DETAILED ACTION
This action is pursuant to the claims filed on 06/24/2026. Claims 1-2 and 5-22are pending. A first action on the merits of claims 1-2 and 5-22 is as follows.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 06/24/2026 has been entered.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-2 and 5-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hill (U.S. PGPub No. 2018/0243549) in view of Kurzeweil (U.S. PGPub No. 2008/0287769).
Regarding claim 1, Hill teaches An accessory for a wearable medical device (WMD) (Figs 5-18 disclose accessory support garments 20), wherein the WMD includes a garment to be worn by a patient, the garment including or coupled to sensors configured to monitor physiological characteristics of the patient, the garment being configured to be worn around the torso of the patient (Fig 1 electrode assembly 10 is to be used in conjunction with the accessory support garment 20; examiner notes the preceding limitations are recited in the preamble and are given little to no patentable weight as they simply are directed to an intended use environment for the accessory; in this case, the accessory must be capable of use with a WMD garment including sensors as recited above), the accessory comprising: a belt portion configured to be secured over the garment (belt 22 capable of being secured over a garment), the belt portion comprising a belt portion cushion ([0102-0103] disclosing material selection of components of support garment 20, including belt 22; any material disclosed for the belt 22 would define a belt portion cushion as said material functions at least partially as a cushion; furthermore, when the belt 22 overlaps (e.g., Fig 12) the overlapped belt materials would form a thicker cushion portion relative to the other portions of the belt 22); a back portion that includes cushioning material (center of belt portion 22 defines a back portion; [0102-0103] disclosing material selection of components of support garment 20; any material disclosed would define a cushioning material for added patient comfort); an upper portion that extends from the belt portion and that includes sides that are attachable to the garment (Figs 3-18 support garments have upper portion extending above belt portions 22 that have sides attachable to electrode assembly 10); wherein the upper portion is repositionable along the belt portion to enable a selected alignment with an upper body of the patient to provide coverage and/or support (Fig 13, upper body 120 can be repositioned along belt 122 via fastening mechanisms 123 disclosed as hook and loop fasteners on both the belt 122 and upper body 120 in [0143]); wherein positioning of the upper portion along the belt portion and/or sides of the garment is achieved by one or more fastening mechanisms (see, for example, Fig 13 bra attachment portion 120 defines an upper portion positioned along the belt portion and/or sides of the garment via fastening mechanisms 124/123), and wherein the accessory is configured to be adjusted on the garment such that electrocardiogram (ECG) electrodes maintain contact with the patient’s skin (fastening mechanism 124 and 125 would enable adjustment and tightening to create skin contact with ECG electrodes 12 of the WMD; examiner notes preceding limitation is strictly functional and in the instant case the accessory of Hill is capable of being adjusted on a garment).
Hill fails to explicitly teach the WMD includes a garment such that the accessory of Hill is for use with a WMD including a garment.
In related prior art, Kurzweil teaches a similar accessory for a wearable medical device (WMD) (Fig 4 bra 20 for use with WMD 60), wherein the WMD includes a garment to be worn by a patient (Fig 4 monitoring device 60 disclosed as garment in [0007-0008]), the garment including sensors for monitoring physiological characteristics of the patient, the garment being configured to be worn around the torso of the patient (Fig 4 sensors 30a-30b of garment to be worn around torso; see also Fig 15). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the WMD of Hill in view of Kurzweil to incorporate the WMD as a garment including sensors to arrive at claim 1. Doing so would be obvious as the use of sensors incorporated into garment materials is well-known in the art to yield the predictable result of positioning sensors against the skin with a substrate that advantageously increases comfort and maintains positioning of the sensors against the skin.
Regarding claim 2, Hill teaches wherein the sensors comprise the ECG electrodes ([0095]).
Regarding claims 4-5, Hill teaches wherein the one or more fastening mechanisms comprise clips, clasps, zippers, lacing, hook-and-loop fasteners, hooks, or any combination thereof (Fig 13, upper body 120 can be repositioned with belt 122 via fastening mechanisms 123 disclosed as hook and loop fasteners in [0143])).
Regarding claim 6, Hill teaches wherein the upper portion of the accessory is securable to the back portion with additional straps extending from the sides of the upper portion (Fig 13, fastening flaps 122, straps 23).
Regarding claim 7, Hill teaches a back cushion extender configured to extend from the cushioning material (Figs 11-13 flap 112) and fold underneath the belt portion, the back cushion extender configured to be folded between the patient's skin and an inner portion of the belt portion (flap 112 is configured to fold up to be located between the patient’s skin and the inner surface of the belt 22).
Regarding claims 8-9, Hill teaches wherein the upper portion further comprises one or more interchangeable straps which are interchangeable based on the patient's preferences ([0110] and Figs 6, 12-19 disclosing different bra attachment portions of upper portions; [0102] disclosing straps 23 having adjustable sizes; Fig 17 discloses a halter strap 152 that would be interchanged if replaced with a different embodiment; [0153] disclosing shortened straps in specific embodiments); wherein the one or more interchangeable straps comprise one or more of shoulder straps, cross-straps, halter-like straps, or any combination thereof (Fig 17 halter strap; Fig 15 short strap 23; Fig 14 longer strap 23).
Hill fails to explicitly teach interchangeable straps as claimed.
However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Hill to incorporate the various bra attachment portions having interchangeable shoulder, halter, and/or cross straps to arrive at claim 8. Doing so would be obvious to one of ordinary skill in the art as Hill explicitly discloses the utilization of a variety of known bra attachment portions to yield predictable results therein ([0110]) and providing interchangeable straps would advantageously enable a user to select a strap that fits them ([0102]).
Regarding claim 10, Hill teaches wherein the upper portion is configured as a tank top ([0129]).
