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 1-20 are pending.
Election/Restrictions
Applicant’s election of group I, claims 1-13 and 15-19 in the reply filed on 23 September 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 14 and 20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 23 September 2026. Claims 1-13 and 15-19 are under examination.
Priority
Applicant’s claim for priority to the filing dates of KR10-2023-0040382 filed 28 March 2023, KR10-2023-0083791 filed 28 June 2023, and KR10-2024-0023521 filed 19 February 2024 is acknowledged. Receipt is acknowledged of certified copies of KR10-2023-0083791 required by 37 CFR 1.55, but no certified copies of KR10-2023-0040382 and KR10-2024-0023521 have been received.
Additionally, the certified copy of KR10-2023-0083791 is in Korean. Applicant’s claim to the foreign priority filing date of KR10-2023-0083791 filed 28 June 2023 can be perfected by filing an English translation of the certified copy.
The effective filing date is 28 February 2024.
Claim Objections
Claims 7, 10, 12-13, 16, and 18-19 are objected to because of the following informalities:
Claim 7 recites the convoluted limitation “the Anaerostipes hadrus is a strain identified by a 16S rDNA base sequence represented by SEQ ID NO: 1”. It is suggested to amend the limitation to recite “the Anaerostipes hadrus comprises the 16S rDNA base sequence of SEQ ID NO: 1”. The limitations for the three other bacterial strains also have this issue, so should be amended accordingly.
Claim 10 recites the Markush group “an active ingredient…selected from the group consisting of Anaerostipes hadrus, Collinsella aerofaciens, Blautia wexlerae, and Bifidobacterium longum strains, which inhibit activity of the Vancomycin-resistant Enterococci, a culture of the strain, a concentrate of the culture, a dried product of the culture, and combinations thereof.” The limitation “which inhibit activity of the Vancomycin-resistant Enterococci” should be moved to the end of the claim into a separate wherein clause, such as: “wherein the Anaerostipes hadrus, Collinsella aerofaciens, Blautia wexlerae, and Bifidobacterium longum strains inhibit activity of the Vancomycin-resistant Enterococci.” The same issue is present in claims 12-13, 16, and 18-19, so should be amended accordingly.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph 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 the first paragraph of pre-AIA 35 U.S.C. 112:
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 his invention.
Claims 3-7 are rejected under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
It is apparent that biological materials Anaerostipes hadrus (accession number: KCTC15409BP), Collinsella aerofaciens (accession number: KCTC15408BP), Blautia wexlerae (accession number: KCTC15396BP), and Bifidobacterium longum (accession number: KCTC15416BP) are required to practice the claimed invention. As such the biological materials must be known and readily available or obtainable by a repeatable method set forth in the specification, or otherwise known and readily available to the public. If it is not so obtainable or available, the requirements of 35 USC 112(a) may be satisfied by a deposit of the biological materials and a statement, affidavit or declaration by Applicants, or by an attorney of record over his or her signature and registration number, or by someone in a position to corroborate the facts of the deposit.
The process disclosed in the specification does not appear to be repeatable, it is not clear that the invention will work with commonly available material and it is not apparent if the Anaerostipes hadrus (accession number: KCTC15409BP), Collinsella aerofaciens (accession number: KCTC15408BP), Blautia wexlerae (accession number: KCTC15396BP), and Bifidobacterium longum (accession number: KCTC15416BP) that are considered necessary to make and use the invention is both known and readily available to the public.
Therefore, a deposit at a recognized depository may be made to obviate this rejection.
If the deposit is made under the terms of the Budapest Treaty, then a statement, affidavit or declaration by Applicants, or by an attorney of record over his or her signature and registration number, or by someone in a position to corroborate the facts of the deposit, that all restrictions imposed by the depositor on the availability to the public on the deposited material will be irrevocably removed upon granting of the patent, would satisfy the deposit requirement made herein.
If the deposit is a non-Budapest Treaty deposit, then in order to certify that the deposit meets the requirements set forth in 37 CFR 1.801-1.809 and MPEP 2402-2411.05, a statement, affidavit or declaration by Applicant or by an attorney of record over his or her signature and registration number, or by someone in a position to corroborate the facts of the deposit would satisfy the requirements herein by stating and providing that:
(a) During the pendency of the application, access to the invention will be afforded to the Commissioner upon request;
(b) All restrictions upon availability to the public will be irrevocably removed upon granting of the patent;
(c) The deposit will be maintained in a public depository for a period of 30 years, or 5 years after the last request or for the enforceable life of the patent, whichever is longer; and
(d) Provide evidence of the test of the viability of the biological material at the time of deposit (see 37 CFR 1.807).
