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 .
References to the specification in this action will use paragraph numbers from the Pre-Grant Publication US-20240096440-A1 in order to avoid ambiguity if the page and line numbers change across versions of the specification.
Election/Restrictions
Applicant’s election without traverse of Group 1 (claims 1-23, drawn to a composition comprising bacteria) in the reply filed on 9 Dec 2025 is acknowledged.
Applicant’s election without traverse of two different groupings in response to the species election is improper (“the composition comprising each of Bacteriodes stercoris, Blautia producta, and Akkermansia muciniphila, and the composition comprising each of Bacteriodes massiliensis, Blautia producta, and Akkermansia muciniphila”). During a telephone conversation with Cameron Applegate on 18 Feb 2026 a provisional election to prosecute the species combination of Bacteriodes stercoris, Blautia producta, and Akkermansia muciniphila, claim 2. Affirmation of this election must be made by applicant in replying to this Office action. Claims 3-23 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Claim Status
The amended claim set filed 9 Dec 2025 is acknowledged. Claims 1-25 are currently pending. Of those, all claims are original. Claims 3-23 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention. No claims are cancelled. Claims 1-2 will be examined on the merits herein.
Priority
The instant application claims priority to provisional applications 62/481,062 (filed 3 Apr 2017), 62/545,733 (filed 15 Aug 2017), 62/620,752 (filed 23 Jan 2018). The instant application is a CON of PCT/US18/25805 (filed 3 Apr 2018) and is a DIV of 16/592,070 (filed 3 Oct 2019). What follows is the examiner’s claim-by-claim analysis of effective filing date for the claims currently under examination. If the applicant disagrees with this examiner’s determination of effective filing date for any claim, the applicant may identify text within the prior applications that provides support the claimed language.
Regarding claim 1, the ‘062 provisional does disclose the specific strains of bacteria recited in the claim, such as Blautia producta DSM 2950. The ‘733 and ‘752 provisional applications also do not disclose the claimed invention because they do not disclose the rRNA thresholds used to define the claim. However, the PCT application discloses the same claim scope (claim 60). Therefore, the effective filing date used for this claim is 3 Apr 2018.
Regarding claim 2, the ‘062 provisional does not provide support for the elected species because it only identifies B. stercoris as a “species of particular interest” (pg. 61) rather than disclosing it as part of a composition for benefiting the health of an animal or human. However, the ‘733 provisional identifies the claimed species as being part of a composition for benefiting the health of an organism (claim 32). Therefore, the effective filing date used for this claim is 15 Aug 2017.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 9 Jan 2024 (4x), 25 July 2024, 7 Jan 2025, and 10 Dec 2025 were filed in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements have been considered by the examiner. Signed copies of these statements are attached with this action.
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered. This paragraph is only a notice to the applicant, it is not a requirement that all references from the specification be submitted in an IDS.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01. The hyperlinks are found at [0154, 0177, and 0200], the requested correction is for only the http:// to be deleted.
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 1-2 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 1-2, the claims each read “a biologically pure culture of” multiple bacterial species, either all from a list in claim 1, or one or more from a list in claim 2. Each claim also is a composition comprising elements, so the claim may include additional elements not specifically written. One of ordinary skill in the art would not be able to determine how to interpret the “biologically pure culture” limitation because the bacteria would cease to be in a biologically pure single species culture when they are mixed with the other species claimed and how a claim limitation of a biologically pure mixed-species culture would interact with the claimed composition that could include other bacterial species that are not listed. Is this limitation requiring that no bacteria other than those explicitly listed be present so that the multi-species culture is biologically pure? Alternately, this could be interpreted as a product-by-process limitation, which would not affect the structure of the bacterial cell itself and would not be considered for patentability as described in MPEP 2113. Clarification is required. In the interest of compact prosecution, in this action the claim limitation will be interpreted as a non-limiting description of the culturing process used to obtain the bacteria used in the composition.
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.
Claim 2 is rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural product without significantly more.
