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, 3, 5, 11 and 13-15 are pending in this application.
Response to Amendment
Applicant’s amendment filed 05/19/2026 in response to the previous Office Action (02/19/2026) is acknowledged. Rejection of claims 1-2, 5 and 7-9 under 35 U.S.C. 102(a)(1) (item 4) and under 35 U.S.C. 112(b) (item 11) and under 35 U.S.C. 112(d) (item 12) has been obviated. The obviousness rejection under 35 U.S.C. 103 (item 8) has been maintained.
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 01/20/2026 is acknowledged. Note that once applicants overcome the prior art rejection, the examiner will rejoin the method claims of Group II.
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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.
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, 3 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Li, Hong CN-106963767 A. Cited reference teaches the following two compounds that are almost the same as applicants when applicant’s Formula 1 has the following substituents: R1 = H, methyl; and R2 = methyl-substituted phenyl; and methyl- substituted benzyl.
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Applicants are claiming compounds of Formula I-2, Formula 1-7, Formula 1-10 and Formula 1-12.
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The two prior art compounds shown above are almost the same as applicants except the presence or absence of a methylene group (see for example Formula 1-2 and the first prior art compound); or the presence or absence of a methyl substituent (see for example Formula 1-7, Formula 1-12 and the first prior art); or the position of a methyl substituent on the phenyl ring (see for example Formula 1-10 and the second prior art compound).
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.
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.
Response to arguments
Applicant’s argument filed 05/19/2026 has been fully considered but it is not persuasive.
Applicants argue that “the corresponding Formula in amended claim 3, differ from Li’s compounds in the identity, connectivity and electronic character of the substituents that interact with the NLRP3 inflammasome binding pocket.” The examiner disagrees with applicant’s argument. How is the first prior art compound shown below differ in identity and how the substituent interact with the NLRP3 inflammasome binding pocket from the claimed compounds in claim 3, see for example the compound of Formula 1-7?
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How is the second prior art compound shown below differ in identity from the claimed compound of Formula 1-10 in claim 3? How is the interaction with the NLRP3 inflammasome binding pocket different for the second prior art compound from the claimed compound of Formula 1-7?
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The only difference between the prior art compounds and the claimed compounds Formula 1-2, Formula 1-7, Formula 1-10 and Formula 1-12 is the presence or absence of a methylene group, the position of a methyl substituent on the phenyl ring or the absence or presence of a methyl substituent on the phenyl ring. Applicant’s lengthy arguments using Example 6 and FIGS 8 and 9 are reviewed but it is not sufficient to overcome the obviousness rejection. For example, as shown above the only difference between the second prior art compound and Formula 1-10 is the position of the methyl substituent on the phenyl ring (ortho vs para substitution).
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Applicants’ arguments above are not relevant to the obviousness rejection. Applicants did not show any data that shows unexpected results over the prior art compounds. Applicants have to compare the prior art compounds with the claimed compounds in claim 3 and show unexpected results under oath.
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.
Conclusion
8. 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.
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, 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
Prosecution Insights