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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 10/13/2025 has been entered.
Response to Amendment
This Office Action is responsive to the amendment filed on 10/13/2025. As directed by the amendment: Claim 1 have been amended, claims 2-5, 10, 12, and 16-75 have been cancelled, and no claims have been added. Thus, claims 1, 6-9, 11, 13-15, and 76-87 are presently under consideration in this application.
Response to Arguments
Applicant’s arguments, see pages 7-12, filed 10/13/2025, with respect to the rejection(s) of the claim(s) under 35 U.S.C. 103 have been fully considered.
Applicant argues on page 9 that
Parker does not disclose or suggest a separate "therapy electrode" that Parker's knitted electrode assembly separates from the tissue. Therefore, the Office Action has not shown, if a person of ordinary skill in the art were to replace Kaib's mesh fabric (415), which the Office Action asserts corresponds to "a mesh interface" of claim 1, with Parker's knitted electrode assembly, why the resulting device would still have a mesh interface forming a part of at least one support pocket, where the support pocket is configured to support at least one therapy electrode with the at least one therapy electrode "physically separated" from a patient's skin. Rather, the Parker structure would become the electrode. The combination thus eliminates the very therapy electrode (135, 140) from Kaib that the at least one support pocket, with the mesh interface forming a part of the at least one support pocket, is supposed to separate. The proposed combination using Parker teaches away from the claimed structure and results in a device that lacks a limitation of independent claim 1.
Examiner agrees because the amendments clarify that the pocket separates the electrode from the skin, rather than the mesh interface.
Applicant then argues on page 11 that
Parker is focused on long- term biocompatibility inside the body, minimizing fibrosis and tissue encapsulation, and withstanding the mechanical stresses of being implanted. The Office Action has not shown why the problems Parker seeks to solve would be relevant to those of Kaib. The Office Action has not shown why a person of ordinary skill in the art working to improve Kaib, an external wearable therapeutic device, would be motivated to look to a long-term implantable device like Parker for its implantable knitted electrode assembly.
Examiner agrees. However, Examiner notes that the “wearable cardiac therapeutic device” is recited as intended use in the preamble as the claims are directed to the garment and makes no relation to the wearable cardiac therapeutic device.
Applicant argues on page 11 that
Oppenheim does not disclose or suggest a support garment for use with a wearable cardiac therapeutic device as specified in independent claim 1. Rather, Oppenheim discloses a "sock or stocking, which is shaped and sized to fit over a foot" for providing "transcutaneous nerve stimulation" to "the tibial nerve to ... relieve the urge to urinate." (Oppenheim, col. 1, lines 5-7, 25-27, and 59-60). A person of ordinary skill in the art would not look to a sock for transcutaneous nerve stimulation when designing a support garment for use with a wearable cardiac therapeutic device as presently claimed.
Examiner disagrees because Oppenheim, although is directed to electrical stimulation of the tibial nerve for overreactive bladder via an electrode on a garment (Abstract and Col. 1 lines 65-66) unlike Kaib which is directed to the defibrillation of the heart using therapy electrodes, solve the same common problem of facilitating the proper fitting of stimulation electrodes on a user for proper/precise positioning of the electrode during stimulation (Col. 2 lines 30-32 and Col. 3 line 23-26).
Lastly, Applicant argues on page 11 that
Oppenheim discloses that their electrodes 26, 28 are formed from electrically conductive yarns, such as yarn 56, which is interknitted with fabric 24 to define electrodes using machinery and methods that are known in the art. Like Parker, Oppenheim does not disclose or suggest a separate "therapy electrode" that Oppenheim's knitted material separates from the tissue. As such, Oppenheim also teaches away from the claimed structure and results in a device that lacks a limitation of independent claim 1. Also, Oppenheim does not disclose at least one support pocket disposed on an inside surface of the support garment, the support pocket being configured to support at least one therapy electrode. Oppenheim's electrodes 26, 28 are interknitted with the fabric 24 without a separate support pocket structure.
Examiner disagrees because Col. 5 lines 37-46 says that the electrode is interknitted with the fabric, and not that the electrodes are formed from the yarn. Furthermore, although the electrode is touching the skin, the electrode is the the electric conductive yarn interknitted with elastic fabric is touching the skin (mesh)(claims 1 and 6 of Oppenheim). Nevertheless, see updated rejection including the “obvious to try” motivation.
Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Kaib et al. (US 20200155826)(Hereinafter Kaib) in view of Oppenheim et al. (US 11103699)(Hereinafter Oppenheim).
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 1, 6-9, 11, 13-15, and 76-87 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 is recites the limitation "the support pocket" in line 4. There is insufficient antecedent basis for this limitation in the claim. Examiner suggests to amend to recite “the at least one support pocket” to fall in line with the scope, specification, and line 3 of claim 1.
Claims 6-9, 11, 13-15, and 76-87 are rejected due to their dependency of independent claim 1.
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 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hill et al. (US 20180243549)(Hereinafter Hill).
Regarding claim 1, Hill teaches A support garment for use with a wearable cardiac therapeutic device (Abstract “A support garment for supporting a patient wearable defibrillator”), the garment comprising:
at least one support pocket disposed on an inside surface of the support garment, the support pocket being configured to support the at least one therapy electrode on the support garment with the at least one therapy electrode physically separated from the patient's skin ([0104] “The inside surface of the back portion support garment 20 includes pocket(s) 25 for receiving one or two therapy electrodes 11 to hold the electrode(s) 11 in position against the patient's back.” The phrase “the support pocket being configured to support the at least one therapy electrode on the support garment with the at least one therapy electrode physically separated from the patient's skin” is intended use. The supporting of the electrode in the pocket and being physically separate from the skin is not actively recited and does not have weight because the pocket (the claimed structure) of [0104] is capable of supporting electrodes, which are also separate from the skin.) wherein the mesh interface forms a part of the at least one support pocket ([0104] “Another pocket 26 made from the same non-elastic, conductive mesh fabric is included on an inside surface of the belt 22 for receiving a therapy electrode 11 and holding the electrode 11 in position against the patient's left side.”)
