DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Election/Restrictions
Applicant’s election without traverse of the Group I, claims 28-36, in the reply filed on 5/15/2026 is acknowledged.
Claims 37-47 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on5/15/2026.
Applicant’s election of the species “representatives of the genus Prevotella” in the reply filed on 5/15/2026 is acknowledged.
Claims 28-36 are under examination to the extent of the claimed scope as encompassing the use of the species “representatives of the genus Prevotella”.
Claim Objections
Claims 28-36 are objected to because of the following informalities:
Latin name of microorganisms should be italicized. Spelling of some names contain typing errors.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
Claims 28-36 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.
Claim 28, line 3, recited “a relative abundance” of Prevotella (step a). This is a relative term which renders the claim indefinite because it is unclear to what entity abundance of Prevotella is compared unlike, for example: step b), wherein “a lower relative abundance” of Prevotella in the subject having ASD is compared to a neurotypical person. The term/phrase in step a) is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Claim 29 recites the limitation "the relative abundance”. There is insufficient antecedent basis for this limitation in the claim because the prior claim 29 recites two “relative” abundance(s). Same rejection is applied to claim 34.
Claims 30 is rendered indefinite by the phrase “at least two” because it is uncle if two refers to 2 representatives of genus Prevotella or detection twice in at least 2 samples or to Prevotella plus unelected “species”. It is suggested to at least delete unelected “Coprococcus, Prevotellaceae, Veollonellacea” .
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent.
Claims 28-34 and 36 are rejected under pre-AIA 35 U.S.C. 102(a) (1) as being anticipated by US 9,707,207 (Finegold).
The cited by US 9,707,207 (Finegold) teaches a method of treating gut microbial imbalance or overgrowth of undesired gut microflora in a subject having autism (see entire document including abstract and col. 1, lines 16-18; col. 2, line 9), wherein the cited method comprises steps of
a) determining abundance of bacterial species including Prevotella in fecal samples from human subjects (whole example 4 including col. 22, line 31 and table 9 at col. 31);
b) identifying the subject as having an imbalance of microbiome in the gut, if the subject is determined to have a lower relative abundance of Prevotella compared to a neurotypical person or normal sibling of autistic subject (table 9, last line); and
c) administering to the autistic subject a probiotic therapy comprising Prevotella (col. 10, lines 26-36; col. 48, lines 32-33).
Thus, the cited US 9,707,207 (Finegold) is considered to anticipated claim 28.
As applied to claims 29-33: the cited method comprises steps of detection of bacterial population including Prevotella in feces of autistic and control individuals by subjecting a nucleic acid from the samples to genotyping assay using sequencing primers (see example 4, see col. 23, line 7), wherein sequencing run was performed multiple times (col. 23, lines 8), thereby, sequencing with a “deep sequencing techniques” within the broadest meaning of the claims and in the light of specification (par. 0081 of published application US 2025/0027172). The nucleic acids to be sequenced are bacterial 16S rRNA genes (col. 19, line 51).
As applied to claim 34: the cited method comprises detection or identification of bacteria in the samples as intended for determination of relative microbial abundance in the subject with autism by protein assays such as detection of soluble proteins or antigens (col. 20, lines 23-25).
As applied to claim 36: the cited method comprises steps of administering an agent to inhibit growth of abnormal microorganisms (col. 2, lines 53-55) or ones having a higher relative abundance in the microbiome of autism spectrum disorder subjects compared with the microbiome of neurotypical subjects.
Thus, the cited US 9,707,207 (Finegold) is considered to anticipated claimed invention.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 28-36 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over US 9,707,207 (Finegold) in view of Wybo et al (“Species identification of clinical Prevotella isolates by Matrix-Assisted Laser Desorption Ionization Time of Flight Mass Spectrometry”. Journal of Clinical Microbiology, 2012, Vol. 50, No. 4, pages 1415-1418).
