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 .
DETAILED ACTION
Claims 1-3 and 5-7 are pending.
Applicant amended claim 1 and replaced the limitation “co-cultured” with “preadapted”. Applicant’s amendment does not overcome the objection or rejections of record.
Claim Objections
Claim 1 remains objected to because of the following informalities: “in vitro” in line 10 should be italicized. Appropriate correction is required.
Terminal Disclaimer
The terminal disclaimers filed on 06/12/2025 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of USPN 11,596,658, USPN 11,491,196, USPN 11,096,971, USPN 11,633,440 and reference application 17/386,266 have been disapproved.
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 1-3 and 5-7 remain rejected under 35 U.S.C. § 101 because the claimed invention is directed to laws of nature and natural phenomena without significantly more.
The claims recite laws of nature and product of nature. These judicial exceptions are not integrated into a practical application and the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception as explained below:
Subject Matter Eligibility Guidance
A three-step inquiry has been established to determine subject matter eligibility under 35 U.S.C. 101, in accordance with MPEP § 2106:
Step (1). Is the claim directed to a process, machine, manufacture, or composition of matter?
Step (2A). Is the claim directed to a law of nature, natural phenomenon (product of nature), or an abstract idea?
Prong 1 – Does the claim recite a law of nature, natural phenomenon, or an
abstract idea?
Prong 2 – If the claim recites a judicial exception, does it recite additional elements that integrate the judicial exception into a practical application?
Limitations that are indicative of integration into a practical application include:
Improvements to the functioning of a computer, or to any other technology or technical field. See MPEP § 2106.05(a)
Applying the judicial exception with, or by use of, a particular machine. See MPEP § 2106.05(b)
Effecting a transformation or reduction of a particular article to a different state or thing. See MPEP § 2106.05(c)
Applying or using a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition. See MPEP § 2106.05(d)
Applying or using the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception. See MPEP § 2106.05(e)
Step (2B). If the recited judicial exception is not integrated into a practical application, does the claim recite additional elements that amount to significantly different than the judicial exception such that they provide an inventive concept? This step includes evaluation of the same considerations under Step (2A), Prong 2, as well as two additional considerations:
Adding a specific limitation or combination of limitations that are not well-understood, routine, conventional activity in the field, which is indicative that an inventive concept may be present; and
Simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, which is indicative that an inventive concept may not be present.
Analysis
Step (1): The answer to this step is yes since claims 1-3 and 5-7 are directed to a composition of matter, which is a statutory category.
Step (2A): The answer to this step is yes because the claimed compositions are directed to laws of nature and natural phenomena, specifically naturally occurring microorganisms, cultures or fermented products of naturally occurring microorganisms, and polysaccharides produced by microorganisms.
Prong 1:
Product of Nature Definition
When a law of nature or natural phenomenon is claimed as a physical product, the courts have often referred to the exception as a "product of nature". See Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576, 580, 106 USPQ2d 1972, 1975 (2013); University of Utah Research Foundation v. Ambry Genetics, 774 F.3d 755, 758-59, 113 USPQ2d 1241, 1243 (Fed. Cir. 2014). As explained in those decisions, products of nature are considered to be an exception because they tie up the use of naturally occurring things, but they have been labeled as both laws of nature and natural phenomena. See Myriad Genetics, Inc., 569 U.S. at 590-91, 106 USPQ2d at 1979.
