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 .
Claims 1-7, 11-16, 20-25, 29 and 30 are pending and are examined together.
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.
Previously presented rejection of claims 1-7, 11-16, 20-25 (compound), 29 and 30 (method) are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 (compound) and 17-20 (method) of U.S. Patent No. 12378241 = US 20220267324 and Thayyil Adv Pharm Bull, 2020, 10(2), 203-212. Although the claims at issue are not identical, they are not patentably distinct from each other because the subject matter of instant base claim 1 (species), falls under the scope of the conflicting claim 1 (genus) is maintained for reasons of record.
Applicants arguments focus on the
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Unique polymorphic nature and composition of the compound of the product claims and also that of Thayyil does not teach how to make the particular crystal.
Response:
Applicants arguments are not persuasive.
The rejection is not under Statutory 101 type double patenting.
Applicant does not provide any citation on why osa would
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mesylate to have better pK profile.
Mesylates are expected to make more soluble salts, compared to for example, HCl salts. See Engel International Journal of Pharmaceutics 198 (2000) 239–247 for an example. According to Engel mesylate provided higher solubility, see Abstract penultimate line. Also see Serajuddin, Advanced Drug Delivery Reviews 59 (2007) 603–616 (for common-ion effect). These references at the minimum suggest that different acids as result effective variables are within the purview of osa for optimization of pK profiles of basic compounds.
Obviousness can be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art.
Consider for example, the language of claims 29 and 30. The method relies on the inherent biological activity, that is, (the instant) small molecule’s interaction with (the instant kinase) protein/enzyme. A compound and its property cannot be separated. There is common ground that the biological activity of a compound depends primarily on its molecular structure. To reach its target the compound will at some point be in solution, e.g. in body fluids, where all differences among salts that is counter ion at biological pH of 7.4 (or polymorphs) disappear. The skilled person would thus expect that all polymorphs of the compound display the same pharmacodynamic profile with respect to the treatment of the disease.
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.
Claims 1 (product) and 29, 30 (method) rejected under 35 U.S.C. 103 as being unpatentable over Chen WO2021018047 further in view of Engel International Journal of Pharmaceutics 198 (2000) 239–247 and Serajuddin, Advanced Drug Delivery Reviews 59 (2007).
Chen teaches compound of claim 1 at Chen claim 15 second pictured compound.
Chen does not specifically recite the sulfonic acid salt of the claim as instantly recited.
The Chen compound falls under the Chen formula I which includes pharmaceutical salts (See Abstract). Thus the instant compound has species relationship with the genus of Chen. Further Chen compounds are FGFR and VEGFR dual inhibitors, represented by formula (I) or a pharmaceutically acceptable salts. The method of using as per instant claims 29 and 30 relies on biological activity, that is, (the instant) small molecule’s interaction with (the instant kinase) protein/enzyme. A compound and its property cannot be separated. There is common ground that the biological activity of a compound depends primarily on its molecular structure. To reach its target the compound will at some point be in solution, e.g. in body fluids, where all differences among salts that is counter ion at biological pH of 7.4 (or polymorphs) disappear. The skilled person would thus expect that all polymorphs of the compound display the same pharmacodynamic profile with respect to the treatment of the disease. Note that mesylates are expected to make more soluble salts, compared to for example, HCl salts. See Engel International Journal of Pharmaceutics 198 (2000) 239–247 for an example. According to Engel mesylate provided higher solubility, see Abstract penultimate line. Also see Serajuddin, Advanced Drug Delivery Reviews 59 (2007) 603–616 (for common-ion effect). These references at the minimum suggest that different acids as result effective variables are within the purview of osa for optimization of pK profiles of basic compounds.
Accordingly, the claims do not recite an unobvious distinction over the prior art. Further, a reference is relevant not only for what it expressly teaches, but also for what it would have conveyed to one of ordinary skill in the art. See In re Opprecht, 12 USPQ2d 1235, 1236 (Fed. Cir. 1989); In re Bode, 193 USPQ 12 (CCPA 1976). In light of the foregoing discussion, the Examiner finds that the claimed subject matter as a whole would have been obvious to one of ordinary skill in the art at the time the invention was made, in view of the cited references and the knowledge generally available in the art. Accordingly, the claims are rejected under 35 U.S.C. § 103.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NIZAL S CHANDRAKUMAR whose telephone number is (571)272-6202. The examiner can normally be reached M-F 8-5 EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Andrew Kosar can be reached at (571) 272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NIZAL S CHANDRAKUMAR/Primary Examiner, Art Unit 1625
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