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
The amendment filed on 03/18/2026 has been entered. Claims 1, 3 and 5-8 have been amended. Claim 4 has been cancelled. New Claim 10 has been added. Claims 1-3 and 5-10 remain pending.
The previously raised rejection under 35 U.S.C. 112(b), regarding the recited “SUS cap” in Claim 1, is withdrawn because the issues have been properly corrected.
Response to Arguments
On Page 6 of Remarks, Applicant argues that, regarding Claim 1, the recited “high-gloss” should be understood as describing the resulting surface state rather than indicating a comparative or relative degree, and is a “conventional technical term widely used in patent literature, supported by two examples of US 2025/0091311 and US 6,203,403. Examiner respectfully disagrees. In the example of US 2025/0091311, the termed “high gloss” included in its claim is supported and specified by specification, Para 0038, “As used herein, the term “high gloss surface” refers to a surface having minimal perceptible surface defects when visually inspected for about three seconds from about 24-28 inches from the viewer and normal to the part surface+/−90 degrees in a well-lit area.”. In the same paragraph, the term “gloss level” is also mentioned. In view of this example, the term “high gloss” does indicate a relative degree. The example of US 6,203,403 describes “high gloss” as “Where a high gloss decorative laminate is desired, the steel press plate is polished until it resembles a mirror.” (Column 1, Lines 25-27), which is different from US 2025/0091311; even though US 6,203,403 does not disclose a definite specification for claimed feature of “high gloss”, the invention is about a method on how to polish a surface to such high gloss finish; in other words, the method itself specifies what the claimed “high gloss surface” would be like. In view of the above discussion, the term “high-gloss” in the recited “high-gloss polished” in Claim 1 indicates a relative degree, and Specification of current application fails to provide detailed specification for the term so as to make the recited “high-gloss polished” indefinite.
On Pages 8-9 of Remarks, Applicant argues that the combination of the prior art does not disclose a feature that provides an edge of the bonding layer is arranged so as to effectively reflect ultrasonic waves generated from the oscillator. Examiner respectfully disagrees. Reference Lewis 2022 discloses such bonding layer for reflecting ultrasonic waves in Para 0136; “… a back-seal to the transducer element that can be accomplished with a mixture of epoxy and microbubbles. This forces the sound to go into the patient versus being absorbed in the ultrasound device itself”. Reference Lewis 2012 (from the same inventor as Lewis 2022) modifies Lewis 2022 by leaving extra gap between a transducer and its housing. Alternatively, the modification can be more properly viewed as the newer application Lewis 2022 modifying Lewis 2012. Nevertheless, the combination of the two applications from a same inventor discloses the claimed features.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-3 and 5-10 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1, Line 14 recites “a predetermined gap is formed between the side of the oscillator and a side of the SUS cap”. Specification does not provide any details on this recited limitation.
Claim 1, Line 16 recites “an edge of the bonding layer is positioned within the predetermined gap”. Specification does not provide any details on this recited limitation.
Claim 10 recites “the predetermined gap annularly encircles the oscillator”. Specification does not provide any details on this recited limitation.
Claims 2-3 and 5-9 are also rejected under 35 U.S.C. 112(a) because they inherit the deficiencies of the claim(s) they respectively depend upon.
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 1-3 and 5-10 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, Line 11, and Claim 2, Line 2, recite “high-gloss polished”. The term “high” is a relative term that renders the claims indefinite, and is not defined by the claims or specified in Specification. For present purposes of examination, the term “high-gloss” is not considered in interpreting the claims.
Claims 3 and 5-10 are also rejected under 35 U.S.C. 112(b) because they inherit the indefiniteness of the claim(s) they respectively depend upon.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 1-2, 5-8 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Lewis (US 20220176163 A1; hereafter Lewis 2022), in view of Ehrenreich et al (US 20150305974 A1; hereafter Ehrenreich), Mody et al (US 20160015259 A1; hereafter Mody) and Lewis (US 20120283605 A1; hereafter Lewis 2012).