Claim Analysis
Independent claim 1 recites a composition, wherein the composition is formulated for intestinal delivery and comprises a functional microbial network, wherein the functional microbial network comprises at least 6 purified bacterial species comprising: Lactobacillus plantarum, Anaerostipes caccae, and Faecalibacterium prausnitzii, wherein the bacterial species have been preadapted in vitro for at least one day to form the functional microbial network, wherein the microbial network produces a higher amount of butyrate relative to an amount of both propionate and acetate together as determined based on molar percentage, compared to a composition comprising the bacterial species which has not been preadapted to form the functional microbial network, and wherein the composition is in the form of a capsule, tablet, microcapsule, granule, powder, troche, pill, or syrup. Applicant’s disclosure shows Lactobacillus plantarum, Anaerostipes caccae, Faecalibacteruim prausnitzii bacteria are found in the gut microbiome, a subgroup of bacterial species of the human gut microbiome (Specification [0027]). In addition, purifying the bacteria or forming them in a tablet or capsule does not change their characteristics compared to their non-purified counterparts. There is no change in any characteristic of the recited products compared to their naturally occurring counterparts and combining them into the recited composition does not change any of their natural characteristics individually or in combination. The claimed product lacks markedly different characteristics, and is a product of nature.
Claims 2 and 3 further limits claim 1 by reciting a SCFA producing bacteria, and wherein the at least one SCFA producing bacterial species further comprises Butyricicoccus pullicaecorum, Roseburia inulinivorans, Akkermansia muciniphila, or Roseburia hominis. These SCFAs producing bacteria are naturally occurring bacteria. There is no change in any characteristic of the recited products compared to their naturally occurring counterparts and combining them into the recited composition does not change any of their natural characteristics individually or in combination. The claimed product lacks markedly different characteristics, and is a product of nature.
Claims 5-7 do not further limit the composition of claim 1.
There is no evidence within the specification that the compositions claimed in claims 1-3 and 5-7 contain markedly different characteristics from their naturally occurring counterparts.
Therefore, the answer to step 2A prong 1 is yes.
Prong 2:
The Prong Two analysis considers the claim as a whole. That is, the limitations containing the judicial exception as well as the additional elements in the claim besides the judicial exception need to be evaluated together to determine whether the claim integrates the judicial exception into a practical application. The instant claims do not introduce any additional limitations which transform or improve on the judicial exceptions recited in claim 1 do not do anything beyond generally linking the use of the judicial exception to a particular technological environment. The claims are limited to only the judicial exceptions themselves. Moreover, the claims are drawn to a composition, and not a method of using the composition for any specific treatment, prophylaxis, etc.
Therefore, the answer to step 2A prong 2 is no.
Step (2B):
Claims 1-3 and 5-7 are limited to only the judicial exception formulated in a
generic composition using well-understood, routine, and conventional
techniques, which would not constitute significantly more than the judicial exception.
Therefore, the answer to step (2B) is no.
Conclusion
In view of the forgoing, claims 1-3 and 5-7 do not qualify as eligible subject matter under 35 U.S.C. § 101. Applicant may consider amending the claim to delete the capsule, microcapsule, granule, and powder limitations in order to obviate the rejection.
Claim Interpretation
The claims in this application are given their broadest reasonable interpretation:
Regarding claim 1, the recitation “wherein the composition is formulated for intestinal delivery” does not add any compositional or structural limitations to the claimed composition. It is a recitation of intended use and is not considered to contribute to the patentability of the claimed composition. See MPEP 2111.02.
Claim 1 recites “wherein the bacterial species have been preadapted in vitro for at least one day to form the functional microbial network, wherein the microbial network produces a higher amount of butyrate relative to an amount of both propionate and acetate together as determined based on molar percentage, compared to a composition comprising the bacterial species which has not been preadapted to form the functional microbial network”. This limitation is considered a product-by-process limitation (See MPEP 2113).
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.
The factual inquiries 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 nonobviousness.
Claims 1-3 and 5-7 remain rejected under 35 U.S.C. 103 as being unpatentable over Duncan (WO 2004/085628, of record in Office Correspondence mailed on 12/04/2023, hereinafter “Duncan”) in view of Marteau (Gut 62.12 (2013): 1673-1673, hereinafter “Marteau”, of record in Office Correspondence mailed on 01/17/2025) and Vesa (Alimentary pharmacology & therapeutics 14.6 (2000): 823-828, of record in Office Correspondence mailed on 01/17/2025).
