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 .
Detailed Action
This office action is a response to applicant’s communication submitted March 25, 2026, wherein the rejections of record in the previous action are traversed. This application is a national stage application of PCT/US21/42886, filed July 23, 2021, which claims benefit of provisional application 63/055371, filed July 23, 2020.
Claims 1-20 are pending in this application.
Claims 1-20 as amended are examined on the merits herein.
Withdrawn Rejections
All rejections of record in the December 3, 2025 office action are withdrawn in view of Applicant’s arguments submitted March 25, 2026. In particular, the previous office action was based on a set of claims other than those actually of record.
The following new grounds of rejection are introduced:
Claim Rejections - 35 USC § 112
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.
Claims 2 and 12 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.
These claims refer to dextrin type 1 and dextrin type 2. However, neither the claims nor the specification actually define what is meant by type 1 or type 2, or whether there exist further types of dextrin. Furthermore a review of the prior art did not indicate that these terms have a clear, well defined meaning that would allow one of skill in the art to clearly know what is meant by this limitation. Therefore claims 2 and 12 are indefinite.
Claim Rejections - 35 USC § 102
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.
Claims 1- are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Li et al. (US pre-grant publication 2018/0250318, cited in 2/6/2025 PTO-1449)
Independent claim 1 claims a method for modulating a bladder microbiome in a subject comprising administering a composition comprising dextrin and a carrier to the urogenital region of the subject. Independent claim 11 claims a similar method wherein the method is directed to treating or preventing overactive bladder, urinary urge incontinence, or urinary tract infections in a subject. Both independent claim 1 and dependent claim 20 further specify that administering the composition promotes the growth of Lactobacillus crispatus relative to Streptococcus anginosus. Based on Applicant’s disclosure, this effect on the relative abundance of bacterial species is an inherent result of administering the therapeutic agent dextrin, and will necessarily result from administering this compound to the urogenital region of a subject. For example table 6 in the present disclosure shows that dextrin selectively promotes growth of Lactobacillus crispatus in competition with Streptococcus anginosus. Therefore administering isomaltulose to the bladder of a subject is reasonably expected to meet this limitation. Dependent claims 2 and 13 specify that the dextrin is type 1 or type 2. As discussed above with respect to 35 USC 112, these terms are indefinite and cannot be given further weight in limiting the scope of the claims. Dependent claims 3 and 14 specify the magnitude of the therapeutic effect, and are similarly considered to be a necessary effect of administering the specific composition to the bladder of a subject. Dependent claims 4 and 15 specify that the composition is applied to the urethra or periurethral region. Dependent claims 5-6, 9, and 16-17 specify the particular components that make up the composition and their amounts. Dependent claims 7, 8, 10, and 18-20 specify the physical form of the composition, which comprises a substrate such as a wipe, liquid, gel, cream, or spray.
Li et al. discloses that the growth of lactobacilli can be synergistically increased by administering compositions comprising a combination of saccharides. (p. 1 paragraph 5) This also inhibits the growth of pathogens associated with urogenital infections, and helps maintain a healthy microflora balance in the urogenital area. This paragraph also specifically describes topical application to the urogenital area of a female for this purpose. In a particular embodiment the composition comprises two separate therapeutic agents, which synergistically enhance the growth of L. crispatus over E. coli. (p. 3 paragraph 27) In a particularly preferred embodiment one of the therapeutic agents is dextrin or inulin. (p. 4 paragraph 33) Furthermore the urogenital tract as described by Li et al. is seen as including the bladder. (p. 3 paragraphs 13 and 22)
In addition, while as discussed above Li et al. describes using an isomaltulose-containing composition to promote a healthy microbiota in the bladder, even if the disclosure of Li et al. is not interpreted as specifically disclosing administering the disclosed composition to the urinary tract in order to affect the bladder microbiota, applying a prebiotic to affect the urogenital region would inherently affect the bladder microbiome. For example, Thomas-White et al. (Reference included with PTO-1449) discloses that the microbiota of the bladder and vagina are interconnected, and that there exists a single urogenital microbiome. (p. 2 left column second and third paragraphs) In particular, both pathogenic bacteria such as S. anginosus and health-promoting bacteria such as L. crispatus are shown to be shared between the vaginal and bladder microbiota. (p. 5 left column second paragraph) Therefore it is reasonably expected that applying the prebiotic compositions described by Li et al. to the urogenital tract would inherently affect the bacterial composition of the bladder microbiome, even if dextrin were not directly applied to the bladder.
