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 August 26, 2025, Applicant amended claims 1, 13, 21, and 27.
Applicant added new claims 29-32.
In the non-final rejection of March 26, 2025, Examiner objected to claims 1, 13, 21, and 27. Applicant amended claims 1, 13, 21, and 27. Objection is withdrawn.
Currently, claims 1-13, 15-18, and 20-32 are under examination.
Claim Objections
Claims 1, 13, 29, and 32 are objected to because of the following informalities:
In regards to claim 1, line 17, “applying the pressure” should be changed to “the applying the pressure”.
In regards to claim 13, line 17, “applying the pressure” should be changed to “the applying the pressure”.
In regards to claim 29, line 13, “the pressure” should be changed to “a pressure”.
In regards to claim 29, line 13, “the suction” should be changed to “a suction”.
In regards to claim 32, line 12, “the pressure” should be changed to “a pressure”.
In regards to claim 32, line 12, “the suction” should be changed to “a suction”.
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.
Claim 31 is 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 31, lines 1-2 recite: “wherein the alternating pressure and suction pattern is a spatial pattern in the irrigation area”; however, such is new matter not described in the Specification.
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 30-31 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.
In regards to claim 30, lines 1-2 recite: “wherein the pressure and the suction are applied simultaneously”. Claim 30 depends upon claim 29. Claim 29, line 9 recites: “an alternating pressure and suction pattern”. It is unclear how the pressure and the suction can be both alternating and simultaneous, which are understood as opposite terms. Claim 31 is rejected by virtue of being dependent upon claim 30.
In regards to claim 31, lines 1-2 recite: wherein “the alternating pressure and suction pattern” is a spatial pattern in the irrigation area. Claim 31 depends upon claim 30. Claim 30, lines 1-2 recite: “wherein the pressure and the suction are applied simultaneously”. It is unclear how the pressure and the suction can be both simultaneous and alternating, which are understood as opposite terms.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 30-31 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
In regards to claim 30, lines 1-2 recite: “wherein the pressure and the suction are applied simultaneously”. Claim 30 depends upon claim 29. Claim 29, line 9 recites: “an alternating pressure and suction pattern”. As claim 29 already establishes the pressure and the suction as alternating, claim 30 reciting “the pressure and the suction are applied simultaneously”, which is the opposite of alternating, is of improper dependent form for failing to include all the limitations of claim 29 upon which it depends. Claim 31 is rejected by virtue of being dependent upon claim 30.
In regards to claim 31, lines 1-2 recite: wherein “the alternating pressure and suction pattern” is a spatial pattern in the irrigation area. Claim 31 depends upon claim 30. Claim 30, lines 1-2 recite: “wherein the pressure and the suction are applied simultaneously”. As claim 30 already establishes the pressure and the suction as simultaneous, claim 31 reciting “the alternating pressure and suction pattern”, which is the opposite of simultaneous, is of improper dependent form for failing to include all the limitations of claim 30 upon which it depends.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 1-3, 5-13, 15, 17-18, 20-24, and 26-27 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) and Freeman (US 2003/0021775).
In regards to claim 1, Larsson teaches a device (Figure 7), the device comprising:
a housing (main body 11 and wound cover 3)
at least one fluid injection mechanism (at least one hollow space 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]: the delivery can take place through the first needles 15)
a pressure/suction mechanism (second main body 21) within an inner section of the housing, wherein the pressure/suction mechanism is configured to apply an alternating pressure (paragraph [0060] states “different substances can also be delivered to the wound bed through both needles”; thus, it is understood that pressure is applied by substances delivered through second needles 25) and suction 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 applying a suction facilitates a flow of the irrigation fluid (paragraph [0060]: suction via the second needles 25)
wherein applying a pressure into the inner section of the housing and onto the skin causes a stop in the flow of the irrigation fluid (paragraph [0060] states “different substances can also be delivered to the wound bed through both needles. Moreover,… the suction via the second needles 25”; from which it is understood that when pressure is applied by substances delivered through second needles 25, suction via the second needles 25 would stop)
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”, wherein applying a suction facilitates a flow of “the at least the portion of the exogenous particles”, and wherein applying a pressure into the inner section of the housing and onto the skin causes a stop in the flow of “the at least the portion of the exogenous particles”, 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 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 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), wherein applying a suction facilitates a flow of the irrigation fluid and the at least the portion of the exogenous particles (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, the removal of at least a portion of the exogenous particles from the irrigation area, and wherein applying a suction facilitates a flow of the at least the portion of the exogenous particles, as taught by Hazut et al, as such will allow for removing a pigmented section of skin which is relatively inexpensive (paragraphs [[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]). And in the combination of Larsson and Hazut et al, it would be expected wherein applying a pressure onto the skin causes a stop in the flow of the irrigation fluid, of Larsson, the flow of the at least the portion of the exogenous particles, of Hazut et al, would also be stopped, as Hazut et al teaches suction facilitates a flow of the irrigation fluid and at least a portion of the exogenous particles.
