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 September 2, 2025, wherein the rejections of record in the previous action are maintained. This application is a national stage application of PCT/US21/42890, filed July 23, 2021, which claims benefit of provisional application 63/055369, filed July 23, 2020.
Claims 11 and 13-20 are pending in this application.
Claims 11 and 13-20 as amended are examined on the merits herein.
Withdrawn Rejections
Applicant’s arguments, submitted September 2, 2025, with respect to the rejection of claims 11 and 13-20 under 35 USC 103 for being obvious over Li et al. in view of Thomas-White et al. in view of Atassi et al., have been fully considered and found to be persuasive to remove the rejection as the present disclosure is shown that the presently utilized prebiotic isomaltulose is specifically useful for favoring the growth of L. crispatus over S. anginosus. Therefore the rejection is withdrawn.
Applicant’s arguments, submitted September 2, 2025, with respect to the rejection of claims 11 and 13-20 under 35 USC 103 for being obvious over Li et al. in view of Thomas-White et al. in view of Govender et al., have been fully considered and found to be persuasive to remove the rejection as the present disclosure is shown that the presently utilized prebiotic isomaltulose is specifically useful for favoring the growth of L. crispatus over S. anginosus. Therefore the rejection is withdrawn.
The following rejections of record in the previous action are maintained:
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, 13-18, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Zeng et al. (US pre-grant publication 2016/0375045, cited in previous action) in view of Thomas-White et al. (Reference of record in previous action) in view of Atassi et al. (Reference of record in previous action)
Independent claim 11 claims a method for modulating a bladder microbiome in a subject comprising administering a composition comprising isomaltulose (also referred to in the art as palatinose) and a carrier to the urogenital region of the subject wherein the method is directed to treating overactive bladder, urinary urge incontinence, or urinary tract infections in a subject. Claim 11 as amended further specifies 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 isomaltulose, 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 isomaltulose 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 claim 13 specifies 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 claim 14 specifies that the composition is applied to the urethra or periurethral region. Dependent claims 15-17 specify the particular components that make up the composition and their amounts. Dependent claims 18-20 specify the physical form of the composition, which comprises a substrate such as a wipe, liquid, gel, cream, or spray.
Zeng et al. discloses a product for increasing the resistance of the vagina to pathogens and restoring the beneficial vaginal flora including L. crispatus. (p. 1 paragraph 10 – p. 2 paragraph 11) THE product preferably comprises isomaltulose at a concentration of 1.5-12%, which substantially overlaps the concentration recited in present claim 15. The composition promotes growth of Lactobacillus compared to pathogenic bacterial and fungi. (p. 2 paragraph 15) The composition can further be a water-soluble gel or cream. (p. 2 paragraph 18) In particular the composition promotes growth of protective bacteria such as L. crispatus. (p. 5 paragraph 47)
Zeng et al. does not disclose a method of treating urinary tract infection, urinary urge incontinence, or overactive bladder. However, 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 Zeng et al. to the urogenital tract would affect the bacterial composition of the bladder microbiome, even if isomaltulose 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 isomaltulose compositions described by Zeng 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 Zeng 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, 13-18 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Zeng et al. (US pre-grant publication 2016/0375045, cited in previous action) in view of Thomas-White et al. (Reference of record in previous action) in view of Govender et al. (Reference of record in previous action)
Independent claim 11 claims a method for modulating a bladder microbiome in a subject comprising administering a composition comprising isomaltulose (also referred to in the art as palatinose) and a carrier to the urogenital region of the subject wherein the method is directed to treating overactive bladder, urinary urge incontinence, or urinary tract infections in a subject. Claim 11 as amended further specifies 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 isomaltulose, 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 isomaltulose 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 claim 13 specifies 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 claim 14 specifies that the composition is applied to the urethra or periurethral region. Dependent claims 15-17 specify the particular components that make up the composition and their amounts. Dependent claims 18-20 specify the physical form of the composition, which comprises a substrate such as a wipe, liquid, gel, cream, or spray.
