CTNF 18/565,787 CTNF 84090 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. This application is the national stage entry of PCT/JP2023/028305, filed 02 Aug 2023; and claims benefit of foreign priority document JAPAN 2022-127106, filed 09 Aug 2022. This foreign priority document is not in English. Claims 1-5 are pending in the current application and are examined on the merits herein. 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 Claims 2-5 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. Claims 2-4 depend from claim 1 and recite limitations conditional on being “after administration of the agent”. Claim 1 recites a “preventive and therapeutic agent for urinary tract infection containing 1-deoxymannose”, interpreted as drawn to a composition and not a process or method. MPEP 2111.04 at I. provides “ Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure. ” In this case the claims are not drawn to a method or process, and do not require steps or a method or process to be performed. Claim 5 recites “The preventive and therapeutic agent for urinary tract infection according to claim 1, being administered orally.” Claim 1 is interpreted as drawn to a composition and not a process or method. It is unclear whether this claim is drawn to a method of administering the preventive and therapeutic agent according to claim 1 orally, if the claim is drawn to the structure of the product and additional limitations which focus on the capabilities of the product and not the specific actions or functions performed by the user, or if the claim is drawn to both a product and the method steps of using it in a single claim. See also MPEP 2173.05(p) at II. Based on the language of claim 1, this claim will be interpreted as drawn to the structure of the product and additional limitations which focus on the capabilities of the product and not the specific actions or functions performed by the user, meaning the structure of the product is such that it is capable of being administered orally. Claim Rejections - 35 USC § 102 07-06 AIA 15-10-15 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. 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 1-5 are rejected under 35 U.S.C. 102( a)(1 ) as being anticipated by Carr et al. (Journal of Biological Chemistry, 1939, 128(2), p425-430, cited in PTO-892) with evidence provided by Hockett et al. (Journal of the American Chemical Society, 1944, 66(3), p464-466, cited in PTO-892) . Carr et al. discloses study of the fate of styracitol in the animal body (page 425, paragraph 1). Carr et al. discloses the synthesis of styracitol according to the method of Zervas. Recent work indicates that styracitol may be 1,5-anhydromannitol (paragraph spanning page 425-426). Carr et al. discloses the working example in which rats are fed an experimental diet of cacao butter and the styracitol (page 426, paragraph 2; table I at page 427), meaning the composition being administered orally as part of the experimental diet and meeting limitations of claim 5. Hockett et al. provides evidence of the structure of styracitol is 1,5-anhydro-D-mannitol by resolving erroneous experimental observations (page 464, left column, paragraph 1 to paragraph spanning pages 464-465). Hockett et al. discloses that styracitol test is synthesized according to the same method as disclosed in Carr et al. (bottom of page 465). The examined application at page 5, paragraph 16 of the specification states 1-deoxymannose is referred to as 1,5-anhydro-D-mannitol. Regarding claims 2-4, Fiege et al. is silent to the properties of this compound after administration. MPEP 2112.01 especially at I. citing In re Best , 562 F.2d 1252, 195 USPQ 430 (C.C.P.A. 1977) and In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990) discusses the support of rejections wherein the prior art discloses subject matter which there is reason to believe inherently includes functions that are newly recited or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to show the products of the applicant and the prior art are not the same or that the prior art products do not necessarily possess the characteristics of the claimed product. MPEP 2112.01 at II. provides “ “Products of identical chemical composition can not have mutually exclusive properties.