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 1-2, 13, 15-18 and 23-35 are pending in this application.
Response to Amendment
Applicant’s amendment filed 07/16/2026 in response to the previous Office Action (04/29/2026) is acknowledged. Rejection of claims 1-2, 13-16 and 23-24 under 35 U.S.C. 102(a)(1)/102(a)(2) has been obviated. Even though applicants overcome the prior art rejection by claim amendment, said amendment raises new issue that need further rejection. Note that the newly added claims 26-35 also raises new issues. Applicants have deleted the non-elected species from the previous claims, but they are now added in the new claims. Since the 102(a)(1)/102(a)(2) rejection is replaced with the obviousness rejection under 35 U.S.C. 103, this action was not made Final.
Election/Restrictions
Applicant’s election with traverse of Group I and a species b. (i.e. T = C, see compound of Example 8, paragraph [0393]) in the reply filed on 12/22/2025 is acknowledged. The traversal is on the ground that the restriction requirement between Groups I and II are without merit. Applicants argue that Groups I and II don’t lack unity of invention. The examiner disagrees with applicant’s argument. As set forth in the Restriction Requirement, Groups I and II lack unity of invention because the groups don’t share the same or corresponding technical feature. Applicants also argue that the examination of Groups I and II should be examined together and would not require an additional burden of search. The examiner disagrees with applicant’s argument. The search for Group II would require search of subclasses unnecessary for the examination of the elected claims. For example, the search for the invention of Group II would include search of class A61K in EAST database and it also requires an additional text search in different databases. Therefore, co-examination of the additional invention would require a serious additional burden of search.
The requirement is still deemed proper and is therefore made FINAL.
Note that once the compounds of Group I are found allowable, the invention of Group II (Claims 25, 32 and 35) would be rejoined.
In order to expedite prosecution and place the case in condition for allowance, it is recommended that applicants delete non-benzo[b]thiophene species of formula (I-1A) of claims 33-34.
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Note that many of the species in claims 33-34 are not embraced by formula (I-1A).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-2, 13, 15, 17-18, and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Yu et al. WO 2022135567 A1 (equivalent to US 20240391895 A1). Cited reference teaches the following compound that is almost the same as applicants when applicants formula (I-1A) has the following substituents: R3 = R4 = R6 = H; R5 = CH3; Rb = H; n = 0 and R7 = ethyl substituted piperidinyl (i.e. Rd = CH2-CH3) or unsubstituted piperidinyl (i.e. Rd = H, see last species in claim 24).
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The only difference between the prior art compound shown above and applicants is in the substitution of the piperidine ring. Applicants amended claim 1 to overcome the prior art rejection raised in the previous Office Action and deleted the choice of Rd to be methyl (see below). The prior art compound shown above is substituted by methyl, but applicants now recite that the piperidine to be substituted by at least ethyl.
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Compounds that differ only by the presence or absence of an extra methyl group or two are homologues. Homologues are of such close structural similarity that the disclosure of a compound renders prima facie obvious its homologue. The homologue is expected to be preparable by the same method and to have generally the same properties. This expectation is then deemed the motivation for preparing homologues. Of course, these presumptions are rebuttable by the showing of unexpected effects, but initially, the homologues are obvious even in the absence of a specific teaching to add or remove methyl groups. See In re Wood, 199 USPQ 137; In re Hoke, 195 USPQ 148; In re Lohr, 137 USPQ 548; In re Magerlein, 202 USPQ 473; In re Wiechert, 152 USPQ 249; Ex parte Henkel, 130 USPQ 474; In re Fauque, 121 USPQ 425; In re Druey, 138 USPQ 39. In all of these cases, the close structural similarity between two compounds differing by one or two methyl groups was itself sufficient show obviousness. See also MPEP 2144.09, second paragraph.
Claims 26-31 and 33-34 are rejected under 35 U.S.C. 103 as being unpatentable over Yu et al. WO 2022135567 A1 (equivalent to US 20240391895 A1). Cited reference teaches the following compound that is almost the same as applicants when applicants formula (I-1A) has the following substituents: R3 = R4 = R6 = H; R5 = CH3; Rb = H; n = 0 and R7 = methyl substituted piperidinyl.
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The only difference between the prior art compound shown above and applicants’ compounds recited in claims 33-34 are:
1. In the position of the methyl attached to the pyridazinyl ring (1,2-diazine ring) (position isomer, R5 = H and R6 = CH3 or R5 =CH3 and R6 = H); and 2. The presence or absence of methyl group on the pyridazinyl ring or thiophene ring (homologues).
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It is well established that position isomers are prima facie structurally obvious even in the absence of a teaching to modify. The isomer is expected to be preparable by the same method and to have generally the same properties. This expectation is then deemed the motivation for preparing the position isomers. This circumstance has arisen many times. See: Ex parte Englehardt, 208 USPQ 343, 349; In re Mehta, 146 USPQ 284, 287; In re Surrey, 138 USPQ 67; Ex Parte Ullyot, 103 USPQ 185; In re Norris, 84 USPQ 459; Ex Parte Naito, 168 USPQ 437, 439; Ex parte Allais, 152 USPQ 66; In re Wilder, 166 USPQ 545, 548; Ex parte Henkel, 130 USPQ 474; Ex parte Biel, 124 USPQ 109; In re Petrzilka, 165 USPQ 327; In re Crownse, 150 USPQ 554; In re Fouche, 169 USPQ 431; Ex parte Ruddy, 121 USPQ 427; In re Wiechert, 152 USPQ 249, In re Shetty, 195 USPQ 753.
For example, “Position isomerism has been used as a tool to obtain new and useful drugs” (Englehardt) and “Position isomerism is a fact of close structural similarity” (Mehta, emphasis in the original). See also MPEP 2144.09, second paragraph.
Compounds that differ only by the presence or absence of an extra methyl group or two are homologues. Homologues are of such close structural similarity that the disclosure of a compound renders prima facie obvious its homologue. The homologue is expected to be preparable by the same method and to have generally the same properties. This expectation is then deemed the motivation for preparing homologues. Of course, these presumptions are rebuttable by the showing of unexpected effects, but initially, the homologues are obvious even in the absence of a specific teaching to add or remove methyl groups. See In re Wood, 199 USPQ 137; In re Hoke, 195 USPQ 148; In re Lohr, 137 USPQ 548; In re Magerlein, 202 USPQ 473; In re Wiechert, 152 USPQ 249; Ex parte Henkel, 130 USPQ 474; In re Fauque, 121 USPQ 425; In re Druey, 138 USPQ 39. In all of these cases, the close structural similarity between two compounds differing by one or two methyl groups was itself sufficient show obviousness. See also MPEP 2144.09, second paragraph.
Objection
8. Claims 16 and 23 are 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.
Conclusion
9. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Kahsay Habte Ph.D. whose telephone number is (571)272-0667. The examiner can normally be reached on 8:30 - 5:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JEFFREY MURRAY can be reached on 571-272-9023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Kahsay Habte/
Primary Examiner, Art Unit 1624
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