Prosecution Insights
Last updated: July 17, 2026
Application No. 18/334,253

METHODS AND COMPOSITIONS FOR TREATING OR PREVENTING A VAGINAL INFECTION OF GARDNERELLA VAGINALIS

Non-Final OA §103§112
Filed
Jun 13, 2023
Priority
Jun 13, 2022 — provisional 63/351,552
Examiner
BEANE, RANDALL L
Art Unit
1654
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Massachusetts Institute of Technology
OA Round
1 (Non-Final)
33%
Grant Probability
At Risk
1-2
OA Rounds
2m
Est. Remaining
70%
With Interview

Examiner Intelligence

Grants only 33% of cases
33%
Career Allowance Rate
144 granted / 440 resolved
-27.3% vs TC avg
Strong +37% interview lift
Without
With
+36.9%
Interview Lift
resolved cases with interview
Typical timeline
3y 3m
Avg Prosecution
70 currently pending
Career history
507
Total Applications
across all art units

Statute-Specific Performance

§101
0.8%
-39.2% vs TC avg
§103
45.1%
+5.1% vs TC avg
§102
12.5%
-27.5% vs TC avg
§112
19.8%
-20.2% vs TC avg
Black line = Tech Center average estimate • Based on career data from 440 resolved cases

Office Action

§103 §112
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 . Claim Status Claims 1-31 are pending. Claims 1-20, 23-26, 28, and 30-31 are withdrawn. Claims 21, 22, 27, and 29 are presently considered. Election/Restriction Applicant’s election of the narrow subgenus of patentably indistinct species identified in the reply filed on 3/16/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). The originally elected narrow subgenus of patentably indistinct species is understood to be defined by Figure 5, 2 wt% poly-galatose (200-mer norbornene-galactose), vaginal administration in humans (see, e.g., Reply filed 3/16/2026 at 1). Accordingly, the originally elected narrow subgenus of patentably indistinct species is understood to be a method of treating or preventing a vaginal infection of Gardnerella vaginalis in a human subject, the method comprising vaginally administering to the subject an effective amount of galactose bonded to a surface, wherein the surface is a polymer, namely a norbornene polymer. The originally elected species was identified as reading upon claims 21-22, 27, and 29 (see, e.g., Reply filed 3/16/2026 at 1). Following extensive search and examination, the originally elected species has been deemed obvious in view of the prior art as applied below. Per MPEP § 803.02(III)(A), Following election, the Markush claim will be examined fully with respect to the elected species and further to the extent necessary to determine patentability. Note that where a claim reads on multiple species, only one species needs to be taught or suggested by the prior art in order for the claim to be anticipated or rendered obvious... If the Markush claim is not allowable, the provisional election will be given effect and examination will be limited to the Markush claim and claims to the elected species, with claims drawn to species patentably distinct from the elected species held withdrawn from further consideration. Accordingly, claims 21, 22, 27, and 29 are rejected in view of the originally elected species and claims that do not read upon the originally elected species are withdrawn. Claims 1-20, 23-26, 28, and 30-31 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 3/16/2026. Accordingly, claims 21-22, 27, and 29 are presently considered. Priority Claim The priority claim to US Provisional 63/351552, filed 6/13/2022, is acknowledged. However, it is noted that the disclosure and claims of Provisional 63/351552 appear to substantially and materially differ from the instant disclosure and claims. Information Disclosure Statement The IDS filed 9/29/2023; 12/04/2024 (6 pages); 12/04/2024 (8 pages); 12/04/2024 (11 pages); 12/30/2024 (8 pages); 12/20/2024 (6 pages); and 1/27/2025 are each acknowledged and presently considered. Applicant should note that one or more documents disclosed on the IDS form submitted on 12/04/2024 (8 pages) were not considered since they did not conform to 37 CFR 1.98(b) by providing a proper date, as 37 CFR 1.98(b) requires that each publication must be identified by publisher, author (if any), title, relevant pages of the publication, and date and place of publication. The date of publication supplied must include at least the month and year of publication, except that the year of publication (without the month) will be accepted if the applicant points out in the information disclosure statement that the year of