DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
Applicant argues in the response filed 08/01/2025 that claim amendment would overcome the “Notice of Non-Compliant Amendment”. The amendment has been accepted.
The applicant argues listing the inventors of a foreign patent publication are not required in an IDS, which the examiner acknowledges. However it is to be noted that copies of each foreign patent document are required, as stated below.
The applicant argues prior art Lebner and Toth in view of Bangera does not disclose, teach or suggest the therapeutic elements are disposed between two or more layers of the first or second panels. The 102 and 103 rejections have been withdrawn. A new rejection with respect to Toth in view of Bangera and Mazar has been made below.
The applicant argues the double patenting rejections is moot in view of the amendments to the claims. However it is to be noted a terminal disclaimer was filed 11/19/2204 with respect to U.S. Patent 11,844,625 and accepted. Therefore, the double patenting rejections over U.S. Patent 11,844,625 have been overcome and withdrawn.
Information Disclosure Statement
The information disclosure statement filed 07/25/2024 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein has not been considered in it its entirety.
Claim Objections
Claim 1 objected to because of the following informalities: lines 11-12 should be amended to read “. Appropriate correction is required.
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.
Claims 1-6 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication 2015/0351690 to Toth in view of U.S. Patent Publication 2008/0262543 to Bangera and in view of U.S. Patent Publication 2011/0144470 to Mazar.
As to claim 1, Toth discloses a method of treating a wound or incision (paragraph 170), the method comprising: adhering a first panel (the left side of patch 210, figure 2b, in the “after a wound closure operation” of paragraph 170) of a wound or incision closure apparatus adjacent a first lateral side of the wound or incision; adhering a second panel of the closure apparatus adjacent a second lateral side of the wound or incision (the right side of patch 210, figure 2b, in the “after a wound closure operation” of paragraph 170); and providing a therapy to a patient with a therapeutic element (the one or more sensors and/or electrode 218a-d, paragraph 319, and/or electrodes 255a,b paragraph 317) disposed on or within one or more of the first or second panels (paragraph 149, 168, 207), providing a therapy to a patient with a therapeutic element (the one or more sensors and/or electrode 218a-d, paragraph 319, and/or electrodes 255a,b paragraph 317) disposed on or within one or more of the first or second panels (paragraph 149, 168, 207), but is silent about the specific step of drawing the first and second panels laterally together to draw the first lateral side and the second lateral side of the wound or incision together, and wherein the first and second panels each include a plurality of layers, the therapeutic element being disposed between two or more of the plurality of layers of one or more of the first or second panels.
Bangera teaches a similar method (tissue approximation with devices with sensors, abstract, paragraph 50) having adhering a first and second panels of closure apparatus adjacent a wound or incision, and drawing the first and second panels laterally together to draw the first lateral side and the second lateral side of the wound or incision together (paragraph 47) for the purpose of using a similar mechanism for closing a wound. The patch of Toth is similar to the mechanism of Bangera (adhesive tissue anchors), and can be used as taught by Bangera to approximate the sides of a wound together in the “wound closure” of Toth. It would have been obvious to one of ordinary skill in the art before the effective filing date to use the method step of Bangera of drawing the first and second panels laterally together in the method with the patch of Toth in order for using a similar mechanism for closing a wound.
Mazar teaches a similar device (adherent patch for physiological monitoring, abstract) having therapeutic element (207a,b,c,d, figure 2b, paragraph 52-53) being disposed between two or more of the plurality of layers (202,203) of one or more of the first or second panels (figure 2b) for the purpose of allowing the device to be comfortable and be able to maintain long term monitoring of the patient (paragraph 6, 10). Toth discloses that the sensors can be within the panels (paragraph 149, 168, 207 of Toth) while Mazar teaches it is beneficial for the sensors to be between layers for protection. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have the therapeutic elements of Toth be disposed between a plurality of layers as taught by Mazar of the first and second panels in order for allowing the device to be comfortable and be able to maintain long term monitoring of the patient
As to claim 2, with the method of Toth, Bangera, and Mazar above, Toth discloses sensing a physiological parameter with a sensory element disposed on or within one or more of the first or second panels (figure 2b,c, the electrodes 255a,b, 218a-d).
As to claim 3, with the method of Toth, Bangera, and Mazar above, Toth discloses the therapy comprises one or more of phototherapy, vibration therapy, ultrasound therapy, drug delivery, heat therapy, cooling therapy, or electrical therapy (paragraph 209).
As to claim 4, with the method of Toth, Bangera, and Mazar above, Toth discloses transmitting the sensed physiological parameter to an external receiving device (paragraph 21-23, 41, 47, 320-322).
As to claim 5, with the method of Toth, Bangera, and Mazar above, Toth discloses the external receiving device comprises one or more of a workstation, a personal computer, a laptop computer, a tablet computer, a smartphone, a wearable computer, or a dedicated receiver (paragraph 48).
As to claim 6, with the method of Toth, Bangera, and Mazar above, Toth discloses the physiological parameter comprises one or more of temperature, motion, moisture, pressure, the concentration of a physiological marker, pH, oxygen levels, carbon dioxide levels, or glucose levels (paragraph 42).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEXANDER J ORKIN whose telephone number is (571)270-7412. The examiner can normally be reached Monday - Friday 9am - 5pm.
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/ALEXANDER J ORKIN/Primary Examiner, Art Unit 3771