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 § 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.
Claims 1-14 and 16-20 are rejected under 35 U.S.C. 103 as being unpatentable over Peyman (US 2019/0091350).
Peyman teaches administering nanoparticles to the body and applying alternating magnetic field for their release (¶ 30). Among the actives which may be delivered include guselkumab, tildrakizumab, secukinumab, (Table 1). The pulse is taught to be aimed at tumor cells and increase the temperature of the cells, as well as release the medication when the energy is less than about 100kHz (¶ 76). It is recognized that the release of actives may produce excessive cytokine levels (¶ 113).
It would have been obvious to one of ordinary skill in the art to vary the method of Peyman by using the various actives taught as suitable and to combine them as needed, releasing them with the alternating electric fields at about 100kHz.
It would further have been obvious to measure cytokine levels both before and during treatment to control the release and limit potential cytokine caused damage. In doing so, the application of medication and energy would work together to optimize treatment of the tumor cells.
Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Peyman (US 2019/0091350) in view of Merchant (US 2017/0152273).
Peyman is discussed above but does not teach the RORyt inhibitors of instant claim 15.
Merchant teaches topical ROR agents were known to include GSK2981278 (¶ 40).
It would have been obvious to use other known actives known in the art in the method of Peyman, such as those disclosed by Merchant.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BENJAMIN J PACKARD whose telephone number is (571)270-3440. The examiner can normally be reached Mon 2-6pm and Tues-Fri (9am-6pm + mid-day flex).
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/BENJAMIN J PACKARD/ Primary Examiner, Art Unit 1612