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 Amendment
This Office Action is responsive to the amendment filed on 12/01/2025. As directed by the amendment: Claims 1-20 have been amended, no claims have been cancelled, and no claims have been added. Thus, claims 1-20 are presently under consideration in this application.
Response to Arguments
Applicant’s arguments, see pages 6-10, filed 12/01/2025, 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 “Meeker fails to disclose, teach, or suggest a change in the shape of pillow structure (between the first shape to the second shape) in response to the application of non-zero pressure, to provide patient compliance, as recited in amended claim 1. Thus, Meeker fails to disclose, teach, or suggest at least the features "the pillow structure is configured to provide patient compliance with the WCD system, wherein to provide the patient compliance, the pillow structure is flexible to acquire a first shape when the electrode assembly is subjected to the nonzero pressure, and a second shape different from the first shape when the electrode is deposited on a flat level surface and the pillow structure is not being subjected to the nonzero pressure," as recited in claim 1.”
Examiner disagrees. Providing patient compliance and changing shape of a pillow structure is intended use. Applicant fails to claim the actual material and structure of the pillow structure. Nevertheless, Meeker shows the change in shape in [0057] and Figs. 5B/C.
Nevertheless, the amendments obviate the rejection of record. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Groteke (US 20140083434)(Hereinafter Groteke) in view of Meeker (US2015/0283391)(Hereinafter Meeker).
Regarding the Provisional Nonstatutory Obviousness Double Patenting rejection, filed 12/01/2025, since the applicant has noted that the rejection will be held in abeyance until identified patentable matter. The rejection is maintained for the reasons of record.
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) 1,6,8-11,16 and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Groteke (US 20140083434)(Hereinafter Groteke) in view of Meeker (US2015/0283391)(Hereinafter Meeker), Foch (US 20130254999), and Keusch et al. (US 4777954)(Hereinafter Keusch).
Regarding claims 1 and 11, Groteke teaches An electrode assembly configured for use with a Wearable Cardiac Defibrillator (WCD) system (Abstract “An apparatus for electrical stimulation therapy comprising a garment and a plurality of electrode pads associated with the garment” [0060] “key aspects of the conductive electrical garment [support structure] disclosed herein are the covering containing a grid of eyelet holes, resistive (preferably orthopedic) pillow/bedding material, and force of gravity to ensure a clean pad-to-skin contact. The covering may be adapted to any pillow, bedding, or other orthopedic cushion, and may offer substantial versatility in electrode pad placement by way of a grid of eyelet holes” Examiner notes that the electrode pads is compatible to be used with a WCD, as the components of the WCD (including the structural support being the garment) are found in Groteke.), the WCD system including a support structure configured to exert nonzero pressure to a body of a patient while worn by the patient, an electronics module, and a signal conductor having a first end terminating in a first electro-mechanical connector and a second end configured to be coupled to the electronics module (Fig. 11 see 1101 element that connects the first electro-mechanical connector connects to the wires that is connected to the electronics module 1116 via the second end (touching the electronics module), in which a user can wear the garment [support structure] (thereby applying nonzero pressure when worn.), the electrode assembly comprising:
an electrode configured to be communicatively coupled to the electronics module (Fig. 3 see electrode 302 connected, via wire 303, to the electronics module 304 (TENS unit).);
a pillow structure coupled to the electrode and placed between the electrode and the first electro-mechanical connector ([0057] “Element 1101 shows the eyelets (101 in FIG. 1), which may still be evenly spaced throughout the alternate covering so that the interface/electrode wires (element 1103) located below the bladders 1115 may pass through and connect with the electrode pads (element 1102), which may be located above the bladders [pillow structures] 1115” Examiner notes that the pillow structure is between the electrode and the electro-mechanical connector, as seen in the below:
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a flexible inner conductor configured to electrically couple the electrode to the first electro-mechanical connector ([0046] “Once the wire [flexible inner conductor] 403 reaches the location of the electrode pad (402), it is threaded through the closest eyelet hole (element 401) so that it may interface with the electrode pad via connectors [first electro-mechanical connector] 408. The connector 408 shown in the figure (male-female connector) is merely an example, and the type of connectors that may be used is not limited to that which is displayed. Optionally, the electrode pad 402 may possess some way to firmly fasten itself to the cover, such as with fabric hook-and-loop fasteners (element 409) located on its underside.”),