Regarding claim 2, as discussed previously, this limitation is indefinite and cannot be taken as imposing any particular limitation on the scope of dextrins required in the claims. Regarding present claim 4, administration to the urogenital region is reasonably considered to be administration to the periurethral region. Regarding claim 5, p. 2 paragraph 14 describes a therapeutic amount as between 0.5-4.5 wt%. More narrowly, p. 8 paragraph 68 describes each therapeutic agent as present in an amount of 0.1-2.0 wt%. Regarding claim 6, less than 10% of therapeutic agent would mean 90% or more of the carrier. Regarding claims 9 and 10, p. 6 paragraph 49 of Li et al. describes including a gelling component.
Regarding claim 11 and its dependent claims, the claimed method is described as a method of preventing or treating overactive bladder, urinary urge incontinence, or urinary tract infection. Because the preamble includes reference to “preventing,” this claim is infringed by methods wherein the subject being treated does not specifically suffer from overactive bladder, urinary urge incontinence, or urinary tract infection, and the treatment has a protective effect against future occurrence of these conditions. Therefore modulating the urogenital microbiome, as is the case with the method described by Li et al., anticipates these claims as improving the composition of these microbiota would reduce the likelihood of these pathological conditions developing, especially urinary tract infection.
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.
Claims 11-20 are rejected under 35 U.S.C. 103 as being unpatentable over Li et al. (US pre-grant publication 2018/0250318, cited in 2/6/2025 PTO-1449) in view of Thomas-White et al. (Reference of record in 2/6/2025 PTO-1449) in view of Atassi et al. (Reference included with PTO-892)
The disclosure of Li et al. is discussed above. While Li et al. is described as inherently leading to prevention of overactive bladder or urinary urge incontinence, even assuming for the sake of argument that claims 11-20 are interpreted such that they require that the subject actually be suffering from one of these conditions, these claims would still have been obvious over Li et al. further in view of the additional references mentioned above.
Thomas-White et al. discloses that the microbiota of the bladder and vagina are interconnected, and that there exists a single urogenital microbiome. (p. 2 left column second and third paragraphs) In particular, both pathogenic bacteria such as S. anginosus and health-promoting bacteria such as L. crispatus are shown to be shared between the vaginal and bladder microbiota. (p. 5 left column second paragraph) Therefore it is reasonably expected that applying the prebiotic compositions described by Li et al. to the urogenital tract would inherently affect the bacterial composition of the bladder microbiome, even if dextrin were not directly applied to the bladder.
Atassi et al. discloses that probiotic Lactobacillus based therapeutics are used to treat urinary tract infections. (p. 2 left column last paragraph, right column first paragraph) Atassi et al. further discloses a study of the inhibitory or killing effect of Lactobacilli including L. crispatus against uropathogenic bacterial strains. (pp. 3-4) It would therefore have been obvious to one of ordinary skill in the art at the time of the invention to administer the prebiotic dextrin compositions described by Li et al. to a subject suffering from a urinary tract infection. One of ordinary skill in the art would have found this to be obvious based on the disclosure by Atassi et al. of using Lactobacillus probiotics to treat UTIs, which would have suggested that any method such as that described by Li et al. which promotes L. crispatus would be expected to be useful for treating UTIs.
Therefore the invention taken as a whole is prima facie obvious.
Claims 11-20 are rejected under 35 U.S.C. 103 as being unpatentable over Li et al. (US pre-grant publication 2018/0250318, cited in 2/6/2025 PTO-1449) in view of Thomas-White et al. (Reference of record in 2/6/2025 PTO-1449) in view of Govender et al. (Reference included with PTO-892)
The disclosure of Li et al. is discussed above. While Li et al. is described as inherently leading to prevention of overactive bladder or urinary urge incontinence, even assuming for the sake of argument that claims 11-20 are interpreted such that they require that the subject actually be suffering from one of these conditions, these claims would still have been obvious over Li et al. further in view of the additional references mentioned above.
