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 with traverse of Species A in the reply filed on 07/21/2026 is acknowledged. The traversal is on the ground(s) that there is no increased search burden by including species B in the search. This is not found persuasive because Species B discloses an additional strap that , from the first and second electrode array subassemblies.
The requirement is still deemed proper and is therefore made FINAL.
Claim Objections
Claims 1 objected to because of the following informalities:
Claim 1, line 2 reads “first and second electrode” should read “a first and a second electrode”.
Claim 8, line 4 reads “hook material” should read “a hook material”.
Claim 8, line 4 reads “loop material” should read “a loop material”.
Claim 14, line 6 reads “subassemblies ; and” should read “subassemblies; and”.
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 3-5 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 3 recites the “flexible coupling” with a limitation of providing “a fixed, non-adjustable spacing”. The claim is indefinite because it is unclear of how the recited spacing remains fixed despite having a coupling that is flexible.
Dependent claims 4-5 inherit the same discrepancies.
Claim 5 recites the limitation "same target" in line 4. There is insufficient antecedent basis for this limitation in the claim.
The term “about” in claims 10 and 21 is a relative term which renders the claims indefinite. The term “about” is not defined by the claims, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The specification does not disclose what value "about" is. Accordingly, the scope of the claim.
Claim 18 recites the limitation "second electrode assembly" in line 1. There is insufficient antecedent basis for this limitation in the claim.
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.
Claims 1, 3, 6-7, 11-14, 16-18, and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Burnes et al. (US 20080154110 A1), hereinafter Burnes.
Regarding claim 1, Burnes teaches an electrode array assembly (Fig. 1, element 100 – sensory array apparatus) comprising:
first and second electrode array subassemblies (see Fig. 1 below), each of the first and second electrode array subassemblies comprising at least one electrode (Fig. 1, elements E9 and E10); and
a flexible coupling extending between, and coupled to, the first and second electrode array subassemblies (Fig. 1, element 202 – flexible substrate), wherein the flexible coupling provides a spacing, measured along a surface of the electrode array assembly, between the first and second electrode array subassemblies (see Fig. 1 below).
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Fig. 1 (from Burnes)
Regarding claim 3, Burnes teaches the electrode array assembly of claim 1, wherein the flexible coupling provides a fixed, non-adjustable spacing (see Fig. 1 above), measured along the surface of the electrode array assembly, between the first and second electrode array subassemblies (para. 0027 (Electrodes E1-E10 are each a predetermined distance relative to central axis "x"), 0038 (Flexible substrate 202 may also be formed with multiple materials with or without elongation… sections without elongation properties would maintain in a fixed relationship to each other)).
Regarding claim 6, Burnes teaches the electrode array assembly of claim 1, wherein the flexible coupling (Fig. 1, element 202 – flexible substrate) permits adjustment of the spacing (Fig. 2A, element 240 – elongation zone), measured along the surface of the electrode array assembly, between the first and second electrode array subassemblies (para. 0038 (Creation of elongation zones would enable some portions of flexible substrate 202 to stretch)).
Regarding claim 7, Burnes teaches the electrode array assembly of claim 6, and the flexible coupling (Fig. 1, element 202 – flexible substrate) comprising an adjustable strap (para. 0038 (elongation zones 240 of flexible substrate 202 may be, for example, a continuous serpentine pattern and/or stretchable cloth-based material suitable for expansion/retraction upon application of flexible substrate 202 to the patient to accommodate body types of varying size/height)).
Regarding claim 11, Burnes teaches the electrode array assembly of claim 1, further comprising at least one additional strap extending between the first and second electrode array subassemblies (Fig. 3, element 228 – fastener straps).
Regarding claim 12, Burnes teaches the electrode array subassembly of claim 11, wherein the at least one additional strap is coupled to the first and second electrode array subassemblies (Fig. 3, element 228 – fastener straps).
Regarding claim 13, Burnes teaches the electrode array subassembly of claim 11, wherein the at least one additional strap (Fig. 3, element 228 – fastener straps) is configured to compressively retain the first and second electrode array subassemblies against the patient (para. (0036 (Clips 236 are configured to permit securing and unsecuring of fastener straps 228 and thus, flexible substrate 202 to the patient)).
