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
2. Applicant’s election without traverse of the following species:
from Group A: Embodiment 1
from Group B: Embodiment 3
from Group C: Embodiment 5
from Group D: Embodiment 8
from Group E: Embodiment 10
from Group F: Embodiment 12
in the reply filed on 12/22/2025 is acknowledged. Thus, claims 1-5, 7-8, 10-11, 14-15, 17-18, and 20 are pending. Claims 6, 9, 12-13, 16, and 19 are withdrawn from consideration. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse
(see MPEP § 818.01(a)). The requirement is still deemed proper and is therefore made FINAL.
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 1-5, 7-8, 10-11, 17-18, and 20 are rejected under 35 U.S.C 103 as being unpatentable over Rainey et al. (US Pub.: 2008/0215128 A1, – Applicant Cited).
Regarding claim 1, Rainey teaches a transducer apparatus for delivering tumor treating fields to a subject's body (e.g. paragraph 0126, – electrical stimulation; Examiner notes that if the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Shoes by Firebug LLC v. Stride Rite Children’s Grp., LLC, 962 F.3d 1362, 2020 USPQ2d 10701 (Fed. Cir. 2020) (See MPEP 2111.02(II)), the transducer apparatus (e.g. Fig. 13. – electrode arrangement 1900) comprising:
an array of electrodes (e.g. Fig. 13; electrodes 1942, 1944, 1946, 1948), the array configured to be positioned over the subject's body with a face of the array facing the subject's body (e.g. abstract; paragraph 0127);
a substrate (e.g. Fig 13. – element 5 in annotated figure below), wherein:
the array of electrodes (1942, 1944, 1946, 1948) is disposed entirely on a first side of the substrate (5), the face of the array faces away from the substrate (5);
and wherein, when viewed from a direction perpendicular to the face of the array, a non-adhesive region (e.g. Fig. 13 – element 6 in annotated figure below), where no adhesive layer is present, is located between a pair of adjacent electrodes of the array (e.g. Fig 13. – electrodes 1942 and 1944), wherein the non-adhesive region spans at least 25% of a total distance between the pair of adjacent electrodes for at least one measurement as measured along a straight line between the pair of adjacent electrodes (e.g. Fig 13. – dashed arrow and element 6 in annotated figure below. The dashed arrow illustrates the distance between adjacent electrode pairs 1942 and 1944. There is no adhesive between the electrode pairs.).
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However, Rainey does not explicitly teach the substrate comprising an adhesive layer for attaching the transducer apparatus to the subject's body and the adhesive layer is on the first side of the substrate facing the same direction as the face of the array.
Rainey, in another embodiment, discloses a substrate comprising an adhesive layer for attaching the transducer apparatus to the subject's body and the adhesive layer is on the first side of the substrate facing the same direction as the face of the array (e.g. paragraph 0089, – adhesive sealing gel 231).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Rainey to include an adhesive layer for attaching the transducer apparatus to the subject's body and the adhesive layer is on the first side of the substrate facing the same direction as the face of the array, as taught and suggested by another embodiment of Rainey, in order to provide the predictable results of enhancing patient comfort by maintaining the electrodes in the proper position when applied to the skin during therapy.
Regarding claim 2, Rainey teaches the transducer apparatus of claim 1 as discussed above, and Rainey further teaches wherein the non-adhesive region spans at least 50% of the total distance between the pair of adjacent electrodes (e.g. Fig 13. – dashed arrow and element 6 in annotated figure above).
Regarding claim 3, Rainey teaches the transducer apparatus of claim 1 as discussed above, and Rainey further teaches wherein the non-adhesive region spans at least 100% of the total distance between the pair of adjacent electrodes (e.g. Fig 13. – dashed arrow and element 6 in annotated figure above).
Regarding claim 4, Rainey teaches the transducer apparatus of claim 1 as discussed above, and Rainey further teaches wherein, when viewed from the direction perpendicular to the face of the array, an external perimeter of the adhesive layer has at least one concave portion (1920); and the non-adhesive region (6) is bounded by a concave portion of the at least one concave portion of the external perimeter (1920).
Regarding claim 5, Rainey teaches the transducer apparatus of claim 4 as discussed above, and Rainey further teaches wherein, when viewed from the direction perpendicular to the face of the array, a second non-adhesive region, where no adhesive layer is present, is located between a second pair of adjacent electrodes of the array (e.g. Fig. 13 – area between electrode 1946 and electrode 1948), wherein the second non-adhesive region spans at least 25% of a total distance between the second pair of adjacent electrodes for at least one measurement as measured along a straight line between the second pair of adjacent electrodes (e.g. Fig. 13 – distance between electrode 1946 and electrode 1948); and the second non-adhesive region is also bounded by the concave portion of the at least one concave portion of the external perimeter (1920).
