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 .
Claims 1-20 are pending in this application and are being examined.
Claim Rejection - 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, 6, 7 and 10-15 are rejected under 35 U.S.C. 101 because;
The claimed invention is directed to a judicial exception, i.e., a natural product without significantly more. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
According to Section I of the 2019 Revised Patent Subject Matter Eligibility Guidance, “the judicial exceptions are for subject matter that has been identified as the ‘‘basic tools of scientific and technological work,’’ which includes ‘‘abstract ideas’’ such as mathematical concepts, certain methods of organizing human activity, and mental processes; as well as laws of nature and natural phenomena”, and “the USPTO has set forth a revised procedure, rooted in Supreme Court caselaw, to determine whether a claim is ‘‘directed to’’ a judicial exception under the first step of the Alice/Mayo test (USPTO Step 2A).” (Also see “2019 Revised Patent Subject Matter Eligibility Guidance, Federal Register / Vol. 84, No. 4 / Monday, January 7, 2019 / Notices, p. 50-57”).
Step 2A asks: Is the claim directed to a law of nature, a natural phenomenon (product of nature) or an abstract idea? In the context of the flowchart in MPEP § 2106, subsection III, Step 2A determines whether:
• The claim as a whole is not directed to a judicial exception (Step 2A: NO) and thus is eligible at Pathway B, thereby concluding the eligibility analysis;
or
• The claim as a whole is directed to a judicial exception (Step 2A: YES) and thus requires further analysis at Step 2B to determine if the claim as a whole amounts to significantly more than the exception itself.
Step 2A is a two-prong inquiry, in which examiners determine in Prong One whether a claim recites a judicial exception, and if so, then determine in Prong Two if the recited judicial exception is integrated into a practical application of that exception.
Claims 1-3, 6, 7 and 10-15 read:
1. A composition comprising a bacterial community wherein the bacterial community comprises a purified bacterial strain of each of: Clostridium hiranonis; and any one or more of Bacteroides thetaiotaomicron, Bacteroides uniformis, Phocaeicola vulgatus, Clostridium scindens, Collinsella aerofaciens, and Desulfovibrio piger.
2. The composition of claim 1,wherein the bacterial community comprises a purified bacterial strain of each of: Clostridium hiranonis; and any one or more or two or more of Phocaeicola vulgatus, Clostridium scindens, Collinsella aerofaciens, and Desulfovibrio piger.
3. The composition of claim 1, wherein the bacterial community comprises a purified bacterial strain of each of Clostridium hiranonis, Clostridium scindens, and Desulfovibrio piger.
6. The composition of claim 1,wherein one or more of the purified bacterial strains are in spore form.
7. The composition of claim 1,wherein one or more of the purified bacterial strains are in vegetative form.
10. The composition of claim 1,wherein the bacterial community inhibits C. difficile toxin production.
11. The composition of claim 1,wherein the bacterial community inhibits C. difficile replication and/or survival.
12. The composition of claim 1,wherein the composition is in the form of a pharmaceutical composition comprising the bacterial community in combination with a pharmaceutically acceptable excipient.
13. The composition of claim 12, wherein the composition is formulated for oral or rectal delivery.
14. The composition of claim 12, wherein the composition is formulated for delivery to the intestine or the colon.
15. The composition of claim 1,wherein the composition is in the form of a food product comprising the bacterial community and a nutrient.
Claims 1- ?? are drawn to composition comprising a bacterial community wherein the bacterial community comprises a purified bacterial strain of each of: Clostridium hiranonis; and any one or more of Bacteroides thetaiotaomicron, Bacteroides uniformis, Phocaeicola vulgatus, Clostridium scindens, Collinsella aerofaciens, and Desulfovibrio piger.
The broadest reasonable interpretation of instant claims 1-3, 6, 7, and 10-15 include bacteria of Clostridium hiranonis; and any one or more of Bacteroides thetaiotaomicron, Bacteroides uniformis, Phocaeicola vulgatus, Clostridium scindens, Collinsella aerofaciens, and Desulfovibrio piger, which are naturally occurring members of microbiota, i.e., Clostridium hiranonis and Bacteroides thetaiotaomicron members of gut community (See for example, p. 3 figure 1B, phylogenetic tree of gut community, of Hromada et al., Mol Syst Biol. 2021 Oct;17(10):e10355, p. 1-19, which is also cited in IDS filed on 08/4/2026).
Thus, the claims as a whole are directed to a judicial exception.
In addition, there is no evidence of any markedly different functional characteristic other than the inherent natural functions or properties of the claimed bacteria, in this case, inhibition C. difficile replication and/or survival, and inhibition of C. difficile toxin production (claims 10 and 11), and forming spore and vegetative cells (claims 6 and 7), are inherent natural functions or properties of the claimed bacteria. Therefore, claims as a whole do not amount to significantly more than the exception itself (Answer to Step 2B: No).
As indicated above, step 2A is a two-prong inquiry, in which examiners determine in Prong One whether a claim recites a judicial exception, and if so, then determine in Prong Two if the recited judicial exception is integrated into a practical application of that exception.
