DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Preliminary Amendments
1) Acknowledgment is made of Applicants’ preliminary amendments filed 02/17/26 and 10/19/23.
Election
2) Acknowledgment is made of Applicants’ election filed 02/17/26 in response to the species election requirement mailed 11/17/25. Applicants have elected the Blautia species belonging to Lachnospiraceae, the raffinose hydrolyzed element species, the tablet composition species, and the bloating condition species. Because Applicants did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (M.P.E.P § 818.03(a)).
Status of Claims
3) Claims 1-45 have been canceled via the preliminary amendment filed 10/19/23.
New claims 46-65 have been added via the preliminary amendment filed 10/19/23.
Claims 48 and 59 have been amended via the preliminary amendment filed 02/17/26.
Claims 46-65 are pending.
Claims 60 and 65 are withdrawn from consideration as being directed to a non-elected species. See 37 C.F.R 1.142(b) and M.P.E.P § 821.03.
Claims 46-59 and 61-64 are examined on the merits.
Information Disclosure Statement
4) Acknowledgment is made of Applicants’ information disclosure statement filed 09/23/24. The information referred to therein has been considered and a signed copy of the same is attached to this Office Action.
Priority
5) The instant AIA application, filed 10/08/2023, is the national stage 371 application of PCT/IB2022/053192 filed 04/06/22, which claims priority to the provisional application 63172735 filed 04/09/2021.
Rejection(s) under 35 U.S.C § 112(a) or (Pre-AIA ) First Paragraph
6) The following is a quotation of 35 U.S.C § 112(a):
(a) IN GENERAL.- The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of 35 U.S.C § 112 (pre-AIA ), first paragraph:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same and shall set forth the best mode contemplated by the inventor of carrying out the invention.
7) Claims 46-57 are rejected under 35 U.S.C § 112(a) or 35 U.S.C § 112 (pre-AlA), first paragraph, as containing subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed had possession of the claimed invention. This is a written description rejection.
The purpose of the written description requirement is “to ensure that the inventor had possession, as of the filing date of the application relied on, of the specific subject matter later claimed by him.” In re Edwards, 568 F.2d 1349, 1351-52, 196 USPQ 465, 467 (CCPA 1978). MPEP § 2163.02 states: ‘[a]n objective standard for determining compliance with the written description requirement is, ‘does the description clearly allow persons of ordinary skill in the art to recognize that he or she invented what is claimed’. The courts have decided:
The purpose of the “written description” requirement is broader than to merely explain how to “make and use”; the applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for the purposes of the “written description” inquiry, whatever is now claimed.
See Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Federal Circuit, 1991). The analysis of whether the as-filed specification complies with the written description requirements calls for the Office to compare the scope of the claims with the scope of the description to determine whether Applicant has demonstrated possession of the full scope of the claimed therapeutic method at the time of the invention. In the instant application, an analysis of the scope of the claims and of the variable genus claimed therein indicates the following.
The independent claim 46 is representative of the claimed invention. Claim 46 is drawn to a method of treating a condition caused by eating cruciferous vegetables or legumes, the method comprising administering to a subject in need thereof at least one microorganism of the class Clostridia. The microorganism administered in the method of the dependent claim 48 is a microorganism of the Lachnospiraceae family. While the elected species of said microorganism is Blautia in claim 49, the claim limitation ‘at least one microorganism of the class Clostridia’ in claim 46 and said microorganism of the Lachnospiraceae family in claim 48 each represents a huge genus encompassing limitless number of antigenically, genetically and functionally divergent species and strains, both live and dead, of the large Clostridia class and the large family of Lachnospiraceae including species and strains that are wild-type and genetically modified or engineered. The limitation “Blautia” also represents a genus encompassing a large number of antigenically, genetically and functionally divergent species. Each microorganism species within the broad genus is required to be an acetogen and hydrolyze raffinose per claims 50 and 51 respectively. Likewise, while the elected condition treated is bloating, the limitation “a condition caused by eating cruciferous vegetables or legumes” represents a huge genus encompassing a large number of medical or disease conditions. The term ‘administering’ encompasses oral, subcutaneous, sublingual, transmucosal, parenteral, intravenous, intra-arterial, buccal, sublingual, topical, vaginal, rectal, ophthalmic, otic, nasal, intramuscular, intraosseous, intrathecal, transdermal, inhalation, ingestion and combinations thereof as is indicated at section [0016] of the as-filed specification. However, at the time of the invention, Applicants were not in possession of a method as claimed broadly, wherein administering to a subject in need, by any route, a representative number and variety of at least one microorganism species of the large genus of Clostridia class, the genus of Lachnospiraceae family, and the large genus of Blautia, treated bloating or any other condition caused by eating any cruciferous vegetables or legumes in a human or non-human animal as claimed broadly.
