DETAILED ACTION
Status of Claims
Claims 1,4,6,8,10,13,15,19,22,24-25,28,31,35,37,45-46,50,54,56,59-63,65,68-70,72-74,76-77,79,82-88,91,93-94,96-99,102, and 108-109 are pending in the instant application.
Claims 45,50,61-62,69-70,72-74,76-77,79,82-88,91,93-94,96-99,102 and 108-109 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 1,4,6,8,10,13,15,19,22,24,25,28,31,35,37,46,54,56,59-60,63,65 and 68 is contained herein.
Information Disclosure Statement
The examiner has considered the information disclosure statement filed most recently of record.
Previous Objections/Rejections
Any rejections or objections stated of record in the office action mailed on 12/2/2025 that are not explicitly addressed herein below, are hereby withdrawn in light of applicant's arguments and/or amendments filed 4/2/2026.
Status of Rejections
Double Patenting
The rejection of claims 1,4,6,8,10,13,15,19,22,24,25,28,31,35,37,46,54,56,59-60,63, and 65 is maintained.
Applicant’s arguments, see Remarks, filed 4/2/2026, with respect to the rejection set forth in the Non-Final Office Action mailed 12/2/2025, have been fully considered and the rejection will be held in abeyance.
Improper Markush Grouping Rejection
The rejection of claims 1,4,6,8,10,13,15,19,22,24,25,28,31,35,37,46,54,56,59,63, and 65 is maintained.
Applicant’s arguments, see Remarks, filed 4/2/2026, with respect to the rejection set forth in the Non-Final Office Action mailed 12/2/2025, have been fully considered but are not found persuasive.
To reiterate the rejection, the claims were 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 § 706.03(y).
In re Harnish, 206 USPQ 300, 305, says, “ …we think it should be clear from our actions in Weber and Haas II that we there recognized the possibility of such a thing as an "improper Markush grouping." The court went on to reverse the rejection, (which had been made by the Board under Rule 196(b)) but not on the lack of a specific statutory basis but rather, “Clearly, they are all coumarin compounds which the board admitted to be "a single structural similarity." We hold, therefore, that the claimed compounds all belong to a subgenus, as defined by appellant, which is not repugnant to scientific classification (see claim 1 below for pictorial example):
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Under these circumstances we consider the claimed compounds to be part of a single invention so that there is unity of invention…” Thus, the rejection was overturned because of the specific facts in the case. The Markush group was held proper in that case, as was the case also in Ex parte Price 150 USPQ 467, Ex parte Beck and Taylor, 119 USPQ 100, and Ex parte Della Bella and Chiarino 7 USPQ2d 1669. Cases where the Markush group was held improper include Ex Parte Palmer, 7 USPQ 11, In re Winnek, 73 USPQ 225, In re Ruzicka, 66 USPQ 226, Ex parte Hentrich, 57 USPQ 419, Ex parte Barnard, 135 USPQ 109, Ex parte Reid, 105 USPQ 251, Ex parte Sun and Huggins, 85 USPQ 516, In re Thompson and Tanner, 69 USPQ 148, In re Swenson, 56 USPQ 180, and In re Kingston, 65 USPQ 371.
Indeed, as was stated in Ex parte Haas, 188 USPQ 374, “The rejection of a claim as containing an improper Markush grouping has a relatively long history in Office practice. The Court of Customs and Patent Appeals, at least as far back as 1942, has recognized that a rejection may be based upon the Examiner's holding that the claim has an improper Markush group. See In re Swenson, 30 CCPA 764, 132 F.2d 336, 56 USPQ 180 , citing Ex parte Palmer, 398 OG 707, 1930 CD 3.”
It should be noted that in Harnish, there was a substantial structural feature from which the common use flowed and that the claimed compounds all belong to a subgenus. That is exactly what is lacking in this case, as there is no substantial structural feature when viewing the compound as a whole. The Markush grouping 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:
For example the following chemical class of compounds as a whole may be obtained:
1) wherein X = CR and Y = N: (classified as substituted 1,5-naphthyridines, C07D 471/04);
2) wherein X = Y = N: (classified as substituted pyrido[3,2-d]pyrimidines, C07D 487/04).
This list is not exhaustive and clearly classifying the above groups as one subgeneric group would be repugnant to scientific classification. Thus, the first requirement is not met as described above. Secondly, there is little evidence provided that the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature.
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.
The examiner recommends that the claims should be amended to include only species that share a single structural similarity and a common use (e.g. drawn to compounds of the formula I-a wherein X = CR and Y = N) to overcome the rejection.
Applicants argue that since the claims have been limited to wherein one of X and Y must be “N” along with the argument that each member of the Markush comprises a central bicyclic heteroaryl core obviates the rejection. The examiner respectfully disagrees. Despite the amendment, the examiner reiterates that the claims must be examined as a whole. As stated previously, the following chemical class of compounds as a whole may be obtained:
1) wherein X = CR and Y = N: (classified as substituted 1,5-naphthyridines, C07D 471/04);
2) wherein X = Y = N: (classified as substituted pyrido[3,2-d]pyrimidines, C07D 487/04).
This list is not exhaustive and clearly classifying the above groups as one subgeneric group would be repugnant to scientific classification. Thus, the first requirement is not met as described above. Secondly, there is little evidence provided that the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. Since Applicants have not provided any evidence to the contrary in regard to the latter statement along with that the claimed alternatives may not be classified into a single class; these arguments are found unpersuasive and the rejection is maintained.
New Objections and Rejections
Claim Objections
Applicant is advised that should claims 13 be found allowable, claim 6 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). In the instant case, the claims are identical in claim scope. Correction is required.
Claim 68 is objected to for requiring commas between each listed species and the word “and” incorporated before the last species.
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.
Claims 56 and 68 are 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 58 does not further limit claim 1 with respect to Formula I-c since claim 1 sets forth the limitation already that L variables are absent. In regard to claim 68, this claim contains species wherein variable A is selected from heterocyclyl (see compound 100 for example) where claim 1 sets forth it must be heteroaryl. Applicants are to be aware of all species which do not further limit claim 1.
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.
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.
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/BRIAN E MCDOWELL/Primary Examiner, Art Unit 1624
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