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 1-22 are currently pending in the instant application. Applicants have canceled claim 23 in an amendment filed on November 25, 2024. Claims 1-22 are rejected in this Office Action.
I. Priority
The instant application is a 371 Of PCT/US2023/023563, filed on May 25, 2023 which claims benefit of US Provisional Application 63/345,780, filed on May 25, 2022.
II. Information Disclosure Statement
The information disclosure statement (IDS) submitted on November 25, 2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
III. Rejections
Claim Rejections - 35 USC § 112
The following is a quotation of the second paragraph of 35 U.S.C. 112:
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 1-21 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. Specifically, the phrase “including hydrates, …” renders the products indefinite as the phrase “including…” can be considered open-ended language when not clearly defined and therefore is including additional subject matter in the compounds of the formula I that is not described in the instant specification and is not particularly pointed out or distinctly claimed. A claim involving a chemical compound cannot be open-ended, but must be claimed with precision. This rejection can be overcome by amending the phrase “including hydrates, solvates, pharmaceutically acceptable salts, prodrugs and complexes thereof” so that it now reads “or a hydrate, solvate, pharmaceutically acceptable salt, prodrug and complex thereof” in claims 1-21.
Claim Rejections - 35 USC § 112(a) (Written Description)
The following is a quotation 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.
Claim 22 is rejected under 35 U.S.C. 112(a) as failing to comply with the written description requirement. The claims contain 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, at the time the application was filed, had possession of the claimed invention.
The claims are drawn to
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for which the specification does not provide an adequate written description to convey that the inventors were in possession of the full scope of the claimed compounds.
MPEP § 2163 states the following:
Possession may be shown in a variety of ways including description of an actual reduction to practice, or by showing that the invention was "ready for patenting" such as by the disclosure of drawings or structural chemical formulas that show that the invention was complete, or by describing distinguishing identifying characteristics sufficient to show that the applicant was in possession of the claimed invention. See, e.g., Pfaff v. Wells Elecs., Inc., 525 U.S. 55, 68, 119 S.Ct. 304, 312, 48 USPQ2d 1641, 1647 (1998); Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406; Amgen, Inc. v. Chugai Pharm., 927 F.2d 1200, 1206, 18 USPQ2d 1016, 1021 (Fed. Cir. 1991) (one must define a compound by "whatever characteristics sufficiently distinguish it"). []
[D]escribing a composition by its function alone typically will not suffice to sufficiently describe the composition. See Eli Lilly, 119 F.3 at 1568, 43 USPQ2d at 1406 (Holding that description of a gene’s function will not enable claims to the gene "because it is only an indication of what the gene does, rather than what it is."); see also Fiers, 984 F.2d at 1169-71, 25 USPQ2d at 1605-06 (discussing Amgen Inc. v. Chugai Pharm. Co., 927 F.2d 1200, 18 USPQ2d 1016 (Fed. Cir. 1991)). An adequate written description of a chemical invention also requires a precise definition, such as by structure, formula, chemical name, or physical properties, and not merely a wish or plan for obtaining the chemical invention claimed.[]
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.)
Factors that can be used to determine if sufficient evidence of possession has been furnished in the disclosure include “level of skill and knowledge in the art, partial structure, physical and/or chemical properties, functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the method of making the claimed invention. Disclosure of any combination of such identifying characteristics that distinguish the claimed invention from other materials and would lead one of skill in the art to the conclusion that the applicant was in possession of the claimed species is sufficient.” MPEP § 2163.
Disclosed Examples of inhibitors of PAPD5
The specification discloses that in certain embodiments the inhibitors of PAPD5 and PAPD7 are a compound of formula (I)
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(see page 3 of the specification). These compounds are the only examples of inhibitors of PAPD5 and PAPD7 present in the specification.
Some of examples are the following:
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Physical/Chemical Properties and Functional Characteristics
According to formula I, the core structure of can be a wide variety of fused het rings based on the definitions of Z1, Z2, X1, X2, X4, X5, etc. These claimed compounds are supposed to be inhibitors of PAPD5 and PAPD7. All of the examples provided in the specification have this common core structure
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(see Table 14 on pages 98-100) which has been shown as important for the above stated inhibitory activity. It is unclear if changing the above core structure of the tested compounds would still result in inhibitors of PAPD5 and PAPD7.
Method of Using the Claimed Invention
It is unclear what structure is required to be able to inhibit PAPD5 and PAPD7 since Applicants have only provided data and description for the compounds of formula I in the instant specification.
Written Description Conclusion
A reasonable structure-function correlation has not been established in the prior art for the claimed PAPD5 and 7 inhibitors in treating HAV infections, which possess structural variation. A person of ordinary skill in the art cannot reasonably predict whether a particular compound would be able to treat a prostate disease due to the lack of structure-function correlation. The specification does not provide a description of the structures required for the claimed function aside from the compounds of formula I depicted above. However, this structure is not of sufficient variety to represent the vast structural diversity of compound embraced by the limitation a “liver selective inhibitor of PAPD5 and 7 found in claim 22. Therefore, the specification does not provide written description for compounds that fall outside of the scope of the compounds of formula I
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.
To overcome the rejection, Applicants are suggested to cancel claim 22 since claim 1 already covers this method using the compounds of formula I.
IV. Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Shawquia Jackson whose telephone number is 571-272-9043. The examiner can normally be reached on 7:00 AM-3:30PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Adam Milligan can be reached on 571-270-7674. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SHAWQUIA JACKSON/Primary Examiner, Art Unit 1626
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