With regard to Claim 1, Lewis 2022 discloses a physical therapy device (Lewis 2022, Para 0005; “The present invention generally relates to, inter alia, devices, methods, and systems for use in medical applications involving long duration ultrasound treatment.”) comprising:
a flexible circuit board (Lewis 2022, Para 0046; “… the electrical network includes electrical components that can include … flexible printed circuit board (PCB) …”);
a plurality of oscillators (Lewis 2022, Para 0057; “the ultrasound transducers are single crystal type transducers made of a lead zirconate titanate (PZT) material.”. The term “oscillator” is specified as receiving electric current and generating ultrasonic waves in Specification of the application. The recited “ultrasound transducer” in Lewis performs the same function) electrically connected to the flexible circuit board (Lewis 2022, Para 0038; “… a plurality of ultrasound transducers arranged in a matrix formation and operably coupled to an electrical network;”; Para 0046; “… the electrical network includes electrical components that can include … flexible printed circuit board (PCB) …”);
a metal cap configured to cover an upper surface of each of the plurality of oscillators (Lewis 2022, Para 0052; “… the mesh structure includes a mechanical mesh material that can include, without limitation, nylon, metal, polymer, silicone, plastic, fibers, a plant-derived compound, or a combination thereof.” Para -136; “The act of securing the transducer element to the mechanical mesh can also provide a back-seal to the transducer element … This forces the sound to go into the patient versus being absorbed in the ultrasound device itself”. These disclosures indicate that a metal (which include stainless steel or SUS) structure covers the upper surface of the transducers);
a silicone cover configured to cover the flexible circuit board, the plurality of oscillators, and the SUS cap (Lewis 2022, Para 0049; “… the ultrasound transducer array includes a plurality of ultrasound transducers embedded in a silicone structure and connected via a flex circuit.”; Para 0119; “Silicone coating prevented delamination and oxidization of any of the devices' electrical features.”; Figs. 12A-12D show that the silicone coating covers the entire device, including the electrical network, the transducers, and the mesh structure);
a hydrogel detachably attached to a rear surface of the silicone cover (Lewis 2022, Para 0137; “… a hydrogel will be coated onto the front face of the transducer array and mesh …”; Para 0138; “… the flexible transducer array may clip into a hydrogel coupling patch that secures and couples the device to the body. … The ultrasound coupling patch could be disposable.”); and
a controller connected to the flexible circuit board (Lewis 2022, Fig. 6 shows that a controller (power source 200) is connected with ultrasound transducer array (110), which comprises a flexible circuit board), the controller being configured to supply current to the plurality of oscillators (Lewis 2022, Para 0074; “… the power source is a power controller device that provides energy to the ultrasound transducer array.”),
wherein the metal cap (the mechanical mesh) has a bonding layer (epoxy, glue, or other connecting medium) that abuts the upper surface of an oscillator of the plurality of oscillators (Lewis 2022, Para 0136; “The electrical/transducer array is then secured to the mechanical mesh via epoxy, glue, or other connecting medium to fabricate a transducer assembly.”).
Lewis 2022 does not clearly and explicitly disclose
wherein the material of the cap is stainless steel,
wherein the rear surface of the silicone cover is high-gloss polished,
wherein the cap is spaced apart from the side of the oscillator,
wherein a predetermined gap is formed between the side of the oscillator and a side of the cap, and
wherein an edge of a bonding layer is positioned within the gap.
Ehrenreich in the same field of endeavor discloses wherein the material of the cap is stainless steel (Ehrenreich, Para 0151; “Examples of suitable materials of which the housings 270, 272 may be formed from are: … stainless steel …”; Fig. 4B shows that the housing 270 covers the drive assembly 220, so corresponds to the SUS cap of the application). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Lewis 2022, as suggested by Ehrenreich, in order to use stainless steel as the material of the cap. One of ordinary skill in the art would have been motivated to make the modification for the benefit of enabling the cap to be biocompatible and to provide adequate protection for the internal components of the device.
Lewis 2022 and Ehrenreich as discussed above do not clearly and explicitly disclose
wherein the rear surface of the silicone cover is high-gloss polished,
wherein the cap is spaced apart from the side of the oscillator,
wherein a predetermined gap is formed between the side of the oscillator and a side of the cap, and
wherein an edge of a bonding layer is positioned within the gap.
Mody in the same field of endeavor discloses wherein the rear surface of the silicone cover is high-gloss polished (Mody, Para 0146; “In one embodiment of constructing a lens 140 of optical grade Liquid Silicone Rubber (LSR), a base lens surface is cast onto a polished surface and cured.”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Lewis 2022 and Ehrenreich, as suggested by Mody, in order to make a silicone cover with polished surface. One of ordinary skill in the art would have been motivated to make the modification for the benefit of increased capability of transmitting and/or focusing ultrasonic energy to the target tissue and therefore more efficient treatment.