the mesh interface being configured to transmit therapeutic electrical pulses between the at least one therapy electrode and a patient's skin ([0104] “The material of the pockets 25, 26 may have a metal coating, such as a silver coating, applied thereto to provide electrical conductivity.”” The claim limitation is intended use. Nevertheless, the claimed structure, the mesh, is capable of transmitting pulses.), the mesh interface comprising:
a plurality of dielectric fibers comprising at least one nonmetallic material ([0103] “the support garment 20 may be formed from an elastic, low spring rate material and constructed using tolerances that are considerably closer than those customarily used in garments… The support garment 20 may be formed from one or more blends of nylon, polyester, and spandex fabric material [plurality of dielectric fibers].” [0104] “the back portion support garment 20 includes pocket(s) 25…Another pocket 26 made from the same non-elastic, conductive mesh fabric is included on an inside surface of the belt 22 for receiving a therapy electrode 11 and holding the electrode 11 in position against the patient's left side. According to one example, the pockets 25, 26 are formed from a knit electrically conductive material. The material of the pockets 25, 26 may have a metal coating, such as a silver coating, applied thereto to provide electrical conductivity.” Examiner interprets that the metal coating [particles] disposed thereon the pockets, composed of to the plurality of non-conductive dielectric fibers (blends of nylon, polyester), allows for the interspersing/scattering of the dielectric and conductive fibers.);
and a plurality of conductive fibers or particles interspersed with the plurality of dielectric fibers, the plurality of conductive fibers being configured to form a plurality of conductive pathways extending through the mesh interface ([0103] “the support garment 20 may be formed from an elastic, low spring rate material and constructed using tolerances that are considerably closer than those customarily used in garments… The support garment 20 may be formed from one or more blends of nylon, polyester, and spandex fabric material [plurality of dielectric fibers].” [0104] “the back portion support garment 20 includes pocket(s) 25…Another pocket 26 made from the same non-elastic, conductive mesh fabric is included on an inside surface of the belt 22 for receiving a therapy electrode 11 and holding the electrode 11 in position against the patient's left side. According to one example, the pockets 25, 26 are formed from a knit electrically conductive material. The material of the pockets 25, 26 may have a metal coating, such as a silver coating, applied thereto to provide electrical conductivity.” Examiner interprets that the metal coating [particles] disposed thereon the pockets, composed of to the plurality of non-conductive dielectric fibers (blends of nylon, polyester), allows for the interspersing/scattering of the dielectric and conductive fibers. Examiner further notes the phrase “the plurality of conductive fibers being configured to form a plurality of conductive pathways extending through the mesh interface” is intended use.)
wherein the plurality of conductive pathways are configured to conduct the therapeutic electrical pulses through the mesh interface from the at least one therapy electrode to the patient's skin (0103] “the support garment 20 may be formed from an elastic, low spring rate material and constructed using tolerances that are considerably closer than those customarily used in garments… The support garment 20 may be formed from one or more blends of nylon, polyester, and spandex fabric material [plurality of dielectric fibers].” [0104] “the back portion support garment 20 includes pocket(s) 25…Another pocket 26 made from the same non-elastic, conductive mesh fabric is included on an inside surface of the belt 22 for receiving a therapy electrode 11 and holding the electrode 11 in position against the patient's left side. According to one example, the pockets 25, 26 are formed from a knit electrically conductive material. The material of the pockets 25, 26 may have a metal coating, such as a silver coating, applied thereto to provide electrical conductivity.” Examiner interprets that the metal coating [particles] disposed thereon the pockets, composed of to the plurality of non-conductive dielectric fibers (blends of nylon, polyester), allows for the interspersing/scattering of the dielectric and conductive fibers.).
Claim(s) 1 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Oskin et al. (US 20120146797)(Hereinafter Oskin).
Regarding claim 1, Oskin teaches A support garment for use with a wearable cardiac therapeutic device (Abstract “A wearable therapeutic device is provided. The wearable therapeutic device includes a garment, and the garment includes an electrode and a conductive thread.”), the garment comprising:
at least one support pocket disposed on an inside surface of the support garment, the support pocket being configured to support the at least one therapy electrode on the support garment with the at least one therapy electrode physically separated from the patient's skin ([0006] “The wearable therapeutic device includes at least one electrode in, for example, a pocket of the wearable therapeutic device. When properly positioned, a conductive surface of the electrode can be disposed in the pocket to face the subject, proximate to the subject's skin so that information (e.g., cardiac information) can be sensed or treatment (e.g., a defibrillation shock) can be applied to the subject.” The phrase “the support pocket being configured to support the at least one therapy electrode on the support garment with the at least one therapy electrode physically separated from the patient's skin” is intended use. The supporting of the electrode in the pocket and being physically separate from the skin is not actively recited and does not have weight because the pocket (the claimed structure) of [0006] is capable of supporting electrodes, which are also separate from the skin.) wherein the mesh interface forms a part of the at least one support pocket ([0015] “The pocket can be formed at least in part from a conductive mesh, and instructions can be provided to position a conductive surface of the electrode facing the conductive mesh.”)
