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 .
Receipt is acknowledged of Applicant’s Amendments and Arguments filed on 04/30/2025 and 07/23/2025.
Claims 54, 57, and 59 have been amended.
Claims 76-88 have been added.
Claims 55 and 56 have been cancelled.
Claims 61-75 have been withdraw from consideration. Accordingly, claims 54, 57-60 and 76-79 are pending and presented for examination.
Newly submitted claims 80-88 directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: the claims to the different species recite the mutually exclusive characteristics of such species--, and provide a description of the mutually exclusive characteristics of each species or grouping of species.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claim80-88 withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 04/30/2025 was noted and the submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Any previous rejections and/or objections not reiterated herein have been withdrawn in view of amendments filed on 04/30/2025. The following rejections and/or objections constitute the complete set presently being applied to the instant application.
Claim Rejections - 35 USC § 102
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.
Claim(s) 54, 57-60 and 76- 79 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tamagnan et al. (US 2007/0258887) is maintained for reasons of record in the previous office action mailed on 12/21/2024.
Tamagnan discloses compounds and amyloid probes, pharmaceutical compositions thereof for diagnosing AD and quantitating the extent or progression of amyloid deposits (plaques) by in vivo imaging of amyloid and/or amyloid deposits in the region of the brain (abstract). In one embodiment, includes a compound or amyloid probe thereof comprising the structure of formula
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in which R1, R2, R3 and R4 are the same or different and can independently be H, F, CN, aryl, heterocycles, heteroaryl, A and D can be each independently be N or C, E, Y, Z can each independently be CH or N, B can be S, O, N or CH, and comprise one or more substituents as a radiolabel (marker or tag). Exemplary labels include radionuclides, radioisotopes or isotopes. For example, an amyloid probe of the invention comprises one or more R1, R2, R3, R.4, R5 and R6, each of which can independently comprise (for example, R1 can be 131I or CH2-CH2-131I) 131I, 124I,.125I,.3H, 123I,19F, 11C, 75Br, 13C, 13N, 15O, 76Br, CH2-CH2-label, O—CH2-CH2-label, CH2-CH2-CH2-label, O-CH2-CH2-CH2-label, -[OCH2-CH2]n-label, ((E) or (Z) configuration), N-CH2=CH-label ((E) or (Z) configuration) in which "label" can independently be 131 I, 124I, 125I, 3H, 123I, 18F, 19F, 11C, 75Br, 13C, 13N, 15O, 76Br, 11C or 13C, or 11C or 13C can be a label (mark or tag) as a substituent (0021. Compounds can be included in a composition comprising a pharmaceutically acceptable carrier. Additional disclosure includes pharmaceutical composition comprising the compounds are related to an in vivo or in vitro method for detecting in a subject one or more amyloid deposits comprising one or more amyloid or amyloidogenic proteins. For example, a method of the invention can comprise administering to a subject thought to be of risk for or suffering from a disease associated with amyloid deposits or amyloidosis, a detectable quantity or effective amount of a compound or amyloid probe thereof (or analogs, salts, pharmaceutical compositions, derivatives, prodrugs or racemic mixtures thereof). Thus, the examiner considers each of the forgoing teaching as clearly anticipating the instantly claimed invention.
Applicant’s arguments filed on 04/30/2025 have been fully considered but they are not persuasive. Applicant argues that Tamagnan includes very broad Markush formulae and does not narrow down to or contain any pointers that would allow a person of skill in the art to arrive at the present claims. Although the reference is silent about the specific compounds, it does not appear that the claim language or limitations results in a manipulative difference in the compounds of instant claims when compared to the prior art disclosure. Consistent with this reasoning, a person of skill in the art would have been selected the various combinations of features claimed from within the prior art disclosure to arrive at the instantly claimed compounds, specifically with a core
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, related to compounds and amyloid probes thereof that bind preferentially to or interact with amyloid proteins or precursors and also discloses that the compounds of the invention are each capable of being readily modified to be an amyloid probe that comprises one or more detectable markers, tags or labels by conventional techniques known to those of ordinary skill in the art.
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.
Claim(s) 54, 57-60 and 76-79 are rejected under 35 U.S.C. 103 as being unpatentable over Tamagnan et al. (US 2007/0258887).
Tamagnan discloses compounds and amyloid probes, pharmaceutical compositions thereof for diagnosing AD and quantitating the extent or progression of amyloid deposits (plaques) by in vivo imaging of amyloid and/or amyloid deposits in the region of the brain (abstract). In one embodiment, includes a compound or amyloid probe thereof comprising the structure of formula
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in which R1, R2, R3 and R4 are the same or different and can independently be H, F, CN, aryl, heterocycles, heteroaryl, A and D can be each independently be N or C, E, Y, Z can each independently be CH or N, B can be S, O, N or CH, and comprise one or more substituents as a radiolabel (marker or tag). Exemplary labels include radionuclides, radioisotopes or isotopes. For example, an amyloid probe of the invention comprises one or more R1, R2, R3, R.4, R5 and R6, each of which can independently comprise (for example, R1 can be 131I or CH2-CH2-131I) 131I, 124I,.125I,.3H, 123I,19F, 11C, 75Br, 13C, 13N, 15O, 76Br, CH2-CH2-label, O—CH2-CH2-label, CH2-CH2-CH2-label, O-CH2-CH2-CH2-label, -[OCH2-CH2]n-label, ((E) or (Z) configuration), N-CH2=CH-label ((E) or (Z) configuration) in which "label" can independently be 131 I, 124I, 125I, 3H, 123I, 18F, 19F, 11C, 75Br, 13C, 13N, 15O, 76Br, 11C or 13C, or 11C or 13C can be a label (mark or tag) as a substituent (0021. Compounds can be included in a composition comprising a pharmaceutically acceptable carrier. Additional disclosure includes pharmaceutical composition comprising the compounds are related to an in vivo or in vitro method for detecting in a subject one or more amyloid deposits comprising one or more amyloid or amyloidogenic proteins. For example, a method of the invention can comprise administering to a subject thought to be of risk for or suffering from a disease associated with amyloid deposits or amyloidosis, a detectable quantity or effective amount of a compound or amyloid probe thereof (or analogs, salts, pharmaceutical compositions, derivatives, prodrugs or racemic mixtures thereof).
This reference differs from the claimed subject matter in that it does not disclose a composition comprising compounds which reads on applicant’s claims with sufficient specificity to constitute anticipation. It would have been obvious to one of ordinary skill in the art at the time the invention was made to generate a composition comprising such compounds because both Applicant and Tamagnan discloses compounds comprising various combinations of features claimed to arrive at the instantly claimed compounds.
Conclusion
No claims are allowed at this time.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAGADISHWAR RAO SAMALA whose telephone number is (571)272-9927. The examiner can normally be reached Monday-Friday 9am-6pm.
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, Hartley G Michael can be reached at 571 272 0616. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/J.R.S/Examiner, Art Unit 1618 /JAKE M VU/Primary Examiner, Art Unit 1618