publication is sufficiently earlier than the effective U.S. filing date and any foreign priority date so that the particular month of publication is not in issue. See MPEP 609.04(a). Here, the earliest priority claim is to US Provisional 63/351552, filed 6/13/2022; therefore, all documents published in 2021 or later must be accompanied by both month and date of publication. References that were not considered have been indicated by strike-though on the attached IDS forms. Although not considered, these documents have been placed in the application file, but the information referred to therein has not been considered as to the merits. Applicant is advised that the date of any re-submission of any item of information contained in this information disclosure statement or the submission of any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the statement, including all certification requirements for statements under 37 CFR 1.97(e). See MPEP § 609.05(a). Claim Interpretation For purposes of examination, the claim scope has been interpreted as set forth below per the guidance set forth at MPEP § 2111. If Applicant disputes any interpretation, Applicant is invited to unambiguously identify any alleged misinterpretations or specialized definitions in the subsequent response to the instant action. Applicant is advised that a specialized definition should be properly supported and specifically identified (see, e.g., MPEP § 2111.01(IV), describing how Applicant may act as their own lexicographer). Claim 21 is representative of the pending claim scope and presently recites: 21. (Original) A method of treating or preventing a vaginal infection of Gardnerella vaginalis in a subject, the method comprising administering to the subject an effective amount of a composition comprising one or more of galactose, N-acetyl D-galactosamine, N-acetyl D-glucosamine, D-fucose, or mucin 5B bonded to a surface. Applicable claim interpretations are discussed below. “Treating or preventing” is interpreted consistent with the description set forth in the specification (see, e.g., Spec. filed 6/13/2023 at ¶¶[0043], [0066]). Treatment is identified as including “preventing”, namely “preventing spread of the disease” (see id). “Administering” is interpreted consistent with the description set forth in the specification (see, e.g., Spec. filed 6/13/2023 at ¶¶[0044], [0057]). Administering is understood to include topical and vaginal administration (see id). “Therapeutically effective amount” is interpreted consistent with the description set forth in the specification (see, e.g., Spec. filed 6/13/2023 at ¶¶[0045]-[0047], [0059]). The “amount” is understood to include any dosage, single or repeated, required to achieve a biological result (see id) including “about 0.001 mg/kg to about 100 mg/kg” and a dose of “from about 0.1 wt% to 50 wt%” (see id). Additional claim interpretations are discussed in the rejections below. Claim Rejections Claim Rejections - 35 USC § 112(b) 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 21, 27, and 29 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 21 recites 21. (Original) A method of treating or preventing a vaginal infection of Gardnerella vaginalis in a subject, the method comprising administering to the subject an effective amount of a composition comprising one or more of galactose, N-acetyl D-galactosamine, N-acetyl D-glucosamine, D-fucose, or mucin 5B bonded to a surface. It is unclear if the phrase “bonded to a surface” at the final line is intended to modify only “mucin 5B”, or if the phrase is intended to modify all compositions enumerated in the claim (i.e., “one or more of galactose, N-acetyl D-galactosamine, N-acetyl D-glucosamine, D-fucose, or mucin 5B”). The difference in potential interpretation materially alters the pending claim scope, and therefore the claim is rejected as indefinite. For purposes of applying prior art, the phrase “bonded to a surface” is reasonably inferred to modify all enumerated compounds. Claims 27 and 29 depend from claim 21, but fail to rectify the indefiniteness of the base claim. Accordingly, these claims are rejected as depending upon an indefinite base claim. Claims 21, 27, and 29 are rejected. Claim Rejections - 35 USC § 103 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 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. [Prior Art Rejection 01] Claims 21, 22, and 27 are rejected under 35 U.S.C. 103 as being unpatentable