DETAILED ACTION
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 .
Priority
Claims 1-20 are deemed to have an effective filing date of June 30, 2023.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the array of at least one electrode of claims 1-6, 15-16, and 19 must be shown or the feature(s) canceled from the claims. No new matter should be entered.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: 803, 903. The Examiner notes that reference numerals 803A, 803B are shown in Fig. 8.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities: Paragraph [0026] recites “anisotropic material as 603, 803, 903” (page 8, line 4), but only Fig. 6 identifies the anisotropic layer as per the recitation.
Appropriate correction is required.
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 10-11 and 13-14 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.
Claim 10, lines 1-2, recites “one or more of the transducer, the layer of anisotropic material, or the substrate”, but claim 1 refers to a transducer apparatus comprising a substrate and a layer of anisotropic material. Thus, it is unclear of “the transducer” in claim 10, line 1 refers to the transducer apparatus, or another transducer element.
Claim 13 recites “the interior slit” twice in lines 2-3 and line 3. While it appears that the claim intends to refer to an interior slit of the substate, claim 1 also refers to “the interior slit” in lines 11 and 12. The use of “an/the interior slit” to refer to two different slits is confusing.
Claims 11 and 14 are rejected because they depend from an indefinite claim.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 18 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 1 recites “when the transducer apparatus is substantially planar” (claim 1, lines 6-7). However, claim 18 recites that “the transducer apparatus is substantially non-planar”. Thus, claim 18 does not further limit the transducer apparatus of claim 15. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
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 1-9 and 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over US Patent Application Publication No. 2020/0171297 to Kirson et al. (hereinafter referred to as “Kirson”) in view of US Patent Application Publication No. 2021/0346693 to Deslauriers.
Regarding claims 1, 9 and 13-14, Kirson discloses a transducer apparatus for delivering tumor treating fields to a subject's body (e.g., titles and abstract), the transducer apparatus comprising: a substrate (e.g., paragraphs [0051], [0055]: transducer array 100 is attached to a patient’s skin with covering adhesive-backed layer 126 and Figs. 1 and 9); and an array of at least one electrode disposed on the substrate (e.g., paragraphs [0039]-[0042] and [0051]: transducer array 100 has a first layout including flex circuit 102 and electrode elements 110, which are disposed on covering adhesive-backed layer 126), the array configured to be positioned over the subject's body with a face of the array facing the subject's body (e.g., paragraph [0042]: electrode elements may be coated with ceramic dielectric material and faces toward the patient’s body so it can make contact with the patient’s skin), the array capable of delivering tumor treating fields to a subject's body (e.g., title, abstract, and paragraph [0054]: TTFields therapy controller is connected to the flex circuit 102); wherein, when viewed from a direction perpendicular to the face of the array, the substrate comprises an interior slit extending substantially along a longitudinal direction of the layer of substrate, the interior slit is surrounded by the substrate, and no electrodes are in the interior slit (e.g., paragraph [0051]: Fig. 9, 128). Kirson differs from the claimed invention in that it does not expressly disclose that the transducer apparatus comprises a layer of anisotropic material positioned on a skin-facing side of the array. However, Deslauriers, in a related art: conductive pad generating tumor treating field, teaches a conductive gel composition with a bulk electron transport agent, such as graphite, for application to a patient’s skin during treatment with TTField-generating system (e.g., paragraph [0102] of Deslauriers) where the bulk electron transport agent may being in a layer or film form (e.g., paragraph [0109] of Deslauriers) and conductive gel element is positioned on a skin-facing side of the array of electrodes (e.g., paragraph [0233]: conductive gel element may include a removeable protection layer covering at least a portion of the conductive gel layer that when removed allows the user to attach the conductive gel layer to the patient’s skin and Fig. 4, substrate 104, electrode element 124, and conductive gel element 128). Accordingly, one of ordinary skill in the art would have recognized the benefits of a conductive gel element between the array of electrodes and the patient’s skin in view of the teachings of Deslauriers (e.g., paragraphs [0102]-[0103], [0109], [0233] of Deslauriers). Consequently, one of ordinary skill in the art would have modified the transducer apparatus of Kirson to have a layer/film of anisotropic material over the electrode array and substrate, as taught by Deslauriers in order to dramatically enhance the electrical and/or thermal conductivity of the electrode array, and because the combination would have yielded a predictable result. With respect to the interior slit being surrounded by anisotropic material/graphite, one of ordinary skill in the art would have covered the array of at least one electrode and the substrate as taught in Fig. 4 of Deslauriers, and thus, the conductive gel element layer/film would also have an interior slit corresponding to the area of the substrate with the interior slit in order that the transducer apparatus is flexible and maintains conformability to the patient’s skin (e.g., paragraph [0051] of Kirson), and because the combination would have yielded a predictable result.
