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 .
Status of claims
Claims 25, 27 and 33-37 as amended on 2/19/2026 are under examination in the instant office action.
Applicant’s election without traverse of “single species” (one product with one specific combination of 2 specific bacteria that is “a combination of Akkermansia sp. strain GGCC- 220 (having SEQ ID NO: 1) and Bacteroides xylanisolvens strain GGCC-0124 (having SEQ ID NO: 3)”, in the reply filed on 8/28/2025 was acknowledged.
Claims 38-44 were withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected groups of inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 8/28/2025.
Claims 26, 28-32 were withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected groups of “single species”, wherein the non-elected claims 26, 28-32 require combinations of more than 3 or from 3 to all 11 bacterial entities including 3-11 strains. Election was made without traverse in the reply filed on 8/28/2025.
Claim Rejections - 35 USC § 102
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.
Claims 25 and 33-37 as amended remain/are rejected under 35 U.S.C. 102 (a) (1) as being anticipated by US 8,906,668 (Henn et al).
US 8,906,668 (Henn et al) discloses a composition for benefiting health, wherein the composition comprises at least 2 types of isolated bacteria wherein OTU of each are independently characterized by at least 97% and more identity to SEQ ID NOs 1-1,864 (col. 19, lines 62-66), wherein OTU is a full 16SrRNA gene sequence (col. 20, lines 21-22). In particular, in the disclosure of US 8,906,668 (Henn et al) the SEQ ID NO: 119 is characterized by 98.5% identify to the claimed SEQ ID NO: 1 and is present in Akkermansia sp. In the disclosure of US 8,906,668 (Henn et al) the SEQ ID NO: 297 is characterized by 100% identify to the claimed SEQ ID NO: 3 and is present in Bacteroides sp.
Thus, the cited document US 8,906,668 (Henn et al) anticipates claim 25.
As applied to claims 33-37, the compositions of the cited document comprises bacteria that are viable and/or in the forms of spore (col.10, lines 33-35), freeze-dried (col. 26, line 7); the composiotns formulated with pharmaceutical carriers for oral and rectal delivery, with enteric coating for delivery to intestines (col. 10, lines 35-38). The cited document recognizes that the disclosed novel combinations of commensal bacterial strains are effective in restoring and enhancing ecological control over gut pathogens in vivo (col.18, lines 55-60), thus, in providing metabolic interdependency within the broadest meaning of the claims.
Thus, the cited document US 8,906,668 (Henn et al) anticipates the claimed invention.
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.
Claims 25, 27 and 33-37 as amended remain/are rejected under 35 U.S.C. 101 because the claimed invention is directed to a product of nature without significantly more.
The claims recite a composition with 2 bacterial cultures or strains that are naturally occurring bacteria since they were isolated from feces of healthy people in view of specification (par. 0218 of published application). The dependent claims further recite natural forms bacteria such as vegetive cells, spores. (Note: claim 36 is rejected over the scope of “vegetative cells” but not “freeze-dried” forms). The claim-recited carriers are generic. Autotrophies as claimed are generic and of bacteria.
This judicial exception is not integrated into a practical application because claimed elements in combination do not add a meaningful limitation or extra-solution to the claimed product, and the claimed product as a whole is nothing more than an attempt to generally link the product of nature to a particular technological environment.
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception because when considered separately and in combination, they do not add significantly more (also known as an “inventive concept”) to the exception.
Response to Arguments
Applicant's arguments filed on 2/19/2026 have been fully considered but they are not all found persuasive.
The rejection of claims under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite, has been withdrawn in view of current claim amendment.
The deposit requirement has been met in the papers filed on 2/29/2026 (deposit statement and deposit receipts). Thus, the rejection of claims under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, has been withdrawn.
With regard to claim rejection under 35 U.S.C. 102 (a) (1) as being anticipated by US 8,906,668 (Henn et al) Applicant argues that the cited document does not discloses the presently claimed strains.
This argument is only persuasive with regard to the scope of pending claim 27 which is now limited to the specific novel strains that are isolated by Applicant (par. 0218 of published application) and deposited in ATCC such as Akkermansia sp. strain GGCC- 220 (ATCC PTA-126870) and Bacteroides xylanisolvens strain GGCC-0124 (ATCC PTA-126864). For this reason claim 27 is free from prior art.
However, the scope of pending claim 25 is broader and is drawn to the similar bacterial strains that have 97% sequence identity to the 16S rRNA of the clam-recited Akkermansia sp. strain GGCC- 220 (ATCC PTA-126870) and Bacteroides xylanisolvens strain GGCC-0124 (ATCC PTA-126864) but not the specific and particular strains Akkermansia sp. strain GGCC- 220 (ATCC PTA-126870) and Bacteroides xylanisolvens strain GGCC-0124 (ATCC PTA-126864).
Applicants admit there would be multiple different strains that share at least or more than 97% 16S identity (response page 12, par. 1). In fact, the cited US 8,906,668 (Henn et al) discloses that the SEQ ID NO: 119 is characterized by 98.5% identify to the claimed SEQ ID NO: 1 and is present in Akkermansia sp. In the disclosure of US 8,906,668 (Henn et al) the SEQ ID NO: 297 is characterized by 100% identify to the claimed SEQ ID NO: 3 and is present in Bacteroides sp. Thus, the disclosure of the cited patent is considered to anticipate the claimed scope.
With regard to claim rejection under 35 U.S.C. 101 Applicant argues that the claimed composition is not a natural composition of matter but a human-crafted composition that exhibits markedly different characteristics from their natural counterpart (that would be a fecal sample for isolation of bacteria, for example). However, nothing in the language of pending claim 25 indicates the features as argued since claimed bacterial strains and their forms (spores, vegetative cells) are natural. With regard to claim 36 it has been noted that this claim is/was rejected over the scope of “vegetative cells” but not “freeze-dried spore”. However, pending claims including claim 36 does explicitly recite “form of freeze-dried spores or freeze-dried vegetative cells” but allows to only natural “vegetative cells” by the virtue of alternative language “or”.
No claims are allowed.
Conclusion
THIS ACTION IS MADE FINAL. 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 VERA AFREMOVA whose telephone number is (571)272-0914. The examiner can normally be reached 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.
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Vera Afremova
June 23, 2026
/VERA AFREMOVA/ Primary Examiner, Art Unit 1653
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