Prosecution Insights
Last updated: April 18, 2026
Application No. 17/296,012

HIGH COMPLEXITY SYNTHETIC GUT BACTERIAL COMMUNITIES

Final Rejection §103§112§DP
Filed
May 21, 2021
Examiner
SINGH, SATYENDRA K
Art Unit
1657
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
The Board Of Trustees Of The Leland Stanford Junior University
OA Round
4 (Final)
61%
Grant Probability
Moderate
5-6
OA Rounds
3y 6m
To Grant
99%
With Interview

Examiner Intelligence

Grants 61% of resolved cases
61%
Career Allow Rate
391 granted / 643 resolved
+0.8% vs TC avg
Strong +66% interview lift
Without
With
+66.4%
Interview Lift
resolved cases with interview
Typical timeline
3y 6m
Avg Prosecution
37 currently pending
Career history
680
Total Applications
across all art units

Statute-Specific Performance

§101
4.8%
-35.2% vs TC avg
§103
35.4%
-4.6% vs TC avg
§102
14.6%
-25.4% vs TC avg
§112
26.8%
-13.2% vs TC avg
Black line = Tech Center average estimate • Based on career data from 643 resolved cases

Office Action

§103 §112 §DP
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 Applicant’s submission filed on 01/09/2026 is duly acknowledged. Interview with Applicant’s Attorney It is noted that there were two different sets of applicant’s remarks and claim amendments were presented on the same date of 01/09/2026, which required clarification as to which one applicants want the examiner to proceed with. To clarify, Examiner contacted applicant’s attorney of record Mr. Alessandro Peschechera on 03/17/2026. Attorney Mr. Peschechera told examiner to proceed with the claims and remarks designated with attorney docket number 091592.0160 (see also attached Examiner-initiated interview summary), which have been taken as applicant’s submission for the record hereinafter. Claims 3, 5-10, 12-13, 15, 17-20, 22-25, 27-28, 30, 32-35, 37, 39, 41-42, 44-45, 48-49, and 53-56 were previously cancelled by applicants. Claims 1-2, 4, 11, 14, 16, 21, 26, 29, 31, 36, 38, 40, 43, 46-47, 50-52 and 57, as amended, are pending in this application. Claims 1-2, 4, 11, 14, 16, 21, 26, 29, 31, 36, 38, 40, 43, 46 and 50 (non-elected inventions of Groups I and II, without traverse) remain withdrawn. Claims 47, 51, 52 and 57 (elected invention of Group III, without traverse; drawn to “A method of making/producing a high-complexity defined gut microbial community”), as currently amended, have been examined on their merits in this action hereinafter. Priority This application has been filed as a 371 of PCT/US2019/062689 (filed on 11/21/2019) that claims domestic priority to US provisional application 62/770,706 filed on 11/21/2018. Claim Rejections - 35 USC § 112 -Withdrawn In view of the current amendments to claim 47, the 112b rejection as previously made by the examiner has been withdrawn. Double Patenting- Withdrawn In view of applicant’s remarks (see REM dated 01/09/2026, pages 13-14), the ODP rejection over conflicting claims of co-pending application 17/999,516 (as a later-filed application), as previously made by the examiner, has been withdrawn. The following contains new grounds of objections/rejections necessitated by applicant’s current amendments to pending claims: Claim Objections 1. Claim 47 (as currently amended) is objected to because of the following informalities: Claim 47 as amended recites the limitations (lines 11-12) as follows: PNG media_image1.png 50 696 media_image1.png Greyscale It is noted that the preposition “to” after the words “cultured together” has been deleted by the current claim amendments, which (has been taken as a typographical error) should be restored in order to correctly recite the intended step of culturing together in step (ii) “to form the defined gut microbial community”. Appropriate correction is required. 2. Claim 51 (as currently amended) is objected to because of the following informalities: Claim 51 recites limitations “in vivo backfill” (see line 3), wherein the term “in vivo” should be properly italicized (such as “in vivo”) in order to conform to standard recitation of said term. Appropriate correction is required. 3. Claim 57 (as amended) is objected to because of the following informalities: claim 57 recites at several places the limitation “C. difficile” (see lines 2, 3, 5, 9, 11, 12, 16, 18, 19), a biological name for bacteria which have not been either underlined or italicized in order to indicate such biological name in terms of genus and species. In addition, the name of the bacteria should be recited in full, at least the first time it appears in a claim set (for instance, “Clostridium difficile (C. difficile)”). Similar situation is noted for limitation “CFUs” (for instance, in lines 11-12, 18-19), as not being recited in full, at the first time it appears in claim. Appropriate correction is required. NOTE: 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. Claim Rejections - 35 USC § 103 – Made/Maintained 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. 