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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 April 8, 2026, has been entered.
Acknowledgments
In the reply, filed on April 8, 2026, Applicant amended claims 1, 13, 29, and 31-32.
In the final rejection of December 8, 2025, Examiner objected to claims 1, 13, 29, and 32. Applicant amended claims 1, 13, 29, and 32. Objection is withdrawn.
Examiner rejected claim 31 under 35 U.S.C. 112(a). Applicant persuasively argued support for claim 31 (Remarks, page 9). Rejection is withdrawn.
Examiner rejected claims 30-31 under 35 U.S.C. 112(b). Applicant amended claims 29 and 31. Rejection is withdrawn.
Examiner rejected claims 30-31 under 35 U.S.C. 112(d). Applicant amended claims 29 and 31. Rejection is withdrawn.
Currently, claims 1-13, 15-18, and 20-32 are under examination.
Claim Objections
Claims 29 and 32 are objected to because of the following informalities:
In regards to claim 29, line 14, “the first and second conduits” should be changed to “the one or more first conduits and the one or more second conduits”.
In regards to claim 32, line 11, “the alternating pressure and suction pattern” should be changed to “the pressure and the suction in the alternating pattern”.
In regards to claim 32, line 15, “the first conduits and second conduits” should be changed to “the one or more first conduits and the one or more second conduits”.
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.
Claims 29 and 32 are rejected under 35 U.S.C. 103 as being unpatentable over Larsson (US 2010/0228206), and further in view of Hazut et al (US 2006/0142708).
In regards to claim 29, Larsson teaches a device (Figure 7), the device comprising:
a housing (11/3)
at least one fluid injection mechanism (16) within an outer section of the housing, the at least one fluid injection mechanism configured to inject an irrigation fluid into the skin to define an irrigation area (paragraph [0060] states “different substances can also be delivered to the wound bed through both needles… the delivery can take place through the first needles 15”; thus it is understood that irrigation fluid is injected through first needles 15)
a pressure/suction mechanism (21) within an inner section of the housing, wherein the pressure/suction mechanism is configured to apply a pressure (paragraph [0060] states “a medicament, a liquid or a gas can be delivered to the wound bed via the second needles 25… different substances can also be delivered to the wound bed through both needles”; thus, it is understood that pressure is applied by medicament/liquid/gas/substances delivered through second needles 25) and a suction in a pattern to the irrigation area to facilitate the removal of the irrigation fluid from the irrigation area (paragraph [0060]: suction via the second needles 25)
wherein the inner section of the housing includes one or more first conduits (some of second needles 25) for applying the pressure to the irrigation area (paragraph [0060] states “a medicament, a liquid or a gas can be delivered to the wound bed via the second needles 25… different substances can also be delivered to the wound bed through both needles”; thus, it is understood that pressure is applied by medicament/liquid/gas/substances delivered through second needles 25) and one or more second conduits (rest of second needles 25) for applying the suction to the irrigation area (paragraph [0060]: suction via the second needles 25), wherein the first and second conduits are different (it is understood that the second needles 25 are different at least with respect to location with respect to the skin)
Larsson does not teach the device specifically “configured to remove exogenous particles from skin”, “wherein the exogenous particles are removeable from the irrigation area with the irrigation fluid”, the removal of “at least a portion of the exogenous particles from the irrigation area”, as Larsson instead teaches the device specifically configured to remove wound fluid from a wound bed (paragraph [0060]: wound fluid can thus be aspirated from the wound bed)(paragraph [0060]: suction via the second needles 25). Hazut et al teaches a device (Figure 1) configured to remove exogenous particles from skin (Abstract: removing pigments from a pigmented section of a skin), wherein the exogenous particles are removeable from an irrigation area with an irrigation fluid (paragraph [0020]: suction of the pigments from said punctured skin by means of the suction means)(paragraph [0015]: "pigments" indicates a mixture of small particles with water, which may… include some dissolved pigments), and wherein a pressure/suction mechanism (needle 11 and suction means 12) is configured to apply a pressure (paragraph [0021] states “injecting of the aqueous material to the skin is performed by dipping the needle(s) in said aqueous material prior to the puncturing of the skin”; thus, it is understood that pressure is applied by aqueous material delivered by needle 11) and a suction in a pattern to the irrigation area to facilitate the removal of the irrigation fluid and at least a portion of the exogenous particles from the irrigation area (paragraph [0020]: suction of the pigments from said punctured skin by means of the suction means)(paragraph [0015]: "pigments" indicates a mixture of small particles with water, which may… include some dissolved pigments). 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 device, of Larsson, to be configured to remove exogenous particles from skin, wherein the exogenous particles are removeable from the irrigation area with the irrigation fluid, and the removal of at least a portion of the exogenous particles from the irrigation area, as taught by Hazut et al, as such will allow for removing a pigmented section of skin which is relatively inexpensive (paragraph [0012]) as compared to other long and expensive procedures, such as dermabrasion, cryosurgery, excision, and lasers (paragraphs [0004][0005][0006][0008][0009]) for people who wish to remove a tattoo from their skin for a variety of reasons (paragraph [0003]).
