DETAILED ACTION
All rejections and objections not mentioned below have been withdrawn.
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 .
Election/Restrictions
Applicant’s election without traverse of Group I, Claims 1-3, 5, 12-14, 17, 20, 22-23, 25-28, 30, 33-34, 36, 39, 42, 44-46, 49-50, 52-53, 55, 58, and 60-63 read on elected Group I, in the reply filed on 02/26/2026 is acknowledged.
Applicant’s election without traverse of compound of Example 35 in Table 1 (shown below), which is included in claims 1-3, 12-14, 17, 25, 70, 71, 74, 75, 78, and 79.
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Elected Species
The elected species has been searched and found to be obvious in view of the prior art. Therefore, the search and examination of the claims was restricted to the claims covered by the elected species and elected group: claims 1-3, 12-14, 17, 25 in so far as they read on the elected species.
Claims 1-3, 12-14, 17, 25 are examined on the merits herein, so far as they read on the elected species.
Claims 5, 20, 23, 26, 63, 70, 71, 74, 75, 78, 79, and 81-87 are withdrawn as they do not read on the elected species.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 3, 12-14, 17, 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over WANG (WANG et al., WO-2005099673-A1, 2005-10-27, previously provided).
The reference Wang teaches the following lead compound, (4-Methyl-pyridin-2-yl)-(4-pyridin-2-yl-thiazol-2-yl)-amine, (Table 1, second compound, page 46), wherein R2= 2-pyridyl, R3=H, R1=2-pyridyl substituted with one C1 alkyl, R4=H. This helps to teach claims 1-3, 12-14, 17, 25.
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The reference Wang teaches the general formula (I) wherein it would be obvious to substitute the lead compound (shown above) with different reference (R1)s from the general formula below (reference claim 1 and 8).The reference Wang also teaches these compounds are useful for treating disease reference claims 19-21.
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The reference Wang does not teach the specific elected compound or the specific compound of the instant claims but instead requires picking and choosing for a list of variables (all claims).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to have modified WANG to get the instant elected compound because Wang teaches the lead compound (shown above) that only differs from the elected compound by two -OCH3 groups and the lead compound would be obvious to modify by adding two -OCH3 groups because the general formula of Wang teaches R1=-OCH3 as specifically pointed out in reference claim 8 and teaches s=1-4. One would be motivated to do so because the compounds of references claims are considered to be useful for treating diseases. One would have a reasonable expectation of success because it is only two small modifications from the lead compound and the specific functional groups require are specifically pointed out in claim 8 in a very short list of options. Furthermore, it would be obvious in view of the lead compound of Wang to get instant compounds 1-2 and 4 (see instant table 1, also covered by instant claims 1-3, 12-14, 17, 25) because they only differ by a single additional methyl group from the lead compound of Wang. It would be obvious to one of ordinary skill in the art to modify the lead compound of Wang to get compounds 1-2 or 4 because the general formula of Wang and reference claim 8 suggest and include this modification. One would have a reasonable expectation of success because it is included in the general formula and specifically pointed out in reference claim 8. One would be motivated to do so because the compounds of references claims are considered to be useful for treating diseases. Further, it is generally noted that the substitution of methyl for hydrogen on a known compound is not a patentable modification absent unexpected or unobvious results. In re Druey, 319 F.2d 237, 138 U.S.P.Q. 39 (C.C. P.A. 1963). Given that applicant did not provide unexpected or unobvious results of the invention, it is concluded that the normal desire of scientists or artisans to improve upon what is already generally known would provide the motivation to substitute the H group for a Me. 2144.08(II)(A)(4)(c).
The specific combination of features claimed is disclosed within the broad generic ranges taught by the reference but such “picking and choosing” within several variables does not necessarily give rise to anticipation. Corning Glass Works v. Sumitomo Elec., 868 F.2d 1251, 1262 (Fed. Circ. 1989).
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However, it must be remembered that “[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious”. KSR v. Teleflex, 127 S,Ct. 1727, 1740 (2007) (quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976)). “[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious”, the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR v. Teleflex, 127 S.Ct. 1727, 1741 (2007). The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742.
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Response to Arguments
Applicant's arguments filed 07/29/2026 have been fully considered but they are not persuasive.