1. Claims 47, 51, 52 and 57 (as currently amended) are/remain rejected under 35 U.S.C. 103 as being unpatentable over HENN et al (WO 2014/145958 A1; FOR previously made of record; also published as US 2016/0030494 A1 cited in applicant’s IDS dated 02/04/2022) taken with GORDON et al (WO 2015/003001 A1; FOR previously made of record). Claim 47 (as currently amended) is directed to “A method of making a high-complexity defined gut microbial community comprising a plurality of between 40 and 500 defined microbial strains, wherein the defined gut microbial community achieves substantial engraftment when administered to a gnotobiotic mouse, and wherein the engrafted defined gut microbial community is stable following a human fecal community microbial challenge, wherein the method comprises a culturing process selected from the group consisting of: (i) individually culture each of the plurality of defined microbial strains and combining each of the individually cultured plurality of defined microbial strains to form the defined gut microbial community; (ii) culture together all of the plurality of defined microbial strains (iii) individually culture one or more of the plurality of defined microbial strains culture together two or more of the defined microbial strains combining together wherein community stability is characterized by (a) up to 10% of the defined microbial strains dropping out following the microbial challenge and (b) the appearance of up to 10% of new strains contributed from the human fecal community appearing following the microbial challenge.” Claim 51 (as currently amended) is directed to “A method of producing a high-complexity defined gut microbial community comprising a plurality of between 40 and 500 defined microbial strains by in vivo backfill, wherein in vivo backfill comprises: (i) combining a plurality of defined microbial strains, (ii) engrafting the combined plurality of defined microbial strains into the gut of an animal to produce an engrafted animal, (iii) challenging the engrafted animal with a human fecal sample, (iv) maintaining the challenged engrafted animal for a time sufficient for enteric colonization of the animal by microbial strains of the human fecal sample, thereby producing an enteric community in the gut of the animal, (v) identifying microbial strains of the enteric community by metagenomic analysis, (vi) identifying whether there are differences between the microbial strains comprising the enteric community and the microbial strains comprising the combined plurality of defined microbial strains, (vii) if there is a significant difference between the microbial strains comprising the enteric community and the microbial strains comprising the combined plurality of defined microbial strains, adding one or more than one additional defined microbial strain that was not present in step (i) to the combined plurality of defined microbial strains, or removing a defined microbial strain that was present in the combined plurality of defined microbial strains of step (i), to produce a modified, combined plurality of defined microbial strains and repeating steps (ii) to (vi) in an animal that has never been engrafted, using the modified, combined plurality of defined microbial strains as the combined plurality of defined microbial strains, and if there are minimal differences, the modified, defined, microbial community in the final step vii) is a high-complexity defined gut microbial community, wherein community stability is characterized by (a) up to 10% of the defined microbial strains dropping out following the microbial challenge and (b) the appearance of up to 10% of new strains contributed from the human fecal community appearing following the microbial challenge.” See also limitations of claims 52 and 57 (both directly depend from claim 51), as currently amended/presented. NOTE: The term “high-complexity” has been defined by applicants to mean “a community having at least 40 defined microbial strains” (see instant specification, page 11, [0045], in particular), wherein “complexity” means the number of strains in a community “without regards to abundance”. It is also noted that the “high-complexity defined gut microbial community” of claims 47 and 51 as currently presented do not represent any specifically gut microbial entity/entities in terms of specific bacterial, fungal, protozoal, or any other microbe(s), and/or species/strains thereof in the community produced/made per se, other than the intended results and/or functional properties as recited in instant claims 47 and 52, as amended. Henn et al (2014), while teaching therapeutic microbial compositions comprising combinations of bacteria that are useful for the maintenance or restoration of a healthy microbiota in the gastrointestinal (GI) tract of a mammalian subject (see title, Abstract and Summary of the invention on page 2, para [008]-[009], for instance), disclose preparation of microbial compositions, i.e. a high-complexity defined gut microbial community comprising a plurality of between 40 and 500 defined microbial strains (see Abstract- “therapeutic compositions containing combinations of bacteria, for the maintenance or restoration of a healthy microbiota in the gastrointestinal tract of a mammalian subject”; para [092], page 50- "In some embodiments, the bacterial composition includes at least. .. 