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
RESPONSE TO ELECTION/RESTRICTION
Applicant’s election without traverse of group I, drawn to compounds of the formula I-a and simple compositions thereof and elected species:
PNG
media_image1.png
140
338
media_image1.png
Greyscale
in the reply filed on 9/22/2025 is acknowledged. The elected species reads on claims 1-2,4,6,8,10,13-15,18-22,24-25,28,31,33-35,37,42-43, 46, 49, 54,56,59-60, 63, 65, and 68.
The requirement is still deemed proper and is therefore made FINAL.
Claims 40,44,45, 50,61,62, 69-70,72-74,76-77,79,82-88,91,93, 94,96-99, 102, and 108-109 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 1-2,4,6,8,10,13-15,18-22,24-25,28,31,33-35,37,42-43, 46, 49, 54,56,59-60, 63, 65, and 68 is contained herein. Applicant’s elected species was found free of the art and the search extended to cover species wherein Y = N, X =CR, and both L variables are absent.
Priority
This application claims priority to U.S. Application No. 63/047,898, filed July 2, 2020;
U.S. Application No. 63/072,921, filed August 31, 2020; and U.S. Application No. 63/126,495, filed December 16, 2020.
Information Disclosure Statement
The examiner has considered the references cited in the information disclosure statement filed of record.
Claim Objections
Claims 1-2,4,6,8,10,13-15,18-22,24-25,28,31,33-35,37,42-43, 46, 49, 54,56,59-60, 63, 65, and 68 are objected to because of the following:
In claim 1 under variables A and B, the text “heteroaryl,,” should just have one comma “heteroaryl,”. Thus the claim and claims dependent on it are objected to. Correction is required.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory obviousness-type double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 1-2,4,6,8,10,13-15,18-22,24-25,28,31,33-35,37,42-43, 46, 49, 54,56,59-60, 63, and 65 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1, 2, 6, 15, 21, 24, 35, 50, 51, 54, 55, 61, 62, 68, 69, 70, 92, 93, and 96 of copending Application No. 18/726,007. Although the conflicting claims are not identical, they are not patentably distinct from each other because there is significant overlap between the two applications.
The genus structure of the instant application is a subgenus of the claimed genus in the copending application ‘007 with respect to Z being selected from nitrogen which is claimed in the instant application (other remaining variables are consistent or slightly narrower in scope). The scope of formula I in the copending application is substantially small that one skilled in the art would have arrived at the claimed subgenus of compounds or compositions thereof. Any recitation referring to functional language such as claims 93 and 96 in the copending application do not make the claims distinct since the compounds are identical in nature and would have possessed the recited features, see In re Schreiber, 128F.3d 1473, 1477 (Fed. Cir. 1997) and Boehringer Ingelheim Vetmedica, Inc. v. Schering-Plough Corp., 320 F.3d 1339, 1345 (Fed. Cir. 2003),
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
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 68 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 pre-AIA the applicant regards as the invention.
Claim 68 recites "compounds shown in Table 1". However, the specific compounds which may fully define the metes and bounds of the claim are not recited therein.
MPEP 2173.05(s) states, “Reference to Figures or Tables. Where possible, claims are to be complete in themselves. Incorporation by reference to a specific figure or table “is permitted only in exceptional circumstances where there is no practical way to define the invention in words …’ ”
This condition is not met here, since it is practical to define the invention in words, simply by putting the compounds into the claim. See Ex parte Fressola, 27 USPQ2d 1608, 1609. Thus, the claim is considered indefinite. The examiner recommends that the specific compounds associated with Table 1 are inserted into the claim.
Claim Rejections – Improper Markush Grouping Rejection
Claims 1-2,4,6,8,10,13-15,18-22,24-25,28,31,33-35,37,42-43, 46, 49, 54,56,59, 63, and 65 are 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):
PNG
media_image2.png
605
882
media_image2.png
Greyscale
.
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.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 2, 4, 42, 43, 46, 49, 54, 56, 59, and 60 are rejected under 35 U.S.C. 102(a)(1) as being anticipated over compound designated as RN 1306730-66-4 in CAS Registry of STNext.
CAS Registry teaches the following compound and information:
PNG
media_image3.png
478
814
media_image3.png
Greyscale
wherein m = n = 0, X = -CH, Y = N, L variables are absent, and A and B are heteroaryl substituted with heterocyclyl. Thus the claims are anticipated.
Claims 1, 2, 4, 42, 43, 46, 49, 54, 56, 59, and 60 are rejected under 35 U.S.C. 102(a)(1) as being anticipated over Singh et al. Inorg. Chem. 2009, 48, 6459–6470-mentioned in IDS.
Singh et al. teach the following compounds (see page 6460, compound 11 and page 6461, compounds 20 and 21):
PNG
media_image4.png
84
170
media_image4.png
Greyscale
PNG
media_image5.png
96
624
media_image5.png
Greyscale
wherein m = n = 0, X = -CH, Y = N, L variables are absent, and A and B are unsubstituted heteroaryl. Thus the claims are anticipated.
Claims 1, 21, 22, 42, 43, 46, 49, 54, 56, 59, and 60 are rejected under 35 U.S.C. 102(a)(1) as being anticipated over WO 2019134978-mentioned in IDS.
WO 2019134978 teach the following compounds (see page 159, compounds 105a and 105b):
PNG
media_image6.png
224
480
media_image6.png
Greyscale
PNG
media_image7.png
210
486
media_image7.png
Greyscale
wherein m = n = 0, X = -CH, Y = N, L variables are absent, and A and B are optionally substituted heterocyclyl. Thus the claims are anticipated. Applicants are to be aware of all species which may potentially anticipate the claims in this document.
Conclusion
No claims are allowed.
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