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 .
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on 1/6/25 has/have been acknowledged and is/are being considered by the Examiner.
Specification
The disclosure is objected to because of the following informalities: the first paragraph of the specification should be updated to indicate the present status of the priority application.
Appropriate correction is required.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-7 in the reply filed on 8/13/26 is acknowledged.
Claims 8-13 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Invention. Election was made without traverse in the reply filed on 8/16/26.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1-2 and 5 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Schmidt et al. (U.S. Pub. 2019/0117970 A1 hereinafter “Schmidt”).
Regarding claim 1, Schmidt discloses a method of treating a portion of a person's body with an electric field (e.g. Fig. 6), the method comprising: inserting a first electrode shaped into a blood vessel of the person's body or a central canal of a spinal cord of the person's body (e.g. 604), the first electrode having a biocompatible outer surface (e.g. ¶131: describes the leads and electrodes that are made from known biocompatible materials. Examiner respectfully submits that the coiled electrodes of the leads inherently have an outer biocompatible surface because the metals used in the electrode coils are biocompatible in nature); positioning a second electrode on or in the person's body (e.g. 610), wherein the second electrode is shaped and dimensioned for either (a) insertion into a blood vessel of the person's body, (b) insertion into the central canal of the spinal cord of the person's body, (c) insertion into a body orifice of the person at a position that contacts an interior surface of the person's body, (d) affixation to skin of the person's body, or (e) insertion into a lymph vessel of the person's body (e.g. ¶62 "The medical device 200 can be partially implanted within the body of a patient 101. In some embodiments, the medical device can be partially implanted and partially external to the body of a patient. In other embodiments, a partially implanted medical device can include a transcutaneous connection between components disposed internal to the body and external to the body": Examiner respectfully submits that because the medical device can partially be positioned within the body of a patient, then the electrode of the medical device is shaped and dimensioned for insertion into a body orifice (e.g. the transcutaneous connection as shown in fig. 2); and applying an AC voltage between the first electrode and the second electrode (fig. 3: electric field generating circuit 320) arranged to impose an AC voltage between the first electrode and the second electrode (e.g. ¶142 "one or more therapeutic parameter sets can be implemented in an alternating fashion" and ¶143 "Plot 1602 shows an alternating electric field, where the frequency is increased over time as the therapy is applied to the cancerous tumor. In some embodiments, a frequency sweep can include alternating between a first frequency sweep covering a range of about 100 kHz to 300 kHz and a second frequency sweep covering a range about 200 kHz to 500 kHz.").
Regarding claim 2, Schmidt further discloses wherein the outer surface of the first electrode is conductive (e.g. ¶131).
Regarding claim 5, Schmidt further discloses wherein the first electrode is shaped and dimensioned for insertion into the central canal of the spinal cord of the person's body, and the second electrode is shaped and dimensioned for affixation to the skin of the person's body (e.g. ¶125).
Claim Rejections - 35 USC § 103
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.
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schmidt as applied to claims 1-2 and 5 above, and further in view of O'Brien et al. (US 2005/0085884 A1 hereinafter “O'Brien”).
Regarding claim 3, Schmidt teaches the method of claim 1, but does not explicitly teach, wherein the outer surface of the first electrode comprises pyrolytic carbon. However, in a similar implantable device with coiled electrode/leads, O'Brien discloses an electrode contact containing pyrolytic carbon (claim 10: "wherein the electrical contact is selected from the group consisting of pyrolytic carbon").
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified method of Schmidt to have the outer surface comprise pyrolytic carbon as disclosed by O'Brien because doing so would have been a simple substitution of prior art elements (the coiled electrode of biocompatible material of Schmidt for the pyrolytic carbon material of O'Brien) using known methods of electrode formation to yield the predictable result of an electrode made from a biocompatible material that contains pyrolytic carbon as an outer layer. Examiner also notes that pyrolytic carbon is also biocompatible and is known to be a suitable material for tissue contacting electrode (O'Brien ¶34).
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schmidt as applied to claims 1-2 and 5 above, and further in view of Sharma et al. (US 2017/0296811 A1 hereinafter “Sharma”).
Regarding claim 4, Schmidt teaches the method of claim 1, but fails to explicitly state that the first electrode is located in the artery supply an organ and a second electrode is located in a vein removing the blood from an organ. However, Sharma teaches a similar system wherein the first electrode is inserted into a first blood vessel of the person's body that supplies oxygenated blood to a target organ, and wherein the second electrode is inserted into a second blood vessel of the person's body that routes deoxygenated blood away from the target organ as taught in Figure 5 and paragraphs 46-59 and 59-60 to provide perfusion of the organ and/or decreased blood to the organ to prevent hemorrhaging.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified method of Schmidt to have electrodes before and after an organ as taught by Sharma because doing so would have been a simple substitution of prior art elements using known methods of controlling blood flow in an organ to provide profusion and/or prevent hemorrhaging.
Claim(s) 6-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schmidt as applied to claims 1-2 above, and further in view of Peichel et al. (US 2019/0160291 A1) herein after Peichel.
Regarding claims 6 and 7, Schmidt teaches the method of claim 1 but does not explicitly teach the apparatus further comprising a capacitor wired in series between the AC voltage generator and the first electrode/second electrode. However, Peichel discloses, in a similar implantable stimulation device, a capacitor wired in series between an AC voltage generator and a first and second electrodes (¶123 "FIG. 7 is a conceptual diagram of circuitry included in the TCC transmitter 90 of FIG. 6, including voltage holding circuit 98, according to one example. In this example, AC coupling capacitor 96 includes two capacitors 96a and 96b, each coupled in series with a respective electrode of the transmitting electrode vector 99 (shown as electrode 24 and housing 15 in FIG. 7").
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the method of Schmidt to further include a capacitor wired in series between the AC voltage generator and the first electrode/the second electrode as disclosed in Peichel because doing so would allow power from the capacitor to directly transfer to the electrode without intermediate electrical components for the current to go through.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Heist et al. (US 2006/0064150 A1) relates to a telescoping dual site stimulation lead containing pyrolytic carbon.
Schroeppel et al. (US 2004/0010290 A1) relates to an implantable cancer treatment device with multiple electrodes.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REX R HOLMES whose telephone number is (571)272-8827. The examiner can normally be reached Monday-Thursday 7:00AM-5:30PM.
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, Jennifer McDonald can be reached at (571) 270-3061. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/REX R HOLMES/ Primary Examiner, Art Unit 3796
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