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 action is in response to the remarks filed on 02/05/2026.
The amendments filed on 02/05/2026 have been entered. Applicant has presently canceled claims 1 and 20. Accordingly claims 3-4, 6-9, and 19 remain pending. Claims 3-4, 6, 8-9, and 19 are presently amended.
Response to Arguments
Applicant’s arguments with respect to amended claim 19 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 19, 3, 8, and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Tomassi et al. (US 2015/0305709, October 29, 2015, hereinafter “Tomassi”) in view of Lindekugel et al. (US 2014/0180116, June 26, 2014, hereinafter “Lindekugel”).
Regarding claim 19, Tomassi discloses an ultrasound transducer interface pad (“conductive medium pad for ultrasound probe” title; also see Abstract), comprising:
a first planar substrate layer having a first surface and a second surface opposite the first surface (second layer 210 in Fig. 2C, reproduced below, and corresponding description);
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a second planar substrate layer having a third surface and a fourth surface opposite the third surface (first layer 208 in Fig. 2C and corresponding description);
a first adhesive layer applied to the third surface of the second planar substrate layer and adhering to the second surface of the first planar substrate layer (“a first layer of an adhesive hydrogel formulation can be cast into a mold and partially cured. Next, a lubricious hydrogel formulation can be cast on top of the partially cured adhesive hydrogel, which is then fully cured to form the multiple layer conductive pad. In another example, the lubricious hydrogel can be cast first, partially cured, and then the adhesive hydrogel can be cast on top of the lubricous hydrogel before completing the final cure.” [0045]); and
a second adhesive layer applied to the fourth surface of the second planar substrate layer (“the second tacky surface includes an adhesive surface coupled to the first hydrogel membrane” [0006]) and configured to removably adhere the ultrasound transducer interface pad to a region of interest on the patient in a first configuration, or removably adhere the ultrasound transducer interface pad to the ultrasound transducer in a second configuration (“the second tacky surface is configured to reversibly couple with at least one of an ultrasound probe” [0004]).
Tomassi fails to disclose a curable hydrophilic material applied to the first surface of the first planar substrate layer forming a dry hydrophilic coating layer upon curing, the dry hydrophilic coating layer having an exposed surface, the dry hydrophilic coating layer activatable upon applying an external source of a liquid to the exposed surface to provide a controlled positive acoustic coupling between an ultrasound transducer and a patient.
However, Lindekugel teaches, in the same field of endeavor, a curable hydrophilic material applied to the first surface of the first planar substrate layer forming a dry hydrophilic coating layer upon curing, the dry hydrophilic coating layer having an exposed surface (“the lubricity of this or other spacer components described herein can be improved by including a suitable coating, such as a hydrophilic or parylene coating, for instance. The coating can be included on one or both of the skin-contacting portion of the spacer component and the portion that contacts the head portion of the ultrasound probe” [0114]; also see [0002] which discloses that the spacer component can include a hydrogel), the dry hydrophilic coating layer activatable upon applying an external source of a liquid to the exposed surface to provide a controlled positive acoustic coupling between an ultrasound transducer and a patient (“In one embodiment, the spacer component 118 and probe cap 110 can be packaged in a sterile solution, such as sterile saline. When the cap 110 is later removed from the sterile solution for use, the spacer component 118 maintains its lubrication via the residual sterile saline solution disposed thereon. In another embodiment, the saline solution can be added to surface of the spacer component 118 by the user immediately prior to use.” [0114]).
Before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to modify the invention of Tomassi with a curable hydrophilic material applied to the first surface of the first planar substrate layer forming a dry hydrophilic coating layer upon curing, the dry hydrophilic coating layer having an exposed surface, the dry hydrophilic coating layer activatable upon applying an external source of a liquid to the exposed surface to provide a controlled positive acoustic coupling between an ultrasound transducer and a patient as taught by Lindekugel in order to assist in ultrasonically coupling the pad to the probe head portion and in enabling smooth movement of the pad over the skin surface ([0114] of Lindekugel).
Regarding claim 3, Tomassi modified by Lindekugel discloses the limitations of claim 19 as stated above but fails to disclose wherein the first planar substrate layer has a thickness ranging from 0.025 millimeters (mm) to 1.00 mm. Although Tomassi does suggest the first planar substrate layer having the claimed thickness, e.g., see Figs. 2A-C and e.g., paragraph [0029], Tomassi does not explicitly disclose the claimed thickness. However, it would have been an obvious matter of design choice to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the first planar substrate layer taught by Tomassi to have a thickness ranging 0.025 mm to 1.00 mm, because Applicant has not disclosed that the claimed thickness range provides an unexpected advantage, is used for a particular purpose, or solves a stated problem. Furthermore, it has been held before that "it is not inventive to discover the optimum or workable ranges by routine experimentation" (see MPEP 2144.05.II.A), one of ordinary skill in the art could have made the modification with known methods with no change in their respective functions and the combination would have yielded nothing more than predictable results (e.g. optimizing ultrasound transmission) to one of ordinary skill in the art at the time of the invention. As such, the modification of thickness would have been considered a mere design consideration which fails to patentably distinguish over the prior art of Tomassi.