Regarding claim 11, Hill teaches wherein the upper portion is configured as a vest ([0176]).
Regarding claim 12, Hill teaches wherein the upper portion is configured with a flap that opens to provide access to the patient's breast (Fig 13, flaps 122 selectively open and close via fasteners 124 to provide access or lack thereof to a breast).
Regarding claims 13-14, Hill teaches wherein the upper portion is configured to receive one or more health-related accessories; wherein the one or more health-related accessories comprises one or more of padding, a breast prosthesis, fluid drainage absorbent, compression pad material, tubing for a drainage port, or any combination thereof ([0141] cups 121 include foam padding to provide support).
Regarding claim 15, Hill teaches wherein the upper portion further includes a detachable modesty panel configured to provide additional coverage of the patient's chest (Fig 7, bra attachment portion 50 is detachable/attachable to upper portion via fastening mechanisms 52 to provide coverage to a patient’s chest).
Regarding claim 16, Hill teaches an ancillary wrap accessory attachable to the sides of the upper portion and configured to be wrapped around the patient's chest to provide additional support for the patient's breasts (Fig 13, bra attachment portion 120 is detachable/attachable to sides of upper portion via flaps 122 to provide additional support for a patient’s breasts).
Regarding claim 17, Hill teaches wherein one end of the ancillary wrap accessory is attachable to an attachment point in a shoulder area of the patient (Fig 13 [0142], flaps 122 wrap attach to straps 23 which is configured to be in the shoulder area of patient).
Regarding claim 18, the Hill/Kurzweil combination teach the device of claim 17 as stated above. Kurzweil further teaches an attachment point on the garment (Fig 4, tabs 62a-c define attachment points on garment of WMD to attach to the accessory).
Hill/Kurzweil discloses substantially all the limitations of the claim(s) except wherein the attachment point is on the garment. It would have been an obvious matter of design choice to one having ordinary skill in the art at before the effective filing date of the claimed invention to have modified Hill in view of Kurzweil to incorporate the attachment point for the ancillary wrap accessory to be on the garment, since applicant has not disclosed that the location of the attachment point solves any stated problem or is for any particular purpose and it appears that the invention would perform equally as well with the attachment point being on a shoulder area of the accessory which is on the garment.
Regarding claim 19, Hill teaches an ancillary wrap accessory attachable the belt portion of the accessory on one end of the ancillary wrap accessory (Fig 13, bra attachment portion 120 is detachable/attachable belt 22 via fastener mechanism 123) and to an attachment point in a shoulder area of the patient on another end of the ancillary wrap accessory (Fig 13, bra attachment portion 120 is detachable/attachable to sides of upper portion via flaps 122 attached to straps 23 which is configured to be in the shoulder area of patient ).
Regarding claim 20, the Hill/Kurzweil combination teach the device of claim 19 as stated above. Kurzweil further teaches an attachment point on the garment (Fig 4, tabs 62a-c define attachment points on garment of WMD to attach to the accessory).
Hill/Kurzweil discloses substantially all the limitations of the claim(s) except wherein the attachment point is on the garment. It would have been an obvious matter of design choice to one having ordinary skill in the art at before the effective filing date of the claimed invention to have modified Hill in view of Kurzweil to incorporate the attachment point for the ancillary wrap accessory to be on the garment, since applicant has not disclosed that the location of the attachment point solves any stated problem or is for any particular purpose and it appears that the invention would perform equally as well with the attachment point being on a shoulder area of the accessory which is on the garment.
Regarding claim 21, in view of the combination of claim 1 above, Hill further teaches wherein the accessory is configured to lift breast tissue of the patient away from the belt portion (Figs 3-18, bra portions 120 are capable of lifting breast tissue of patient away from belt 122).
Claim(s) 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hill in view of Kurzeweil, and in further view of Malik (U.S. Patent No. 10,136,681).
Regarding claim 22, in view of the combination of claim 15 above, Hill further teaches wherein the upper portion further includes breast cups (Fig 7 cups 51).
Hill fails to teach wherein the detachable modesty panel is attached to a rim portion between the breast cups.
In related prior art, Malik teaches a similar device comprising an upper portion including breast cups (Fig 1 cups 112) and a detachable modesty panel configured to provide additional coverage of the patient's chest (Figs 4-5 band 132); wherein the detachable modesty panel is attached to a rim portion between the breast cups (Figs 4-5 bands 132 connect to cups 112 via loops 116 at rim portion between cups 112). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Hill in view of Kurzweil and Malik to incorporate the upper portion including breast cups and a detachable modesty panel attached to a rim portion between the breast cups to arrive at claim 22. Doing so would advantageously provide additional modularity to the accessory for women (Col 9 line 31- Col 10 line 18).
Response to Arguments
Applicant's arguments filed 06/24/2026 have been fully considered but they are not persuasive. Applicant alleges that “Hill does not teach or suggest than an accessory to the support garment 20 of WMD…” On page 8 of the remarks, the applicant asserts that the support garment 20 of Hill cannot be mapped to the accessory as claimed and appears to falsely interpret that the support garment 20 of Hill is part of the WMD, rather than defining the accessory. This is unpersuasive. The examiner notes the claims are directed solely to “An accessory for a wearable medical device (WMD)” and the “garment” of the WMD is not positively recited in the claim. The support garment 20 of Hill is interpreted as an accessory as claimed that is capable of use with a WMD (electrode assembly 10) including a garment.
Applicant’s arguments to remaining dependent claims are equally unpersuasive for the reasons stated above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Adam Z Minchella whose telephone number is (571)272-8644. The examiner can normally be reached M-Fri 7-3 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joseph Stoklosa can be reached at (571) 272-1213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ADAM Z MINCHELLA/Primary Examiner, Art Unit 3794
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