Zeng et al. discloses a product for increasing the resistance of the vagina to pathogens and restoring the beneficial vaginal flora including L. crispatus. (p. 1 paragraph 10 – p. 2 paragraph 11) THE product preferably comprises isomaltulose at a concentration of 1.5-12%, which substantially overlaps the concentration recited in present claim 15. The composition promotes growth of Lactobacillus compared to pathogenic bacterial and fungi. (p. 2 paragraph 15) The composition can further be a water-soluble gel or cream. (p. 2 paragraph 18) In particular the composition promotes growth of protective bacteria such as L. crispatus. (p. 5 paragraph 47)
Zeng et al. does not disclose a method of treating urinary tract infection, urinary urge incontinence, or overactive bladder. However, 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 Zeng et al. to the urogenital tract would inherently affect the bacterial composition of the bladder microbiome, even if isomaltulose 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 isomaltulose compositions described by Zeng 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 Zeng 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 11 and 13-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 5, 11-16 and 18-20 of copending Application No. 18/997917 (unpublished, of record in previous action, herein referred to as ‘917) in view of Thomas-White et al. (Reference of record in previous action) in view of Atassi et al. (Reference of record in previous action)
Claim 11 of ‘917 claims a method of modulating growth of urogenital microorganisms in a subject comprising administering to a subject a prebiotic compositions comprising isomaltulose. Dependent claims 13-16 further define the composition as affecting the same two bacterial species recited in the present claims. Claims 1, 4, and 5 claim a prebiotic formulation wherein the prebiotic agents comprise between 0.01-20% of the prebiotic formulation, and additionally a carrier. This range substantially overlaps the range recited in present claim 16, and furthermore if the remainder of the composition is a carrier substantially overlaps the carrier range in present claim 16. Regarding present claims 17 and 20, claim 12 of ‘917 specifies that the composition can be a liquid, spray, or gel, for example, all of which would imply the present of water as a carrier. Claims 18-20 of ‘917 further describe the composition being applied by an adsorbent article, as recited in present claims 18 and 19.
The claims of ‘917 do not claim a method of treating urinary tract infection, urinary urge incontinence, or overactive bladder, or specifically modulating the bladder microbiome. However, 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 anginose 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 the claims of ‘917 to the urogenital tract would inherently affect the bacterial composition of the bladder microbiome, even if isomaltulose 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 compositions claimed by ‘917 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 ‘917 which promotes L. crispatus would be expected to be useful for treating UTIs.
Therefore the invention taken as a whole is prima facie obvious.
This is a provisional nonstatutory double patenting rejection.
Claims 11 and 13-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 5, 11-16 and 18-20 of copending Application No. 18/997917 (unpublished, of record in previous action, herein referred to as ‘917) in view of Thomas-White et al. (Reference of record in previous action) in view of Govender et al. (Reference of record in previous action)
Claim 11 of ‘917 claims a method of modulating growth of urogenital microorganisms in a subject comprising administering to a subject a prebiotic compositions comprising isomaltulose. Dependent claims 13-16 further define the composition as affecting the same two bacterial species recited in the present claims. Claims 1, 4, and 5 claim a prebiotic formulation wherein the prebiotic agents comprise between 0.01-20% of the prebiotic formulation, and additionally a carrier. This range substantially overlaps the range recited in present claim 16, and furthermore if the remainder of the composition is a carrier substantially overlaps the carrier range in present claim 16. Regarding present claims 17 and 20, claim 12 of ‘917 specifies that the composition can be a liquid, spray, or gel, for example, all of which would imply the present of water as a carrier. Claims 18-20 of ‘917 further describe the composition being applied by an adsorbent article, as recited in present claims 18 and 19.
The claims of ‘917 do not claim a method of treating urinary tract infection, urinary urge incontinence, or overactive bladder, or specifically modulating the bladder microbiome. However, 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 anginose 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 the claims of ‘917 to the urogenital tract would inherently affect the bacterial composition of the bladder microbiome, even if isomaltulose 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 isomaltulose compositions claimed by ‘917 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 claimed by ‘917 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.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicant’s arguments, submitted September 2, 2025, with respect to the above grounds of rejection, have been fully considered and not found to be persuasive to remove the rejections.
