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 amended claim set filed on 12 December 2025 is acknowledged. Claims 1-8, 11-15, and 17-18 are currently pending. Of those, claims 1, 7-8, and 18 are amended. There are no new claims and claims 15 and 17-18 are withdrawn. Claims 9-10, and 16 are cancelled. Claims 1-8 and 11-14 will be examined on the merits herein.
Election/Restrictions
Applicant's election with traverse of Group I (claims 1-8 and 11-14) in the reply filed on 12 December 2025 is acknowledged. The traversal is on the ground(s) that US 2019/0083550 (“Baram”) does not teach or suggest a step of cultivating a complex community of microorganisms in at least three bioreactors, wherein said bioreactors have different pH, as is recited in amended claim 1. This is not found persuasive because the shared technical feature does not make a contribution over the prior art, as is set forth in the rejection under 35 U.S.C. 103, below.
The requirement is still deemed proper and is therefore made FINAL.
Claims 15 and 17-18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 12 December 2025.
Priority
The instant application is a 371 of application PCT/EP2021/087619 (filed 23 December 2021) and claims priority to foreign application EP 20306685.7 (filed 23 December 2020). Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. Therefore, the effective filing date of instant claims 1-8 and 11-14 is 23 December 2020.
Claim Interpretation
Regarding claims 2-6 and 14, each of these claims recites one or more limitations beginning with “preferably” and/or “more preferably”. MPEP 2111.04 states: “Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure.” The recited “preferabl[e]” limitations are interpreted as optional limitations and, thus, are not required by the claim.
Claim 12 recites the phrase, “step (a) or steps (a) and (b) are repeated at least once”. This phrase is interpreted to mean that step (a) or steps (a) and (b) are repeated at least once in addition to the initial performance of the step(s) in claim 1, i.e., in repeating step (a) once, the step is performed a total of two times.
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 5-6 and 11 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.
Regarding claims 5-6 (which depend upon claim 1), the claims recite “a first bioreactor”, “a second bioreactor”, and “a third bioreactor”. The antecedent basis for these terms is unclear because one of ordinary skill in the art cannot determine of the terms refer to the first, second, and third bioreactors recited in claim 1 or to a different first, second, and third bioreactors. In the interest of compact prosecution, it is assumed that the first, second, and third bioreactors recited in claims 5-6 refer to the corresponding first, second, and third bioreactors in claim 1.
Regarding claim 11, the claim recites, “the complex community of microorganisms used in step (a) is under the form of a suspension”. It is unclear if “under” is a typographical error or if the claim is describing that the community of microorganisms is physically underneath a suspension. In the interest of compact prosecution, the claims is interpreted as reciting “the complex community of microorganisms used in step (a) is in the form of a suspension”.
Clarification is requested.
Claim Rejections - 35 USC § 103
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.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-8 and 11-14 are rejected under 35 U.S.C. 103 as being unpatentable over Baram et al. (US 2019/0083550 A1; cited in IDS; herein “Baram”).
Regarding claims 1 and 7-8, Baram teaches a method for obtaining a composition comprising a co-culture of at least two distinct bacterial families having differing growth and/or proliferative conditions (para. 23) comprising dividing a plurality of bacterial genera (i.e., a complex community of microorganisms) into a plurality of bacterial solution subsets, i.e., at least two (para. 28), culturing each bacterial solution subset in a growth medium (i.e., in a bioreactor or device useful for cultivating microorganisms in which culture parameters can be controlled) and under proliferative conditions suitable for the proliferation of the individual subset (para. 29), and removing the growth medium (i.e., harvesting inocula) and recombining the individual subsets (i.e., mixing the harvested inocula) (para. 30). Baram teaches examples of culturing individual subsets in 8 different proliferative conditions (para. 127-136) and four different proliferative conditions (para. 142-143). Baram teaches that the proliferative condition for each subset may include a pH gradient based on the known pH of the sample’s origin tissue, and that the pH for the individual subsets may be between about 6.6 to about 7.5, about 5.6 to about 7.9, about 4.5 to about 8, about 4.0 to about 7.0, about 7.0 to about 7.5, or about 5.5 to about 7.5 (para. 93).
Regarding claims 2-6, Baram teaches that the incubation time of the proliferative conditions (i.e., a retention time greater than or equal to the incubation time) may be 1, 2, 3, 4, 5, 6, 10, 12, 15 hours, or any value therebetween, or at least 1, 2, 3, 4, 5, 6, 7, or 10 days (para. 92).