With respect to claim 2, Kirson in view of Deslauriers teaches the transducer apparatus of claim 1, wherein, when viewed from a direction perpendicular to the face of
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the array, the interior slit divides a first portion of the layer of anisotropic material from a second portion of the layer of anisotropic material, and the first portion and the second portion have an approximately same size and an approximately same shape (see annotated figure.
As to claim 3, Kirson in view of Deslauriers teaches the transducer apparatus of claim 1, but does not expressly teach, when viewed from a direction perpendicular to the face of the array, the interior slit is situated along a centerline running through a longest dimension of the layer of anisotropic material. However, depending upon the target body portion and the number of electrodes, the interior slit could be positioned along a centerline running through the longest dimension of the layer of the anisotropic material. It would have been obvious to one of ordinary skill in the art at the time the invention was made to have an interior slit running through a longest dimension of the layer of anisotropic material, since it has been held that rearranging parts of a prior art structure involves only routine skill in the art. In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950).
With respect to claim 4, Kirson in view of Deslauriers teaches the transducer apparatus of claim 1, wherein, when viewed from a direction perpendicular to the face of the array, the interior slit comprises a percentage of a surface area of the layer of anisotropic material (see Fig. 9 of Kirson), but does not expressly teach that interior slit comprises approximately 0.5% to approximately 10% of a surface area of the anisotropic material. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the transducer apparatus as taught by Kirson in view of Deslauriers so that the interior slit comprises approximately 0.5% to approximately 10% of the surface area of the anisotropic material, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art [In re Aller, 105 USPQ 233] and Applicant does not appear to provide criticality for the surface area percentage of the interior slit.
As to claims 5-6, Kirson in view of Deslauriers teaches the transducer apparatus of claim 1, wherein, when viewed from a direction perpendicular to the face of the array, the interior slit has a width and a length (e.g., paragraph [0051] of Kirson: slots 128 are preferably narrower than the fingers 130, which are wider than the diameters of the electrode elements, see Kirson’s Fig. 9, 128 for the width and length). However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the transducer apparatus as taught by Kirson in view of Deslauriers so that the interior slit is approximately 0.5 mm to approximately 10.0 mm wide and/or is approximately 1.0 cm to approximately 10.0 cm long, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art [In re Aller, 105 USPQ 233] and Applicant does not appear to provide criticality for the width and length of the interior slit.
With respect to claim 7, Kirson in view of Deslauriers teaches the transducer apparatus of claim 1, but does not expressly teach that the layer of anisotropic material includes only one interior slit. However, depending upon the target body portion and the number of electrodes, the number of interior slit could be one. It would have been obvious to one of ordinary skill in the art at the time the invention was made to have only one interior slit, in the absence of criticality, since it has been held that discovering the optimum or workable ranges involves only routine skill in the art [In re Aller, 105 USPQ 233] and the Examiner considers the number of slits/slots to depend on the target body area and the number of electrodes being attached via the substrate/anisotropic material transducer apparatus.
As to claim 8, Kirson in view of Deslauriers teaches the transducer apparatus of claim 1, wherein the layer of anisotropic material includes two discontinuous non-parallel interior slits (e.g., see Fig. 9, 128 of Kirson– there are two discontinuous non-parallel slits on one side of each finger 130).
Claims 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Kirson in view of Deslauriers as applied to claim 1 above, and further in view of US Patent Application Publication No. 2017/0056682 to Kumar et al. (hereinafter referred to as “Kumar”) and US Patent Application Publication No. 2017/0112983 to Thorne et al. (hereinafter referred to as “Thorne”).
