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 .
Acknowledgments
In the reply, filed on October 20, 2025, Applicant amended claims 12, 15, and 21.
Applicant cancelled claims 14 and 22-23.
In the non-final rejection of May 20, 2025, Examiner objected to claim 21. Applicant amended claim 21; however, Applicant did not address all of the objections. Objection is maintained.
Examiner rejected claims 22-23 under 35 U.S.C. 112(a). Applicant cancelled claims 22-23. Rejection is withdrawn.
Currently, claims 12 and 15-21 are under examination.
Claim Objections
Claim 21 is objected to because of the following informalities:
In regards to claim 21, line 3, “applying” should be changed to “the applying”.
Appropriate correction is required.
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 12 and 15-21 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.
In regards to claim 12, lines 2-6 recite: a pressure application device configured to apply a pressure to a patient’s skin and “generate a fluid flow in a direction pointing deeper into the patient’s skin to move a first portion of freed pigment particles after a procedure that frees the pigment particles of a tattoo from cells along the direction of the fluid flow to move the freed pigment particles deeper within the patient's skin”; however, such is new matter not described in the Specification. Claims 15-21 are rejected by virtue of being dependent upon claim 12.
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.
Claims 12 and 15-21 are rejected under 35 U.S.C. 103 as being unpatentable over Garibyan et al (US 2018/0311079), and further in view of Vangipuram et al (Accelerated tattoo removal with acoustic shock wave therapy in conjunction with a picosecond laser).
In regards to claim 12, Garibyan et al teaches a system (Figures 2A-2B) comprising:
a pressure application device configured to apply a pressure to a patient's skin to move a first portion of freed pigment particles (Figure 2A)(paragraph [0035]: The center chamber (channel formation device 16) allows… pressure (x) (shown in FIG. 2B) to flow… After a time, pressure (+) is forced into the chamber and pushes down on to the skin causing movement of the ink particles) after a procedure that frees the pigment particles of a tattoo from cells (paragraph [0030]: After a single laser removal treatment, thousands of microscopic tattoo particles (e.g., exogenous particles) are released from cells in the dermis of the skin)
wherein the first portion of the freed pigment particles become less visible (paragraph [0056]: any residual tattoo particles remaining after laser therapy are less visible)
a fluid delivery device configured to deliver a fluid into the patient's skin to suspend the pigment particles after the pigment particles have been freed from the tattoo in the fluid beneath a surface of the patient's skin, wherein the fluid delivery device includes one or more first conduits for delivering the fluid into the patient's skin (Figure 2A)(paragraph [0035]: Small conduits (fluid conduit 14) can enter the skin and pressurized fluid could pass through them)
a fluid removal device configured to facilitate removal of the fluid and a second portion of the pigment particles from the patient's skin, wherein the fluid removal device includes one or more second conduits configured to form one or more channels in the patient's skin (Figure 2A)(paragraph [0035]: The center chamber (channel formation device 16) allows alternating suction (o)… to flow such that when suction is on, the skin is pulled into the chamber and small conduits pierces the skin and allows suction (o) within the skin to occur, simultaneously causing fluid flow through)
Garibyan et al does not teach the pressure application device configured to “generate a fluid flow in a direction pointing deeper into the patient’s skin to move a first portion of freed pigment particles after a procedure that frees the pigment particles of a tattoo from cells along the direction of the fluid flow to move the freed pigment particles deeper within the patient's skin”, wherein the first portion of the freed pigment particles become less visible “as a result of being pushed deeper within the patient’s skin”. Vangipuram et al teaches a system comprising: a pressure application device (page 891: acoustic shock wave therapy (ASWT) using the Zwave device (Zimmer Medizin Systems; Irvine, CA)) configured to apply a pressure (page 891: shock wave) to a patient's skin and generate a fluid flow in a direction pointing deeper into the patient’s skin to move a first portion of freed pigment particles (page 892: AWST may enhance tattoo clearance by increasing lymphatic drainage… thereby accelerating the clearance of dermal pigment vacuoles produced by the picosecond laser) after a procedure that frees the pigment particles of a tattoo from cells (page 891: A picosecond-domain 1,064-nm Nd:YAG laser (PicoWay; Syneron Candela, Wayland, MA) was used to treat the patient. Three milliliters of 1% lidocaine with 1:100.00 epinephrine and sodium bicarbonate were injected into the treatment area prior to each laser treatment. The black tattoo ink was first treated at 1,064 nm with a 4-mm spot size, a fluence of 2.8 J/cm2, and a laser repetition rate of 2 Hz. Two passes with the perfluorodecalin (PFD) patch (Merz; Raleigh, NC) with a total of 59 pulses were