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 response filed 10/02/2024. As directed by the amendment, claims 1, 6, 12 and 13 have been amended and claims 27-32 have been added. With claims 14-26 being previously cancelled, claims 1-13 and 27-32 are presently pending.
The amendments to the claims noted above are sufficient to overcome the 35 U.S.C 112(b) rejections from the previous Office action. Those rejections are hereby withdrawn.
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, 4, 5-8, 12-13, 27 and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Ramdas et al., US 20140200487 A1, hereinafter "Ramdas" in view of Bhavaraju et al., US 20140296774 A1 hereinafter “Bhavaraju” and claims 1, 4, 5-8 , 12-13, 28, 29, 31 and 32 are rejected under 35 U.S.C. 103 as being unpatentable over Ramadas in view of Bhavaraju and in view Williams et al., US 20070286809 A1 hereinafter “Williams”.
Regarding claim 1, Ramdas discloses a therapeutic ultrasound treatment apparatus (Figs. 1-3,[0001]) comprising: a transmission layer comprising a transmission material configured to transmit vibrational energy ([0084] “Applicator is also provided with both top, bottom and optional side coverings to form a compact, protective casing for the transducer and other electronics involved in the applicator. The bottom covering is in continuous contact with the treatment area and should be made of metal or silicon rubber or any other material known in the art that is capable of transmitting generated energies efficiently to the treatment area” and [0093] “In addition the applicator further includes support material which is a thin flexible sheet made of polymer, or rubber, or resin, or textile, or thin metal acceptable for medical applications and at least a part of the support material have adhesive to stick it to the skin and can be perforated” – examiner’s note: the top, bottom, side coverings and support material read on transmission layer and transmission material because ultrasound energy of the transducer(s) necessarily navigate through to the treatment area and ultrasound energy is a form of vibrational energy), a plurality of ultrasonic transducers ([0047] and [0077] “Applicator comprises of plurality of transducers for generation and transfer of the said energies to the skin/treatment area”) embedded within the transmission material (see cited [0084] and [0093] and illustration Fig. 5A, ultrasound transducer “8” can be described as being embedded within the transmission layer, i.e., embedded within the top, bottom, side coverings and support material), and a plurality of perforations extending through the transmission material ([0093] “part of the support material have adhesive to stick it to the skin and can be perforated”); and an adhesive layer positioned on an underside of the transmission layer ([0093] “part of the support material have adhesive to stick it to the skin and can be perforated”).
Ramdas does not explicitly disclose a cover layer positioned above the transmission layer. Bhavaraju, in the same field of endeavor of wound healing, discloses in [0146] that it was known in the prior art to provide a protective member (“92”) on a wound dressing, to prevent puncture, abrasion, snagging, evaporation, wetting, soiling and the like. In view of these teachings, it would have been obvious to one having ordinary skill in the art at the time of filing the claimed invention, to have modified ultrasound treatment apparatus of Ramadas to include a protecting member or cover layer positioned above the transmission layer, so as to prevent puncture, abrasion, snagging, evaporation, wetting, soiling and the like, considering the apparatus of Ramadas functions inherently as a wound dressing.
Ramadas in view of Bhavaraju as discussed above does not explicitly disclose a wicking layer configured to facilitate fluid passage.
Bhavaraju further discloses in [0155] a tenting member positioned at the rim of the dressing, to provide for lateral evaporation, Examiner’s Note:, the tenting member reads on a wicking layer that necessarily facilitates fluid passage, to allow for evaporation. In view of the teachings of Bhavaraju, it would have been obvious to one having ordinary skill in the art at the time of filing the claimed invention, to have further modified Ramadas to include a tenting member positioned at the rim of the applicator, to facilitate for evaporation from the wound.