The written description requirement can be met by describing the claimed subject matter to a person skilled in the art using sufficiently detailed, relevant identifying characteristics such as functional characteristics, and correlating those functional characteristics with a disclosed structure. See Enzo Biochem v. Gen-Probe, 323 F.3d 956, 964, 967, 968 (Fed. Cir. 2002). Sufficient description to show possession of a genus may be achieved by means of description of a substantial number of the members or species of the claimed genus, or alternatively describe a representative member of the claimed genus, which shares a particularly defining feature common to at least a substantial number of the members of the claimed genus, which would allow the skilled artisan to immediately recognize and distinguish its members from others, so as to reasonably convey to the skilled artisan that Applicant has possession the claimed invention. In the instant case, Applicants have not described a sufficient number and variety of the at least one Clostridial species and Lachnospiraceae family members, acetogens or non-acetogens, that are representative of the huge genus of antigenically, genetically, and functionally highly variable bacterial species and strains, each having the requisite cruciferous vegetables-consumption-caused or legumes-consumption-caused condition-treating or bloating condition-treating therapeutic effect(s) or functions. A representative number and variety of said at least one microorganism species within each of the claimed broad genus have not been correlated with the above-identified requisite therapeutic functions supra. Note that possession may not be shown by merely describing how to obtain members of the claimed genus or how to identify their common structural features. Applicants should note that written description requires more than a mere statement that something is a part of the invention and a reference to a potential method for isolating it. See Fiers v. Revel, 25 USPQ2d 1601, 1606 (CAFC 1993) and Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016. A mere statement that the invention includes the features recited in the claims is insufficient to meet the adequate written description requirement of the claimed invention. A convincing structure-function relationship must exist between the structure of a representative number and variety of the various microorganism species and the therapeutic function(s) of said species.
A review of the as-filed specification indicates that the scope of the instant claims is broader than that which is justified within the as-filed specification. The disclosure in the single Example of the as-filed specification is limited to a showing wherein, in order to mitigate the symptoms associated with raffinose intolerance, human subjects were administered orally with a probiotic pill comprising 109 CFU for 28 days of an unspecified acetogen from the class Clostridia having the ability to hydrolyze or consume raffinose along with providing, 24 h thereafter, a daily meal including 100 grams of baked beans, i.e. legumes. It is stated that said administration for 28 days reduced symptoms associated with raffinose intolerance compared to a corresponding control group administered with a placebo probiotic pill comprising only excipient. The specific acetogen microorganism species of the broad genus of the Clostridia class that hydrolyzed or consumed raffinose and reduced symptoms associated with raffinose intolerance is not identified. There is no evidence that the microorganism species administered to these human subjects is at least one species or strain of the Blautia genus having the capacity to hydrolyze raffinose and being an acetogen. This disclosure is insufficient to show possession of the full scope of the method of treating as claimed broadly. No part of the as-filed specification identifies the Blautia genus or any individual species thereof and correlated or ties it to the cruciferous vegetables-consumption-caused condition-treating or legumes-consumption-caused condition-treating or bloating condition-treating therapeutic effect(s). A representative number and variety of members within the class of Clostridia, the family of Lachnospiraceae, and the genus of Blautia have not been correlated with the above-identified requisite therapeutic or treating functions. In the instant case, a skilled artisan cannot immediately envision or recognize at least a substantial number of members of each of said genus, each having the recited requisite therapeutic function(s). A convincing structure-function correlation for the entire genus is lacking. This is important because the art strongly associates the Blautia genus with bowel symptoms especially diarrhoea in IBS. The art recognizes associations between bowel symptoms and diarrhea in IBS with increased abundance of Blautia. The family of Lachnospiraceae to which the genus of Blautia belongs has been observed to be associated with several diseases. See ‘Conclusion’, ‘Results’, and 2nd full paragraph under ‘Discussion’ of Brunkwall et al. J. Gastroenterol. Hepatol. 36: 174-180, 2021. Given what is known in the art, there is no predictability that any at least one microorganism of the large class of Clostridia and the large family of Lachnospiraceae including numerous species within the Blautia genus, when administered to a subject in need by oral or non-oral route, would elicit the requisite cruciferous vegetables-consumption-caused or legumes-consumption-caused condition-treating or bloating condition-treating therapeutic effect(s).