Regarding claim 8, Tomassi further discloses wherein the first adhesive layer comprises a non-silicone-based adhesive coating including an acrylic adhesive material or a synthetic rubber-based adhesive material (“the adhesive sheet includes a pressure sensitive adhesive (PSA) [...] the PSA can be based on, but is not limited to, acrylics, butyl rubbers, natural rubber, nitrile rubber, ethylene-vinyl acetate, silicone rubbers, and styrene-rubber block copolymers” [0044]).
Regarding claim 9, Tomassi further discloses further comprising a release layer applied to the second adhesive layer, the release layer removable to adhere the second adhesive layer to the ultrasound transducer (“A custom-made adhesive backing was fabricated from a polyester fusible web tape (Wonder-Web) that was adhered with pressure to one side of a Scotch double-sided adhesive (scrapbooking tape), which had a release liner on one side.” [0060]).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Tomassi in view of LIndekugel as applies to claim 19 above and further in view of Lin (US 2016/0325024, November 10, 2016).
Regarding claim 4, Tomassi modified by Lindekugel discloses the limitations of claim 19 as stated above but fails to disclose wherein the curable hydrophilic material comprises one of an ultra-violet (UV) light curable hydrophilic material or a heat curable hydrophilic material.
However, Lin teaches, in the same field of endeavor, wherein the curable hydrophilic material comprises one of an ultra-violet (UV) light curable hydrophilic material or a heat curable hydrophilic material (“According to several exemplary embodiments, the second mixture can contain a UV curable or UV-C curable cross-linkers, where UV-C refers to the range of UV light extending from 100-190 nm.” [0031]; also see [0052], [0055], [0081]).
Before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to modify the invention of Tomassi with wherein the curable hydrophilic material comprises one of an ultra-violet (UV) light curable hydrophilic material or a heat curable hydrophilic material as taught by Lin. One of ordinary skill in the art would have been capable of applying this known technique to a known device that was ready for improvement and the results would have been predictable to one of ordinary skill in the art. see MPEP 2143 since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Claims 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Tomassi in view of Lindekugel as applied to claim 19 above and further in view of Berard-Andersen et al. (US 2015/0018686, January 15, 2015, hereinafter “Berard”).
Regarding claim 6, Tomassi modified by Lindekugel discloses the limitations of claim 19 as stated above but is silent on wherein the second adhesive layer comprises a silicone gel adhesive coating having a thickness ranging from 0.025 millimeters (mm) to 0.2 mm.
However, Berard teaches, in the same field of endeavor, wherein the second adhesive layer comprises a silicone gel adhesive coating (“The tape may include a first adhesive surface for adhesion of the silicone gel to the skin and a second adhesive surface for adhesion of the silicone gel to the ultrasound probe.” [0010]) having a thickness ranging from 0.025 millimeters (mm) to 0.2 mm (“The thickness of the tape may be in the range 100 to 500 .mu.m, for example” [0014]; also see “For the above Silbione.TM. adhesives Bluestar Silicones use a test with a steel probe and an adhesive layer thickness of 0.25 mm” [0015]).
Before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to modify the invention of Tomassi with wherein the second adhesive layer comprises a silicone gel adhesive coating having a thickness ranging from 0.025 millimeters (mm) to 0.2 mm as taught by Berard in order to provide an adhesive layer with improved adhesion to typical ultrasound probe materials ([0008] of Berard).
Regarding claim 7, Tomassi modified by Lindekugel and Berard discloses the limitations of claim 6 as stated above but does not explicitly teach wherein the silicone gel adhesive coating has a coat weight in a range of 100 grams per square meter (gsm) to 200 (gsm). However, it would have been an obvious matter of design choice to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the silicone gel adhesive coating taught by Tomassi in view of the teachings of Berard to have a coat weight in a range of 100 to 200 gsm, because Applicant has not disclosed that the claimed coat weight range provides an unexpected advantage, is used for a particular purpose, or solves a stated problem. Furthermore, it has been held before that "it is not inventive to discover the optimum or workable ranges by routine experimentation" (see MPEP 2144.05.II.A), one of ordinary skill in the art could have made the modification with known methods with no change in their respective functions and the combination would have yielded nothing more than predictable results (e.g. optimizing tackiness of the adhesive layer) to one of ordinary skill in the art at the time of the invention. As such, the modification of coat weight would have been considered a mere design consideration which fails to patentably distinguish over the prior art of Tomassi in view of Berard.
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 AMINAH ASGHAR whose telephone number is (571)272-0527. The examiner can normally be reached M-W, F 9am-5pm EST.
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/A.A./ Examiner, Art Unit 3797
/CHRISTOPHER KOHARSKI/ Supervisory Patent Examiner, Art Unit 3797