With respect to claim 10, Kirson in view of Deslauriers teaches the transducer apparatus of claim 1, but does not expressly teach that the one or more of the transducer, the layer of anisotropic material, or the substrate has a substantially pear-shaped or rounded triangular-shaped surface having an opening located towards a wider portion of the substantially pear-shaped or rounded triangular-shaped surface.
However, Kirson discloses that the transducer array 100 may be shaped to follow the branching configuration of the flex circuit (e.g., paragraph [0046] of Kirson), and the use of slits/slots so that portions of the covering adhesive-backed layer to move independently of each other in order to maintain conformability of the transducer array and adhesion to the patient’s skin even as the patient moves (e.g., paragraph [0051] of Kirson). That is, the shape of the transducer array depends upon the target body area and the number of electrodes in the array. Kumar teaches, in a related art: patches adhered to a patient to provide electrical energy to the patient, that the shape of the substrate/patch may be substantially pear-shaped or rounded triangular shaped on the chest of a female user and that the shape can be optimized to fit on the pectoral region of the wearing (e.g., paragraph [0121] and Figs. 31 A-C, 3100, 3102 of Kumar). Accordingly, one of ordinary skill in the art would have recognized the benefits of using a pear-shaped or rounded triangular shaped substrate/patch in view of the teachings of Kumar. Consequently, one of ordinary skill in the art would have modified the transducer apparatus of Kirson in view of Deslauriers to have a pear-shaped or rounded triangular shape in order to target a tumor in the pectoral region of the female patient in view of the teachings of Kumar that such a shape was well-known to those skilled in the medical arts, and because the combination would have yielded a predictable result. With respect to the rounded triangular patch having an opening located towards a wider portion of the rounded triangular patch, Thorne teaches, in a related art: electrical stimulation of a breast of a patient, that the stimulation component may be sized to fit a garment about the breast and may define an opening to be located proximate a nipple of the breast where an array of electrodes are disposed on inserts 304 that may encompass the breast in a shallow cone shape (e.g., abstract and paragraphs [0041]-[0043] and [0125] of Thorne). Accordingly, one of ordinary skill in the art would have recognized the benefits of providing an opening in the insert/patch in view of the teachings of Thorne. Consequently, one of ordinary skill in the art would have modified the transducer array of Kirson, Deslauriers, and Kumar so that the electrodes are located about the nipple of the breast during stimulation in view of the teachings of Thorne that such was a well-known expedient for stimulating breasts and would have optimized the transducer array of Kirson in view of Deslauriers and Kumar, and because the combination would have yielded a predictable result.
As to claim 11, Kirson in view of Deslauriers, Kumar, and Thorne teaches the transducer apparatus of claim 10, wherein the opening defines a substantially C-shaped surface (as shown in Figs. 3A-C of Thorne, the opening is “C-shaped” in that the letter C can be seen in the opening) at the wider portion of the substantially pear-shaped or rounded triangular-shaped surface (see Fig. 3C where the opening is located at a wider portion of the triangular-shaped surface). One of ordinary skill in the art would have recognized the benefits of a C-shaped opening at the wider portion of the rounded triangular patch in view of the teachings of Thorne. Consequently, one of ordinary skill in the art would have modified the transducer apparatus of Kirson in view of Deslauriers, Kumar, and Thorne so that the opening is “C-shaped” and is located at the wider portion of the substantially rounded triangular shape as such was a known engineering expedient for stimulating the pectoral region proximal to a woman’s nipple as taught by Thorne, and because the combination would have yielded a predictable result.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Kirson in view of Deslauriers as applied to claim 1 above, and further in view of Thorne.
Kirson in view of Deslauriers teaches the transducer apparatus of claim 1, but does not expressly teach that the transducer apparatus is substantially non-planar, wherein the transducer apparatus is substantially shaped as a truncated elliptical paraboloid or truncated oblique cone. However, Thorne teaches, in a related art: electrical stimulation of a breast of a patient, that the stimulation component may be sized to fit a garment about the breast and may define an opening to be located proximate a nipple of the breast where an array of electrodes are disposed on inserts 304 that may encompass the breast in a shallow cone shape (e.g., abstract and paragraphs [0041]-[0043] and [0125] of Thorne). Accordingly, one of ordinary skill in the art would have recognized the benefits an insert/patch with an electrode array being substantially non-planar, and in the shape of a truncated oblique cone where a substantially circular opening is formed by an opening at a truncated portion of the truncated oblique cone in view of the teachings of Thorne. Consequently, one of ordinary skill in the art would have modified the transducer array of Kirson in view of Deslauriers so that the electrodes are located about the nipple of the breast in a cone shape during stimulation in view of the teachings of Thorne that such was a well-known expedient for stimulating breasts and would have optimized the transducer array of Kirson in view of Deslauriers, and because the combination would have yielded a predictable result.