The applicants argue that the compounds of the instant invention are not obvious over the compounds of the reference Wang. This is not persuasive because the only difference from the lead compound (Table 1, second compound, page 46) and the compound of claims 1, 3, 12-14, 17 and 25 is a single methyl group. The generic formula of the reference includes this modification and further, it is generally noted that the substitution of methyl for hydrogen on a known compound is not a patentable modification absent unexpected or unobvious results. In re Druey, 319 F.2d 237, 138 U.S.P.Q. 39 (C.C. P.A. 1963). Given that applicant did not provide unexpected or unobvious results of the invention, it is concluded that the normal desire of scientists or artisans to improve upon what is already generally known would provide the motivation to substitute the H group for a Me. 2144.08(II)(A)(4)(c).
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It would also be obvious to add the two OCH3 groups because these are also suggested by the general reference formula and thus the elected compound is also obvious in view of the reference.
The applicant further argues that there is no reason to modify the lead compound. One would be motivated to do so because the compounds of references claims are considered to be useful for treating diseases. The argument is not persuasive because the reason is to discover new drugs for the same diseases that are similar in structure to those mentioned by the reference as these are also included under the general formula there is a reasonable expectation that they would have similar enough structure to also be used for the same purpose.
The person of ordinary skill in the art had reason to select the lead compound because it was suggested by the reference. Disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments. In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971). Furthermore, "[t]he prior art’s mere disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed…." In re Fulton, 391 F.3d 1195, 1201, 73 USPQ2d 1141, 1146 (Fed. Cir. 2004).
A person of ordinary skill in the art would have reason to modify the lead compound in this particular manner because they have reason to discover new drugs for the same diseases as treated by the compound of the reference. These modifications are also included under the general formula so there is a reasonable expectation that they would have similar enough structure to also be used for the same purpose.
As adding a methyl group or a OCH3 is a relatively small change to the structure and also suggested by the reference general formula there is a reasonable expectation of success.
Even if the OCH3 replacement is considered too much picking and choosing (the examiner find this argument unpersuasive as it is only two small changes to the structure) the 103 rejection still hold because the claims are obvious over only one simply H to methyl replacement, which is not considered a patentably medication without unexpected results.
It is the Examiner’s understanding that Applicant repeatedly alleges the existence of unexpected results commensurate in scope with the requirements of MPEP §716, §716.01, and §716.02, wherein such results are sufficient to rebut prima facie obviousness. However, to establish unexpected results, the evidence must establish that the expected results occur to an unexpected extent (see, e.g., MPEP § 716.02(a)(I)), on the basis of statistically and practically significant evidence (see, e.g., MPEP § 716.02(b)(I)), which is fully explained (see, e.g., MPEP § 716.02(b)(II)), commensurate in scope with the claimed invention (see, e.g., MPEP § 716.02(d)), and wherein a comparison of the claimed invention with the closest prior art of record is provided (see, e.g., MPEP § 716.02(e)). Furthermore, even if evidence satisfying MPEP §§ 716.02, 716.02(a), 716.02(b), 716.02(d), and 716.02(e) is set forth on record, such evidence may not be sufficient to rebut prima facie obviousness because the evidence of expected and unexpected results must be weighed (see, e.g., MPEP § 716.02(c)(I)) and the totality of the record considered (see, e.g., MPEP § 716.02(f)), including teachings in the prior art and evidence of expected results which weigh in favor of a determination of obviousness (see, e.g., MPEP § 716.02(c)(II)).
The unexpected results are not considered persuasive because Table 1 only consists of 238 compounds while the generic formula of the instant claims is likely to contain hundreds of thousands of structurally different compounds do to the many combinations of variables. As the applicant themselves point out on page 52 of their arguments “Biological activity is unpredictable and small structural modifications can have dramatic effects on binding affinity, selectivity, and therapeutic efficacy” thus there is no expectation that all of these compounds would have the same unexpected effects. Thus the claims are not commensurate in scope with the unexpected results. In addition, unexpected results must be compared to the closest available art in this case the lead compound of Wang that only differs by one methyl group to determine if this is truly unexpected over the prior art. Thus the unexpected results are not persuasive.
Conclusion
Claims 1, 3, 12-14, 17, 25 are rejected.
Claims 5, 20, 23, 26, 63, 70, 71, 74, 75, 78, 79, and 81-87 are withdrawn as they do not read on the elected species.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 ALISON AZAR HASTINGS whose telephone number is (703)756-4584. The examiner can normally be reached Mon-Thurs 7:30am-5pm EST Friday 7:30-4pm EST (every other Friday off).
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/A.A.H./ Examiner, Art Unit 1627
/Kortney L. Klinkel/ Supervisory Patent Examiner, Art Unit 1627
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