view of Yar. One of ordinary skill would have been motivated to do so with a reasonable expectation of success because PAH discloses their wound healing composition comprising a bitterant and healing components for treating injuries in pets, while preventing them from licking or disturbing the affected area; further because Yar discloses would healing composition formulations in the form of biocompatible matrix materials or hydrogels, and discloses that these compositions may contain polycaprolactone or gelatin, respectively. Regarding claim 10 , it would have been prima facie obvious to one of ordinary skill prior to the effective filing date of the claimed invention to treat an injury in a pet with a composition resulting from combining the teachings of PAH and Yar. One of ordinary skill would have been motivated to do so with a reasonable expectation of success because PAH teaches their compositions are able to treat injuries in pets, while discouraging them from disturbing the affected area; further because Yar discloses formulations for wound healing compositions in the forms of hydrogels and biocompatible matrix materials, which would facilitate the application process and maximize comfort for pets . 07-21-aia AIA Claim s 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over Pinnaclife Animal Health (Retrieved from prnewswire.com [retrieved on 11/21/2025 <URL: https://www.prnewswire.com/news-releases/pinnaclife-animal-health-features-seal-n-heal-wound-shield-in-new-veterinary-dermatologist-tested-and-approved-product-line-179352931.html#:~:text=(Logo:%20http://photos.,tasks%20traditionally%20requiring%20four%20products.>) (“PAH”); as applied to claims 1, 3, and 10-11; in view of Dosoky et al. ( Int. J. Mol. Sci. 2018, 19, 1966, 25 pages) (“Dosoky”) . The teachings of PAH are disclosed above and incorporated herein. While PAH doesn’t teach their composition comprising an odorant, like citrus based odorants (claims 8-9); the teachings of Dosoky are relied upon for these disclosures. Dosoky teaches the biological activities and safety considerations of citrous essential oils (reading on citrus based odorants) ( abstract ). Table 3 ( starting on page 5 ) discloses the biological activities of certain citrous oils, with most exhibiting antibacterial, antifungal, and pain relief properties. Therefore, regarding claims 8-9 , it would have been prima facie obvious to one of ordinary skill prior to the effective filing date of the claimed invention to prepare a wound healing composition for animals comprising a wound healing agent, a bittering agent, and a citrous oil, as taught by PAH in view of Dosoky. One of ordinary skill would have been motivated to do so with a reasonable expectation of success because PAH discloses their wound healing composition comprising a bitterant and healing components for treating injuries in pets, while preventing them from licking or disturbing the affected area; further because Dosoky teaches certain citrous oils exhibit antibacterial, antifungal, and pain relief properties, which would be further beneficial to accelerate wound healing. Applicant is reminded, the courts have found that “[i]t is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art. Regarding claim 10 , it would have been prima facie obvious to one of ordinary skill prior to the effective filing date of the claimed invention to treat an injury in an animal with a composition resulting from combining the teachings of PAH and Dosoky. One of ordinary skill would have been motivated to do so with a reasonable expectation of success because PAH teaches their compositions are able to treat injuries in pets, while discouraging them from disturbing the affected area; further because Dosoky teaches certain citrous oils exhibit antibacterial, antifungal, and pain relief properties, which would be further beneficial to accelerate wound healing. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to JACKSON J HERNANDEZ whose telephone number is (571)272-5382. The examiner can normally be reached Mon - Thurs 7:30 to 5. Examiner interviews are available via telephone 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, Kortney L. Klinkel can be reached at (571) 270-5239. 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. /JACKSON J HERNANDEZ/Examiner, Art Unit 1627 /Kortney L. Klinkel/Supervisory Patent Examiner, Art Unit 1627 Application/Control Number: 18/453,663 Page 2 Art Unit: 1627 Application/Control Number: 18/453,663 Page 3 Art Unit: 1627 Application/Control Number: 18/453,663 Page 4 Art Unit: 1627 Application/Control Number: 18/453,663 Page 5 Art Unit: 1627 Application/Control Number: 18/453,663 Page 6 Art Unit: 1627 Application/Control Number: 18/453,663 Page 7 Art Unit: 1627 Application/Control Number: 18/453,663 Page 8 Art Unit: 1627 Application/Control Number: 18/453,663 Page 9 Art Unit: 1627 Application/Control Number: 18/453,663 Page 10 Art Unit: 1627 Application/Control Number: 18/453,663 Page 11 Art Unit: 1627