Regarding claim 14, Burnes teaches a system (Fig. 1, element 100 – sensory array apparatus) comprising:
a plurality of electrode array assemblies including at least a first electrode assembly and a second electrode assembly (see Fig. 2 below),
each of the plurality of electrode array assemblies comprising at least a first electrode array subassembly and a second electrode array subassembly (see Fig. 2 below) and a flexible coupling extending between, and coupled to, the first and second electrode array subassemblies (Fig. 1, element 202 – flexible substrate); and
at least one additional strap extending between the first electrode array subassembly of the first electrode assembly and the first electrode array subassembly of the second electrode assembly (Fig. 3, element 228 – fastener straps);
wherein each of the first and second electrode array subassemblies comprises at least one electrode (Fig. 1, elements E9 and E10); and
wherein the flexible coupling provides a spacing, measured along a surface of the electrode array assembly, between the first and second electrode array subassemblies (see Fig. 2 below).
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Fig. 2 (from Burnes)
Regarding claim 16, Burnes teaches a method (Fig. 2A – sensor array apparatus applied to the torso of the patient) comprising:
positioning, on a body of a patient, an electrode array assembly (Fig. 1, element 100 – sensor array apparatus, abstract (sensor array apparatus for monitoring medical signals includes a flexible substrate adapted for positioning relative to the torso of a patient), para. (0009 (sensor array apparatus is adapted to conform to body types of various sizes, and, preferably, at least partially spans a body portion, e.g., the torso of the subject)) comprising:
a plurality of electrode array subassemblies, the plurality of electrode array subassemblies comprising at least a first electrode array subassembly and a second electrode array subassembly (para. 0021 (Medical electrodes of sensor array apparatus 100 are configured to be in contact with the torso of the patient), see Fig. 3 below),
wherein each electrode array subassembly of the plurality of electrode array subassemblies comprises at least one electrode (Fig. 1, para. 0022 (sensor array apparatus 100 includes flexible substrate 202, medical electrodes E1-E10 disposed on the substrate 202)); and
a flexible coupling extending between, and coupled to, the first and second electrode array subassemblies (Fig. 1, element 202 – flexible substrate), wherein the flexible coupling provides a spacing, measured along a surface of the electrode array assembly, between the first and second electrode array subassemblies (see Fig. 3 below).
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Fig. 3 (from Burnes)
Regarding claim 17, Burnes teaches the method of claim 16, wherein positioning the electrode array assembly comprises:
applying the first electrode array subassembly on a first location of the body of the patient (see Fig. 4 below); and
applying the second electrode array subassembly on a second location of the body of the patient that is spaced along the surface of the body by the spacing, measured along the surface of the electrode array assembly, between the first and second electrode subassemblies (see Fig. 4 below, para. 0021 (electrodes of sensor array apparatus 100 are configured to be in contact with the torso of the patient), 0035 (flexible substrate 202 is applied to the torso of a human subject)).
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Fig. 4 (from Burnes)
Regarding claim 18, Burnes teaches the method of claim 17, wherein, upon applying the second electrode assembly, the flexible coupling (Fig. 1, element 202 – flexible substrate) contacts the body of the patient along substantially an entire length of the flexible coupling (para. 0038 (Flexible substrate 202 may also be formed with multiple materials with or without elongation… sections without elongation properties would maintain in a fixed relationship to each other), the flexible substrate without elongation properties allows the entire length of the flexible coupling to provide a spacing, thus allowing the placement of the second electrode subassembly).
Regarding claim 20, Burnes teaches the method of claim 16, wherein the flexible coupling (Fig. 1, element 202 – flexible substrate) comprises an adjustable strap (Fig. 2, element 240 – elongation zone), the method further comprising adjusting a length of the adjustable strap (para. 0038 (elongation zones 240 of flexible substrate 202 may be, for example, a continuous serpentine pattern and/or stretchable cloth-based material suitable for expansion/retraction upon application of flexible substrate 202 to the patient to accommodate body types of varying size/height)).
Claim Rejections - 35 USC § 103
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 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 2, 8, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Burnes and in further view of Freeman (US 20220370788 A1).
Regarding claim 2, Burnes teaches the electrode array assembly of claim 1. Burnes does not teach wherein the at least one electrode of each of the first and second electrode array subassemblies comprises a plurality of electrodes.
Freeman teaches wherein the at least one electrode of each of the first and second electrode array subassemblies (Fig. 2A, element 102 – first assembly, Fig. 2A, element 107 – second assembly comprises a plurality of electrodes (Fig. 2A, element 110 – therapy electrode, Fig. 2C, element 110 – therapy electrode, para. 0091 (a plurality of therapy electrodes and/or a plurality of ECG sensing electrodes can be integrated with the pad)).
