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 .
DETAILED ACTION
The Amendments to the claims filed on September 29, 2025 in response to the Office Action of June 17, 2025 is acknowledged and has been entered. Claims 9-29, 31, 34, 37-38 and 40-42 are canceled. Claims 43-44 are new. Claims 1-8, 30, 32-33, 35-36, 39 and 43-44 are pending and under examination in this Office action.
Response to Amendment
The objection to the drawings is now withdrawn in view of the claim cancellation.
The rejection to claims 41-42 under 35 U.S.C. 112(a), written description requirement is now withdrawn in view of the claim cancellation.
The rejections to claims 31-33, 35-36 and 41-42 under 35 U.S.C. 112(b) are now withdrawn in view of the claim cancellation or claim amendment.
The rejections to claims 1-8, 30-33, 35-36 and 39 under 35 U.S.C. 103 are now withdrawn in view of the claim amendments. A new ground of rejection is now made.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 September 29, 2025 has been entered.
Information Disclosure Statement
As an initial reminder, Applicant is advised to file an IDS for all the references disclosed in the specification as their entirety being incorporated by reference.
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Claim Objections
Claims 1 and 7 are objected to because of the following informalities:
In claims 1 and 7, except for when it is recited the first time in line 3, the term “therapeutic vibrational energy” should be corrected to –the therapeutic vibrational energy--.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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, 3-6, 30-33, 35-36 and 39 are rejected under 35 U.S.C. 103 being unpatentable over Jaeb et al., US 2007/0239078 A1, hereinafter Jaeb, in view of Collinson et al., US 2014/0316359, hereinafter Collinson, further in view of Roper et al., “ultrasonic stimulation of mouse skin reverses the healing delays in diabetes and aging by activation of Rac1”. Journal of Investigative Dermatology (2015) 135, 2842-2851, hereinafter Roper.
Claim 1. Jaeb teaches in FIG.1 a therapeutic ultrasound wound treatment apparatus (11) ([0028]: the multipurpose wound dressing 11) comprising:
a wound contact layer configured to transmit therapeutic vibrational energy ([0032]: a gel may be placed between the distribution manifold 20 and the wound site 100 prior to the transmission of ultrasonic energy through the distribution manifold 20 to enhance energy transmission) – the gel is the “wound contact layer” as claimed;
a delivery layer (20) positioned over the wound contact layer ([0028]: the distribution manifold 20 is configured to be placed adjacent to the wound site 100),
the delivery layer comprising a porous portion ([0028]: the distribution manifold 20 includes a plurality of flow channels or pathways to facilitate the distribution of reduced pressure of fluids to or from the wound site. In one embodiment, the distribution manifold 20 is porous foam) and
a transmission portion, the transmission portion comprising a transmission material (20) configured to transmit therapeutic vibrational energy ([0032]: the distribution manifold 20 performs both the functions of a manifold and a transmission medium for ultrasonic energy) – the distribution manifold 20 hence functions as both the “delivery layer” and the “transmission portion that comprises a transmission material” as recited,
the transmission material (20) in contact with the wound contact layer such that therapeutic vibrational energy is directed through the wound contact layer to a wound (the gel between 20 and 100; and [0032]: the distribution manifold 20 acts as a transmission medium to relay ultrasonic energy to the wound site 100…a gel may be placed between the distribution manifold 20 and the wound site 100 prior to the transmission of ultrasonic energy through the distribution manifold 20 to enhance energy transmission);
an ultrasonic transducer (50),the ultrasonic transducer positioned over the transmission portion (FIG.1: the ultrasound transducer 50 is over the manifold 20 that is considered the transmission portion, see [0032] cited above for the transmission portion limitation),
the ultrasonic transducer configured to deliver therapeutic vibrational energy ([0031]: the ultrasonic energy transducer 50 may include a frequency generator and an amplified and is used to transmit ultrasonic energy to the wound site 100) at a therapeutic frequency and a therapeutic acoustic power ([0033]: high frequency (about 800 to 4000 kHz), or low frequency (about 20 to 120 kHz)) - an ultrasound transducer is knowns to be powered by an electrical signal that causes the transducer to vibrate at a frequency to generate ultrasonic waves. Any ultrasonic waves carries a frequency and acoustic power. An ultrasound energy that promotes wound healing is considered therapeutic;
an absorbent layer positioned over the delivery layer, the absorbent layer configured to absorb wound exudate ([0029]: a reduced pressure applicator 40 is placed…over the distribution manifold 20; and [0036]: following the second selected duration, transmission of ultrasonic energy is ceased, and reduced pressure is applied through the distribution manifold by the reduced pressure source. The reduced pressure removes the delivered fluid from the wound and distribution manifold, as well as wound exudate and debrided tissue); and
a cover layer (30) overlying the absorbent layer ([0029]: the drape 30 is positioned over the distribution manifold 20 when an open wound site is treated to seal and isolate the wound site).
