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 .
Information Disclosure Statement
The information disclosure statement (IDS) dated 07/10/2023 has been received and considered.
Claim Objections
Claim 1 is objected to because of the following informalities: “an acoustic shock wave applicator” is recited in lines 6, 8, and 10. It is suggested to correct the second and third instances of “an acoustic shock wave applicator” to “the acoustic shock wave applicator”.
Claim 1 recites multiple instances and variations of “skin surface”. It is suggested to amend the claim to have consistent terminology to preserve antecedent basis. The following is suggested:
“An improved method of treating excess, sagging skin of a patient using acoustic shock waves comprises the steps of: providing a patient with excess sagging skin tissue in need of an acoustic shock wave treatment; applying a liquid based topical treatment to a surface[[s]] of the excess sagging skin and an acoustic shock wave applicator configured to acoustically couple to the skin surface[[s]] to enhance transmission of the acoustic shock waves; placing [[an]] the acoustic shock wave applicator on the skin surface; activating an acoustic shock wave generator or source to emit acoustic shock waves from [[an]] the acoustic shock wave applicator; and wherein the acoustic shock waves are transmitted from the acoustic shock wave applicator through the skin surface sending the emitted acoustic shock waves into the excess sagging skin tissue of the patient by holding or pressing the acoustic shock wave applicator firmly against the skin surface[[s]] to enhance the acoustic coupling and to drive a portion of the topical treatment below the skin surface into the dermis tissue.”
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 3and 7-8 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 3 recites the limitation "the pressure pulses" in line 4. There is insufficient antecedent basis for this limitation in the claim. It is not clear whether the pressure pulses are emitted by the acoustic shock waves in the method of claim 1, or if “the pressure pulses” refers to something else. It is suggested, based on specification [0042], to amend the claim to recite “…and wherein the acoustic shock waves are the pressure pulses are an acoustic pulse” or similar.
Claim 7 is rejected for the same reason as claim 3. Claim 8 is rejected as dependent upon claim 7.
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.
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 1-11 are rejected under 35 U.S.C. 103 as being unpatentable over Schultheiss et al. (US 2006/0100550 A1), hereafter Schultheiss, in view of Iger (US 2014/0276370 A1), hereafter Iger, further in view of Eppstein (US 2003/0078499 A1), hereafter Eppstein.
Regarding Claim 1, Schultheiss discloses an improved method of treating excess, sagging skin of a patient ([0021] and [0035] skin smoothing) using acoustic shock waves (title and abstract) comprises the steps of: providing a patient with excess sagging skin tissue in need of an acoustic shock wave treatment ([0044] and [0035]); applying a liquid based topical treatment to surfaces of the excess sagging skin ([0155]) and an acoustic shock wave applicator to acoustically couple skin surfaces to enhance transmission of the acoustic shock waves ([0155]); placing an acoustic shock wave applicator on a surface of the skin tissue ([0159]); activating an acoustic shock wave generator or source to emit acoustic shock waves from an acoustic shock wave applicator ([0155]); and wherein the acoustic shock waves are transmitted from the acoustic shock wave applicator through the surface sending the emitted acoustic shock waves into the skin tissue of the patient ([0155]).
However, Schultheiss is silent on holding or pressing the applicator firmly against skin surfaces to enhance the acoustic coupling and to drive a portion of the topical treatment below the skin surface into the dermis tissue.
Iger teaches a method for applying a treatment method of tissue (fig. 3 [0064] energy delivery system 50 may include a micro-transducer [0045] for delivering ultrasound [0066]) that includes applying pressure to the skin surface (fig. 3, 340 [0064] and fig. 1B, the energy delivery mechanism is placed on the target tissue using pressure applicator 70 [0046-0047]). The treatment is used to insert an administered material such as collagen into the skin tissue ([0059]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include in Schultheiss’ method of treating sagging skin by holding or pressing the acoustic shock wave applicator firmly against the skin to enhance acoustic coupling and drive a portion of a topical treatment into the skin in order to provide effective skin rejuvenation (Iger [0002]) and drug delivery into the skin (Iger [0008] and [0053]).
In the event that it is not obvious that dermis tissue is included in Schultheiss and Iger’s teaching of treating the skin tissue, as the dermis is a layer of the skin, Eppstein teaches a method of using ultrasound to deliver a topical solution through the skin (fig. 28 [0237] drug-containing solution 312, ultrasonic transducer 316, dermis 340). This includes delivering to the dermis if desired ([0141]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to drive a portion of the topical treatment through the skin into the dermis layer as taught by Eppstein, if the dermis is the desired target tissue for the selected depth of delivery of the treatment to be delivered (Eppstein [0141]), for example, delivering an anesthetic to the dermis for managing pain (Eppstein [0237]).
Regarding Claim 2, Schultheiss discloses an improved method of claim 1, wherein the step of activating the acoustic shock wave generator or source emits low energy or unfocused acoustic shock waves ([0127]).