In this case, there is no additional elements recited in the claims 12-15, and the phrase “is in the form of a pharmaceutical composition comprising the bacterial community in combination with a pharmaceutically acceptable excipient” (claim 12), and formulated for oral or rectal delivery (claim 13), formulated for delivery to the intestine or the colon (claim 14), and in the form of a food product comprising the bacterial community and a nutrient (claim 15), are specified at a high level of generality, and thus are not considered ‘significantly more’ than the judicial exception.
In addition, purifying bacteria strain does not improve the judicial exception or do not use the judicial exception in a particular technological environment such that the claim as a whole is more than a drafting effort designed to monopolize the exception.
Therefore, claims 1-3, 6, 7 and 10-15 do not integrate the judicial exception into a practical application of that exception (Answer to Step 2A Prong Two: No).
In Funk Brothers the Supreme court concluded that naturally-occurring bacteria, isolated from their natural surroundings, was not patent eligible: “[t]he qualities of these bacteria, like the heat of the sun, electricity, or the qualities of metals, are part of the storehouse of the knowledge of all men…manifestations of laws of nature, free to all…and reserved exclusively to none…” the qualities of the bacteria being “.. the work of nature…unaltered by the hand of man.”.
Therefore, the subject matter of claims 1-3, 6, 7 and 10-15 as a whole is not directed to patent eligible subject matter.
Claim Rejection - 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 9-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hromada et al. (Mol Syst Biol. 2021 Oct;17(10):e10355, p. 1-19, which is also cited in IDS filed on 08/4/2026).
Regarding claim 1, Hromada et al. disclose a composition comprising a bacterial community wherein the bacterial community comprises a purified bacterial strain of each of: Clostridium hiranonis; and any one or more of Bacteroides thetaiotaomicron, Bacteroides uniformis, Phocaeicola vulgatus, Clostridium scindens, Collinsella aerofaciens, and Desulfovibrio piger (a synthetic composition comprising Clostridium hiranonis and any one or more of Bacteroides thetaiotaomicron) (See for example, p. 3 Figure 2B and related description and right-hand column).
Regarding claim 2, Hromada et al. disclose the bacterial community comprises a purified bacterial strain of each of: Clostridium hiranonis; and any one or more or two or more of Phocaeicola vulgatus, Clostridium scindens, Collinsella aerofaciens, and Desulfovibrio piger (a synthetic composition comprising Clostridium hiranonis and Phocaeicola vulgatus) (See for example, p. 3 Figure 2B and related description and right-hand column).
Regarding claim 3, Hromada et al. disclose the bacterial community comprises a purified bacterial strain of each of Clostridium hiranonis, Clostridium scindens, and Desulfovibrio piger (a synthetic composition comprising Clostridium hiranonis and Desulfovibrio piger ) (See for example, p. 3 Figure 2B and related description and right-hand column).
Regarding claim 9, Hromada et al. disclose the bacterial community comprises bacterial strains purified from different sources (cultured fecal samples are used) (See for example. p. 12 left-hand column “Discussion”).
Regarding claims 10 and 11, Hromada et al. disclose the bacterial community inhibits C. difficile replication and/or survival, and inherently disclose the bacterial community inhibits C. difficile toxin production, since toxin is produced by growing cells (C. difficile was inhibited by all community members, and abundance of C. difficile was reduced) (See for example, p. 12 left-hand column last paragraph, and p. 3 both columns below figure 1 and its description).
Hromada et al. therefore anticipate the claimed composition.
Claim Rejection - 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 1-26 are rejected under 35 U.S.C. 103 as being unpatentable over Hromada et al. as applied to claims 1-3 and 9-11 above, and further in view of Reygner et al. (Gut Microbes. 2020 Sep 2;11(5):1405-1422) and Cook et al. (U.S. Patent No. 9,956,282 B2).
The teachings of Hromada et al. with respect to the limitations of claims 1-3 and 9-11 were discussed above.
Hromada et al. do not teach the composition is devoid of any bacterial strains of B. hydrogenotrophica, E. lenta, or B. hydrogenotrophica and E. lenta (claim 4), the composition is devoid of any bacterial strains of Clostridium hathewayi, Blautia hansenii, …, at least 53, or each of the foregoing. (claim 5), the one or more of the purified bacterial strains are in spore form (claim 6), one or more of the purified bacterial strains are in vegetative form (claim 7), each of the purified bacterial strains is lyophilized (claim 8), the composition is in the form of a pharmaceutical composition comprising the bacterial community in combination with a pharmaceutically acceptable excipient (claim 12), the composition is formulated for oral or rectal delivery (claim 1), the composition is formulated for delivery to the intestine or the colon (claim 14), the composition is in the form of a food product comprising the bacterial community and a nutrient (claim 15), therapeutically effective amount (claim 16), wherein the subject is an asymptomatic C. difficile carrier (claim 17), the subject is administered one or more doses of an antibiotic prior to administration of the composition (claim 18), the subject has not been administered an antibiotic prior to administration of the composition (claim 19), and the composition is administered to the subject by oral administration or rectal administration (claim 20)
However, regarding claims 4-5, Hromada et al. teach the design of the bacterial community can be optimized to treat C. difficile infection and inhibit C. difficile (see for example, p. 12 left-hand column “Discussion”). As such, the type of bacterial strain(s) not included in the bacterial community in the composition taught by Hromada et al. would have been optimizable by a person of ordinary skill in the rt before the effective filing date of the invention.