Lewis 2022, Ehrenreich and Mody as discussed above do not clearly and explicitly disclose
wherein the cap is spaced apart from the side of the oscillator,
wherein a predetermined gap is formed between the side of the oscillator and a side of the cap, and
wherein an edge of a bonding layer is positioned within the gap.
Lewis 2012 in the same field of endeavor discloses
wherein the cap is spaced apart from the side of the oscillator (Lewis 2012, Para 0091; “Notches 72b position piezoelectric component 60 so that there is space between the outer edges of piezoelectric component and the inner surface of support wall 83.”),
wherein a predetermined gap is formed between the side of the oscillator and a side of the cap (Lewis 2012, Para 0091; “Notches 72b position piezoelectric component 60 so that there is space …”. Size of the disclosed notches determines the thickness of the gap between the transducer and the side wall of the support housing), and
wherein an edge of a bonding layer is positioned within the gap (Lewis 2012, Para 0091; “ … the glue layer being disposed between piezoelectric component 60 and front end base portion 71a … this space allows for excess glue … to be exuded … into the space …”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Lewis 2022, Ehrenreich and Mody, as suggested by Lewis 2012, in order to leave pre-determined space between the cap or side wall and a side of the oscillator and allow edge of bonding layer to enter the space. One of ordinary skill in the art would have been motivated to make the modification for the benefit of efficient transfer of energy from an oscillator to target tissue by ensuring sufficient contact of the oscillator with any layer under the oscillator (Lewis 2012, Para 0091; “this space allows for excess glue and air bubbles contained in the glue to be exuded from between the contact point of piezoelectric component 60 and front end base portion 71a and into the space, thereby allowing a functionally sufficient and efficient contact between piezoelectric component 60 and lens portion 71.”).
With regard to Claim 2, Lewis 2022, Ehrenreich, Mody and Lewis 2012 disclose all the limitations of Claim 1 as discussed above, including wherein the rear surface of the silicone cover is high-gloss polished (Mody, Para 0146; “In one embodiment of constructing a lens 140 of optical grade Liquid Silicone Rubber (LSR), a base lens surface is cast onto a polished surface and cured.”)
Lewis 2022 further discloses wherein the silicone cover is formed by hot pressing using a mold (Lewis 2022, Para 0124; “FIG. 15B illustrates the ultra flexible array (16×16) having an over mold double-copper array with medical-silicone.”).
With regard to Claim 5, Lewis 2022, Ehrenreich, Mody and Lewis 2012 disclose all the limitations of Claim 1 as discussed above.
Lewis 2022 further discloses wherein the plurality of oscillators is disposed in a polygonal shape (Lewis 2022, Para 0058; “the ultrasound transducers can have a shape that includes, without limitation, the shape of a disk, rectangle, triangle, square, oval, and any other geometric shape”).
With regard to Claim 6, Lewis 2022, Ehrenreich, Mody and Lewis 2012 disclose all the limitations of Claim 5 as discussed above. Lewis 2022 further discloses wherein the plurality of oscillators is disposed in a triangular shape (Lewis 2022, Para 0058; “the ultrasound transducers can have a shape that includes, without limitation, the shape of a disk, rectangle, triangle, square, oval, and any other geometric shape”).
Lewis 2022, Ehrenreich, Mody and Lewis 2012 as discussed above do not clearly and explicitly disclose disposing a plurality of oscillators on two sides of a controller.
Ehrenreich further discloses disposing a plurality of oscillators on two sides of a controller (Ehrenreich, Para 0359; “As shown in Fig. 19D, the therapy providing system 6001 includes a pair of housings 6005 and a central housing 6000. In this embodiment, it is contemplated that the housings 6005 contain the driver assembly 220 as described herein above. The central housing 6000 may then contain the other components such as at least one circuit board and an energy source.”. Fig. 19D is cited below). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Lewis 2022, Ehrenreich, Mody and Lewis 2012, as further suggested by Ehrenreich, in order to dispose oscillators on two sides of the controller. One of ordinary skill in the art would have been motivated to make the modification for the benefit of efficiently focusing energy to a target tissue by transmitting from two different directions using two separately disposed oscillators.
Fig. 19D of Ehrenreich
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With regard to Claim 7, Lewis 2022, Ehrenreich, Mody and Lewis 2012 disclose all the limitations of Claim 1 as discussed above.