the mesh interface being configured to transmit therapeutic electrical pulses between the at least one therapy electrode and a patient's skin ([0039] “the mesh material can be a conductive (e.g., metallic) fabric in a fine grid or mesh pattern included in the lateral side of pocket 160 that is facing the subject. The mesh material can facilitate an electrical connection between sensing electrode 135 or therapy electrode 140 and the subject's skin.” The claim limitation is intended use. Nevertheless, the claimed structure, the mesh, is capable of transmitting pulses.), the mesh interface comprising:
a plurality of dielectric fibers comprising at least one nonmetallic material ([0014] “the electrode can be housed in a pocket of the garment, and the conductive thread can be woven into the pocket.” [0056] “FIG. 3 depicts a portion of garment 105 where pocket 160 includes conductive thread 150 in accordance with an embodiment. With reference to FIG. 3, conductive thread 150 can be sewn into the fabric [dielectric fibers] of lateral side 305 of pocket 160.” [0037] “For example, at least part of pocket 160 can have elastic characteristics [dielectric fibers] so that at least a portion expands to accommodate entry of sensing electrode 135 or therapy electrode 140, and contracts to secure any electrode housed in pocket 160.” Examiner interprets that the sewing of the conductive fibers into the elastic fabric of the pocket garment is considered the mesh, because a mesh means the interlacing of a structure, and when the conductive fibers are stitched onto the elastic pocket garment, that forms a mesh with interspersed fibers between the elastic and conductive thread.);
and a plurality of conductive fibers or particles interspersed with the plurality of dielectric fibers, the plurality of conductive fibers being configured to form a plurality of conductive pathways extending through the mesh interface ([0014] “the electrode can be housed in a pocket of the garment, and the conductive thread can be woven into the pocket.” [0056] “FIG. 3 depicts a portion of garment 105 where pocket 160 includes conductive thread 150 in accordance with an embodiment. With reference to FIG. 3, conductive thread 150 can be sewn into the fabric [dielectric fibers] of lateral side 305 of pocket 160.” [0037] “For example, at least part of pocket 160 can have elastic characteristics [dielectric fibers] so that at least a portion expands to accommodate entry of sensing electrode 135 or therapy electrode 140, and contracts to secure any electrode housed in pocket 160.” Examiner interprets that the sewing of the conductive fibers into the elastic fabric of the pocket garment is considered the mesh, because a mesh means the interlacing of a structure, and when the conductive fibers are stitched onto the elastic pocket garment, that forms a mesh with interspersed fibers between the elastic and conductive thread. Examiner further notes the phrase “the plurality of conductive fibers being configured to form a plurality of conductive pathways extending through the mesh interface” is intended use.)
wherein the plurality of conductive pathways are configured to conduct the therapeutic electrical pulses through the mesh interface from the at least one therapy electrode to the patient's skin ([0039] “the mesh material can be a conductive (e.g., metallic) fabric in a fine grid or mesh pattern included in the lateral side of pocket 160 that is facing the subject. The mesh material can facilitate an electrical connection between sensing electrode 135 or therapy electrode 140 and the subject's skin.”).
Claim(s) 1 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kaib et al. (US 20200155826)(Hereinafter Kaib).
Regarding claim 1, Kaib teaches A support garment for use with a wearable cardiac therapeutic device ([0005] “The wearable therapeutic device includes a garment that can be configured to contain an external defibrillator.”), the garment comprising:
at least one support pocket disposed on an inside surface of the support garment, the support pocket being configured to support the at least one therapy electrode on the support garment with the at least one therapy electrode physically separated from the patient's skin ([0055] “For example, first therapy electrode 135 or second therapy electrode 140 can be housed in a pocket of garment 105, with a surface or side wall of garment 105 between the subject's skin and electrode 135 or electrode 140 having a metallic mesh pattern. The metallic mesh can include silver or other conductive metals to lower impedance between the subject's skin and the conductive surface of electrode 135 or electrode 140.” The phrase “the support pocket being configured to support the at least one therapy electrode on the support garment with the at least one therapy electrode physically separated from the patient's skin” is intended use. The supporting of the electrode in the pocket and being physically separate from the skin is not actively recited and does not have weight because the pocket (the claimed structure) of [0055] is capable of supporting electrodes, which are also separate from the skin.) wherein the mesh interface forms a part of the at least one support pocket ([0055] “For example, first therapy electrode 135 or second therapy electrode 140 can be housed in a pocket of garment 105, with a surface or side wall of garment 105 between the subject's skin and electrode 135 or electrode 140 having a metallic mesh pattern. The metallic mesh can include silver or other conductive metals to lower impedance between the subject's skin and the conductive surface of electrode 135 or electrode 140.”)
the mesh interface being configured to transmit therapeutic electrical pulses between the at least one therapy electrode and a patient's skin ([0053] “In one embodiment, conductive fluid enters the area between conductive surface 405 of electrode 135 or 140 and the subject's skin and forms a conduction path 410 from electrode 135 or 140 to the subject's skin.” [0043] “external defibrillator 115 will apply a shock via at least two electrodes, such as any of first therapy electrodes 135 or second therapy electrodes 140. In one embodiment, first therapy electrode 135 includes at least one front therapy electrode positioned in garment 105 in front (e.g., anterior or about the chest) of the subject, and second therapy electrode 140 includes at least one therapy electrode positioned in garment 105 at the rear (e.g. posterior or about the back) of the subject.” The claim limitation is intended use. Nevertheless, the claimed structure, the mesh, is capable of transmitting pulses.), the mesh interface comprising:
a plurality of dielectric fibers comprising at least one nonmetallic material ([0011] “the first therapy electrode is disposed in a first pocket of the garment and the second therapy electrode is disposed in a second pocket of the garment. The first or second pocket can include conductive thread sewn into the garment.” [0010] “The belt can include an elastic material [plurality of dielectric fibers] configured to hold the receptacle proximate to at least one of the first therapy electrode and the second therapy electrode. The belt can include a breathable fabric [plurality of dielectric fibers]. At least one of the first therapy electrode and the second therapy electrode can include conductive thread sewn into the breathable fabric.” Examiner interprets that the sewing of the conductive fibers into the elastic fabric of the pocket garment is considered the mesh, because a mesh means the interlacing of a structure, and when the conductive fibers are stitched onto the elastic pocket garment, that forms a mesh with interspersed fibers between the elastic and conductive thread.);
and a plurality of conductive fibers or particles interspersed with the plurality of dielectric fibers, the plurality of conductive fibers being configured to form a plurality of conductive pathways extending through the mesh interface ([0011] “the first therapy electrode is disposed in a first pocket of the garment and the second therapy electrode is disposed in a second pocket of the garment. The first or second pocket can include conductive thread sewn into the garment.” [0010] “The belt can include an elastic material [plurality of dielectric fibers] configured to hold the receptacle proximate to at least one of the first therapy electrode and the second therapy electrode. The belt can include a breathable fabric [plurality of dielectric fibers]. At least one of the first therapy electrode and the second therapy electrode can include conductive thread sewn into the breathable fabric.” [0038] “Garment 105 may also include a wicking material (e.g., microfiber, spandex nylon, or spandex polyester) [dielectric fibers] to enhance subject comfort by wicking moisture such as sweat away from the subject, which can provide a cooling effect.” Examiner interprets that the sewing of the conductive fibers into the elastic fabric of the pocket garment is considered the mesh, because a mesh means the interlacing of a structure, and when the conductive fibers are stitched onto the elastic pocket garment, that forms a mesh with interspersed fibers between the elastic and conductive thread. Examiner further notes the phrase “the plurality of conductive fibers being configured to form a plurality of conductive pathways extending through the mesh interface” is intended use.)