applied)(page 892: dermal pigment vacuoles produced by the picosecond laser) along the direction of the fluid flow to move the freed pigment particles deeper within the patient's skin (page 892: AWST may enhance tattoo clearance by increasing lymphatic drainage… thereby accelerating the clearance of dermal pigment vacuoles produced by the picosecond laser)(Figure 1D)(page 892: At 7-week follow-up after the third treatment session, the black tattoo showed 80% clearance of the medial portion of the tattoo), wherein the first portion of the freed pigment particles become less visible as a result of being pushed deeper within the patient’s skin (page 892: AWST may enhance tattoo clearance by increasing lymphatic drainage… thereby accelerating the clearance of dermal pigment vacuoles produced by the picosecond laser)(Figure 1D)(page 892: At 7-week follow-up after the third treatment session, the black tattoo showed 80% clearance of the medial portion of the tattoo). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the pressure application device configured to apply the pressure to the patient's skin, of the system of Garibyan et al, to also generate a fluid flow in a direction pointing deeper into the patient’s skin to move a first portion of freed pigment particles after a procedure that frees the pigment particles of a tattoo from cells along the direction of the fluid flow to move the freed pigment particles deeper within the patient's skin, wherein the first portion of the freed pigment particles become less visible as a result of being pushed deeper within the patient’s skin, as taught by Vangipuram et al, as such will result in a decrease in epidermal side effects of erythema, edema, and crusting (page 892: The decrease in epidermal side effects of erythema, edema, and crusting on the side treated with ASWT may be a result of increased microcirculation and lymphatic drainage).
In regards to claim 15, in the modified system of Garibyan et al and Vangipuram et al, Garibyan et al teaches wherein the pressure is a positive pressure (paragraph [0043]: positive pressure).
In regards to claim 16, in the modified system of Garibyan et al and Vangipuram et al, Garibyan et al does not state wherein the pressure applied to the patient's skin includes an oscillating pressure; however, as Garibyan et al teaches wherein the pressure applied to the patient's skin is provided as a shock wave (paragraph [0054]: shock wave), and it is known that a shock wave “is when lots of energy comes from a very small spot and shakes the material around it. The energy makes the material around the spot move very quickly, and very hard. This is a special type of vibration” (Shock wave: https://simple.wikipedia.org/wiki/Shock_wave) and vibration “is a mechanical phenomenon whereby oscillations occur about an equilibrium point” (Vibration: https://en.wikipedia.org/wiki/Vibration), it is understood that the pressure applied to the patient's skin, in Garibyan et al, includes an oscillating pressure.
In regards to claim 17, in the modified system of Garibyan et al and Vangipuram et al, Garibyan et al does not state wherein the oscillating pressure oscillates between a positive pressure and a negative pressure; however, as Garibyan et al teaches wherein the pressure applied to the patient's skin is provided as a shock wave (paragraph [0054]: shock wave), and it is known that a shock wave “is when lots of energy comes from a very small spot and shakes the material around it. The energy makes the material around the spot move very quickly, and very hard. This is a special type of vibration” (Shock wave: https://simple.wikipedia.org/wiki/Shock_wave) and vibration “is a mechanical phenomenon whereby oscillations occur about an equilibrium point” (Vibration: https://en.wikipedia.org/wiki/Vibration), and “shock waves are characterized by a single, mostly positive pressure pulse followed by a comparatively small tensile wave component (negative pressure pulse) (Fig. 2)” (What are shock waves? Physics and Technology: https://www.storzmedical.com/en/physics-and-technology), it is understood that the oscillating pressure, of Garibyan et al, oscillates between a positive pressure and a negative pressure.
In regards to claim 18, in the modified system of Garibyan et al and Vangipuram et al, Garibyan et al does not state wherein the oscillating pressure comprises a negative pressure; however, as Garibyan et al teaches wherein the pressure applied to the patient's skin is provided as a shock wave (paragraph [0054]: shock wave), and it is known that a shock wave “is when lots of energy comes from a very small spot and shakes the material around it. The energy makes the material around the spot move very quickly, and very hard. This is a special type of vibration” (Shock wave: https://simple.wikipedia.org/wiki/Shock_wave) and vibration “is a mechanical phenomenon whereby oscillations occur about an equilibrium point” (Vibration: https://en.wikipedia.org/wiki/Vibration), and “shock waves are characterized by a single, mostly positive pressure pulse followed by a comparatively small tensile wave component (negative pressure pulse) (Fig. 2)” (What are shock waves? Physics and Technology: https://www.storzmedical.com/en/physics-and-technology), it is understood that the oscillating pressure, of Garibyan et al, comprises a negative pressure.
