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 .
Acknowledgments
This office action is in response to the reply filed on 9/12/25. In the reply, the applicant amended claims 1, 5, 14. Claims 1-14, 18-19 are pending.
Claim objection to claim 5 is withdrawn due to applicant’s amendment.
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.
Claims 1-7, 10-14, 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Azure et al. (US 9,526,911) (“Azure”) in view of Nitto Denko Corp (CA 2 852 537) (“Nitto”).
Azure discloses: a. exposing a target site of the subject to an alternating electric field for a period of time, the alternating electric field having a frequency and field strength C8L36-57. Azure does not directly disclose b. contacting the target site of the subject to a vasodilator, wherein the vasodilator increases circulation at the target site of the subject. However, Azure does disclose the synergistic effect of an agent/adjuvant and electric field, Fig. 1, claim 14. Nitto, in the analogous art, teaches the sequential or simultaneous use of an enhancer and an energetic field to actively drive a permeant into tissue, page 9 lines 3-14. The enhancer is biocompatible for topical application (page 11 lines 21-26) and a vasodilator as a peptide is used (page 12 line 26- page 13 line 17). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention for the immunostimulatory agent or adjuvant in Azure to be a vasodilator, compound or peptide as taught by Nitto as part of the design consideration wherein a multitude of enhancers or adjuvants are contemplated. The vasodilator increasing circulation to maintain or decrease temperature is a resultant that is obvious over Azure/Nitto in the same way as applicant claims based on results of a method.
Azure further discloses: the frequency of the alternating electric field is between 100 and 500 kHz; between 180 and 220 kHz. C8L36-57
the target site comprises a cancer cell (see title of Azure); the cancer cell is a glioblastoma cell or lung metastatic carcinoma cell. C17L60-C18L6
the target site is exposed to the alternating electric field and vasodilator simultaneously or consecutively. C6L24-33 (and see Nitto page 9 lines 3-14)
contacting the target site of the subject to a vasodilator comprises transdermal administration of the vasodilator to the subject at the target site. (see claim 14, “local administration” and “delivering or administering” C6L24-26, “administering” is interpreted as transdermal administration in the context of Azure and Nitto page 11 lines 21-26
The target site is the subject's head, chest, or extremity. (design choice) C17L60-C18L6 Azure
Claim 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Azure in view of Nitto.
Azure as modified by Nitto teaches the invention as substantially claimed, see above. The vasodilator being nitroprusside, nitroglycerin, minoxidil, or hydralazine are design choices as obvious examples of vasodilators as well known in the art. Also, the increase in blood circulation is 1% greater than blood circulation prior to exposure to the vasodilator is a design choice that is a measurable result of the method as well known in the art to take this measurement.
Response to Arguments
Applicant’s arguments with respect to the claims have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DEANNA K HALL whose telephone number is (571)272-2819. The examiner can normally be reached M-F 9:00am-5:30pm est.
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, Kevin Sirmons can be reached at 571-272-4965. 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.
/DEANNA K HALL/Primary Examiner, Art Unit 3783