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 .
Current Status of 17/773, 404
This Office Action is responsive to the amended claims and Applicant remarks of 06/04/2026. Claims 1-2, 4, 7-10, 16-20, 22-37, and 40-71 are pending and claims 54-71 are withdrawn. Claims 1-2, 4, 7-10, 16-20, 22-37, and 40-53 have been examined on the merits.
Priority
The instant application is a national stage entry of PCT/US2020/059226, international filing date 5 November 2020, which claims priority to U.S. Provisional Application No. 63/046,476, filed 30 June 2020, U.S. Provisional Application No. 62/931,627, filed 6 November 2019, and U.S. Provisional Application No. 62/931,174, 5 November 2019.
Base claim 1 is not fully supported by 62/931,174. The following elements of instant claim 1 are supported in 62/931,627 and are given the effective filing date of 6 November 2019: R200 is independently C3-6 cycloalkyl; 5-10 member heterocycloalkyl having 1-3 ring heteroatoms selected from N, O, and S; C1-6 alkyl and C3-6 cycloalkyl are optionally substituted with 4 substituents.
The following elements of base claim 1 do not find support in any of the provisional applications, but find support in PCT/US2020/059226 and are given the effective filing date of 5 November 2020: M1 is 4-10 member heterocycloalkyl having 1-3 ring heteroatoms independently selected from N, O, and S (only 5-10 member is claimed in 62/931,174); M2 is C5-10 spiroalkyl (62/931,174 only discloses C6-10 spiroalkyl); M2 is 4-10 member heterocycloalkyl having 1-3 ring heteroatoms independently selected from N, O and S (62/931,174 only discloses 5-10 membered substituents).
All other elements of base claim 1 and claims 2-11, 13, 14, 16-20, 22-37, and 40-53 find support in 62/931,627 and are given the effective filing date of 5 November 2019.
Response to Arguments
Claim Objections:
Applicants have amended claim 52 to include the structures of Compounds E001-E003, rendering the previous objection to the claim moot. This objection is withdrawn due to this amendment.
Rejections Under 35 U.S.C. 112(b)
Applicants have amended claim 1, limiting the substitutions of G1-G5 to include pyridinyl, pyrazinyl, or pyrimidinyl rings. The amendments also further restrict L1 to O. However, these amendments are insufficient to overcome the rejection. A detailed explanation is provided below.
Applicants have amended claim 1 to remove the definition of M2 which recited “5-10 member heteroaryl.” This amendment renders the previous rejection moot and the rejection is withdrawn.
Rejections Under 35 U.S.C. 112(d)
Applicants have amended claim 52 to remove compounds E054, E121, E153, E161, E242, and E287, which were identified as being outside the scope of the compounds embodied by claim 1. This amendment renders the previous rejection moot, and the rejection is withdrawn.
Rejections Under 35 U.S.C. 102
Applicants allege that the compound of reference Tipparaju no longer anticipates the compounds of instant claim 1 due to the amendments removing C1-C3 alkoxy from the allowed M1 substituents. These amendments distinguish the claimed compounds from the reference and the rejection is withdrawn.
Applicants allege that the compounds of reference Whitten no longer anticipates the compounds of instant claim 1 due to the amendment removing C6-10 aryl from the definition of M2. These amendments distinguish the claimed compounds from the reference and the rejection is withdrawn.
Applicants allege that the compound of Houze does not anticipate the compound of claim 1 owed to the wherein clause that recites “that one of G2, G3, and G4 is -C-L1-M1.” Applicants further contend that this limits the ring defined by G1-G5 may include one -C-L1-M1 substituent. This argument is not persuasive. Applicants have improperly extended this limitation to include G5 when only G2, G3, and G4 are limited to one of these substituents being substituted with a -C-L1-M1 group. The compound of Houze discloses a compound where G1 is N, G2 and G4 are CH, and G3 and G5 are -C-L1-M1. G1 satisfies the limitation requiring G1 or G5 to be N. G3 is the only one of G2, G3, and G4 that is -C-L1-M1, thereby satisfying the limitation that only one of G2, G3, and G4 is -C-L1-M1. However, Applicants have amended claim 1 limiting L1 to only include -O-. the L1 of G3’s substituent is -CH2- and is not allowed by the claim. The reference compound is not anticipatory owed to this limitation and the rejection is withdrawn.
Regarding the rejection of claim 1 in view of reference Horie, Applicants allege that the wherein clause defining that G1 or G5 is N; or G1 and G4, or G2 and G5, or G3 and G5 are N, and one of G2, G3, and G4 is -C-L1-M1 directs the claimed compounds to include pyridinyl, pyrazinyl, or pyrimidinyl rings and that the compound of Horie fails to meet these criteria. These arguments are not persuasive. However, claim 1 has been amended to limit L1 to -O-. Horie’s compound required L1 to be -O-(CH2)w-. This limitation prevents the compound from anticipating the instant compound of Formula I. The rejection is withdrawn.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 1 is rejected on the basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117.
The Markush grouping of the compounds of Formula I is improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons: G1-G5 are each independently N, C-H, or -C-L1-M1 provided that at least one of G1-G5 is N. Applicants have amended claim 1 to include a wherein clause specifying that G1 or G5 is N; or G1 and G4, or G2 and G5, or G3 and G5 are N, and one of G2, G3, and G4 is -C-L1-M1. However, this amendment continues to encompass compounds with different monoaza and diaza ring cores. Additionally, the claim encompasses different positional arrangements of the -C-L1-M1 group within these rings. The amendment narrows the number of permitted combinations but continues to group multiple alternative compounds and regioisomers within Formula I.
Although the amendment narrows the scope, it does not establish that the remaining compounds belong to the same recognized class or are functionally equivalent for the claimed use. The remaining ring positions are not sufficiently defined to provide a clear, structurally related grouping of compounds.
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use.
Claim 1 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 has been amended to include the limitation “wherein: G1 or G5 is N; or G1 and G4, or G2 and G5, or G3 and G5 are N, and one of G2, G3, and G4 is -C-L1-M1,” which alleges to limit the permitted arrangements of the G1-G5 ring atoms. However, the amended language fails to clearly define the permitted number and positions of nitrogen atoms in the ring.
As written, it is unclear whether the limitation that “G1 or G5 is N” requires at least one of G1 or G5 to be N, while permitting each of the remaining G positions to independently be selected from N, CH, or -C-L1-M1, or if it is intended to define a mononitrogen substituted ring where the only nitrogen is present at either G1 or G5. Under the former interpretation, when G1 is N, G2-G5 may each independently be selected from N, CH, or -C-L1-M1, and arrangements such as G1 and G2 both being N remain within the scope of the claim. Under the later interpretation, the subsequently recited G pairs of G1 and G4, G2 and G5, and G3 and G5 may be interpreted as an exhaustive identification of the permitted dinitrogen ring arrangements, and would exclude a G1/G2 dinitrogen moiety. Because both interpretations of the claim are reasonable, the metes and bounds of the claim are unclear.
Additionally, it is unclear whether the phrase “and one of G2, G3, and G4 is -C-L1-M1” is meant to be applied to each preceding nitrogen arrangement, only the dinitrogen arrangements, or only to the preceding G3/G5 dinitrogen arrangement. It is also unclear whether “one of” requires exactly one or at least one of G2-G4 to be -C-L1-M1.
Conclusion
Claim 1 is rejected.
Claims 2, 4, 7-10, 16-20, 22-37, and 40-53 are objected to for being dependent upon a rejected base claim.
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.
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/C.K.E./Examiner, Art Unit 1625 /Andrew D Kosar/Supervisory Patent Examiner, Art Unit 1625
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