Regarding claim 1, Duncan teaches a composition comprising at least Anaerostipes caccae and at least one lactic acid producing bacteria such as Lactobacillus spp. (claims 19-20, page 8 lines 6-12, page 23 Example 5). Duncan teaches the composition can comprise 6 bacteria (claims 19-20). Duncan teaches the strains are purified (page 12 lines 15-16). Duncan teaches co-culture with any one of lactate utilizers (such as Anaerostipes caccae), resulted in complete conversion of the L-lactate formed by the lactic acid producing bacteria, and some of the acetate into butyric acid, and this corresponded with greatly increased growth of the lactate utilizers (such as Anaerostipes caccae) (page 23 lines 31-32 through page 24 lines 1-6), and resulted in a higher amount of butyrate compared to a composition comprising the bacterial species having been cultured in vitro which have not been co-cultured (Fig. 2). Applicant defines preadapted as growing the bacteria together i.e., co-culturing (Specification [0019]). Duncan teaches F. prausnitzii is capable of utilizing lactate and acetate to produce formate and butyrate (Table 1 page 15 row 1). Duncan teaches composition comprises Lactobacillus spp. (claim 19). Duncan teaches composition is used for inflammatory bowel disorders (Abstract). Duncan teaches the composition can be in form in capsules (page 9 lines 22-25).
Marteau teaches butyrate-producing bacteria as pharmabiotics for inflammatory bowel disease (title) and teaches Eubacterium hallii, Anaerostipes caccae, and Escherichia coli are some of the endogenous butyrate-producing bacteria that use lactate as a substrate and they can be cross-fed by lactic acid bacteria which tend to co-occur with them such as bifidobacteria and lactobacilli (column 2 lines 21-28). Marteau teaches F. prausnitzii and Roseburia spp. as the major endogenous bacteria that produce butyrate (column 2 lines 29-31).
Duncan and Marteau do not teach the species Lactobacillus plantarum. However, Vesa teaches Lactobacillus plantarum is a lactic acid bacterium with high survival in the human gastrointestinal tract compared to other lactobacilli (Abstract). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the composition taught by Duncan by adding other butyrate producing bacteria such as F. prausnitzii and Roseburia spp. as suggested by Duncan and Marteau, and Lactobacillus plantarum as the lactobacillus strain as suggested by Vesa, with a reasonable expectation of success. One of ordinary skill in the art would be motivated to do so in order to produce a butyrate-producing composition for the treatment of inflammatory bowel disease, as suggested by Marteau, and to use strains capable of surviving for a long period in the human gastrointestinal tract, as suggested by Vesa
Regarding claim 2, Duncan teaches Anaerostipes caccae produces acetate and butyrate, and teaches the strain is co-cultured with B. adoloscentis L2-32 which produces formate and acetate (Fig 2).
Regarding claim 3, Marteau teaches subjects with inflammatory bowel disease (IBD) have lower fecal counts of Butyricicoccus pullicaecorum and teaches Butyricicoccus as a candidate for treatment of IBD (first column first para., last column first para.). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the composition taught by Duncan by adding Butyricicoccus pullicaecorum as suggested by Marteau. One of ordinary skill in the art would be motivated to do so in order to provide a composition for the treatment of IBD.
Regarding claim 5, Duncan teaches the composition can comprise 6 bacteria, which falls within the limitation of the instant claim of “at least 6 bacterial species” and up to 14 bacterial members (claims 19-20).
Regarding claims 6-7, Duncan teaches the viable counts (cfu/ml) after 24 hours growth for Ll-92 (A. caccae strain), SM 6/1 (Eubacterium hallii strain) and L2-7 (Eubacterium hallii strain) were, respectively, 1.7 x 109, 6.8 x 108 and 5.4 x 109, in the presence of B. adolescentis, and the growth of B. adolescentis was 4.3 x 108 cfu/ml, which falls within the limitation of the instant claims 6-7 of at least 105 colony forming units and 105 to 1011 colony forming units, respectively (page 24 lines 4-11).