Jaeb does not teach (1) a wicking layer in contact with the wound contact layer, the wicking layer configured to transport would exudate from a wound bed while allowing the transmission material to be in contact with the wound contact layer; and (2) the therapeutic acoustic power is configured to stimulate ultrasound-dependent cellular pathways within wound tissue to improve wound healing.
In regard to (1), in an analogous wound dressing and treatment apparatus field of endeavor, Collinson teaches
a wicking layer (3440, 3450) in contact with the wound contact layer (3460) (FIG.4A), the wicking layer configured to transport wound exudate from a wound bed ([0078]: the transmission layer 3450 may comprise a porous material or 3D fabric configured to allow for the passage of fluids therethrough away from the wound site and into the upper layers of the dressing 3400).
In regard to the feature of the wicking layer allowing the transmission material to be in contact with the wound contact layer, Jaeb teaches that the transmission material (20) is in contact with the wound contact layer (the gel). Since the wicking layer is sandwiched between the transmission material and the wound contact layer, as along as the area of the wicking layer is smaller than the wound contact layer (shown in Collison, FIG.4A), the wicking layer still would allow the transmission material to be in contact with the wound contact layer.
Therefore, it would have been obvious to one of the ordinary skilled in the art before the effective filing date of the claimed invention to have the apparatus of Jaeb employ such a feature of “a wicking layer in contact with the wound contact layer, the wicking layer configured to transport would exudate from a wound bed while allowing the transmission material to be in contact with the wound contact layer” as taught in Collinson for the advantage of “ensuring that an open air channel can be maintained to communicate negative pressure over the wound area…so that the whole wound site sees an equalized negative pressure”, as suggested in Collinson, [0078].
In regard to (2), in an analogous ultrasound-based wound healing field of endeavor, Roper teaches that
the therapeutic acoustic power is configured to stimulate ultrasound-dependent cellular pathways within wound tissue to improve wound healing (p.2850, Coo. Left, Ultrasound stimulation: mouse wounds…were coupled to 2.5-cm diameter ultrasound transducer using water-based gel. During stimulation experiments, the transducer generated 30 mWcm-2 pulsed ultrasound with a 1.5-MHz wave frequency, pulsed at 1 kHz for a duration of 20 minutes; p.2844, Col. Left: to test whether the migration effect is applicable to human chronic wound samples, we repeated the experiment using senescent-like fibroblasts isolated from the chronic venous leg ulcer of a 71-year-old female patient with wound duration of greater than 7 months; and p.2843, Col. Left, ¶-2: In this study, we identify a mechanism of Rac1 activation that can substitute for the fibronectin-dependent pathway that operates in healing of healthy skin. We demonstrate that activation of the pathway by mechanical stimulation, with ultrasound, rescues healing defects caused by diabetes, age, or defects in fibronectin signaling by enhancing wound fibroblast migration. We go on to shot ha such treatments have similar effects on patient chronic wound fibroblast, indicating that such approaches could be efficacious in clinical situation).
Therefore, it would have been obvious to one of the ordinary skilled in the art before the effective filing date of the claimed invention to have the ultrasound transducer of Jaeb as modified employ such a feature of “the therapeutic acoustic power is configured to stimulate ultrasound-dependent cellular pathways within wound tissue to improve wound healing” as taught in Roper for the advantage of “demonstrating that the approach is applicable to human chronic samples, which identifies future opportunities for management of chronic wounds”, as suggested in Roper, p.2841, Abstract.
