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 .
Claim Objections
Claim 32 is objected to because of the following informalities: “between between” should read --between--. Appropriate correction is required.
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.
(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 15, 16, 18 and 20 are rejected under 35 U.S.C. 102(a)(1) and (2) as being anticipated by Salahieh et al. (US 2017/0042614, hereinafter “Salahieh”).
In regards to claim 15, Salahieh discloses a method of applying an alternating electric field (pars. 0005, 0135) to a target region in a subject's body, the method comprising: applying an alternating voltage between a first sheet of graphite (pars. 0118-0120) that has been previously implanted in the subject's body and a second sheet of graphite that has been previously implanted in the subject's body (par. 0092; Figs. 9A-63C depict several embodiments of implantable embodiments), wherein the first sheet of graphite and the second sheet of graphite are positioned on opposite sides of the target region (Figs. 67A and 67B).
In regards to claim 16, the method further comprises implanting the first sheet of graphite in the subject's body prior to the applying; and implanting the second sheet of graphite in the subject's body prior to the applying (abstract; ablating or stimulating internal organs requires implanting the device before applying the energy).
In regards to claim 18, the first sheet of graphite is supported by a first sheet of biocompatible material, and wherein the second sheet of graphite is supported by a second sheet of biocompatible material (Fig. 1A; each electrode 6 is supported by flexible membrane 34).
In regards to claim 20, the first sheet of graphite comprises pyrolytic graphite, graphitized polymer film (par. 0120), or graphite foil made from compressed high purity exfoliated mineral graphite, or at least partially oxidized forms thereof.
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 17 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Salahieh in view of Hong et al. (US 20210290944, hereinafter “Hong”).
Salahieh discloses the essential features of the claimed invention including wherein a layer of a biocompatible insulating polymer material is disposed on at least one face of the first sheet of graphite, and wherein a layer of a biocompatible insulating polymer material is disposed on at least one face of the second sheet of graphite (par. 0101-0102, the electrodes each have a dielectric insulating layer); and wherein the first sheet of graphite is in the form of “fibers” that add structural integrity to the electrode (par. 0120).
Salahieh does not expressly disclose that the dielectric material has a dielectric constant of at least 10 or that the fibers form a mesh. However, Hong in the same field of endeavor of high frequency electrical stimulation teaches providing an insulating material having a dielectric constant of at least 10 (par. 0105) to provide the predictable results of extremely excellent energy efficiency with substantially little energy loss (par. 0054); and providing the electrode in the form of a mesh (par. 0128) to provide the predictable results of effectively spreading charge at the stimulation site (pars. 0120-0122).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Salahieh by providing an insulating material having a dielectric constant of at least 10 to provide the predictable results of extremely excellent energy efficiency with substantially little energy loss; and providing the electrode in the form of a mesh to provide the predictable results of effectively spreading charge at the stimulation site.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Salahieh in view of Helland et al. (US 4,033,357, hereinafter “Helland”).
Salahieh discloses the essential features of the claimed invention except that the first sheet of graphite comprises pyrolytic graphite. However, Helland in the same field of endeavor of implantable electrodes teaches providing the electrode with pyrolytic graphite (col. 5, lines 19-28) to provide the predictable results of a highly conductive electrode that is resistant to thrombus and fibrous buildup thereby reducing stimulation thresholds and reducing power demands (col. 3, lines 33-51).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Salahieh by providing the electrode with pyrolytic graphite (col. 5, lines 19-28) to provide the predictable results of a highly conductive electrode that is resistant to thrombus and fibrous buildup thereby reducing stimulation thresholds and reducing power demands.
Claims 22 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Salahieh in view of Kroll et al. (US 2005/0222623, hereinafter “Kroll”).
Salahieh discloses the essential features of the claimed invention, including a graphite electrode, but does not expressly disclose the electrode has an area of at least 1 cm2 or 1-40 cm2. However, Kroll in the same field of endeavor of applying an alternating electric field (par. 0059) teaches providing a carbon electrode with an area of at least 1 cm2 or 1-40 cm2 (par. 0156) to provide the predictable results of minimization of any edge effects that may tend to burn or otherwise injure the body (par. 0156).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Salahieh by providing a carbon electrode with an area of at least 1 cm2 or 1-40 cm2 to provide the predictable results of minimization of any edge effects that may tend to burn or otherwise injure the body.
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Salahieh in view of Helland and Eiger (US 2013/0197608, hereinafter “Eiger”).