500, 550, 600, or greater numbers of bacteria types"; para [0278], page 95 “The identity of the bacterial species which grow up from a complex fraction can be determined ... such that individual 16S signatures can be identified in a complex mixture”); wherein the defined gut microbial community achieves substantial engraftment when administered to a gnotobiotic mouse (see para [071] page 20- “the administration of the formulation results in engraftment of at least one type of spore-forming bacteria present in the therapeutic composition”; also see para [036] page 33 “Engrafted OTUs can establish for a transient period of time, or demonstrate long-term stability in the microbial ecology that populates the host post treatment with a bacterial composition”; see also para [0421]-[0423], pages 141-142- “Ob and Ln mice prepared as described by Ridaura et al. (2013) can be used to test the therapeutic potential of a bacterial composition for obesity. Ob and Ln mice are generated by introducing via oral gavage fecal samples from twins discordant for obesity into 8-9 week old adult male germ-free C57BL/6J mice. One gnotobiotic isolator is used per microbiota sample and each recipient mouse is individually caged within the isolator ... At day 15 post colonization, the bacterial composition containing at least 108 CFU/ml per strain is administered daily by oral gavage for 4 weeks to half of the Ob mice and half of the Ln mice”; para [0446] page 148- “each bacterial composition is assessed for the ability of the bacterial composition test article to induce a healthy microbiome, as measured by engraftment, augmentation and increase in microbiota diversity”); wherein the engrafted defined gut microbial community is stable following a human fecal community microbial challenge (see para [0318] page 108- “Provision of fecal material. Fresh fecal samples were obtained from healthy human donors who have been screened”; see also para [0320] page 109- “Generation of a Spore Preparation from Alcohol Treatment of Fecal Material A 10% w/v suspension of human fecal material in PBS was filtered ... the suspension was centrifuged at high speed to concentrate spores into a pellet containing a purified spore containing preparation”; see also para [0361]-[0362] pages 123-124- “To test the therapeutic potential of the bacterial composition such as but not limited to a spore population, a prophylactic mouse model of C. difficile infection was used ... On day -1, test articles are spun for 5 minutes at 12,100 rcf, their supernatants' removed, and the remaining pellets are resuspended in sterile PBS, prereduced if bacterial composition is not in spore form, and delivered via oral gavage. On day 0 they were challenged by administration of approximately 4.5 log 10 cfu of C. difficile.... Of those 157 arms, 136 of the arms and 73 of the networks performed better than the respective experiment's vehicle control arm by at least one of the following metrics: cumulative mortality, mean minimum relative weight, and mean maximum clinical score. Examples of efficacious networks include but are not limited to networks N1979 as tested in SP-361 which had 0% cumulative mortality, 0.97 mean minimum relative weight, and O mean maximum clinical score”); and wherein the isolated bacteria include those bacteria (isolated from fecal materials, i.e. originated from gut microbiome of one or more donors; see para [0136] on page 59) that are cultured, even if such cultures are not monocultures (see para [030], page 31; and para [0141] on page 60); wherein “a spore population may be derived through culture methods starting from isolated spore former species or spore former OTUs or from a mixture of such species, either in vegetative or spore form” (see [052] on page 38, for instance); wherein “one or more than one bacterial spores, bacteria, or types of bacterial spores are generated in culture and combined to form a purified bacterial composition” (see para [0141] on page 60, for instance). Henn et al demonstrate engrafting and augmentation of certain bacterial species in patients treated with the microbial composition (see para [095]-[097] on page 24- “Figure 8 shows species engrafting versus species augmenting in patients microbiomes after treatment with a bacterial composition … according to an embodiment of the invention. Relative abundance of species that engrafted or augmented as described were determined based on the number of 16S sequence reads. Each plot is from a different patient treated with the bacterial composition…for recurrent C. difficile”; and employ metagenomic analysis for characterization of extracted nucleic acids from the microbial samples (see para [0269] on page 90; [0277] on page 94; and [0368] on page 125, for instance); wherein the fecal samples were collected and assessed for pathogen (i.e. C. difficile) carriage and reduction by microbiological methods (see para [0363] on page 124, for