Office Action Predictor
Application No. 18/031,723

COMPOSITIONS AND METHODS FOR IMPROVING SKIN HEALTH AND FOR THE TREATMENT AND PREVENTION OF DISEASES, DISORDERS AND CONDITIONS ASSOCIATED WITH FUNGI AND OTHER PATHOGENIC MICROBES

Final Rejection §101§102§103§112§DP
Filed
Apr 13, 2023
Examiner
PAGUIO FRISING, MICHELLE F
Art Unit
1651
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Dermbiont, INC.
OA Round
2 (Final)
70%
Grant Probability
Favorable
3-4
OA Rounds
2y 9m
To Grant
99%
With Interview

Examiner Intelligence

70%
Career Allow Rate
392 granted / 557 resolved
Without
With
+41.3%
Interview Lift
avg trend
2y 9m
Avg Prosecution
28 pending
585
Total Applications
career history

Statute-Specific Performance

§101
9.3%
-30.7% vs TC avg
§103
32.3%
-7.7% vs TC avg
§102
16.2%
-23.8% vs TC avg
§112
24.4%
-15.6% vs TC avg
Black line = Tech Center average estimate • Based on career data

Office Action

§101 §102 §103 §112 §DP
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 Amendments Claims 1 and 118 have been amended to remove the three other probiotics such that the composition only comprises “Alcaligenes faecalis” in combination with a cryoprotectant. Moreover, the invention of claim 84 has been changed from a composition to “A method of treating, inhibiting, or preventing a diseases, disorder or condition associated with a pathogenic microorganism in a subject in need thereof”. Claims 2, 5-6, 14-15, and 135 have also been amended to address minor informalities and 112(b) rejections. No new matter has been added. Election/Restrictions Claim 84 was previously drawn to “A composition” (product) but has been amended to recite “A method of treating, inhibiting, or preventing a diseases, disorder or condition associated with a pathogenic microorganism in a subject in need thereof” (method of use). The newly claimed method is directed to an invention that lacks unity with the invention originally claimed for the following reasons: the method of claim 84 and the product of claims 1-2, 4-6, 8-10, 13-16, 19, 118, 129, and 134-136 do not share the same technical feature. In particular, the special technical feature of claim 84 is a metabolite, cell lysate, or postbiotic from at least one species of human-isolated or synthetic Alcaligenes faecalis, which is not required by the other claims. On the other hand, the special technical feature of claims 1-2, 4-6, 8-10, 13-16, 19, 118, 129, and 134-136 is a probiotic comprising human-isolated or synthetic Alcaligenes faecalis, which is not required by claim 84. Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claim 84 is withdrawn from consideration as being directed to a nonelected invention. See 37 CFR 1.142(b) and MPEP § 821.03. To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention. Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention. Information Disclosure Statement The information disclosure statement (IDS) filed on 12/01/2025 is in compliance with the provisions of 37 C.F.R. 1.97 and all references have been fully considered. Drawings RE: Objection to the drawings The substitute drawings rectify all minor informalities identified in the last office action, thereby obviating the objection to the drawings. Specification RE: Objection to the specification The deletion of the last 2 sentences in the abstract is sufficient to meet the maximum allowed number of words. Thus, the objection has been withdrawn. Claim Objections RE: Objection to claims All minor informalities have been corrected. The claims objections have therefore been withdrawn. New objection Claim 136 is objected to because of the following minor informality: lack of comma after the phrase “The probiotic composition of claim 118”. 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. RE: Rejection of claims 1-6, 8-10, 13-16, 19, 129, and 134-135 under 35 USC 112(b) for indefiniteness The omission of other probiotics in claim 1 no longer requires a conjunction between the recited species. Moreover, the deletion of “the pharmaceutical composition” in claim 84 obviates lack of antecedent basis. Hence, the rejections have been withdrawn. Claim Rejections - 35 USC § 101 35 U.S.C. 101 reads as follows: Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title. RE: Rejection of claim 84 under 35 USC 101 Applicant has amended claim 84 such that it is no longer drawn to a composition comprising natural products. Accordingly, the rejection has been withdrawn. 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. (a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention. RE: Rejection of claims 1-2, 8-9, 13-16, 19, 118, and 136 under 35 U.S.C. 102(a)(1)/102(a)(2) as being anticipated by Kim et al. as evidenced by Xing et al.; and claim 84 as being anticipated by Deaton et al. Applicant points out that the rejections are now moot because the probiotic has been limited to Alcaligenes faecalis. The claim amendments are sufficient to overcome the rejections under 35 U.S.C. 102, which rely on Kim et al.’s compositions containing Bacillus pumilus, Bacillus subtilis, and Janthinobacterium lividum, as well as Deaton et al.’s compositions comprising B. subtilis metabolites Hence, the rejections of record have been withdrawn. 