over US2006/0105963A1 (18 May 2006) in view of US2019/0117682A1 (25 April 2019). Claim interpretation: The applicable claim interpretation has been set forth in a preceding section and preceding rejections, as set forth above; those interpretations are incorporated into the instant rejection. Additional claim interpretations are set forth below. Regarding instant claim 21 and a method of treating a vaginal infection of Gardnerella vaginalis by topically administering a therapeutic composition comprising galactose, US’963 teaches methods for inhibiting and treating vaginal infections, including by Gardnerella vaginalis, by topically administering a therapeutic composition comprising the hexose sugar of D-galactose, or isomers thereof, at least at concentrations of about 0.2 wt/vol% to about 5 wt/vol % of the administered composition (see, e.g., US’963 at claims 1, 9-10, and 18-19; see also id. at ¶¶[0031], [0039]), which is understood to be a therapeutically effective amount (see, e.g., US’963 at ¶[0031]). The primary reference differs from instant claims 21-22 and 27 as follows: US’963 does not specifically teach that the administered D-galactose is “bonded to a surface”, wherein the surface “is a polymer”. However, regarding modifications to the therapeutic composition utilized in the disclosed methods, US’963 does explicitly direct and informs artisan that the treatment compositions utilized in the disclosed methods “may contain a preservative or preservative system to inhibit the growth of microorganisms over an extended period of time” (see, e.g., US’963 at ¶[0043]), and informs artisans that the treatment composition “is generally applied in the form of …. slow releasing polymer” (see, e.g., US’963 at ¶[0046]). Glycosylated polymers (i.e., “synthetic mucins”) useful for treating infections in humans were known in the prior art: US’682 pertains to “synthetic mucins” and glycosylated polymers useful in methods of inhibiting microbial virulence and treating microbial infections (see, e.g., US’682 at title, abs, claims 1, 10, 24, 27-28, and 34; see also US’682 at ¶¶[0018], [0050], [0071]-[0072], [0110]-[0113]), wherein the “glycosylated polymer” utilized may be galactose (see, e.g., US’682 at claim 10) bonded to the surface of the polymer of carboxymethyl cellulose (see, e.g., US’682 at claims 1, 10, 43; see also US’682 at ¶¶[0050], [0071]-[0072], [0103]). US’682 reduces “Gal-CMC” to practice (see, e.g., US’682 at ¶[0198], Fig. 2) and shows that it is functional and exhibits desirable antimicrobial properties (see id). US’682 identifies that such compositions may be utilized to treat surfaces “in or on a subject” (see, e.g., US’682 at ¶[0113]); wherein the subject may be human (see, e.g., US’682 at ¶[0114]); wherein the infection may be bacterial, protozoan, or fungal (see, e.g., US’682 at ¶¶[0111], [0172]-[0173], [0175]); wherein vaginal administration is explicitly contemplated (see, e.g., US’682 at ¶[0136]; see also id. at ¶¶[0140]-[0141], discussing topical formulations); wherein such compounds may be administered in a therapeutically effective amount such as “about 0.1 mg/kg to about 100 mg/kg” or 0.1 to 20% w/w (see, e.g., US’682 at ¶¶[0059]-[0060], [0111], [0143], [0145]); and wherein such formulations may comprise additional therapeutically effective agents (see, e.g., US’682 at ¶¶[0146]-[0147]). Glycosylated polymers were identified in the prior art as having desirably and beneficial activity relative to both unmodified polymer alone and unbound sugars: US’682 identifies that “CMC alone did not have an inhibitory effect whereas each of the glycosylated polymers prevented or significantly inhibited biofilm formation” (see, e.g., US’682 at ¶[0199]), and identifies that polymer with unbound glucose “did not inhibit biofilm formation” (see, e.g., US’682 at ¶[0200]). US’682 explains the observation by noting that polymer-bound glucose is “unable to be metabolized” by microbes, and therefore is not a nutrient source (see, e.g., US’682 at ¶[0200]). Accordingly, an artisan would reasonably extend this observation and explanation to other disclosed and claimed glycosylated polymers, and would reasonably predict and expect that such glycosylated polymers would exhibit enhanced antimicrobial effects relative to unbound sugars since the polymer-bound sugars would not be metabolized or utilized as a nutrient source by microbes. Therefore, it would have been obvious to one of ordinary skill in