wherein the electrode assembly is configured to be coupled to the support structure so that the electrode assembly is placed against the body due to the nonzero pressure when the support structure is worn ( Figs. 7 and 8 and [0060] “key aspects of the conductive electrical garment [support structure] disclosed herein are the covering containing a grid of eyelet holes, resistive (preferably orthopedic) pillow/bedding material, and force of gravity to ensure a clean pad-to-skin contact. The covering may be adapted to any pillow, bedding, or other orthopedic cushion, and may offer substantial versatility in electrode pad placement by way of a grid of eyelet holes…Alternative embodiments may also allow for air bladders to either replace sections of the covering, added to, or be included underneath the cover and provide additional support for the patient and improved contact between the electrode pads and patient's skin.”),
wherein the pillow structure is configured to provide patient compliance with the WCD system, wherein to provide the patient compliance, the pillow structure is flexible to acquire a first shape when the electrode assembly is subjected to the nonzero pressure, and a second shape different from the first shape when the electrode is deposited on a flat level surface and the pillow structure is not being subjected to the nonzero pressure ([0057] “The air pressure in the bladders 1115 may be adjustable by the user/patient. This may offer users/patients greater control to ensure their body is properly positioned when resting, to allow for improved contact between the electrode pads 1102 and the patient's skin, and thus, for improved efficiency of electrical stimulation therapy.” [0052] “the conductive electrical cover 100, because of the presence of the eyelets 101, provides a high degree of flexibility to the user/patient or his doctor as to where the pads 602 are specifically located in order to accommodate to patient's body shape and size and correspond to the areas that need treatment [Examiner notes that when no nonzero pressure is applied, the electrodes/pads are flat leveled to the user.].”), and
wherein the flexible inner conductor is configured to flex when the pillow structure transitions from the first shape to the second shape ([0044] “bedding and pillows made out of ideal resistive material (such as memory foam) may have the ability to easily flex when the wires are pushed down by the weight of the patient, resulting in wiring that is unnoticeable by the patient.” The wires/flexible inner conductor must bend and rearrange its shape when transitioning from when a subject is wearing the garment to no wearing the garment to achieve the original state. ), and wherein the flexible inner conductor includes a first portion that is coextensive with a main surface of the electrode (See Fig. 4 where the electrode 402 contains the wire touching a surface of the electrode.), and a second portion that is configured to make contact with the first electro-mechanical connector (See Fig. 11 where the end of the wire is touching the first electro-mechanical connector 1101.).
Although Groteke teaches that the air pressure of the bladders may be adjustable ([0057], Groteke does not explicitly teach the pillow structure is flexible so as to acquire a first shape due to the electrode assembly being subjected to the nonzero pressure, and a second shape different from the first shape when the pillow structure is not being subjected to the nonzero pressure. Meeker, in the same field of endeavor, teaches an inflatable pouch containing a conductive fluid with an electrode for defibrillation (Abstract and [0059]), and further teaches wherein the pillow structure is configured to provide patient compliance with the WCD system, wherein to provide the patient compliance, the pillow structure is flexible to acquire a first shape when the electrode assembly is subjected to the nonzero pressure, and a second shape different from the first shape when the electrode is deposited on a flat level surface and the pillow structure is not being subjected to the nonzero pressure (See Fig. 5B/C where nonzero pressure is applied (first shape) and Fig. 5A shows no nonzero pressure applied (second shape). [0057] “As shown in FIG. 5C, an object 512 (e.g., a person's finger) can apply a force to the flexible container 504.”) to ensure proper positioning of electrodes and enhanced electrical conductance (Fig. 5D and [0059]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the system of Groteke, with the pillow structure is flexible so as to acquire a first shape due to the electrode assembly being subjected to the nonzero pressure, and a second shape different from the first shape when the pillow structure is not being subjected to the nonzero pressure of Meeker, because such a modification would allow to ensure proper positioning of electrodes and enhanced electrical conductance.
Neither Groteke and Meeker do not teach the moisture barrier. Foch, in the same field of endeavor, teaches a pillow structure defining a cavity (Abstract), and further teaches the moisture barrier ([0048] “Polyethylene is classified into several different categories based mostly on its density and branching. This material was chosen because it allows for the pillow body to be comfortable and at the same time water resistant. The pores inside the polymer foam does not allow sand to and moisture to inter inside of the pillow body.”) to not allow moisture to enter inside of the pillow body ([0048]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the system of Groteke, with the moisture barrier of Foch, because such a modification would allow to not allow moisture to enter inside of the pillow body.