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 3-6, 8-13, and 15-19 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 3-6 recite parenthetical limitations (accession number: KCTC15409BP), (accession number: KCTC15408BP), (accession number: KCTC15396BP), and (accession number: KCTC15416BP). It is unclear whether the contents of the parenthetical phrases are part of the claim limitations and intended to be limiting, or if the contents of the parenthetical phrases are merely exemplary and thus not required.
Claim 4 recites the composition of claim 3 “includes the Anaerostipes hadrus (accession number: KCTC15409BP), Collinsella aerofaciens (accession number: KCTC l5408BP), and Blautia wexlerae (accession number: KCTC15396BP)”. It is unclear if:
(1) the word “includes” limits claim 3’s composition to comprise Anaerostipes hadrus (accession number: KCTC15409BP), Collinsella aerofaciens (accession number: KCTC l5408BP), and Blautia wexlerae (accession number: KCTC15396BP) in addition to the at least two or more strains selected from the group consisting of: Anaerostipes hadrus, Collinsella aerofaciens, Blautia wexlerae, and Bifidobacterium longum as recited in parent claim 1; or
(2) the word “includes” limits the Anaerostipes hadrus, Collinsella aerofaciens, and Blautia wexlerae of parent claim 1 to be Anaerostipes hadrus (accession number: KCTC15409BP), Collinsella aerofaciens (accession number: KCTC l5408BP), and Blautia wexlerae (accession number: KCTC15396BP).
Claims 5-6 recite a similar issue as with claim 4, differing only in which strains are recited.
Claims 10, 12-13, 16, and 18-19 recite “an active ingredient at least one selected from the group consisting of two or more strains selected from the group consisting of Anaerostipes hadrus, Collinsella aerofaciens, Blautia wexlerae, and Bifidobacterium longum strains”. It is unclear if the claims require at least one strain (i.e. a minimum of one strain) be selected from the group consisting of Anaerostipes hadrus, Collinsella aerofaciens, Blautia wexlerae, and Bifidobacterium longum, or if two or more strains (i.e. a minimum of two strains) must be selected.
Claim 17 depends on claim 16 and is indefinite for the same reasons.
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 1-13 and 15-19 are rejected under 35 U.S.C. 101 because the claimed invention is directed to the judicial exception of product of nature without significantly more.
Claims 1-13 and 15-19 are drawn to the statutory category of a composition of matter (Step 1: Yes).
Claim 1 recites an antibacterial composition comprising two or more strains selected from the group consisting of: Anaerostipes hadrus, Collinsella aerofaciens, Blautia wexlerae, and Bifidobacterium longum strains, and claim 2 recites that the strains are isolated from human feces. The bacteria Anaerostipes hadrus, Collinsella aerofaciens, Blautia wexlerae, and Bifidobacterium longum are naturally occurring bacterial species isolated in human feces, as evidenced by claim 2 and pg. 5 para. 1 of the Specification.
Claims 3-7 recite the Anaerostipes hadrus is Anaerostipes hadrus (accession number: KCTC15409BP), the Collinsella aerofaciens is Collinsella aerofaciens (accession number: KCTC15408BP), the Blautia wexlerae is Blautia wexlerae (accession number: KCTC15396BP), and the Bifidobacterium longum is Bifidobacterium longum (accession number: KCTC15416BP). Example 1 indicates that the specific strains Anaerostipes hadrus RC1, Collinsella aerofaciens RC2, Blautia wexlerae RC3, and Bifidobacterium longum RC4 were isolated from human feces as well (Specification pgs. 23-24). Strain designations RC1, RC2, RC3, and RC4 correspond to claimed accession numbers KCTC15409BP, KCTC15408BP, KCTC15396BP, and KCTC15416BP, respectively (Specification pg. 5 para. 2). Accordingly, claim 3’s strains and their accession numbers are also naturally occurring being isolated from human feces.
Claim 8 recites the strains have antibiotic-resistant bacteria inhibitory activity, which is interpreted as being an intended properties of the claimed strains, but do not add any new structural limitations to the naturally occurring compositions.
Claim 9 recites the antibiotic-resistant bacteria are Vancomycin-resistant Enterococci, and claim 15 recites the antibiotic-resistant bacteria are Carbapenem-resistant Enterobacteriaceae (CRE). These limitations are interpreted as being intended properties of the antibiotic-resistant bacteria, but do not add any new structural limitations to the naturally occurring compositions.
