DETAILED ACTION
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 .
This is the first action on the merits.
Claims 1-22, 26 and 27 are pending and claims 26 and 27 are under examination. Claims 1-22 are withdrawn based on the restriction requirement.
Election/Restrictions
Applicant's election without traverse of Groups III and IV in the reply filed on November 21, 2025 is acknowledged. Groups III and IV, drawn compounds of formulas (I) and (IA), embraced by claims 26 and 27 was elected by Applicant. The Examiner has agreed to examine both Groups III and IV. Applicant has not pointed to any errors in the Examiner’s analysis of the different inventions. The requirement is still deemed proper and is therefore made FINAL.
Specification
The substitute specification filed January 3, 2023 has been entered.
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 26 and 27 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fensome et al. (Journal of Medicinal Chemistry, 2018, 61(19), 8597-8612, cited on IDS).
The reference teaches the following species of formulas (I) and (IA):
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185
180
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68
697
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, where the free base is made in step (e) and the salt in step (f), see pages 8608-8609.
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344
328
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254
340
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Claims 26 and 27 are product-by-process claims, and as such, are rendered anticipated by Fensome et al. When the reference teaches a product that appears to be the same as, or an obvious variant of, the product set forth in a product-by-process claim is anticipated although produced by a different process. See In re Marosi, 710 F.2d 799, 218 USPQ 289 (Fed. Cir. 1983) and In re Thorpe, 777 F.2d 695,227 USPQ 964 (Fed. Cir. 1985).
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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 26 and 27 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-3, 5, 7, 9, 13, 14 and 22-26 of U.S. Patent No. 9663526. Although the conflicting claims are not identical, they are not patentably distinct from each other because the present claims are drawn to the compound of formula (I) and the tosylate salt (formula IA) thereof.
The claims in the ‘526 patent embrace the compound of formula (I), see claim 10 for the specific compound, and salts thereof. The tosylate salt is defined in column 21, line 50. Claims 7 and 13 are drawn to the (R) stereoisomer versus the present (S) and several species do not have a methyl on the pyrazole ring as currently claimed.
Since a methyl group is considered a homolog of hydrogen these compounds are considered equivalent. The MPEP 2144.09 states “Compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977).
A prima facie case of obviousness may be made when chemical compounds have very close structural similarities and similar utilities. "An obviousness rejection based on similarity in chemical structure and function entails the motivation of one skilled in the art to make a claimed compound, in the expectation that compounds similar in structure will have similar properties." In re Payne, 606 F.2d 303, 313, 203 USPQ 245, 254 (CCPA 1979). Applicants are requested to note that MPEP § 2144.09 teaches that stereoisomers are prima facie obvious. See also In re May, 574 f.2d 1082, 197 USPQ 601 (CCPA 1978).
Moreover, there is no patentable distinction between compounds and methods of intended use of said compounds.
Claims 26 and 27 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-2 of U.S. Patent No. 10463675. Although the conflicting claims are not identical, they are not patentably distinct from each other because the present claims are drawn to the compound of formula (I) and the tosylate salt (formula IA) thereof.
The claims in the ‘675 patent embrace a method of treating Chron’s disease, lupus, inflammatory bowel disease, among others, utilizing a the (R) stereoisomer of the present compound with a non-methylated pyrazole ring, see claim 2, column 180, lines 50-52, and salts thereof. The tosylate salt is defined in column 21, line 49.
Since a methyl group is considered a homolog of hydrogen these compounds are considered equivalent. The MPEP 2144.09 states “Compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977).
A prima facie case of obviousness may be made when chemical compounds have very close structural similarities and similar utilities. "An obviousness rejection based on similarity in chemical structure and function entails the motivation of one skilled in the art to make a claimed compound, in the expectation that compounds similar in structure will have similar properties." In re Payne, 606 F.2d 303, 313, 203 USPQ 245, 254 (CCPA 1979). Applicants are requested to note that MPEP § 2144.09 teaches that stereoisomers are prima facie obvious. See also In re May, 574 f.2d 1082, 197 USPQ 601 (CCPA 1978).
Moreover, there is no patentable distinction between compounds and methods of intended use of said compounds.
Claims 26 and 27 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 10980815. Although the conflicting claims are not identical, they are not patentably distinct from each other because the present claims are drawn to the compound of formula (I) and the tosylate salt (formula IA) thereof.
The claims in the ‘815 patent embrace a method of treating psoriasis utilizing the compound of formula (I), see claim 1 for the specific compound, and salts thereof. The tosylate salt is defined in column 21, line 51. Claims 2, among others, is drawn to the non-methylated pyrazole ring as the methyl-pyrazole currently claimed.
Since a methyl group is considered a homolog of hydrogen these compounds are considered equivalent. The MPEP 2144.09 states “Compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977).
A prima facie case of obviousness may be made when chemical compounds have very close structural similarities and similar utilities. "An obviousness rejection based on similarity in chemical structure and function entails the motivation of one skilled in the art to make a claimed compound, in the expectation that compounds similar in structure will have similar properties." In re Payne, 606 F.2d 303, 313, 203 USPQ 245, 254 (CCPA 1979), see MPEP § 2144.09.
Moreover, there is no patentable distinction between compounds and methods of intended use of said compounds.
Claims 26 and 27 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 11197867. Although the conflicting claims are not identical, they are not patentably distinct from each other because the present claims are drawn to the compound of formula (I) and the tosylate salt (formula IA) thereof.
The claims in the ‘867 patent embrace the compound of formula (I), see claim 8 for a small genus of compounds, and salts and compositions thereof. The tosylate salt is defined in column 21, line 56.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUSANNA MOORE whose telephone number is (571)272-9046. The examiner can normally be reached Monday - Friday, 10:00 am to 7:00 pm.
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/SUSANNA MOORE/Primary Examiner, Art Unit 1624