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. Priority This application, filed 24 August, 2023 claims the benefit of U.S. Provisional Application 63/400,629, filed 24 August, 2022. Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) as follows: The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc. , 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994). The disclosure of the prior-filed application, Application No. 63/400,629, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. The Provisional application discloses study summaries involving a single polyacetylene compound, p a n axynol , evaluated in colon-specific inflammatory and colorectal cancer contexts. In contrast, the claims of the present application recite methods of treating inflammatory diseases broadly using polyacetylene compounds as a class. The provisional application does not describe or enable polyacetylene compounds as a class, nor does it describe or enable methods of treating inflammatory diseases as a class, including diverse disease conditions recited in the present specification. As a result, the provisional application does not reasonably convey possession of, or enable, the full scope of the presently claimed subject matter. Accordingly, none of the claims are entitled to the filing date of the provisional application and are entitled only to the filing date of the present application, 24 August, 2023 . Information Disclosure Statement The information disclosure statement (IDS) submitted on 9 May, 2024, is acknowledged and has been considered. Status of the Application Receipt is acknowledged of Applicant’s claimed invention, filed 24 August, 2023 , in the matter of Application N° 18/ 455 ,12 4 . Said documents have been entered on the record. No additions, amendments, or cancellations have been made to the originally-filed claims. The issue of new matter is moot. Thus, C laims 1- 20 represent all claims currently under consideration. Claim Rejections - 35 USC § 112 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. The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112: 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 of carrying out his invention. Claim s 1 -20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA), first paragraph, as failing to comply with the written description and enablement requirement s . The claim(s) 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, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention , nor enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention . Claim 1 recites “[a] method of treating an inflammatory disease …administering…a polyacetylene compound .” The specification defines “inflammatory disease” broadly as a disease caused by, resulting from, or resulting in inflammation , including acute or chronic inflammatory condition s, which can result from infections or non-infectious causes , and expressly lists diverse diseases such as inflammatory bowel disease, psoriasis, colorectal cancer, chronic inflammation, autoimmune disease, colorectal cancer, Familial Adenomatous Polyposis (FAP), and Lynch Syndrome (instant Specification, Pg. 10, Para 0091.) These conditions involve distinct tissues, cell types, biological pathways, and mechanisms of disease, including, for example, epidermal keratinocyte – driven immune dysregulation in psoriasis, macrophage-mediated intestinal inflammation in colitis, and oncogenic transformation associated with chronic inflammation in colorectal cancer. Similarly, the specification broadly defines “polyacetylene compounds” as compounds isolated from natural sources. Polyacetylenes constitute a chemically diverse class of compounds known in the art to exhibit a wide range of biological activities and uses, including antimicrobial, cytotoxic, neurotoxic, and anti-inflammatory effects, depending on structure and context. The specification, however, discloses and experimentally evaluates only a single polyacetylene compound, p a n axynol , and does so exclusively in colon-specific inflammatory and colorectal cancer models, including colitis, AOM-DSS-induced colorectal cancer, macrophage activity, mucosal structure, and intestinal barrier function (instant Specification, Pg. 17-33, Para 00123-00166, § Examples.) In view of this disclosure, the specification does not reasonably convey to one of ordinary skill in the art that Applicant was in possession of methods for treating inflammatory diseases as a class using polyacetylene compounds as a class . Disclosure of p a n axynol in colon-specific inflammatory and cancer models does not provide a representative number of polyacetylene species, does not identify common structural features predictive of activity across polyacetylene compounds, and does not demonstrate possession of therapeutic methods applicable to the diverse inflammatory diseases encompassed by the claims. The claims are also not enabled across their full scope. Given the substantial biological and mechanistic differences among the inflammatory diseases expressly encompassed by the claims, and the known structural and functional diversity of polyacetylene compounds, the specification provides no