The written description inquiry is case- and context-specific. It “depend[s] on the nature of the claimed invention and the knowledge of one skilled in the art at the time an invention is made and a patent application is filed.” Ariad, 560 at 1372. A number of factors guide the inquiry, including “the existing knowledge in the particular field, the extent and content of the prior art, the maturity of the science or technology, and the predictability of the aspect at issue.” Ariad, 560 at 1372 [Emphasis added]. According to MPEP 2163:
The description needed to satisfy the requirements of (pre-AIA ) 35 U.S.C § 112 “varies with the nature and scope of the invention at issue, and with the scientific and technologic knowledge already in existence.” Capon v. Eshhar, 418 F.3d at 1357, 76 USPQ2d at 1084. Patents and printed publications in the art should be relied upon to determine whether an art is mature and what the level of knowledge and skill is in the art.
Evidence required to demonstrate possession of the invention is fact-specific and varies inversely with the maturity and predictability of the technology area. Inventions in “unpredictable” arts are subject to greater scrutiny under the written description requirement, and require a greater showing of possession than more predictable arts. In the instant application, this is important because there is no predictability that any at least one microorganism of the large class of Clostridia and the large family of Lachnospiraceae including numerous species within the Blautia genus, administered to a subject in need by oral or non-oral route, would elicit the requisite the cruciferous vegetables-consumption-caused or legumes-consumption-caused condition-treating or bloating-treating therapeutic effect(s). Note that for inventions in emerging and/or unpredictable technologies, or for inventions characterized by factors not reasonably predictable which are known to one of ordinary skill in the art, more evidence is required to show possession. Regents of the University of California v. Eli Lilly & Co., 119 F.3d 1559, 1568 (Fed. Cir. 1997), cert. denied, 523 U.S. 1089, 118 S. Ct. 1548 (1980) holds that an adequate written description requires ‘not a mere wish or plan for obtaining the claimed ……. invention.’ Clearly, in the instant case, Applicants did not describe the invention of the instant claims sufficiently to show that they had possession of the full breadth of the variable genus and the full scope of the method as claimed at the time of the invention.
To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. MPEP § 2163.02 states: ‘an objective standard for determining compliance with the written description requirement is, does the description clearly allow persons of ordinary skill in the art to recognize that he or she invented what is claimed’. The courts have decided that the purpose of the ‘written description’ requirement is broader than to merely explain how to ‘make and use’; the Applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. Again, the invention is, for purposes of the ‘written description’ inquiry, whatever is now claimed. See Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Federal Circuit, 1991). Furthermore, the written description provision of 35 U.S.C § 112(a) or 35 U.S.C § 112(pre-AIA ), first paragraph is severable from its enablement provision. Instant claims do not meet the written description provision of 35 U.S.C § 112(a) or (pre-AIA ), first paragraph.
Rejection(s) under 35 U.S.C § 101
8) 35 U.S.C § 101 states:
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.