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.
Claims 1-3 and 5-7 remain provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 30, 32, 35, and 39 of copending Application No. 17/386,266 (reference application) in view of Duncan.
Regarding instant claim 1, co-pending claim 30 recites a method for culturing a bacterial community, comprising: providing at least 3 bacterial species, wherein the bacterial species comprise: Lactobacillus plantarum; Anaerostipes caccae; and Faecalibacterium prausnitzii; and co-culturing the at least 3 bacterial species for at least one day, to form a functional microbial network, wherein when the functional microbial network is cultured in vitro it produces a higher amount of butyrate when measured by gas chromatography compared to an amount of butyrate generated by an equivalent amount of any one of the bacterial species alone. Co-pending claim 35 recites the bacterial members comprise up to 14 bacterial members. Co-pending claim 32 recites the bacterial species are isolated (i.e., purified). Co-pending claim 30 does not recite the composition is in the form of a capsule. However, Duncan teaches a composition comprising 6 bacterial species including A. caccae and Lactobacillus sp. and teaches the composition can be in form in capsules (page 9 lines 22-25). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the composition recited in co-pending claim 30 by encapsulating the composition as suggested by Duncan. One of ordinary skill in the art would be motivated to do so in order to facilitate the administration of the composition to a subject.
Regarding instant claims 2 and 3, co-pending claim 39 recite wherein the at least 3 bacterial species further comprise Butyricicoccus pullicaecorum, Roseburia inulinivorans, Akkermansia muciniphila, or Roseburia hominis.
Regarding instant claim 5, co-pending claim 35 recites the bacterial members comprise up to 14 bacterial members
Regarding instant claims 6-7, co-pending claim 30 does not recite an amount of bacteria. However, Duncan teaches the viable counts (cfu/ml) after 24 hours growth for Ll-92 (A. caccae strain), SM 6/1 (Eubacterium hallii strain) and L2-7 (Eubacterium hallii strain) were, respectively, 1.7 x 109, 6.8 x 108 and 5.4 x 109, in the presence of B. adolescentis, and the growth of B. adolescentis was 4.3 x 108 cfu/ml. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the composition recited in co-pending claim 30 by using an amount of 105 and 1011 colony forming units of bacteria as taught by Duncan, with a reasonable expectation of success. One of ordinary skill in the art would be motivated to do so in order to produce an effective composition with an acceptable number of bacteria.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-3 and 5-7 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of U.S. Patent No. 11,491,196 . Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated by the conflicting claims.
Regarding instant claims 1-3, patent claim 1 recites composition, wherein the composition is formulated for intestinal delivery and comprises a mixture of bacterial species that are purified and present in an effective amount for increasing butyrate when measured by gas chromatography after 48 hours of in vitro growth in a culture compared to measurement of butyrate generated by an equivalent amount of any one strain of the bacterial species alone, wherein the bacterial species comprise Lactobacillus plantarum; Anaerostipes caccae; and Faecalibacterium prausnitzii. Patent claim 8 recites the composition of claim 1, further comprising Butyricicoccus pullicaecorum, Roseburia inulinivorans, and Akkermansia muciniphila (i.e., at least 6 bacterial species and up to 14 bacterial species). Patent claim 2 recites the composition of claim 1, wherein the composition is in the form of a capsule.
Regarding instant claim 6, patent claim 3 recites the composition of claim 1, wherein the composition comprises at least 10^5 colony-forming units of bacteria.
Regarding instant claim 7, patent claim 4 recites the composition of claim 1, wherein the composition comprises 10^5 to 10^11 colony-forming units of bacteria.
Claims 1-3 and 5-7 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,096,971 in view of Duncan.