Thomas-White et al. discloses that the microbiota of the bladder and vagina are interconnected, and that there exists a single urogenital microbiome. (p. 2 left column second and third paragraphs) In particular, both pathogenic bacteria such as S. anginosus and health-promoting bacteria such as L. crispatus are shown to be shared between the vaginal and bladder microbiota. (p. 5 left column second paragraph) Therefore it is reasonably expected that applying the prebiotic compositions described by Li et al. to the urogenital tract would inherently affect the bacterial composition of the bladder microbiome, even if dextrin were not directly applied to the bladder.
Govender et al. discloses a review of the association of the female urinary microbiome with urinary incontinence. (p. 2 left column first paragraph) Lactobacillus including L. crispatus was reduced in both urinary urge incontinence (UUI) and overactive bladder, (OAB) suggesting a role of bacterial dysbiosis in these conditions. (p. 3 left column fifth paragraph – right column second paragraph) Govender et al. further suggests using vaginal probiotics to restore a healthy urobiome. (p. 7 right column first paragraph) It would therefore have been obvious to one of ordinary skill in the art at the time of the invention to administer the prebiotic dextrin compositions described by Li et al. to a subject suffering from UUI or OAB. One of ordinary skill in the art would have found this to be obvious based on the suggestion by Govender et al. of using vaginal probiotics to treat these conditions, which would have suggested that any method such as that described by Li et al. which promotes L. crispatus would be expected to be useful for treating UUI and OAB.
Therefore the invention taken as a whole is prima facie obvious.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-5 and 11-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of U.S. Patent No. 12419898. (Cited in PTO-892, herein referred to as ‘898) Although the claims at issue are not identical, they are not patentably distinct from each other because these claims describe a method of supporting a healthy microflora balance of L. crispatus relative to a different bacterial species, comprising administering a combination of polysaccharides including dextrin, in an amount of 0.1-2.0%. While the claims of ‘898 do not specifically describe the method as increasing the population of L. crispatus relative to S. anginosus, this is reasonably considered to be an inherent effect of administering the same composition described in the present specification to the same subject. Similarly, it is reasonably considered that administering this composition to a healthy subject would prevent the development of overactive bladder or urinary urge incontinence.
Claims 11-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of U.S. Patent No. 12419898. (Cited in PTO-892, herein referred to as ‘898) in view of Thomas-White et al. (Reference of record in 2/6/2025 PTO-1449) in view of Atassi et al. (Reference included with PTO-892)
The claims of ‘898 discussed above. While the method described in these claims is described as inherently leading to prevention of overactive bladder or urinary urge incontinence, even assuming for the sake of argument that claims 11-16 are interpreted such that they require that the subject actually be suffering from one of these conditions, these claims would still have been obvious over the claims of ‘898 further in view of the additional references mentioned above.
Thomas-White et al. discloses that the microbiota of the bladder and vagina are interconnected, and that there exists a single urogenital microbiome. (p. 2 left column second and third paragraphs) In particular, both pathogenic bacteria such as S. anginosus and health-promoting bacteria such as L. crispatus are shown to be shared between the vaginal and bladder microbiota. (p. 5 left column second paragraph) Therefore it is reasonably expected that applying the prebiotic compositions described in the claims of ‘898 to the urogenital tract would inherently affect the bacterial composition of the bladder microbiome, even if dextrin were not directly applied to the bladder.
Atassi et al. discloses that probiotic Lactobacillus based therapeutics are used to treat urinary tract infections. (p. 2 left column last paragraph, right column first paragraph) Atassi et al. further discloses a study of the inhibitory or killing effect of Lactobacilli including L. crispatus against uropathogenic bacterial strains. (pp. 3-4) It would therefore have been obvious to one of ordinary skill in the art at the time of the invention to administer the prebiotic dextrin compositions described by Li et al. to a subject suffering from a urinary tract infection. One of ordinary skill in the art would have found this to be obvious based on the disclosure by Atassi et al. of using Lactobacillus probiotics to treat UTIs, which would have suggested that any method such as that claimed by ‘898 which promotes L. crispatus would be expected to be useful for treating UTIs.
Therefore the invention taken as a whole is prima facie obvious.
Conclusion
No claims are allowed in this action.
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/ANDREA OLSON/ Primary Examiner, Art Unit 1693 5/19/2026
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