guidance enabling one of ordinary skill in the art to determine, without undue experimentation, which polyacetylene compounds would be effective for which inflammatory diseases, or how such compounds would be administered across the full breadth of the claims. With respect to the dependent Claims 2-20, while certain dependent claims narrow the scope of C laim 1 in one respect, none eliminate all unsupported subject matter. For example, Claim 3 limits the polyacetylene compound to p a n axynol but retains the broad recitation of treating “an inflammatory disease,” encompassing diseases and biological contexts not supported by the disclosure. Conversely, Claim s 11-13 narrow t he inflammatory disease to a co lo recta l or colon-associated condition, but continues to encompass polyacetal compounds as a class, for which possession and enablement are not demonstrated. As no dependent claim simultaneously narrows both the polyacetylene compound and the inflammatory disease to t he specific subject matter actually disclosed, each dependent claim retains unsupported breadth and likewise fails to satisfy the written description and enablement requirements of 35 U.S.C. § 112(a). Examiner notes the deficiencies referenced above rise from the scope of the claims relative to the disclosure, and cannot be overcome by argument alone absent amendment of the claims to more closely correspond to the subject matter actually described and enabled in the specification. 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 appl icant regards as his invention. Claim s 2 -3 , 9, 11-13 , and 15- 20 , are 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. Claim 2 recites “ wherein the polyacetylene compound comprises an anti-tumor agent .” A polyacetylene compound is a single chemical entity, whereas an “anti-tumor agent” refers to a therapeutic agent or functional role. It is unclear how a single compound can “comprise” an agent, as the claim does not specif y whether the polyacetylene compound is itself the anti-tumor agent, is chemically linked to an anti-tumor agent, or is part of a composition that includes an anti-tumor agent. Accordingly, the scope of the claim cannot be determined with reasonable certainty. Claim 3 recites “ wherein the polyacetylene compound comprises panaxynol .” A polyacetylene compound is a single chemical entity, whereas the term “comprises” denotes inclusion of one or more components. It is unclear how a single compound can “comprise” panaxynol , as the claim does not specify whether the polyacetylene compound is panaxynol itself, a mixture including panaxynol , or a composition containing panaxynol . Accordingly, the scope of the claim cannot be determined with reasonable certainty. Claim 9 recites “ wherein the inflammatory disease comprises is selected from the group consisting of …” This limitation combines the open-ended transitional phrase “comprises” with th e closed-ended phrase “is selected from the group consisting of,” resulting in an internally inconsistent and grammatically unclear construction. As a result, it is unclear whether the inflammatory disease is required to be one of the lis t ed diseases or may include additional, unrecited diseases. Accordingly, the scope of the claim cannot be determined with reasonable certainty. Claims 11-13 each recite that “ the inflammatory disease comprises ” a single disease conditions, such as colon cancer, colitis, or colorectal cancer. It is unclear how a disease can “comprise” another disease, or whether the claims require treatment of the specified disease alone or permit treatment of additional, unrecited disease conditions. Accordingly, the scope of Claims 11-13 cannot be determined with reasonable certainty. Claims 15 and 16 recite an “increase” or a “decrease” in the expression level of at least one biomarker without specifying the baseline or reference point relative to which the change is determined, the magnitude of change required, or the biomarker(s) to be measured. As a result, it is unclear what constitutes an increase or decrease in expression level for purposes of the claims, and the scope of the claims cannot be determined with reasonable certainty. Claim 17 recites “ comprises a cell, a macrophage cell, a micro-RNA, or any combination thereof .” The use of the open-ended transitional phrase “comprises” together with “ a cell, a macrophage cell, a micro-RNA, or any combination thereof ” renders the scope of the claim unclear, as it is not reasonably certain whether the claim requires at least one of a cell , a macrophage cell, or a micro-RNA , exactly one of a cell , a macrophage cell, or a micro-RNA , all of a cell , a macrophage cell, and a micro-RNA , or permits additional, unrecited elements beyond a cell , a macrophage cell, and a micro-RNA . Accordingly, the scope of the claim cannot be determined with reasonable certainty. Claim 18, depend s from Claim 17 . I n addition to inheriting the indefiniteness of Claim 17, it also recites additional limitations using the phrases “comprise” and “or any combination thereof” with a different enumerated list. The claim does not make clear whether one, more than one, or all of the listed