Regarding instant claims 1-3 and 5, patent claim 1 recites a method of treating a subject to reduce symptoms associated with a gastro-intestinal disorder, the method comprising administering to the subject a composition consisting of bacteria species Faecalibacterium prausnitzii, Butyricicoccus pullicaecorum, Roseburia inulinivorans, Roseburia hominis, Akkermansia muciniphila, Lactobacillus plantarum, and Anaerostipes caccae (i.e., at least 6 bacterial species and up to 14 bacterial species). Patent claim 1 does not recite the composition is in the form of capsule. However, Duncan teaches a composition comprising 6 bacterial species including A. caccae and teaches the composition can be in form in capsules (page 9 lines 22-25). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method recited in patent claim 1 by enclosing the composition is a capsule as suggested by Duncan. One of ordinary skill in the art would be motivated to do so for ease of administering the composition to a subject.
Regarding instant claims 6-7, patent claim 1 does not recite an amount of bacteria. However, Duncan teaches the viable counts (cfu/ml) after 24 hours growth for Ll-92 (A. caccae strain), SM 6/1 (Eubacterium hallii strain) and L2-7 (Eubacterium hallii strain) were, respectively, 1.7 x 109, 6.8 x 108 and 5.4 x 109, in the presence of B. adolescentis, and the growth of B. adolescentis was 4.3 x 108 cfu/ml. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the composition recited in patent claim 1 by using an amount of 105 and 1011 colony forming units of bacteria as taught by Duncan, with a reasonable expectation of success. One of ordinary skill in the art would be motivated to do so in order to produce an effective composition with an acceptable number of bacteria.
Claims 1-3 and 5-7 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4-8 of U.S. Patent No. 11,633,440 in view of Duncan.
Regarding instant claims 1-3 and 5, patent claim 1 recites pharmaceutical composition comprising a functional microbial network, wherein the functional microbial network comprises an effective amount of bacterial species isolated from one or more samples and co-cultured for at least 1 day, wherein when the functional microbial network is cultured in vitro it produces a higher amount of butyrate relative to an amount of both propionate and acetate together compared to a composition comprising the bacterial species cultured in vitro which have not been cocultured to form the functional microbial network, wherein relative amounts of butyrate, acetate, and propionate are determined based on molar percentage and wherein the bacterial species comprise at least three of the following: Lactobacillus plantarum, Anaerostipes caccae, Faecalibacterium prausnitzii, Butyricicoccus pullicaecorum, Roseburia inulinivorans, Akkermansia muciniphila, or Roseburia hominis. Patent claim 4 recites wherein the functional microbial network comprises bacterial species isolated from one or more fecal samples. Patent claim 5 recites wherein the functional microbial network comprises up to 14 bacterial species. Patent claim 6 recites wherein the bacterial species comprise the following: Lactobacillus plantarum, Anaerostipes caccae, Faecalibacterium prausnitzii, Butyricicoccus pullicaecorum, Roseburia inulinivorans, Akkermansia muciniphila, and Roseburia hominis. Patent claim 1 does not recite the composition is in the form of capsule. However, Duncan teaches a composition comprising 6 bacterial species including A. caccae and teaches the composition can be in form in capsules (page 9 lines 22-25). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method recited in patent claim 1 by enclosing the composition is a capsule as suggested by Duncan. One of ordinary skill in the art would be motivated to do so for ease of administering the composition to a subject.
Regarding instant claim 6, patent claim 7 recites wherein the functional microbial network comprises at least 10^5 colony-forming units of bacteria.
Regarding instant claim 7, patent claim 8 recites wherein the functional microbial network comprises 10^5 to 10^11 colony-forming units of bacteria.
Claims 1-3 and 5-7 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4-5 and 9 of U.S. Patent No. 11,596,658. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated by the conflicting claims.
Regarding instant claims 1-3 and 5, patent claim 1 recites pharmaceutical composition comprises a mixture of bacterial species that are purified and present in an effective amount for increasing butyrate when measured by gas chromatography after 48 hours of in vitro growth in a culture compared to measurement of butyrate generated by an equivalent amount of any one strain of the bacterial species alone, and wherein the mixture of bacterial species comprises: Lactobacillus plantarum; Anaerostipes caccae; and Faecalibacterium prausnitzii. Patent claim 9 recites the method further comprising Butyricicoccus pullicaecorum, Roseburia inulinivorans, and Akkermansia muciniphila. Patent claim 2 recites wherein the pharmaceutical composition is in the form of a capsule.