Regarding claim 11, Baram teaches that the plurality of bacterial genera comprising microbiota sample(s) is in the form of a suspension using saline solution (para. 24-25, 100, and 127).
Regarding claim 12, Baram teaches that the culturing of individual subsets may be repeated with changing the growth medium and proliferation conditions, e.g., pH (para. 102 and FIG. 1).
Regarding claim 13, Baram teaches that the composition comprising the recombined subsets is lyophilized (para. 103 and FIG. 1).
Regarding claim 14, Baram teaches that the plurality of bacterial genera (i.e., complex community of microorganisms) is derived from one or more samples from a fecal sample (para. 58).
However, Baram does not explicitly teach a first bioreactor with a pH between 4.5 and 5.8, a second bioreactor with a pH between 5.9 and 6.8, as in claim 1, bioreactors with different retention times of between 6 and 102 hours, as in claim 2, at least one bioreactor with a retention time of between 6 and 18 hours, as in claim 3, at least one bioreactor with a retention time of between 18 and 30 hours, as in claim 4, a first bioreactor with a retention time between 18 and 30 hours and a second bioreactor with a retention time of between 6 and 18 hours or between 42 and 54 hours, as in claim 5, a first bioreactor with a retention time of between 6 and 18 hours, a second bioreactor with a retention time between 18 and 30 hours, and a third bioreactor with a retention time of between 42 and 54 hours, as in claim 6, a first bioreactor with a pH between 5 and 5.6 and a second bioreactor with a pH between 6 and 6.6, as in claim 7, or a first bioreactor with a pH between 5.2 and 5.4, a second bioreactor with a pH between 6.2 and 6.4, and a third bioreactor with a pH between 7.2 and 7.4, as in claim 8.
Therefore, it would have been prima facie obvious, before the effective filing date of the claimed invention, to a person of ordinary skill in the art, to modify the method taught by Baram by optimizing the pH conditions of the cultures of the individual bacterial subsets and optimizing the retention time for each of the bacterial subsets, thereby arriving at the claimed invention. The person of ordinary skill in the art would have been motivated to make the modification because Baram teaches that the pH gradient for each subset is based on the pH of the sample’s origin tissue, so the pH conditions will vary based on the type of microbiota sample. Therefore, the combination is also desirable (see MPEP 2144(II)). The person of ordinary skill in the art would have had a reasonable expectation of success because Baram teaches pH condition ranges and incubation time ranges broader than what is claimed, so one would predict that culturing microorganisms using the narrower claimed pH and time ranges would result in an expanded community of microorganisms at least as well as with the conditions taught by Baram. Therefore, the combination leads to expected results because each element performs the same function as is does individually.
Regarding the pH ranges of claims 1 and 7-8, Baram teaches proliferative conditions having a pH of 6.6-7.5, 5.6-7.9, 4.5-8, 7.0-7.5, and 5.5-7.5 (para. 93), all of which encompass or overlap with one or more of the claimed pH ranges. Regarding the time ranges of claims 2-6, Baram teaches incubation time of the proliferative conditions may be 1, 2, 3, 4, 5, 6, 10, 12, 15 hours, or any value therebetween, which includes times that fall within the ranges recited in claims 2-3 and 5-6, or at least 1, 2, 3, 4, 5, 6, 7, or 10 days, which includes times that fall within the ranges recited in claims 4-6. It is noted that the courts have stated where the claimed ranges “overlap or lie inside the ranges disclosed by the prior art” and even when the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have similar properties, a prima facie case of obviousness exists (see In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990); Titanium Metals Corp. of America v. Banner, 778 F2d 775. 227 USPQ 773 (Fed. Cir. 1985) (see MPEP 2144.05.01).
The courts have also found that “where 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 (II).
Therefore, the claimed ranges merely represent an obvious variant and/or routine optimization of the values of the cited prior art.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BAILEY M MORGAN whose telephone number is (703)756-5388. The examiner can normally be reached M-F 9-5 ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, DANIEL KOLKER can be reached at (571) 272-3181. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BAILEY M MORGAN/Examiner, Art Unit 1645
/BAO-THUY L NGUYEN/Supervisory Patent Examiner, Art Unit 1677 April 28, 2026
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