Regarding claim 7, Rainey teaches the transducer apparatus of claim 1 as discussed above, and Rainey further teaches wherein when viewed in the direction perpendicular to the face of the array, an opening is present within the adhesive layer (e.g. Fig. 13 – aperture 1970), the opening (1970) having a perimeter surrounded on all sides by the adhesive layer (1920); and the non-adhesive region (6) is located within the perimeter of the opening (1970).
Regarding claim 8, Rainey teaches the transducer apparatus of claim 7 as discussed above, and Rainey further teaches wherein, when viewed from the direction perpendicular to the face of the array, a second non-adhesive region, where no adhesive layer is present, is located between a second pair of adjacent electrodes of the array (e.g. Fig. 13 – area between electrode 1946 and electrode 1948), wherein the second non-adhesive region spans at least 25% of a total distance between the second pair of adjacent electrodes for at least one measurement as measured along a straight line between the second pair of adjacent electrodes (e.g. Fig. 13 – distance between electrode 1946 and electrode 1948); and the second non-adhesive region is also located within the perimeter of the opening (1970).
Regarding claim 10, Rainey teaches the transducer apparatus of claim 1 as discussed above, and Rainey further teaches wherein when viewed from the direction perpendicular to the face of the array, the substrate (5) has at least two separate adhesive layers spaced apart from each other by the non-adhesive region (e.g. Fig. 13; adhesive layers are separated by the non-adhesive region).
Regarding claim 11, Rainey teaches the transducer apparatus of claim 1 as discussed above, and Rainey further teaches wherein the non-adhesive region is a space where no portion of the substrate is located (e.g. Fig. 13 – aperture 1970).
Regarding claim 17, Rainey teaches a method of applying tumor treating fields to a subject's body (e.g. paragraph 0126, – electrical stimulation; Examiner notes that if the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Shoes by Firebug LLC v. Stride Rite Children’s Grp., LLC, 962 F.3d 1362, 2020 USPQ2d 10701 (Fed. Cir. 2020) (See MPEP 2111.02(II)), the method comprising:
locating a first transducer in a first position on the subject's body (e.g. paragraph 0016), the first transducer (e.g. Fig. 13 – electrode arrangement 1900) comprising:
an array of electrodes (e.g. Fig. 13; electrodes 1942, 1944, 1946, 1948), the array configured to be positioned over the subject's body with a face of the array facing the subject's body (e.g. abstract; paragraph 0127);
a substrate (e.g. Fig 13. – element 5 in annotated figure above as applied in claim 1), wherein:
the array of electrodes (1942, 1944, 1946, 1948) is disposed entirely on a first side of the substrate, the face of the array faces away from the substrate (5);
and wherein, when viewed from a direction perpendicular to the face of the array, a non-adhesive region, where no adhesive layer is present, is located between a pair of adjacent electrodes of the array (e.g. Fig 13. – element 6 in annotated figure above as applied in claim 1), wherein the non-adhesive region spans at least 25% of a total distance between the pair of adjacent electrodes for at least one measurement as measured along a straight line between the pair of adjacent electrodes (e.g. Fig 13. – element 6 in annotated figure above); inducing an electric field between the first transducer and a second transducer located on the subject's body (e.g. paragraph 0126). However, Rainey does not explicitly teach a substrate comprising an adhesive layer for attaching the transducer apparatus to the subject's body and the adhesive layer is on the first side of the substrate facing the same direction as the face of the array.
Rainey, in another embodiment, discloses a substrate comprising an adhesive layer for attaching the transducer apparatus to the subject's body and the adhesive layer is on the first side of the substrate facing the same direction as the face of the array (e.g. paragraph 0089, – adhesive sealing gel 231).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Rainey to include an adhesive layer for attaching the transducer apparatus to the subject's body and the adhesive layer is on the first side of the substrate facing the same direction as the face of the array, as taught and suggested by another embodiment of Rainey, in order to provide the predictable results of enhancing patient comfort by maintaining the electrodes in the proper position when applied to the skin during therapy.
Regarding claim 18, Rainey teaches the method of claim 17 as discussed above, and Rainey further teaches wherein, when viewed from the direction perpendicular to the face of the array, an external perimeter of the adhesive layer has at least one concave portion (1920); and the non-adhesive region (6) is bounded by a concave portion of the at least one concave portion of the external perimeter (1920).
