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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 7/23/26 has been entered.
Election/Restrictions
Claims 27-29 were previously withdrawn from consideration as being directed to a non-elected invention.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.
Claims 1-7, 12, 14-16, 19, 24-26, 32 and 34 are 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 1, the last paragraph, “cease generation of electric field” is vague and seems to be misworded. It is unclear which electric field is being discussed or if multiple fields are being discussed. Does this mean “cease generation of any electric field between…”, or something else?
Similarly, claim 24 uses this language and is vague.
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.
Claims 1-3, 12, 14, 16, 19, 24-26, 32 and 34 are rejected under 35 U.S.C. 102a1 as being anticipated by Schmidt et al (2019/0117969). Schmidt discloses the claimed limitations as follows:
--0.1 V/cm to 10 V/cm (e.g. paras. 33, 137, etc.) and frequency of 50-500 KHz (e.g. paras. 10, 129, etc.)
--electric field generator (e.g. figures 3, 5, etc.)
--a plurality of electrodes (e.g. figure 6, elements 604-618, on two separate leads; figure 17, 1702-1712, etc.)
--an implantable device having the first and second electrodes for positioning proximate to or within a target site (e.g. figures 6, 17, etc.)
--generate for a first duration a first electric field between a first pair of electrodes, after the first duration generate a second electric field between a second different pair of electrodes to change a direction of the field, where the electric field of the first pair of electrodes ceases during generation of the second electric field (e.g. figures 17-18, paras. 170-175, sequential field rotating around the tumor, etc.).
For claim: 2, 14, 19, 25, elongated thin substrate for the electrodes (e.g. figures 6, 17, paras. 174, 205-216, etc.); 12, configured for the brain (e.g. para. 207, etc.); 16, the rigid electrode body, Schmidt states that the lead is linear/straight and therefore requires a rigid body, and/or states that it can have a bendable core that keeps it shape, therefore providing for a rigid body until bent into a different shape (e.g. para. 215, in the alternative, see the 103 rejection below); 26, different polarities (e.g. paras. 55, 118, 119, alternating field, etc.); 32, 34, orthogonal fields, first pair spaced along a first axis, second pair intersects the first axis (e.g. figure 6, figure 17, para. 130, etc.).
Claims 1, 6, 7, 24-26, 32 and 34 are rejected under 35 U.S.C. 102a1 as being anticipated by Palti (7917227). Palti discloses the claimed limitations as follows:
--0.1 V/cm to 10 V/cm (e.g. col. 2, line 61, etc.) and frequency of 50-500 KHz (e.g. col. 2, lines 60-61, etc.)
--electric field generator (e.g. figure 5, etc.)
--a plurality of electrodes (e.g. figures 1, 5, etc.)
--an implantable device having the first and second electrodes for positioning proximate to or within a target site (e.g. col. 3, lines 20-23, incorporated document 6868289, etc.)
--generate for a first duration a first electric field between a first pair of electrodes, after the first duration generate a second electric field between a second different pair of electrodes to change a direction of the field, where the electric field of the first pair of electrodes ceases during generation of the second electric field (e.g. col. 1, lines 55-64, figure 2, etc.).
For claims: 6 and 7, the change of field once per second or at a frequency of 0.03-0.5 seconds (e.g. col. 2, lines 7-8, 30-35, 55-57, etc.); 25, electrode coupled to a substrate (e.g. col. 3, lines 20-23, incorporated document 6868289, etc.); 26, having different polarities from the alternating electric field.
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.
Claims 1-7, 12, 14-15, 19, 24-26, 32, and 34 are rejected under 35 U.S.C. 103 as being unpatentable over Schmidt et al (11607542) in view of Palti (7917227), or over Schmidt ‘542 in view of Schmidt et al (2019/0117969). Schmidt ‘542 has support from provisional 62/837401 and discloses the claimed invention as follows:
--for the 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.).
Schmidt ‘542 discloses that multiple electric fields are delivered between pairs of electrodes (e.g. figure 6, etc.) and can be orthogonal to each other (e.g. col. 2, line 21, etc.), but does not disclose specifically how and when the fields are delivered between the pairs of electrodes, such as generating for a first duration a first electric field between a first pair of electrodes, after the first duration generating a second electric field between a second different pair of electrodes to change a direction of the field, where the electric field of the first pair of electrodes ceases during generation of the second electric field.
Palti teaches a system to generate for a first duration a first electric field between a first pair of electrodes, after the first duration generate a second electric field between a second different pair of electrodes to change a direction of the field, where the electric field of the first pair of electrodes ceases during generation of the second electric field to provide an effective TTField for destroying proliferating cells in tumors. Similarly, Schmit ‘969 teaches this.
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 ‘542, with the system or method to generate for a first duration a first electric field between a first pair of electrodes, after the first duration generate a second electric field between a second different pair of electrodes to change a direction of the field, where the electric field of the first pair of electrodes ceases during generation of the second electric field, as taught by Palti or Schmidt ‘969, since it would provide the predictable results of an effective TTField for destroying proliferating cells in tumors.
-Schmidt ‘542 also specifically notes the electrode positions and leads 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 ‘542 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). However, if it is argued that Schmidt ‘542 does not have these limitations for claims 6 and 7, Palti discloses the change of field once per second or at a frequency of 0.03-0.5 seconds (e.g. col. 2, lines 7-8, 30-35, 55-57, etc.) to provide the predictable results of an effective TTField for destroying proliferating cells in tumors; 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 16 is rejected under 35 U.S.C. 103 as being unpatentable over Schmidt ‘542 in view of Palti or Schmidt ‘969 (i.e. “modified Schmidt”). Modified 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 modified 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.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Schmidt ‘969. Schmidt ‘969 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 to have modified the system and method as taught by Schmidt ‘969, 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 102/103 rejections.
Conclusion
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.
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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 9/3/26
