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 . Claims 1-11, 14-15, 18, 24-25, 28-29 and 31 are pending in this application.
Election/Restrictions
Applicant’s election without traverse of species c. (i.e. three compounds of Formula (II) shown in claim 28) in the reply filed on 03/09/2026 is acknowledged.
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Claims 1-11, 14-15, 25 and 28 read on the elected species. Claims 18, 24, 29 and 31 are withdrawn from prosecution as being drawn to non-elected species.
3. The claims are drawn to multiple inventions for reasons set forth in the restriction requirement. The claims are examined only to the extent that they read on the elected invention. Cancellation of the non-elected subject matter is recommended in response to this Office Action.
Claim Rejections - 35 USC § 112
4. 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 pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], 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.
5. Claims 1-11, 14-15 and 25 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 § 2117.
The Markush grouping of “an inhibitor of a BRD4 polypeptide” in general and non-elected species a., b., d. and e. 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: An inhibitor of a BRD4 polypeptide is very broad and it is unclear what is embraced and what is not. The non-elected species as set forth in the Restriction Requirement (see below) have different technical features.
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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. It is recommended that applicants insert the three compounds of claim 28 into claims 1, 10 and 14 and also amend claim 25 according to the elected species or delete claim 25.
Claim Rejections - 35 USC § 102
6. 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.
7. Claims 10-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Carlson et al. ACS Medicinal Chemistry Letters (2019), 10(9), 1296-1301. Cited reference at page 1296 teaches the treatment of inflammation using the following prior art compound (bromodomain inhibitors) that is the same as applicants. Said bromodomain inhibitors are interesting targets for the treatment of inflammation (see abstract).
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Said compound is also disclosed at page 1299 (See Table 5. compound 29, wherein R = H, X = O and Y = CH).
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Since the prior art compound shown above is a bromodomain inhibitor and used for the treatment of inflammation, the 102(a)(1) rejection is proper.
Double Patenting
8. 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.
9. Claims 1-11, 14-15, 25 and 28 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of U.S. Patent No. 11,987,572. Although the claims at issue are not identical, they are not patentably distinct from each other because there is overlap between the two applications. The genus structure of formula (Ic) in patent ‘572 is the same as the three elected species of the instant application when R1 = methyl; F = O; G = CH; R3 = H, CH2-CH2-N(CH3)2; and R2 = dimethyl-substituted phenyl or dibromo-substituted phenyl. Note that the specification of patent ‘572 discloses that the compounds are used for the treatment of various diseases that includes inflammation.
10. Claims 1-11, 14-15, 25 and 28 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 13, 18-19 and 24 of copending Application No. 18/639,608. Although the claims at issue are not identical, they are not patentably distinct from each other because there is overlap between the two applications. The genus structure of formula (I) in said copending application is the same as the three elected species of the instant application when R1 = methyl; F = O; G = CH; A = B = D = C; E = N; R3 = H, CH2-CH2-N(CH3)2; and R2 = dimethyl-substituted phenyl or dibromo-substituted phenyl. For example, in claim 18 of said copending application the first species recited at page 7 is the same compound as applicants (see below).
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Note that the specification of copending Application No. 18/639,608 discloses that the compounds are used for the treatment of various diseases that includes inflammation.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Information Disclosure Statement
11. Applicant’s Information Disclosure Statement, filed on 12/31/2024 has been acknowledged. Please refer to Applicant’s copies of the 1449 submitted herewith.
Conclusion
12. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Kahsay Habte Ph.D. whose telephone number is (571)272-0667. The examiner can normally be reached on 8:30 - 5:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JEFFREY MURRAY can be reached on 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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/Kahsay Habte/
Primary Examiner, Art Unit 1624