wherein the plurality of conductive pathways are configured to conduct the therapeutic electrical pulses through the mesh interface from the at least one therapy electrode to the patient's skin ([0053] “In one embodiment, conductive fluid enters the area between conductive surface 405 of electrode 135 or 140 and the subject's skin and forms a conduction path 410 from electrode 135 or 140 to the subject's skin.” [0043] “external defibrillator 115 will apply a shock via at least two electrodes, such as any of first therapy electrodes 135 or second therapy electrodes 140. In one embodiment, first therapy electrode 135 includes at least one front therapy electrode positioned in garment 105 in front (e.g., anterior or about the chest) of the subject, and second therapy electrode 140 includes at least one therapy electrode positioned in garment 105 at the rear (e.g. posterior or about the back) of the subject.”).
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) 15, and 79-80 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kaib et al. (US 20200155826)(Hereinafter Kaib) in view of Oppenheim et al. (US 11103699)(Hereinafter Oppenheim).
Regarding claim 15, Kaib teaches the invention of claim 1. Kaib does not teach plurality of dielectric fibers of the mesh interface comprises a dielectric yarn and the plurality of conductive fibers or particles of the mesh interface comprises a conductive yarn, and wherein the dielectric yarn and the conductive yarn are intertwined together to form the mesh interface. Oppenheim, although is directed to electrical stimulation of the tibial nerve for overreactive bladder via an electrode on a garment (Abstract and Col. 1 lines 65-66) unlike Kaib which is directed to the defibrillation of the heart using therapy electrodes, solve the same common problem of facilitating the proper fitting of stimulation electrodes on a user for proper/precise positioning of the electrode during stimulation (Col. 2 lines 30-32 and Col. 3 line 23-26), similar to the device of Kaib ([0038], [0043], and [0049]). Oppenheim further teaches wherein the plurality of dielectric fibers of the mesh interface comprises a dielectric yarn and the plurality of conductive fibers or particles of the mesh interface comprises a conductive yarn, and wherein the dielectric yarn and the conductive yarn are intertwined together to form the mesh interface (Fig. 2 and Col. 5 lines 18-24 “the courses of knitted loops of yarn 56 are interlaid with strands of an elastic conductive yarn, which is made of an elastomeric monofilament 60 [dielectric fibers] with an electrically-conductive thread 58 [conductive fibers] crocheted around the monofilament. Monofilament 60 may comprise an elastic polyurethane fiber[nonmetallic material], such as Lycra®, for example, or another polymer or natural rubber thread.”) to allow for a breathable and snugly fit over a user (Col. 3 lines 31-35) and avoid direct metal contact to the skin, thereby preventing charge leaks and allowing a more uniform distribution of stimulation. It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the invention of Kaib, with the plurality of conductive fibers or particles interspersed with the plurality of dielectric fibers, the plurality of conductive fibers being configured to form a plurality of conductive pathways extending through the mesh interface of Oppenheim, because such a modification would allow for a breathable and snugly fit over a user and avoid direct metal contact to the skin, thereby preventing charge leaks and allowing a more uniform distribution of stimulation.
Regarding claim 79, Kaib teaches the invention of claim 1. Kaib does not teach a conductive yarn being a silver-plated nylon yarn. Oppenheim, although is directed to electrical stimulation of the tibial nerve for overreactive bladder via an electrode on a garment (Abstract and Col. 1 lines 65-66) unlike Kaib which is directed to the defibrillation of the heart using therapy electrodes, solve the same common problem of facilitating the proper fitting of stimulation electrodes on a user for proper/precise positioning of the electrode during stimulation (Col. 2 lines 30-32 and Col. 3 line 23-26), similar to the device of Kaib ([0038], [0043], and [0049]). Oppenheim further teaches wherein the conductive yarn comprises silver-plated nylon yarn (Col. 5 lines 7-12 “Yarn 56 typically comprises an elastomer, such as nylon or another suitable polymer, with an electrically conductive coating. This coating may comprise, for example, a metal, such as silver or gold, or a carbon-based conductor, such as graphene.”) to precisely position the electrodes in the proper location (Col. 3 line 23-26). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the invention of Kaib, with the conductive yarn being a silver-plated nylon yarn of Oppenheim, because such a modification would allow to precisely position the electrodes in the proper location.
Regarding claim 80, Kaib teaches the invention of claim 1. Kaib does not teach a nonmetallic material being cotton. Oppenheim, although is directed to electrical stimulation of the tibial nerve for overreactive bladder via an electrode on a garment (Abstract and Col. 1 lines 65-66) unlike Kaib which is directed to the defibrillation of the heart using therapy electrodes, solve the same common problem of facilitating the proper fitting of stimulation electrodes on a user for proper/precise positioning of the electrode during stimulation (Col. 2 lines 30-32 and Col. 3 line 23-26), similar to the device of Kaib ([0038], [0043], and [0049]). Oppenheim further teaches wherein the at least one nonmetallic material comprises nylon or cotton (Col. 4 lines 61-63 “fabric 24 of sock 22 comprises knitted strands of a yarn 50, for example a suitable cotton, wool or synthetic yarn.”) to precisely position the electrodes in the proper location (Col. 3 line 23-26). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the invention of Kaib, with nonmetallic material being cotton of Oppenheim, because such a modification would allow to precisely position the electrodes in the proper location.
Claim(s) 86-87 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kaib et al. (US 20200155826)(Hereinafter Kaib) in view of Oskin et al. (US 10589110)(Hereinafter Oskin).
