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 .
Response to Amendments
Applicant’s amendments to the claims of January 12, 2026, in response to the Office Action of October 10, 2025, are acknowledged.
Response to Arguments
Rejections not reiterated herein have been withdrawn.
With respect to the § 102 rejection as anticipated by, or in the alternative, obvious over Sjogren, Applicant argues that none of the genus of the instant claims anticipate the amended claimed. Applicant argues that carbon atoms at positions 8 and 9 is Sjogren have a double bond in the examples. The instant claims require a single bond at positions 8 and 9.
The examiner notes that teachings of a prior art reference are not limited to examples. The core Formula (I) taught by Sjogren clearly include a double bond or a single bond in the claimed position between carbons 8 and 9 as shown below.
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As such, this argument is not persuasive. While it is true that the examples include a single bond at this position, the teachings certainly encompass both. Further, numerous examples of compounds that do not have a double bond in positions 8 and 9 are shown. For example,
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140
268
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or
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. The “dotted” line is defined as inclusive of a single or a double bond.
As such, the rejection under Sjogren is maintained.
With respect to the § 102 rejection as anticipated by Jung, Applicant argues that R1 now must be alkyl. R1 can no longer form a ring together.
The examiner notes that m is still defined to include 0. Thus R1 can be absent.
Jung teaches the following formula:
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169
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. See p6, third compound shown. Further, R7 can be alkyl. See p9, line 7. Q is CH; Y is 0; Z is N or CH. This is a claimed compound of Formula (I) wherein R5 is hydrogen; and R4 is alkyl; R2 and R3 are hydrogen; G1 is nitrogen.
In the above, R1 is equivalent to R1 of Formula (I) of claim 1. Further, y is equivalent to m each of which can be 0 making the R1 group effectively absent.
As such, the rejection under Jung is also maintained.
As previously noted, the elected species compound 136 is free of the prior art and non-obvious in light thereof. In an effort to expedite prosecution of this application, the examiner has expanded his search to a single additional species encompassed by the claims.
That species is taught by Sjogren et al., (WO2003/082871 A1) (cited in ISR) as shown below.
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The compound above has an R2 variable that is alkyl; a “A” variable is absent; a “Y” variable is aryl; and “Z1” is CH. The claims that read on the expanded search include: 1, 2, 6, 8, 9, 12, 15, 23, 24, 29, 33, and 34.
Claims 18, 22, 28, 32 are preliminarily objected to for not reading on the expanded search. New claims 46 and 48-51 are withdrawn for being directed to a non-elected species. Claim 47 is examined as it is directed to the elected compound.
Status of Claims
Claims 1, 2, 6, 8, 9, 12-15, 18, 22, 24, 25, 27-29, 31-34, 37, 38, 40, 43-51 are pending. Claims 13, 14, 25, 27, 31, 37, 38, 40, 43-45, 46, and 48-51 are withdrawn. Claims 1, 2, 6, 8, 9, 12, 15, 24, 29, 33 and 34 are examined. Claims 18, 22, 28, and 32 are preliminarily objected to.
Allowable Subject Matter
Claim 47 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claim Rejections - 35 USC § 102/103
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102/103 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) 1, 2, 6, 8, 9, 12, 15, 24, 29, 33 and 34 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by, or in the alternative, obvious over Sjogren et al., (WO2003/082871 A1) (cited in ISR).
Sjogren teaches protein kinase inhibitor kinase compounds. These compounds have a Formula (I) shown below.
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The compound above has an R2 value that can be an alkyl; the A variable can be absent; the Y variable can be optionally substituted aryl; and Z1 can be CH. This is a compound of Formula (I) of claim 1, wherein R2 is optionally substituted aryl; R5 is hydrogen; R4 is alkyl; m is 0; and n is 1. Sjogren also teaches inclusion of carriers and excipients. See p23 and 24. Prodrugs are contemplated, which is an additional API. See prior art claim 1. A POSA would immediately envisage combining treatment with other agents also known to treat the same condition.
Alternatively, 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). 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.). The examiner contends that a different resonance structure is shown rather than an isomer.
Claim(s) 1, 2, 6, 8, 9, 12, 15, 24, 29, 33 and 34 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Jung et al., (WO2018/005860) (cited in ISR).
Jung teaches the following formula:
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. See p6, third compound shown. Further, R7 can be alkyl. See p9, line 7. Q is CH; Y is 0; Z is N or CH. This is a claimed compound of Formula (I) wherein R5 is hydrogen; and R4 is alkyl; R2 and R3 are hydrogen; G1 is nitrogen.
Jung teaches a carrier or diluent for use with the composition. See p16, line 20. Further, compounds of therapeutics can be used to treat a proliferative disorder, e.g. See p5, line 5.
Alternatively, 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). 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.). The examiner contends that a different resonance structure is shown rather than an isomer.
Conclusion
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 extension fee 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 JARED D. BARSKY whose telephone number is (571)-272-2795. The examiner can normally be reached on Monday through Friday from 8:30 to 5:30. If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Amy L. Clark can be reached on 571-272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JARED BARSKY/Primary Examiner, Art Unit 1628
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