Claims 10-11 recites a pharmaceutical composition comprising two or more strains selected from the group consisting of: Anaerostipes hadrus, Collinsella aerofaciens, Blautia wexlerae, and Bifidobacterium longum. As with claim 1, the pharmaceutical composition is comprised wholly of naturally occurring bacteria that are isolated from human feces. Claim 10 also recites that the strains “inhibit activity of the Vancomycin-resistant Enterococci”, which is interpreted as being an intended capability of the claimed strains, but does not add any new structural limitations to the naturally occurring compositions. Claim 10 also recites the intended use of “for preventing or treating Vancomycin-resistant Enterococci (VRE) infections”, but this limitation does not add any new structural limitations to the naturally occurring compositions. Claim 10 also recites “a culture of the strain, a concentrate of the culture, a dried product of the culture…”. A culture of bacteria comprises the bacteria, and no other non-natural ingredients are recited. A concentrate of the culture means the concentration of the bacteria is increased, but does not recite any non-natural ingredients. A dried product of the culture means that a product from the culture was dried, but does not recite any non-natural ingredients.
Claim 12 recites a health functional food comprising two or more strains selected from the group consisting of: Anaerostipes hadrus, Collinsella aerofaciens, Blautia wexlerae, and Bifidobacterium longum. As with claim 1, the health functional food is comprised wholly of naturally occurring bacteria that are isolated from human feces. No other ingredients are recited. Claim 12 also recites that the strains “inhibit activity of the Vancomycin-resistant Enterococci”, which is interpreted as being an intended capability of the claimed strains, but does not add any new structural limitations to the naturally occurring compositions. Claim 12 also recites the intended use of “for inhibiting activity of Vancomycin-resistant Enterococci (VRE)”, but this limitation does not add any new structural limitations to the naturally occurring compositions. As discussed with claim 10 above, a culture of the strain, a concentrate of the culture, and a dried product of the culture do not include any additional non-natural ingredients.
Claim 13 recites a feed additive comprising two or more strains selected from the group consisting of: Anaerostipes hadrus, Collinsella aerofaciens, Blautia wexlerae, and Bifidobacterium longum. As with claim 1, the feed additive is comprised wholly of naturally occurring bacteria that are isolated from human feces. No other ingredients are recited. Claim 13 also recites that the strains “inhibit activity of the Vancomycin-resistant Enterococci”, which is interpreted as being an intended capability of the claimed strains, but does not add any new structural limitations to the naturally occurring compositions. Claim 13 also recites the intended use of “for inhibiting activity of Vancomycin-resistant Enterococci (VRE)”, but this limitation does not add any new structural limitations to the naturally occurring compositions. As discussed with claim 10 above, a culture of the strain, a concentrate of the culture, and a dried product of the culture do not include any additional non-natural ingredients.
Claims 16-17 recites a pharmaceutical composition comprising two or more strains selected from the group consisting of: Anaerostipes hadrus, Collinsella aerofaciens, Blautia wexlerae, and Bifidobacterium longum. As with claim 1, the pharmaceutical composition is comprised wholly of naturally occurring bacteria that are isolated from human feces. Claim 16 also recites that the strains “inhibit activity of Carbapenem-resistant Enterobacteriaceae (CRE)”, which is interpreted as being an intended capability of the claimed strains, but does not add any new structural limitations to the naturally occurring compositions. Claim 16 also recites the intended use of “for preventing or treating Carbapenem-resistant Enterobacteriaceae (CRE) infections”, but this limitation does not add any new structural limitations to the naturally occurring compositions. As discussed with claim 10 above, a culture of the strain, a concentrate of the culture, and a dried product of the culture do not include any additional non-natural ingredients.
Claim 18 recites a health functional food comprising two or more strains selected from the group consisting of: Anaerostipes hadrus, Collinsella aerofaciens, Blautia wexlerae, and Bifidobacterium longum. As with claim 1, the health functional food is comprised wholly of naturally occurring bacteria that are isolated from human feces. No other ingredients are recited. Claim 18 also recites that the strains “inhibit activity of Carbapenem-resistant Enterobacteriaceae (CRE)”, which is interpreted as being an intended capability of the claimed strains, but does not add any new structural limitations to the naturally occurring compositions. Claim 18 also recites the intended use of “for inhibiting activity of inhibit activity of Carbapenem-resistant Enterobacteriaceae (CRE)”, but this limitation does not add any new structural limitations to the naturally occurring compositions. As discussed with claim 10 above, a culture of the strain, a concentrate of the culture, and a dried product of the culture do not include any additional non-natural ingredients.