Regarding claim 86-87, Kaib teaches the invention of claim 1. However, Kaib does not teach the conductive gel dispensed after establishing electrical contact between the mesh and the skin and monitoring proper positioning of electrodes based on an electrical signal from electrodes to the skin. Oskin, in the same field of endeavor, teaches an a wearable garment that holds electrodes for measuring ECG and conductive capabilities (Abstract), similar to the device of Kaib, and further teaches wherein the mesh interface is configured to provide electrical contact between the at least one therapy electrode and the patient's skin before conductive gel is dispensed from the at least one therapy electrode and passes through the mesh interface… further comprising a defibrillation module configured to:
provide an electrical signal that passes from the at least one therapy electrode to the patient's skin through the mesh interface before the conductive gel is dispensed; and
monitor the electrical signal to confirm that the at least one therapy electrode is properly positioned on the patient (Col. 7 lines 27-40 “The mesh material can facilitate an electrical connection between sensing electrode 135 or therapy electrode 140 and the subject's skin…control unit 130 [defibrillation module] detects electrical connections, (e.g., current) between conductive thread 150 and sensing electrode 135 or therapy electrode 140 to determine proper or improper positioning of electrodes 135, 140. In one embodiment, prior to sensing cardiac information or applying therapy, a conductive fluid is released from capsules proximate to the mesh fabric. The capsules may be located in or proximate to pocket 160. The conductive fluid can cover at least part of the mesh fabric and the subject's skin, and a conductive surface of sensing electrode 135 or therapy electrode 140 to reduce impedance.” Examiner notes that the electrical connection must be established with the electrodes, mesh and skin prior to application of gel in order to be able to send the therapeutic shock to the skin.) to cause a more efficient and comfortable application of therapy from therapy electrode (Col. 7 lines 27-40). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the invention of Kaib, with the conductive gel dispensed after establishing electrical contact between the mesh and the skin and monitoring proper positioning of electrodes based on an electrical signal from electrodes to the skin of Oskin, because such a modification would allow to cause a more efficient and comfortable application of therapy from therapy electrode.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kaib et al. (US 20200155826)(Hereinafter Kaib) in view of Mushahwar et al. (US 20150057734)(Hereinafter Mushahwar).
Regarding claim 9, Kaib teaches the invention of claim 1. Kaib teaches the mesh interface being configured to facilitate transfer of conductive gel dispensed from the at least one therapy electrode to the patient's skin via the plurality of openings ([0054] “The conductive silver mesh 800 in FIG. 8 includes a thin and open structure that allows for gel transmission through the mesh prior to a defibrillation procedure”).
However, Kaib do not teach a plurality of openings extending through the mesh interface from a first to a second interface. Mushahwar, in the same field of endeavor, teaches the electrical stimulation using electrodes on a garment ([0036]), similar to the devices of Kaib, and further teaches wherein the mesh interface further comprises a plurality of openings extending through the mesh interface from a first surface of the mesh interface to a second surface of the mesh interface ([0041] “the at least one "opening" portion 14 may be fabricated from non-stretchy material having [plurality of] holes therein (i.e. permeable). For example, the at least one opening portion 14 may comprise thin, non-wrinkling micro mesh or netting” See Fig. 5 that shows the back (first surface) and notes that there is the skin facing surface (second surface).) to minimize electrical stimulation related discomfort and potential injury ([0041]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the invention of Kaib, with the plurality of openings extending through the mesh interface from a first to a second interface of Mushahwar, because such a modification would allow to minimize electrical stimulation related discomfort and potential injury.
Claim(s) 13-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kaib et al. (US 20200155826)(Hereinafter Kaib) in view of HVALSØE et al. (US 20210101006)(Hereinafter HVALSØE).
Regarding claim 13, Kaib teaches the invention of claim 1. However, Kaib does not teach 2-1000 opening per square inch of the mesh interface. HVALSØE, in the same field of endeavor, teaches electrodes used for electrical stimulation, similar to the device of Kaib, and further teaches wherein the mesh interface comprises a plurality of openings, the plurality of openings comprising approximately 2-1000 openings per square inch of the mesh interface ([0057] “a smaller footage could introduce pin lengths and dimple depths shorter than 2 mm without jeopardizing internal structure strength and integrity of the electrode unit. It is foreseen that pin lengths in such applications could be as short as 0.1 mm and still be providing a sufficient grip integrally in the electrode unit…in an embodiment a pin length and/or a dimple depth of at least one pin or dimple is in the range 0.1 mm to 10 mm.” Examiner notes that if the length of an opening is .1 mm, there will have to be a minimum of 2 opening per square inch as the openings are found next to each other in Fig. 7.) to enhancing the integrity of the gel-member ([0057]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the invention of Kaib, with the 2-1000 opening per square inch of the mesh interface of HVALSØE, because such a modification would allow to enhancing the integrity of the gel-member.
Regarding claim 14, Kaib teaches the invention of claim 1. However, Kaib does not teach an opening’s average diameter in a range of approximately 0.005" - 0.3" (0.13 mm - 7.6 mm). HVALSØE, in the same field of endeavor, teaches electrodes used for electrical stimulation, similar to the device of Kaib, and further teaches wherein the mesh interface comprises a plurality of openings having an average diameter in a range of approximately 0.005" - 0.3" (0.13 mm - 7.6 mm) ([0057] “a smaller footage could introduce pin lengths and dimple depths shorter than 2 mm without jeopardizing internal structure strength and integrity of the electrode unit. It is foreseen that pin lengths in such applications could be as short as 0.1 mm and still be providing a sufficient grip integrally in the electrode unit.”) to enhancing the integrity of the gel-member ([0057]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the invention of Kaib, with the opening’s average diameter in a range of approximately 0.005" - 0.3" (0.13 mm - 7.6 mm) of HVALSØE, because such a modification would allow to enhancing the integrity of the gel-member.
Claim(s) 7-8, 11, and 81 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kaib et al. (US 20200155826)(Hereinafter Kaib) in view of Chahine et al. (US 20170056644)(Hereinafter Chahine).