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id. ” In this case Carr et al. with evidence provided by Hockett et al. discloses styracitol which is 1,5-anhydro-D-mannitol which is capable of being administered orally. Since products of identical chemical composition can not have mutually exclusive properties, there is reason to believe the 1,5-anhydro-D-mannitol disclosed in Carr et al. inherently includes functions that are newly recited . 07-15 AIA Claim s 1-5 are rejected under 35 U.S.C. 102( a)(1 ) as being anticipated by Fiege et al. (ChemBioChem, 2015, 16, p1235-1246, provided by Applicant in IDS filed 30 Nov 2023) with evidence provided by Carr et al. (Journal of Biological Chemistry, 1939, 128(2), p425-430, cited in PTO-892) and Hockett et al. (Journal of the American Chemical Society, 1944, 66(3), p464-466, cited in PTO-892) . Fiege et al. discloses urinary tract infections caused by uropathogenic E. coli are among the most prevalent infectious diseases. The mannose-specific lectin FimH mediates the adhesion of the bacteria to the urothelium, thus enabling host cell invasion and recurrent infections. An attractive alternative to antibiotic treatment is the development of FimH antagonists that mimic the physiological ligand (page 1235, abstract). The first successful demonstration of the anti-adhesion strategy was of the protective effect of methyl α-D-mannoside in a UTI mouse model (page 1235, right column, paragraph 1). In addition to high-affinity antagonists, Fiege et al. also studied methyl α-D-mannoside (8), n-butyl α-D-mannoside (9), and 1,5-anhydromannitol (10) (page 1237, left column, paragraph 2; table 1 at page 1237, left column), where 1,5-anhydromannitol is depicted as 1,5-anhydro-D-mannitol. 1,5-Anhydromannitol (10) is the smallest structural motif that still shows specific binding to the mannose pocket of FimH-CRD (page 1238, right column, paragraph 3). Fiege et al. disclose the working examples of the NMR study of FimH-CRD bound to each of the antagonists 1 to 11 (page 1244, right column, paragraphs 2-3; page 1238, right column, paragraph 2-3). The examined application at page 5, paragraph 16 of the specification states 1-deoxymannose is referred to as 1,5-anhydro-D-mannitol, and at paragraph 17 depicts the same chemical structural formula including stereochemistry as shown in Fiege et al. Regarding claims 2-4, Fiege et al. is silent to the properties of this compound after administration. MPEP 2112.01 especially at I. citing In re Best , 562 F.2d 1252, 195 USPQ 430 (C.C.P.A. 1977) and In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990) discusses the support of rejections wherein the prior art discloses subject matter which there is reason to believe inherently includes functions that are newly recited or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to show the products of the applicant and the prior art are not the same or that the prior art products do not necessarily possess the characteristics of the claimed product. MPEP 2112.01 at II. provides “ “Products of identical chemical composition can not have mutually exclusive properties.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id. ” In this case Fiege et al. discloses 1,5-anhydro-D-mannitol shown to be an antagonist mannose-specific lectin FimH in the context of anti-adhesion strategy for treatment of urinary tract infections caused by uropathogenic E. coli . Based on this disclosure there is reason to believe the 1,5-anhydro-D-mannitol disclosed in Fiege et al. inherently includes functions that are newly recited. Regarding claim 5, Carr et al. and Hockett et al. disclose as above and provide evidence that 1,5-anhydro-D-mannitol is capable of being administered orally. Therefore there is reason to believe the 1,5-anhydro-D-mannitol disclosed in Fiege et al. inherently includes this same capability. Conclusion No claim is found to be allowable. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jonathan S Lau whose telephone number is (571)270-3531. The examiner can normally be reached Monday-Friday 9a-5p Eastern. 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, Scarlett Goon can be reached at (571)270-5241. 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. /JONATHAN S LAU/ Primary Examiner, Art Unit 1693 Application/Control Number: 18/565,787 Page 2 Art Unit: 1693 Application/Control Number: 18/565,787 Page 3 Art Unit: 1693 Application/Control Number: 18/565,787 Page 4 Art Unit: 1693 Application/Control Number: 18/565,787 Page 5 Art Unit: 1693 Application/Control Number: 18/565,787 Page 6 Art Unit: 1693 Application/Control Number: 18/565,787 Page 7 Art Unit: 1693 Application/Control Number: 18/565,787 Page 8 Art Unit: 1693