Claims 15-16 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Kirson in view of Kumar and Thorne.
Referring to claim 15, Kirson discloses a transducer apparatus for delivering tumor treating fields to a subject's body (e.g., titles and abstract), the transducer apparatus comprising: a substrate (e.g., paragraphs [0051], [0055]: transducer array 100 is attached to a patient’s skin with covering adhesive-backed layer 126 and Figs. 1 and 9); and an array of at least one electrode disposed on the substrate (e.g., paragraphs [0039]-[0042] and [0051]: transducer array 100 has a first layout including flex circuit 102 and electrode elements 110, which are disposed on covering adhesive-backed layer 126), the array configured to be positioned over the subject's body with a face of the array facing the subject's body (e.g., paragraph [0042]: electrode elements may be coated with ceramic dielectric material and faces toward the patient’s body so it can make contact with the patient’s skin); wherein, when viewed from a direction perpendicular to the face of the array and when the transducer apparatus is substantially planar, the substrate comprises an interior slit extending substantially along a longitudinal direction of the substrate, and no electrodes are in the interior slit (e.g., paragraph [0051]: Fig. 9, 128). Kirson differs from the claimed invention in that it does not expressly disclose that the transducer apparatus has a substantially pear-shaped or rounded triangular-shaped surface having an opening located towards a wider portion of the substantially pear-shaped or rounded triangular-shaped surface. However, Kirson discloses that the transducer array 100 may be shaped to follow the branching configuration of the flex circuit (e.g., paragraph [0046] of Kirson), and the use of slits/slots so that portions of the covering adhesive-backed layer to move independently of each other in order to maintain conformability of the transducer array and adhesion to the patient’s skin even as the patient moves (e.g., paragraph [0051] of Kirson). That is, the shape of the transducer array depends upon the target body area and the number of electrodes in the array. Kumar teaches, in a related art: patches adhered to a patient to provide electrical energy to the patient, that the shape of the substrate/patch may be substantially pear-shaped or rounded triangular shaped on the chest of a female user and that the shape can be optimized to fit on the pectoral region of the wearing (e.g., paragraph [0121] and Figs. 31 A-C, 3100, 3102 of Kumar). Accordingly, one of ordinary skill in the art would have recognized the benefits of using a pear-shaped or rounded triangular shaped substrate/patch in view of the teachings of Kumar. Consequently, one of ordinary skill in the art would have modified the transducer apparatus of Kirson to have a pear-shaped or rounded triangular shape in order to target a tumor in the pectoral region of the female patient in view of the teachings of Kumar that such a shape was well-known to those skilled in the medical arts, and because the combination would have yielded a predictable result. With respect to the rounded triangular patch having an opening located towards a wider portion of the rounded triangular patch, Thorne teaches, in a related art: electrical stimulation of a breast of a patient, that the stimulation component may be sized to fit a garment about the breast and may define an opening to be located proximate a nipple of the breast where an array of electrodes are disposed on inserts 304 that may encompass the breast in a shallow cone shape (e.g., abstract and paragraphs [0041]-[0043] and [0125] of Thorne). Accordingly, one of ordinary skill in the art would have recognized the benefits of providing an opening in the insert/patch in view of the teachings of Thorne. Consequently, one of ordinary skill in the art would have modified the transducer array of Kirson in view of Kumar so that the electrodes are located about the nipple of the breast during stimulation in view of the teachings of Thorne that such was a well-known expedient for stimulating breasts and would have optimized the transducer array of Kirson in view of Kumar, and because the combination would have yielded a predictable result.