Firstly, Applicant argues that there is no reasonable expectation of success in treating overactive bladder, urinary urge incontinence, or urinary tract infections by modulating the bladder microbiome, using a method comprising administering isomaltulose to the urogenital region of the subject. Applicant’s argument is based on the statement that Zeng specifically teaches modulating the bladder microbiome to treat bacterial vaginosis rather than a bladder-related condition, and that discussion in the prior art of using vaginal probiotics to treat overactive bladder does not provide a reasonable expectation that probiotics would have the same utility.
However, as described in the rejections under 35 USC 103, the cited secondary references Thomas-White, Atassi, and Govender do provide such a reasonable expectation of success. In particular, the disclosure by Thomas-White that there is microbiological communication between the vagina and bladder microbiomes specifically suggests that a treatment affecting one microbial population is reasonably expected to affect the other. Furthermore Atassi specifically explores the ability of L. crispatus to kill uropathogenic microbes, suggesting that the authors expected this approach to be useful for inhibiting pathogenic microbes in the bladder as well as the vagina. Finally, the disclosure of Govender (e.g. p. 7 right column) suggests that vaginal probiotics could be used to treat urinary tract infections based on the interconnectedness of the two microbiomes. Still further, there is no particular reason to expect that, if the use of probiotics for this purpose is suggested in the art, that there would be no reasonable expectation of success in using prebiotics for the same purpose. Both classes of therapeutic agents are seen to produce similar effects of modulating the microbiome, and there is no reason to believe that modulating the vaginal microbiota with prebiotics would not have a similar effect to using probiotics for the same purpose.
Still further a review of the art indicates that using vaginal biotherapeutic agents is a known technique for affecting the bladder microbiome and treating bladder microbiome associated conditions. For example, Reid et al. (Reference included with PTO-892) discloses that the use of Lactobacilli probiotics as vaginal biotherapeutic agents has been used to protect against urinary tract infections. (See pp. 249-252 section 4)
Applicant further argues that the present disclosure includes evidence of unexpected results persuasive to overcome a prima facie case of obviousness. In particular, Applicant points to tables 1-7 in the specification, which allegedly demonstrate that the presently claimed probiotic isomaltulose unexpectedly produces modulation of commensal bladder microbiota while not supporting growth of apathogenic microbes. Specifically, of the various prebiotics tested, Applicant noted that only isomaltulose supports growth of L. crispatus while not supporting growth of S. anginosus. This is supported most clearly by tables 6-7 on pp. 12-14 wherein it is demonstrated that palatinose (isomaltulose) provides a significantly better therapeutic effect (growth of L. crispatus relative to S. anginosus) compared to a number of other prebiotic candidates. Notably, palatinose was found to produce a much better therapeutic effect than 2-deoxy-D-ribose and maltitol, both prebiotics suggested by Li as being usable in place of palatinose. These results therefore overcome the rejections based on Li et al. as one of ordinary skill in the art would, based on table 3 on p. 6 of Li, expected palatinose to be at best modestly better than these other agents. However, the primary reference Zeng specifically identifies isomaltulose as the active ingredient. Therefore the mere fact that isolmaltulose is superior to other prebiotics is not in itself evidence of unexpected results that would overcome the prima facie case of obviousness.