However, Groteke, Foch, and Meeker do not teach the moisture barrier between the electrode and the pillow structure. Keusch, in the same field of endeavor, teaches electrical contact via an electrode for defibrillation (Abstract), and further teaches the moisture barrier between the electrode and the pillow structure (Col. 20 lines 24-30 “The construction of the electrode of FIGS. 7 and 8 is similar to that of the electrode of FIGS. 5 and 6, except that the member for providing electrical connection between the base of eyelet 22, mounted on the exposed face of foam pad 60 [pillow structure], and hydrogel 12 [moisture barrier (silicone based polymer)] is a metallized conductive strip 72 adhesively affixed to the bottom face of foam pad 60”) to allow for strong adhesion to the skin (Col. 7 lines 18-30). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the system of Groteke, with the moisture barrier between the electrode and the pillow structure of Keusch, because such a modification would allow to not allow moisture to enter inside of the pillow body.
However, Groteke, Foch, Keusch, and Meeker fails to teach the arrangement of moisture barrier between the electrode and the pillow structure. Keusch teaches the moisture barrier (hydrogel) (Fig. 2, 4, 6, and 8 (12)) within the pillow structure (foam layer) (Figs. 6 and 8 (60) and Fig. 2(16)), nevertheless the arrangement of moisture barrier between the electrode and the pillow structure would allow to optimize the wicking of sweat of the skin. Therefore, the combination of Groteke, Foch, Keusch, and Meeker would provide the arrangement of moisture barrier between the electrode and the pillow structure to optimize the wicking of sweat of the skin. It would have been obvious to one having ordinary skill in the art at before the effective filing date of the claimed invention to set the moisture barrier between the electrode and pillow structure, since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70.
Regarding claims 6 and 16, Groteke teaches wherein the first shape is a squeezed version of the second shape ([0057] “The air pressure in the bladders 1115 may be adjustable by the user/patient. This may offer users/patients greater control to ensure their body is properly positioned when resting, to allow for improved contact between the electrode pads 1102 and the patient's skin, and thus, for improved efficiency of electrical stimulation therapy.” Because the bladders are air adjustable, they can take on different shapes including when pressure is applied when worn (squeezed version) by the user and no pressure is applied when a user is not wearing the conductive electrical cover/garment.).
Regarding claims 8 and 18, Groteke fails to discloses a pouch filled with a fluid.
However, Meeker discloses a pouch filled with a fluid [0008,0067-0068]. Thus, it would have been obvious to one of ordinary skills in the art by the time the invention was made to modified Groteke to have a pouch filled with a fluid in view of Meeker teachings as such is well known.
Regarding claims 9 and 19, Groteke teaches a pillow structure includes a pouch filled with air ([0057] “The air pressure in the bladders 1115 may be adjustable by the user/patient. This may offer users/patients greater control to ensure their body is properly positioned when resting, to allow for improved contact between the electrode pads 1102 and the patient's skin, and thus, for improved efficiency of electrical stimulation therapy.”).
Regarding claims 10 and 20, Groteke teaches wherein the first portion of the flexible inner conductor is larger than the second portion of the flexible inner conductor (Examiner notes that the wire touching the electrode to the first electro-mechanical connector, in Fig. 11, is part of the first portion, and is longer/larger that the connection of the male to female region of the connector. ).
Claim(s) 2-3 and 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Groteke (US 20140083434)(Hereinafter Groteke) in view of Meeker (US2015/0283391)(Hereinafter Meeker), Foch (US 20130254999), and Keusch et al. (US 4777954)(Hereinafter Keusch) as applied to claims 1,11 above, and further in view of Powers US2008/0255625.
Regarding claims 2 and 12, Groteke, Meeker, Foch, and Keusch fail to disclose that the first electro-mechanical connector includes a snap mechanical contact.
However, Powers discloses electro-mechanical connector includes a snap mechanical contact [0028,0034].
Thus, it would have been obvious to one of ordinary skills in the art as of the effective filing date to modify Groteke to have electro-mechanical connector includes a snap mechanical contact in view of Power teachings as such is well known in the art.
Regarding claims 3 and 13, Groteke discloses the electrode has a main surface but failed to discloses an average thickness measured in a direction perpendicular to the main surface of less than 4 mm.
It would have been obvious to a person of ordinary skill in the art at the time the invention was made to an average thickness measured in a direction perpendicular to the main surface of less than 4 mm, since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Claim(s) 5 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Groteke (US 20140083434)(Hereinafter Groteke) in view of Meeker (US2015/0283391)(Hereinafter Meeker), Foch (US 20130254999), and Keusch et al. (US 4777954)(Hereinafter Keusch) as applied to claims 1,11 above, and further in view of Dupelle et al US2003/0055477.
Regarding claims 5 and 15, Groteke, Meeker, Foch, and Keusch fail to discloses wherein the electrode assembly is configured to be removably attached to the support structure.
