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.
Non-Compliant Amendment
The amendment to the specification and claims filed 04/11/2025 is improper. The amendment does not comply with 37 CFR 1.173 which sets forth the manner of making amendments in reissue applications. While the improper amendment has been entered and considered, Applicant’s next response should be a compliant amendment. An amendment filed after final rejection that fails to comply with 37 CFR 1.173 will not be entered.
All amendment changes must be made relative to the patent to be reissued, not relative to a previous submitted amendment. Pursuant to 37 CFR 1.173(d), any such changes which are made to the specification, including the claims, must be shown by employing the following markings:
(1) The matter to be omitted by reissue must be enclosed in brackets, i.e., single brackets; and (2) The matter to be added by reissue must be underlined.
The non-compliance issues are as follows:
The amendment to col. 1, lines 28-33 of the specification does not use single bracketing and underlining to show the numerous changes made relative to col. 1, lines 28-33 of the ‘744 patent.
In claim 1, on p. 3 of the amendment, the definition of “X” for Formula (Id) has changed -NR3- at col. 846, line 37 of the ‘744 patent to -NR3- without using single bracketing and underlining. The change to -NR3- should be made, but it must be done with single bracketing and underlining.
In claim 1, on p. 3 of the amendment, at the last line in the definition of RA, the term “heterocycloalky l” should be presented as “heterocycloalkyl” because that is how the term is presented at col. 846, line 64 of the ‘744 patent. No underlining or bracketing is need for the correction.
In claim 1, on p. 3 of the amendment, the hyphen in the first occurrence of the term “ortho-hydroxy” in the definition of ring Q is not present at col. 846, line 65 of the ‘744 patent. In order to add the hyphen, the term [ortho hydroxy] should be used for deletion, and then the term ortho-hydroxy for addition. As noted in MPEP 1411, “[c]hange in only a part of a word or chemical formula is not permitted. Entire words or chemical formulas must be shown as being changed.”
Specification
The disclosure is objected to because of the following informalities: The copy of the issued specification and claims from the ‘744 patent, i.e., the copy of column numbers 1-854, are blurred and difficult to read. Please provide a clear copy of column numbers 1-854. Appropriate correction is required.
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 1-7 and 11-18 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2019/191229 A1 to Sydorenko et al (hereinafter “Sydorenko”).
With respect to claims 1, 3-7, 11-13, 15 and 16, Sydorenko teaches the following compounds of Formula (I) and Formula (II) for the treating or ameliorating of Huntington’s disease (Abstract, p. 2, lines 1-15, and p. 3, lines 1-3), wherein the various groups and parameters are defined on pp. 3-4:
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Note that Formulas (I) and (II) differ from each other solely in that Formula (I) has
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, whereas Formula (II) has
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.
Sydorenko’s exemplary compound Nos. 21, 22, 77, 78, 87 and 408, reproduced below, are within the scope of Sydorenko’s Formula (I) (see pp. 25, 29, 30 and 55):
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.
Sydorenko’s compound Nos. 21, 22, 77, 78 and 408 were tested in an endogenous Huntington protein assay and were given a five-star rating based on the fact that their IC50 value is ≤ 0.1 µM (see Example 1 and Table 1 on pp. 222-227).
Sydorenko’s compound Nos. 21, 22, 77, 78 and 408 differ from instant Formula (Id) in that compound Nos. 21, 22, 77, 78 and 408 have said
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as per Sydorenko’s Formula (I) instead of
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as per Sydorenko’s Formula (II).
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 Sydorenko’s compound Nos. 21, 22, 77, 78 and 408 by replacing
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with
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so as to prepare compounds within the scope of Sydorenko’s Formula (II) suitable for treating Huntington’s disease. Huntington’s disease is the same disease treated by the instant compounds (see, e.g., col. 465, lines 40-60 and issued claim 1 of the ‘744 patent).
Instant claim 2 requires certain stereochemistry for Formula (Id), in particular, claim 2 requires that Formula (Id) has Formula (If):
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Sydorenko’s compound Nos. 21, 22, 77, 78 and 408 indicate chirality with respect to the instant “E” group, i.e., the NH or NCH3 group in Sydorenko’s compounds. A skilled artisan would have recognized the additional chirality with respect to the instant W, X and R2 groups in Sydorenko’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 Sydorenko’s modified compound Nos. 21, 22, 77, 78 and 408, such as the isomer here claimed, so as to prepare an active compound within the scope of Sydorenko’s Formula (II) suitable for treating Huntington’s disease. See MPEP 2144.09.II, which notes that stereoisomers are prima facie obvious.
With respect to claims 14, 17 and 18, Sydorenko’s compound Nos. 21, 22, 77 and 78 have each of the instant R15 to R18 as hydrogen. Sydorenko’s compound No. 408 has each of instant R15 and R18 as a CH3 group. More generally, the instant R15 to R18 in Sydorenko’s compounds are Sydorenko’s R2 group, which can be, inter alia, hydrogen, halogen or C1-4alkyl (see p. 3, lines 9-22).
While Sydorenko does not require that one of instant R16 and R17 is hydrogen and the other fluorine (claim 14), one of instant R15 and R18 is hydrogen and the other is -CH3 (claim 17), or that at least one of instant R15 and R18 is or comprises a fluorine, it would have been obvious to one of ordinary skill in the art to have further modified Sydorenko’s compound Nos. 21, 22, 77, 78 and 408 to have such features because Sydorenko teaches that its R2 substituent can be hydrogen, halogen or C1-4alkyl.
Claims 1-18 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.
With respect to claims 1, 3-8, 11-13, 15 and 16, Luzzio ‘440 teaches small molecule splicing modulators of the following Formula (IV) (p. 2):
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wherein the groups and parameters are defined on pp. 2-4. In particular, 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):
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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’s compounds Nos. 28, 44, 67 and 162 reproduced below for convenience:
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366
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118
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.
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
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is
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in the exemplified compounds instead of being
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. 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:
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.
Note that Sydorenko’s Formulas (I) and (II) have
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and
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, which are within the scope of Luzzio ‘440’s
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.
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
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with
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because
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is not only within the scope of Luzzio ‘440’s
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, it is suitable for use in compounds for treating Huntington’s disease, as taught by Sydorenko.
Instant claim 2 requires certain stereochemistry for Formula (Id), in particular, claim 2 requires that Formula (Id) has Formula (If):
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.
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
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(¶ 0022), which also render obvious the claimed ring Q.
With respect to claim 10, Luzzio ‘440 teaches that ring Q can be a fused heteroaryl such as
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(¶ 0029), which corresponds to the instantly claimed ring Q of formula
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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).
With respect to claims 14, 17 and 18, Luzzio ‘440’s compound Nos. 28, 44 and 152 have each of the instant R15 to R18 as hydrogen. Luzzio ‘440’s compound No. 67 has each of instant R15 and R18 as a CH3 group. More generally, the instant R15 to R18 in Luzzio ‘440’s compounds can be, inter alia, hydrogen, fluorine, or C1-4alkyl (see p. 3, lines 26-29 of Luzzio ‘440).
While Luzzio ‘440 does not require that one of instant R16 and R17 is hydrogen and the other fluorine (claim 14), one of instant R15 and R18 is hydrogen and the other is -CH3 (claim 17), or that at least one of instant R15 and R18 is or comprises a fluorine, 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, halogen or C1-4alkyl.
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.
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.
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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
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