Salahieh discloses the essential features of the claimed invention except for wherein the first sheet of graphite has a first thermal conductivity in a direction that is perpendicular to its front face and the thermal conductivity of the sheet in directions parallel to the front face is more than two times higher than the first thermal conductivity.
However, Helland in the same field of endeavor of implantable electrodes teaches providing the electrode with pyrolytic graphite (col. 5, lines 19-28) to provide the predictable results of a highly conductive electrode that is resistant to thrombus and fibrous buildup thereby reducing stimulation thresholds and reducing power demands (col. 3, lines 33-51), and Eiger in the same field of endeavor of implantable therapy devices teaches providing pyrolytic graphite in a form such that the first sheet of graphite has a first thermal conductivity in a direction that is perpendicular to its front face and the thermal conductivity of the sheet in directions parallel to the front face is more than two times higher than the first thermal conductivity (par. 0031) to provide the predictable results of excellent properties for spreading heat over an area, and thus very thin layers of the material may be used for heat spreading (par. 0031), such as the heat generated by an electrode.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Salahieh by providing pyrolytic graphite in a form such that the first sheet of graphite has a first thermal conductivity in a direction that is perpendicular to its front face and the thermal conductivity of the sheet in directions parallel to the front face is more than two times higher than the first thermal conductivity to provide the predictable results of a highly conductive electrode that is resistant to thrombus and fibrous buildup thereby reducing stimulation thresholds and reducing power demands, and excellent properties for spreading heat over an area, and thus very thin layers of the material may be used for heat spreading, such as the heat generated by an electrode.
Claims 27, 28, 30, 31 and 32 are rejected under 35 U.S.C. 103 as being unpatentable over Salahieh in view of Schmidt et al. (US 2020/0110756, hereinafter “Schmidt”).
Salahieh discloses the essential features of the claimed invention except for wherein internal wiring/circuitry in the subject's body is connected to external wiring/circuitry outside of the subject's body via one or more ports positioned on or across the subject's skin;
wherein internal wiring/circuitry in the subject's body is connected to external wiring/circuitry outside of the subject's body via one or more separate connector positioned outside the subject's body;
wherein the alternating voltage is supplied by an electric field generator and/or AC signal generator that is located outside of the subject's body;
wherein the alternating voltage has a frequency between 50 kHz and 1 MHz; or
wherein the alternating voltage has a frequency between between 100 kHz and 500 kHz.
However, Schmidt in the same field of endeavor of applying alternating electric fields teaches providing a system wherein internal wiring/circuitry in the subject's body is connected to external wiring/circuitry outside of the subject's body via one or more ports positioned on or across the subject's skin (Fig. 8, element 820) to provide the predictable results of allowing for a variety of devices to access the cancerous region (par. 0069);
wherein internal wiring/circuitry in the subject's body is connected to external wiring/circuitry outside of the subject's body via one or more separate connector positioned outside the subject's body (e.g., Fig. 10, lead connector to the medical device, par. 0055) to provide the predictable results of effectively placing the medical device at the site of the tumor to allow the leads to surround the tumor (pars. 0051, 0071);
wherein the alternating voltage is supplied by an electric field generator and/or AC signal generator that is located outside of the subject's body to provide the predictable results of effectively placing the medical device at the site of the tumor to allow the leads to surround the tumor (pars. 0051, 0071);
wherein the alternating voltage has a frequency between 50 kHz and 1 MHz; and
wherein the alternating voltage has a frequency between 100 kHz and 500 kHz (par. 0087) to provide the predictable results of applying a signal known to be effective at treating cancerous tumors (par. 0110).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Salahieh by providing a system wherein internal wiring/circuitry in the subject's body is connected to external wiring/circuitry outside of the subject's body via one or more ports positioned on or across the subject's skin to provide the predictable results of allowing for a variety of devices to access the cancerous region;
wherein internal wiring/circuitry in the subject's body is connected to external wiring/circuitry outside of the subject's body via one or more separate connector positioned outside the subject's body to provide the predictable results of effectively placing the medical device at the site of the tumor to allow the leads to surround the tumor;
wherein the alternating voltage is supplied by an electric field generator and/or AC signal generator that is located outside of the subject's body to provide the predictable results of effectively placing the medical device at the site of the tumor to allow the leads to surround the tumor;
wherein the alternating voltage has a frequency between 50 kHz and 1 MHz; and
wherein the alternating voltage has a frequency between 100 kHz and 500 kHz to provide the predictable results of applying a signal known to be effective at treating cancerous tumors.