the art, either before the effective filing date of the claimed invention (AIA ) or otherwise at the time the invention was made (pre-AIA ), to arrive at the instantly claimed invention in view of the prior art for at least the following reason(s): First, the claimed invention is the simple substitution of one known element (i.e., the antimicrobial agent of D-galactose) in place of another (i.e., the antimicrobial agent of galactose bound to a polymer, such as CMC) according to known methods of treating vaginal infections of Gardnerella vaginalis in humans by topically administering a galactose-comprising composition as taught and suggested by the primary reference, wherein such substitution would yield predictable results, namely the expected and predicted treatment of bacterial, protozoan, or fungal infections (including Gardnerella vaginalis), wherein the polymer-bound galactose would be predicted and expected to provide superior results relative to unbound galactose in view of the secondary reference because it would not be predicted to be metabolized or used as a nutrient source for microbes (see, e.g., MPEP §§ 2143(I)(B), (G)). Second, or alternatively, the claimed invention is the application or usage of the known technique of bonding galactose to a polymer (e.g., CMC) for use in antimicrobial methods as taught by the secondary reference to the prior art method of treating vaginal infections of Gardnerella vaginalis in humans by topically administering a galactose-comprising composition as taught and suggested by the primary reference, wherein the use or application of the technique of bonding galactose to a polymer would predictably improve such methods because polymer-bound galactose would be predicted and expected to provide superior antimicrobial activity relative to unbound galactose in view of the secondary reference because bound galactose would not be predicted to be metabolized or used as a nutrient source for microbes (see, e.g., MPEP §§ 2143(I)(C), (D), (G)). Third, or alternatively, the claimed invention is the combination of prior art elements (i.e., unbound galactose, and polymer-bound galactose) according to known methods of treating microbial infections and specifically vaginal infections of Gardnerella vaginalis in humans by topically administering a galactose-comprising composition as taught and suggested by the primary and secondary references, wherein such combination would predictably and expectedly yield a method of treating vaginal infections of Gardnerella vaginalis in humans, because both galactose and polymer-bound galactose are art-recognized antimicrobial compounds, and per MPEP § 2144.06, "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art" . Furthermore, each prior art component, in combination, would merely perform its art-recognized function (see, e.g., MPEP §§ 2143(I)(A), 2144.06(I)). No evidence of unexpected results commensurate in scope with the requirements of MPEP §§ 716, 716.01, and 716.02 have been placed on record to date. Furthermore, there would be a reasonable expectation of success because the prior art is presumed fully enabled (see, e.g., MPEP § 2121(I)) for all that it discloses (see, e.g., MPEP §§ 2123(I)-(II)). Furthermore, it is well within the ordinary skill in the antimicrobial and infection treatment arts to make, use, and combine known compounds according to known methods to obtain known and art-recognized results with a reasonable expectation of success. Accordingly, claims 21, 22, and 27 are rejected. [Prior Art Rejection 02] Claims 21-22, 27, and 29 are rejected under 35 U.S.C. 103 as being unpatentable over US2006/0105963A1 (18 May 2006) in view of US2019/0117682A1 (25 April 2019) as applied to claims 21-22 and 27 above, and further in view of Kruger et al.1 Claim interpretation: The applicable claim interpretation has been set forth in a preceding section and preceding rejections, as set forth above; those interpretations are incorporated into the instant rejection. Additional claim interpretations are set forth below. Regarding instant claims 21-22, and 27, the teachings of US’963 in view of US’682 as applied to instant claims 21-22 and 27 has been discussed above in a preceding rejection, and those discussions are incorporated into the instant rejection. Regarding the amount of a synthetic mucin required for treatment of an infectious disease, US’682 identifies that a synthetic mucin comprising a glycosylated polymer