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 .
Applicant’s amendment and remarks filed on 10/22/2025 are acknowledged. Claims 19-23 are cancelled. Claims 1-18 are pending.
Election/Restrictions
Applicant’s election without traverse of Group I and the species 5-dodecenoate in the reply filed on 10/22/2025 is acknowledged. Claims 15-18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention or species, there being no allowable generic or linking claim. The species 5-dodecenoate appears to be free of the prior art. Claims 1-14 are currently under examination.
Information Disclosure Statement
The information disclosure statements filed on 4/18/2023, 10/10/2024, and 12/16/2025 have been considered. Signed copies are enclosed.
Claim Objections
Claims 8 and 10 are objected to because of the following informalities: Claim 8 contains a misspelling of the name Bacteroides vulgatus and claim 10 contains a misspelling of the name Erysipelotrichaceae. Appropriate correction is required.
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 7 and 9-10 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 pre-AIA the applicant regards as the invention.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 7 recites the broad recitations Lachnospiraceae, Streptococcaceae, Pasteurellaceae, and Bacteroidaceae, and the claim also recites Streptococcus, Blautia, Haemophilus, Bacteroides, Roseburia, Fusicatenibacter, and Lachnospira which are narrower statements of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 9 recites the limitation "the bacterial species that is enriched in the sample" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 10 recites the broad recitations Lachnospiraceae, Bacteroidaceae, and Erysipelotrichaceae and the claim also recites Bacteroides, Blautia, Holdemania, and Faecalicatena which are narrower statements of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
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 1-3 and 12-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bartolucci et al (US Patent Application Publication 2018/0256601; IDS filed 10/10/2024).
The instant claims are drawn to methods of treating autism spectrum disorder by administering (i) a composition comprising a therapeutically effective amount of one or more metabolites selected from glutamate, malate, ursodeoxycholate, 5-dodecenoate, N-acetyl-L-glutamate, citrate, glycodeoxycholate, or carboxyethyl aminobutyric acid (CEGABA); or (ii) a composition comprising one or more bacterial species selected from Bifidobacterium bifidum, Eggerthella lenta, Eisenbergiella massilien, Prevotella copri, Romboutsia timonensis, Blautia wexlerae, Ruminiclostridium siraeum, Bacteroides intestinalis, Faecalicatena lactaris, Dialister invisus, or Ruminococcus callidus.
Bartolucci et al disclose methods of treating austism spectrum disorder by administering ursodeoxycholic acid (see paragraphs 0034). Additional metabolites and additional treatments can also be administered, including citrate (see paragraph 0114 and 0118-0125). The composition can be an oral liquid or tablet and can be administered in daily doses (see paragraph 0022 and 0093). The patient can be human and has been diagnosed with the condition (see paragraph 0021).
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.
Claims 1-3 and 11-14 are rejected under 35 U.S.C. 103 as being unpatentable over Bartolucci et al (US Patent Application Publication 2018/0256601; IDS filed 10/10/2024).
The instant claims are drawn to methods of treating autism spectrum disorder by administering (i) a composition comprising a therapeutically effective amount of one or more metabolites selected from glutamate, malate, ursodeoxycholate, 5-dodecenoate, N-acetyl-L-glutamate, citrate, glycodeoxycholate, or carboxyethyl aminobutyric acid (CEGABA); or (ii) a composition comprising one or more bacterial species selected from Bifidobacterium bifidum, Eggerthella lenta, Eisenbergiella massilien, Prevotella copri, Romboutsia timonensis, Blautia wexlerae, Ruminiclostridium siraeum, Bacteroides intestinalis, Faecalicatena lactaris, Dialister invisus, or Ruminococcus callidus.
Bartolucci et al disclose methods of treating austism spectrum disorder by administering ursodeoxycholic acid (see paragraphs 0034). Additional metabolites and additional treatments can also be administered, including citrate (see paragraph 0114 and 0118-0125). The composition can be an oral liquid or tablet and can be administered in daily doses (see paragraph 0022 and 0093). The patient can be human and has been diagnosed with the condition (see paragraph 0021). The patient may have autistic disorder, which is severe autism (see paragraph 0037 and 0042).
Bartolucci et al differs from the instant invention in that they do not use MARA to diagnose the autism as severe.
It would have been obvious to use the methods of Bartolucci et al to treat subjects with severe autism, as identified by MARA, because subjects with severe autism are in need of treatment regardless of how they are identified.
One would have had a reasonable expectation of success because Bartolucci et al disclosed treatment of subjects with severe autism using their methods. The efficacy of treatment would not change simply because a different method of identification was used.
Claims 1-8 and 11-14 are rejected under 35 U.S.C. 103 as being unpatentable over Bartolucci et al (US Patent Application Publication 2018/0256601; IDS filed 10/10/2024) in view of De Angelis et al (PLOS One, 8:e76993, 1-18, 2013).
The instant claims are drawn to methods of treating autism spectrum disorder by administering (i) a composition comprising a therapeutically effective amount of one or more metabolites selected from glutamate, malate, ursodeoxycholate, 5-dodecenoate, N-acetyl-L-glutamate, citrate, glycodeoxycholate, or carboxyethyl aminobutyric acid (CEGABA); or (ii) a composition comprising one or more bacterial species selected from Bifidobacterium bifidum, Eggerthella lenta, Eisenbergiella massilien, Prevotella copri, Romboutsia timonensis, Blautia wexlerae, Ruminiclostridium siraeum, Bacteroides intestinalis, Faecalicatena lactaris, Dialister invisus, or Ruminococcus callidus.
Bartolucci et al disclose methods of treating austism spectrum disorder by administering ursodeoxycholic acid (see paragraphs 0034). Additional metabolites and additional treatments can also be administered, including citrate (see paragraph 0114 and 0118-0125). The composition can be an oral liquid or tablet and can be administered in daily doses (see paragraph 0022 and 0093). The patient can be human and has been diagnosed with the condition (see paragraph 0021). The patient may have autistic disorder, which is severe autism (see paragraph 0037 and 0042).
Bartolucci et al differs from the instant invention in that they do not disclose detecting a dysbiosis with specific species as enriched or depleted in a sample from the subject.
DeAngelis et al disclose that autism is associated with autism and investigated the fecal microbiota of healthy and autistic individuals (see abstract and introduction). Roseburia intestinalis was found to be decreased in samples from autistic subjects and Bacteroides specie were found to be enriched in samples from autistic subjects (see Table 2). DeAngelis et al also disclose that, based on the microbiota alterations, dietary implementation with prebiotics and probiotics could be a useful tool to restore some microbial gaps (see page 15, column 2).
It would have been obvious to determine whether a dysbiosis exists in a subject being treated with the method of Bartolucci, including a depletion of Roseburia intestinalis and an enrichment of Bacteroides, because this would allow dietary alteration and implementation to restore microbial gaps.
One would have had a reasonable expectation of success because DeAngelis showed that various bacterial strains are depleted or enriched in subjects with autism and Bartolucci showed that autism could be treated using their method.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Brian J Gangle whose telephone number is (571)272-1181. The examiner can normally be reached M-F, 9-6:30.
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/BRIAN GANGLE/Primary Examiner, Art Unit 1645