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 filed 1/20/2026 with respect to the rejection of Independent Claim 1 under 35 USC 102 have been fully considered and are persuasive. Claim 1 has been amended to clarify order in which the recited sheet of graphite, layer of conductive material, and first electrode are arranged relative to the skin of a subject. The Examiner agrees that Palti does not disclose such an arrangement. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground of rejection is made in view of Palti as evidenced by CN 107693866 A, US 2020/0187375 A1 and US 2004/0044337 A1.
Applicant’s arguments regarding the rejection of Claims 2-14 are based on Applicant’s arguments regarding Independent Claim 1. Applicant’s arguments have been fully considered and are persuasive for the same reasons as explained above with respect to Claim 1.
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 1, and Claims 2-14 by dependency, 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.
Regarding Independent Claim 1, Claim 1 recites “at least one layer of conductive material disposed on the front face of the sheet, wherein the at least one layer of conductive material has a biocompatible front surface configured to be positioned against a subject's skin.” As the “at least one layer” is “disposed on the front face of the sheet,” one of its two surfaces must contact said sheet. The other of its two surfaces (i.e., the “biocompatible front surface”) is recited as “configured to be positioned against a subject's skin.” In an instance where only one such “layer of conductive material” is present, the mechanics of such a configuration (i.e., one surface in contact with the front face of the sheet, the other surface positioned against a subject's skin) is clear. However, Claim 1 recites “at least one layer of conductive material…,” which allows for more than one layer. In the instance where “at least one layer of conductive material” is more than one layer (e.g., two layers), it is unclear what configuration is contemplated. That is, by virtue of the term “layer,” in a configuration wherein “at least one layer” comprises two layers, it is unclear in what sense both layers may be simultaneously disposed on the front face of the sheet, positioned against a subject's skin, and “layered.”
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.
Claims 1-9 and 12-14 are rejected under 35 U.S.C. 103 as being unpatentable over previously cited US 2006/0276858 A1 to Palti (“Palti”) as evidenced by CN 107693866 A (“CN ‘866”), US 2020/0187375 A1 to Sauter-Starace et al. (“Sauter-Starace”) and US 2004/0044337 A1 to Shafirstein et al. (“Shafirstein”).
Regarding Independent Claim 1, Palti teaches:
An apparatus for applying an alternating electric field to a subject's body, the apparatus comprising: (Para. [0002]: This invention concerns the application of alternating electric fields…in patients);
a sheet of graphite having a front face and a rear face; (Para. [0026]: Suitable materials for the conductive layer 32 include…graphite; Fig. 2, “conductive layer 32;” see Annotated Fig. 2B, below);
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at least one layer of conductive material…, (Fig. 2B, “conductive gel 48;” see Annotated Fig. 2B, above);
Palti discloses “at least one layer of conductive material” (i.e., Palti’s “conductive gel 48”), but Palti does not disclose “wherein the at least one layer of conductive material is ‘disposed on the front face of the sheet’” as Claim 1 requires. That is, Palti’s “at least one layer of conductive material” is arranged differently than the arrangement of Claim 1. This deficiency is addressed below.
wherein the at least one layer of conductive material has a biocompatible front surface configured to be positioned against a subject's skin; (Para. [0028], “A conductive layer 48 is preferably provided between the dielectric 46 and the patient's body to improve the electrical contact with the patient's body.”);
and a first electrode element positioned behind the sheet, (Fig. 2B, “electrodes 40;” see Annotated Fig. 2B, above);
the first electrode element having a first front face disposed in electrical contact with the rear face of the sheet. (Para. [0026]).
Palti’s “electrodes 40” are in electrical contact with the entirety of Palti’s “sheet” (i.e., Palti’s “conductive layer 32”) by virtue of the “sheet” being conductive, as explained at Palti Para. [0026]).
It is noted that this limitation does not require such direct, mechanical contact as required elsewhere in the claim. The Examiner’s interpretation to this effect is consistent with the configuration depicted in Fig. 3A of the Present Drawings.
Palti does not disclose:
… disposed on the front face of the sheet
That is, Palti discloses a “at least one layer of conductive material” (i.e., Palti’s “conductive gel 48”), but Palti does not disclose “wherein the at least one layer of conductive material is ‘disposed on the front face of the sheet’” as Claim 1 requires.
That is to say, Palti differs from the invention of Claim 1 in that Palti’s parts are arranged in a different order than the order of Claim 1. As shown below in Annotated Comparison 1, Palti’s “sheet of graphite” and Palti’s “electrode” are arranged in the reverse order of that required by Claim 1:
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It would have been obvious for a person of ordinary skill in the art to modify the device of Palti such that Palti’s “at least one layer of conductive material” is “disposed on the front face of the sheet” (i.e., to reverse the order of Palti’s “graphite sheet” and “electrode”) because such a modification entails a mere rearrangement of parts, which is a common practice the court has held normally requires only ordinary skill in the art and hence is considered a routine expedient. MPEP 2144.04(VI)(C).
