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 1-19 are pending.
Priority and Domestic Benefit
Applicant’s claim for priority to the filing date of KR10-2018-0117123 filed 01 October 2018 and PCT/KR2019/012024 filed 18 September 2019 is acknowledged. Applicant’s claim to the domestic benefit of US application no. 17/512,813 filed 28 October 2024 is also acknowledged.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
However, the certified copy of KR10-2018-0117123 is in Korean. Applicant’s claim to the foreign priority filing date of KR10-2018-0117123 can be perfected by filing an English translation of the certified copy.
Therefore, the effective filing date is currently 18 September 2019.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 18 September 2024 is being considered by the examiner.
Claim Objections
Claims 2 and 6 is objected to because of the following informalities:
Claim 2 requires the word “by” after the phrase “reducing muscle atrophy”.
Claim 6 requires the indefinite article “a” before the word “carrier”.
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 1-19 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The instant claims are drawn to a method for preventing or treating a muscle disease in a subject in need thereof and a method for increasing muscle strength and/or muscle mass in a subject in need thereof, comprising administering a composition comprising any strain of Akkermansia muciniphila, a culture thereof, or a lysate thereof.
The instant disclosure only provides written description of the specific strain of Akkermansia muciniphila strain HB05 preventing or treating a muscle disease and increasing muscle strength and/or muscle mass in a subject (Specification pgs. 13-20 Examples 2-3 and Figs. 2-8).
Due to the lack of disclosure for any other strains of Akkermansia muciniphila being able to treat or prevent muscle disease, one of ordinary skill in the art would be required to consult the prior art for an adequate description showing how other Akkermansia muciniphila strains would be able to prevent or treat a muscle disease and increase muscle strength and/or muscle mass in a subject.
The prior art is silent on the use of any Akkermansia muciniphila strain to prevent or treat a muscle disease and increase muscle strength and/or muscle mass in a subject. The closest prior art would be Cutcliffe et al. (WO 2018106844 A1, 14 June 2018), which teaches administration of compositions comprising Akkermansia muciniphila (Cutcliffe [109]) in order to treat various microbiome-associated health conditions and metabolic disorders (Cutcliffe [188]-[190] and [196]-[203]). However, none of these conditions/disorders are muscle diseases, and Cutcliffe fails to disclose any guidance or description as to how any given Akkermansia muciniphila strains are useful for preventing or treating a muscle disease and increasing muscle strength and/or muscle mass in a subject. Cani et al. (US 20180250347 A1, 06 September 2018) teaches the administration of pasteurized Akkermansia muciniphila and fragments thereof to treat metabolic disorders (Cani abstract). However, Cani does not disclose any guidance or description as to how any given Akkermansia muciniphila strains are useful for preventing or treating a muscle disease and increasing muscle strength and/or muscle mass in a subject.
Due to the absence of written description in the instant disclosure and in the prior art, one of ordinary skill in the art would not reasonably conclude that Applicant had possession of the entire genus used in the claimed invention.
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 1-19 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 1 and 11 recite administering a composition comprising as an active ingredient at least one selected from the group consisting of Akkermansia muciniphila, a culture thereof, and a lysate thereof. The word “an” in the phrase “as an active ingredient” suggests that Akkermansia muciniphila is only one of the possible active ingredients in the composition; however the disclosure does not suggest any other compositional ingredients which might serve as active ingredients suitable for preventing or treating a muscle disease and increasing muscle strength and/or muscle mass in a subject. It is therefore unclear if the administered composition is limited to only comprise Akkermansia muciniphila as the sole active ingredient within the composition, or if the claimed composition also comprises other active ingredients as well as inactive ingredients in addition to Akkermansia muciniphila.
Claims 2 and 12 recite that the method is increasing myogenesis by increasing mRNA expression of follistatin and/or decreasing muscle atrophy by reducing mRNA expression of atrogin-1 in muscle cells. It is unclear if the claims are reciting an additional method step to the method of parent claims 1 and 11, or if the limitations are merely a consequence of practicing the method steps recited in parent claims 1 and 11.
Claims 5 and 15 recite that the Akkermansia muciniphila cells of the parent claims are dead cells which are heat-treated and dried. It is unclear how the Akkermansia muciniphila cells of the parent claims are able to be dead cells if they are being cultured by performing the limitations of the parent claims. Culturing describes the cultivation and growth of cells. Dead cells are unable to grow, so are unable to be cultured.
Claims 7 and 17 recite the Akkermansia muciniphila comprising composition may be in the form of a quasi-drug. It is unclear what the meaning of “quasi-drug” is in the context of the invention. The specification provides some guidance, stating that: “the term “quasi-drug” of the present invention refers to a product that is not an instrument, machine, or device, among the products used for diagnosing, curing, relieving, treating, preventing, or alleviating diseases of humans or animals, and to a product that is not an instrument, machine, or device, among the products used for exerting pharmaceutical influences on structures and functions of humans or animals, and also encompasses externally applied preparations for skin and personal hygiene products.” The specification appears to be limiting the meaning of quasi-drug by describing what it is not, but the specification does not definitively state or point out what the metes and bounds of the claim term “quasi-drug” are; thus, the claims are indefinite.
Claims 2-10 depend on claim 1, claims 3-6 depend on claim 2, claim 6 depends on claim 5, claims 12-19 depend on claim 11, claims 13-16 depend on claim 12, and claim 16 depends on claim 15, so those claims are indefinite for the same reasons.
Pertinent Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Cutcliffe et al. (WO 2018106844 A1, 14 June 2018) teaches administration of compositions comprising Akkermansia muciniphila (Cutcliffe [109]) in order to treat various microbiome-associated health conditions and metabolic disorders (Cutcliffe [188]-[190] and [196]-[203]). However, none of these conditions/disorders are muscle diseases, and Cutcliffe fails to disclose any guidance or description of administering Akkermansia muciniphila for preventing or treating a muscle disease and increasing muscle strength and/or muscle mass in a subject.
Cani et al. (US 20180250347 A1, 06 September 2018) teaches the administration of pasteurized Akkermansia muciniphila and fragments thereof to treat metabolic disorders (Cani abstract). However, Cani does not disclose any guidance or description of administering Akkermansia muciniphila for preventing or treating a muscle disease and increasing muscle strength and/or muscle mass in a subject.
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
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