Burnes and Freeman are considered to be analogous to the claimed invention because they are in the same field of wearable garments comprising electrodes. 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 Burnes to incorporate the teachings of Freeman listed above and provide a plurality of electrodes. Doing so would allow more electrodes to sense ECG signals within the same target, to enhance the signal generated.
Regarding claim 8, Burnes teaches the electrode array assembly of claim 7, and the flexible coupling (Fig. 1, element 202 – flexible substrate).
Burnes does not teach the flexible coupling comprising at least one of: an adjustable slide strap adjuster; or hook material on a first portion of the flexible coupling and loop material on a second portion of the flexible coupling.
Freeman teaches an adjustable slide strap adjuster; or hook material on a first portion of the flexible coupling and loop material on a second portion of the flexible coupling (Fig. 6B, element 52 – closure mechanism, para. 0136 (53 comprises a closure mechanism including at least one of a ratchet strap, an adjustable buckle, an extendable and moveable hook and loop fastener strip)).
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 Burnes to incorporate the teachings of Freeman listed above and provide a flexible coupling comprising an adjustable slide strap adjuster. Doing so would allow adjustment of the electrode subassemblies to be within a specified target of a patient.
Regarding claim 15, Burnes teaches the system of claim 14 and the at least one additional strap (Fig. 3, element 228 – fastener straps) extends compressively around a patient and retains at least the first electrode array subassembly of the first electrode assembly and the first electrode array subassembly of the second electrode array assembly against the patient (para. (0036 (Clips 236 are configured to permit securing and unsecuring of fastener straps 228 and thus, flexible substrate 202 to the patient)).
Burnes does not teach wherein the additional strap extends compressively around a torso of a patient.
Freeman teaches an additional strap extends compressively around a torso of a patient (Fig. 9, element 945 – auxiliary strap) and retains at least the first electrode array subassembly of the first electrode assembly and the first electrode array subassembly of the second electrode assembly against the torso of the patient (para. 0154 (removable garment 953 can include an auxiliary strap 945… configured to prevent the removable garment 953 from shifting and/or rotating)).
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 Burnes’ additional strap to incorporate the teachings of Freeman listed above and provide an additional strap to retain the electrode subassemblies against the patient. Doing so ensures that the subassemblies do not shift or rotate while the patient is wearing them.
Claims 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over Burnes and in further view of Hill et al. (US 20180243549 A1), hereinafter Hill.
Regarding claims 4 and 5, Burnes teaches the electrode array assembly of claim 3, and the fixed, non-adjustable spacing (para. 0038 (Flexible substrate 202 may also be formed with multiple materials with or without elongation… sections without elongation properties would maintain in a fixed relationship to each other)) that positions the first and second electrode array subassemblies over a first and second target location in or on the patient or over opposite sides of the same target location in or on the patient (see Fig. 4 above)
Burnes does not teach wherein the fixed, non-adjustable spacing is a patient-specific spacing.
Hill teaches a patient-specific garment (para. 0190 (support garment 190 is advantageous because it provide for a customized garment for all patients made from standardized components and allows for the breast support structure to be fully integrated with the components for attaching the electrode assembly 10 to the garment)).
Burnes and Hill are considered to be analogous to the claimed invention because they are in the same field of wearable garments comprising electrodes. 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 Burnes to incorporate the teachings of Hill listed above and provide a patient-specific spacing. Burnes teaches a fixed non-adjustable spacing between the first and second electrode subassemblies, and a template that allows for electrode placement location on a patient’s skin (Burnes para. 0038, 0024, 0027). Burnes does not disclose a patient-specific spacing. Hill teaches a customizable wearable garment that includes electrode arrays to be worn on a patient. Therefore, incorporating Hill’s teaching listed above would allow Burnes’ device to be customizable, allowing the spacing to accommodate the patient. Doing so would ensure that the electrode subassemblies are in the correct placement for all patients.
Claims 9 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Burnes and in further view of Freeman et al. (US 20200101278 A1), hereinafter Freeman ‘20.
Regarding claim 9, Burnes teaches the electrode array assembly of claim 1, and the flexible coupling (Fig. 1, element 202 – flexible substrate).