9) Claims 58, 59 and 61-63 are rejected under 35 U.S.C § 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Instant claim 58 is directed to a composition comprising an effective dose of an organism within the class of Clostridia at a concentration of from about 1 to about 10% wt of the composition and a carrier. The microorganism in claim 59 is of the family of Lachnospiraceae, the elected species. Per claim 63, the organism is a vegetative cell. The organism in the composition of claim 61 is an acetogen and the microorganism in the composition of claim 62 is configured to hydrolyze raffinose. Because these elements are composed of matter, at least one embodiment encompassed within the broadest reasonable interpretation (BRI) of the instant claims is directed to a statutory category, i.e., a composition of matter (Step 1: YES). There is no indication within the as-filed application that the recited organism within the class of Clostridia, within the family of Lachnospiraceae, or within the genus of Blautia is modified either genetically or in any other way compared to its naturally occurring counterpart organisms. The Clostridia are known to occur naturally in various environments from the soil to the human gastrointestinal tract. Clostridia occur naturally in human microbiome representing 10%-40% of the total gut bacterial load. See 2nd full paragraph of the document by Dr. Jaime Cloyd, GI Health, Rupa Health, pages 1/8 to 8/8, 23 May 2023. This means that 10% of the faecal weight being Clostridia is well within the normal range for a healthy gut microbiome. See section ‘Typical Abundance’ on page 1 of the document entitled ‘Normal Presence of Clostridia in Human Faeces’, Copilot Search, pages 1-2 (No publication date). Thus, the claimed organism is a naturally occurring product. The claimed composition comprises a carrier, for example inert water, which is also a naturally occurring element. The acetogen and the raffinose hydrolyzing activities are the qualities or characteristics of the recited organism in the composition that are the handiwork of nature. Thus, for at least one embodiment encompassed within the broadest reasonable interpretation (BRI), the claimed organism or the composition do not display markedly different characteristics compared to the naturally occurring elements or counterparts. Accordingly, each component of the composition is a ‘product of nature’ exception, and the claims are directed to judicial exceptions (Step 2A Prong One: YES). Judicial exceptions include all natural products including those derived from natural sources such as naturally occurring microorganisms and other substances found in or derived therefrom, or from nature. The presence of naturally occurring judicial exceptions by themselves or with natural elements does not change it markedly significantly different and therefore does not make it subject matter eligible. Having a carrier with the recited organism does not integrate the judicial exception(s) into a practical application (Step 2A Prong Two: NO). There are no additional features in instant claims that would either integrate the judicial exceptions under Step 2A Prong 2, or add significantly more under Step 2B. The claims as a whole add nothing significant beyond the sum of their parts taken separately. Therefore, the claims are not directed to a patent eligible subject matter.
The rationale for this determination is formed in view of the 2019 PEG, the 2015 Update of the 2014 Interim Guidance on Patent Subject Matter Eligibility (79 FR 4618) (hereafter Interim Eligibility Guidance) dated 16 December 2014, the Life Sciences Examples issued in May 2016, and in view of Myriad v Ambry, CAFC 2014-1361, -1366, 17 December 2014. The unpatentability of laws of nature was confirmed by the U.S. Supreme Court in Mayo Collaborative Services v. Prometheus Laboratories, Inc., No. 10-1150 (March 20, 2012). The unpatentability of natural products was confirmed by the U.S. Supreme Court in Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. (June13, 2013).
Rejection(s) under 35 U.S.C § 112(b) or (Pre-AIA ) Second Paragraph
10) 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.
11) Claims 48-54, 58, 59 and 61-64 are rejected under 35 U.S.C § 112(b) or pre-AIA , second paragraph, as being indefinite, for failing to particularly point out and distinctly claim the subject matter which inventor or a joint inventor, or for the pre-AIA the Applicants regard as the invention.
(a) Claims 50 and 52 are ambiguous and indefinite for having improper antecedence in the limitation “said organism”. These claims depend from claim 46, which does not include any recitation of an “organism”.
(b) Claims 48, 49 and 54 are ambiguous and indefinite in the limitation “said microorganism”. Claims 48 and 54 depend from claim 46, which includes the recitation of “at least one microorganism”. For proper antecedence and for the purpose of distinctly claiming the subject matter, it is suggested that Applicants replace the above-identified limitation with --said at least one microorganism--.
