DETAILED ACTION
Claims 1-20 are pending in the present application.
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 .
Priority
The claim to priority as a 371 filing of PCT/CN2023/095172 filed on May 19, 2023, which claims benefit of CN 202210553394.8 filed on May 20, 2022 is acknowledged in the present application file.
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 10 and 13 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 present claims are drawn to a method of treating a disease or disorder associated with myosin regulation in a patient by administering a compound of claim 1 or composition of claim 8. The disease or disorder to be treated can be any disease or disorder as long as there is some association with myosin.
The present specification only provides description with respect to inhibiting myosin in order to treat diseases such as hypertrophic cardiomyopathy. See the paragraph bridging pages 6-7 of the present specification as filed. There is no description as to how additional diseases and disorders that are associated with agonizing myosin can be treated the presently claimed compounds.
The Applicant is reminded of the written description guidelines set out by the USPTO in MPEP 2163:
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice (see i)(A) above), reduction to drawings (see i)(B) above), or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus (see i)(C) above). See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
The genus or the treatment diseases or disorders associated with myosin in general is not sufficiently detailed to show that the Applicant was in possession of the full scope of the claimed invention at the time of filing. Namely, that the definitions described above, while not being indefinite, are not sufficiently detailed in order to stand on their own as being adequately described. Therefore, the “representative number of species” standard is used to determine whether the claims are adequately described. MPEP 2163 goes on to describe what a "representative number of species" is:
Satisfactory disclosure of a "representative number" depends on whether one of skill in the art would recognize that the applicant was in possession of the necessary common attributes or features possessed by the members of the genus in view of the species disclosed. For inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus. See, e.g., Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. Instead, the disclosure must adequately reflect the structural diversity of the claimed genus, either through the disclosure of sufficient species that are "representative of the full variety or scope of the genus," or by the establishment of "a reasonable structure-function correlation." Such correlations may be established "by the inventor as described in the specification," or they may be "known in the art at the time of the filing date." See AbbVie, 759 F.3d at 1300-01, 111 USPQ2d 1780, 1790-91 (Fed. Cir. 2014) (Holding that claims to all human antibodies that bind IL-12 with a particular binding affinity rate constant (i.e., koff) were not adequately supported by a specification describing only a single type of human antibody having the claimed features because the disclosed antibody was not representative of other types of antibodies in the claimed genus, as demonstrated by the fact that other disclosed antibodies had different types of heavy and light chains, and shared only a 50% sequence similarity in their variable regions with the disclosed antibodies.). Description of a representative number of species does not require the description to be of such specificity that it would provide individual support for each species that the genus embraces. For example, in the molecular biology arts, if an applicant disclosed an amino acid sequence, it would be unnecessary to provide an explicit disclosure of nucleic acid sequences that encoded the amino acid sequence. Since the genetic code is widely known, a disclosure of an amino acid sequence would provide sufficient information such that one would accept that an applicant was in possession of the full genus of nucleic acids encoding a given amino acid sequence, but not necessarily any particular species. Cf. In re Bell, 991 F.2d 781, 785, 26 USPQ2d 1529, 1532 (Fed. Cir. 1993) and In re Baird, 16 F.3d 380, 382, 29 USPQ2d 1550, 1552 (Fed. Cir. 1994). If a representative number of adequately described species are not disclosed for a genus, the claim to that genus must be rejected as lacking adequate written description under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph.
The specie of the inhibition of myosin in order to treat disease in the specification does not cover the entire genus such that it is a representative sample of the genus as the species only describes an extremely small portion of the claimed genus or treatment disease or disorder associated with myosin. Therefore, the claims lack written description and are properly rejected under 35 U.S.C. 112(a).
Allowable Subject Matter
Claims 1-9 and 16-20 are allowed.
Claims 11, 12, 14, and 15 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Closest Prior Art
The following is an examiner’s statement of reasons for allowance: the closest prior art is that of WO 2022/105852, which details the synthesis of the compound of the present claims. However, the prior art does not detail the solid phase structure of the produced compound or the methods described in the present application for making the crystal forms A-E. Therefore, the present claims are prima facie allowable over the prior art.
Conclusion
Claims 10 and 13 are rejected. Claims 11, 12, 14, and 15 are objected to. Claims 1-9 and 16-20 are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Joseph Kosack whose telephone number is (571)272-5575. The examiner can normally be reached M-F 8:00-4:30.
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/JOSEPH R KOSACK/Primary Examiner, Art Unit 3991
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