Claim 19 recites a feed additive comprising two or more strains selected from the group consisting of: Anaerostipes hadrus, Collinsella aerofaciens, Blautia wexlerae, and Bifidobacterium longum. As with claim 1, the feed additive is comprised wholly of naturally occurring bacteria that are isolated from human feces. No other ingredients are recited. Claim 19 also recites that the strains “inhibit activity of Carbapenem-resistant Enterobacteriaceae (CRE)”, which is interpreted as being an intended capability of the claimed strains, but does not add any new structural limitations to the naturally occurring compositions. Claim 19 also recites the intended use of “for inhibiting activity of Carbapenem-resistant Enterobacteriaceae (CRE)”, but this limitation does not add any new structural limitations to the naturally occurring compositions. As discussed with claim 10 above, a culture of the strain, a concentrate of the culture, and a dried product of the culture do not include any additional non-natural ingredients.
Therefore, the instant invention recites a judicial exception of a product of nature (Step 2A Prong One: Yes).
This judicial exception is not integrated into a practical application and do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims are directed to a composition of matter. The claims do not recite any active steps that require the administration of the instant composition for a particular therapeutic purpose. Although claims 11 and 17 recite the Anaerostipes hadrus, Collinsella aerofaciens, Blautia wexlerae, and Bifidobacterium longum strains are administered by one or more routes selected from the group consisting of oral, rectal, and colonic routes, the limitation is interpreted as being intended administration routes in the intended uses of the compositions: claim 11’s preventing or treating VRE infections and claim 17’s preventing or treating CRE infections. These limitations do not recite an active step of administering the product of nature in methods of preventing or treating VRE or CRE infections.
Therefore, the instant invention is directed to the judicial exception of a product of nature, and does not include any additional elements that amount to significantly more than the recited judicial exception of a product of nature, and so the instant invention is not patent eligible subject matter under 35 USC §101 (Step 2A Prong Two and Step 2B: No).
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an 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.
Claims 1-2, 8-13, and 15-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Scharl et al. (US 20220054560 A1 published 24 February 2022)
Regarding claims 1, 12-13, and 18-19, Scharl teaches a composition comprising Anaerostipes hadrus, Collinsella aerofaciens, Blautia wexlerae, and Bifidobacterium longum ([266]-[276]).
The antibacterial composition, the health functional food, and feed additive recited in claims 1, 12-13, and 18-19 do not recite any additional ingredients besides the Anaerostipes hadrus, Collinsella aerofaciens, Blautia wexlerae, and Bifidobacterium longum strains. Since Scharl teaches a composition comprising those strains, Scharl’s composition is the same as the claimed antibacterial composition, health functional food, and feed additive.
Regarding claim 2, the claim recites that the Anaerostipes hadrus, Collinsella aerofaciens, Blautia wexlerae, and Bifidobacterium longum strains are isolated from human feces, which is product-by-process language used to describe how the claimed strains are produced. MPEP §2113(I) states that product-by-process claims are not limited by the manipulations of the process, only by the implied structure of the steps. If the strains in the product-by-process claim are the same as or obvious from a product of the prior art, the claim is unpatentable even if the prior product was made by a different process.
Regarding claim 8, the claim recites the strains have antibiotic-resistant bacteria inhibitory activity, which is interpreted as being an intended properties of the claimed strains, but do not add any new structural limitations to the composition; thus, if a composition in the prior art teaches all of the structural limitations of the claimed composition, claims 8 is considered to be anticipated.
Regarding claims 9 and 15, claim 9 recites the antibiotic-resistant bacteria are Vancomycin-resistant Enterococci, and claim 15 recites the antibiotic-resistant bacteria are Carbapenem-resistant Enterobacteriaceae (CRE). These limitations are interpreted as being intended properties of the antibiotic-resistant bacteria, but do not add any new structural limitations to the composition; thus, if a composition in the prior art teaches all of the structural limitations of the claimed composition, claims 9 and 15 will be considered to be anticipated.
Regarding claims 10-11 and 16-17, Scharl teaches the composition may be a pharmaceutical composition ([74]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEXANDER M DURYEE whose telephone number is (571)272-9377. The examiner can normally be reached Monday - Friday 9:00 am - 5:00 pm.
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/Alexander M Duryee/Examiner, Art Unit 1657 /LOUISE W HUMPHREY/Supervisory Patent Examiner, Art Unit 1657