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. 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. RE: Rejection of claims 1-4, 8-9, 13-16, 19, 118, and 135-136 under 35 U.S.C. 103 as being unpatentable over Kim et al. as evidenced by Xing et al., in view of Deaton et al.; and claims 1-2, 5-6, 8-10, 13-16, 19, 118, 129, and 136 as being unpatentable over Kim et al. as evidenced by Xing et al. Applicant states that the 103 rejections are also now moot since claims have been amended to specify that the claimed composition comprises Alcaligenes faecalis as the probiotic. It is conceded that none of the cited prior art teaches a composition comprising Alcaligenes faecalis. The rejections have therefore been withdrawn. New Rejections Claims 1-2, 4, 8-9, 13, 19, 118, and 135-136 are rejected under 35 U.S.C. 103 as being unpatentable over Nieuwdorp et al. (Pub. No. WO 2013/032328 A1) in view of Mare et al. (Nature 1964, Vol. 203, pages 430-431). Nieuwdorp et al. discloses a pharmaceutical, food, or feed composition comprising Alcaligenes faecalis and/or Eubacterium hallii for preventing and/or treating insulin resistance and/or insulin related complications like metabolic syndrome and dyslipidemia (Abstract; lines 14-19, page 2). Nieuwdorp et al.’s composition is comparable to the instant application’s composition as follows: Regarding claim 1: the pharmaceutical, food, or feed composition comprising Alcaligenes faecalis- (lines 27-28, page 6) is analogous to “A composition comprising a probiotic, wherein the probiotic comprises human-isolated or synthetic Alcaligenes faecalis”. In an embodiment, the composition comprises a cryoprotectant like lactose, trehalose, or glycogen (lines 11-12, page 7), which meets the requirement that the claimed composition also comprises “a cryoprotectant”. The prior art is different from the claimed invention in that the A. faecalis is not explicitly taught to be “human-isolated or synthetic” (the term “human-isolated” is defined by applicant to mean “isolated from a human source”; par. [0111]), which is considered a product-by-process limitation as it only defines the origin of the A. faecalis-. A product-by-process limitation is considered only for the distinct structural properties it imparts to the product. MPEP § 2113 states “The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985)”. In this case, the origin does not impart a structural or biochemical distinction to A. faecalis. There is no evidence that the source of the probiotic is critical to the claimed invention. Nieuwdorp et al. also differs from the instant claim in that it does not teach that A. faecalis is present in the composition “in an amount effective to treat a disease, disorder, or condition associated with a pathogenic microorganism”. Despite this, Mare et al. teaches that various A. faecalis strains inhibit microbes like Escherichia, Salmonella, Serratia, Staphylococcus, and Proteus (second par. in left col., page 431) and that this inhibitory activity is due to the antibiotics produced by A. faecalis (third par. in right col., page 430). Since these microbes are associated with diseases or conditions like cellulitis, necrotizing fasciitis, and urinary tract infection, a person with ordinary skill in the art before the effective filing date of the claimed invention would have modified Nieuwdorp et al.’s composition by formulating it with A. faecalis in an amount that would effectively inhibit a pathogenic strain of any of these microbes and would have expected that such modification would allow its use for treatment of a disease or condition caused by Escherichia, Salmonella, Serratia, Staphylococcus, and/or Proteus. The obviousness of the instant claim is based on some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention. See MPEP § 2143.01 and KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385, 1395-97 (2007). Claim 1 is therefore obvious over Nieuwdorp et al. in view of Mare et al.. Regarding claim 2: Although the disclosed composition is not particularly taught to be “formulated for topical application to a mammal”, Nieuwdorp et al. indicates that it can be provided in the form of a liquid or solid pharmaceutical composition that further contains a carrier such as sterile water or inert solids (lines 27-29 and 35-36, page 6; lines 1-10, page 7). On with ordinary skill in the art would have recognized that either form is suitable for application to the skin of a mammal and is thus deemed to satisfy the limitation of the instant claim. The phrase “for treating the disease, disorder, or condition, wherein the disease disorder, or condition is an infection” is considered an intended use and does not bear patentable weight. Regarding claim 4: the composition being lyophilized (line 11, page 7) corresponds to “the composition is frozen or lyophilized”. Regarding claims 8-9: one example of an applicable cryoprotectant is trehalose, which is a disaccharide and therefore fulfills “the cryoprotectant comprises a disaccharide” and “the disaccharide comprises trehalose”, respectively. Regarding claim 13: Nieuwdorp et al. teaches that the disclosed composition can comprise E. hallii such as strain L2-7 (lines 10-12, page 9). Given that said strain was isolated from