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 .
Status of Claims
Claims 1-8, 10, and 22-25 are pending in the instant application. Claim 25 is new and drawn to the elected invention. However, an election of species requirement has been required in the instant application where the Markush claim has been expanded and rejected to cover another nonelected species. In reference to MPEP 803.02: If the examiner determines that the elected species is allowable over the prior art, the examination of the Markush claim will be extended. If prior art is then found that anticipates or renders obvious the Markush claim with respect to a nonelected species, the Markush claim shall be rejected; claims to the nonelected species would still be held withdrawn from further consideration. The prior art search will not be extended unnecessarily to cover all nonelected species, and need not be extended beyond a proper Markush grouping. See subsection III.C.2, below, for additional guidance. Thus due to the prior art of record and subject matter presented in new claim 25 being outside said art; this species claim is withdrawn. Thus claims 2 and 25 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.
An action on the merits of claims 1, 3-8, 10, and 22-24 is contained herein.
Status of Rejections
35 USC § 103
The 103 rejection of claims 1, 3-7, 10, and 23-24 is still maintained.
Applicant’s arguments, see Remarks, filed 6/29/2026, with respect to the Office Action mailed 3/27/2026, have been fully considered but are not found persuasive.
To reiterate the rejection of record; the instant claims may be drawn to compounds of formula I wherein R1 = H or alkyl, R2,3 = H, ring embracing Y variables form an unsubstituted phenyl ring, X = -CH=CH, Z = -CH, R4 = heteroaryl substituted with alkyl, R5 = alkyl, and R6 = H.
US Patent 5,846,990 teaches the following compound at col. 46, example 15, compositions described at col. 8, li. 38-57:
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wherein R1-3 = H, ring embracing Y variables form an unsubstituted phenyl ring, X = -CH=CH, Z = -CH, R4 = heteroaryl substituted with alkyl, and R5,6 = H.
The difference between this compound and the claimed species stems at variable R5 (hydrogen versus alkyl). However the document teaches that this ring may be substituted with alkyl groups and other groups such as alkoxy (see col. 2, li. 7-10 for variables R13,14). Additionally the imidazole ring may be further substituted with alkyl groups as well (see variables R1,2, col. 1, li. 40). Thus, the claimed species would have been considered obvious.
Once again Applicants continue to argue that one skilled in the art would not have arrived at the above claimed compounds due to the document listing over “two and a half pages” of alternative substituents which may be used for variables R13,14 in addition to “alkyl groups and other groups such as alkoxy” along with teaching over 284 example compounds. The examiner respectfully disagrees once again. The document clearly teaches that the groups may be used as equivalents and are interchangeable on the phenyl and imidazole rings (see for example col. 2, li. 7-10 for variables R13,14). The latter is motivation to arrive at the claimed species in the instant application. Applicant’s arguments suggesting the document teaches other example compounds again is not found persuasive. There is no teach away aspect from using the cited species in the document.
Attention is directed to MPEP 2141.02 (VI) which deals with references that may "teach away" but also states that alternative embodiments should not be confused with "teaching away" citing a recent decision, In re Fulton (73 USPQ2d 1141). Note the following passage in Fulton at 1146: "The 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 the ′198 application. Indeed, in the case cited by appellants, In re Gurley, we held that the invention claimed in the patent application was unpatentable based primarily on a prior art reference that disclosed two alternatives, one of which was the claimed alternative. Accordingly, mere disclosure of alternative designs does not teach away".
The examiner assumes that Applicant is also arguing the “lead compound analysis” as one skilled in the art would not have selected example 15 out of the other alternatives for further derivatization. Attention is noted towards MPEP 2143 Section B regarding the “lead compound” analysis:
The Federal Circuit in Eisai makes it clear that from the perspective of the law of obviousness, any known compound might possibly serve as a lead compound: "Obviousness based on structural similarity thus can be proved by identification of some motivation that would have led one of ordinary skill in the art to select and then modify a known compound (i.e. a lead compound) in a particular way to achieve the claimed compound." Eisai, 533 F.3d at 1357, 87 USPQ2d at 1455. Thus, Office personnel should recognize that a proper obviousness rejection of a claimed compound that is useful as a drug might be made beginning with an inactive compound, if, for example, the reasons for modifying a prior art compound to arrive at the claimed compound have nothing to do with pharmaceutical activity. The inactive compound would not be considered to be a lead compound by pharmaceutical chemists, but could potentially be used as such when considering obviousness. Office personnel might also base an obviousness rejection on a known compound that pharmaceutical chemists would not select as a lead compound due to expense, handling issues, or other business considerations.
It is evident that the document discloses a reasonable number of working examples (including example 15) useful in a pharmaceutical setting and explicit teachings useful for further derivatization and evaluation. Therefore, example 15 or any of those examples disclosed would be categorized as a “lead compound” in regard to MPEP 2143.
Other arguments presented by Applicant such as the identification of AT2 receptor agonists or treating related disorders as demonstrated in the instant application are once again found unpersuasive since the claims are drawn to the compounds themselves and not methods of using thereof. Additionally, Applicant has not provided any data of record in declaration form showing that the prior art compound is less superior to those currently claimed in reference to biological activity. Rebuttal evidence and arguments can be presented in the specification, In re Soni, 54 F.3d 746, 750, 34 USPQ2d 1684, 1687 (Fed. Cir. 1995), by counsel, In re Chu, 66 F.3d 292, 299, 36 USPQ2d 1089, 1094-95 (Fed. Cir. 1995), or by way of an affidavit or declaration under 37 CFR 1.132, e.g., Soni, 54 F.3d at 750, 34 USPQ2d at 1687; In re Piasecki, 745 F.2d 1468, 1474, 223 USPQ 785, 789-90 (Fed. Cir. 1984). However, arguments of counsel cannot take the place of factually supported objective evidence. See, e.g., In re Huang, 100 F.3d 135, 139-40, 40 USPQ2d 1685, 1689 (Fed. Cir. 1996); In re De Blauwe, 736 F.2d 699, 705, 222 USPQ 191, 196 (Fed. Cir. 1984).
Thus based on the preponderance of evidence presented by the examiner, the claims remain rejected.
Conclusion
Claims 1, 3-7, 10, and 23-24 are rejected. Claims 8 and 22 are allowable.
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 BRIAN E MCDOWELL whose telephone number is (571)270-5755. The examiner can normally be reached on 8:30-6 MF.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Murray can be reached at 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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/BRIAN E MCDOWELL/ Primary Examiner, Art Unit 1624
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