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 .
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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) 41 and 44-54 is/are rejected under 35 U.S.C. 102a1 as being anticipated by Kostenich et al. (WO 2016/038565, cited by applicants).
Kostenich discloses synthetic somatostatin receptor ligands which include SEQ ID 16, DPhe-Arg-Cys-Phe-Dtrp-Lys-Thr-Phe-A (meeting formula A when R3 is Arg, R4 is Phe and R6 is PHe), the amino acid sequence at the terminus A can be selected as N-thioethyl glycine, within the scope of the claimed NTAG group R6. See entire disclosure, especially abstract and claims. The somotastatin ligands were used to identify and treat cancerous tumors overexpressing somatostatin receptors SSTRx (including SSTR3). See Fig. 8, Fig 9, Fig 12, page 8 line 28-page 10 line 11, experimental including tables table 2. Regarding claims 44-48 and 54, the somatostatin analogues included chelating agents such as DOTA bound to radioactive elements such as gallium-68. See page 43 line 31-page 45 line 15.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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) 41-55 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kostenich et al, cited above, as applied to claims 41 and 44-54 above in view of Graupner et al. (AU 2005203401 A1), in view of Griffiths et al. (WO 03/048207) in view of Stiles et al. “Desmoplastic small round cell tumor: A nationwide study of a
Rare sarcoma”, J. Surg. Oncol. 2018;117:1759–1767.
Kostenich is disclosed. The reference while teaching treatment/imaging of cancerous tissue is silent with respect to sarcoma and desmoplastic small round tumor recited in claim 42-43. Furthermore, Kostenich while teaching use of radioactive elements is silent with respect to the radioactive elements of claim 55.
Graupner is used primarily for its disclosure on the ability of somatostatin compounds to target sarcomas which overexpress SSTRx. See entire disclosure, especially abstract, and claims, especially 45-46. Stiles is used only for its disclosure that Desmoplastic small round cell tumors were rare yet aggressive sarcomas. See entire disclosure, especially introduction page 1759. Since Kostenich already teaches somatostatin analogs which target cancerous cells overexpressing SSTRx and Graupner teaches somatostatin compounds target sarcomas one of ordinary skill in the art would have a very high expectation of success in using the compounds of Kostenich to treat and/or diagnose sarcomas which could extend to the rare and aggressive desmoplastic small round cell tumors. Applying these ideas to Kostenich is no more than following the suggestions or teachings of the art.
Griffiths is used primarily for its disclosure that actinium-225 and lutetium-177 were well known radioactive agents used in DOTA substituted peptide conjugates. See entire disclosure, especially abstract, [0018]-[0023] and claims. Since Kostenich teaches use of radioactive elements chelated to DOTA one of ordinary skill in the art would have a very high expectation of success in substituting actinium-225 and lutetium-177 to DOTA. The artisan would recognize that, based on the disclosure of Kostenich that numerous radioactive elements, including actinium-225 and lutetium-177 could be substituted into the peptide DOTA conjugate with similar results.
Thus the claimed invention would have been prima facie obvious since all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAMES W ROGERS whose telephone number is (571)272-7838. The examiner can normally be reached 9:30-6:00 PM.
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/JAMES W ROGERS/ Primary Examiner, Art Unit 1618
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