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 .
Reissue Applications
For reissue applications filed on or after September 16, 2012, all references to 35 U.S.C. 251 and 37 CFR 1.172, 1.175, and 3.73 are to the current provisions. This application, filed April 11, 2025, is a reissue of U.S. Patent 11,845,744 (hereinafter the ‘744 patent), which issued from U.S. application Serial No. 17/390,163 (the ‘163 application) with claims 1-18 on December 19, 2023.
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 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.
Claim 18 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 18 states “wherein at least one of R15, R16, R17, and R18 is or comprises fluorine.” This does not further limit claim 1 because claim 1 already requires that at least one of R16 and R17 is F. Further, while one of R16 and R17 in claim 1 can be F, they cannot “comprise F” since the alternative for R16 or R17 in claim 1 is H. It is suggested that claim 18 state “wherein at least one of R15 and R18 is or comprises fluorine.”
Rejection Overcome
The rejection of claims 1-7 and 11-18 under 35 U.S.C. 103 over Sydorenko alone has been overcome by Applicant’s amendment of claim 1 to require “wherein R16 is F and R17 is hydrogen or wherein R16 is hydrogen and R17 is F.” As noted in the Remarks (pp. 12-13), in view of Sydorendko’s closest exemplified compounds, one skilled in the art would not only have to replace one triazine with another, but also select a particular position (the instant R16 or R17) that is not singled out by Sydorenko so as replace H with F. These changes, along with the instantly claimed compounds’ blood barrier penetration data in Example A-11 and Table 5 of the ‘744 patent specification (Remarks, p. 14), favor non-obviousness of the instant claims.
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, 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.
Claims 1-13 and 15-18 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2019/028440 A1 to Luzzio et al (hereinafter “Luzzio ‘440”) in view of Sydorenko et al (hereinafter “Sydorenko”).
With respect to claims 1, 3-8, 11-13 and 15-18, Luzzio ‘440 teaches small molecule splicing modulators of the following Formula (IV) (p. 2):
PNG
media_image1.png
146
258
media_image1.png
Greyscale
wherein the groups and parameters are defined on pp. 2-4. In particular, R11 to R18 are each independently selected from, inter alia, H, F and C1-C6 alkyl (see ¶ 0006). Each A in the above formula is independently N or CRA wherein RA is defined on p. 2. For example, Luzzio ‘440 teaches that (¶ 0007):
PNG
media_image2.png
70
536
media_image2.png
Greyscale
Luzzio ‘440 further teaches that (0040):
PNG
media_image3.png
106
474
media_image3.png
Greyscale
Luzzio ‘440 teaches numerous compounds, such as compound Nos. 6, 28-97, 127, 128, 139-141, 144, 146-153, 161-258, etc. (pp. 115-169), with Luzzio ‘440’s compounds Nos. 28, 44, 67 and 162 reproduced below for convenience:
PNG
media_image4.png
104
368
media_image4.png
Greyscale
PNG
media_image5.png
86
366
media_image5.png
Greyscale
PNG
media_image6.png
118
356
media_image6.png
Greyscale
PNG
media_image7.png
122
380
media_image7.png
Greyscale
.
Luzzio ‘440 teaches that its compounds can be used to treat Huntington’s disease (see ¶ 0750).
Luzzio ‘440’s exemplified compounds, such as compound Nos. 6, 28-97, 127, 128, 139-141, 144, 146-153 and 161-258, differ from the compound of instant Formula (Id) in that Luzzio ‘440’s
PNG
media_image8.png
90
114
media_image8.png
Greyscale
is
PNG
media_image9.png
88
110
media_image9.png
Greyscale
in the exemplified compounds instead of being
PNG
media_image10.png
80
72
media_image10.png
Greyscale
. Nonetheless, as noted above, Luzzio ‘440 teaches that A is independently N or CRA (see p. 2).
Sydorenko teaches the following compounds of Formula (I) and Formula (II), reproduced below, which overlap in scope with Luzzio ’440’s general Formula (IV), wherein, like Luzzio ‘440, Sydorenko’s compounds are used for the treating or ameliorating Huntington’s disease (Abstract, p. 2, lines 1-15, and p. 3, lines 1-3 of Sydorenko), and wherein the various groups and parameters are defined on pp. 3-4 of Sydorenko:
PNG
media_image11.png
164
456
media_image11.png
Greyscale
.
Note that Sydorenko’s Formulas (I) and (II) have
PNG
media_image12.png
68
66
media_image12.png
Greyscale
and
PNG
media_image13.png
66
64
media_image13.png
Greyscale
, which are within the scope of Luzzio ‘440’s
PNG
media_image8.png
90
114
media_image8.png
Greyscale
.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Luzzio ‘440’s above noted, exemplified compounds so as to replace
PNG
media_image9.png
88
110
media_image9.png
Greyscale
with
PNG
media_image10.png
80
72
media_image10.png
Greyscale
because
PNG
media_image10.png
80
72
media_image10.png
Greyscale
is not only within the scope of Luzzio ‘440’s
PNG
media_image8.png
90
114
media_image8.png
Greyscale
, it is suitable for use in compounds for treating Huntington’s disease, as taught by Sydorenko.