elements are required, nor how the listed elements interact with one another or with unrecited elements permitted by the open-ended transitional language. Accordingly, the scope of the claim cannot be determined with reasonable certainty. Claim 19, depends from Claim 17. In addition to inheriting the indefiniteness of Claim 17, it also recites “ the cell comprises a regulatory T cell .” It is unclear how a cell can “comprise” another cell, and the claim does not specify whether the cell is intended to be a regulatory T cell, a population of cells including regulatory T cells, or some other arrangement. Accordingly, the scope of the claim cannot be determined with reasonable certainty. Claim 20, depends from Claim 17. In addition to inheriting the indefiniteness of Claim 17, it also recites “ the macrophage cell comprises CD4 + , CD3 + , CD45 + , CD8 + , CD11b, or CD68. ” A macrophage cell is a defined immune cell type, whereas the listed CD markers represent phenotypic expression markers associated with different immune lineages, including T lymphocytes ( CD4 + , CD3 + , CD8 + ) , myeloid cells ( CD11b, CD68 ), and leukocytes generally ( CD45 + ). The claim do es not specify the biological relationship between macrophage cell and the listed markers (e.g., expression, positivity, or defining characteristics), nor does it clarify which markers are required to define the macrophage cell. Additionally, the use of the open-ended term “comprises” together with mutually inconsistent alternatives renders the scope of the claim unclear. Accordingly, the scope of the claim cannot be determined with reasonable certainty. Claim Rejections - 35 USC § 102 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 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 – (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. Claim s 1, 3, and 9 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Nadler and Natarajan (WO 96/34943 A1 , published in 1996. ) Nadler and Natarajan teach a method for the treatment of a human patient suffering from a cytokine mediated autoimmune , inflammatory or atherosclerotic disorder which comprises administering to said patient a human 12 lipoxygenase inhibitor in an amount therapeutically effective to mediate the action of said cytokine on human vascular smooth muscle (‘943, Pg. 61, Claim 11), wherein the inhibitor is panaxynol (‘943, Pg. 61, Claim 14.) As such, Nadler and Natarajan anticipate Claims 1, 3, and 9. Claims 1- 13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by McDonald et al. (Am J Physiol Gastrointest Liver Physiol 325: G318–G333, 2023, published 25 July, 2023 , cited in IDS ), hereinafter McDonald . Reference shares two common inventors with instant application . McDonald discloses experimental materials, methods, and results corresponding to those described in the Examples section of the instant specification, including administration of panaxynol (PA) in the same disease model and observation of the same biological effects. Regarding Claim s 1 - 13, McDonald discloses a study wherein 2.5 mg/kg PA was administered 3 times/ wk via oral gavage over 12 w ks , as therapeutic agent to ameliorate colorectal cancer (CRC) tumorigenesis . The results suggest that panaxynol (PA) is a promising therapeutic compound to treat CRC and improve clinical symptoms given its ability to inhibit macrophages and modulate the inflammatory environment in the colon . McDonald teaches panaxynol possesses anticancer properties in vitro and suppresses murine colitis through its proapoptotic and anti-inflammatory properties (McDonald, Abstract.) As such, McDonald anticipates Claims 1-13. Claim Rejections - 35 USC § 103 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. 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 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 1-3 are rejected under 35 U.S.C. 103 as being unpatentable over Dong et al. ( KR20160065402A , published in 2016), hereinafter Dong . Dong teaches a functional composition for prevention and anticancer comprising edible carbohydrates and polyacetylene components isolated from Panax ginseng (‘402, Pg. 1, Intro), and in particular, the polyacetylene component falcarinol (‘402, Pg. 5, Para 0039.) Note : falcarinol is also known as panaxynol . It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to administer the composition comprising panaxynol as disclosed by Dong for the treatment of cancer, because Dong expressly teaches panaxynol as an anticancer agent, and administration of an anticancer composition to a subject in need thereof represents routine and expected use. Claims 14-20 are rejected under 35 U.S.C. 103 as being unpatentable over McDonald (Am J Physiol Gastrointest Liver Physiol 325: G318–G333, 2023 , cited in IDS . ) Reference shares two common inventors with instant application . The teachings of McDonald (20 23 ) are set forth in the above 35 U.S.C. 102 Rejections and are incorporated herein. McDonald teaches administration of p anaxynol alleviates colorectal cancer in a murine model via suppressing macrophages and inflammation . Regarding Claims 14 and 20 , McDonald teaches administration of panaxynol for