With respect to claim 16, Kirson in view of Kumar and Thorne teaches the transducer apparatus of claim 15, wherein, when viewed from a direction perpendicular to the face of the array and when the transducer apparatus is substantially planar, the substrate has at least one concave edge defining the opening between two opposing sides of the substrate (e.g., paragraph [0042] of Thorne: insert 304 may be a shallow cone shape – shallow = substantially planar, and Figs. 3A-C33 of Thorne illustrate a circular opening which would necessarily have a concave edge), and the opening defines a substantially C-shaped surface (as shown in Figs. 3A-C of Thorne, the opening is “C-shaped” in that the letter C can be seen in the opening) at the wider portion of the substantially pear-shaped or rounded triangular-shaped surface(see Fig. 3C of Thorne where the opening is located at a wider portion of the triangular-shaped surface). One of ordinary skill in the art would have recognized the benefits of a C-shaped opening at the wider portion of the rounded triangular patch in view of the teachings of Thorne. Consequently, one of ordinary skill in the art would have modified the transducer apparatus of Kirson in view of Kumar, and Thorne so that the opening is “C-shaped” and is located at the wider portion of the substantially rounded triangular shape as such was a known engineering expedient for stimulating the pectoral region proximal to a woman’s nipple as taught by Thorne, and because the combination would have yielded a predictable result.
As to claim 18, Kirson in view of Kumar and Thorne teaches the transducer apparatus of claim 15, wherein the transducer apparatus is substantially non-planar (e.g., paragraph [0042] of Thorne: insert 304 may be a shallow cone shape – shallow = substantially non-planar), wherein the transducer apparatus is substantially shaped as a truncated elliptical paraboloid or truncated oblique cone (e.g., abstract and paragraphs [0041]-[0043] and [0125] of Thorne: the stimulation component may be sized to fit a garment about the breast and may define an opening to be located proximate a nipple of the breast where an array of electrodes are disposed on inserts 304 that may encompass the breast in a shallow cone shape). Accordingly, one of ordinary skill in the art would have recognized the benefits an insert/patch with an electrode array being substantially non-planar, and in the shape of a truncated oblique cone where a substantially circular opening is formed by an opening at a truncated portion of the truncated oblique cone in view of the teachings of Thorne. Consequently, one of ordinary skill in the art would have modified the transducer array of Kirson in view of Kumar and Thorne so that the electrodes are located about the nipple of the breast in a cone shape during stimulation in view of the teachings of Thorne that such was a well-known expedient for stimulating breasts and would have optimized the transducer array of Kirson in view of Kumar and Thorne, and because the combination would have yielded a predictable result.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Kirson in view of Kumar and Thorne as applied to claim 15 above, and further in view of International Publication No. WO 2021/224678 to Schwarz et al. (hereinafter referred to as “Schwarz”).
With respect to claim 17, Kirson in view of Kumar and Thorne teaches the transducer apparatus of claim 16, but does not expressly teach a gap defined by the substantially C-shaped surface being situated on one side of the substrate and is defined by a centerline running through a longest dimension of the substrate and through a center of the gap. However, Schwarz, in a related art: apparatus for electrical stimulation, teaches different shapes of pads used for electrical contact therapy where the pads comprise at least one active element/electrode and are available in various shapes and layouts so that they may cover a variety of different treatment areas and accommodated individual patient needs (e.g. paragraph [0101] of Schwarz); and teaches that a horseshoe shape 4.3 that has a gap defined by the substantially C-shaped surface on one side of the pad/substrate and is defined by a center line running through a longest dimension of the pad and through the center of the gap (e.g., Fig. 3B; paragraphs [0103]-[0104]: horseshoe shaped pad 4.3). Accordingly, one of ordinary skill in the art would have recognized that the shape of the substrate/pad can be annular, oblong, polygonal, or formless and that a C-shaped opening may have a gap depending upon the patient’s anatomy being treated in view of the teachings of Schwarz. Consequently, one of ordinary skill in the art would have modified the C-shaped opening of Kirson in view of Kumar and Thorne to have a gap as recited in claim 17 because it was known to those skilled in the art that such substrates/pads could have any known shape that covers different treatment areas and accommodates individual patient needs and a C-shaped opening with a gap was such a known structure as taught by Schwarz, and because the combination would have yielded a predictable result.
Claims 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Kirson in view of Kumar and Thorne as applied to claim 15 above, and further in view of Deslauriers.