Regarding claim 7, Kaib teaches the invention of claim 1. However, Kaib does not teach the pathway to the mesh interface approximately .01-5 ohms. Chahine, in the same field of endeavor, teaches a garment with electrical pathway with non-conductive and conductive fibers for electrical stimulation (Abstract and [0003]), and further teaches wherein the mesh interface is configured to provide an electrical impedance of the plurality of conductive pathways extending through the mesh interface from a first surface of the mesh interface to a second surface of the mesh interface of approximately 0.01-5 Ω (0163] “A sensor (e.g. one or more segments of the conductive pathway) with various weaknesses is configured to move differently than the fabric attached to the sensor. A solution provides: (A) yarn for wicking; (B) about 0.01 ohms;” Examiner notes the yarn fabric touching the sensor is the first surface and the second surface is the fabric yarn to the skin.) to optimize the resistance of the sensing ([0195]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the invention of Kaib, with the pathway to the mesh interface approximately .01-5 ohms of Chahine, because such a modification would allow to optimize the resistance of the sensing.
Regarding claim 8, Kaib teaches the invention of claim 1. Kaib does not teach the impedance measure of approximately 10-250 Ω /meter. Chahine, in the same field of endeavor, teaches a garment with electrical pathway with non-conductive and conductive fibers for electrical stimulation (Abstract and [0003]), and further teaches wherein the plurality of conductive fibers or particles comprises an impedance measure of approximately 10-250 Ω /meter ([0195] “The electrical heating system can include an electrical resistance wire made of multifilament stainless steel having (for example) about 70 ohms per lineal meter, or any predetermined lineal resistance value, etc.”) to optimize the resistance of the wire ([0195]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the invention of Kaib, with the impedance measure of approximately 10-250 Ω /meter of Chahine, because such a modification would allow to optimize the resistance of the wire.
Regarding claim 11, Kaib teaches the invention of claim 1. Kaib teaches wherein the conductive gel ([0054] “The conductive silver mesh 800 in FIG. 8 includes a thin and open structure that allows for gel transmission through the mesh prior to a defibrillation procedure.”).
However, Kaib does not teach the pathway to the mesh interface approximately .01-5 ohms. Chahine, in the same field of endeavor, teaches a garment with electrical pathway with non-conductive and conductive fibers for electrical stimulation (Abstract and [0003]), and further teaches wherein the mesh interface is configured to provide an electrical impedance of the plurality of conductive pathways extending through the mesh interface from a first surface of the mesh interface to a second surface of the mesh interface of approximately 0.01-5 Ω (0163] “A sensor (e.g. one or more segments of the conductive pathway) with various weaknesses is configured to move differently than the fabric attached to the sensor. A solution provides: (A) yarn for wicking; (B) about 0.01 ohms;” Examiner notes the yarn fabric touching the sensor is the first surface and the second surface is the fabric yarn to the skin.) to optimize the resistance of the sensing ([0195]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the invention of Kaib, with the pathway to the mesh interface approximately .01-5 ohms of Chahine, because such a modification would allow to optimize the resistance of the sensing.
Regarding claim 81, Kaib teaches the invention of claim 1. Kaib does not teach the mesh interface providing improved skin comfort. Chahine, in the same field of endeavor, teaches a garment with electrical pathway with non-conductive and conductive fibers for electrical stimulation (Abstract and [0003]), and further teaches wherein the mesh interface provides improved skin comfort as determined by a Human Skin Irritation Test (ISO 10993-10 C3.3 set forth in Annex C of the ANSI/AAMI/ISO 10993-10:2010) ([0211] “The layer of fabric 1401 in contact with the skin 1402 contains a knitted fabric conductive patch 1406, with no metal contact, for increased comfort of the wearer.”) to increase comfort for the wearer ([0211]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the invention of Kaib, with the mesh interface providing improved skin comfort of Chahine, because such a modification would allow to increase comfort for the wearer.
However, Kaib does not teach the Human Skin Irritation Test (ISO 10993-10 C3.3) standard. Nevertheless, Chahine would use the ISO standard to test for the increased comfort of the wearer. It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the invention of Kaib, with the Human Skin Irritation Test (ISO 10993-10 C3.3) standard, because such a modification would allow to test for the increased comfort of the wearer.
Claim(s) 82 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kaib et al. (US 20200155826)(Hereinafter Kaib) in view of Oppenheim et al. (US 11103699)(Hereinafter Oppenheim), and Mushahwar et al. (US 20150057734)(Hereinafter Mushahwar).
Regarding claim 82, Kaib teaches the invention of claim 1. Kaib does not teach a support pocket for the support of a therapy electrode in which the mesh forms the support structure. Oppenheim, in the same field of endeavor, teaches the electrical stimulation via a garment that is knitted with an electrically conductive yarn, similar to the device of Kaib, and further teaches further comprising a first surface configured to be oriented toward the at least one therapy electrode supported by the support garment, a second surface configured to be oriented toward the patient’s skin of a patient wearing the support garment (Fig. 2 and claim 12 “an elastic knitted fabric, which is shaped and sized as a sock or stocking to fit snugly over a foot of a human subject; at least one electrode, comprising an electrically-conductive yarn interknitted with the elastic knitted fabric in a predefined location so as to make electrical contact with a skin surface of the human subject when the garment is worn on the foot;” Abstract “one electrode, which includes an electrically-conductive yarn interknitted with the elastic knitted fabric in a predefined location so as to make electrical contact with a skin surface” Examiner notes that the first surface is the side of the electrically-conductive yarn touching the electrode and the second surface is the side that the electrically-conductive yarn that touches the skin.) to allow the socks to be laundered without compromising the stimulation circuitry (Col. 4 lines 55-56). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the invention of Kaib, with the support pocket for the support of a therapy electrode in which the mesh forms the support structure of Oppenheim, because such a modification would allow to allow the socks to be laundered without compromising the stimulation circuitry.
