DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
Applicant’s arguments filed 2/4/2026 have been considered but are moot in view of the new ground(s) of rejection as necessitated by the applicant’s claim amendments. The phrase “elongate” was only used for the markings in original claim 11. Now that “elongate” is being used for the slots, that changes the scope allowing the examiner to make this action final.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1, 7-8, 10, 18, 21, 23-26 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Voegele et al. (Pub. No.: US 2013/0304175 A1); hereinafter referred to as “Voegele”.
Regarding claims 1 and 18, Voegele discloses a system comprising: an electrode array comprising a plurality of electrodes (e.g. see [0055]-[0058], “electrodes”), wherein the electrode array defines at least one elongated slot therethrough (e.g. see [0074]. Note: [0074] states “A corresponding number of reference location transparent windows, keyholes, openings or cutouts are provided in the transdermal electrical stimulation patch so that when properly aligned over the body the markings or tattooed indicia are visible therethrough confirming its correct placement on the body”. “Windows” and “keyholes” both may be interpreted as “elongated slots”); and a marker (e.g. see [0073]-[0074], “markings or tattooed indicia”) configured to be associated with skin of a patient for indicating a location on the skin for positioning the electrode array, wherein the marker comprises a visible marker that is configured to be visible through the at least one elongated slot when the electrode array is in the location on the skin for positioning the electrode array (e.g. see [0073]-[0074]).
Regarding claim 7, Voegele discloses the visible marker comprises a temporary tattoo (e.g. see [0073]. Note: [0073] discloses “The ink or dye may be permanent or temporary. In the case of a temporary ink or dye the timing of its disappearance may be coordinated with the timing of a follow-up visit to a physician or technician”)
Regarding claim 8, Voegele discloses the visible marker further comprises indications of at least a portion of a perimeter of the electrode array (e.g. see [0073]. Note: The “markings or tattooed indicia” indicate electrode positioning which will include the perimeters of the electrodes).
Regarding claims 10 and 21, Voegele discloses the at least one elongated slot comprises a plurality of elongated slots therethrough (e.g. see [0074]. Note: “Windows” and “keyholes” both may be interpreted as “elongated slots”), wherein the at least one visible marker comprises a plurality of visible markers (e.g. see [0073]-[0074], “markings or tattooed indicia”) that are visible through respective elongated slots of the plurality of elongated slots when the electrode array is in the location on the skin for positioning the electrode array (e.g. see [0073]-[0074]).
Regarding claim 23, Voegele discloses the plurality of elongated slots (e.g. see [0074]. Note: “Windows” and “keyholes” both may be interpreted as “elongated slots”) are configured to be aligned with the plurality of visible markers in only a single orientation of the electrode array relative to the plurality of visible markings (e.g. see figure 6 element 605, [0073], [0074]. Note: The location of the openings 605 in figure 6 will only allow a “single orientation”).
Regarding claim 24, Voegele discloses the plurality of elongated slots (e.g. see [0074]. Note: “Windows” and “keyholes” both may be interpreted as “elongated slots”) comprises a first slot having a first length and a second slot having a second length that is longer than the first length (e.g. see figure 6 element 605, [0073], [0074]. Note: [0074] states “A corresponding number of reference location transparent windows, keyholes, openings or cutouts are provided in the transdermal electrical stimulation patch so that when properly aligned over the body the markings or tattooed indicia are visible therethrough confirming its correct placement on the body”. “Windows” will have sides with different lengths. Also, the openings 605 in figure 6 have different lengths).
Regarding claim 25, Voegele discloses a first slot of the at least one slot has a pair of parallel edges (e.g. see figure 6 element 605, [0073], [0074]. Note: [0074] states “A corresponding number of reference location transparent windows, keyholes, openings or cutouts are provided in the transdermal electrical stimulation patch so that when properly aligned over the body the markings or tattooed indicia are visible therethrough confirming its correct placement on the body”. “Windows” have a “pair of parallel edges”).
Regarding claim 26, Voegele discloses the electrode array comprises a first electrode and a second electrode spaced along a first axis (e.g. see figure 15B, 15C, 15E, element 1515, [0057]).
Claim(s) 16 and 27-29 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wahlgren et al. (Pub. No.: US 2008/0147146 A1); hereinafter referred to as “Wahlgren”.