treatment of colorectal cancer and measurement of biomarker expressions to assess biological effects ; to include the isolation and incubation of colonic LP cells , wherein biomarkers were measured , such as , the Live CD45+ population, CD11b+ CD68+ cells were identified as macrophages , or neutrophil cell-surface markers: CD45, CD11b , and Ly6g (McDonald, Pg. G321, § Flow Cytometry.) Regarding Claims 15, McDonald teaches in support of PA’s anti-tumor effects, colonic tumors of PA-treated AOM/DSS mice exhibited a significant increase in the percentage of apoptotic cells compared with VEH (McDonald, Pg. G323, Col 2, Para 2.) Regarding Claims 16-19, McDonald teaches colons of PA-treated AOM/DSS mice exhibited significant downregulation of proinflammatory genes IL-1b and IL-6 , important contributors of clinical symptoms and intestinal inflammation in CRC that are associated with M1 macrophages and to lesser extent T-cells (McDonald, Pg. G325, Col 2, Para 1.) It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to obtain biological samples prior to and after administration, compare biomarker expression levels, and continue or cease administration based on t he observed results, as such monitoring and adjustment of therapy represents routine and predictable clinical practice. Claim s 1 -2, 9, 11, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Chen et al. ( Fitoterapia 167 (2023) 105490 , published 28 March, 2023 ), hereinafter Chen . Chen discloses the results of a study of nine polyacetylenes in which the cytotoxic and apoptotic effects of isolates on colon cancer cells were studied using the CT-26 cell lines (2023, Pg. 1, Introduction.) Chen teaches the polyacetylenes in A. macrocephala may be prospective for the treatment of colorectal cancer (2023, Pg. 1, Abstract), i n particular, polyacetylenes may be the active ingredients of A. macrocephala for the anti-tumor treatment (2023, Pg. 1, Introduction.) It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to administer the polyacetylene compound in A. macrocephala as disclosed by Chen for the treatment of colorectal cancer , because Chen expressly teaches its antitumor properties , and administration of an antitumor compound to a subject in need thereof represents routine and expected use. Claims 1- 4 , 6 -10, 12, 14-17, and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Chaparala et al. ( Oncotarget , 2020, Vol. 11, (No. 22), pp: 2026-2036 , cited in IDS), hereinafter Chaparala . Regarding Claims 1-3, 9-10, and 12, Chaparala teaches that panaxynol ( PA ) effectively treats colitis in a Dextran Sulfate Sodium (DSS) mouse model by targeting macrophages for DNA damage and apoptosis. Chaparala discloses PA has been shown to have anti-cancer properties ( Chaparala , Pg. 2027, Para 3.) This study provides additional mechanistic evidence that American ginseng can be used for conventional treatment of colitis and other diseases associated with macrophage dysfunction ( Chaparala , Pg. 2026, Abstract.) Regarding Claim 4, Chaparala teaches a dose of PA at 1 mg/kg/day ( Chaparala , Pg. 2029, Figure 2.) Regarding Claims 6-8, Chaparala teaches 1 mg/kg per day by oral gavage for one week – from day 7 to day 14 ( Chaparala , Pg. 2033, Col 2, Para 2.) Regarding Claim 1 4 , Chaparala teaches examin ation of a biomarker of inflammation involved test ing each colon section for cyclooxygenase-2 (COX-2) immunoreactivity using immunohistochemistry ( Chaparala , Pg. 2027, Col 2, Para 4.) Regarding Claim 15, Chaparala teaches PA significantly increased the percentage of apoptotic cells ( Chaparala , Pg. 2031, Figure 4.) Regarding Claim 16, Chaparala teaches a decreased expression of COX-2 with PA treatment ( Chaparala , Pg. 2027, Col 2, Para 4, and Figure s 2C, 2E . ) Regarding Claim s 17 and 19-20, Chaparala teaches isolation of CD4+CD25- T cells ( Chaparala , Pg. 2033, Col 1, Para 1.) It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to administer the anti-cancer compound panaxynol as disclosed by Chaparala for the treatment of colitis and other diseases associated with macrophage dysfunction , because Chaparala expressly teaches its anti-inflammatory and anti-cancer properties, and administration of an anti-inflammatory and anti-cancer compound to a subject in need thereof represents routine and expected use. Furthermore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to obtain biological samples prior to and after administration, compare biomarker expression levels, and continue or cease administration based on the observed results, as such monitoring and adjustment of therapy represents routine and predictable clinical practice. Co mmunication Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT Donna M. Nestor whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (703)756-5316 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT generally (w/flex): 5:30a-5p EST M-Th . 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, FILLIN "SPE Name?" \* MERGEFORMAT Kortney Klinkel can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT 571-270-5239 . The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. 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