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 .
Election/Restrictions
Applicant’s election without traverse of invention I the apparatus (related the Restriction between Invention I and II) in the reply filed on 5/4/26 is acknowledged.
Applicant's election with traverse of the species restriction in the reply filed on 5/4/26 is acknowledged. The traversal is on the ground(s) that with regards to Species A and B “. . . the application presents these as alternative embodiments of the same inventive concept: . . .”. This is not found persuasive because the two are mutually exclusive embodiments which require different searches etc. Furthermore, Applicants themselves have admitted they are “alternative embodiments”. Examiner notes that Applicants are improperly applying the analysis, whether or not the alternatives are trying to solve the same problem does not negate that they are separate species. Therefore, the argument is not persuasive.
In view of Applicants arguments and after further consideration with regards to what claims are “generic claims” to the alternative species; Examiner agrees claims 1, 4-6, 10-19 are generic. With regards to claim 21 in view of the species election and MPEP 803.02(III)(A), the claim will be examined with respect to the elected species.
In view of the above discussion and the elections for the restriction and species of Invention I and Species A, claims 1-6, 10-19 and 21 are examined.
The requirement is still deemed proper and is therefore made FINAL.
Claim Objections
Claim 1 is objected to because of the following informalities: claim 1 recites “wherein the transducer apparatus is substantially planar” and later recites “wherein the transducer apparatus is capable of being deformed from being substantially planar to being non-planar”. Reading the claims in view of the specification, Applicants are claiming two different states of the device. The transducer is flexible and conforms to the shape of what it is resting on, thus its planar resting on a flat surface etc. and forms the other claimed shapes when for example mounted on a breast. Reading the specification Examiner understood what Applicants meant but it should be clearer that they are alternative states and the “form” is not set but relative. Applicants could have just as easily stated “wherein the transducer apparatus is capable of being deformed from being substantially planar to being non-planar” and capable of being deformed to be planar. 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.
Claim(s) 1-2, 4, 10, 15-16, 21 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by US 20250242150 to Bouton et al. (hereinafter Bouton).
Regarding Claim 1, an interpretation of Bouton discloses a transducer apparatus for delivering tumor treating fields to a subject's body, the transducer apparatus (Figs. 6, 9-10, Fig. 14A-E) comprising:
a substrate ([0046]-[0047], [0082]); and
an array of at least one electrode disposed on the substrate, the array configured to be positioned over the subject's body with a face of the array facing the subject's body ([0046]-[0047], [0081]-[0082], [0140]-[0142] including “electrode array”, Fig. 6, 13-14E);
wherein, when viewed from a direction perpendicular to the face of the array, the substrate has a substantially rounded triangular-shaped surface (1310 Fig. 13, [0081]-[0082] including “The electrode arrays can be shaped to accommodate various body parts.”, [0140]-[0142] see also [0046]-[0047], Figs. 6, 9-10, Fig. 14A-E; The “transducer” with electrodes is “substantially . . . rounded triangular shaped” see annotated Fig. 13 below) having an opening located towards a wider portion of the substantially rounded triangular-shaped surface, and no electrodes are in the opening (1310 Fig. 13, [0081]-[0082] including “The electrode arrays can be shaped to accommodate various body parts.”, [0140]-[0142] see also [0046]-[0047], Figs. 6, 9-10, Fig. 14A-E; “transducer" with electrodes with a “substantially . . . rounded triangular shaped” and no electrodes in the opening, see annotated Fig. 13 below)
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Annotated 1310 of Fig. 13
wherein the transducer apparatus is substantially planar ([0046]-[0047] including “flexible, wearable system described herein.”, [0081]-[0082] including “The electrode arrays can be shaped to accommodate various body parts.”, [0140]-[0142], Fig. 13 see also Figs. 6, 9-10, Fig. 14A-E; The “transducer” is flexible when it is resting on a flat surface it is substantially planar but when placed on the body it conforms to the body. To the extent this is an intended use recitation the structure of the prior art device is functionally capable of performing the intended use.),