instance; and para [0278] on page 95), including colony counting from samples of treated patients (see para [0341] on page 116, for instance); wherein the microbial network ecology was defined “in terms of the metabolic pathways and associated gene products required for the metabolism of nondigestible carbohydrates via fermentation by colonic bacteria and by the gene products leading from mono- and di-saccharides and simple substrates such as acetate and lactate to butyrate (Figures 12-15). We then used the 1MG functional database…to generate a metabolic function matrix .... This matrix was restricted to OTUs known to reside in the gastrointestinal tract” (see para [0396] on page 136), and for utilization (i.e. metabolism) of variety of complex carbon sources including polysaccharides, steroids, and other carbon sources such as fructans, starches, cellulose, inulin, xylans, pectins, glycoproteins, glycopeptides, etc. (see para [0412]-[0413], on page 140, for instance; and [0379]-[0380] of Example 16, starting on page 129) using nutrient utilization assays, for example. However, Henn et al do not disclose and/or exemplify the method of producing the “high-complexity defined gut microbial community comprising a plurality of between 40 and 500 defined microbial strains”- wherein “community stability is characterized by (a) up to 10% of the defined microbial strains dropping out following the microbial challenge and (b) the appearance of up to 10% of new strains contributed from the human fecal community appearing following the microbial challenge” (see instant claim 47); and wherein the “high-complexity defined gut microbial community” is prepared by “in vivo backfill” method as specifically recited in instantly amended claim 51. Gordon et al (2015) disclose design and investigation of a 12-member model, artificial human gut microbial community which is referred to as a first generation artificial community of modest complexity and that e.g. taxa (e.g., Proteobacteria, Bifidobacteria) and microbial guilds (e.g., butyrate producers) typical of human gut communities that are absent from the defined assemblage that could be used to augment the system, as part of future attempts to systematically increase microbial complexity (see detailed disclosure in Examples 1-22, and paragraphs [0176]-[0180], in particular). Such augmentation would involve moving back and forth between in vivo and ex vivo analyses, using one to inform the other, involving the application and integration of high resolution DNA-, mRNA-, and protein-level analyses can be applied to study artificial communities of sequenced human gut microbes e.g. colonizing gnotobiotic mice. Thus, the disclosure of Gordon et al can be considered as a first step in the design of a first generation artificial human gut microbial community or consortium for application, e.g. stable engrafting into the gut of an animal, e.g. a human, such as for the treatment of diseases related to e.g. reflected in gut microbiota dysbiosis. Gordon et al clearly disclose the importance and involvement of in vivo testing of factors such as stability, efficiency and sufficiency of a defined microbial consortia. Therefore, given the detailed disclosure for the importance and involvement of in vivo testing of factors (in suitable animal model of disease, for instance) such as stability, efficiency and sufficiency of a defined microbial consortia by both cited prior art references of Henn et al and Gordon et al, as discussed above, it would have been obvious to an artisan of ordinary skill in the art of gut microbiome, to modify the method of preparation of defined gut microbial community with high complexity using in vivo colonization in animal models that are challenged with human fecal samples, and assessed for the disease outcome by analyzing and/or identifying the fecal microbial species, the information from which can in turn be used to modify the defined microbial strains as per need, in order to improve the treatment modalities, including in patients infected with C. difficile, as already suggested by the combined teachings from Henn et al taken with the disclosure from Gordon et al, as discussed above. Since, the metagenomic technology for comparing and identifying strains and sequences thereof, standard microbiological detection and counting techniques as well as the functional nutrient utilization and product matrix analyses and related methodologies have already been known in the art and disclosed in the cited prior art references of record with particular reference to gnotobiotic mouse model studies, such modifications in the method of making defined, high complexity gut microbial community would have been obvious and/or fully contemplated by an artisan in the art, unless evidence/data provided on the record for the entire scope of the invention as claimed (see instant claim 47 and 51, in particular), which is currently lacking on record (see instant disclosure, Examples 1-7, and page 46, paragraph [0144], for instance). It is also to be noted that instant claims do not require