The limitation of “the therapeutic acoustic power is configured to stimulate ultrasound-dependent cellular pathways within wound tissue to improve wound healing” is considered an intended use of the claimed ultrasound transducer. Such a limitation does not further limit the structure of the claimed ultrasound transducer. There is no recitation in the claim what structural limitation causes the claimed function to be carried out. The function that an ultrasound transducer is capable of performing depends on the setting of the transducer and the characteristics of the ultrasound energy, such as the frequency, the power, the duration, and the duty cycle, etc. Using the ultrasound energy to debride the tissue, or to regulate certain cellular pathways requires the particular setting of the ultrasound transducer. Since the claim merely broadly recites the ultrasound transducer is configured to deliver energy at a frequency and power that is configured to stimulate cellular pathways for improving the wound healing, to incorporate the setting of the transducer of Roper into Jaeb would enable the transducer to perform the recited function. As such, Roper is considered reading on the above identified limitation. For the above consideration, see MPEP § 2114.II: "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987).
Claim 3. Jaeb further teaches that
The transmission portion extends through an entire thickness of the delivery layer ([0032]: the distribution manifold performs both the functions of a manifold and a transmission medium for ultrasonic energy) – since the distribution manifold performs dual function of ultrasound transmission and a manifold (i.e., the “delivery layer” as claimed), it covers the entire thickness of itself.
Claim 4. Jaeb further teaches that
the ultrasonic transducer comprises a piezoelectric transducer ([0031]: the ultrasonic energy transducer may be a piezoelectric transducer).
Claim 5. Jaeb further teaches
a fluid connector (42) attached to the cover layer, the fluid connector (42) in communication with a space under the cover layer (30) (30) ([0028]: the multipurpose wound dressing 11 includes…a tube 42 for fluidly communicating with the distribution manifold and optionally a drape 30; FIG.1).
Claim 6. Jaeb further teaches that
the fluid connector is configured to be in fluid communication with a source of negative pressure ([0030]: the tube 42 is fluidly connected at a distal end to the applicator 40 and is fluidly connected at a proximal end to the reduced pressure source 12, which may be a pump or a wall suction outlet).
Claim 30. Collinson further teaches that
the wicking layer (3450) is positioned over the wound contact layer (3460) (FIG.4A).
Claim 32. As applied to claim 1, Jaeb teaches the wound contact layer 100 and the delivery layer 20, and Collinson teaches the wicking layer 3450.
When Jaeb and Collinson are combined, the wicking layer 3450 is positioned above the would contact area for transporting the wound exudate away from the wound bed, hence, this wicking layer would be positioned beneath the delivery layer 20, i.e., between the delivery layer 20 and the wound contact layer 100.
Claim 33. Collinson further teaches that
the wicking layer (3440, 3450) comprises a wicking core (3450) ([0093]: some embodiments of the dressing 500 may comprise a transmission or wicking layer; and [0076]: the transmission layer 3450) – the transmission layer 3450 is considered the “transmission core” as claimed.
Claim 35. Collinson further teaches that
the wicking layer comprises a plurality of wicking cores ([0079]: the transmission layer 3450 can have a top layer…a bottom layer…a third layer sandwiched between).
Claim 36. Collinson further teaches that
the wicking layer is positioned beneath the absorbent layer (FIG.4A: the wicking layer 3450 is positioned beneath the absorbent layer 3430)
Claim 39. Collinson further teaches that
the wound contact layer comprises silicone ([0077]: the wound contact layer may comprise three layers…a lower adhesive layer and an upper adhesive layer…a pressure sensitive adhesive, which may be a silicone…may be formed on both sides or optionally on a selected one side of the wound contact layer).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Jaeb in view of Collinson and Roper, as applied to claim1, further in view of Blott et al., US 2019/0015648 A1, hereinafter Blott.
Claim 2. Jaeb and Collinson combined teaches all the limitations of claim 1.
Jaeb further teaches that the transmission portion comprises gels ([0032]: the distribution manifold acts as a transmission medium to relay ultrasonic energy to the wound site 100. When a reticulated foam is used, the transmission efficiency of the foam may be enhanced by using…gels).
Neither Jaeb nor Collinson teaches that the gel is silicone gel.
However, in an analogous field of endeavor of ultrasound-based wound treatment apparatus for supplying vibrational energy, Blott teaches that the gel is silicone gel ([0267]: sheet or membrane with a filler…examples of suitable fluids contained in the hollow body or bodies defined by a film, sheet or membrane include…liquids; and [0271]: examples also include gels, such as silicone gels)
Therefore, it would have been obvious to one of the ordinary skilled in the art before the effective filing date of the claimed invention to have the apparatus of Jaeb, Collinson and Roper combined employ such a feature of comprising silicone gel as taught in Blott for the advantage of “using it as a coupling gel that is needed to transmit the energy to the irrigant and/or exudate under the wound-facing face of the wound dressing”, as suggested in Blott, [0081].
