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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 9/15/22 and 6/10/22 were filed in a timely manner. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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) 26-43 is/are rejected under 35 U.S.C. 103 as being unpatentable over the combined disclosures of Donnelly et al (WO 2010/066010 A1 hereafter Donnelly) in view of Rashidian et al (US 2016/0287734 A1 hereafter Rashidian).
Donnelly discloses a method of in vivo diagnostic imaging of a neurodegenerative disease or disorder comprising administration to a patient a composition comprising an antibody and a asymmetrical bis(thiosemicarbazone) where the formula
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(abstract, pg. 1, 20, 26-34, 36-37, 43). R1-3 are selected from the group consisting of H, an alkylene, alkylene, alkynylene, arylene, benzylene and heteroarylene (pg. 4-3). The neurodegenerative disease include Alzheimer’s disease (pg. 36). The disorder can also be characterized by aggregated protein disorders like Lewy body disease (pg. 37). A metal complex is added to the formula where the metal is a copper ion such as copper 64
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(pg. 1, Example 8).
While the reference discloses a method of in vivo diagnostic imaging, the compound is silent to the inclusion of a tetrazine addition. The application of tetrazine to imaging compounds is well known in the art as seen in the Rashidian.
Rashidian discloses radiolabeled compounds that comprise a labeled protein as useful for positron emission tomography [abstract]. The protein has a peptide substrate that comprises click-chemistry including a tetrazine handle like a tetrazine dienophile [0006, 0082, Table 1]. In some embodiments the antibody/protein is linked to a radiolabeled agent, a reactive moiety such as click chemistry handle like a tetrazine and where the agent is a thiosemicarbazone [Fig. 4D, 0006, 0077, 0393]. The proteins can be antibody that bind to specific tissues including tumors [0350-0351, 0366]. These embodiments comprising these components are useful in diagnostic applications for imaging where the radiolabel is a metal ion such as copper-64 [0086, 30393]. It would have been obvious to include the click-chemistry handle of the Rashidian into the formulation of Donnelly as they solve the same problem of radiolabeling proteins that target specific tissues and conditions.
With these aspects in mind it would have been obvious to combine the prior art with an expected result of a stable method of diagnostic imaging specific tissues. It would have been obvious to include a tetrazine handle of Rashidian to the compound and method of Donnelly as they both disclose the labeling of and antibody that targets specific tissues in the body, and using metallic radiolabels for improved diagnostic imaging. This combination would have been obvious as they solve the same problem in the same field of endeavor. One of ordinary skill in the art would have been motivated to combine the prior art with an expected result of a stable means of diagnosing and imaging damaged tissue.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICAH PAUL YOUNG whose telephone number is (571)272-0608. The examiner can normally be reached Monday through Friday, 9:00 am to 5:30 pm.
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/MICAH PAUL YOUNG/Primary Examiner, Art Unit 1618