In the alternative, Williams in the same field of endeavor of wound treatment using ultrasound discloses a wound dressing 16, comprising a foam layer “26” placed in contact with the wounded tissue and preferably covers substantially all of the wound, a supply line “20” delivers a fluid to the foam layer as illustrated in Fig. 1 ([0027]), and an ultrasound system “14” facilities transfer of oxygen from the liquid carrier to the wound, ([0030]), Examiner’s Note: the foam reads on a wicking layer that facilitates fluid passage from the wound dressing to the wound. In view of this teaching, it would have been obvious to one having ordinary skill in the art at the time of filing the claimed invention, to have modified Ramadas in view of Bhavaraju to include a foam layer supplied with a fluid as taught by Williams, positioned in contact with the wound to be treated below the transmission layer, so as to allow for transfer of oxygen to the wound by the aid of ultrasound to facilitate wound healing.
Regarding claim 4, [0047] and/or [0081] of Ramdas regarding piezoelectric transducers.
Regarding claims 5-8 and 12-13, [as to claims 5-6], see discussion in claim 1 above, and further Fig. 1 microcontroller unit, programmable duty cycle 5% to 95%, and [0080] “The controller herein described is a programmable controller” as such the device is programmable hence configured to pulse vibrational energy at 20% duty cycle, [as to claim 7], see Fig 1, [0034-0035], [0079], for controller configured to deliver vibrational energy continuously; [as to claim 8-9 and 12-13], as noted above in [0080] “The controller herein described is a programmable controller”, the programmable controller is thus configured to apply vibrational energy at any frequency within the disclosed range 0.5 MHz to 10Mhz and at any intensity within the disclosed range of 0.05W/cm2 to 3W/cm2 (i.e., acoustic power) ( [0009], [0047], [0081]).
Regarding claim 27 , see discussion in claim1 above, in Ramdas in view of Bhavaraju, the tenting member positioned on the rim of the transmission layer reads on a wicking layer positioned above the transmission layer.
Regarding claim 28 see discussion in claim 1 above, in Ramdas in view of Bhavaraju and Williams, the foam layer (wicking layer) will be positioned below the transmission layer.
Regarding claim 29, see discussion in claim 1 above, Ramadas is modified to include the two alternative discussed in claim 1 above, and therefore the modified apparatus will comprise a first wicking layer positioned above the transmission layer (tenting member as modified by Bhavaraju) and a second wicking layer below the transmission layer (foam layer as modified by Williams) for the combined benefit of both the wicking layer above and below the transmission layer.
Regarding claim 31, see discussion in claim 1 above, Ramadas in view of Bhavaraju or Ramadas in view of Bhavaraju and Williams does not explicitly disclose the shape of the wicking layer, however, it is generally known to provide a wound dressing with a shape that conforms to the shape of the wound or sufficiently covers the wound, it is Examiner’s position that a rectangular shape of the wound dressing and components thereof, i.e., to include a wicking layer are within the scope of this teaching. Moreover, it had been held that mere changes in shape are not sufficient to patentably distinguish a claimed invention over the prior art. In re Dailey, 357 F.2d 669, 149 USPQ.
Regarding claim 32, see discussion in claim 1 above, Ramdas does not explicitly disclose wherein the ultrasound transducers are arranged in an array, however, Williams discloses that it was known to arrange ultrasound transducers in an array, for the same purpose of wound treatment. In view of this, it would have been obvious to one having ordinary skill in the art at the time of filing the claimed invention, to have arranged the ultrasound transducers in an array, so as to effectively transmit ultrasound or vibrationally energy to the wound.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Ramdas in view of Bhavaraju or in the alternative, in view of Bhavaraju and in view Williams as applied to claim 1 above, and further in view of Woltjer et al., US 20170258386 A1 hereinafter "Woltjer".