In regards to claim 32, Larsson teaches a method (paragraph [0060]), the method comprising:
attaching a device (Figure 7) to the skin (paragraph [0036]: wound cover 3 is preferably secured on the healthy skin surrounding the wound, in particular with an adhesive tape), wherein the device comprises a housing (11/3), at least one fluid injection mechanism (16) within an outer section of the housing, the at least one fluid injection mechanism configured to inject an irrigation fluid into the skin to define an irrigation area (paragraph [0060] states “different substances can also be delivered to the wound bed through both needles… the delivery can take place through the first needles 15”; thus it is understood that irrigation fluid is injected through first needles 15), and a pressure/suction mechanism (21) within an inner section of the housing, the pressure/suction mechanism configured to apply a pressure (paragraph [0060] states “a medicament, a liquid or a gas can be delivered to the wound bed via the second needles 25… different substances can also be delivered to the wound bed through both needles”; thus, it is understood that pressure is applied by medicament/liquid/gas/substances delivered through second needles 25) and a suction in an alternating pattern to the irrigation area (paragraph [0060]: suction via the second needles 25)
injecting the irrigation fluid into the skin to define the irrigation area (paragraph [0060] states “different substances can also be delivered to the wound bed through both needles… the delivery can take place through the first needles 15”; thus it is understood that irrigation fluid is injected through first needles 15)
applying the alternating pressure (paragraph [0060] states “a medicament, a liquid or a gas can be delivered to the wound bed via the second needles 25… different substances can also be delivered to the wound bed through both needles”; thus, it is understood that pressure is applied by medicament/liquid/gas/substances delivered through second needles 25) and suction pattern to the irrigation area to remove the irrigation fluid (paragraph [0060]: suction via the second needles 25)
wherein the inner section of the housing includes one or more first conduits (some of second needles 25) for applying the pressure to the irrigation area (paragraph [0060] states “a medicament, a liquid or a gas can be delivered to the wound bed via the second needles 25… different substances can also be delivered to the wound bed through both needles”; thus, it is understood that pressure is applied by medicament/liquid/gas/substances delivered through second needles 25) and one or more second conduits (rest of second needles 25) for applying the suction to the irrigation area (paragraph [0060]: suction via the second needles 25), wherein the first conduits and second conduits are different (it is understood that the second needles 25 are different at least with respect to location with respect to the skin)
Larsson does not teach the method specifically “for removing exogenous particles from skin”, “wherein the exogenous particles are removeable from the irrigation area with the irrigation fluid”, to remove “at least a portion of the exogenous particles from the irrigation area”, as Larsson instead teaches the method for removing wound fluid from a wound bed (paragraph [0060]: wound fluid can thus be aspirated from the wound bed)(paragraph [0060]: suction via the second needles 25). Hazut et al teaches a method for removing exogenous particles from skin (Abstract: method for removing pigments from a pigmented section of a skin), wherein the exogenous particles are removeable from an irrigation area with an irrigation fluid (paragraph [0020]: suction of the pigments from said punctured skin by means of the suction means)(paragraph [0015]: "pigments" indicates a mixture of small particles with water, which may… include some dissolved pigments), applying an alternating pressure (paragraph [0021] states “injecting of the aqueous material to the skin is performed by dipping the needle(s) in said aqueous material prior to the puncturing of the skin”; thus, it is understood that pressure is applied by aqueous material delivered by needle 11) and suction pattern to the irrigation area to remove the irrigation fluid and at least a portion of the exogenous particles from the irrigation area (paragraph [0020]: suction of the pigments from said punctured skin by means of the suction means)(paragraph [0015]: "pigments" indicates a mixture of small particles with water, which may… include some dissolved pigments). 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 method, of Larsson, to be for removing exogenous particles from skin, wherein the exogenous particles are removeable from the irrigation area with the irrigation fluid, and to remove at least a portion of the exogenous particles from the irrigation area, as taught by Hazut et al, as such will allow for removing a pigmented section of skin which is relatively inexpensive (paragraph [0012]) as compared to other long and expensive procedures, such as dermabrasion, cryosurgery, excision, and lasers (paragraphs [0004][0005][0006][0008][0009]) for people who wish to remove a tattoo from their skin for a variety of reasons (paragraph [0003]).
