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
The amendment of 05/13/2026 has been entered. Claims 66-70, 72-75, and 77-87 are currently under examination and were examined on their merits.
Terminal Disclaimer
The terminal disclaimers filed on 05/13/2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of copending Application Nos. 15/990256 and 19/366149 have been reviewed and are accepted. The terminal disclaimers have been recorded.
Withdrawn Objections
The objection to the claims for being numbered improperly as set forth in the previous Office action is withdrawn in light of the amendment of 05/13/2026, which corrected the claim numbering
All rejections of claim 71 and 76 set forth in the previous Office action are withdrawn in light of the amendment of 05/13/2026, which canceled claims 71 and 76.
The provisional rejections of the claims on the ground of nonstatutory double patenting as being patentably indistinct from the claims of copending Application Nos. 15/990256 and 19/366149 are withdrawn in light of the terminal disclaimers filed 05/13/2026, which disclaimed the terminal portion of any patent granted on this application which would extend beyond the expiration date of copending Application Nos. 15/990256 and 19/366149.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 73 and 78 are newly rejected as necessitated by amendment 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 73 recites that the first and second components of the composition are “derived from” feces “without isolation.” The meaning of this limitation is unclear because deriving something from a complex substance such as feces inherently requires isolation of at least some sort, even if said “isolation” is the “isolation” of an aliquot of the complex substance from the sample as a whole. As such, one of ordinary skill in the art would be unable to determine the metes and bounds of claim 73, rendering it indefinite.
Because claim 78 depends from claim 73 and provides no clarification of the indefinite language therein, claim 78 is also indefinite. Therefore, claims 73 and 78 are rejected under 35 U.S.C. 112(b).
In the interest of compact prosecution, the Examiner has interpreted claim 73 to recite that the first and second components of the composition are “derived from” feces and claim 78 to recite that the first and second components are non-aqueous substances “derived from” feces. The instant specification indicates that the terms feces, fecal matter, fecal material, and fecal sample “encompass solid, semisolid, or liquid metabolic waste” and that fecal samples “may include undigested plant material such as cellulose…minerals such as calcium phosphate…[and] protein” (specification as filed, page 18), but the terms “solid, semisolid, or liquid metabolic waste or undigested plant material” as instantly recited are considerably broader than the terms “feces, fecal matter, fecal material, and fecal sample” and are not limited to these terms by definition in the specification. As such, any substance that could potentially be found in fecal material will be interpreted to read on the components “derived from feces” of claims 73 and 78. For example, because water is a waste product of cellular respiration and is excreted from the body as a component of fecal material, water can be interpreted as a component “derived from” feces as recited in claim 73.
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.
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.
Claims 66-70, 72-75, and 77-85 remain rejected, and claims 86-87 are newly rejected as necessitated by amendment under 35 U.S.C. 103 as being unpatentable over US patent application 2016/0143962 filed by Berry et al., published 05/26/2016.
Please note that the rejections of claims 66-75 and 77-85 have been slightly augmented to incorporate discussion of newly-added limitations in the amended claims of 05/13/2026. However, because the basis of the rejections are unchanged, the rejections have been maintained.