wherein the transducer apparatus is capable of being deformed from being substantially planar to being non-planar and substantially shaped as a truncated elliptical paraboloid or truncated oblique cone planar ([0044], [0046]-[0047] including “flexible, wearable system described herein.”, [0081]-[0082] including “conform to a body part or a portion of a body part (e.g., by curving or folding),”, [0140]-[0142], Figs. 14D-E see also Figs. 6, 9-10, 13, 14A-C; The “transducer” is flexible and is capable of being to a non-planar shape which is substantially one of the claimed shapes. For example, when the flexible “transducer” is placed on the body such as the thumb it conforms to the shape of the body and wraps around the thumb at which point the “transducer” is substantially shaped like one of the claimed shapes. To the extent this is an intended use recitation the structure of the prior art device is functionally capable of performing the intended use.),
wherein when the transducer apparatus is substantially shaped as a truncated elliptical paraboloid or truncated oblique cone, a substantially circular opening is formed by the opening at a truncated portion of the truncated elliptical paraboloid or truncated oblique cone ([0044], [0046]-[0047] including “flexible, wearable system described herein.”, [0081]-[0082] including “conform to a body part or a portion of a body part (e.g., by curving or folding),”, [0140]-[0142], Figs. 14D-E see also Figs. 6, 9-10, 13, Fig. 14A-C; The “transducer” is flexible and is capable of being to a non-planar shape which is substantially one of the claimed shapes. For example, when the flexible “transducer” is placed on the body such as the thumb it conforms to the shape wrapping around the thumb with a “substantially circular” opening at the truncated portion (side of “transducer” toward the distal end of the thumb). To the extent this is an intended use recitation the structure of the prior art device is functionally capable of performing the intended use.).
Regarding Claim 2, an interpretation Bouton discloses wherein when viewed from a direction perpendicular to the face of the array and when the transducer apparatus is substantially planar, the transducer apparatus comprises a first end portion separated from a second end portion by a gap ([0046]-[0047] including “flexible, wearable system described herein.”, [0081]-[0082] including “The electrode arrays can be shaped to accommodate various body parts.”, [0140]-[0142], Figs. 13, 14D-E see also Figs. 6, 9-10, Fig. 14A-C; The “transducer” is flexible when it is resting on a flat surface it is substantially planar. The “transducer" with electrodes with opposite end portions on either side of the opening, see annotated Fig. 13 above. To the extent this is an intended use recitation the structure of the prior art device is functionally capable of performing the intended use.),
wherein when the transducer apparatus is substantially shaped as a truncated elliptical paraboloid or truncated oblique cone, the first end portion abuts, touches, or overlaps the second end portion ([0044], [0046]-[0047] including “flexible, wearable system described herein.”, [0081]-[0082] including “conform to a body part or a portion of a body part (e.g., by curving or folding),”, [0140]-[0142], Figs. 14D-E see also Figs. 6, 9-10, 13, Fig. 14A-C; The “transducer” is flexible and is capable of being to a non-planar shape which is substantially one of the claimed shapes. For example, when the flexible “transducer” is placed on the body such as the thumb it conforms to the shape wrapping around the thumb with a “substantially circular” opening at the truncated portion (side of “transducer” toward the nail of the thumb) with the ends of the “transducer” substrate abut, touch, or overlap. To the extent this is an intended use recitation the structure of the prior art device is functionally capable of performing the intended use.).
Regarding Claim 4, an interpretation of Bouton further discloses 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 ([0046]-[0047], [0081]-[0082], [0140]-[0142], Figs. 13, 14D-E see also Figs. 6, 9-10, Fig. 14A-C; The “transducer” is flexible when it is resting on a flat surface it is substantially planar. The “transducer" with a concave edge defining the opening, see annotated Fig. 13 above.), and the opening defines a substantially C-shaped surface at the wider portion of the substantially rounded triangular-shaped surface ([0046]-[0047], [0081]-[0082], [0140]-[0142], Figs. 13, 14D-E see also Figs. 6, 9-10, Fig. 14A-C; The “transducer” is flexible when it is resting on a flat surface it is substantially planar. The “transducer" opening defines a substantially C-shaped surface, see annotated Fig. 13 above).
Regarding Claim 10, an interpretation of Bouton further discloses wherein the substrate is adapted to be positioned on or around an anatomical feature of a subject ([0044], [0046]-[0047] including “flexible, wearable system described herein.”, [0081]-[0082] including “conform to a body part or a portion of a body part (e.g., by curving or folding),”, [0140]-[0142], Figs. 14D-E see also Figs. 6, 9-10, 13, Fig. 14A-C; To the extent the element is an intended use the device disclosed by the prior art is functionally capable of performing the intended use).
