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 12/9/22, 9/14/23 and 3/8/24 were mailed in a timely fashion. 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) 1-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over the combined disclosures of Bourinet et al (US 2012/0040909 A1 hereafter Bourinet) in view of Kim et al (Design and synthesis of dye-conjugated hepsin inhibitors, Bioorganic Chemistry 89, 2019 hereafter Kim) and Dimasi et al (US 2013/0330350 A1 hereafter Dimasi).
Bourinet discloses a peptide compound of Formula I YCQKFLWTCDSERPCCEGLVCRLWCKIN (SEQ ID NO 1) [abstract, 0037]. The peptide is formulated with acceptable carriers [0064] and can be delivered parenteral administration [0065], meeting limitations of claims 8, 9, 13-15, 18 and 19.
While the reference discloses a peptide similar to the instant claims, it is silent to the chelating cation of the fluorophore of claim 1. The peptide is however useful for cancer treatment [0034-0035]. Chelating cations are useful in active agent delivery while fluorophores are useful for imaging and diagnosis in cancer treatments. It is known to include fluorophores and chelating cations to peptides that are useful in cancer treatments as seen in the Kim and Dimasi.
Kim discloses a dye-conjugated hepsin inhibitor useful in cancer treatments [abstract]. The peptide comprises a fluorophore conjugated to the structure where the fluorophore is BODIPY665 [page 2, Fig. 4], meeting limitations of claim 2 and 3. The peptide can be useful in imaging cancers such as prostate, ovarian and breast cancer sue to its hepsin inhibition and fluorescent energy [page 2]. The fluorine atom in the BODIPY665 can be replaced 18F for PET imaging, such that the peptide is administered prior to imaging [page 2, 2.1]. This allows for microscopic imaging by administered and imaging the tissues and biological activities in vivo [2.1], meeting limitations of claims 10-12. It would have been obvious to combine the fluorophore of Kim to the peptide of Bourinet as they are attempting to solve the same problem.
The combination discloses a peptide with a fluorophore useful in imaging and identifying tissues. The combination is silent to a chelating cation additives, however the use of such additives are known in the art as seen in the Dimasi.
Dimasi discloses an engineered peptide that is selective for Nav1.7 [0202]. The peptide additional comprises a chelating cation such as DOTA which further comprises radiometals such as 177Lu, 111In and 68Ga [0277, claims], meeting limitations of claims 5-6. It would have been obvious to include the chelating cation compound to improve the drug delivery properties of the peptide formulation of Bourinet as it can be used to deliver cancer fighting compounds.
One of ordinary skill in the art would have been motivated to combine the prior art in order to provide an imaging peptide that can also be used to treat cancer conditions. It would have been obvious to an artisan of ordinary skill to combine the fluorophore of Kim and the chelator of Dimasi to the cancer treatment peptide as they all solve the same problem of treating and imaging cancer by administering the peptide parenterally and microscopically imaging the tissues. The chelating cation would increase or improve drug delivery for cancer treatments, and the fluorophore of Kim can be used for diagnostic imaging showing tumors and separating healthy tissue from unhealthy tissue. 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 treating cancer.
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