Berry teaches therapeutic compositions containing probiotic, non-pathogenic bacterial populations and networks thereof for the prevention, control, and treatment of diseases, disorders, and conditions, particularly immune and inflammatory diseases in subjects (see entire document, including page 1, paragraph 0005). Preferred bacterial cells for use in the invention include bacterial cells of the genera Sutterella, Collinsella, Faecalibacterium, Blautia, Fusobacterium, Dorea, Bacteroides, Clostridium, Oscillospira, Ruminococcus, and Coprococcus (page 15, paragraph 0167; cf. claims 66 and 86-87; the Examiner notes that the instant claims do not require the first and second components to be separated from one another in any way, and so any composition containing all of the claimed ingredients can be interpreted as having the “first component” and “second component” of claim 66; the Examiner further notes that every living cell will contain at least one molecule of a substance that may be found in fecal material, such as water and glucose, and so this teaching of Berry also applies to instant claims 73 and 78, as discussed above under Claim Rejections – 35 USC 112). The bacterial cells may be isolated from the fecal matter of a subject (page 11, paragraph 0150). Individual strains may be cultured from the fecal material of one or a plurality of mammalian donor subjects (page 14, paragraph 0159; cf. claim 79). The subject may be a dog or cat (page 10, paragraph 0132; cf. claims 66, 69, 74, 80, and 82-83; the Examiner notes that dogs and cats are “non-human companion mammals” as recited in the instant claims; the Examiner further notes that dogs and cats intrinsically have recipient fecal microbiota as recited in instant claims 69 and 74). The composition comprises at least 1×103 CFU per dose of each bacterial strain (page 24, paragraph 0198; cf. claim 66). The compositions may be administered orally in the form of a tablet or capsule (page 25, paragraph 0199; cf. claim 67). The composition may be administered to the subject for the treatment of various autoimmune and inflammatory diseases, including IBD, ulcerative colitis, type I diabetes, and dermatitis (page 33, paragraphs 0276-0277; cf. claims 66 and 80-83; the Examiner notes that IBD and ulcerative colitis will involve vomiting, diarrhea, and/or constipation as recited in instant claim 81). The composition may be administered once a day over a variety of time periods, including for at least two weeks (page 35, paragraphs 0291 and 0296; cf. claims 66 and 68). All numerical parameters, including quantities of ingredients, may vary depending upon the desired properties to be obtained (page 88, paragraph 0428). The patient may be treated with antibiotics or colon-cleansing to alter the patient microbial ecosystem prior to administration of the composition to prepare the patient to receive the administered microbes and enhance the ability of the composition to affect the patient’s microbiome (page 34, paragraphs 0284-0285; cf. claims 84-85).
However, Berry does not explicitly teach the administration of a lyophilized composition containing the microbes of Berry to a non-human mammal according to the administration schedule recited in instant claim 66.
While Berry does not explicitly teach the administration of a lyophilized composition containing the microbes of Berry to a non-human mammal according to the administration schedule recited in instant claim 66, it would have been obvious to one of ordinary skill in the art to do so based on the teachings of Berry because Berry suggests the incorporation of these microbes, which may be lyophilized, into a composition that is administered to a subject, which may be a dog or cat, according to schedules that fall within the ranges recited in instant claim 66. One of ordinary skill in the art would have a reasonable expectation that administering the compositions suggested by Berry to the subjects suggested by Berry in the manner suggested by Berry would successfully result in the prevention, control, and treatment of diseases, disorders, and conditions, particularly immune and inflammatory diseases.
Berry does not teach that the amounts of the microorganisms in administered composition fall within the ranges recited in instant claims 66, 70, 72, 75, 77, and 86-87. However, the recited ranges would be within the realm of routine experimentation. Generally, differences in concentration will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP § 2144.05 part II A. It would have been obvious to one of ordinary skill in the art at the time Applicants' invention was made to determine all operable and optimal concentrations of each microbial strain in the composition because the amounts of particular microbial strains administered to a patient for the treatment of a condition are art-recognized, result-effective variables known to affect the treatment of the condition, which would have been optimized in the pharmaceutical art to provide the desired therapeutic effect. As discussed above, Berry specifically states that all numerical parameters, including quantities of ingredients, may vary depending upon the desired properties to be obtained (page 88, paragraph 0428).
As such, claims 66-70, 72-75, and 77-87 are rendered obvious by Berry and are rejected under 35 U.S.C. 103.
The Supreme Court has acknowledged:
When a work is available in one field of endeavor, design incentives and other market forces can prompt variations of it, either in the same field or a different one. If a person of ordinary skill can implement a predictable variation…103 likely bars its patentability…if a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond that person’s skill. A court must ask whether the improvement is more than the predictable use of prior-art elements according to their established functions……the combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results (see KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 U.S. 2007) (emphasis added).
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Response to Arguments
Applicant has traversed the above rejection of the claims under 35 U.S.C. 103 as being unpatentable over Berry. In support of their arguments in the remarks of 05/13/2026, Applicant has filed the Declaration of Holly Ganz, submitted 05/13/2026. Many of the arguments set forth in the remarks and the Declaration are the same. In these cases, the Examiner will respond to the arguments in the remarks and the Declaration at the same time, for the sake of brevity.
Applicant and Declarant state that the instant claims require the administration of a combination of microorganisms that often form a substantial portion of a fecal microbiota together with microorganisms from genera that consistently form only a small proportion of the microorganisms in a fecal microbiota, which Applicant and Declarant state was neither known nor suggested in the prior art. Applicant and Declarant state that the low-abundance taxa recited in the instantly recited method can still be ecologically and functionally important and potentially disproportionately important for the restoration of microbiome stability and that prior wisdom in the art supported the idea that abundant microorganisms were more important or likely to be beneficial than rare genera (remarks, pages 8-11; Declaration filed 05/13/2026, paragraphs 8, 11-13, 18, and 21). This argument has been fully considered but has not been found persuasive.