Additionally, Luzzio ‘440 does not require that one of instant R16 and R17 is hydrogen and the other is fluorine as in instant claim 1 and its dependent claims, or one of instant R15 and R18 is hydrogen and the other is -CH3 as in instant claim 17. However, it would have been obvious to one of ordinary skill in the art to have further modified Luzzio ‘440’s exemplified compounds to have such features because, as noted above, Luzzio ‘440’s substituents can be hydrogen, F or C1-6 alkyl.
Instant claim 2 requires certain stereochemistry for Formula (Id), in particular, claim 2 requires that Formula (Id) has Formula (If):
PNG
media_image14.png
152
242
media_image14.png
Greyscale
.
For example, Luzzio ‘440’s compound Nos. 67 and 162, as modified above, differ from this compound since they do not provide the stereochemistry for the instant R2. However, a skilled artisan would have recognized the chirality of the instant R2 group in Luzzio ‘440’s compounds.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have arrived at an appropriate isomer of Luzzio ‘440’s modified compound Nos. 67 and 162, such as the isomer here claimed, so as to prepare an active compound within the scope of Luzzio ‘440’s Formula (IV) suitable for treating Huntington’s disease. See MPEP 2144.09.II, which notes that stereoisomers are prima facie obvious.
With respect to claim 9, Luzzio ‘440 teaches that ring Q in Formula (IV) can be 2-napthyl substituted at the 3-position with hydroxy (¶ 0021), which renders obvious the instantly claimed ring Q. Luzzio ‘440’s ring Q can also be
PNG
media_image15.png
64
268
media_image15.png
Greyscale
(¶ 0022), which also renders obvious the claimed ring Q.
With respect to claim 10, Luzzio ‘440 teaches that ring Q can be a fused heteroaryl such as
PNG
media_image16.png
114
156
media_image16.png
Greyscale
(¶ 0029), which corresponds to the instantly claimed ring Q of formula
PNG
media_image17.png
76
132
media_image17.png
Greyscale
when Luzzio ‘440’s m is 2 and the RB attached to the phenyl is an ortho hydroxy (see, for example, ¶¶ 0307, 395 and 502 of Luzzio ‘440 for the definitions of m and RB).
Response to Arguments
Applicant's arguments filed August 18, 2026 have been fully considered but they are not persuasive.
Applicant argues that Luzzio ‘440 published on 02/07/2019 and is owned by the same Applicant and thus, does not qualify as prior art (Remarks, p. 14). Applicant argues that the instant reissue application claims priority back to provisional applications having filing dates of Feb. 5-6, 2019 (Remarks, pp. 14-15).
Applicant’s arguments are unpersuasive. A review of Applicant’s provisional applications reveals that the instant claims are supported by them, and thus, the instant claims have an effective filing date as late as Feb. 6, 2019. Luzzio ‘440, which has a different inventive entity than the instant application, published on Feb. 7, 2019 (i.e., later than the instant effective filing date), but has an international filing date of Aug. 3, 2018. Thus, Luzzio ‘440 qualifies as prior art only under 35 USC 102(a)(2).
To the extent Applicant seeks to remove Luzzio ‘440 as a reference using the common ownership exception of 35 USC 102(b)(2)(C), simply stating “common ownership” is insufficient. There must be a signed statement on the record that the common ownership existed not later than the effective filing date of the claimed invention. See 37 CFR 1.104(c)(4)(i), which states “[s]ubject matter which would otherwise qualify as prior art under 35 U.S.C. 102(a)(2) and a claimed invention will be treated as commonly owned for purposes of 35 U.S.C. 102(b)(2)(C) if the applicant or patent owner provides a statement to the effect that the subject matter and the claimed invention, not later than the effective filing date of the claimed invention, were owned by the same person or subject to an obligation of assignment to the same person.” See also MPEP 2154.02(c). Accordingly, the rejection over Luzzio ‘440 in view of Sydorenko is maintained.
Duty to Disclose
Applicant is reminded of the continuing obligation under 37 CFR 1.178(b), to timely apprise the Office of any prior or concurrent proceed-ing in which Patent No. 11,845,744 is or was involved. These proceedings would include interferences, reissues, reexaminations, and litigation. Applicant is further reminded of the continuing obligation under 37 CFR 1.56, to timely apprise the Office of any information which is mate-rial to patentability of the claims under consideration in this reissue appli-cation. These obligations rest with each individual associated with the filing and prosecution of this application for reissue. See also MPEP §§ 1404, 1442.01 and 1442.04.
Conclusion
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.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALAN D DIAMOND whose telephone number is (571)272-1338. The examiner can normally be reached Monday through Thursday 5:30 am to 3:00 pm, and Fridays from 5:30 am to 9:30 am.
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, Patricia Engle can be reached at 571-272-6660. 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.
Signed:
/ALAN D DIAMOND/Patent Reexamination Specialist
Central Reexamination Unit 3991
Conferees:
/JOSEPH R KOSACK/Patent Reexamination Specialist
Central Reexamination Unit 3991
/Patricia L Engle/SPRS, Art Unit 3991
Prosecution Insights