Lewis 2022 further discloses wherein the plurality of oscillators is disposed in line in a longitudinal direction of the flexible circuit board while being spaced apart from each other (Lewis 2022, Para 0041; “A suitable matrix formation can include, without limitation, an m-by-n matrix.” When n equals 1, the transducers are disposed in a line. As an example, every 4 transducers in a vertical line in Fig. 1 are in a longitudinal direction of the circuit board and are apart from each other.).
With regard to Claim 8, Lewis 2022, Ehrenreich, Mody and Lewis 2012 disclose all the limitations of Claim 7 as discussed above.
Lewis 2022 further discloses wherein the plurality of oscillators is spaced apart from each other by different distances (Lewis 2022, Para 0041; “Further, the ultrasound transducers need not be in a straight alignment …”. With the electrical network being flexible, the transducers can be disposed with any set of different distances).
With regard to Claim 10, Lewis 2022, Ehrenreich, Mody and Lewis 2012 disclose all the limitations of Claim 1 as discussed above, but do not explicitly and clearly disclose wherein the predetermined gap annularly encircles the oscillator.
Lewis 2012 further discloses wherein the predetermined gap annularly encircles the oscillator (Lewis 2012, Fig. 17 shows that inside the disclosed support wall 83 with notches 72b, a piezoelectric component 60 (assembly process shown in Fig. 15B) would be encircled by an annular gap or space). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Lewis 2022, Ehrenreich, Mody and Lewis 2012, as further suggested by Lewis 2012, in order to assemble the transducer and the housing support so that a gap annularly encircles the transducer. One of ordinary skill in the art would have been motivated to make the modification for the benefit of ensuring a sufficient and efficient contact between the transducer and the front/rear surface of the support housing by allowing excess bonding material and/or air to be exuded along all the 360-degree direction.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Lewis 2022, Ehrenreich, Mody and Lewis 2012, in view of Lewis et al (US 20150231415 A1; hereafter Lewis 2015).
With regard to Claim 3, Lewis 2022, Ehrenreich, Mody and Lewis 2012 disclose all the limitations of Claim 1 as discussed above, but do not clearly and explicitly disclose wherein the hydrogel has at least one bending slit extending from a periphery thereof.
Lewis 2015 in the same field of endeavor discloses wherein the hydrogel has at least one bending slit extending from a periphery thereof (Lewis 2015, Para 0092; “The adhesive fabric 80 may be composed of, but not limited to, … polyurethane foam.”; Polyurethane foam is one type of hydrogel. Para 0099; “The bottom or tail portion of the "Y" is split into two strips and is placed on the articulating surfaces of the joint.”. The bending slit is shown in the cited Fig. 3C). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Lewis 2022, Ehrenreich, Mody and Lewis 2012, as suggested by Lewis 2015, in order to include at least one bending slit extending from a periphery of the hydrogel. One of ordinary skill in the art would have been motivated to make the modification for the benefit of reliable attachment of the hydrogel and thus the device to tissues with complex or articulating surfaces (Lewis 2015, Para 0099; “The bottom or tail portion of the "Y" is split into two strips and is placed on the articulating surfaces of the joint. The "Y" shaped adhesive fabrics 80 provide relief when moving the joints and prevent pulling and discomfort while treating the joints.”).
Figure 3c of Lewis 2015
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Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Lewis 2022, Ehrenreich, Mody and Lewis 2012, in view of Jones (US 20140277294 A1; hereafter Jones).
With regard to Claim 9, Lewis 2022, Ehrenreich, Mody and Lewis 2012 disclose all the limitations of Claim 1 as discussed above, but do not clearly and explicitly disclose wherein the silicone cover has a thickness of 0.1 mm to 2 mm.
Jones in the same field of endeavor discloses wherein the silicone cover has a thickness of 0.1 mm to 2 mm (Jones, Para 0119; “… the patch can be held in place … by the use of a very soft silicone with natural temporary adherence, such as a 0.1-2 mm thick transparent Durometer 5-10 hardness silicone gel pad. … Ultrasonic energy, heat, or vibration may also be applied through this device.”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Lewis 2022, Ehrenreich, Mody and Lewis 2012, as suggested by Jones, in order to use a silicone cover with a thickness of 0.1 to 2 mm. One of ordinary skill in the art would have been motivated to make the modification for the benefit of increased transmission of energy from therapy device to target tissue by using ultra-thin silicone cover.
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.
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/L.Z./Examiner, Art Unit 3798
/PASCAL M BUI PHO/Supervisory Patent Examiner, Art Unit 3798
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