The Examiner notes that the instant claims recite only the administration of genera of microorganisms that were known in the prior art to be administered to companion mammals for therapeutic purposes; see the teachings of Berry, as cited above. The relative importance of “low-abundance taxa” and “high-abundance taxa” for ecological and functional reasons is not relevant to the instant claims, which do not recite any requirement of “low-abundance taxa” and “high-abundance taxa.” What Applicant’s claims recite is the administration of a composition requiring only taxa that are known in the teachings of Berry.
Applicant and Declarant extensively discuss results obtained from one particular method of administration of one highly specific, defined composition of fecal material containing particular microorganisms of particular species in particular amounts and assert that these results indicate that the claimed method, which encompasses any method of administration of any open-ended composition comprising any microorganisms of any species from the recited genera in significantly broader amounts, would have been unexpected to one of ordinary skill in the art, citing the teachings of Berlanda, Brown, Ural, Rojas, and Rojas as support for their assertion that the results would have been unexpected (remarks, pages 11-14; Declaration filed 05/13/2026, paragraphs 13-29). These arguments have been fully considered but have not been found persuasive because the instantly recited method is vastly broader in scope than the experiments described in Applicant’s disclosure and/or in the Declaration. Unexpected results must be commensurate in scope with the claimed invention in order to overcome a rejection under 35 U.S.C. 103. See MPEP § 716.02(d).
Applicant states that Berry does not teach the use or creation of a mixture of specific microbes found in fecal microbiota, wherein certain microbes are present in low abundance, but the administration and culturing of isolated microbes. Applicant states that Berry does not teach that the therapeutic relevance of the microbes is abundance-dependent or provide any way to identify the rare genera from the genera in Berry’s Table 1. Applicant and Declarant state that Berry provides a listing of approximately 342 genera in Table 1 that would result in large numbers of possible combinations of genera without direction for selecting the specific genera recited in the instant claims (remarks, pages 15-17; Declaration filed 05/13/2026, paragraphs 9-10). This argument has been fully considered but has not been found persuasive.
The Examiner notes that the instant claims are drawn to a method comprising the administration of a composition comprising certain genera of microbes. Nothing about the instantly claimed method limits the presence of isolated microbes in the composition or prevents the presence of any other microbe or substance in the composition. The rejection presented above and in the previous Office action does not rely on Berry’s Table 1 but, rather, the significantly shorter listing in paragraph 0167 on page 15 of Berry. See citations above. However, even if, arguendo, the Examiner had relied upon Table 1, Berry’s teachings provide sufficient support for a composition comprising all of the genera in Table 1, which would satisfy the limitations of the open-ended composition administered in the instantly recited method. Regarding the “abundance” of various genera in the composition, the Examiner notes that all of Applicant’s claims that discuss the amounts of various microorganisms in the composition do so using broad ranges of “less than” certain percentages. None of Applicant’s claims require a particular “abundance” of any microbe or that the “abundance” of any microbe be higher or lower than that of any other microbe, and a composition containing a single cell of each of the recited genera in a large quantity of carrier would satisfy Applicant’s claims.
Applicant states that Berry’s teachings include genera containing organisms that may compete metabolically, inhibit one another, occupy different ecological niches, or be associated with disease states. Applicant states that, accordingly, one of ordinary skill in the art would not reasonably assume that all genera listed in Berry could safely or effectively be combined into a therapeutic composition for administration to dogs or cats (remarks, pages 15-16). This argument has been fully considered but has not been found persuasive.
The Examiner notes that all of Applicant’s statements regarding Berry’s genera are equally applicable to Applicant’s claims, which recite many broad genera and require no particular species or strains within those genera. One of ordinary skill in the art would understand which species in the genera would be associated with disease states. Also, nothing in Applicant’s claims requires that the microbes in the composition do not compete metabolically or inhibit one another or occupy the same ecological niche.
Therefore, the Examiner has maintained the rejections presented above.
Conclusion
No claims are 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 Erin M. Bowers, whose telephone number is (571)272-2897. The examiner can normally be reached Monday-Friday, 7:30-5:00.
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, Sharmila Landau, can be reached at (571)272-0614. 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.
/Erin M. Bowers/Primary Examiner, Art Unit 1653 06/03/2026
Prosecution Insights