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 .
Response to Arguments
Applicant’s arguments combined with the claim amendments have been fully considered and are found persuasive with respect to the previous rejection(s); however, upon further search and consideration due to the change in scope, an updated grounds of rejection is presented below, necessitated by 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 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.
In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
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 of this title, 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.
Claims 1-7, 9, 11-18, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Sivo (US 2013/0261711; hereinafter “Sivo”) in view of Carter et al. (US 2021/0339035; hereinafter “Carter”).
Regarding claim 1, Sivo discloses a device for treatment of solid cancers, the device comprising: an external portable induction coil (e.g. ¶¶ 38); and a power source operatively connected to the external portable induction coil and configured to generate an induced electric field (iEF) in the solid cancers by the external portable induction coil (e.g. ¶¶ 40-42), and wherein the external portable induction coil is adapted to provide the iEF near or within a solid cancer (e.g. ¶¶ 12 – cancerous tumors) to alter a tumor microenvironment to reduce migratory potential of cancer cells (e.g. ¶¶ 7 – “directed specifically toward adversely altering the bio-regulatory electrical energies of cancer cells”; e.g. ¶¶ 10 – “adversely affecting, beyond a tolerance of normal biologic homeostasis, the bio-regulatory electric energy interactions that govern the biologic, biochemical, biophysical and physiologic processes of cancer cells and cancerous tumor growth and proliferation.”).
Sivo fails to expressly disclose the induced electric field generated is between 1-2.4 mV/cm peak field strength. In the same field of endeavor, Carter discloses generating an induced electric field between 1-2.4mV/cm peak field strength (e.g. ¶¶ 65-66 - “range is between 100 uV/mm to 1000 uV/mm” – where the examiner notes this converts to 1-10mV/cm, falling within the claimed range) in order to treat cancerous cells via an externally applied electrical field from a coil in a patch on the skin. It would have been obvious, to one of ordinary skill in the art, prior to the effective filing date of the present invention, to apply the known technique of applying electrical field stimulation between 1-2.4 mV/cm field strength, as taught by Carter, to the known device of Sivo, ready for improvement to yield predictable results of treating cancerous cells.
Regarding claim 11, Sivo teaches a method for treatment of solid cancers, the method comprising: generating an induced electric field (iEF) in the solid cancers using a portable induction coil (e.g. ¶¶ 38); and providing the iEF near or within a solid cancer (e.g. ¶¶ 12 – cancerous tumors) to alter a tumor microenvironment to reduce migratory potential of cancer cells (e.g. ¶¶ 7 – “directed specifically toward adversely altering the bio-regulatory electrical energies of cancer cells”; e.g. ¶¶ 10 – “adversely affecting, beyond a tolerance of normal biologic homeostasis, the bio-regulatory electric energy interactions that govern the biologic, biochemical, biophysical and physiologic processes of cancer cells and cancerous tumor growth and proliferation.”).
Sivo fails to expressly disclose the induced electric field generated is between 1-2.4 mV/cm peak field strength. In the same field of endeavor, Carter discloses generating an induced electric field between 1-2.4mV/cm peak field strength (e.g. ¶¶ 65-66 - “range is between 100 uV/mm to 1000 uV/mm” – where the examiner notes this converts to 1-10mV/cm, falling within the claimed range) in order to treat cancerous cells via an externally applied electrical field from a coil in a patch on the skin. It would have been obvious, to one of ordinary skill in the art, prior to the effective filing date of the present invention, to apply the known technique of applying electrical field stimulation between 1-2.4 mV/cm field strength, as taught by Carter, to the known device of Sivo, ready for improvement to yield predictable results of treating cancerous cells.
Regarding claim 12, Sivo discloses the iFE is generated by an external portable induction coil with an associated power source (e.g. Fig. 4 – external coil secured by Velcro to the patient).
Regarding claims 2 and 13, Sivo discloses the external portable induction coil and the associated power source is configured to be worn by a patient having the solid cancer (e.g. Fig. 4 – external coil secured by Velcro to the patient).
Regarding claims 3 and 14, Sivo discloses the external portable induction coil and the associated power source is configured to be worn by the patient continuously until treatment of the solid cancer is completed (e.g. Fig. 4 – external coil secured by Velcro to the patient – where the examiner considers the treatment to be completed in whatever the timeframe the patient has the coils velcro’d on).
Regarding claims 4 and 15, Sivo discloses the external portable induction coil and the associated power source is configured to be worn by the patient for a predetermined duration (e.g. Fig. 4 – external coil secured by Velcro to the patient – where the examiner considers the predetermined time to be the time for which the Velcro straps are secured on the patient).
Regarding claims 5 and 16, Sivo discloses the external portable induction coil and the associated power source is integral to a fabric worn by a patient having the solid cancer (e.g. Fig. 4 – where the examiner considers the Velcro straps to fall under fabric worn by the patient, and the power lines are clearly leading into that structure).
Regarding claims 6 and 17, Sivo discloses the external portable induction coil and the associated power source are embedded in a mattress or other piece of furniture or object, on which a patient having the solid cancer would sleep or rest (e.g. Fig. 4 – where the examiner considers the Velcro to be the object and the patient is resting during the treatment).
Regarding claims 7 and 18, Sivo fails to expressly disclose the induced electric field generated is between 1-2.4 mV/cm peak field strength. In the same field of endeavor, Carter discloses generating an induced electric field between 1-2.4mV/cm peak field strength (e.g. ¶¶ 65-66 - “range is between 100 uV/mm to 1000 uV/mm” – where the examiner notes this converts to 1-10mV/cm, falling within the claimed range) in order to treat cancerous cells via an externally applied electrical field from a coil in a patch on the skin. It would have been obvious, to one of ordinary skill in the art, prior to the effective filing date of the present invention, to apply the known technique of applying electrical field stimulation between 1-2.4 mV/cm field strength, as taught by Carter, to the known device of Sivo, ready for improvement to yield predictable results of treating cancerous cells.
Regarding claims 9 and 20, Sivo discloses a 100 kHz, 20 Vpp sawtooth waveform is used to generate the iEF (e.g. ¶¶ 12 – “sawtooth”; ¶¶ 45 – “100 kHz”).
Regarding claims 8, 10, and 19, Sivo fails to expressly disclose a coil having an inductance of approximately 437 microH and a resistance of approximately 28 ohms and providing an electrical current of approximately 55 mA. Sivo discloses a plurality of different coils may be used with a variety of different settings in order to produce the most effective cancer treatment for the patient (e.g. ¶¶ 44-49). Accordingly, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the coil of Sivo to have an inductance of approximately 437 microH and a resistance of approximately 28 ohms and provide an electrical current of approximately 55 mA, since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michael D’Abreu whose telephone number is (571) 270-3816. The examiner can normally be reached on 7AM-4PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached at (571) 270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL J D'ABREU/Primary Examiner, Art Unit 3796
