DETAILED ACTION
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 .
Election/Restrictions
Applicant’s response to the restriction/ election requirement from 1/6/2026 is acknowledged. Applicant has elected without traverse the invention of Group II (claims 39, 42, 50-51, 54, 57, 67 and 72-73). Applicant has further elected as species compound 36, without traverse, and designated that claims 39, 42, 54, 57, 67, 72 and 73 read on it.
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As a species of neurodegenerative disease Applicant has elected Alzheimer’s disease.
On further consideration of the art, the election of a species of a neurodegenerative disease is hereby withdrawn. Applicant’s claimed species was found to be free of art, and the search was expanded to the whole genus of claim 42. The restriction/ election requirement is hereby MADE FINAL. Claims 39, 42, 50-51, 54, 57, 67 and 72-73 read on the elected species, and have been examined herewith.
Claim Objections
Claims 39, 42 and 57 are objected to because of the following informalities: they recite that X1 in claims 39 and 42, and Y2 and Y3 in claim 57 can be “halo”. In claim 39, Y2 and Y3 are properly spelled out to be “halogen”.
Appropriate correction is requesting by changing all instances of “halo” with “halogen”.
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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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 39, 42, 50-51 and 72-73 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2019160980 A1 to Scanlan (“Scanlan”).
Scanlan discloses compounds of Formula (I) that function as thyromimetics, and compositions thereof with pharmaceutically acceptable excipients, which compounds have utility for treating diseases such as neurodegenerative disorders, such as X-Iinked adrenoleukodystrophy or multiple sclerosis.
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(Abstract, p. 2, ll. 6-12, p. 3, ll. 1-14).
This compound of Formula (I) overlaps with Applicant’s compound of Formula (II’), wherein in Formula (II’), X1 is halogen, Y2 is H, Y1 is H, R1 is NR1aR1b, and wherein R1a and R1b are
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There is a small difference between the claimed structure of Formula (I) and Applicant’s Formula (II’) with respect to Y3, which in both formulas can be halogen, but with the difference being that it is a position isomer occupying a different place on the phenyl ring. This renders the compound structures obvious. "Compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977). See also In re May, 574 F.2d 1082, 197 USPQ 601 (CCPA 1978) (stereoisomers prima facie obvious); Aventis Pharma Deutschland v. Lupin Ltd., 499 F.3d 1293, 84 USPQ2d 1197 (Fed. Cir. 2007) (5(S) stereoisomer of ramipril obvious over prior art mixture of stereoisomers of ramipril.)." MPEP 2144.09
Claims 39, 42, 50-51, 54, 57 and 72-73 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2020118564 A1 to Von Geldern et al. A1 (“Von Geldern”).
Von Geldern discloses compounds of Formula (I) that function as thyromimetics, and compositions thereof with pharmaceutically acceptable excipients, which compounds have utility for treating diseases such as neurodegenerative disorders, such as X-Iinked adrenoleukodystrophy or multiple sclerosis. (Abstract, p. 3, ll. 1-13, claim 1).
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This compound of Formula (I) overlaps with Applicant’s compound of Formula (II’), wherein in Formula (II’), X1 is lower alkyl, Y2 is H, Y1 is H, R1 is NR1aR1b or OR1c, and wherein R1a and R1b are
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.
And wherein R1c is
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Disclosed compounds include Formula (IV).
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There is a small difference between the claimed structure of Formula (I) and Applicant’s Formula (II’) with respect to Y3, which in both formulas can be halogen, but with the difference being that it is a position isomer occupying a different place on the phenyl ring. This renders the compound structures obvious. "Compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977). See also In re May, 574 F.2d 1082, 197 USPQ 601 (CCPA 1978) (stereoisomers prima facie obvious); Aventis Pharma Deutschland v. Lupin Ltd., 499 F.3d 1293, 84 USPQ2d 1197 (Fed. Cir. 2007) (5(S) stereoisomer of ramipril obvious over prior art mixture of stereoisomers of ramipril.)." MPEP 2144.09.
Claims 39, 42, 50-51, 54, 57 and 72-73 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2021108549 A1 to Geldern et al. A1 (“Geldern”).
Geldern discloses compounds of Formula (I) that function as thyromimetics, and compositions thereof with pharmaceutically acceptable excipients, which compounds have utility for treating diseases such as neurodegenerative disorders, such as X-Iinked adrenoleukodystrophy or multiple sclerosis. (Abstract, p. 3, ll. 1-13, claim 1).
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Geldern further discloses compounds of Formula (II).
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(claim 5).
This compound of Formula (II) overlaps with Applicant’s compound of Formula (II’), with respect to all substituents, except for the position of X2 on the ring, with the difference being that it is a position isomer occupying a different place on the phenyl ring. This renders the compound structures obvious. "Compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977). See also In re May, 574 F.2d 1082, 197 USPQ 601 (CCPA 1978) (stereoisomers prima facie obvious); Aventis Pharma Deutschland v. Lupin Ltd., 499 F.3d 1293, 84 USPQ2d 1197 (Fed. Cir. 2007) (5(S) stereoisomer of ramipril obvious over prior art mixture of stereoisomers of ramipril.)." MPEP 2144.09.
Claim Objections
Claim 67 is objected to as dependent on a rejected based claim, but would be allowable in independent claim format.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SVETLANA M IVANOVA whose telephone number is (571)270-3277. The examiner can normally be reached 8:30-5:00.
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/SVETLANA M IVANOVA/ Primary Examiner, Art Unit 1627