Regarding claims 6 and 7, before the effective filing date of the invention Cook et al. teach a composition comprising a bacterial community wherein the bacterial community comprises a purified bacterial strain of each of: Clostridium hiranonis; and any one or more of Bacteroides thetaiotaomicron, Bacteroides uniformis, Phocaeicola vulgatus, Clostridium scindens, Collinsella aerofaciens, and Desulfovibrio piger (See for example, column 10 lines 4, 5, 50, 55 and 59-60), and the purified bacterial strains are in spore and vegetative form (See for example, column 24 lines 43-47).
Regarding claim 8, before the effective filing dated of the invention, Reygner et al. teach technique of freeze-drying or lyophilizing bacterial community to preserve viability, etc. (See for example, p. 1416 Methods). Therefore, a person of ordinary skill in the art before the effective filing date of the invention would have been capable of applying the known technique of lyophilizing taught by the prior with a reasonable expectation of success in lyophilizing the bacterial strains taught by Hromada et al. and provide the claimed composition of claim 8. The motivation as taught by Reygner et al. would be to preserve viability.
Regarding claims 12-15 and 20, Cook et al. teach the composition is in the form of a pharmaceutical composition comprising the bacterial community in combination with a pharmaceutically acceptable excipient (formulated pharmaceutical preparation for rectal) (See column 17 lines 26-31 and column 28 lines 24-38), Cook et al. teach the composition is formulated for oral or rectal delivery (oral or eternal nutrition, and formulated pharmaceutical preparation for rectal) (see column 25 line 50-52, and column 17 lines 26-31), Cook et al. teach the composition is formulated for delivery to the intestine or the colon (oral or eternal nutrition) (see column 25 line 50-52), and Cook et al. teach the composition is in the form of a food product comprising the bacterial community and a nutrient (food supplement) (see column 25 line 50-52).
Therefore, a person of ordinary skill in the art before the effective filing date of the invention would have been motivated to combine the teachings of Cook et al. and provide the composition taught by Hromada et al. with a reasonable expectation of success in providing the composition is in the form of a pharmaceutical composition comprising the bacterial community in combination with a pharmaceutically acceptable excipient, the composition is formulated for oral or rectal delivery, the composition is formulated for delivery to the intestine or the colon and composition is in the form of a food product comprising the bacterial community and a nutrient. Because Cook et al. teach a composition comprising a bacterial community wherein the bacterial community comprises a purified bacterial strain of each of: Clostridium hiranonis; and any one or more of Bacteroides thetaiotaomicron, Bacteroides uniformis, Phocaeicola vulgatus, Clostridium scindens, Collinsella aerofaciens, and Desulfovibrio piger, the composition is in the form of a pharmaceutical composition comprising the bacterial community in combination with a pharmaceutically acceptable excipient, the composition is formulated for oral or rectal delivery, the composition is formulated for delivery to the intestine or the colon (oral or eternal nutrition) (see column 25 line 50-52), and Cook et al. teach the composition is in the form of a food product comprising the bacterial community and a nutrient.
Regarding claim 16, Hromada et al. teach the bacterial community can be optimized to treat C. difficile infection (see for example, p. 12 left-hand column “Discussion”). Therefore, Hromada et al. envisaged a method of treating a C. difficile infection in a subject, the therapeutically effective amount would have been optimized by a person of ordinary skill in the art before the effective filing date of the invention by routine optimization based on the subject being treated and severity of the infection.
Regarding claims 17-19, Hromada et al. teach antibiotic use increased risk of C. difficile infection or CDI (see for example, p. 12 right -hand column 1st paragraph). Therefore, a person of ordinary skill in the art before the effective filing date of the invention would have been motivated to administer the composition taught by Hromada et al. to a subject that is an asymptomatic C. difficile carrier, or to a subject that is previously administered one or more doses of an antibiotic, or to a subject that has not been administered an antibiotic. The motivation would be to optimize treatment regimen and infection control.
Double Patenting Rejection
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.
At least claims 1-5, 7 and 10-16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 10, 11, 13, 19, 20 and 22-26 of copending Application No. 19/670, 856.
Because the composition as taught by claims 1, 10, 11, 13, 19, 20 and 22-26 of copending Application No. 19/670, 856 makes obvious the claimed composition and the method of treating a C. difficile infection in a subject, of at least claims 1-5, 7 and 10-16 of instant application.
This is a provisional nonstatutory double patenting rejection.
Conclusion(s):
No claims(s) is allowed at this time.
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/KADE ARIANI/Primary Examiner, Art Unit 1651
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