Regarding Claim 21, an interpretation of Bouton further discloses wherein the substantially circular opening in the non-planar configuration is formed by: opposing end portions of the substrate abutting, touching, or overlapping ([0044], [0046]-[0047] including “flexible, wearable system described herein.”, [0081]-[0082] including “conform to a body part or a portion of a body part (e.g., by curving or folding),”, [0140]-[0142], Figs. 14D-E see also Figs. 6, 9-10, 13, Fig. 14A-C; The “transducer” is flexible and is capable of being to a non-planar shape which is substantially one of the claimed shapes. For example, when the flexible “transducer” is placed on the body such as the thumb it conforms to the shape wrapping around the thumb with a “substantially circular” opening at the truncated portion (side of “transducer” toward the nail of the thumb) with the ends of the “transducer” substrate abut, touch, or overlap. To the extent this is an intended use recitation the structure of the prior art device is functionally capable of performing the intended use.).
Regarding Claim 15, an interpretation of Bouton discloses a transducer apparatus for delivering tumor treating fields to a subject's body, the transducer apparatus comprising:
a substrate ([0046]-[0047], [0082]); and
an array of at least one electrode disposed on the substrate, the array configured to be positioned over the subject's body with a face of the array facing the subject's body ([0046]-[0047], [0081]-[0082], [0140]-[0142] including “electrode array”, Fig. 6, 13-14E);
wherein the transducer apparatus is substantially non-planar, wherein the transducer apparatus is substantially shaped as a truncated elliptical paraboloid, truncated oblique cone, or truncated cone ([0044], [0046]-[0047] including “flexible, wearable system described herein.”, [0081]-[0082] including “conform to a body part or a portion of a body part (e.g., by curving or folding),”, [0140]-[0142], Figs. 14D-E see also Figs. 6, 9-10, 13, 14A-C; The “transducer” is flexible and is capable of being to a non-planar shape which is substantially one of the claimed shapes. For example, when the flexible “transducer” is placed on the body such as the thumb it conforms to the shape of the body and wraps around the thumb at which point the “transducer” is substantially shaped like one of the claimed shapes. To the extent this is an intended use recitation the structure of the prior art device is functionally capable of performing the intended use.), and a substantially circular opening is formed by an opening at a truncated portion of the truncated elliptical paraboloid, truncated oblique cone, or truncated cone ([0044], [0046]-[0047] including “flexible, wearable system described herein.”, [0081]-[0082] including “conform to a body part or a portion of a body part (e.g., by curving or folding),”, [0140]-[0142], Figs. 14D-E see also Figs. 6, 9-10, 13, Fig. 14A-C; The “transducer” is flexible and is capable of being to a non-planar shape which is substantially one of the claimed shapes. For example, when the flexible “transducer” is placed on the body such as the thumb it conforms to the shape wrapping around the thumb with a “substantially circular” opening at the truncated portion (side of “transducer” toward the distal end of the thumb). To the extent this is an intended use recitation the structure of the prior art device is functionally capable of performing the intended use.).
Regarding Claim 16, an interpretation of Bouton further discloses wherein the substrate is adapted to be positioned on or around an anatomical feature of a subject ([0044], [0046]-[0047] including “flexible, wearable system described herein.”, [0081]-[0082] including “conform to a body part or a portion of a body part (e.g., by curving or folding),”, [0140]-[0142], Figs. 14D-E see also Figs. 6, 9-10, 13, Fig. 14A-C).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
Claim(s) 3, 5-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bouton.