Regarding claim 16, Wahlgren discloses a system comprising: an electrode array (e.g. see figure 1 element 18, [0034]) comprising: a plurality of electrodes (e.g. see figure 1 elements 2, [0033]); a marker sensor (e.g. see figure 9 element 32, [0047]. Note: “central cutout”, element 32, is “configured to detect proximity of or alignment with a marker”) that is configured to detect proximity of or alignment with a marker; and an indicator (e.g. see figure 9 element 28, [0049]. Note: “patch magnets”, element 28 is configured to “cause an indication upon the marker sensor being in proximity of or alignment with the marker”) in communication with the marker sensor, wherein the indicator is configured to cause an indication upon the marker sensor being in proximity of or alignment with the marker, wherein the indicator comprises a haptic indicator (e.g. see figure 9 element 28, [0049]. Note: “patch magnets”, element 28 will provide haptic indication when the magnet attaches).
Regarding claim 27, Wahlgren discloses the marker (e.g. see figure 9 element 31, [0049]), wherein the marker is configured to be associated with skin of a patient for indicating a location on the skin for positioning the electrode array (e.g. see figure 9 element 31, [0049]).
Regarding claim 28, Wahlgren discloses the marker is configured to be implanted under the skin of the patient (e.g. see figure 9 element 31, [0049]).
Regarding claim 29, Wahlgren discloses the marker comprises a material that is configured to guide an electric field (e.g. see figure 9 element 31, [0049]. Note: Magnets are “a material configured to guide an electric field”).
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.
Claim(s) 12-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Voegele in view of Dar et al. (Pub. No.: US 2017/0296121 A1); hereinafter referred to as “Dar”.
Regarding claims 12-14, Voegele discloses the claimed invention except for the electrode array comprises an orientation sensor that is configured to detect an orientation of the electrode array, the orientation sensor is in communication with an orientation indicator, wherein the orientation indicator is configured to cause an indication upon the sensor being in a proper orientation, and the orientation indicator is coupled to the electrode array. Dar teaches that it is known to use such a modification as set forth in [0256] to provide an indication for proper placement of the device (e.g. see [0256]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to use an orientation sensor as taught by Dar in the system/method of Voegele, since said modification would provide the predictable results of an indication for proper placement of the device.
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Voegele and Dar as applied to claims 12 and 13 above, and further in view of Keller et al. (Pub. No.: US 2017/0106189 A1); hereinafter referred to as “Keller”.
Regarding claim 15, Voegele and Dar discloses the claimed invention except for the orientation indicator is associated with a device that is separate from the electrode array. Keller teaches that it is known to use such a modification as set forth in [0050]-[0051] to provide an orientation sensor that can be at a different location than the stimulator. It would have been obvious to one having ordinary skill in the art at the time the invention was made to use a separate, discrete orientation sensor as taught by Keller in the system/method of Voegele and Dar, since it has been held that simple substitution of one known element for another to obtain predictable results involves only routing skill in the art (per KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007)).
Claim(s) 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Voegele in view of Basser (Pub. No.: US 2017/0014637 A1).
Regarding claim 22, Voegele discloses the claimed invention but is silent as to generating tumor treating fields having alternating electric fields at frequencies between 50 kHz and 1 MHz through a target region. Basser teaches that it is known to use such a modification as set forth in [0004]-[0006] to provide moderate frequency electric fields or tumor treating fields (TTFs) sufficient to interfere with mitosis or possibly other cellular and extracellular processes that allow cancer cells to divide and grow (e.g. see [0026]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to use tumor treating fields as taught by Basser in the system/method of Voegele, since said modification would provide the predictable results of moderate frequency electric fields or tumor treating fields (TTFs) sufficient to interfere with mitosis or possibly other cellular and extracellular processes that allow cancer cells to divide and grow.
Claim(s) 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wahlgren in view of Schmidt et al. (Pub. No.: US 2019/0117972 A1); hereinafter referred to as “Schmidt”.
Regarding claim 30, Wahlgren discloses the invention but is silent as to the material of the marker that is configured to guide the electric field is a dielectric material. Schmidt teaches it is known to use such a modification as set forth in [0122]-[0125] (e.g. see [0123] for the dielectric material to provide electric field shaping into many 3-dimensional configurations (e.g. see [0125]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to use a dielectric material to guide the electric field as taught by Schmidt in the system/method of Wahlgren, since said modification would provide the predictable results of electric field shaping into many 3-dimensional configurations.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/P.C.E/Examiner, Art Unit 3792
/UNSU JUNG/Supervisory Patent Examiner, Art Unit 3792
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