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 1, 2, 12, as amended and new claims 43-53 as filed on 8/21/2025 are pending and under examination in the instant office action.
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, 2, 12, as amended and new claims 43-53 are rejected under 35 U.S.C. 103 as being unpatentable over US 2017/0042860 (Kashyap et al), WO 2013/037068 (Allen-Vercoe et al) and Stackebrandt et al (International Journal of Systematic Bacteriology, 1994, Vol. 44, No. 4, pages 846-849).
The cited document US 2017/0042860 (Kashyap et al) teaches a method of treating gastrointestinal disorders associated with alteration of levels of tryptamine and/or 5-hydroxytryptamine (5HT), wherein the method comprises a step of administering a mixed bacterial composition with at least one bacterial species having tryptophan decarboxylase activity (see entire document including abstract and par. 0009-0011, 0034) to a subject in need thereof; and wherein the subject in need thereof has an irritable bowel syndrome, an inflammatory bowel disease including an infectious colitis, an ulcerative colitis, a Crohn’s disease, an ischemic colitis, a radiation colitis, a microscopic colitis or a constipation (par.0045). The cited document US 2017/0042860 (Kashyap et al) recognizes that bacterial tryptophan decarboxylase provides for tryptamine and/or low 5-hydroxytryptamine (par. 0016-0019) that play important role in gastrointestinal health (par. 0008). The cited document teaches that administration of a composition with at least one bacterial species having tryptophan decarboxylase activity provides for improvement of gastrointestinal function (0045).
In particular, a therapeutic composition of the cited document US 2017/0042860 (Kashyap et al) comprises Clostridium sporogenes and Ruminococcus gnavus (0011, 0037, 0039), as well as Lachnospiraceae bacterium 2-1-58FAA and Blautia hansenii (par. 0027). Thus, as applied to the currently amended claim 1, the therapeutic composition of cited document US 2017/0042860 (Kashyap et al) comprises several bacterial species from the claimed group of “second bacterial species”. But the cited document US 2017/0042860 (Kashyap et al) is silent about administration of Clostridium aldenense as the claim-recited “first bacterial species” to the subject having an irritable bowel syndrome, an inflammatory bowel disease including an infectious colitis, an ulcerative colitis, a Crohn’s disease, etc.
However, the prior art, for example: the cited document WO 2013/037068 (Allen-Vercoe et al) teaches administration of a mixed composition with at least two and more bacterial species including Clostridium aldenense (see page 4, par. 3) to the subject having an irritable bowel syndrome, an inflammatory bowel disease including an infectious colitis, an ulcerative colitis, a Crohn’s disease, etc (see abstract and see page 5, last 3 lines). The other bacterial species in the mixed therapeutic composition of WO 2013/037068 (Allen-Vercoe et al) include claim-recited Bacteroides ovatus, Ruminococcus torques, Clostridium citroniae (page 4, par. 3).
Therefore, it would have been obvious to one having ordinary skill in the art at the time the claimed invention was filed to add a bacterial species belonging to Clostridium aldenense to a mixed therapeutic composition in the method of the cited document US 2017/0042860 (Kashyap et al) with a reasonable expectation of success in treating subjects having an irritable bowel syndrome, an inflammatory bowel disease including an infectious colitis, an ulcerative colitis, a Crohn’s disease, etc because a bacteria belonging to the bacterial species of Clostridium aldenense has been knonw and used for treating subjects having an irritable bowel syndrome, an inflammatory bowel disease including an infectious colitis, an ulcerative colitis, a Crohn’s disease as clearly taught by WO 2013/037068 (Allen-Vercoe et al) and because gastrointestinal disorders including an irritable bowel syndrome, an inflammatory bowel, ulcerative colitis, a Crohn’s disease are knonw to be associated with altered tryptophan levels in patients in need of such treatment. One of skill in the art would have been motivated to add a bacterial species belonging to Clostridium aldenense to a mixed therapeutic composition in the method of the cited document US 2017/0042860 (Kashyap et al) for additional therapeutic benefits suitable in treating patients with gastrointestinal disorders including an irritable bowel syndrome, an inflammatory bowel, ulcerative colitis, a Crohn’s disease that are knonw to be associated with altered tryptophan levels.
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.
With regard to claim-recited limitations drawn to identify of 16S rDNA sequences of claim-recited therapeutic bacteria, it is noted that the cited prior art recited bacterial species are the same as claimed, and that thrash hole identification on the level of bacterial species is 97% (see abstract of Stackebrandt). Thus, the cited prior art recited bacterial species are the same and/or substantially the same as encompassed by the claims (claims 1, 48-50) within the broadest meaning of the claims (claims 1, 48-50) as drawn to identification and/or characterization of bacterial representatives in the therapeutic composition.
Further, the cited document US 2017/0042860 (Kashyap et al) teaches administration of therapeutic mixed bacterial compositions in a form of capsules or powder (par. 0042), orally, with enteric coating for release in intestines (par. 0042) and with pharmaceutically acceptable carriers (par. 0042) including glycerol as cryoprotecting preservative (par. 0060). The cited document WO 2013/037068 (Allen-Vercoe et al) also teaches administration of therapeutic mixed bacterial compositions in a form of capsules, with enteric coating and pharmaceutically acceptable carriers including glycerol as cryoprotecting preservative (page 41) and by rectal colonoscopy or oral routes (page 6, par. 3).
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.
Response to Arguments
Applicant's arguments filed on 8/21/2025 have been fully considered but they are not all found persuasive with respect to the currently pending claims.
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 rejection of claims under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, (deposit requirement), has been withdrawn in view of current claim amendment.
The rejection of claim under 35 U.S.C. 102(a) (1) as being anticipated by US 2017/0042860 (Kashyap et al) because the cited refence does not describe administration of Clostridium aldenense in a combination with other gut bacteria.
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.
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Vera Afremova
December 1, 2025
/VERA AFREMOVA/ Primary Examiner, Art Unit 1653