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 1-16 are pending.
Election/Restrictions
Applicant’s election without traverse of group I claims 1-12 in the reply filed on 01 June 2026 is acknowledged.
Claims 13-16 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 01 June 2026.
Claims 1-12 are under examination.
Priority and Domestic Benefit
Applicant’s claim for priority to the filing date of KR10-2019-0103511 filed 23 August 2019, KR10-2020-0033878 filed 19 March 2020, and PCT/KR2020/006179 filed 11 May 2020 is acknowledged. Applicant’s claim to the domestic benefit of US Application no. 17/258,522 is also acknowledged. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
The effective filing date is 23 August 2019.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 12 August 2024 and 09 June 2026 are being considered by the examiner.
Claim Objections
Claims 1-12 are objected to because of the following informalities:
Claims 1-12 misspell the species “Akkermansia muciniphila” as “Akkermansia mucinipilia”.
Claim 5 recites “a pasteurized forms of the strain”. The singular indefinite article “a” does not match the plural term “forms”. The word “forms” should be changed to the singular “form”.
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 3-12 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 material Akkermansia muciniphila EB-AMDK19 is required to practice the claimed invention. As such the biological material 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) or pre-AIA 35 U.S.C. 112, first paragraph, may be satisfied by a deposit of the biological material Akkermansia muciniphila EB-AMDK19.
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 Akkermansia muciniphila EB-AMDK19 that is considered necessary to make and use the invention is both known and readily available to the public.
It is noted that Applicants have deposited Akkermansia muciniphila EB-AMDK19 under the terms of the Budapest Treaty and given accession number KCTC 13761BP (specification pg. 51 lns. 16-21), but there is no indication in the specification as to public availability. 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.
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 1-12 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 1 and 4 recite the parenthetical phrase “(accession number KCTC 13761BP)”. 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.
Claims 2-12 depend on claim 1, and claims 7 and 9 depend on claim 4, so are indefinite for the same reason.
Claims 3-8 and 10-12 recite the limitation "said Akkermansia muciniphilia EB-AMDK19". There is insufficient antecedent basis for this limitation in the claims.
Claim 9 depends on claim 4, so is indefinite for the same reason.
Claim 11 recites the Akkermansia muciniphila EB-AMDK19 strains are formulated in a composition which is packaged for aerosol delivery. It is unclear if the Akkermansia muciniphila EB-AMDK19 containing composition is being limited to an aerosol form for aerosol delivery, or if the composition is merely being packaged into a box or container that is intended for aerosol delivery.
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 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cani et al. (US 20180250347 A1, published 06 September 2018).
Cani teaches a method of treating metabolic disorder comprising administering Akkermansia muciniphila, wherein the metabolic disorder is asthma and the Akkermansia muciniphila is pasteurized (Cani claim 17 and 19).
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 4-10 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Cani as applied to claims 1-2 above.
As described in the 35 USC §112(b) rejection above, claims 3-8 and 10-12 recite the limitation "Akkermansia muciniphila EB-AMDK19", but there is insufficient antecedent basis for this limitation in the claims. Claim 9 is dependent on claim 4, so is also indefinite for this reason. Claims 3-12 are interpreted as limiting the Akkermansia muciniphila strain of claim 1 to Akkermansia muciniphila EB-AMDK19.
Cani does not teach that their Akkermansia muciniphila strain is Akkermansia muciniphila EB-AMDK19.
However, one of ordinary skill in the art would not consider Cani's different strains of Akkermansia muciniphila to be significantly functionally different from the present invention’s Akkermansia muciniphila EB-AMDK19 because Cani teaches strains of the bacterial species Akkermansia muciniphila treat asthma, just like the claimed Akkermansia muciniphila EB-AMDK19, and there is no evidence that demonstrates the inefficacy of Cani's Akkermansia muciniphila strains to perform the claimed method, nor any unexpected results of the instant Akkermansia muciniphila EB-AMDK19 in treating asthma. Thus, Akkermansia muciniphila EB-AMDK19 would be expected by one of ordinary skill in the art to be functionally equivalent to the species of Akkermansia muciniphila as disclosed by Cani.
Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the present invention to modify Cani’s method of treating asthma comprising administering Akkermansia muciniphila strains by incorporating any given strain of Akkermansia muciniphila strain into Cani’s composition. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success because Cani already taught the advantageous use of a composition comprising strains of Akkermansia muciniphila to treat asthma, and thus one of ordinary skill in the art would have been motivated to use any strain of species Akkermansia muciniphila to attempt to treat asthma with reasonable expectations of success.
