DETAILED ACTION
Claims 1-10 are pending.
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 .
Priority
The instant application, 18721999, filed 6/20/2024 is a National Stage entry of PCT/US2022/053328, International Filing Date: 12/19/2022. PCT/US2022/053328 claims Priority from Provisional Application 63298726, filed 1/12/2022. PCT/US2022/053328 claims Priority from Provisional Application 63413569, filed 10/5/2022, now abandoned; and claims foreign priority to PCT/US2021/064278, filed 12/20/2021 and claims foreign priority to PCT/US2022/034518, filed 6/22/2022.
Information Disclosure Statement
The Information Disclosure Statements (IDS) submitted on 10/15/2024 and 1/31/2025, are in compliance with the provisions of 37 CFR 1.97. Accordingly, the Information Disclosure Statements are being considered by the Examiner.
Claim Rejections – Improper Markush Grouping
Claims 1-10 are rejected on the judicially-created basis that they contain 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). The improper Markush grouping includes species of the claimed invention that do not share both a substantial structural feature and a common use that flows from the substantial structural feature.
A Markush claim contains an “improper Markush grouping” if: (1) the species of the Markush group do not share a single structural similarity,” or (2) the species do not share a common use. Members of a Markush group share a "single structural similarity” when they belong to the same recognized physical or chemical class or to the same recognized physical or chemical class or to the same art-recognized class. Members of a Markush group share a common use when they are disclosed in the Specification or known in the art to be functionally equivalent (see Federal Register, Vol. 76, No. 27, Wednesday, February 9, 2011, p. 7166, left and middle columns, bridging paragraph).
The members of the improper Markush grouping do not share a substantial feature and/or a common use that flows from the substantial structural feature for the following reasons:
The variable structure of Formula (I) is defined in Claim 1 as seen below:
PNG
media_image1.png
188
458
media_image1.png
Greyscale
The structure of Formula (I) varies greatly in the identity of each cyclic group (Q1, Q2, Q3, Q4, Q5, Q6, Q7, and QX) regarding the size, present, or absence of heteroatoms, and whether they are monocyclic, fused, or spirocyclic. Additionally, Z1, Z2, Z4,and Z5 are so broad that its full scope requires hundreds of searches as it reads on ring structures that are extremely large and/or variable.
Clearly no ‘‘single structural similarity’’ can be seen.
This rejection is for claims 2-3 as well. The structures of
Claim 2:
PNG
media_image2.png
236
458
media_image2.png
Greyscale
And Claim 3:
PNG
media_image3.png
236
442
media_image3.png
Greyscale
were not able to be searched due to their structural dissimilarity.
In response to this rejection, Applicant should either amend the claim(s) to recite only individual species or grouping of species that share a substantial structural feature as well as a common use that flows from the substantial structural feature, or present a sufficient showing that the species recited in the alternative of the claim(s) in fact share a substantial structural feature as well as a common use that flows from the substantial structural feature. This is a rejection on the merits and may be appealed to the Board of Patent Appeals and Interferences in accordance with 35 U.S.C. § 134 and 37 CFR41.31 (a) (1) (emphasis provided).
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 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); 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 nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
US 11903950
Claims 1-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-28 of U.S. Patent No. 11903950. Although the claims at issue are not identical, they are not patentably distinct from each other because the genus of ‘950 in claim 1:
PNG
media_image4.png
362
696
media_image4.png
Greyscale
The reference patent overlaps in the lower half, see claim 13:
PNG
media_image5.png
188
292
media_image5.png
Greyscale
Then when one envisages the R2 group in the reference claim to be a cyclic structure, the reference application anticipated the instant claims. The reference states R2 can be one of many cyclic compounds, as such the claimed genus is anticipatory to the instant claims.
US 11279711
Claims 1-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 11279711. Although the claims at issue are not identical, they are not patentably distinct from each other because ‘711:
PNG
media_image6.png
220
370
media_image6.png
Greyscale
is anticipatory when the R2 is a ring and R9 taken together to form a ring as claimed. As such the claimed genus is anticipatory to the instant claims.