Burnes does not teach wherein the flexible coupling has a length that permits simultaneous positioning of the first electrode array subassembly on a front portion of a torso of a patient and the second electrode array subassembly on a back portion of the torso of the patient.
Freeman ‘20 teaches a flexible coupling (Fig. 13A, element 806 – harness) has a length that permits simultaneous positioning of the first electrode array subassembly on a front portion of a torso of a patient and the second electrode array subassembly on a back portion of the torso of the patient (Fig. 13A, para. 0200 (a garment 805 integrated with the anterior and posterior adhesively coupled pads at least in part traces a path from the anterior adhesively coupled pad 807 coupled to an upper anterior region of the torso 5, over the shoulder of the patient, and terminates at a posterior region of the torso 5 at the posterior adhesively coupled pad 802)).
Burnes and Freeman ‘20 are considered to be analogous to the claimed invention because they are in the same field of wearable garments comprising electrodes. 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 Burnes to incorporate the teachings of Freeman ’20 listed above and provide a flexible coupling that permits positioning of the electrode subassemblies on the front and back of the patient’s torso. Doing so ensures that the flexible coupling has the length to apply electrode subassemblies to targets needed across the front and back of the torso for therapy.
Regarding claim 19, Burnes teaches the method of claim 17. Burnes does not teach wherein the first location is on a front of a torso of the body of the patient, and wherein the second location is on a back of the torso of the body of the patient.
Freeman ’20 teaches wherein the first location is on a front of a torso of the body of the patient, and wherein the second location is on a back of the torso of the body of the patient (Fig. 13A, para. 0200 (a garment 805 integrated with the anterior and posterior adhesively coupled pads at least in part traces a path from the anterior adhesively coupled pad 807 coupled to an upper anterior region of the torso 5, over the shoulder of the patient, and terminates at a posterior region of the torso 5 at the posterior adhesively coupled pad 802)).
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 Burnes to incorporate the teachings of Freeman ’20 listed above and provide a first location on the front of the torso and a second location on the back of the torso. Doing so allows the electrode subassemblies to be applied to targets needed across the front and back of the torso for therapy.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Burnes.
Regarding claim 10, Burnes teaches the electrode array assembly of claim 1, and the spacing measured along the surface of the electrode array assembly (see Fig. 1 above).
Although Burnes does not teach the spacing between the first and second electrode array subassemblies is from about 0.05 m to about 1.5 m, a person of ordinary skill in the art would have been motivated to have a spacing between the specified range, to ensure that the first and second electrode subassemblies are able to extend to the proper electrode placements on a patient. Doing so enhances the versatility of the device, by allowing patients with varying size/height to use the device.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Burnes and in further view of Palti (US 20060149341 A1).
Regarding claim 21, Burnes teaches the method of claim 16, and the at least one electrode of the first electrode array subassembly and the at least one electrode (Fig. 1, elements E9 and E10) of the second electrode array subassembly (see Fig. 3 above).
Burnes does not teach the method further comprising applying an electric field between the first electrode array subassembly and the second electrode array subassembly, wherein applying the electric field comprises applying an alternating electric field having an alternating current waveform at frequencies in a range from about 50 kHz to about 1 MHz.
Palti teaches applying an electric field between electrodes, wherein applying the electric field comprises applying an alternating electric field having an alternating current waveform at frequencies in a range from about 50 kHz to about 1 MHz (para. 0012 (alternating fields of medium frequencies (about 50 kHz-1 MHz), which were traditionally assumed not to have any biological effect except due to heating, can be applied to a conductive medium, such as a human body, via insulated electrodes)).
Burnes and Palti are considered to be analogous to the claimed invention because they are in the same field of applying electrodes to patients for therapy. 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 Burnes’ electrodes to incorporate the teachings of Palti listed above and provide an electric field. Although Burnes teaches at least one electrode of the electrode subassemblies, the electrodes are for sensing ECG signals. Palti teaches electrodes that provide alternating electric fields. Modifying electrodes is common in the art of applying therapies to patients. Incorporating Palti’s electric field into Burnes’ electrodes would improve the device’s versatility, by allowing the electrodes to sense ECG signals, as well as providing electric fields for therapy to the patient.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EILEEN ROBLES whose telephone number is (571)429-9383. The examiner can normally be reached Monday-Friday: 8:00 - 5:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Niketa Patel can be reached at (571) 272-4156. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/EILEEN ROBLES/Examiner, Art Unit 3792
/William J Levicky/Primary Examiner, Art Unit 3796
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