Regarding claims 4 and 10, Cani teaches the composition is a pharmaceutical composition combined with a pharmaceutically acceptable vehicle/carrier (Cani claim 26), and composition also comprises an excipient (Cani claim 24).
Regarding claim 5, Cani teaches the administered composition comprises pasteurized cells (Cani claim 17). Cani also teaches the administration of live probiotic cells of Akkermansia muciniphila (Cani [200]).
Regarding claims 6 and 12, Cani teaches the Akkermansia muciniphila can be co-administered with another probiotic and/or prebiotic (Cani 23).
Regarding claim 7, Cani teaches the composition is orally administered (Cani claim 20).
Regarding claim 8, Cani teaches the administered composition comprises 104 to 1012 cells/g (Cani 21).
Regarding claim 9, Cani teaches the composition is a nutritional composition (Cani claim 25).
Claims 3 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Cani as applied to claims 1-2, 4-10, and 12 above, and further in view of Cutcliffe et al. (WO 2018106844 A1, published 14 June 2018).
Regarding claim 3, Cani does not teach their Akkermansia muciniphila composition is lyophilized and/or enteric coated.
Cutcliffe teaches a composition comprising Akkermansia muciniphila (Cutcliffe [13] and [67]) that is lyophilized so that the microorganisms are oxygen stable (Cutcliffe [19]). Cutcliffe also teaches that lyophilization can be used to preserve the microbial cultures and minimize the damage caused by strictly drying the sample, promotes high cell viability and metabolic activity when administered (Cutcliffe [145]). Cutcliffe also teaches the Akkermansia muciniphila composition is encapsulated in an enteric coating (Cutcliffe [34]), which protects the contents of oral formulation from stomach acidity and provides delivery to ileum and upper colonic regions (Cutcliffe [250]).
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the present invention to modify Cani’s Akkermansia muciniphila composition to be lyophilized and/or enteric coated. One of ordinary skill in the art would have been motivated to lyophilize Cani’s composition with a reasonable expectation of success because Cutcliffe teaches that lyophilization protects the microbial cultures in the composition, minimizes the damage caused by strictly drying the sample, and promotes high cell viability and metabolic activity when administered (Cutcliffe [145]). One of ordinary skill in the art would have been motivated to enteric coat Cani’s composition with a reasonable expectation of success because Cutcliffe teaches that enteric coatings protect the contents of the oral composition from stomach acidity and provides delivery to ileum and upper colonic regions (Cutcliffe [250]).
Regarding claim 11, Cani does not teach their Akkermansia muciniphila composition is formulated for aerosol delivery. Cutcliffe teaches their Akkermansia muciniphila composition may be in the form of an aerosol (Cutcliffe [291]), and administered by aerosolization or inhalation (Cutcliffe [264]).
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the present invention to modify Cani’s Akkermansia muciniphila composition to be in the form of an aerosol that is administered by aerosolization and inhalation. One of ordinary skill in the art would have been motivated to do so to provide Cani’s asthma therapeutic composition comprising Akkermansia muciniphila in another administrable form factor that would be more familiar to subjects being treated for asthma (e.g. inhalers). One of ordinary skill in the art would have had a reasonable expectation of success because Cutcliffe taught that Akkermansia muciniphila compositions may be formulated for aerosol delivery.
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 1-2, 4-5, and 8-9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, and 7-8 of U.S. Patent No. US 12,636,319 B2.
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 1-2, conflicting claim 1 recites a method for alleviating or ameliorating asthma or allergic rhinitis in a subject comprising administering a composition comprising Akkermansia muciniphila EB-AMDK19 (KCTC13761BP).
Regarding instant claim 5, conflicting claim 3 recites the Akkermansia muciniphila EB-AMDK19 is live or pasteurized.
Regarding instant claim 8, conflicting claim 7 recites the composition comprises 108 to 1012 CFU of live or pasteurized Akkermansia muciniphila EB-AMDK19.
Regarding instant claims 4 and 9, conflicting claim 8 recites the composition is a pharmaceutical composition, foodstuff, or dietary supplement.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Louise Humphrey can be reached on (571)-272-5543. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LOUISE W HUMPHREY/Supervisory Patent Examiner, Art Unit 1657
/Alexander M Duryee/Examiner, Art Unit 1657
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