Regarding claim 20, Rainey teaches a transducer apparatus for delivering tumor treating fields to a subject's body (e.g. paragraph 0126, – electrical stimulation; Examiner notes that if the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Shoes by Firebug LLC v. Stride Rite Children’s Grp., LLC, 962 F.3d 1362, 2020 USPQ2d 10701 (Fed. Cir. 2020) (See MPEP 2111.02(II)), the transducer apparatus comprising:
an array of electrodes (e.g. Fig. 13; electrodes 1942, 1944, 1946, 1948), the array configured to be positioned over the subject's body with a face of the array facing the subject's body (e.g. abstract; paragraph 0127);
a substrate (e.g. Fig 13. – element 5 in annotated figure above as used in claim 1).
However, Rainey does not explicitly teach a substrate with at least one adhesive region thereon for attaching the transducer apparatus to the subject's body; wherein, when viewed from a direction perpendicular to the face of the array, a ratio Sa/Se of a surface area of the at least one adhesive region (Sa) to a surface area of the array of electrodes (Se) is less than 1.5, wherein the surface area of the at least one adhesive region (Sa) is defined as all adhesive portions of the transducer apparatus that touch the subject's skin upon application of the transducer apparatus to the subjects body, and excludes any areas of the adhesive region overlapping the electrodes of the array.
Rainey, in another embodiment, discloses a substrate with at least one adhesive region thereon for attaching the transducer apparatus to the subject's body (e.g. paragraph 0089, – adhesive sealing gel 231); wherein, when viewed from a direction perpendicular to the face of the array, a ratio Sa/Se of a surface area of the at least one adhesive region (Sa) to a surface area of the array of electrodes (Se) is less than 1.5, wherein the surface area of the at least one adhesive region (Sa) is defined as all adhesive portions of the transducer apparatus that touch the subject's skin upon application of the transducer apparatus to the subjects body (e.g. paragraph 0089), and excludes any areas of the adhesive region overlapping the electrodes of the array (e.g. paragraph 0089).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Rainey to incorporate at least one adhesive region thereon for attaching the transducer apparatus to the subject's body; wherein, when viewed from a direction perpendicular to the face of the array, a ratio Sa/Se of a surface area of the at least one adhesive region (Sa) to a surface area of the array of electrodes (Se) is less than 1.5, wherein the surface area of the at least one adhesive region (Sa) is defined as all adhesive portions of the transducer apparatus that touch the subject's skin upon application of the transducer apparatus to the subjects body, and excludes any areas of the adhesive region overlapping the electrodes of the array, as taught and suggested by another embodiment of Rainey, in order to provide the predictable results of enhancing patient comfort by maintaining the electrodes in the proper position when applied to the skin during therapy and making it easier to remove from the skin once therapy is concluded.
Claim 14 is rejected under 35 U.S.C 103 as being unpatentable over Rainey and further in view of Palero et al. (US Pub.: 2017/0189704 A1).
Regarding claim 14, Rainey teaches the transducer apparatus of claim 1 as
discussed above. However, Rainey does not explicitly teach wherein one or more of the electrodes of the array have a triangular shape, a substantially triangular shape with rounded corners, a truncated triangular shape, a substantially truncated triangular shape with rounded corners, a wedge shape, a substantially wedge shape with rounded corners, a truncated wedge shape, or a substantially truncated wedge shape with rounded corners.
Palero, in a same field of endeavor of electrical stimulation, discloses wherein one or more of the electrodes of the array have a triangular shape, a substantially triangular shape with rounded corners, a truncated triangular shape, a substantially truncated triangular shape with rounded corners, a wedge shape, a substantially wedge shape with rounded corners, a truncated wedge shape, or a substantially truncated wedge shape with rounded corners (e.g. paragraph 0030, – triangular electrode).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the transducer of Rainey to include wherein one or more of the electrodes of the array have a triangular shape, as taught and suggested by Palero, because it is a simple substitution of one known electrode shape for another in order to obtain the predictable results of effective electrical stimulation performed on the skin.
Claim 15 is rejected under 35 U.S.C 103 as being unpatentable over Rainey and further in view of Rubinson et al. (US Pub.: 2013/0001090 A1).
Regarding claim 15, Rainey teaches the transducer apparatus of claim 1 as discussed above. However, Rainey does not explicitly teach wherein the electrodes in the array comprise polymer films.
Rubinson, in a same field of endeavor of electrical stimulation, discloses wherein the electrodes in the array comprise polymer films (e.g. paragraphs 0009, 0098).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the transducer of Rainey to incorporate wherein the electrodes in the array comprise polymer films, as taught and suggested by Rubinson, in order to improve/enhance the flexibility of the electrodes as well as to lower electrical impedance (Rubinson, paragraph 0098).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL TEHRANI whose telephone number is (571)270-0697. The examiner can normally be reached 9:00am-5:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Benjamin Klein can be reached at 571-270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/D.T./Examiner, Art Unit 3792
/Benjamin J Klein/Supervisory Patent Examiner, Art Unit 3792