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
This application is a continuation of U.S. Patent Application No. 17/568,991, now U.S. Patent No. 12,064,426 filed on January 5, 2022, which claims priority to U.S. Provisional Application No. 63/134,458 filed January 06, 2021.
Claim 2 cites the term “cerebral cavernous malformations” which does not have basis in either of the priority documents. Accordingly, the effective filing date of claim 2 is the filing date of the instant application, 07/04/2024. The effective filing date of claims 1 and 3-11 is January 06, 2021.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 07/30/2024 was filed in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claims 1-2 and 6 are objected to because of the following informalities:
Claims 1 and 6 have structures that are unclear. These should be replaced with clear structures.
Claim 2 recites "... psoriasis, , urticaria, …". The extraneous comma should be removed. 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 and 3-11 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for treatment or alleviation of ROCK1 or ROCK2-mediated diseases, does not reasonably provide enablement for treatment or alleviation of all kinase-mediated diseases. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
The criteria for enablement set out in In re Wands, MPEP 2164.01(a), considers the following factors:
Breadth of the claims—The instant claims encompass treating or alleviating any and all protein kinase-mediated diseases with a compound of formula 1.
Level of skill in this art—There is no one drug that can treat or alleviate any and all protein kinase-mediated diseases. A PHOSITA understands that different protein kinase-mediated diseases have different etiologies and thereby different treatment modalities based upon the target protein kinase(s). A single drug would not be expected to treat or alleviate any and all diseases mediated by protein kinases.
State of the prior art—Xu et al. (see 07/30/2024 IDS NPL Cite No 1) discloses structurally similar compounds (Table 2) and their protein kinase activities (Table 3). It is clear that no single compound can be reasonably expected to have therapeutic activity at all protein kinase targets and therefore cannot be expected to treat or alleviate all protein kinase-mediated diseases.
Working examples—The specification (Examples 3 and 4) shows biological activity assays for ROCK1 and ROCK2 kinase inhibition but shows no activity data for other kinases.
Direction and Guidance—The amount of guidance presented in the specification as to which compounds are sufficiently active to be useful for the breadth claimed uses, namely for treating all protein kinase-mediated diseases including those not mediated by ROCK1 or ROCK2, is nonexistent.
Thus, while the specification has enabled treatment or alleviation of ROCK1 or ROCK2-mediated diseases, treatment or alleviation of all protein-kinase mediated diseases is not enabled.
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 and 3-11 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.
Claim 1 recites “protein kinase-mediated disease”. The metes and bounds of the term “protein kinase-mediated disease” are unclear. While the definition on pp. 13-14 of the specification is acknowledged, it is insufficient to define the scope. Protein kinases are involved in numerous biological pathways and it is unclear to what degree a disease must be “mediated” by protein kinase to be considered a “protein kinase-mediated disease”. Furthermore, the term does not appear to be known to a PHOSITA to define a genus of diseases.
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.
Claim(s) 2 is/are rejected under 35 U.S.C. 102(a)(1)as being anticipated by US 2023/0082993 A1 to Lee et al.
Lee et al. teaches Compound 27 at Para. [0741]
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112
287
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which is a compound of instant formula 1 wherein X is H; Y is CH; A, B, and E are each CH;
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19
31
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is a double bond; R1 is C(O)NH-CH2-CH2-(2-pyridinyl); and R3 is pyrazolyl. The compounds of the disclosure are taught as being useful for treating claimed diseases such as asthma at Para. [0097], thereby anticipating instant claim 2.
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 1-11 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12,064,426.
Although the claims at issue are not identical, they are not patentably distinct from each other because claims 12-20 of the issued patent are drawn to treating or alleviating a ROCK-mediated disease or disorder with the same compounds as those administered in the instant claims. Each of the claimed uses of issued claims 12-20 anticipates instant claims 1 and 3-11 which are drawn to the broader genus of kinase-mediated diseases. Furthermore, issued claims 1-11 are drawn to compounds for which the instantly claimed uses are known. See Col. 2, lines 36-43 and Col. 14, lines 52-60 of the issued patent. In Sun Pharm. Indus., 611 F.3d at 1386-88, 95 USPQ2d at 1801-02 it was established that when ascertaining the scope of the reference’s claim(s) to a compound, the examiner should consider the reference’s specification, including all of the compound’s uses that are disclosed. Accordingly, issued claims 1-11 render instant claims 1-11 obvious because the reference’s specification discloses the instantly claimed uses.
Conclusion
Claims 1-11 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JED A KUCHARCZK whose telephone number is (571)270-5206. The examiner can normally be reached Mon-Fri 7:30 to 5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Adam Milligan can be reached at (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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/JED A KUCHARCZK/Examiner, Art Unit 1623
/VALERIE RODRIGUEZ-GARCIA/Primary Examiner, Art Unit 1621
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