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 .
This Office action is responsive to Applicant’s amendment and remarks, filed 10 June 2026, in which claim 1 is amended and claims 2-5 are canceled.
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.
Claim 1 is pending in the current application and are examined on the merits herein.
Rejections Withdrawn
Applicant’s amendment, filed 10 June 2026, with respect that 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 has been fully considered and is persuasive, as claims 2-5 are canceled.
This rejection has been withdrawn.
The following are modified grounds of rejection necessitated by Applicant’s amendment, filed 10 June 2026, in which claim 1 is amended and claims 2-5 are canceled.
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.
Amended Claim 1 is 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, of record) with evidence provided by Hockett et al. (Journal of the American Chemical Society, 1944, 66(3), p464-466, of record).
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 the wherein clauses of claim 1, Carr 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.
Response to Applicant’s Remarks:
Applicant’s remarks, filed 10 June 2026, have been fully considered and not found to be persuasive.
Applicant notes that, as provided in MPEP 2131, ““A claim is anticipated only if each and every element as set forth in the claim is found, either expressly or inherently described, in a single prior art reference.” Verdegaal Bros. v. Union Oil Co. of California, 814 F.2d 628, 631, 2 USPQ2d 1051, 1053 (Fed. Cir. 1987).” However, as detailed in the previous Office action, the invention of amended claim 1 reciting “A preventive and therapeutic agent for a urinary tract infection comprising 1-deoxymannose…” is 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. As detailed in the rejection above, Carr et al. discloses the working example in which rats are fed an experimental diet of cacao butter and the styracitol (1,5-anhydro-D-mannitol), or a composition comprising 1-deoxymannose that is capable of being administered orally. This disclosed composition meets each and every element of the particular structure as set forth in the claim, and as explained above the claim scope is not limited by claim language that does not require steps to be performed.
Further, the filed application describes in working example 1 at page 8, paragraph 29 in which 1 g of 1-deoxymannose was dissolved in water to prepare a 20% w/w solution as a sample for oral administration. This description does not specify a particular carrier or formulation or a particular structure of the claimed agent in order to result in the function or property of being detected in human urine after oral administration.
Applicant notes that most orally administered sugars are not excreted in the urinary tract. Carr et al. at page 426 discloses in fasting rats the styracitol is utilized to form additional glycogen in the liver, and excreted urine and the urine removed from the bladder at the time of killing did not yield detectable quantities of styracitol upon analysis. However, as detailed above, 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.” While Carr et al. does not disclose the property of the styracitol to be excreted in urine in humans, there is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the relevant time, but only that the subject matter is in fact inherent in the prior art reference. See MPEP 2112 at II. citing Schering Corp. v. Geneva Pharm. Inc., 339 F.3d 1373, 1377, 67 USPQ2d 1664, 1668 (Fed. Cir. 2003) Further, MPEP 2112 at I. provides ““[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).” In this case, the claiming of a new function or unknown property of the styracitol (1,5-anhydro-D-mannitol) formulated for oral administration disclosed in Carr et al. which are inherently present in the prior art does not make the claim patentable.
Further, Carr et al. at page 425 states “The anhydrides of these sugar alcohols are generally non-metabolizable by either microorganisms or the mammalian body.” and at page 426 “In previous experiments with the unmetabolized anhydrides invariably these compounds could be detected unchanged in the excreted urine.” This suggests that the function or property of the styracitol to be metabolized by fasting rats disclosed in Carr et al. would not have been interpreted as evidence that styracitol would also be metabolized by humans, and suggests that anhydrides of these sugar alcohols would have been predicted to possess the function or property of being unmetabolized and excreted in urine in a mammal by a person of ordinary skill in the art at the relevant time. Therefore the disclosure of Carr et al. taken as a whole does not provide evidence that the function or property of the agent comprising 1-deoxymannose as claimed is not necessarily present in the styracitol disclosed in the Carr et al.
Amended Claim 1 is 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, of record) and Hockett et al. (Journal of the American Chemical Society, 1944, 66(3), p464-466, of record).
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 the wherein clauses of claim 1, 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. Further, 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.
Response to Applicant’s Remarks:
Applicant’s remarks, filed 10 June 2026, have been fully considered and not found to be persuasive.
Applicant’s remarks regarding Fiege et al. are not persuasive for the same reasoning discussed above regarding the styracitol disclosed in Carr et al.
Conclusion
The claim is not found to be allowable.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/JONATHAN S LAU/ Primary Examiner, Art Unit 1693
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