Regarding Claim 3, an interpretation Bouton discloses wherein when viewed from a direction perpendicular to the face of the array and when the transducer apparatus is substantially planar, the substrate includes an opening between an exterior edge of the substrate and an edge of the opening, wherein the opening separates a first end portion of the transducer apparatus from a second end portion of the transducer apparatus ([0046]-[0047] including “flexible, wearable system described herein.”, [0081]-[0082] including “The electrode arrays can be shaped to accommodate various body parts.”, [0140]-[0142], Figs. 13, 14D-E see also Figs. 6, 9-10, Fig. 14A-C; The “transducer” is flexible when it is resting on a flat surface it is substantially planar. The “transducer" with electrodes with opposite end portions on either side of the opening, see annotated Fig. 13 above. To the extent this is an intended use recitation the structure of the prior art device is functionally capable of performing the intended use.),
wherein when the transducer apparatus is substantially shaped as a truncated elliptical paraboloid or truncated oblique cone, the first end portion overlaps the second end portion ([0044], [0046]-[0047] including “flexible, wearable system described herein.”, [0081]-[0082] including “conform to a body part or a portion of a body part (e.g., by curving or folding),”, [0140]-[0142], Figs. 14D-E see also Figs. 6, 9-10, 13, Fig. 14A-C; The “transducer” is flexible and is capable of being to a non-planar shape which is substantially one of the claimed shapes. For example, when the flexible “transducer” is placed on the body such as the thumb it conforms to the shape wrapping around the thumb with a “substantially circular” opening at the truncated portion (side of “transducer” toward the nail of the thumb) with the ends of the “transducer” overlapping. To the extent this is an intended use recitation the structure of the prior art device is functionally capable of performing the intended use.).
The Bouton reference discloses an opening between the edge of the interior space and the exterior edge as well as separating the respective end portions, the difference between the disclosed element and the prior art reference is it being a “slit” which in view of their specification (while not to scale) would be narrower. Reviewing Applicants specification, Applicants provide different alternatives for this opening such as a slit, gap etc. thus “slit” does not have criticality. Taking the disclosure of Bouton in view of the MPEP 2144.04(IV)(A)-(B) It would have been an obvious matter of design choice to make the different portions of the substrate of whatever form or shape (to narrow the opening to a slit) was desired or expedient. A change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47.
Regarding Claim 5, an interpretation of Bouton may not explicitly disclose wherein the substrate has reflectional symmetry.
The Bouton reference discloses the transducer with the substrate and electrodes as well as the opening and other elements. While, the Bouton reference discloses the above the difference between the claimed element and the prior art reference is that the claimed substrate has “reflectional symmetry”. Reviewing Applicants specification, Applicants provide different alternatives for the layout including ones which do not require “reflectional symmetry” see for example Fig. 4A, [0040] (using PG Pub) and claim 6. Thus, the substrate having “reflectional symmetry” does not have criticality. Taking the disclosure of Bouton in view of the MPEP 2144.04(IV)(A)-(B) It would have been an obvious matter of design choice to make the different portions of the substrate of whatever form or shape (having reflectional symmetry) was desired or expedient. A change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47.
Regarding Claim 6, an interpretation of Bouton may not explicitly disclose wherein a gap defined by the substantially C-shaped surface ([0046]-[0047], [0081]-[0082], [0140]-[0142], Figs. 13, 14D-E see also Figs. 6, 9-10, Fig. 14A-C; The “transducer” is flexible when it is resting on a flat surface it is substantially planar. The “transducer" opening defines a substantially C-shaped surface, see annotated Fig. 13 above).
An interpretation of Bouton may not explicitly disclose the substantially C-shaped surface is 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.
The Bouton reference discloses the transducer with the substrate and electrodes as well as the opening and other elements. While, the Bouton reference discloses the above the difference between the claimed element and the prior art reference is that the claimed “the substantially C-shaped surface is 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.”. Reviewing Applicants specification, Applicants provide different alternatives for the layout including ones which do not require “the substantially C-shaped surface is 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.” see for example Fig. 3A, [0031]-[0032] (using PG Pub) and claim 5. Thus “the substantially C-shaped surface is 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.” does not have criticality. Taking the disclosure of Bouton in view of the MPEP 2144.04(IV)(A)-(B) It would have been an obvious matter of design choice to make the different portions of the substrate of whatever form or shape (having the substantially C-shaped surface is situated on one side of the substrate) was desired or expedient. A change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47.
Claim Rejections - 35 USC § 103
Claim(s) 11-12, 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bouton in view of US 20230181919 to Wendel et al. (hereinafter Wendel; included in IDS dated 8.14.24).
Regarding Claim 11, an interpretation of Bouton may not explicitly disclose wherein the anatomical feature is a breast.
However, in the same field of endeavor (medical stimulation devices), Wendel teaches wherein the anatomical feature is a breast ([0017], [0021] including “contouring over the breast while avoiding the nipple 108” see also [0003], [0014], [0074]; To the extent this is an intended use of the device the device disclosed by the prior art is functionally capable of performing the intended use). Examiner notes that Wendel also discloses reflectional symmetry see Figs. 4A-G.