any particular combination of between 40 or 500 specific “defined microbial strains”, or specific combination set(s) thereof, per se. The limitations of claims 47 and 51, wherein “community stability is characterized by (a) up to 10% of the defined microbial strains dropping out following the microbial challenge and (b) the appearance of up to 10% of new strains contributed from the human fecal community appearing following the microbial challenge”, would have also been obvious to an artisan in the art because Henn et al teach the fact that the administered microbial community causes augmentation and engraftment of new or previously low population microbial strains in the host gut, thus stably increasing the number of microbial strains that populate the gut (page 20, [0071]- “the administration of the formulation results in engraftment of at least one type of spore-forming bacteria present in the therapeutic composition”; [033] on page 35- “"augmentation" refers to the establishment or significant increase of a population of microbes that are (i) absent or undetectable (as determined by the use of standard genomic and microbiological techniques) from the administered therapeutic microbial composition.... and (iii) are found after the administration of the microbial composition or significantly increased, for instance 2-fold, 5-fold, 1 x 102, 1 x 103, 1 x 104, 1 x 105, 1 x 106, 1 x 107, or greater than 1 x 108, in cases where they were present at low frequencies; page 33, [036]- “"Microbial Engraftment" or simply "engraftment" refers to the establishment of OTUs present in the bacterial composition in a target niche that are absent in the treated host prior to treatment. The microbes that comprise the engrafted ecology are found in the therapeutic microbial composition and establish as constituents of the host microbial ecology upon treatment. Engrafted OTUs can.... demonstrate long-term stability in the microbial ecology that populates the host post treatment with a bacterial composition ... capable of catalyzing a shift from a dysbiotic ecology to one representative of a health state”); and is substantially effective to reduce Clostridium difficile from a feces challenge (page 67, para [0170]- “a single administration is substantially effective to reduce Clostridium difficile (i.e., C. difficile) and/or C. difficile toxin content and/or toxin activity, in a mammalian subject to whom the composition is administered. Substantially effective means that Cl. difficile and/or C. difficile toxin content in the subject is reduced by at least 10% ... or greater than 99% following administration of the composition”; page 101, [0295]- “Samples with mean log inhibition greater than the 99% confidence interval…”. Since Henn et al further disclose quantitative determination of different bacteria strains that have populated the gastrointestinal tract of the mice after treatment with the bacterial composition (see disclosure on page 75, [0208], for instance), it would have been obvious to one of ordinary skill in the art that the same methods/techniques could be employed and/or used to treat a subject such that less than up to 10% of the defined microbial strains dropping out, and up to 10% of new strains contributed from the human fecal community appear following the microbial challenge, since the engraftment levels taught by Henn et al combined with the disclosed inhibition of C. difficile after feces challenge could effectively produce such level of community stability, for example, by iterative selection of a desired microbial community with high stability using the ordinary course of experimentation, in order to enhance therapeutic efficacy of the resulting microbial composition. Therefore, the invention as a whole, as currently amended (see instant claims 47 and 51, in particular), does not appear to distinguish itself over the combined teachings and/or suggestions from the cited prior art of record, as discussed above. Thus, the claim as a whole would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention as claimed. As per MPEP 2111.01, during examination, the claims must be interpreted as broadly as their terms reasonably allow. In re American Academy of Science Tech Center, F.3d, 2004 WL 1067528 (Fed. Cir. May 13, 2004)(The USPTO uses a different standard for construing claims than that used by district courts; during examination the USPTO must give claims their broadest reasonable interpretation.). This means that the words of the claim must be given their plain meaning unless applicant has provided a clear definition in the specification. In re Zletz, 893 F.2d 319, 321, 13 USPQ2d 1320, 1322 (Fed. Cir. 1989). Examiner’s Response to Applicant’s Arguments Applicant’s arguments filed on 01/09/2026 with respect to claims 47, 51, 52 and 57 under examination (see REM, pages 12-13) have been considered but are not found to be persuasive in view of the 103(a) rejection as discussed above, and at least for the following reasons of record: Regarding the 103(a) rejection of record, applicants appear to argue that the