Claims 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Jaeb in view of Collinson and Roper, as applied to claim 1, further in view of Talish et al., US 2007/0208280 A1, hereinafter Talish.
Claim 7. Jaeb, Collinson and Roper combined teaches all the limitations of claim 1, including the feature of the ultrasonic transducer being positioned over a transmission portion and configured to deliver therapeutic vibrational energy at a therapeutic frequency and therapeutic acoustic power (FIG.1, [0032], and [0033]).
Jaeb further teaches a second transmission portion (FIG.1: the transmission portion has a plurality of sub-portions).
Neither Jaeb nor Collinson teaches that there is a second ultrasonic transducer.
However, in an analogous field of endeavor of ultrasound-based wound treatment apparatus for supplying vibrational energy, Talish teaches a second ultrasonic transducer ([0042]: the ultrasound transducer array…can be obtained by forming an array of a plurality of the foregoing transducer materials 32; FIGS.5 and 10 shows a plurality of transducer materials 32 disposed on or within at least a portion of adhesive layer 36).
Therefore, it would have been obvious to one of the ordinary skilled in the art before the effective filing date of the claimed invention to have the transducer of Jaeb, Collinson and Roper combined employ such a feature of comprising a second ultrasonic transducer and a second transmission portion as taught in Talish for the advantage of “choosing the number based on the size and position of the wound and the relative position…to provide enhanced healing treatment to wound”, as suggested in Talish, [0052].
Claim 8. Jaeb, Collinson, Roper and Talish combined teaches all the limitations of claim 7, including the plurality of ultrasonic transducers (Talish: FIGS. 5 and 10).
Talish further teaches that
the plurality of ultrasonic transducers comprises five ultrasonic transducers ([0042]: the ultrasound transducer array…can be obtained by forming an array of a plurality of the foregoing transducer materials 32; FIGS.5 and 10 shows a plurality of transducer materials 32 disposed on or within at least a portion of adhesive layer 36; and [0052]: the number, position and size of ultrasonic bandages used at the external skin location are chosen based on the size and position of the wound and the relative position and proximity of the bone from which the ultrasonic waves are reflected. Thus, more than one ultrasound bandage or ultrasound transducer array bandage can be employed at the site of the wound).
In regard to the number of the ultrasonic transducer to be five, and the transducers are arranged in a cross pattern, there provides no criticality for the number to be five, and the arrangement to be a cross pattern. Since Talish teaches that the number, position and size of the ultrasound transducer arrays are adjustable, it would be obvious to one of ordinary skill in the art to select the number of transducers and to determine their arrangement based on the particular utility as desired. One of ordinary skill in the art would be able to employ five transducers arranged in a cross pattern through routine experimentation. See MPEP 2144.04.VI.B. Duplication of Parts: In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960) (Claims at issue were directed to a water-tight masonry structure wherein a water seal of flexible material fills the joints which form between adjacent pours of concrete. The claimed water seal has a "web" which lies in the joint, and a plurality of "ribs" projecting outwardly from each side of the web into one of the adjacent concrete slabs. The prior art disclosed a flexible water stop for preventing passage of water between masses of concrete in the shape of a plus sign (+). Although the reference did not disclose a plurality of ribs, the court held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced.); and MPEP 2144.04.VI.C. Rearrangement of Parts: In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950) (Claims to a hydraulic power press which read on the prior art except with regard to the position of the starting switch were held unpatentable because shifting the position of the starting switch would not have modified the operation of the device.); In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975) (the particular placement of a contact in a conductivity measuring device was held to be an obvious matter of design choice).
Claims 43 and 44 are rejected under 35 U.S.C. 103 as being unpatentable over Jaeb in view of Collinson and Roper, as applied to claim 1, further in view of Maan et al., “Noncontact, low-frequency ultrasound therapy enhances neovascularization and wound healing in diabetic mice”. Plastic Reconstr Surg. 2014; 134(3): 402e-411e, hereinafter Maan.
Claim 43 and 44. Jaeb, Collinson, Roper and Talish combined teaches all the limitations of claim 1, including the wound contact layer being a layer of gel (Jaeb: [0032]).
Neither of Jaeb, Collinson and Roper teaches that the wound contact layer is continuous and it comprises a continuous layer of silicone.