may be utilized within a wide range of concentrations (see, e.g., US’682 at ¶[0119]). The teachings of US’963 in view of US’682 differs from instant claims 21-22, 27, 29, and the originally elected subgenus of patentably indistinct species as follows: US’963 in view of US’682 does not teach that the polymer in the polymer-bound galactose may be a norbornene polymer. US’682 pertains to synthetic mucins for use in methods of treating microbial infections (see, e.g., US’682 at title, abs, claims), but is substantially limited to synthetic mucins comprising a carboxymethyl cellulose (CMC) backbone (see, e.g., US’682 at title, abs, ¶¶[0004]-[0005], [0070]-[0072], claims 1, 10, 24, 27-28, and 34). Accordingly, the relevant issue is whether or not an artisan would extend the teachings of US’963 and US’682 to other, art-recognized synthetic mucins comprising galactose, as taught in the prior art. Kruger identifies and discloses that galactose-substituted cis-poly(norbornene) polymers are prior art elements (see, e.g., Kruger at Figs. 1-2 on 625, S9-S13), wherein galactose substitution can from at least 25% up to 100% substitution, and wherein the degree of polymerization may be 200 (see, e.g., Kruger at title, abs, Figs. 1-2 on 625, 626 at col I at 1st partial ¶, S9-S13, Supp. Figure 3, Fig. 5 on 627, 625 at col I at 1st full ¶ to col II at final ¶, referring to “representative cis- and trans-200mers that were 50% functionalized with galactose”). Kruger summarizes the results as follows: These extended-backbone polymers have enhanced water solubility and more effectively sequester a microbial virulence factor. Our findings outline a critical design principle for synthetic mucin mimics that will guide future studies of mucin’s role in microbial symbiosis and pathogenesis and serve as a blueprint for generating mucin mimics that act as lubricants or control microbiome composition and infectious disease. (see Kruger at 628 at col I at 1st full ¶, emphasis added). In addition, Kruger identifies that 200-mer galactose-substituted cis-poly(norbornene) polymers exhibited substantially more “relative potency” relative to both Muc5B and monomeric galactose (see, e.g., Krueger at Fig. 5 on 627). Accordingly, an artisan would reasonably predict and expect that the galactose-substituted cis-poly(norbornene) polymers would exhibit improved properties relative to monomeric galactose in applications for controlling infectious diseases (see Kruger at 628 at col I at 1st full ¶, emphasis added). In sum, an artisan would readily appreciate that galactose-substituted cis-poly(norbornene) polymers were (i) prior art elements, (ii) art-recognized synthetic mucins, (iii) reasonably expected to be more potent that Muc5B and monomeric galactose, and (iv) were understood to be applicable to methods for controlling infectious diseases. In view of Kruger and US’682, an artisan would readily appreciate the utility, functionality, and expected and predicted applications of synthetic mucins in methods of controlling infection. Therefore, it would have been obvious to one of ordinary skill in the art, either before the effective filing date of the claimed invention (AIA ) or otherwise at the time the invention was made (pre-AIA ), to arrive at the instantly claimed invention in view of the prior art for at least the following reason(s): First, the claimed invention is the simple substitution of one known, antimicrobial agent (i.e., the antimicrobial agent of D-galactose as taught by US’963) in place of another (i.e., a synthetic mucin comprising galactose bound to a polymer, such as norbornene) according to known methods of treating vaginal infections of Gardnerella vaginalis in humans by topically administering a galactose-comprising composition as taught and suggested by the primary reference, wherein such substitution would yield predictable results, namely the expected and predicted treatment of infections (including Gardnerella vaginalis), wherein the polymer-bound galactose would be predicted and expected to exhibit antimicrobial activity and additionally to provide superior results relative to unbound galactose in view of the guidance provided by the secondary and tertiary references (see, e.g., MPEP §§ 2143(I)(B), (G)). Second, or alternatively, the claimed invention is the improvement of the existing method of the primary reference, namely treating vaginal infections of Gardnerella vaginalis in humans by topically