Claims 30-31 are rejected under 35 U.S.C. 103 as being unpatentable over Larsson and Hazut et al, as applied to claim 29 above, and further in view of Myung et al (US 2015/0305930).
In regards to claim 30, in the modified device of Larsson and Hazut et al, Larsson does not teach wherein the pressure and the suction are applied simultaneously, as Larsson teaches the pressure and the suction are applied not simultaneously or at different times from each other (Figure 7; paragraph [0060] states “a medicament, a liquid or a gas can be delivered to the wound bed via the second needles 25… different substances can also be delivered to the wound bed through both needles”; thus, it is understood that pressure is applied by medicament/liquid/gas/substances delivered through second needles 25)(paragraph [0060]: suction via the second needles 25). Myung et al teaches a device (Figure 1) wherein a pressure (107) and a suction (106) are applied simultaneously (Figure 1). 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 and the suction, of the modified device of Larsson and Hazut et al, to be applied simultaneously, as taught by Myung et al, as such will allow for suction application to cause pressure to be applied in an accelerated fashion across the outer layer (epithelium) without the need for debridement of the epithelium (paragraph [0131]).
In regards to claim 31, in the modified device of Larsson, Hazut et al, and Myung et al, Larsson teaches wherein the pattern is a spatial pattern in the irrigation area (Figure 7).
Response to Arguments
Applicant's arguments filed April 8, 2026, have been fully considered but they are not persuasive:
In regards to claims 29 and 32, Applicant argued: Instead, the plain grammatical reading of paragraph [0060] supports only that delivery and suction are allocated to different needle sets in different operational arrangements, i.e., alternative embodiments or modes of operation, rather than a single embodiment in which different subsets of the same conduits simultaneously apply pressure and suction. This grammatical reading is further confirmed by FIG. 7 of Larsson, which shows needles 25 collectively connected to the inner body 21, with no disclosure of structural separation, valving, or routing that would allow some of the same conduits to deliver fluid while others simultaneously apply suction. Critically, Larsson does not disclose any mechanism for designating "some of' the second needles for delivery and "the rest" for suction, nor does it explain how such simultaneous, segregated functionality would be implemented. The Examiner's interpretation therefore requires reading into Larsson a structural and functional capability that is neither described nor illustrated. Because Larsson does not teach or suggest different first conduits for applying pressure and different second conduits for applying suction within the inner section, as expressly required by claims 29 and 32, the cited combination of Larsson and Hazut fails to disclose the claimed subject matter. Accordingly, claims 29 and 32 are not rendered obvious by the cited references, and withdrawal of the § 103 rejection is respectfully requested (Remarks, page 13). Examiner disagrees. First, Larsson (paragraph [0060]) states “As is shown in FIG. 7, the wound fluid can thus be aspirated from the wound bed through the first needles 15 and, without changing the position of the device according to the invention, a medicament, a liquid or a gas can be delivered to the wound bed via the second needles 25. This delivery can take place at the same time as the suction or at a different time. However, different substances can also be delivered to the wound bed through both needles. Moreover, the delivery can take place through the first needles 15 and the suction via the second needles 25” from which it is understood that all conduits 15/25 can alternatively inject fluid applying pressure and apply suction. When the device of Larsson is operated in the mode delivering substances through the first needles 15, this correlates to the claimed at least one fluid injection mechanism. When the device of Larsson is operated in the mode delivering medicament/liquid/gas/substances through the second needles 25, this correlates to the claimed pressure mechanism. And when the device of Larsson is operated in the mode suctioning via the second needles 25, this correlates to the claimed suction mechanism. Second, claims 29 and 32 do not exclude the conduits of the pressure mechanism from also being able to alternatively apply suction, and claims 29 and 32 do not exclude the conduits of the suction mechanism from also being able to alternatively apply pressure. Third, claims 29 and 32 do not require the same conduits “simultaneously” apply pressure and suction.
In regards to claims 30-31, Applicant argued: The Office alleges that Myung teaches simultaneous pressure and suction. This reading is erroneous. Paragraph [0131] of Myung explains that vacuum (106) creates a pressure gradient, causing diffusion (107) into tissue, and not a simultaneous application of positive pressure and suction as claimed. Element 107 in Myung refers to diffusion direction, not applied pressure. Thus, Myung teaches the opposite flow behavior from that claimed, and does not remedy the deficiencies of Larsson and Hazut (Remarks, page 13). Examiner disagrees. Myung et al (paragraph [0131]) states “The pores 104 of the vacuum tip allow for the drug solution 103 that is injected in through the fluid port 105. Application of vacuum pull 106 (negative pressure) over-lying the drug solution creates pressure gradient between the drug solution 103 and the cornea 101. This vacuum application causes the drug to diffuse 107 into the cornea in an accelerated fashion across its outer layer (epithelium) without the need for debridement of the epithelium” from which it is understood that drug injection and vacuum occur simultaneously, as shown in Figure 1. Drug injection 107 is understood to apply pressure simultaneously with vacuum 106 applying suction.