The Examiner notes the following with respect to the conclusion that the above modification is a mere rearrangement of parts within the level of ordinary skill:
The arrangement of Claim 1 (i.e., “electrode, graphite, conductive material”) is known in the art. For example, CN ‘866 describes such an arrangement at Embodiments 4 and 5 (see Machine Translation of CN ‘866 at Pg. 3 of 5, Second through Fifth Paragraphs), and Sauter-Starace describes such an arrangement at Para. [0046]).
The benefit of graphite in such a configuration is known in the art. For example, Shafirstein describes the benefit of the heat transfer and conductivity properties of graphite at Paras. [0015] through [0016], and at Para. [0036] (“Pyrolytic graphite has unique thermal properties in that it acts as a resistor axially but is conductive radially.”).
In the proposed rearrangement, Palti’s graphite would serve the same purpose (see Palti at Para. [0028], “Graphite has the advantage in that it has a much higher electric conductance, as compared with gels, and that it is inert and has extremely high biocompatibility.”), and as such would not modify the operation of the device. See MPEP 2144.04(VI)(C), citing In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950) (Claims to a hydraulic power press which read on the prior art except with regard to the position of the starting switch were held unpatentable because shifting the position of the starting switch would not have modified the operation of the device.).
Regarding Claim 2, Palti renders obvious the entirety of Claim 1 as explained above.
Palti additionally teaches:
wherein the first electrode element comprises (i) a first layer of dielectric material having a front face and a rear face (Fig. 2B, “dielectric layer 46;” Para. [0027], “…each electrode 40 includes…a thin dielectric layer 46…”);
and (ii) a first layer of metal disposed on the rear face of the first layer of dielectric material, (Fig. 2B, “conductive core 42;” Para. [0027], “…each electrode 40 includes conductive core 42 made of…metal…”);
wherein the front face of the first layer of dielectric material is the first front face of the first electrode element, (Fig. 2B, “dielectric layer 46”);
and wherein the apparatus further comprises a first rear layer of conductive material positioned between the first front face of the first electrode element and the rear face of the sheet, (Fig. 2B, “conductive adhesive 44;” Para. [0027], “…one layer of conductive adhesive 44 is provided between the core 42 and the conductive layer 32…”);
and wherein the first rear layer of conductive material facilitates the electrical contact between the first front face of the first electrode element and the rear face of the sheet. (Para. [0026], “A lead 38 is wired in electrical contact with the conductive flexible layer 32 to facilitate application of the appropriate AC signals to each patch 20.”).
Regarding Claim 3, Palti renders obvious the entirety of Claim 2 as explained above.
Palti additionally teaches:
further comprising a second electrode element positioned behind the sheet, (Figs. 2A and 2B, “electrodes 40;” Para. [0024], “…electrode patch 20 is actually a composite of many small electrodes 40 that are mounted on a…substrate…;” Figs. 2A and 2B depict multiple electrode elements 40 and therefore a second electrode element in Figs. 2A and 2B );
the second electrode element having a second front face disposed in electrical contact with the rear face of the sheet, (Figs. 2A and 2B, “electrodes 40” are so-disposed);
Palti’s “electrodes 40” are in electrical contact with the entirety of Palti’s “sheet” (i.e., Palti’s “conductive layer 32”) by virtue of the “sheet” being conductive, as explained at Palti Para. [0026]).
wherein the second electrode element comprises (i) a second layer of dielectric material having a front face and a rear face (Fig. 2B, “dielectric layer 46;” Para. [0027], “…each electrode 40 includes…a thin dielectric layer 46…”);
and (ii) a second layer of metal disposed on the rear face of the second layer of dielectric material, (Fig. 2B, “conductive core 42;” Para. [0027], “…each electrode 40 includes conductive core 42 made of…metal…”);
wherein the front face of the second layer of dielectric material is the second front face of the second electrode element, (Fig. 2B, “dielectric layer 46”);
and wherein the first rear layer of conductive material is positioned between the second front face of the second electrode element and the rear face of the sheet, (Fig. 2B “conductive adhesive 44;” Para. [0027]: one layer of conductive adhesive 44 is provided between the core 42 and the conductive layer 32);
and wherein the first rear layer of conductive material facilitates the electrical contact between the second front face of the second electrode element and the rear face of the sheet. (Para. [0026], “A lead 38 is wired in electrical contact with the conductive flexible layer 32 to facilitate application of the appropriate AC signals to each patch 20).”)
Regarding Claim 4, Palti renders obvious the entirety of Claim 2 as explained above.