The cited US 9,707,207 (Finegold) teaches a method of treating gut microbial imbalance or overgrowth of undesired gut microflora in a subject having autism (see entire document including abstract and col. 1, lines 16-18; col. 2, line 9), wherein the cited method comprises steps of identifying the subject as having an imbalance of microbiome in the gut, if the subject is determined to have a lower relative abundance of Prevotella compared to a neurotypical person or normal sibling of autistic subject (table 9, last line); and administering to the autistic subject a probiotic therapy comprising Prevotella (col. 10, lines 26-36; col. 48, lines 32-33). The identification of microbiome bacteria is done by sequencing techniques and by protein assays involving antibodies.
The cited document is silent about at least one specific protein assays of claim 35.
However, the prior art teaches the use of proteins assay such as MALDI TOF-MS for identification of Prevotella, for example: see abstract of Wybo.
Therefore, it would have been obvious to one having ordinary skill in the art at the time the claimed invention was filed to apply various prior techniques for identification of fecal bacteria including Prevotella in the method of US 9,707,207 (Finegold) including protein assays such as MALDI TOF-MS with a reasonable expectation of success detecting presence and identifying relative abundance of fecal bacteria including Prevotella because the use of proteins assay such as MALDI TOF-MS for identification of Prevotella has been knonw and used in prior art applications.
Thus, the claimed invention as a whole was clearly prima facie obvious, especially in the absence of evidence to the contrary.
The claimed subject matter fails to patentably distinguish over the state art as represented be the cited references. Therefore, the claims are properly rejected under 35 USC § 103.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
A. Claims 28-36 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of US 9,719,144 (Krajmalnik-Brown et al).
Although the claims at issue are not identical, they are not patentably distinct from each other because they are directed to similar methods for treating patients including patients with autism, wherein the methods comprise:
a) determining the abundance of a Prevotella species including relative abundance Prevotella in a fecal microbiota from a human subject having autism (pending claim 28 and issued claim 1); and
b) administering to said subject a pharmaceutical composition comprising a probiotic Prevotella to the subject (pending claim 1 and issued claim 1).
Both methods encompass determining abundance of Prevotella species by using 16S rRNA (pending claims 29-33 and issued claims 5 and 13) and protein assays (pending claims 35 and issued claim 10).
Accordingly, the claimed methods in the issued patent and in the present application are obvious variants.
Therefore, the inventions as claimed are co-extensive.
B. Claims 28-36 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of US 11,542,560 (Krajmalnik-Brown et al).
Although the claims at issue are not identical, they are not patentably distinct from each other because they are directed to similar methods for treating patients including patients with autism, wherein the methods comprise:
a) determining the abundance of a Prevotella species including relative abundance Prevotella in gut or fecal microbiota of subject with autism and neurotypical subjects (pending claim 28 and issued claims 1 and 12); and
b) administering to said subject a pharmaceutical composition comprising a probiotic Prevotella to the subject (pending claim 28 and issued claims 1 and 12).
Accordingly, the claimed methods in the issued patent and in the present application are obvious variants.
Therefore, the inventions as claimed are co-extensive.
C. Claims 28-36 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of US 12,084,727 (Krajmalnik-Brown et al).
Although the claims at issue are not identical, they are not patentably distinct from each other because they are directed to similar methods for treating patients including patients with autism, wherein the methods comprise:
a) determining the abundance of a Prevotella species in gut or fecal microbiota of subject with autism (pending claim 28 and issued claim 1);
b) identifying the subject as having an imbalance of microbiome in the gut, if the subject is determined to have a lower relative abundance of Prevotella compared to a neurotypical person or normal sibling of autistic subject (pending claim 28 and issued claim 1); and
c) administering to said subject a pharmaceutical composition comprising a probiotic Prevotella to the subject (pending claim 28 and issued claim 1).
Both methods encompass determining and/or identifying Prevotella species by using 16S rRNA (pending claims 29-33 and issued claim 6).
Accordingly, the claimed methods in the issued patent and in the present application are obvious variants.
Therefore, the inventions as claimed are co-extensive.
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 Monday-Friday: 8.30am-5pm EST.
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Vera Afremova
July 17, 2026
/VERA AFREMOVA/ Primary Examiner, Art Unit 1653
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