(c) Claim 51 is ambiguous and indefinite in the limitation “the microorganism”. Claim 51 depends from claim 46, which includes the recitation of “at least one microorganism”. For proper antecedence and for the purpose of distinctly claiming the subject matter, it is suggested that Applicants replace the above-identified limitation with --the at least one microorganism--.
(d) Claim 58 is indefinite and internally inconsistent in the limitations “an organism” of broader scope in line 1 and said “microorganism” of narrower scope in line 2. For proper antecedence and for the purpose of distinctly claiming the subject matter, it is suggested that Applicants replace the limitation “an organism” in line 1 with --a microorganism-- along with the replacement of the limitation “said organism” in line 1 of the dependent claims 51 and 53 with the limitation --said microorganism--.
(e) Claim 58 is ambiguous and indefinite for having improper antecedence in the limitation “said microorganism” in line 2. There is no prior recitation in the claim of a microorganism. For proper antecedence and for the purpose of distinctly claiming the subject matter, it is suggested that Applicants replace the limitation “an organism” in line 1 with --a microorganism--.
(f) Claims 59 and 61-64, which depend from claim 58, are also rejected as being indefinite due to the indefiniteness identified supra in the base claim 58.
Notice Re Prior Art Available under Both Pre-AIA and AIA
In the event the determination of the status of the application as subject to AIA 35 U.S.C § 102 and 35 U.S.C § 103 (or as subject to pre-AIA 35 U.S.C § 102 and 35 U.S.C § 103) is incorrect, any correction of the statutory basis 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.
Rejection(s) under 35 U.S.C § 102
12) 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
13) Claims 46-48 and 50-57 are rejected under 35 U.S.C § 102(a)(1) and 35 U.S.C § 102(a)(2) as being anticipated by WO 2021044376 A1 (WO ‘376, Applicants’ IDS) as evidenced by the reference of Antonella Dewell entitled Low FODMAP Beans: Your Complete Guide to Enjoying Legumes Without IBS Symptoms, pages 1/16 to 16/16, 07/21/2025 ;and Hasler WL (Gastroenterology 21: 689-707, 2007).
WO ‘376 disclosed a pharmaceutical preparation (composition) comprising a carrier, prebiotics, and a live vegetative culture of at least one Clostridium or Blautia for use in the treatment of bloating including bloating associated with Irritable Bowel Syndrome (IBS) in an animal and a method of daily oral administration of an effective dose of the composition to the animal including a human patient. The animal administered with the composition included a dog, cat, sheep, horse, cattle, swine, or goat, i.e., domestic or farm animal. The pharmaceutical preparation is provided in the form of a tablet. See sections [0024], [0019], [0025], [0012], [0022], [0064], [0083] to [0086], [0103]. [0091], [0104], [00107], and [0109]; and claims 5-6, 8, 30, 18-29 and 1. The prior art method of treating bloating in IBS via the administration of said pharmaceutical preparation (composition) comprising a carrier and a live vegetative culture of at least one Clostridium or Blautia is expected to treat bloating caused by eating legumes since bloating in IBS is known to be caused notoriously by beans and legumes due to poor absorption of certain carbohydrates as disclosed by Antonella Dewell in the document entitled “Low FODMAP Beans: Your Complete Guide to Enjoying Legumes Without IBS Symptoms, pages 1/16 to 16/16, 07/21/2025 (see lines 8-9 on page 2/16) and since undigestible raffinose oligosaccharide is known to be abundant in legumes, beans and brussels sprouts as disclosed by Hasler WL (see 2nd full paragraph on page 693; Table I). The acetogen and raffinose-hydrolyzing activities are the inherent characteristics intrinsic to the prior art bloating-treating live vegetative cells of Clostridium or Blautia genus and are inseparable therefrom absent evidence to the contrary. Since the Office does not have the facilities for examining and comparing Applicants’ method with that of the prior art method, the burden is on the Applicants to show a novel or an unobvious difference between the instantly claimed method and the prior art method. See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzerald et al., 05 USPQ 594. Note that as long as there is evidence establishing inherency, failure of those skilled in the art to contemporaneously recognize an inherent property, function, or ingredient of a prior art reference does not preclude a finding of anticipation. Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1349, 51 USPQ2d 1943, 1948 (Fed. Cir. 1999).