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the device of Bouton to have the “transducer” proportioned to contour to a user’s breast as disclosed by Wendel because the recitations of Wendel are directed to transducers which provide greater flexibility and continuity for placement around areas of the body, including the breast, which are difficult to place without causing discomfort ([0017]).
Regarding Claim 12, an interpretation of Bouton discloses wherein the substrate is adapted to be positioned on or around an anatomical feature of a subject ([0044], [0046]-[0047] including “flexible, wearable system described herein.”, [0081]-[0082] including “conform to a body part or a portion of a body part (e.g., by curving or folding),”, [0140]-[0142], Figs. 14D-E see also Figs. 6, 9-10, 13, Fig. 14A-C); wherein the substantially circular opening coincides with a first location on a subject and no electrodes of the transducer array are located over the first location ([0044], [0046]-[0047] including “flexible, wearable system described herein.”, [0081]-[0082] including “conform to a body part or a portion of a body part (e.g., by curving or folding),”, [0140]-[0142], Figs. 14D-E see also Figs. 6, 9-10, 13, Fig. 14A-C; Wraps around a thumb with no electrodes on the distal portion of the thumb.).
an interpretation of Bouton may not explicitly disclose wherein the first location comprises a nipple, and no electrodes of the transducer array are located over the nipple.
However, in the same field of endeavor (medical stimulation devices), Wendel teaches wherein the portion of the body the device is adapted to the breast ([0017], [0021] including “contouring over the breast while avoiding the nipple 108” see also [0003], [0014], [0074]) and the first location comprises a nipple, and no electrodes of the transducer array are located over the nipple ([0017], [0021] including “contouring over the breast while avoiding the nipple 108”; To the extent this is an intended use of the device the device disclosed by the prior art is functionally capable of performing the intended use).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the device of Bouton to have the “transducer” proportioned to contour to a user’s breast while avoiding the nipple as disclosed by Wendel because the recitations of Wendel are directed to transducers which provide greater flexibility and continuity for placement around areas of the body, including the breast, which are difficult to place without causing discomfort ([0017], [0021]).
Regarding Claim 17, an interpretation of Bouton discloses wherein the substrate is adapted to be positioned on or around an anatomical feature of a subject ([0044], [0046]-[0047] including “flexible, wearable system described herein.”, [0081]-[0082] including “conform to a body part or a portion of a body part (e.g., by curving or folding),”, [0140]-[0142], Figs. 14D-E see also Figs. 6, 9-10, 13, Fig. 14A-C); wherein the substantially circular opening coincides with a first location on a subject and no electrodes of the transducer array are located over the first location ([0044], [0046]-[0047] including “flexible, wearable system described herein.”, [0081]-[0082] including “conform to a body part or a portion of a body part (e.g., by curving or folding),”, [0140]-[0142], Figs. 14D-E see also Figs. 6, 9-10, 13, Fig. 14A-C; Wraps around a thumb with no electrodes on the distal portion of the thumb.).
an interpretation of Bouton may not explicitly disclose wherein the first location comprises a nipple, and no electrodes of the transducer array are located over the nipple.
However, in the same field of endeavor (medical stimulation devices), Wendel teaches wherein the portion of the body the device is adapted to the breast ([0017], [0021] including “contouring over the breast while avoiding the nipple 108” see also [0003], [0014], [0074]) and the first location comprises a nipple, and no electrodes of the transducer array are located over the nipple ([0017], [0021] including “contouring over the breast while avoiding the nipple 108”; To the extent this is an intended use of the device the device disclosed by the prior art is functionally capable of performing the intended use).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the device of Bouton to have the “transducer” proportioned to contour to a user’s breast while avoiding the nipple as disclosed by Wendel because the recitations of Wendel are directed to transducers which provide greater flexibility and continuity for placement around areas of the body, including the breast, which are difficult to place without causing discomfort ([0017], [0021]).
Claim Rejections - 35 USC § 103
Claim(s) 13-14, 18-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bouton in view of US 20210346693 to Deslauriers (hereinafter Desa).
Regarding Claim 13, an interpretation of Bouton discloses the use of a hydrogel ([0078], [0084]).
