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 .
Election/Restrictions
Claims 27-30 were previously withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03. Upon claims 1 and 24 being allowable, claims 27-30 will be rejoined if applicable.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 6 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
In claim 6, the multiple uses of “the electric field” and “an electric field” are vague as claim 1 uses the terms “electric fields”, “first electric field”, and “second electric field” and it is unclear in claim 6 if the multiple uses of the different electric fields are referring to the electric fields used in claim 1 or not. If they are the same, then “the first electric field”, “the second electric field”, etc. should be used in claim 6.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-7, 12, 14-15, 19 and 24-26 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Schmidt et al (11607542). Schmidt has support from provisional 62/837401 and discloses the claimed invention as follows:
--for the new claim limitation of 0.1 V/cm to 10 V/cm (e.g. col. 17, lines 27-42, etc.)
--an implantable thin substrate device having first and second electrodes (e.g. figure 6 below, internal implantable element 506/106 having first top electrode 508/108 and second bottom electrode 508/108, and similar in figures 5-12, etc.)
--electric field generator (e.g. element 102, figure 6, and similar in figures 5-12, figures 13 and 14, col. 12, lines 1-55, etc.) operating from about 50 kHz to about 500 kHz (e.g. e.g. col. 7, lines 35-36, col. 17, lines 9-13, etc.).
--note that the claims are open ended “comprising” claims and do not preclude the use of additional fields, or fields going to both pairs of electrodes at the same time.
--where the generator generates during a first duration (e.g. figure 3 below) a first electric field to a first pair of electrodes (e.g. figure 6 below) and after the first duration, generates a second electric field (e.g. figure 3 below) to a second pair of electrodes that are different than the first pair of electrodes (e.g. figure 6 below). As the current is an “alternating current” (e.g. figure 3, col. 4, line 66, i.e. necessarily changing field directions due to the alternating current and different polarities on the electrodes, etc.), the first electric field will go from the left electrode 508 to the right electrode 509, then alternate to the second electric field from the bottom right electrode 509 to the bottom left electrode 508.
--For claim 33, as the first duration ends (i.e. the waveform passes the zero point in figure 3), the first electric field going from left to right will cease, and no longer be generated. In addition, an alternative meeting of claim 33 and the independent claims is that Schmidt also discloses two different electric fields can be generated (e.g. col. 7, lines 29-44, etc.) with one alternating field sweep being generated followed by another different alternating field sweep.
--Schmidt also specifically notes the electrode positions can be changed, allowing for the skew/orthogonal fields and that the fields may be off from one another by 90 degrees (e.g. col. 16, lines 10-11, col. 5, lines 9-28, etc.).
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--Schmidt discloses the electrodes/implanted devices can be placed near a tumor or tumor resection cavity/brain (e.g. figures 5-12, note that the electrodes are implantable and are capable of meeting the functional use recitation presented in the claims since they are implantable, small, and may be implanted in those locations such as the head, col. 5, lines 25-35, etc.). For claim 6, due to the frequency, the field does change directions at least once per second to the first and second pair of electrodes. For claim 7, the claim is an open-ended “comprising” claim and does not preclude the use of additional alternating current pulses that are delivered between the electrodes outside the time of between 0.03 and 0.5 seconds (in the alternative for claim 7, see the 103 rejection below). For claim 19, Schmidt also uses two internal devices having electrodes (e.g. figures 9-12, second implanted device 506 having 3rd and 4th electrodes 508, etc.).
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.
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 7 is rejected under 35 U.S.C. 103 as being unpatentable Schmidt in view of Cosman, SR. (2017/0050021). Schmidt discloses the claimed invention except for the change of direction of the field at a frequency of between 0.03 seconds and 0.5 seconds. Cosman teaches that is it known to change the direction of the field at a frequency of between 0.03-0.5 seconds (e.g. figure 2A, paras. 81, 91, 0.5 seconds turn on, with 0.5 seconds turned off before next field change, etc.) so the device can be used painlessly and avoiding usual discomforts of standard RF heating procedures. It would have been obvious to one having ordinary skill in the art at the time the invention was made/before it was effectively filed to have modified the system and method as taught by Schmidt, with changing the direction of the field at a frequency between 0.03 and 0.5 second as taught by Cosman, since it would provide the predictable results of using the device painlessly and avoiding usual discomforts of standard RF heating procedures.
In addition, or in the alternative, it would have been an obvious matter of design choice to a person of ordinary skill in the art (and is admitted prior art as the applicant has not pointed out the errors in the examiner’s findings and/or provided evidence of non-obviousness) to modify the time between the changing of the direction of the field such as a frequency between 0.03 and 0.5 seconds, because Applicant has not disclosed that changing of the direction of the field such as a frequency between 0.03 and 0.5 seconds provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected Applicant’s invention to perform equally well with the RF alternating/sinusoidal changing electric field as taught by Schmidt, because it effectively destroys the cancer/tumor and recognizes the results of changing the field between electrodes. Therefore, it would have been an obvious matter of design choice to modify Schmidt to obtain the invention as specified in the claim(s).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Schmidt. Schmidt discloses the claimed invention except for the elongated body for the electrodes being rigid. It would have been obvious to one having ordinary skill in the art at the time the invention was made/before it was effectively filed (and is admitted prior art as the applicant has not pointed out the errors in the examiner’s findings and/or provided evidence of non-obviousness) to have modified the system and method as taught by Schmidt, to have elongated body for the electrode being rigid, as is well known and common knowledge in the art (see MPEP 2144I, 2144.03), since it would provide the predictable results of providing an implantable lead that can be stereotactically guided to an exact location in the patient for providing therapy to a targeted location.
Response to Arguments
Applicant’s arguments with respect to the claims have been considered but are moot in view of the new grounds of rejection necessitated by amendment as addressed above in the 102 rejections.
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 George Robert Evanisko whose telephone number is (571)272-4945. The examiner can normally be reached M-F 8AM-5PM.
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, Benjamin Klein can be reached on 571-270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/George R Evanisko/Primary Examiner, Art Unit 3792 4/21/26
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