Claims 46-48 and 50-57 are anticipated by WO ‘376. The reference by Antonella Dewell and the reference of Hasler WL are not used as secondary references in combination with WO ‘376, but rather are used to show that every element of the claimed subject matter is disclosed by WO ‘376 with the unrecited limitation(s) being inherent as evidenced by the state of the art. See In re Samour 197 USPQ (CCPA 1978). Note that the critical date of the extrinsic evidence need not antedate the filing date. See MPEP 2124.
Rejection(s) under 35 U.S.C § 103
14) 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 of this title, 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 claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 148 USPQ 459, that are applied 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 unobviousness.
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 at the time any inventions covered therein were effectively filed 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 at the time a later invention was effectively filed 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.
15) Claims 58, 59 and 61-64 are rejected under 35 U.S.C § 103 as being unpatentable over WO 2021044376 A1 (WO ‘376, Applicants’ IDS) as evidenced by the reference of Antonella Dewell entitled Low FODMAP Beans: Your Complete Guide to Enjoying Legumes Without IBS Symptoms, pages 1/16 to 16/16, 07/21/2025; and Hasler WL (Gastroenterology 21: 689-707, 2007).
The disclosure of WO ‘376 is set forth supra which is silent on the percent weight concentration of the Clostridium genus in the composition as claimed in claim 58.
However, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant application to arrive at a percent weight concentration falling in the recited broad range of about 1 to about 10% of the total composition through routine standardization and optimization since doing so was well within the realm of routine experimentation. It is considered routine to experiment with the percent wt concentration ranges of the microorganism in a composition. Moreover, the instant specification does not provide any examples or demonstrate any technical effect or advantage associated with the claimed composition wherein the Lachnospiraceae microorganism is present in the recited concentration range. Therefore, in the absence of a surprising effect or technical advantage across the full scope of the claims, the claimed composition is considered merely an alternative in the art that a person skilled in the art would achieve through routine testing and optimization.
Claims 58, 59 and 61-64 are prima facie obvious over the prior art of record.
Claim(s) Objection(s) - Suggestion(s)
16) Claims 46 and 49 are objected to for the following reason(s):
(a) Claim 49 is objected to for the incorrect or confusing recitation: selected from the group consisting of “as” ........ Blautia”. See line 2. The purpose of the term “as” in the claim is not understood.
(b) Claim 49 is further objected to for the non-italicized recitation “Blautia”. To be consistent with the practice in the art of scientific nomenclature of bacteria, it is suggested that Applicants delete the above-identified limitation via strikethrough, Blautia and replace it with the italicized limitation –Blautia-- with underlining.
(c) Claim 46 is objected to for the limitation “class clostridia” which is inconsistent with the correct recitation --class Clostridia-- in claim 58.
Conclusion
17) No claims are allowed.
Correspondence
18) Any inquiry concerning this communication or earlier communications from the Examiner should be directed to S. Devi, Ph.D., whose telephone number is (571) 272-0854. A message may be left on the Examiner’s voice mail system. The Examiner is on a flexible work schedule, however she can normally be reached Monday to Friday from 8.00 a.m. to 4.00 p.m. (EST). If attempts to reach the Examiner by telephone are unsuccessful, the Supervisor of AU 1645, Daniel E. Kolker, can be reached at (571) 272-3181. The fax phone number for the organization where this application or proceeding is assigned (571) 273-8300.
19) Information regarding the status of an application may be obtained from Patent Center. Status information for unpublished applications is available through Patent Center or Private PAIR to authorized users only. Should you have questions about access to Patent Center or the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, Applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
/S. DEVI/
S. Devi, Ph.D.Primary Examiner
Art Unit 1645
April, 2026
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