Palti additionally teaches:
further comprising a second electrode element positioned behind the sheet, (Figs. 2A and 2B, “electrodes 40;” Para. [0024], “…electrode patch 20 is actually a composite of many small electrodes 40 that are mounted on a…substrate…;” Figs. 2A and 2B depict multiple electrode elements 40 and therefore a second electrode element in Figs. 2A and 2B );
the second electrode element having a second front face disposed in electrical contact with the rear face of the sheet, (Figs. 2A and 2B, “electrodes 40” are so-disposed);
Palti’s “electrodes 40” are in electrical contact with the entirety of Palti’s “sheet” (i.e., Palti’s “conductive layer 32”) by virtue of the “sheet” being conductive, as explained at Palti Para. [0026]).
wherein the second electrode element comprises (i) a second layer of dielectric material having a front face and a rear face (Fig. 2B, “dielectric layer 46;” Para. [0027], “…each electrode 40 includes…a thin dielectric layer 46…”);
and (ii) a second layer of metal disposed on the rear face of the second layer of dielectric material, wherein the front face of the second layer of dielectric material is the second front face of the second electrode element, (Fig. 2B, “conductive core 42;” Para. [0027], “…each electrode 40 includes conductive core 42 made of…metal…”);
and wherein the apparatus further comprises a second rear layer of conductive material positioned between the second front face of the second electrode element and the rear face of the sheet, (Fig. 2B “conductive adhesive 44;” Para. [0027]: one layer of conductive adhesive 44 is provided between the core 42 and the conductive layer 32);
and wherein the second rear layer of conductive material facilitates the electrical contact between the second front face of the second electrode element and the rear face of the sheet. (Para. [0026], “A lead 38 is wired in electrical contact with the conductive flexible layer 32 to facilitate application of the appropriate AC signals to each patch 20).”).
Regarding Claim 5, Palti renders obvious the entirety of Claim 2 as explained above.
Palti additionally teaches:
wherein the first rear layer of conductive material comprises a conductive adhesive. (Fig. 2B “conductive adhesive 44;” Para. [0027]: one layer of conductive adhesive 44 is provided between the core 42 and the conductive layer 32).
Regarding Claim 6, Palti renders obvious the entirety of Claim 5 as explained above.
Palti additionally teaches:
wherein the conductive adhesive comprises an adhesive polymer and carbon powder, particles, fibers, flakes or nanotubes. (Para. [0028]: suitable materials for this conductive layer 48 include conductive gels and carbon (graphite) powders).
Regarding Claim 7, Palti renders obvious the entirety of Claim 1 as explained above.
Palti additionally teaches:
wherein the first electrode element comprises a piece of metal having a front face, and wherein the front face of the piece of metal is the first front face of the first electrode element. (Fig. 2B, “conductive core 42;” Para. [0027], “…each electrode 40 includes conductive core 42 made of…metal…”).
Regarding Claim 8, Palti renders obvious the entirety of Claim 7 as explained above.
Palti additionally teaches:
further comprising a first rear layer of conductive material positioned between the first front face of the first electrode element and the rear face of the sheet, (Fig. 2B “conductive adhesive 44;” Para. [0027]: one layer of conductive adhesive 44 is provided between the core 42 and the conductive layer 32).
wherein the first rear layer of conductive material facilitates the electrical contact between the first front face of the first electrode element and the rear face of the sheet. (Para. [0027]: one layer of conductive adhesive 44 is provided between the core 42 and the conductive layer 32).
Regarding Claim 9, Palti renders obvious the entirety of Claim 7 as explained above.
Palti does not disclose:
wherein the first front face of the first electrode element is positioned in direct contact with the rear face of the sheet.
However, per the proposed modification explained at Claim 1 (i.e., reversing the order of Palti’s “graphite sheet” and “electrode”), Palti’s first front face of the first electrode element is positioned in direct contact with the rear face of the sheet.
It would have been obvious for a person of ordinary skill in the art to modify the device of Palti such that Palti’s “first front face of the first electrode element is positioned in direct contact with the rear face of the sheet” (i.e., to reverse the order of Palti’s “graphite sheet” and “electrode”) because such a modification entails a mere rearrangement of parts, which is a common practice the court has held normally requires only ordinary skill in the art and hence is considered a routine expedient. MPEP 2144.04(VI)(C).
The Examiner notes the following with respect to the conclusion that the above modification is a mere rearrangement of parts within the level of ordinary skill:
The arrangement of Claim 1 (i.e., “electrode, graphite, conductive material”) is known in the art. For example, CN ‘866 describes such an arrangement at Embodiments 4 and 5 (see Machine Translation of CN ‘866 at Pg. 3 of 5, Second through Fifth Paragraphs), and Sauter-Starace describes such an arrangement at Para. [0046]).