Regarding Claim 3, Schultheiss discloses an improved method of claim 1, wherein the acoustic shock waves are waves having amplitudes above 0.1 MPa ([0056]) and rise times of the amplitude are below 100 nanoseconds ([0056]) with a duration of a shock wave being below 3 microseconds for the positive part of a cycle ([0056]) and wherein the pressure pulses ([0052] pressure pulse and shock wave are the same thing) are an acoustic pulse which includes several cycles of positive and negative pressure with amplitudes of the positive part of such a cycle being above 0.1 MPa and the pressure pulse time duration is from below a microsecond to about a second, rise times of the positive part of the first pressure cycle is in the range of nanoseconds up to several milliseconds ([0056]).
Regarding Claim 4, Schultheiss discloses an improved method of claim 1, further includes subjecting the skin to the acoustic shock waves stimulating said excess sagging skin, the skin being positioned within a path of the emitted shock waves stimulating a cellular response ([0107]).
Regarding Claim 5, Schultheiss discloses an improved method of claim 1, wherein the acoustic shock wave applicator is electrohydraulic ([0166]) and has a fluid filled flexible membrane ([0166] water cushion).
Regarding Claim 6, Schultheiss discloses an improved method of claim 1, wherein the acoustic shock wave applicator is either a ballistic, a piezoelectric ([0166]), a radial or a spherical applicator device ([0175]).
Regarding Claim 7, Schultheiss discloses an improved method of claim 1, wherein the emitted shock waves or pressure pulses are convergent, divergent, planar or near planar ([0186]).
Regarding Claim 8, Schultheiss discloses an improved method of claim 7, wherein the emitted shock waves or pressure pulses are convergent having one or more geometric focal volumes or points located at a distance X, X being defined as the distance from an exit window to the one or more focal volumes or points from the generator or source ([0028]), the excess sagging skin being positioned at the distance X or less than the distance X from the exit window source ([0028]the target tissue is positioned at a distance less than X; [0035] the tissue can include skin that needs to be smoothed, i.e., sagging skin).
Regarding Claim 9, Schultheiss as modified discloses an improved method of claim 1, wherein the method of treatment further has the step of increasing the temperature of the skin ([0118] shock waves involve thermal heating) being treated to change tissue impedance to improve tissue stimulation by opening pores of the skin to absorb the topical treatment deep into the dermis below the surface as the acoustic shock waves impinge the skin (as modified by Iger, [0059] the method allows the applied cosmetic material to be absorbed by capillary action into the skin tissue).
Regarding Claim 10, Schultheiss as modified discloses an improved method of claim 1, wherein the topical based treatment is a composition having collagen as an active ingredient (as modified by Iger, [0059] collagen can be delivered into the skin tissue).
Regarding Claim 11, Schultheiss as modified discloses an improved method of claim 10, wherein the composition contains or other suitable skin treatment components (Iger [0059] Botox can be one of the skin treatments) but is silent on wherein the composition contains one or more of glycerin, elastin, live yeast cell derivative, hyaluronic acid, preservatives, protein fractions, peptides.
Eppstein teaches that additional substances delivered can include proteins and peptides ([0110]) and glycerin ([0254]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to additionally include other suitable skin treatments in the modified Schultheiss’s method, such as peptides or glycerin, as there are known substances in the art that were known to be able to be delivered transdermally through ultrasound application (Eppstein [0110]) or to include glycerin to reduce skin irritation (Eppstein [0254]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Shimonov et al (US 2023/0149683 A1) discloses an improved method of treating excess, sagging skin of a patient (abstract, treating skin aging with collagen and/or hyaluronic acid depletion or loss) using acoustic shock waves ([0107], [0114]) comprises the steps of: providing a patient with excess sagging skin tissue in need of an acoustic shock wave treatment ([0008]); applying a liquid based topical treatment to surfaces of the excess sagging skin ([0010], [0112] and [0114] acoustic cavitation of a liquid medium is used to deliver intradermally) and an acoustic shock wave applicator ([0199]) to acoustically couple skin surfaces to enhance transmission of the acoustic shock waves (claim 1); placing an acoustic shock wave applicator on a surface of the skin tissue (claim 1, (c)); activating an acoustic shock wave generator or source to emit acoustic shock waves from an acoustic shock wave applicator (claim 1, step (c)); and wherein the acoustic shock waves are transmitted from the acoustic shock wave applicator through the surface sending the emitted acoustic shock waves into the skin tissue of the patient.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARA K. TOICH whose telephone number is (703)756-1450. The examiner can normally be reached M-Th 7:30 am - 4:30 pm, every other F 7:30-3:30 ET.
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/SARA K TOICH/Examiner, Art Unit 3785
/BRANDY S LEE/Supervisory Patent Examiner, Art Unit 3785