An interpretation of Bouton may not explicitly disclose a layer of anisotropic material on a skin-facing side of the array.
However, in the same field of endeavor (medical stimulation systems), Desa teaches a layer of anisotropic material on a skin-facing side of the array ([0102]-[0103], [0233] see also [0109], [0796]).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified electrodes and their skin interface to include the layer of anisotropic material on skin facing side of the electrode because it dramatically enhances the electrical and/or thermal conductivity ([0102]).
Regarding Claim 14, an interpretation of Bouton may not explicitly disclose wherein the anisotropic material is a sheet of graphite.
However, in the same field of endeavor (medical stimulation systems), Desa teaches wherein the anisotropic material is a sheet of graphite ([0102]-[0103], [0109] including “the bulk electron transport agent may be provided in a layer or film”, [0233] see also [0796]).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified electrodes and their skin interface to include the layer of anisotropic graphite material on skin facing side of the electrode because it dramatically enhances the electrical and/or thermal conductivity ([0102]).
Regarding Claim 18, an interpretation of Bouton discloses the use of a hydrogel ([0078], [0084]).
An interpretation of Bouton may not explicitly disclose a layer of anisotropic material on a skin-facing side of the array.
However, in the same field of endeavor (medical stimulation systems), Desa teaches a layer of anisotropic material on a skin-facing side of the array ([0102]-[0103], [0233] see also [0109], [0796]).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified electrodes and their skin interface to include the layer of anisotropic material on skin facing side of the electrode because it dramatically enhances the electrical and/or thermal conductivity ([0102]).
Regarding Claim 19, an interpretation of Bouton may not explicitly disclose wherein the anisotropic material is a sheet of graphite.
However, in the same field of endeavor (medical stimulation systems), Desa teaches wherein the anisotropic material is a sheet of graphite ([0102]-[0103], [0109] including “the bulk electron transport agent may be provided in a layer or film”, [0233] see also [0796]).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified electrodes and their skin interface to include the layer of anisotropic graphite material on skin facing side of the electrode because it dramatically enhances the electrical and/or thermal conductivity ([0102]).
Claim Rejections - 35 USC § 103
Claim(s) 1 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wendel.
Regarding Claim 1, an interpretation of Wendel discloses transducer apparatus for delivering tumor treating fields to a subject's body ([0018]-[0020], [0025]), the transducer apparatus comprising:
a substrate ([0003], [0013], [0031]); and
an array of at least one electrode disposed on the substrate, the array configured to be positioned over the subject's body with a face of the array facing the subject's body ([0003] including “The transducer apparatus includes a substrate and an array of electrodes disposed on the substrate. The array is configured to be positioned over the subject's body with a face of the array facing the subject's body.”, [0018]-[0019], [0030]);
wherein, when viewed from a direction perpendicular to the face of the array, the substrate has having an opening, and no electrodes are in the opening ([0017]-[0018], [0021], [0026], [0030]-[0031], Figs. 4A-4F; ),
wherein the transducer apparatus is substantially planar, wherein the transducer apparatus is capable of being deformed from being substantially planar to being non-planar and substantially shaped as a truncated elliptical paraboloid or truncated oblique cone ([0017]-[0018], [0021], [0026], [0030]-[0031], Figs. 4A-4F; The “transducer” is flexible when it is resting on a flat surface it is substantially planar but when placed on the body it conforms to the body.),
wherein when the transducer apparatus is substantially shaped as a truncated elliptical paraboloid or truncated oblique cone, a substantially circular opening is formed by the opening at a truncated portion of the truncated elliptical paraboloid or truncated oblique cone ([0003] including “The transducer apparatus includes a substrate and an array of electrodes disposed on the substrate. The array is configured to be positioned over the subject's body with a face of the array facing the subject's body.”, [0018]-[0019], [0030]; The “transducer” is flexible when it is resting on a flat surface it is substantially planar but when placed on the body it conforms to the body. For example, with the recited when placed on the breast will conform to the body with the transducer arrayed around the nipple but not covering, then the transducer is “substantially shaped as a truncated elliptical paraboloid, truncated oblique cone, or truncated cone, and a substantially circular opening is formed by an opening at a truncated portion”. To the extent this is an intended use recitation the structure of the prior art device is functionally capable of performing the intended use.).