The benefit of graphite in such a configuration is known in the art. For example, Shafirstein describes the benefit of the heat transfer and conductivity properties of graphite at Paras. [0015] through [0016], and at Para. [0036] (“Pyrolytic graphite has unique thermal properties in that it acts as a resistor axially but is conductive radially.”).
In the proposed rearrangement, Palti’s graphite would serve the same purpose (see Palti at Para. [0028], “Graphite has the advantage in that it has a much higher electric conductance, as compared with gels, and that it is inert and has extremely high biocompatibility.”), and as such would not modify the operation of the device. See MPEP 2144.04(VI)(C), citing In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950) (Claims to a hydraulic power press which read on the prior art except with regard to the position of the starting switch were held unpatentable because shifting the position of the starting switch would not have modified the operation of the device.).
Regarding Claim 12, Palti renders obvious the entirety of Claim 1 as explained above.
Palti additionally teaches:
wherein the at least one layer of conductive material comprises a conductive adhesive. (Fig. 2B, “conductive adhesive 44;” Para. [0027], “…one layer of conductive adhesive 44 is provided between the core 42 and the conductive layer 32…”);
Regarding Claim 13, Palti renders obvious the entirety of Claim 1 as explained above.
Palti additionally teaches:
further comprising a flexible self-adhesive backing configured to support the sheet, the first electrode element, and the at least one layer of conductive material so that the front surface of the at least one layer of conductive material can be positioned against a subject's skin. (Fig. 2B, “biocompatible adhesive 36,” Para. [0028]: biocompatible adhesive 36 to help the patch 20 adhere to the patient's body)
Regarding Claim 14, Palti renders obvious the entirety of Claim 1 as explained above.
Palti additionally teaches:
further comprising a lead that is electrically connected to the first electrode element. (Para. [0026]: A lead 38 is wired in electrical contact with the conductive flexible layer 32).
Claims 10 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over previously cited US 2006/0276858 A1 to Palti (“Palti”) as evidenced by CN 107693866 A (“CN ‘866”), US 2020/0187375 A1 to Sauter-Starace et al. (“Sauter-Starace”) and US 2004/0044337 A1 to Shafirstein et al. (“Shafirstein”) as applied to Claim 1 above, and further in view of US 2021/0305639 A1 to Zhamu (“Zhamu”).
Regarding Claim 10, Palti renders obvious the entirety of Claim 1 as explained above.
Palti does not disclose:
wherein the sheet of graphite is a sheet of pyrolytic graphite.
Zhamu is analogous art. Zhamu teaches:
wherein the sheet of graphite is a sheet of pyrolytic graphite. (Para. [0029]: a graphitic film selected from a flexible graphite sheet, an artificial (pyrolytic) graphite film obtained from carbonization and graphitization of a carbon precursor film (e.g. a pitch film or polymer film), or a combination thereof)
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device Palti with the teachings of Zhamu (i.e., to employ such a pyroltic graphite as taught by Zhamu as the graphite of Palti) in order to to provide the benefit of removing the heat and keeping device temperature at or below a desired temperature (Zhamu at Para. [0026]).
Regarding Claim 11, Palti renders obvious the entirety of Claim 1 as explained above.
Palti does not disclose:
wherein the sheet of graphite is a sheet of graphite foil made from compressed high purity exfoliated mineral graphite or graphitized polymer film..
Zhamu is analogous art. Zhamu teaches:
wherein the sheet of graphite is a sheet of graphite foil made from compressed high purity exfoliated mineral graphite or graphitized polymer film. (Para. [0029]: graphite film obtained from carbonization and graphitization of a carbon precursor film (e.g. …polymer film); Para. [0065]: graphite worms can be re-compressed to obtain flexible graphite sheets or foils (106))
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device Palti with the teachings of Zhamu (i.e., to employ such a foil sheet made from graphitized polymer film as taught by Zhamu for the sheet of Palti) in order to provide the benefit of removing the heat and keeping device temperature at or below a desired temperature (Zhamu at Para. [0026]).
Art Made of Record Although Not Relied Upon
The Examiner makes note of the following prior art, which is deemed relevant although not relied upon in the foregoing rejection:
US 2009/0099500 A1 describes a similar configuration to that of Claim 1 at Fig. 2B using two back-to-back electrodes.
US 2017/0209684 A1 describes a similar configuration to that of Claim 1 at Figs. 1-3 using a dual-sided electrode.
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 CHRISTOPHER J MUTCHLER whose telephone number is (571)272-8012. The examiner can normally be reached M-F 7:00 am - 4:00 pm.
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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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/C.J.M./Examiner, Art Unit 3796
/Jennifer Pitrak McDonald/Supervisory Patent Examiner, Art Unit 3796
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