Allowable Subject Matter
Claims 1-13, 15-18, and 20-28 are allowed.
In regards to independent claim 1, the prior art of record does not disclose or render obvious before the effective filing date of the claimed invention the combination of a device configured to remove exogenous particles from skin, as claimed, specifically including wherein the applying the pressure includes applying a mechanical force onto a surface of the skin.
Larsson teaches a device (Figure 7).
And while Larsson teaches wherein the applying the pressure includes applying a medicament, a liquid, a gas, or different substances (paragraph [0060] states “a medicament, a liquid or a gas can be delivered to the wound bed via the second needles 25… different substances can also be delivered to the wound bed through both needles”; thus, it is understood that pressure is applied by a medicament, a liquid, a gas, or different substances delivered through second needles 25), Larsson is silent about whether such includes applying a mechanical force onto a surface of the skin.
Freeman (US 2003/0021775) teaches a device (Figure 1) wherein applying a pressure includes applying a mechanical force onto a surface of skin (paragraph [0073]: the protease solution is delivered to the site of treatment with sufficient force to effect a mechanical, "stripping" action in addition to the enzymatic digestion of matrix proteins. The novel combination of a directional, mechanical force and enzymatic disruption of the lesion tissue provided by the present invention enables the removal of cells and tissue from the treated surfaces).
Applicant persuasively argues: However, Freeman is not combinable with Larsson in the manner proposed without destroying Larsson's intended function. Freeman applies protease solution onto the surface of tissue to create mechanical stripping. By contrast, Larsson's device relies on penetration elements to inject and aspirate fluid below the tissue surface. Substituting Freeman's applicator into Larsson results in one of two impermissible outcomes: 1. If Larsson's penetration elements are retained, Freeman's solution would be injected subdermally, thereby eliminating surface mechanical force entirely. 2. If Larsson's penetration elements are removed, Larsson's inner portion can no longer aspirate fluid delivered by the outer portion, thus defeating its primary purpose. In either case, the proposed combination is structurally incompatible and renders Larsson inoperable for its intended function. Such a modification is improper. See MPEP 2143.01 (Remarks, page 10).
Thus, independent claim 1 is allowed. Dependent claims 2-12, 20, and 23-25 are allowed by virtue of being dependent upon independent claim 1.
In regards to independent claim 13, the prior art of record does not disclose or render obvious before the effective filing date of the claimed invention the combination of a method for removing exogenous particles from skin, as claimed, specifically including wherein the applying the pressure includes applying a mechanical force onto a surface of the skin.
Larsson teaches a method (paragraph [0060]).
And while Larsson teaches wherein the applying the pressure includes applying a medicament, a liquid, a gas, or different substances (paragraph [0060] states “a medicament, a liquid or a gas can be delivered to the wound bed via the second needles 25… different substances can also be delivered to the wound bed through both needles”; thus, it is understood that pressure is applied by a medicament, a liquid, a gas, or different substances delivered through second needles 25), Larsson is silent about whether such includes applying a mechanical force onto a surface of the skin.
Freeman teaches a method (Figure 1) wherein applying a pressure includes applying a mechanical force onto a surface of skin (paragraph [0073]: the protease solution is delivered to the site of treatment with sufficient force to effect a mechanical, "stripping" action in addition to the enzymatic digestion of matrix proteins. The novel combination of a directional, mechanical force and enzymatic disruption of the lesion tissue provided by the present invention enables the removal of cells and tissue from the treated surfaces).
Applicant persuasively argues: However, Freeman is not combinable with Larsson in the manner proposed without destroying Larsson's intended function. Freeman applies protease solution onto the surface of tissue to create mechanical stripping. By contrast, Larsson's device relies on penetration elements to inject and aspirate fluid below the tissue surface. Substituting Freeman's applicator into Larsson results in one of two impermissible outcomes: 1. If Larsson's penetration elements are retained, Freeman's solution would be injected subdermally, thereby eliminating surface mechanical force entirely. 2. If Larsson's penetration elements are removed, Larsson's inner portion can no longer aspirate fluid delivered by the outer portion, thus defeating its primary purpose. In either case, the proposed combination is structurally incompatible and renders Larsson inoperable for its intended function. Such a modification is improper. See MPEP 2143.01 (Remarks, page 10).
Thus, independent claim 13 is allowed. Dependent claims 15-18, 21-22, and 26-28 are allowed by virtue of being dependent upon independent claim 13.
Conclusion
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/SHEFALI D PATEL/Primary Examiner, Art Unit 3783
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