However, Kaib in view of Oppenheim do not teach a plurality of openings extending through the mesh interface from a first to a second interface. Mushahwar, in the same field of endeavor, teaches the electrical stimulation using electrodes on a garment ([0036]), similar to the devices of Kaib in view of Oppenheim, and further teaches and a plurality of openings extending through the mesh interface from the first surface to the second surface ([0041] “the at least one "opening" portion 14 may be fabricated from non-stretchy material having [plurality of] holes therein (i.e. permeable). For example, the at least one opening portion 14 may comprise thin, non-wrinkling micro mesh or netting” See Fig. 5 that shows the back (first surface) and notes that there is the skin facing surface (second surface).) to minimize electrical stimulation related discomfort and potential injury ([0041]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the invention of Kaib in view of Oppenheim, with the plurality of openings extending through the mesh interface from a first to a second interface of Mushahwar, because such a modification would allow to minimize electrical stimulation related discomfort and potential injury.
Claim(s) 83 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kaib et al. (US 20200155826)(Hereinafter Kaib) in view of Hayashi et al. (US 20220322987)(Hereinafter Hayashi).
Regarding claim 83, Kaib teaches the invention of claim 1. Kaib do not teach a thickness of the mesh to be approximately 0.005" - 0.5" (0.13 mm - 12.7 mm). Hayashi, in the same field of endeavor, teaches a bioelectrode with a fabric structure and wiring (Abstract), similar to the device of Kaib, and further teaches wherein a thickness of the mesh interface from the first surface to the second surface is approximately 0.005" - 0.5" (0.13 mm - 12.7 mm) ([0249] “A knitted fabric of sheet-like structure containing a conductive fiber was prepared by knitting the covering yarn by a quadruple layer smooth knitting structure with 22 gauges…The knitted fabric had a thickness of 1.2 mm and the size of diameter 35 cm×length 50 cm in a cylindrical shape.”) to provide a compact structure for the electrode to retain moisture ([0110]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the invention of Kaib, with the thickness of the mesh to be approximately 0.005" - 0.5" (0.13 mm - 12.7 mm) of Hayashi, because such a modification would allow to provide a compact structure for the electrode to retain moisture.
Claim(s) 77 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kaib et al. (US 20200155826)(Hereinafter Kaib) in view of Senthilkumar et al. (“Moisture Management in an Active Sportswear: Techniques and Evaluation- A Review Article” The Institution of Engineers (India) 2013, Springer, 07/30/2013)(Hereinafter Senthilkumar).
Regarding claim 77, Kaib teaches the invention of claim 1. Kaib do not teach providing comfort via wicking moisture away from the skin. Senthilkumar, in the same field of endeavor, teaches interwoven fabric worn by a user (Abstract), and further teaches wherein the mesh interface is configured to provide a comfortable feel on the patient's skin and to wick moisture away from the patient's skin (Pg. 63 right col. lines 21-36) to make the wearer feel comfortable (Abstract). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the invention of Kaib, with the providing comfort via wicking moisture away from the skin of Senthilkumar, because such a modification would allow to make the wearer feel comfortable.
Claim(s) 84-85 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kaib et al. (US 20200155826)(Hereinafter Kaib) in view of Shibaoka et al. (US 20070190881)(Hereinafter Shibaoka).
Regarding claim 84, Kaib teaches the invention of claim 1. Kaib do not teach fusible fibers for shrinking in volume relative to the conductive fibers when exposed to heat. Shibaoka, in a similar field of endeavor, teaches the woven and knitted fabric of both conductive and non-conductive fiber (Abstract), that can be used for electrodes ([0009]), and further teaches wherein the plurality of dielectric fibers comprise, at least in part, fusible fibers that are configured to shrink in volume relative to the plurality of conductive fibers or particles when the mesh interface is exposed to heat ([0042] “The woven/knitted fabric of the invention using the above-mentioned core-sheath type composite filament yarn is obtained by fusion by melting the low meting point polyester [shrinking the volume] according to the heating treatment for the woven/knitted fabric.” [0044] “The above-mentioned heating treatment may be carried out at a temperature higher than the melting point of the low melting point component of the sheath of the composite filament yarn by at least 10.degree. C., preferably by at least 15.degree. C. and lower than the melting point of the polyethylene terephthalate [fusible fiber].”) to prevent electric charge of static electricity ([0006]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the invention of Kaib, with the fusible fibers for shrinking in volume relative to the conductive fibers when exposed to heat of Shibaoka, because such a modification would allow to prevent electric charge of static electricity.
Regarding claim 85, Kaib teaches the invention of claim 1. Kaib do not teach fusible fibers for shrinking in volume relative to the conductive fibers when exposed to heat resulting in the plurality of conductive fibers or particles expressing more relative to the plurality of dielectric fibers. Shibaoka, in a similar field of endeavor, teaches the woven and knitted fabric of both conductive and non-conductive fiber (Abstract), that can be used for electrodes ([0009]), and further teaches wherein the fusible fibers are configured to shrink in volume relative to the plurality of conductive fibers or particles when the mesh interface is exposed to heat resulting in the plurality of conductive fibers or particles expressing more relative to the plurality of dielectric fibers ([0045] “Use of those having a low dry thermal shrinkage ratio as then on-conductive fiber doesn't cause extreme shrinkage during weaving and knitting or processing of dyeing etc. and thus suppresses occurrence of blister of the conductive fiber and increases the size stability of the woven/knitted fabric.”) to prevent electric charge of static electricity ([0006]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the invention of Kaib, with the fusible fibers for shrinking in volume relative to the conductive fibers when exposed to heat resulting in the plurality of conductive fibers or particles expressing more relative to the plurality of dielectric fibers of Shibaoka, because such a modification would allow to prevent electric charge of static electricity.
Claim(s) 76 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kaib et al. (US 20200155826)(Hereinafter Kaib) in view of Shibaoka et al. (US 20070190881)(Hereinafter Shibaoka) and Chahine et al. (US 20170056644)(Hereinafter Chahine).