Regarding claim 2, see discussion in claim 1 above, Ramdas teaches use of an adhesive layer [0040], but may not explicitly disclose that the adhesive comprises silicone adhesive. However, silicone adhesive is well-known type of adhesive for application of ultrasound energy because silicone adhesive “[. ..] can be used multiple times and also allows proper acoustic coupling for ultrasound applications. E.g. without a use of an ultrasound gel” as exemplified by Woltjer in [0118]. In view of these, it would have been obvious to one having ordinary skill in the art at the time of filing the claimed invention, to have modified the treatment apparatus of Ramadas with silicone adhesive, to perform the same function of attaching the apparatus to the treatment area, because silicone adhesive is well known to perform this function while allow proper acoustic coupling.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Ramadas in view of Bhavaraju or in the alternative, in view of Bhavaraju and in view Williams as applied to claim 1 above, and further in view of Talish et al., US 20070208280 A1 hereinafter "Talish".
Regarding claim 3, see discussion in claim 1 above, Ramdas teaches use of an adhesive layer [0040], but may not explicitly disclose that the adhesive layer comprises a plurality of opening, the opening aligned with the perforations. However, Talish discloses in [0033] that it was known in the prior art to provide an adhesive layer to include openings (holes or permeable material), to allow moisture to escape and provide oxygen to the skin, in the same field of endeavor. In view of these teachings, it would have been obvious to one having ordinary skill in the art at the time of filing the claimed invention, to have modified the adhesive of Ramdas to include holes, that are aligned with the perforations, to allow moisture to escape and/or provide oxygen to the treatment area.
Claims 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Ramdas in view of Bhavaraju or in the alternative, in view of Bhavaraju and in view Williams as applied to claim 1 above, and further in view of technical review article titled "ULTRASOUND ASSISTED WOUND CARE" authored by Krishnasamy .
Regarding claims 10 and 11, Ramadas discloses the invention of claim 1 as discussed above, a programmable controller is disclosed ([0080]), vibrational energy at a frequency of 3Mhz is also disclosed (e.g., [0009], [0047], [0081]). Ramadas may not explicitly disclose that the controller is configured to deliver vibrational energy with acoustic power of about 3 mW/Cm2 to 30 mW/Cm2 [claim 10] or at 30 mW/Cm2 [claim 11], however, in view of the review article noted above, in last paragraph of section 6.2.1 in page 6, it was already documented in literature that acoustic power of 15 to 30 mW/cm2 was suitable for inducing angiogenesis and healing in wounds. In view of these teachings, it would have been obvious to one of ordinary skill in the art at the time of filing the claimed invention, to have configured the controller of Ramadas to deliver vibrational energy with an acoustic power in the range of 15 to 30 mW/Cm2 as taught in the review article, because vibrational energy in this range was known to be suitable for inducing angiogenesis and healing in wounds.
Claim 30 is rejected under 35 U.S.C. 103 as being unpatentable over Ramdas in view of Bhavaraju or in the alternative, in view of Bhavaraju and in view Williams as applied to claim 1 above, and further in view of Hoggarth et al., US 20180125722 A1 hereinafter "Hoggarth".
Regarding claim 30, see discussion in claim 1 above, Ramdas as modified by Bhavaraju or as modified by Bhavaraju and Williams discloses the aspect of a wicking layer, but does not explicitly disclose the wicking layer comprises a net. However, in view of thew teachings of Hoggarth in [0059], known wicking materials of textile type in the art of wound treatment were known to comprise a net. In view of these teaching, it would have been obvious to one having ordinary skill in the art to have applied a textile type wicking material as the tenting member or as the foam member, because a textile material comprising a net was a known wicking material and it has been previously held to be a matter of obvious design choice and 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 of the invention. In re Leshin, 125 USPQ 416.
Response to Arguments
Applicant’s arguments with respect to the pending claims 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.
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BONIFACE N NGANGA whose telephone number is (571)270-7393. The examiner can normally be reached Mon. - Thurs. 5:30 am - 4:00 pm.
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/BONIFACE N NGANGA/Primary Examiner, Art Unit 3797 November 2, 2024