administering a galactose-comprising composition, by applying the known technique of modifying galactose by bonding it to a polymer (e.g., norbornene) to form a synthetic mucin, wherein the synthetic mucin would be predicted and expected to retain antimicrobial activity and would additionally and desirably be expected to have increased potency relative to unbound, monomeric galactose as taught by the tertiary reference, which would be understood to be attributable to the bound galactose not being metabolized or used as a nutrient source for microbes, as suggested in view of the secondary reference (see, e.g., MPEP §§ 2143(I)(C), (D), (G)). Third, or alternatively, the claimed invention is the combination of prior art elements (i.e., unbound galactose, and one or two synthetic mucins comprising a polymer-bound galactose, such as galactose-substituted cis-poly(norbornene)) according to known methods of treating microbial infections and specifically vaginal infections of Gardnerella vaginalis in humans by topically administering a galactose-comprising composition as taught and suggested by the primary and secondary references, wherein such combination would predictably and expectedly yield a method of treating vaginal infections of Gardnerella vaginalis in humans, because both monomeric galactose and polymer-bound galactose are art-recognized antimicrobial compounds suitable for use in controlling infectious agents, and per MPEP § 2144.06, "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art" . Furthermore, each prior art component, in combination, would merely perform its art-recognized function (see, e.g., MPEP §§ 2143(I)(A), 2144.06(I)). No evidence of unexpected results commensurate in scope with the requirements of MPEP §§ 716, 716.01, and 716.02 have been placed on record to date. Furthermore, there would be a reasonable expectation of success because the prior art is presumed fully enabled (see, e.g., MPEP § 2121(I)) for all that it discloses (see, e.g., MPEP §§ 2123(I)-(II)). Furthermore, it is well within the ordinary skill in the antimicrobial and infection treatment arts to make, use, and combine known compounds according to known methods to obtain known and art-recognized results with a reasonable expectation of success. Accordingly, claims 21, 22, 27, and 29 are rejected. Pertinent Prior Art The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Cervin et al.2 pertains to Fucose-Galactose Polymers that inhibit cholera toxin binding, wherein the polymers have a norbornene backbone (see, e.g., Cervin at title, abs, Scheme 1 on 1193). US2008/286211A1 pertains to mucin glycoproteins and their applications (see, e.g., US’211 at title, abs, claims). Schiller et al.3 pertains to biological hydrogels utilized as barriers against pathogens (see, e.g., Schiller at title, abs, Fig. 5 at 2880, Fig. 6 on 2882). Conclusion No claims are allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to RANDALL L BEANE whose telephone number is (571)270-3457. The examiner can normally be reached Mon.-Fri., 7 AM to 2 PM ET. 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, Lianko G. Garyu can be reached at (571) 270-7367. 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. /RANDALL L BEANE/ Primary Examiner, Art Unit 1654 1 Kruger et al., Stereochemical Control Yields Mucin Mimetic Polymers. ACS Cent Sci. 2021 Apr 28;7(4):624-630 and Supplemental pages 1-59. doi: 10.1021/acscentsci.0c01569. Epub 2021 Mar 30. PMID: 34056092; PMCID: PMC8155468; hereafter “Kruger”. 2 Cervin et al., Fucose-Galactose Polymers Inhibit Cholera Toxin Binding to Fucosylated Structures and Galactose-Dependent Intoxication of Human Enteroids. ACS Infect Dis. 2020 May 8;6(5):1192-1203, Supplemental pages 1-29. doi: 10.1021/acsinfecdis.0c00009. Epub 2020 Mar 19. PMID: 32134631; PMCID: PMC7227030; hereafter “Cervin”. 3 Schiller et al., Tuning Barrier Properties of Biological Hydrogels. ACS Appl Bio Mater. 2020 May 18;3(5):2875-2890. doi: 10.1021/acsabm.0c00187. Epub 2020 May 6. PMID: 35025336; hereafter “Schiller”.
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Prosecution Timeline

Jun 13, 2023
Application Filed
May 14, 2026
Non-Final Rejection mailed — §103, §112 (current)

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Prosecution Projections

1-2
Expected OA Rounds
33%
Grant Probability
70%
With Interview (+36.9%)
3y 3m (~2m remaining)
Median Time to Grant
Low
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