a human gut, this teaching meets “further comprising at least one additional isolated or synthetic microbe”. Regarding claim 19: the instant claim further limits the disease, disorder, or condition associated with a pathogenic microorganism. However, the claims are drawn to a product and not to a method of use. The additional limitation therefore does not bear patentable weight. Regarding claims 118 and 136: the modified composition comprising A. faecalis and a cryoprotectant is equivalent to “A probiotic composition comprising at least one of Alcaligenes faecalis and a cryoprotectant”. The phrases “for use as a medicament” (claim 118) and “for use in the treatment of a disease, disorder, or condition associated with at least one pathogenic microorganism” are merely intended uses. Recitations of an intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In this case, all the recited components of the claimed composition are present in Nieuwdorp et al.’s composition. With the presence of all the recited components, the disclosed composition would be deemed structurally the same as the claimed probiotic composition. A chemical composition and its properties are inseparable, thus if the prior art teaches the chemical composition, the properties are necessarily present. Regardless, Nieuwdorp et al. teaches using the disclosed composition as a medicament (lines 2-4, page 1; claim 10). Regarding claim 135: as discussed above (rejection for claim 1), Mare et al. teaches that several A. faecalis strains were found to produce antibiotics (third par. in right col., page 430). It would have thus been obvious to include the produced antibiotics (i.e., postbiotics) in the modified composition as the inhibitory activity of A. faecalis is attributed to the antibiotics they form. Claims 1-2, 4-6, 8-10, 13, 19, 118, and 135-136 and are rejected under 35 U.S.C. 103 as being unpatentable over Nieuwdorp et al. (Pub. No. WO 2013/032328 A1) in view of Mare et al. (Nature 1964, Vol. 203, pages 430-431), as evidenced by Xing et al. (Zhongguo Rupin Gongye 2009, Vol. 37, pages 15-17; English translation of abstract). Nieuwdorp et al. and Mare et al.’s teachings are set forth above and applied herein. These prior art render claims 1-2, 4, 8-9, 13, 19, 118, and 135-136 obvious. The modified composition of Nieuwdorp et al. and Mare et al. is comparable to the claims below: Regarding claims 5-6: the cryoprotectant in the composition of claims 1 and 2 is further required to result in “a greater percent recovery of the probiotic after freezing or lyophilization as compared to a composition comprising the same probiotic without the cryoprotectant” and “greater efficacy, stability, and/or viability of the pharmaceutical composition against the pathogenic organism as compared to a pharmaceutical composition comprising the same probiotic without the cryoprotectant”, respectively. Nieuwdorp et al. and Mare et al. do not teach the limitations of the instant claims. Cryoprotectants, however, are known in the art to protect cells from undesirable effects of freezing and drying. Xing et al. teaches that D-trehalose was found to be the most effective cryoprotectant among the seven cryoprotectants tested. Furthermore, Xing et al. demonstrates that freezing bacterial cells in the presence of 10% D-trehalose and 10% skim milk leads to a 100% survival rate of the bacteria. Since the modified composition comprises a carrier like trehalose, there is reasonable expectation that the presence of trehalose would result in greater survival of the probiotics or higher number of remaining viable cells compared to the probiotic composition without trehalose. Hence, claims 5-6 are obvious over Nieuwdorp et al. and Mare et al., as evidenced by Xing et al.. Regarding claim 10: the trehalose in the composition of claim 9 is further defined as comprising “about 2-20% of the composition by weight”. Xing et al. teaches that incorporating 10% D-trehalose helps preserve bacteria by as much as 100%. It would have therefore been obvious to further alter the modified composition such that it comprises 10% D-trehalose and expect that the bacteria present therein would be preserved. Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention. Id. Claims 1-2, 4, 8-9, 13-16, 19, 118, 129, and 135-136 are rejected under 35 U.S.C. 103 as being unpatentable over Nieuwdorp et al. (Pub. No. WO 2013/032328 A1) in view of Mare et al. (Nature 1964, Vol. 203, pages 430-431) and Kim et al. (Pub. No. US 2017/0065647 A1). The teachings of Nieuwdorp et al. and Mare et al. are described previously and applied herein. Nieuwdorp et al. and Mare et al. render claims 1-2, 4, 8-9, 13, 19, 118, and 135-136 obvious. The modified composition is similar to the following claims: Regarding claims 14 and 16: the additional isolated or synthetic microbe in claim 13 is further limited to “a human-isolated or synthetic Bacillus altitudinis, Bacillus pumilus, Bacillus subtilis, or Janthinobacterium lividum” and the composition of claim 1 is further stipulated to comprise “a first additional isolated microbe and a second additional isolated microbe, wherein the first and second additional isolated microbes are independently selected from bacteria, virus, yeast, fungus, or