However, in an analogous wound care field of endeavor, Mann teaches that
the wound contact layer is continuous and it comprises a continuous layer of silicone (p.3, Surgical Wounding and Assessment: a donut-shaped silicone splint with a 10-mm diameter is centered on the wound and fixed to the skin).
A silicone splint is a widely-used accessory in the field of wound care as a medical device for protect the wound and promote the wound healing after an injury or surgery. Since it is single piece material, it is hence a “continuous layer of silicone” as claimed.
Therefore, it would have been obvious to one of the ordinary skilled in the art before the effective filing date of the claimed invention to have the wound contact layer of Jaeb, Collinson and Roper combined employ such a feature of being continuous and comprising a continuous layer of silicone as taught in Maan for the well-acknowledged advantage known in the field of art of being flexible and biocompatible for supporting and protecting the wound to promote wound healing.
Response to Arguments
Applicant’s arguments in regard to the rejection to claim 1 have been fully considered but they are not persuasive.
Applicant asserted that Jaeb discloses ultrasound for the use of debridement, rather than stimulate ultrasound-dependent cellular pathways within wound tissue to improve wound healing. Examiner respectfully notes that, Examiner acknowledges that the ultrasound energy of Jaeb is configured for debridement. Hence the newly cited Roper is relied upon for the teaching of the ultrasound energy being configured for stimulate certain cellular pathways to promote wound healing. As noted in the rejection, the function that an ultrasound transducer is capable of performing depends on the setting of the transducer and the characteristics of the ultrasound energy, such as the frequency, the power, the duration, and the duty cycle, etc. Using the ultrasound energy to debride the tissue, or to regulate certain cellular pathways requires the particular setting of the ultrasound transducer. Since the claim merely broadly recites the ultrasound transducer is configured to deliver energy at a frequency and power that is configured to stimulate cellular pathways for improving the wound healing, to incorporate the setting of the transducer of Roper into Jaeb would enable the transducer to perform the recited function. As such, Roper is considered providing appropriate and sufficient teaching to this limitation.
Applicant further asserted that “the transmission layer of Collison is described as a 3D fabric layer configured to allow for the passage of fluid. Collison, para. [0078]. Such a fabric layer interposed between the transducer and he wound would reduce and/or block transmission of vibrational energy to the wound…Further the transmission layer of Collison is a full 3D fabric transmission layer, which when interposed between the delivery layer and eh wound contact layer would prevent contact between the transmission material and the wound contact layer”. Examiner respectfully disagrees and notes that, the transmission layer of Collison, as considered in the rejection, is equivalent to the “wicking layer” recited in the claim. The function of the wicking layer of the claimed invention is to “facilitate passage of fluid through the layers below the wicking layer” (PG Pub [0265]). The function of the transmission layer of Collison is to “allow for the passage of fluids therethrough away from the wound site” (Collison, [0078]). Hence, it is Examiner’s intension to rely on the transmission layer of Collison for the teaching of the wicking layer recited in the claim.
In regard to the transmission layer being a 3D fabric layer that would reduce and/or block transmission of vibration energy to the wound, the material may attenuate the ultrasound transmission, yet still capable of transmit the ultrasound waves. Since the transmission layer of Collison is made or a porous material (it is “a porous layer” ([0062])), it is reasonably considered that it would not completely block the ultrasound transmission. There is no teaching in Collison that a 3D fabric layer may complete block the ultrasound transmission. More importantly, the claim does not require any ultrasound energy transmission property for the wicking layer.
In regard to the transmission layer being disposed between the delivery layer and the wound contact layer, and would prevent contact between the transmission material and the wound contact layer as require in claim 1, as considered in the rejection, Examiner considers whether the sandwiched layer would prevent the contact of the two outer layers would depend on the relative size of the layers. Since in Collison, FIG.4, it illustrates that the transmission layer is substantially smaller than the wound contact layer, when incorporating the transmission layer of Collison to be in between the wound contact layer and the delivery layer of Jaeb would still allow the wound contact layer to be in contact with the transmission material.
The newly cited Maan is relied upon for the teaching of the newly added claims 43 and 44 for the gel of Jaeb as modified to be specifically a single piece of silicone gel, hence a continuous payer.
Based on the above considerations, the pending claims are rejected.
Conclusion
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/YI-SHAN YANG/Primary Examiner, Art Unit 3798