Regarding claim 76, Kaib teaches the invention of claim 1. Kaib does not teach plurality of dielectric fibers and the plurality of conductive fibers in a predetermined ratio. Shibaoka, in a similar field of endeavor, teaches the woven and knitted fabric of both conductive and non-conductive fiber (Abstract), that can be used for electrodes ([0009]), and further teaches wherein the mesh interface comprises the plurality of dielectric fibers and the plurality of conductive fibers in a predetermined ratio configured to provide a comfortable feel on the patient's skin ([0038] “As the above-mentioned core-sheath type composite filament yarn, those which are conventionally used as a core-sheath type fused yarn may be used without any particular limit and since being capable of firmly fixing the above-mentioned conductive fiber in the woven/knitted fabric and excellent in the size stability and morphology retention property at the time of forming a material, those which consist of a polyethylene terephthalate as a core component and a low melting point polyester as a sheath component are preferable.” [0043] “the ratio of the piling number of the above-mentioned core-sheath type composite filament yarn and the piling number of the non-conductive fiber other than the above-mentioned core-sheath type composite filament yarn (the number of core-sheath type composite filament yarn: the number of non-conductive fiber other than the core-sheath type composite filament yarn) is preferably in a range from (10:1) to (1:10).”) to provide comfort for a user. It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the invention of Kaib, with the plurality of dielectric fibers and the plurality of conductive fibers in a predetermined ratio of Shibaoka, because such a modification would allow to provide comfort for a user.
However, Kaib in view of Shibaokoa does not teach the pathway to the mesh interface approximately .01-5 ohms. Chahine, in the same field of endeavor, teaches a garment with electrical pathway with non-conductive and conductive fibers for electrical stimulation (Abstract and [0003]), and further teaches to provide an electrical impedance of the plurality of conductive pathways extending through the mesh interface from a first surface of the mesh interface to a second surface of the mesh interface of approximately 0.01-5 Ω ([0163] “A sensor (e.g. one or more segments of the conductive pathway) with various weaknesses is configured to move differently than the fabric attached to the sensor. A solution provides: (A) yarn for wicking; (B) about 0.01 ohms;”) to optimize the resistance of the sensing ([0195]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the invention of Kaib in view of Shibaoka, with the pathway to the mesh interface approximately .01-5 ohms of Chahine, because such a modification would allow to optimize the resistance of the sensing.
Claim(s) 78 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kaib et al. (US 20200155826)(Hereinafter Kaib) in view Mushahwar et al. (US 20150057734)(Hereinafter Mushahwar), and Chahine et al. (US 20170056644)(Hereinafter Chahine).
Regarding claim 78, Kaib teaches the invention of claim 1. Kaib teaches wherein the mesh interface is configured to be porous to conductive gel ([0052] “when the subject is defibrillated, the conductive fluid of doses 205 reduces impedance between at least one of first therapy electrode 135 and second therapy electrode 140”).
However, Kaib do not teach a plurality of openings extending through the mesh interface from a first to a second interface. Mushahwar, in the same field of endeavor, teaches the electrical stimulation using electrodes on a garment ([0036]), similar to the devices of Kaib, and further teaches dispensed through a plurality of holes in the at least one therapy electrode ([0041] “the at least one "opening" portion 14 may be fabricated from non-stretchy material having [plurality of] holes therein (i.e. permeable). For example, the at least one opening portion 14 may comprise thin, non-wrinkling micro mesh or netting” See Fig. 5 that shows the back (first surface) and notes that there is the skin facing surface (second surface).) to minimize electrical stimulation related discomfort and potential injury ([0041]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the invention of Kaib, with the plurality of openings extending through the mesh interface from a first to a second interface of Mushahwar, because such a modification would allow to minimize electrical stimulation related discomfort and potential injury.
However, Kaib in view of Mushahwar does not teach the pathway to the mesh interface approximately .01-5 ohms. Chahine, in the same field of endeavor, teaches a garment with electrical pathway with non-conductive and conductive fibers for electrical stimulation (Abstract and [0003]), and further teaches to provide a predetermined electrical impendence of the plurality of conductive pathways extending through the mesh interface from a first surface of the mesh interface to a second surface of the mesh interface of approximately 0.01-5 Ω (0163] “A sensor (e.g. one or more segments of the conductive pathway) with various weaknesses is configured to move differently than the fabric attached to the sensor. A solution provides: (A) yarn for wicking; (B) about 0.01 ohms;” Examiner notes the yarn fabric touching the sensor is the first surface and the second surface is the fabric yarn to the skin.) to optimize the resistance of the sensing ([0195]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the invention of Kaib in view of Mushahwar, with the pathway to the mesh interface approximately .01-5 ohms of Chahine, because such a modification would allow to optimize the resistance of the sensing.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kaib et al. (US 20200155826)(Hereinafter Kaib) in view of Kaib et al. (US 20110288605)(Hereinafter Kaib2).
Regarding claim 6, Kaib teaches the invention of claim 1. Kaib does not teach a fall off signal to determine the electrode being correctly positioned on the body. Kaib2, in the same field of endeavor, teaches an ambulatory medical device with electrodes for monitoring ECG (Abstract), similar to the device of Kaib, and further teaches wherein the mesh interface is configured to transmit a falloff signal from the at least one therapy electrode to the patient's skin configured to determine that the at least one therapy electrode is correctly positioned on the patient's body ([0104] “FIG. 6 illustrates a noise/fall-off detection process that may be executed by the at least one processor 410 of the control unit 30 (FIG. 4) in accordance with an aspect of the present invention to improve the quality of monitoring and analysis of ECG signals and/or to reduce the number of fall-off alarms. In act 610 the at least one processor monitors and analyzes selected ECG signals from different pairings of ECG sensing electrodes… In act 620, the at least one processor makes a determination as to whether there is noise in the ECG signal of a selected pairing of ECG sensing electrodes, or whether there has been a fall-off or at least partial loss of contact with the body of the patient by a selected pairing of ECG sensing electrodes.”) to determine a loss of contact with the body ([0104]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the invention of Kaib, with the fall off signal to determine the electrode being correctly positioned on the body of Kaib2, because such a modification would allow to determine a loss of contact with the body.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Tsukada et al. (“Validation of wearable textile electrodes for ECG monitoring” Heart Vessels. 2019 Jan 24;34(7):1203–1211. doi: 10.1007/s00380-019-01347-8)
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MOUSSA M HADDAD whose telephone number is (571)272-6341. The examiner can normally be reached M-TH 8:00-6:00.
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/MOUSSA HADDAD/Examiner, Art Unit 3796
/Jennifer Pitrak McDonald/Supervisory Patent Examiner, Art Unit 3796