The Bouton reference discloses an opening between the edge of the interior space and the exterior edge as well as separating the respective end portions, the difference between the disclosed element and the prior art reference is substrate shaped as “a substantially pear-shaped or rounded triangular-shaped surface”. Reviewing Applicants specification, Applicants provide different alternatives for the shape (see for Example Figs. 6C-D) thus it does not have criticality. Taking the disclosure of Wendel in view of the MPEP 2144.04(IV)(A)-(B) It would have been an obvious matter of design choice to make the different portions of the substrate of whatever form or shape was desired or expedient. A change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47.
Claim Rejections - 35 USC § 102
Claim(s) 15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wendel.
Regarding Claim 15, an interpretation of Wendel discloses a transducer apparatus for delivering tumor treating fields to a subject's body ([0018]-[0020], [0025]), the transducer apparatus comprising:
a substrate ([0003], [0013], [0031]); and
an array of at least one electrode disposed on the substrate, the array configured to be positioned over the subject's body with a face of the array facing the subject's body ([0003] including “The transducer apparatus includes a substrate and an array of electrodes disposed on the substrate. The array is configured to be positioned over the subject's body with a face of the array facing the subject's body.”, [0018]-[0019], [0030]);
wherein the transducer apparatus is substantially non-planar, wherein the transducer apparatus is substantially shaped as a truncated elliptical paraboloid, truncated oblique cone, or truncated cone, and a substantially circular opening is formed by an opening at a truncated portion of the truncated elliptical paraboloid, truncated oblique cone, or truncated cone ([0003] including “The transducer apparatus includes a substrate and an array of electrodes disposed on the substrate. The array is configured to be positioned over the subject's body with a face of the array facing the subject's body.”, [0018]-[0019], [0030]; The “transducer” is flexible when it is resting on a flat surface it is substantially planar but when placed on the body it conforms to the body. For example, with the recited when placed on the breast will conform to the body with the transducer arrayed around the nipple but not covering, then the transducer is “substantially shaped as a truncated elliptical paraboloid, truncated oblique cone, or truncated cone, and a substantially circular opening is formed by an opening at a truncated portion”. To the extent this is an intended use recitation the structure of the prior art device is functionally capable of performing the intended use.).
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 1-6, 10-19, 21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 18757028 (reference application, hereinafter App ‘028). Although the claims at issue are not identical, they are not patentably distinct from each other because App ‘028 claims 1 and 15 (independent claims) both teach a transducer with a substrate and an array of electrodes, claims 15 (see also claim 11) further discloses the “substantially pear-shaped or rounded triangular shaped surface” which is planar and claim 18 (see also claim 12) recite the paraboloid or truncated oblique cone which anticipates both claims 1 and 15 of the current app.
Claims 2, 4, 10, 16, 21 are rejected by ‘028 at least claim 18 in view of the Bouton reference, which is in the same field of endeavor and Bouton teaches the recitation of the elements see the 102 and/or 103 rejections above for citations from Bouton.
Claims 3, 5-6 are rejected by ‘028 at least claim 18 in view of the Bouton reference and the MPEP, which is in the same field of endeavor and Bouton teaches the recitation of the elements (see the 102 and/or 103 rejections above for citations from Bouton and MPEP).
Claims 13-14, 18-19 are rejected by ‘028 at least claim 9 in view of the Bouton reference, which is in the same field of endeavor and Bouton teaches the recitation of the elements see the 102 and/or 103 rejections above for citations from Bouton and MPEP.
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified ‘028 in view of Bouton because as Bouton discloses it provides advantages of transducer (substrate with electrode(s)) accommodating any body part by conforming to the body and while maintaining mechanical contact between the body and every electrode ([0082]).
Claims 11-12, 17 are rejected by ‘028 at least claim 18 in view of the Bouton reference in further view of Wendel, which is in the same field of endeavor and Bouton and Wendel respectively teaches the recited elements (see the 102 and/or 103 rejections above for citations from Bouton and Wendel).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified ‘028 in view of Bouton in further view of Wendel because the recitations of Wendel are directed to transducers which provide greater flexibility and continuity for placement around areas of the body, including the breast, which are difficult to place without causing discomfort ([0017], [0021]).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 20220305275 see [0107], [0135]-[0137], Figs. 3A-C
US 4233987 see abstract, Fig. 1
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/James Moss/Examiner, Art Unit 3792
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