Claim 29 is rejected under 35 U.S.C. 103 as being unpatentable over Salahieh in view of Palti (US 2007/0225766, hereinafter “Palti”). Salahieh discloses the essential features of the claimed invention, including providing graphite electrodes, but does not expressly disclose implanting an additional two electrodes in the subject's body on opposite sides of the target region, and applying an AC voltage between the original electrodes to impose an alternating electric field with a first orientation in the target region, and applying an AC voltage between the additional electrodes to impose an alternating electric field with a second orientation in the target region.
However, Palti in the same field of endeavor of applying an alternating electric field teaches implanting an additional two electrodes in the subject's body on opposite sides of the target region, and applying an AC voltage between the original electrodes to impose an alternating electric field with a first orientation in the target region, and applying an AC voltage between the additional electrodes to impose an alternating electric field with a second orientation in the target region (Fig. 1; pars. 0010-0011) to provide the predictable results of improving the effectiveness of tumor therapy (par. 0003). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Salahieh by implanting an additional two electrodes in the subject's body on opposite sides of the target region, and applying an AC voltage between the original electrodes to impose an alternating electric field with a first orientation in the target region, and applying an AC voltage between the additional electrodes to impose an alternating electric field with a second orientation in the target region to provide the predictable results of improving the effectiveness of tumor therapy.
Allowable Subject Matter
Claims 25 and 26 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. The prior art fails to disclose or fairly render obvious the combination of claim elements, including electrodes comprising sheets of graphite that have a resistance in the planar direction that is less than half the resistance in the normal direction; or that the electrodes are supported by sheets of biocompatible material, at least one of them being a sheet of graphite mesh. These features avoid the prior art of record.
Response to Arguments
Applicant's arguments filed 1/20/2026 have been fully considered but they are not persuasive. Applicant argued that Salahieh fails to disclose electrodes “of” graphite because the electrodes contain other elements. The examiner respectfully maintains that the plain meaning of this claim scope is not exclusive (e.g., “consisting of”), but the scope would include a sheet that contains graphite. For instance, the disclosure is replete with discussion of the sheet “comprising” graphite (e.g., par. 0012), which has a plain meaning of “including, but not limited to.” See MPEP 2111.03.
Applicant further argued that Salahieh’s thin film of material is not necessarily a sheet. However, Salahieh sets forth several embodiments where the electrodes are described as flat, planar, and flexible (abstract, pars. 0008, 0105, 0108, 0118; Figs. 9A, 9B, 13A, 13B, 18A-18R, etc.). Salahieh specifically describes the electrodes as “a thin film material” (par. 0118) with a “relatively large surface area” and “large overall electrode area” (par. 0118). As an element that has a large surface area that is thin enough and flexible enough to be folded or bent, the examiner respectfully maintains that this structure falls within the fair meaning of a “sheet.” In regards to Salahieh referring to other elements as a “sheet,” the examiner is unaware of any legal relevance to Salahieh using the word “sheet” to describe other elements and disagrees that this is in some way an implicit disclosure that the electrodes are not “sheets.”
In regards to the rejection of claim 17, Applicant argued that covering Salahieh’s electrodes with an insulator would render the electrodes inoperable, the examiner is not proposing in the rejection to provide an insulator to entirely coat the electrodes. The claim merely requires an additional layer of insulating polymer on at least a portion of at least one face of the respective sheets of graphite. Salahieh already discloses this at pars. 0101-0102, and Hong is merely relied upon for a dielectric constant of at least 10 since Salahieh is silent as to the value of the dielectric constant of the insulator used. As the motivation in Hong is to provide extremely excellent energy efficiency with substantially little energy loss (e.g., by exceeding the breakdown voltage of the insulator), the examiner respectfully maintains the proposed modification of providing Salahieh’s disclosed insulator with a dielectric constant of at least 10 would have been obvious for the reasons set forth in the rejection. The examiner respectfully maintains the previous grounds of rejection and applies new grounds of rejection, necessitated by amendment, to the new claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Imran (US 2010/0331811) is another example of an electrode including pyrolytic graphite.
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 MICHAEL W KAHELIN whose telephone number is (571)272-8688. The examiner can normally be reached M-F, 8-5.
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 at (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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/MICHAEL W KAHELIN/ Primary Examiner, Art Unit 3792