However, Dupelle discloses electrode assembly is configured to be removably attached to the support structure [0025]. Thus, it would have been obvious to one of ordinary skills in the art by the time the invention was made to modified Groteke to have electrode assembly is configured to be removably attached to the support structure in view of Dupelle teachings as such is well known.
Claim(s) 7 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Groteke (US 20140083434)(Hereinafter Groteke) in view of Meeker (US2015/0283391)(Hereinafter Meeker), Foch (US 20130254999), and Keusch et al. (US 4777954)(Hereinafter Keusch) as applied to claims 1,11 above, and further in view of Lisogurski et al US2006/0178706.
Regarding claims 7 and 17, Groteke, Meeker, Foch, and Keusch fail to discloses wherein the pillow structure includes a piece of foam.
However, Lisogurski a pillow structure includes a piece of foam (54) [see fig.20]. Thus, it would have been obvious to one of ordinary skills in the art by the time the invention was made to modified Groteke to have in view of Lisogurski teachings in order to provide comfort.
Claim(s) 4 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Groteke (US 20140083434)(Hereinafter Groteke) in view of Meeker (US2015/0283391)(Hereinafter Meeker), Foch (US 20130254999), and Keusch et al. (US 4777954)(Hereinafter Keusch) as applied to claims 1 and 11 above, and further in view of Mortimer US 5,987,361.
Regarding claims 4 and 14, Groteke, Meeker, Foch, and Keusch fail substantially the invention as claimed but failed to discloses wherein the electrode includes a metal foil. However, Mortimer discloses an electrode that included a metal foil [Abstract; Col.2, lines 1-5].
Thus, it would have been obvious to one of ordinary skills in the art by the time the invention was made to modified Groteke to have an electrode made from metal foil in view of Mortimer teachings as such is known to be used for electrodes
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-2,3-4,6-8,11-12,13-14,16-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 9-10,11,14,18-19 of U.S. Patent No. 11,745,006. Although the claims at issue are not identical, they are not patentably distinct from each other because,
Instant claims 1 and 11 encompasses and/or conflicts with claim 9 of patent ‘006.
Instant claims 2 and 12 encompasses and/or conflicts with claim 10 of patent ‘006.
Instant claims 3 and 13 encompasses and/or conflicts with claim 11 of patent ‘006.
Instant claims 4 and 14 encompasses and/or conflicts with claim 14 of patent ‘006.
Instant claims 6 and 16 encompasses and/or conflicts with claim 14 of patent ‘006.
Instant claims 7 and 17 encompasses and/or conflicts with claim 18 of patent ‘006.
Instant claims 8 and 18 encompasses and/or conflicts with claim 19 of patent ‘006.
Claims 5 and 15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 9 of U.S. Patent No.11,745,006 as applied to claims 1,11 above and further in view of Dar et al US2012/0330394.
Instant claims 5 and 15 differ from claim 9 of patent 006’ in that instant claim 5 and 15 discloses that the electrode assembly is configured to be removably attached to the support structure. However, Dar discloses electrode assembly is configured to be removably attached to the support structure [0075]. Thus, it would have been obvious to one of ordinary skills in the art to modify patent claim 9 to have the electrode assembly is configured to be removably attached to the support structure in view of Dar teachings in order to provide therapy.
Claims 1,7-9,11,17-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 21,22-24 of U.S. Patent No. 11,097,094. Although the claims at issue are not identical, they are not patentably distinct from each other because,
Instant claims 1 and 11 encompasses and/or conflicts with claim 21 of patent ‘094.
Instant claims 7 and 17 encompasses and/or conflicts with claim 22 of patent ‘094.
Instant claims 8 and 18 encompasses and/or conflicts with claim 23 of patent ‘094.
Instant claims 9 and 19 encompasses and/or conflicts with claim 24 of patent ‘094.
Claims 1,3-4,6,10,11,13-14,16 and 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2,4,14 of U.S. Patent No. 10,632,302. Although the claims at issue are not identical, they are not patentably distinct from each other because,
Instant claims 1 and 11 encompasses and/or conflicts with claim 1 of patent ‘302.
Instant claims 3 and 13 encompasses and/or conflicts with claim 2 of patent ‘302.
Instant claims 4 and 14 encompasses and/or conflicts with claim 4 of patent ‘302.
Instant claims 6 and 16 encompasses and/or conflicts with claim 30 of patent ‘302
Instant claims 10 and 20 encompasses and/or conflicts with claim 14 of patent ‘302.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Keusch (US 4777954), Haak et al. (US 5158537), and Kitagawa et al. (US 4947846).
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.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer McDonald can be reached at (571) 270-3061. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MOUSSA HADDAD/Examiner, Art Unit 3796
/ALLEN PORTER/Primary Examiner, Art Unit 3796