Finally, while the present claims differ from the disclosure of Zheng in that they are directed to a method of treating various urinary conditions rather than bacterial vaginosis, the proferred evidence of unexpected results do not particularly demonstrate any difference between the effect of this probiotic in modulating vaginal microbes and bladder microbes. Regarding table 3, various prebiotics were tested against 17 different bacterial strains, mostly taken from bladder microbiota, with some from culture collections and one (LC-4) from vaginal microbiota. Isomaltulose was seen to support growth of Lc-3 (bladder) Lc-4 (vagina) and Lj-1. (bladder) It did not support Lc-2. (bladder) Thus there seems to be no particular evidence that the effect of isomaltulose on bladder microflora is unexpectedly superior to its effect on the vaginal microflora. The data presented in tables 4-5 similarly fail to show any unexpected superiority for treatment of bladder vs. vaginal microbes. Of five pathogenic E. coli strains tested, neither the bladder nor the vaginal specimens grew on isomaltulose. Overall one of ordinary skill in the art would therefore conclude that there is no evidence of isomaltulose as a bladder prebiotic having any superior effect to that already described by Zeng et al. for its modulation of L. crispatus in the vaginal microflora.
Regarding S. anginosus, as discussed by Thomas-Witte et al. (of record in previous action) this pathogenic bacterial species is shared between the vagina and bladder. Furthermore Tao et al. (Reference included with July 9, 2024 PTO-1449) describes S. anginosus as a significant vaginal pathogen. Therefore the fact that isomaltulose can stimulate the growth of L. crispatus at the expense of S. anginosus is not surprising either.
For these reasons the rejections are deemed proper and maintained.
The following new grounds of rejection are introduced:
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.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Zeng et al. (US pre-grant publication 2016/0375045, cited in previous action) in view of Thomas-White et al. (Reference of record in previous action) in view of Atassi et al. (Reference of record in previous action) as applied to claims 11, 13-18, and 20 above, and further in view of Li et al. (US pre-grant publication 2018/0256615, of record in previous action)
The disclosures of Zeng et al., Thomas-White et al., and Atassi et al. are discussed above. Zeng et al. in view of Thomas-White et al. in view of Atassi et al. does not disclose an embodiment wherein the composition is applied to a wipe or adsorbent article. However, Li et al. discloses a similar vaginal composition for promoting dominance of Lactobacilli which contains a prebiotic that can be isomaltulose. (p. 1 paragraphs 5-8) Furthermore this composition can be administered using an applicator which can be a web such as a gauze or cotton swab, or a tissue web, which are reasonably considered to be a wipe or adsorbent article as described in claim 19. (p. 1 paragraph 9) It would have been obvious to one of ordinary skill in the art at the time of the invention to administer the isomaltulose-containing prebiotic described by Zeng using one of the adsorbent articles described by Li et al. One of ordinary skill in the art would have found this to be obvious because Li clearly describes these modes of administration as being suitable for vaginally administering prebiotics.
Therefore the invention taken as a whole is prima facie obvious.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Zeng et al. (US pre-grant publication 2016/0375045, cited in previous action) in view of Thomas-White et al. (Reference of record in previous action) in view of Govender et al. (Reference of record in previous action) as applied to claims 11, 13-18, and 20 above, and further in view of Li et al. (US pre-grant publication 2018/0256615, of record in previous action)
The disclosures of Zeng et al., Thomas-White et al., and Govender et al. are discussed above. Zeng et al. in view of Thomas-White et al. in view of Govender et al. does not disclose an embodiment wherein the composition is applied to a wipe or adsorbent article. However, Li et al. discloses a similar vaginal composition for promoting dominance of Lactobacilli which contains a prebiotic that can be isomaltulose. (p. 1 paragraphs 5-8) Furthermore this composition can be administered using an applicator which can be a web such as a gauze or cotton swab, or a tissue web, which are reasonably considered to be a wipe or adsorbent article as described in claim 19. (p. 1 paragraph 9) It would have been obvious to one of ordinary skill in the art at the time of the invention to administer the isomaltulose-containing prebiotic described by Zeng using one of the adsorbent articles described by Li et al. One of ordinary skill in the art would have found this to be obvious because Li clearly describes these modes of administration as being suitable for vaginally administering prebiotics.
Therefore the invention taken as a whole is prima facie obvious.
Conclusion
No claims are allowed in this action.
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/ERIC OLSON/ Primary Examiner, Art Unit 1693 10/21/2025