DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Claims and Response to Amendments
The amendments filed on May 21, 2026 have been acknowledged and entered. Claims 1, 3-17, and 19-22 are pending. Claims 2 and 18 are cancelled.
Status of Priority
The present application is a 35 U.S.C. § 371 national stage patent application of International patent application PCT/US2022/033159, filed on June 11, 2022. This application also claims the benefits of foreign priority to CN202110653751.3, filed on June 11, 2021 and CN202210187387.0, filed on February 28, 2022.
Specification - Disclosure
The specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Withdrawn Rejections
Applicant is notified that any outstanding rejection or objection that is not expressly maintained in this office action has been withdrawn or rendered moot in view of applicant' s amendments and/or remarks
Claim Objections
Claim 19 is objected to because of the following informalities:
For consistency, claim 19 should read:
“… ring A is phenyl or 5- or 6-membered heteroaryl…”
Appropriate correction is required.
-------------------------------------- Maintained Rejections --------------------------------------
Claim Rejections - 35 USC § 112(b)
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 5 and 10 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.
Examiner interprets claim 5 to mean that moiety A can be substituted with 0 to 3 R10 at any position. Under this interpretation, this also includes:
a moiety A wherein the R4 group of moiety A can be further substituted with a R10. This means if R4 is a C1-6 alkyl group, it can be substituted with a R10 wherein R10 = C1-3 alkoxy;
However, R4 being an alkyl group that is substituted with an alkoxy group is not encompassed by claim 4 (i.e., the claim in which claim 5 is dependent upon). Thus, there is insufficient antecedent basis for this limitation in the claim;
a moiety A wherein the methyl groups bonded to P can be substituted with R10 = C1-3 alkoxy;
However, claim 4 requires the methyl groups bonded to P be unsubstituted.
Thus, there is insufficient antecedent basis for the limitation “moiety A substituted with 1 to 3 R10” in claim 5.
Examiner also interprets claim 10 to mean that moiety C as a whole can be substituted with 0 to 3 R10 at any position. This means, according to claim 10, the cyclopropyl groups bonded to P(=O) can be substituted with C1-3 alkoxy, for instance. However, R5 or R6 being a cyclopropyl-alkoxy group is not encompassed by instant claim 9 (i.e., the claim in which claim 10 is dependent upon). Note: claim 9 specifically requires the two cyclopropyl groups bonded to P(=O) to be unsubstituted. Thus, there is insufficient antecedent basis for the limitation “moiety C substituted with 1 to 3 R10” in claim 10.
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, 3-17, and 19-22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over:
claims 1-6, 9-20, 24, and 25 of U.S. Patent Application No. 18881281 (‘281)
Although the claims are not identical, they are not patentably distinct from each other because the compounds claimed in the co-pending application are obvious homologs of the compounds claimed in the present application.
The claim set of ‘281 discloses a compound of the following formula (herein, referred to as Formula-I-281):
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325
253
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.
Formula-I-281 (with the exception of the region indicated by the dashed circle) encompasses the corresponding structural regions of instant Formula (I). The main structural distinction between Formula-I-281 and instant Formula (I) resides in the circled region. Specifically, Formula-I-281 requires the substituent in that position to be -NH2, whereas instant Formula (I) recites that if the substituent in that position is an amino group, it can only be -NH(C1-6 alkyl) or a -NH(deuterated C1-6 alkyl) group.
According to MPEP 2144.09:
I. REJECTION BASED ON CLOSE STRUCTURAL SIMILARITY IS FOUNDED ON THE EXPECTATION THAT COMPOUNDS SIMILAR IN STRUCTURE WILL HAVE SIMILAR PROPERTIES
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 In re Papesch, 315 F.2d 381, 137 USPQ 43 (CCPA 1963) (discussed in more detail below) and In re Dillon, 919 F.2d 688, 16 USPQ2d 1897 (Fed. Cir. 1990) (discussed below and in MPEP § 2144) for an extensive review of the case law pertaining to obviousness based on close structural similarity of chemical compounds. See also MPEP § 2144.08, subsection II.A.4.(c).
II. HOMOLOGY AND ISOMERISM ARE FACTS WHICH MUST BE CONSIDERED WITH ALL OTHER RELEVANT FACTS IN DETERMINING OBVIOUSNESS
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). See also In re May, 574 F.2d 1082, 197 USPQ 601 (CCPA 1978) (stereoisomers prima facie obvious); Aventis Pharma Deutschland v. Lupin Ltd., 499 F.3d 1293, 84 USPQ2d 1197 (Fed. Cir. 2007) (5(S) stereoisomer of ramipril obvious over prior art mixture of stereoisomers of ramipril.).
In other words, hydrogen and methyl are considered to be homologs, and substitution between homologous groups is a routine modification that is presumed to yield compounds with similar properties. The compounds (which are homologs of the instantly claimed compounds), are also used in a method for treating a disease or disorder by inhibiting TYK2 mediated signal transduction in a subject suffering therefrom wherein the disease or disorder includes psoriasis.
Thus, the claimed compounds are not patentably distinct from those of the co-pending application.
------------------------ Rejections necessitated by Applicant Amendment ------------------------
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 8 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
For context, claim 1 recites that R2 is -NRdC(O)Ra. Then in claim 1, it states that Ra can only be alkyl, deuterated alkyl, halo-alkyl, or cycloalkyl. In other words, claim 1 does not allow R2 to be the following groups: -NRdC(O)H or -NRdC(O)D. Note: Rd is H according to claim 1.
However, in claim 8 (which is dependent on claim 1), it does allow Ra to be hydrogen or deuterium. In other words, claim 8 now broadens the scope of R2 (which is the -NHR9 group in formula (IV) as recited in claim 8 wherein R9 is -C(O)Ra) to include: -NHC(O)H or -NHC(O)D.
Thus, claim 8 fails to further limit the subject matter of the claim upon which it depends and, instead, broadens the scope of claim 1.
Conclusion
No claims are allowed.
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 KRISTEN ROMERO whose telephone number is (571)272-6478. The examiner can normally be reached M-F 9:30 AM - 6:00 PM ET.
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/KRISTEN W ROMERO/Examiner, Art Unit 1624 /JEFFREY H MURRAY/Supervisory Patent Examiner, Art Unit 1624
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