The claim recites “A composition for benefiting the health of an animal or a human, the composition comprising i) one or more carriers or excipients and ii) a biologically pure culture from one or a combination of: Megamonas funiformis, Megamonas hypermegale ,Acidaminococcus intestini, Bacteroides massiliensis, Bacteroides stercoris, Barnesiella intestinihominis, Faecalibacterium prausnitzii, Subdoligranulum variabile, Anaerostipes caccae, Anaerostipes hadrus, Clostridium symbiosum, Clostridium bolteae, Blautia hydrogenotrophica, Marvinbryantia formatexigens, Clostridium scindens, Blautia producta, and Akkermansia muciniphila.” The species election was that the bacteria are the combination of Bacteroides stercoris, Blautia producta, and Akkermansia muciniphila. The instant specification teaches that the bacterial species are isolated from the human gut [0200-0201]. However, the examiner has not found evidence of a human simultaneously having all three species of bacteria in their gut naturally. So, the combination has been analyzed for markedly different characteristics relative to the natural species. See MPEP 2106.04(c): “In Myriad, the Supreme Court made clear that not all changes in characteristics will rise to the level of a marked difference, e.g., the incidental changes resulting from isolation of a gene sequence are not enough to make the isolated gene markedly different. Myriad, 569 U.S. at 580, 106 USPQ2d at 1974-75.” Like in Myriad, any incidental changes from isolating the bacteria into a biologically pure culture do not rise to the level of a marked difference, particularly because the claimed product is not required to be biologically pure and can be mixed with any number of other species like in the natural microbiome context. The instant specification does not teach any modifications to the bacteria relative to their natural states; instead the specification teaches that the desired functionalities were already present in the bacteria isolated from the gut microbiome [0201]. The specification teaches that for the full GUT-103 bacterial combination, the combination of strains has different properties because “the GUT-103 consortium model does indeed predict growth for the GUT-103 consortium in minimal medium, without the need to include additional nutrients, even though none of the GUT-103 consortium strains alone are predicted to be capable of growing in this medium” [0209]. However, this markedly different property was not found for the elected species of Bacteroides stercoris, Blautia producta, and Akkermansia muciniphila. For example, Table 6 teaches that Bacterioides stercoris must consume L-histidine, but the producing species of Blautia hydrogenica is not present in the elected composition. Also, the other elements of the claim (“comprising (i) one or more carriers or excipients” and the preamble “for benefiting the health of an animal or a human”) does not make the bacterial composition markedly different because the carrier could be only water, which has the benefit of being hydrating, and which is already naturally present in combination with the bacterial strains in the gut. Therefore, the elected species that the bacteria are the combination of Bacteroides stercoris, Blautia producta, and Akkermansia muciniphila is not markedly different from the natural species individually, and the claim recites a natural product.
This judicial exception is not integrated into a practical application because the composition itself is not markedly different from a natural product; there are no additional elements that could integrate the judicial exception. The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception because the composition itself is not markedly different from a natural product; there are no additional elements that could integrate the judicial exception.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 2 is rejected under 35 U.S.C. 103 as obvious over Cook et al. (US-20160317653-A1; hereafter Cook; PTO-892).
Cook teaches compositions useful for treatment of immune system disorders [Title] that contain a carrier [0028]. Cook states: “In some embodiments, the composition comprises or consists essentially of species selected from the group consisting of … Akkermansia muciniphila, … Bacteroides stercoris, … [and] Blautia producta” [0053]. Therefore, Cook teaches compositions comprising each bacterial species individually present, see MPEP 2131.02: “when the species is clearly named, the species claim is anticipated no matter how many other species are additionally named. See Ex parte A, 17 USPQ2d 1716 (Bd. Pat. App. & Inter. 1990)”.
One of ordinary skill in the art at the time of filing would consider it prima facie obvious to modify the Cook compositions comprising the bacteria individually by combining the compositions, thereby arriving at the claimed invention, because "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted).
Additionally, KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007), discloses that combining prior art elements according to known methods to yield predictable results, is obvious unless its application is beyond that person's skill. KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007) also discloses that the combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results. In the instant case all elements (i.e. compositions comprising each bacteria individually) were known in the art. In addition, combining these elements yields a composition wherein each element merely performs the same function as it does separately; thus the results of the combination would be recognized as predictable to one of ordinary skill in the art. Specifically, the result of producing the mixed composition that is claimed would be predictable. Also, there is no evidence of record that the combination of Bacteroides stercoris, Blautia producta, and Akkermansia muciniphila leads to a composition having any unexpected results when being produced or used. Therefore, the claimed invention is prima facie obvious in view of the teachings of the prior art, absent any convincing evidence to the contrary.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMELIA NICOLE DICKENS whose telephone number is (571)272-0381. The examiner can normally be reached M-R 8:30-4:30, and every other F 8:30-4:30 (EDT/EST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Dan 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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/AMELIA NICOLE DICKENS/Examiner, Art Unit 1645
/DANIEL E KOLKER/Supervisory Patent Examiner, Art Unit 1645