US 11365206
Claims 1-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 11365206. Although the claims at issue are not identical, they are not patentably distinct from each other because the genus of the reference:
PNG
media_image7.png
218
400
media_image7.png
Greyscale
is anticipatory when the R2 is a ring and R9 taken together to form a ring as claimed. As such the claimed genus is anticipatory to the instant claims.
US 12220419
Claims 1-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 12220419. Although the claims at issue are not identical, they are not patentably distinct from each other because the genus of ‘419 is to:
PNG
media_image8.png
360
670
media_image8.png
Greyscale
The reference patent overlaps in the lower half, see claim 17:
PNG
media_image5.png
188
292
media_image5.png
Greyscale
Then when one envisages the R2 group in the reference claim to be a cyclic structure, the reference application anticipated the instant claims. The reference states R2 can be one of many cyclic compounds, as such the claimed genus is anticipatory to the instant claims.
US 12552784
Claims 1-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of U.S. Patent No. 12552784. Although the claims at issue are not identical, they are not patentably distinct from each other because ‘748 is directed to:
PNG
media_image9.png
262
670
media_image9.png
Greyscale
This genus of ‘784 when one envisages the R2 group to be any cyclic structure anticipates the instant genus below of claim 6:
PNG
media_image10.png
198
460
media_image10.png
Greyscale
as such the claimed genus is anticipatory to the instant claims.
US 12583853
Claims 1-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 12583853. Although the claims at issue are not identical, they are not patentably distinct from each other because the claimed genus of ‘853:
PNG
media_image11.png
254
540
media_image11.png
Greyscale
Anticipates the instant genus when the R2 group is envisaged as a ring, and the Rd structure is also envisaged as a ring. As such the claimed genus is anticipatory to the instant claims.
Application 17764285
Claims 1-10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1, 3-7, and 15 of copending Application No. 17764285 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the genus claimed in ‘285:
PNG
media_image12.png
234
522
media_image12.png
Greyscale
is anticipatory to the instant claims when one envisages the R2 as a ring, and when two R10 groups are taken together to form a ring as claimed. As such the claimed genus is anticipatory to the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Application 18268632
Claims 1-10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 7-8 of copending Application No. 18268632 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claimed genus of the reference application:
PNG
media_image13.png
194
332
media_image13.png
Greyscale
is anticipatory to the instant when one envisaged R4 to be a ring as claimed. As such the claimed genus is anticipatory to the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Application 18526158
Claims 1-10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 29-30 of copending Application No. 18526158 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claimed method of using the genus is anticipatory to the instant compound genus. The ‘158 application claims:
PNG
media_image14.png
184
378
media_image14.png
Greyscale
when one envisages the R2 group as a ring, and 2 R10s together as a ring, as claimed this genus anticipates the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Application 18722153
Claims 1-10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of copending Application No. 18722153 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claimed genus of ‘153 anticipated the instant claimed genus. ‘153 is drawn to:
PNG
media_image15.png
156
320
media_image15.png
Greyscale
This genus is anticipatory to the instant when one envisaged R4 to be a ring as claimed. As such the claimed genus is anticipatory to the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Closest Prior Art
The closest Prior art relevant to the lower core structure of Bcl-2 compounds is WO 2020041406 which teaches the lower half of the core structure, though does not teach a tetracyclic structure as instantly claimed, as one can see from claim 14 below, the prior art did not ever make or make obvious a tetracyclic lower portion.
PNG
media_image16.png
580
566
media_image16.png
Greyscale
The closest Prior art relevant to the upper core structure of Bcl-2 compounds is WO 2020140005. This is seen below in Formula C-2. Though the instantly claimed compounds are dired to having another ring off the Q4 ring in the structure below.
PNG
media_image17.png
642
550
media_image17.png
Greyscale
The prior art doesn’t make this ring substitution, or render obvious making the ring structure. As such the combination of the 2 references would not allow one to make the 2 new rings as instantly claimed.
Conclusion
No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL J SCHMITT whose telephone number is (571)270-7047. The examiner can normally be reached M-F 8-6 MidDay Flex.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Lundgren can be reached at 571-272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MICHAEL J SCHMITT/Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629
Prosecution Insights