In regards to claim 19, in the modified system of Garibyan et al and Vangipuram et al, Garibyan et al teaches wherein the pressure applied to the patient's skin includes a vibration (paragraph [0054]: vibration).
In regards to claim 20, in the modified system of Garibyan et al and Vangipuram et al, Garibyan et al teaches wherein the pressure application device is embodied in a wearable device (Figure 2A)(paragraph [0035]: wearable device).
In regards to claim 21, in the modified system of Garibyan et al and Vangipuram et al, Garibyan et al does not teach wherein the first portion of the freed pigment particles move from a dermis into a subcutaneous tissue of the patient's skin after applying the pressure. Vangipuram et al teaches wherein the first portion of the freed pigment particles move from a dermis into a subcutaneous tissue of the patient's skin after applying the pressure (page 892: AWST may enhance tattoo clearance by increasing lymphatic drainage… thereby accelerating the clearance of dermal pigment vacuoles produced by the picosecond laser). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the first portion of the freed pigment particles, of the modified system of Garibyan et al and Vangipuram et al, to move from a dermis into a subcutaneous tissue of the patient's skin after applying the pressure, as taught by Vangipuram et al, as such will result in a decrease in epidermal side effects of erythema, edema, and crusting (page 892: The decrease in epidermal side effects of erythema, edema, and crusting on the side treated with ASWT may be a result of increased microcirculation and lymphatic drainage).
Response to Amendment
The Declaration of Richard Anderson under 37 CFR 1.132 filed October 20, 2025, is insufficient to overcome the rejection of claims 12 and 15-21 based upon Vangipuram et al applied under 35 U.S.C. 103 as set forth in the last Office action because:
Applicant argued: ASWT as described in Vangipuram et al. and understood in the field does not cause a fluid flow in a tissue. Therefore, applying ASWT in the manner applied in the Office Action would not cause the claimed ink particles to move deeper into the skin, as claimed (Declaration, page 2, paragraphs 7-8). Examiner disagrees. Vangipuram (page 892) states: “AWST may enhance tattoo clearance by increasing lymphatic drainage” and increasing metabolic activity in the treated area, “thereby accelerating the clearance of dermal pigment vacuoles produced by the picosecond laser”. Lymphatic drainage is understood as the removal of fluid by the lymphatic system, wherein lymph vessels collect fluid to drain into deeper lymph nodes. Thus, it is understood that ASWT moves fluid, including dermal pigment vacuoles, deeper into the skin by way of lymphatic system drainage being increased.
Response to Arguments
Applicant's arguments filed October 20, 2025, have been fully considered but they are not persuasive:
In regards to claim 12, Applicant argued: Vangipuram, which teaches a method of applying acoustic shock wave therapy (ASWT) in between the application of a laser to enhance the removal of ink particles through lymphatic drainage, fails to cure the deficiency of Garibyan in generating a fluid flow to move ink particles from the dermis deeper into the subcutaneous tissue. As explained in the declaration of Dr. Anderson submitted herewith, ASWT applies "a mechanically generated external sound wave to the tissue" and increases "mediators such as vascular endothelial growth factor which increases local blood circulation" (pg. 892). ASWT, as described in Vangipuram et al. and understood in the field, does not cause a fluid flow in a tissue. Thus, applying ASWT in a combination with Garibyan in the manner applied in the Office Action would not function to move ink particles deeper into the skin, as claimed (Remarks, pages 6-7). Examiner disagrees. Vangipuram (page 892) states: “AWST may enhance tattoo clearance by increasing lymphatic drainage” and increasing metabolic activity in the treated area, “thereby accelerating the clearance of dermal pigment vacuoles produced by the picosecond laser”. Lymphatic drainage is understood as the removal of fluid by the lymphatic system, wherein lymph vessels collect fluid to drain into deeper lymph nodes. Thus, it is understood that ASWT moves fluid, including dermal pigment vacuoles, deeper into the skin by way of lymphatic system drainage being increased.
Conclusion
THIS ACTION IS MADE FINAL. 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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/SHEFALI D PATEL/Primary Examiner, Art Unit 3783