cited prior art references do not provide motivation to a person of ordinary skill in the art to modify the teachings with a reasonable expectation of success, and thus the proposed combination is insufficient to support an assertion of obviousness under 35 USC § 103 (see REM, p. 12), and further state that “…absent the teachings of the present application and as conceded by the Examiner, a skilled artisan would have been faced with the necessity of conducting countless trial-and-error experiments to ascertain whether the claimed augmentation and engraftment outcomes could be achieved” (see REM, p. 13). Applicant’s arguments are duly noted and considered. However, it is to be noted that instant process claims 47 and 51 as currently presented do not require any specificity in terms of “defined” microbial strains, and/or particular combination(s) thereof in the “microbial community” per se. Furthermore, the wherein clause recited (in both instant claim 47 and 51) in the form of intended results for the “community stability” following microbial challenge, would have been obvious to an artisan in the art by the combined disclosure from the cited prior art references, as specifically discussed given the detailed teachings from Gordon et al as discussed in the rejection of record above. In addition, since both the cited prior art references teach making of gut microbial compositions for the maintenance or restoration of a healthy microbiota in the gastrointestinal tract of a mammalian subject and support growth of beneficial bacterial strains in the gut of a subject in need thereof, the argument for the lack of motivation in the art is not found to be persuasive. Also, as already noted earlier in the previous office action (paper dated 07/09/2025, p. 17-18), since Henn et al disclose the required quantitative methods for determination of different bacterial strains that have populated the gastrointestinal tract of the mice after treatment with the bacterial composition (see disclosure on page 75, [0208], for instance), it would have been obvious to an artisan of ordinary skill in the art that the same methods could be successfully employed and/or used to treat a subject such that up to 10% of the defined microbial strains drop out, and up to 10% of new strains contributed from the human fecal community appear following such microbial challenge, since the engraftment levels taught by Henn et al combined with the disclosed inhibition of C. difficile after feces challenge could effectively produce such level of community stability, for example, by the use of iterative selection of a given microbial community with high stability using the ordinary course of experimentation, in order to enhance the therapeutic efficacy of the resulting microbial composition. It is noted that no reasonable evidence/data has been presented on record by the applicants in order to demonstrate such experimental unpredictability per se. Therefore, in the absence of evidence/data on record to the contrary commensurate with the scope of the claimed process, the applicant’s argument for the lack of reasonable expectation of success or undue experimentation, is duly considered, but is also not found to be persuasive. It is noted to applicants that the scope of the showing must be commensurate with the scope of claims to consider evidence probative of unexpected results, for example. In re Dill, 202 USPQ 805 (CCPA, 1979), In re Lindner 173 USPQ 356 (CCPA 1972), In re Hyson, 172 USPQ 399 (CCPA 1972), In re Boesch, 205 USPQ 215, (CCPA 1980), In re Grasselli, 218 USPQ 769 (Fed. Cir. 1983), In re Clemens, 206 USPQ 289 (CCPA 1980). It should be clear that the probative value of the data is not commensurate in scope with the degree of protection sought by the claims (see instant claims 47 and 51, in particular). The 103(a) rejection of record as discussed above, is therefore properly made/maintained. Conclusion NO claims are currently 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 SATYENDRA K. SINGH whose telephone number is (571)272-8790. The examiner can normally be reached M-F 8:00- 5:00. 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, LOUISE W HUMPHREY can be reached on 571-272-5543. 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. SATYENDRA K. SINGH Primary Examiner Art Unit 1657 /SATYENDRA K SINGH/ Primary Examiner, Art Unit 1657
Read full office action

Prosecution Timeline

May 21, 2021
Application Filed
Mar 20, 2024
Non-Final Rejection — §103, §112, §DP
Sep 26, 2024
Response Filed
Dec 23, 2024
Final Rejection — §103, §112, §DP
Jun 30, 2025
Request for Continued Examination
Jul 02, 2025
Response after Non-Final Action
Jul 07, 2025
Non-Final Rejection — §103, §112, §DP
Jan 09, 2026
Response Filed
Mar 17, 2026
Examiner Interview (Telephonic)
Mar 31, 2026
Final Rejection — §103, §112, §DP (current)

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Prosecution Projections

5-6
Expected OA Rounds
61%
Grant Probability
99%
With Interview (+66.4%)
3y 6m
Median Time to Grant
High
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