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 .
DETAILED ACTION
Status of Claims
Claims 116-142 are pending in the instant application. Claims 138-142 are new claims and drawn to the elected invention while claim 139 encompasses the elected species. Thus, claims 121-125, 128-138, and 140-142 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 116-120, 126-127, and 139 is contained herein.
Previous Objections/Rejections
Any rejections or objections stated of record in the office action mailed on 10/1/2025 that are not explicitly addressed herein below, are hereby withdrawn in light of applicant's arguments and/or amendments filed 2/19/2026.
Status of Rejections
35 USC § 102 (a)(2)
The rejection of claims 116-120 and 126 is maintained.
Applicant’s amendments, see Remarks, filed 2/19/2026, with respect to the rejection set forth in the Non-Final Office Action mailed 10/1/2025, have been fully considered but are not found persuasive.
To reiterate the rejection of record, claims 116-120 and 126 are rejected under 35 U.S.C. 102(a)(2) as being anticipated over WO 2020/006233 -mentioned in IDS.
WO 2020/006233 teach the following compound (see page 28, compound 31):
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wherein for formula I, n = 1, X1,2 = O, L = H, R1 = H, T = -C(O), and Rx is
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wherein rings bearing W variables make up a benzene ring, Z = -NH, Y2 = -CH, and Y1 = N. Thus the claims are anticipated. Applicants are advised to be aware of other species in this document which may anticipate the claims.
Applicants argue that claim 116 was amended to exclude the prior art compound above wherein the proviso compound is shown below:
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The examiner notes that this compound is not synonymous with the prior art compound (note the amide linker is at a different position on the phenyl ring):
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Thus the claims are still anticipated and the rejection is maintained.
35 USC § 103
The rejection of claims 116-120 and 126-127 is maintained.
Applicant’s amendments, see Remarks, filed 2/19/2026, with respect to the rejection set forth in the Non-Final Office Action mailed 10/1/2025, have been fully considered but are not found persuasive.
To reiterate the rejection of record, the claims may be drawn to Applicant’s elected species:
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wherein for formula I, n = 1, X1,2 = O, L = H, R1 = H, T = -C(O), and Rx is
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144
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wherein rings bearing W variables make up a benzene ring, Z = -NH, Y2 = -CMe, and Y1 = N
WO 2020/006233 teach the following compound as described previously:
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The only difference between Applicant’s compound and the prior art compound is an additional or lack thereof of a methyl group on the imidazole ring. However the prior art document teaches that the ring system formed at this position (see ring formed between variable R1,2) may be optionally substituted (see page 18 and below):
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The document further teaches that representative substituents include alkyl groups at [0056]. Thus one skilled in the art would have readily arrived at the claimed compound and would have been considered obvious.
Applicants argue the concept of “lead compound” and that a person of ordinary skill would not have selected the prior art compound because there are other compounds which may exhibit substantially higher binding affinities such as compound 23 of the document. This argument is found unpersuasive. In particular MPEP 2143 discusses the concept of “lead compound” as stated in Eisai where any known compound may serve as a lead compound:
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. However, there must be some reason for starting with that particular lead compound other than the mere fact that the "lead compound" exists. See Altana Pharma AG v. Teva Pharm. USA, Inc., 566 F.3d 999, 1007, 91 USPQ2d 1018, 1024 (Fed. Cir. 2009) (holding that there must be some reason "to select and modify a known compound"); Ortho-McNeil Pharm., Inc. v. Mylan Labs, Inc., 520 F.3d 1358, 1364, 86 USPQ2d 1196, 1201 (Fed. Cir. 2008).
The prior art compound was indeed shown to possess biological activity as Applicants have conveniently pointed out and would have been selected by one skilled in the art for further derivatization despite not being the most “potent” compound as described in MPEP 2143. Applicants then argue that there is no motivation to arrive at the claimed methyl substituted derivative. The examiner disagrees as the document clearly taught that the ring system may be further substituted with alkyl groups.
Furthermore, it is well established that the substitution of a lower alkyl for a hydrogen atom on a known compound is not a patentable modification absent unexpected or unobvious results. In re Lincoln, 53 U.S.P.Q. 40 (C.C.P.A. 1942), In re Druey, 138 USPQ 39 (C.C.P.A. 1963), In re Wood, 199 U.S.P.Q. 137 (C.C.P.A. 1978) and In re Lohr, 137 U.S.P.Q. 548, 549 (C.C.P.A. 1963). The motivation to make the claimed compounds derives from the expectation that structurally similar compounds would possess similar activity as in the instant case which is true here.
Applicants also argue the “obvious to try” rationale and how there is no direction to arrive at the claimed genus. This argument is found moot since the rejection of record is based on the obviousness of Applicant’s elected species over the prior art compound and not a subgenus. Thus based on the preponderance of evidence presented by the examiner and the lack of convincing arguments and/or secondary considerations to counter; the rejection is maintained.
New Objections and Rejections
Claim Objections
Claims 116-120, 126-127, and 139 is are objected to because of the following informalities:
In claim 116, the following chemical structures are objected to because of the embedded “NR” groups:
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It should be clearly articulated that the bonds are intended to be bonded to the nitrogen atoms with respect to the other variables and not the R variables for clarity. Thus the claim and claims dependent on it are objected to. Correction is required.
Newly amended claim 116 is directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: The claim embraces a new limitation for variable Rx being selected from:
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which was not originally presented as an option for this variable at time of examination (see the amended claim set filed 6/1/2023).
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, this subject matter is objected to as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
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.
Claims 116-120 and 126 are 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 pre-AIA the applicant regards as the invention.
In claim 116, variable “R2” recited in the definition for variable V is not defined in the claim. Thus the scope of the claim and claims dependent on it which do not rectify the issue are indefinite. Correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), fourth paragraph:
Subject to the [fifth paragraph of 35 U.S.C. 112 (pre-AIA )], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 118 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 118 does not further limit claim 116 with respect to variable V being selected from “CR2” since claim 116 recites “CR2” for this variable.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 of this title, 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.
Claim 139 is rejected under 35 U.S.C. 103(a) as being unpatentable over WO 2020/006233 -mentioned in IDS.
The claim may be drawn to Applicant’s elected species:
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wherein for formula I, n = 1, X1,2 = O, L = H, R1 = H, T = -C(O), and Rx is
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144
148
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wherein rings bearing W variables make up a benzene ring, Z = -NH, Y2 = -CMe, and Y1 = N
WO 2020/006233 teach the following compound as described previously:
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.
The only difference between Applicant’s compound and the prior art compound is an additional or lack thereof of a methyl group on the imidazole ring. However the prior art document teaches that the ring system formed at this position (see ring formed between variable R1,2) may be optionally substituted (see page 18 and below):
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806
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The document further teaches that representative substituents include alkyl groups at [0056]. Thus one skilled in the art would have readily arrived at the claimed compound and would have been considered obvious.
Conclusion
No claims are allowed.
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 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.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/BRIAN E MCDOWELL/Primary Examiner, Art Unit 1624
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