Kirson in view of Kumar and Thorne teaches the transducer apparatus of claim 15, but does not expressly teach that the transducer apparatus further comprises a layer of anisotropic material, sheet of graphite, on a skin-facing side of the array. However, Deslauriers, in a related art: conductive pad generating tumor treating field, teaches a conductive gel composition with a bulk electron transport agent, such as graphite, for application to a patient’s skin during treatment with TTField-generating system (e.g., paragraph [0102] of Deslauriers) where the bulk electron transport agent may being in a layer or film form (e.g., paragraph [0109] of Deslauriers) and conductive gel element is positioned on a skin-facing side of the array of electrodes (e.g., paragraph [0233]: conductive gel element may include a removeable protection layer covering at least a portion of the conductive gel layer that when removed allows the user to attach the conductive gel layer to the patient’s skin and Fig. 4, substrate 104, electrode element 124, and conductive gel element 128). Accordingly, one of ordinary skill in the art would have recognized the benefits of a conductive gel element between the array of electrodes and the patient’s skin in view of the teachings of Deslauriers (e.g., paragraphs [0102]-[0103], [0109], [0233] of Deslauriers). Consequently, one of ordinary skill in the art would have modified the transducer apparatus of Kirson in view of Kumar and Thorne to have a layer/film of anisotropic material, such as graphite, on a skin-facing side of the array, as taught by Deslauriers in order to dramatically enhance the electrical and/or thermal conductivity of the electrode array, and because the combination would have yielded a predictable result.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-14 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 4 of copending Application No. 18/756,587 in view of Kirson and Deslauriers.
Claims 1, 9, 10, and 12 of the instant application are conflicting or coextensive with claim 1 of the ‘587 application. Claim 1 differs from claim 1 of the 587 application in that the claim does not recite a layer of anisotropic material and an interior slit surrounded by anisotropic material. However, as discussed above, with respect to the rejection of claim 1, Kirson discloses such an interior slit, and Deslauriers teaches a layer/film of anisotropic material (graphite). Accordingly, one of ordinary skill in the art would have modified the transducer apparatus of claim 1 of the ‘587 application as discussed above in the rejection of claim 1.
Claims 2-8 of the instant application are conflicting or coextensive with claim 1 of ‘587 application as modified by Kirson as discussed above with respect to the rejections of claims 2-8 of the instant application.
Claim 11 of the instant application is conflicting or coextensive with claim 4 of the ‘587 application.
Claims 13-14 of the instant application are conflicting or coextensive with claim 1 of the ‘587 application as modified by Kirson and Deslauriers as discussed above with respect to the rejections of claims 13-14.
This is a provisional nonstatutory double patenting rejection.
Claims 15-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 6, 13 and 14 of copending Application No. 18/756,587 in view of Kirson.
Claim 15 of the instant application is conflicting or coextensive with claim 1 of the ‘587 application, except for the substrate comprising an interior slit substantially along a longitudinal direction of the substrate where no electrodes are in the interior slit. However, as discussed above with respect to the rejection under 35 USC 103 of claim 1, Kirson discloses such an interior slit. One of ordinary skill in the art would have modified the transducer apparatus of claim 1 of the ‘587 application to have such an interior slit for the reasons set forth in the rejection of claim 1 of the instant application.
Claim 16 of the instant application is conflicting or coextensive with claim 4 of the ‘587 application.
Claim 17 of the instant application is conflicting or coextensive with claim 6 of the ‘587 application.
Claim 18 of the instant application is conflicting or coextensive with claim 1 of the ‘587 application.
Claim 19 of the instant application is conflicting or coextensive with claim 13 of the ‘587 application.
Claim 20 of the instant application is conflicting or coextensive with claim 14 of the ‘587 application.
This is a provisional nonstatutory double patenting rejection.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US Patent No. 6,327,487 to Stratbucker is directed to a bioelectric interface containing at least two electrodes where a slit (S) is surrounded by the substrate material and no electrodes are in the slit (e.g., column 16, line 61 – column 17, line 41).
US Patent Application Publication No. 2018/0177430 to De Limon et al. is directed to apparatus and method for analyzing a region of a human body using electrodes for bipolar stimulation where slits are cut through the substrate to enhance the local flexibility of the substrate (e.g., paragraphs [0048], [0107], [0144] of De Limon).
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/CATHERINE M VOORHEES/Primary Examiner, Art Unit 3792