any combination thereof”, respectively. What differentiates Nieuwdorp et al. from the instant claim is that the disclosed composition is not taught to be combined with any of the recited bacteria. Nevertheless, combination therapy is routine in the art. Kim et al., for example, discloses a topical formulation comprising one or more non- and/or low-pathogenic species of bacteria (Abstract; par. [0022]) and a carrier like trehalose (par. [0049]). Preferred bacterial species include B. pumilus, B. subtilis, J. lividum, Lactobacillus, and Propionibacterium (par. [0039]). The topical formulation can be employed to treat skin conditions caused by a microbial infection (par. [0052]). A person with ordinary skill in the art before the effective filing date of the claimed invention would have further changed the modified composition by adding non- and/or low-pathogenic bacteria with reasonable expectation that the resulting composition would advantageously allow for multiple pathogenic microorganisms to be targeted. Obviousness is based on the rationale that some teaching, suggestion, or motivation in the prior art would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention. See MPEP § 2143.01 and KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385, 1395-97 (2007). Claims 14 and 16 are thus obvious over Nieuwdorp et al. in view of Mare et al. and Kim et al.. Regarding claim 15: the additional isolated or synthetic microbe in claim 13 is defined as comprising “one or more microbes selected from Lactobacillus, Lactococcus, Cutibacterium, and Propionibacterium”, which is satisfied by Kim et al.’s preferred embodiment of Lactobacillus and Propionibacterium as the non- and/or low-pathogenic species of bacteria. Regarding claim 129: Nieuwdorp et al. does not disclose “A kit comprising (i) at least one vial comprising the composition of claim 1, and (ii) instructions”. Nonetheless, a kit comprising a probiotic-containing composition is conventional in the art as substantiated by Kim et al.. Kim et al. teaches providing an antimicrobial agent and a topical formulation comprising one or more bacterial strains as part of a kit for treating a skin condition (par. [0011], [0022]). Accordingly, one with ordinary skill in the art would have provided the modified composition in a kit such as Kim et al.’s and predict that the kit would allow a subject to conveniently use said modified composition. Although Kim et al. does not teach that the topical formulation is in at least one vial, it would have been obvious for one with ordinary skill in the art to provide it in a container such as a vial because it would protect the probiotics and allow them to be stored and/or transported until use. With regards to instructions, the courts have held that nonfunctional printed matter such as instructions provided with a kit does not distinguish a claimed product from otherwise identical prior art product. MPEP § 2112.01(III) states “Where the only difference between a prior art product and a claimed product is printed matter that is not functionally related to the product, the content of the printed matter will not distinguish the claimed product from the prior art. In re Ngai, 367 F.3d 1336, 1339, 70 USPQ2d 1862, 1864 (Fed. Cir. 2004)”. Claim 129 is therefore obvious over Nieuwdorp et al. in view of Mare et al. and Kim et al.. 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. RE: Nonstatutory double patenting over U.S. Patent No. 11,040,077 in view of Vedel et al.; over U.S. Patent No. 12,064,459 in view of Vedel et al.; and over co-pending Application No. 18/762414 in view of Vedel et al. Applicant submits that all double patenting rejections are moot because the claimed invention requires A. faecalis, which is not disclosed or rendered obvious by any of the cited references. Applicant’s argument has been considered and is found persuasive. The claims of the two U.S. patents and co-pending application are directed to pharmaceutical compositions comprising J. lividum or treatment methods using said composition. None of them recites having or using A. faecalis in a pharmaceutical composition. Hence, the double patenting rejections have been withdrawn. Conclusion No claim is allowed. 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. Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHELLE F PAGUIO FRISING whose telephone number is (571)272-6224. The examiner can normally be reached Monday-Friday, 8:00 a.m. - 4:00 p.m.. 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, Melenie L. Gordon can be reached at (571) 272-8037. 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. /Michelle F. Paguio Frising/Primary Examiner, Art Unit 1651
Read full office action

Prosecution Timeline

Apr 13, 2023
Application Filed
Aug 25, 2025
Non-Final Rejection — §101, §102, §103
Nov 26, 2025
Response Filed
Dec 27, 2025
Final Rejection — §101, §102, §103
Mar 31, 2026
Request for Continued Examination
Apr 01, 2026
Response after Non-Final Action

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Prosecution Projections

3-4
Expected OA Rounds
70%
Grant Probability
99%
With Interview (+41.3%)
2y 9m
Median Time to Grant
Moderate
PTA Risk
Based on 557 resolved cases by this examiner