Regarding instant claim 6, patent claim 4 recites wherein the functional microbial network comprises at least 10^5 colony-forming units of bacteria.
Regarding instant claim 7, patent claim 5 recites wherein the functional microbial network comprises 10^5 to 10^11 colony-forming units of bacteria.
Response to Arguments
Applicant argues the claims relate to markedly different subject matter from the natural counterparts and are not a product of nature.
In response to the argument, the recited bacteria in the form of a powder, granule or capsule are a product of nature. Applicant may consider amending the claim to delete these formulations. The composition in the form of tablet, troche, pill or syrup is understood to contain non-natural components and thus it is not a product of nature.
The affidavit by Dr. Sam Possemiers under 37 CFR 1.132 filed 06/12/2025 is insufficient to overcome the rejection of claims 1-3 and 5-7 based upon obviousness in view of Duncan, Marteau and Vesa as set forth in the last Office action because:
Applicant argues the results show that a composition of purified Lactobacillus plantarum, Anaerostipes caccae, and Faecalibacterium prausnitzii bacteria demonstrates superior features for increasing butyrate levels when measured by gas chromatography after 48 hours of in vitro growth in a culture compared to measurement of butyrate generated by an equivalent amount of any one strain of the bacterial species alone or cumulatively.
Duncan teaches in Fig. 2 butyrate-producing strain A. caccae (L1-92) alone produced 1.5 mM butyrate. Lactate producer B. adolescentis (L2-32) did not produce any butyrate. However, when A. caccae is co-cultured with lactate producer B. adolescentis (L2-32), it produced 7.5 mM butyrate after 24 hours growth, a five-fold increase in butyrate production (page 44 Fig.2). Applicant defines preadapted as growing the bacteria together i.e., co-culturing (Specification [0019]). Duncan teaches Lactobacillus is a lactate producer. Duncan teaches F. prausnitzii is also capable of utilizing lactate to produce butyrate. Thus, the increase in butyrate production when co-culturing the butyrate-producing bacteria A. caccae or F. prausnitzii with a lactate producer such as Lactobacillus is not unexpected. In addition, Marteau teaches butyrate-producing bacteria Anaerostipes caccae use lactate as a substrate and it can be cross-fed by lactic acid bacteria such as lactobacilli (column 2 lines 21-28) and teaches F. prausnitzii is the major endogenous bacteria that produce butyrate (column 2 lines 29-31).
Applicant argues that neither Duncan, Marteau, nor Vesa, alone or in combination, teach or suggest a functional microbial network comprising at least 6 purified bacterial species, "wherein the bacterial species have been preadapted in vitro for at least one day to form the functional microbial network.
In response to the argument, Duncan teaches the composition can comprise 6 bacteria (claims 19-20) and teaches the strains are purified (page 12 lines 15-16). Duncan and Marteau teach co-culturing or co-feeding of butyrate producers such as A. caccae and lactate producers such as Lactobacilli increases the butyrate production as discussed above. Marteau teaches F. prausnitzii is the major endogenous bacteria that produce butyrate. Duncan teaches co-culturing A. caccae and lactate producer B. adolescentis (L2-32) produced 7.5 mM butyrate after 24 hours growth. Vesa teaches Lactobacillus plantarum is a lactic acid bacterium with high survival in the human gastrointestinal tract compared to other lactobacilli (Abstract)
One of ordinary skill in the art would be motivated to modify the composition taught by Duncan by adding F. prausnitzii due to its high production of butyrate, and lactobacillus plantarum due to its lactate production and high survival in the guts.
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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/LOUISE W HUMPHREY/Supervisory Patent Examiner, Art Unit 1657
/MARY A CRUM/Examiner, Art Unit 1657