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 .
Claims 1-5 are pending.
Claim Objections
Claim 5 is objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim should refer to other claims in the alternative only. See MPEP § 608.01(n). Accordingly, the claim5 not been further treated on the merits.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1 and 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tornesello, Anna Lucia, et al. "New insights in the design of bioactive peptides and chelating agents for imaging and therapy in oncology." Molecules 22.8 (2017) : 1282 in view of Popik, Piotr, and Ree, Jan M. Van. "Long term facilitation of social recognition in rats by vasopressin related peptides: A structure-activity study." Life sciences 50.8 (1992) : 567-572.
Tornesello et al. discloses various peptide-based analogues with different chelating agents for imaging and therapy in oncology (see abstract; Table 1). The used bifunctional chelator is selected from group comprising DOTA, DATA, NOTA, DOTAGA, NODAGA (see page 4, para 03; page 13, para 03; figure 3-4; page 11, para 3.2.2). The modified peptide moiety covalently bounded to the chelator through a linker (see figure 1).
Popik et al. discloses that the use of the cyclic peptide compound Cys-Tyr-Phe-Gln-Asn-Cys-Pro-Arg-Gly-NH2 (Amino-acid composition of vasopressin (AVP) ) for long term facilitation of social recognition wherein this peptide is 90% identical with the claimed cyclic peptide of the present application (see abstract; table 1). Standardizing the molar ratio of desmopressin analogue and bifunctional chelator is considered routine experimentation within reach of a person skilled in the art.
In view of the disclosures of Popik et al. combined with Tornesello et al., it would be obvious for a person skilled in the art to arrive at the molecular imaging complex comprising desmopressin analogue and a bifunctional chelator conjugated with the radioisotope for tomography imaging as claimed in claims 1 and 2
Claim(s) 3 and 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tornesello, Anna Lucia, et al. "New insights in the design of bioactive peptides and chelating agents for imaging and therapy in oncology." Molecules 22.8 (2017) : 1282 in view of Popik, Piotr, and Ree, Jan M. Van. "Long term facilitation of social recognition in rats by vasopressin related peptides: A structure-activity study." Life sciences 50.8 (1992) : 567-572 as applied to claims 1 and 2 above, and further in view of Ebenhan, Thomas, et al. "Peptide synthesis, characterization and 68Ga-radiolabeling of NOTA-conjugated ubiquicidin fragments for prospective infection imaging with PET/CT." Nuclear Medicine and Biology 41.5 (2014) : 390-400.
Teachings of Tornesello et al. and Popik et al. are discussed above.
Regarding claim 3, Ebenhan et al. discloses a synthesis and purification of Ga-68 radiolabeling of NOTA conjugated ubiquitin peptides using solid phase extraction (SPE) technique. Further, the characterizations are performed using analytical HPLC and LC/MS (see abstract; page 12, para Purification (solid phase extraction)
It would have been prima facie obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to further modifiy the combination of Tornesello et al. and Popik et al. with Ebenhan et al. to arrive at the molecular imaging complex comprising desmopressin analogue and a bifunctional chelator further conjugated with radioisotope for tomography imaging as claimed in claim 3.
Regarding claim 4, Tornesello et al. teaches different isotopes Yttrium, Indium, Gallium, Lutetium, and Copper radioisotope for conjugation with peptide-based analogues (see para 3.2.2). The Gallium radioisotope with DOTA derivative requires heating at 80-100 °C (see page 12, para 01)
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT S CABRAL whose telephone number is (571)270-3769. The examiner can normally be reached M-F 8 am - 5 pm.
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, Ali Soroush can be reached at 571-272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ROBERT S CABRAL/Primary Examiner, Art Unit 1614