Further, while Larsson teaches wherein applying the pressure includes applying a medicament, a liquid, a gas, or different substances onto a surface of the skin (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 the surface of the skin. Freeman 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). 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 applying the pressure, of the device of Larsson and Hazut et al, to include applying a mechanical force onto a surface of the skin, as taught by Freeman, as such will effect a mechanical, "stripping" action to enable the removal of cells and tissue from the treated surfaces (paragraph [0073]) causing gentle but effective tissue erosion for histological analysis and/or cell culture, affording a method of "enzymatic biopsy" (Abstract).
In regards to claim 2, in the modified device of Larsson, Hazut et al, and Freeman, Larsson teaches wherein the inner section of the housing is configured to form one or more channels within a portion of the irrigation area (paragraph [0059]: These penetration elements 24 preferably also have a sharp-pointed and/or cutting shape. Their dimensions can be the same as or greater or smaller than those of the first-mentioned penetration elements 14. In particular, their through-channels 25 can have the same internal diameter as, or a greater or smaller internal diameter than, the through-channels 15 of the first penetration elements 14)(paragraph [0051]: continuous channels are created between the hollow space… or drainage tube and the wound bed W), wherein the irrigation fluid is removed through the one or more channels (paragraph [0060]: suction via the second needles 25). However, Larsson does not teach “the at least the portion of the exogenous particles are removed through the one or more channels”, as Larsson instead teaches wound fluid removed through the one or more channels 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 wherein the irrigation fluid and the at least the portion of the exogenous particles are removed through one or more channels (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)(paragraph [0018]: each needle can be… hollow)(paragraph [0033]: suction means 12 coupled to needle 11 via the tube system (not shown) of the skin puncturing device 10). 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 modified device, of Larsson, Hazut et al, and Freeman, with wherein the irrigation fluid and the at least the portion of the exogenous particles are removed through one or more channels, as taught by Hazut et al, as such will allow for removing a pigmented section of skin which is relatively inexpensive (paragraphs [[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 3, in the modified device of Larsson, Hazut et al, and Freeman, Larsson teaches wherein the inner section of the housing comprises at least one microneedle or coring needle (paragraph [0059]: penetration elements 24, in particular hollow needles. These penetration elements 24 preferably also have a sharp-pointed and/or cutting shape) to form the one or more channels within the portion of the irrigation area.
In regards to claim 5, it is recited “wherein the irrigation area is within a dermis of the skin”. Note: claim 5 is drawn to a device intended to be used with an irrigation area within a dermis of the skin, and thus the irrigation area within the dermis of the skin is not a positively recited structure of the claimed device. The combination of Larsson, Hazut et al, and Freeman teaches the claimed device of claim 5 having the ability to be used with an irrigation area within a dermis of the skin, as claimed. In other words, the modified device, of Larsson, Hazut et al, and Freeman, is capable of being used with the irrigation area within the dermis of the skin.
In regards to claim 6, in the modified device of Larsson, Hazut et al, and Freeman, Larsson teaches an adhesive material (paragraph [0036]: adhesive tape) along at least a portion of the housing to attach the housing to the skin (paragraph [0036]: wound cover 3 is preferably secured on the healthy skin surrounding the wound, in particular with an adhesive tape).
In regards to claim 7, in the modified device of Larsson, Hazut et al, and Freeman, Larsson teaches wherein the housing comprises a domed portion (11) to be placed away from the skin and a substantially flat portion (3) to be placed on the skin, wherein the adhesive material is along at least a portion of the substantially flat portion (paragraph [0036]: wound cover 3 is preferably secured on the healthy skin surrounding the wound, in particular with an adhesive tape).
In regards to claim 8, it is recited “wherein the irrigation fluid comprises a biocompatible fluid and an additive”. Note: claim 8 is drawn to a device intended to be used with an irrigation fluid comprising a biocompatible fluid and an additive, and thus the irrigation fluid comprising the biocompatible fluid and the additive is not a positively recited structure of the claimed device. The combination of Larsson, Hazut et al, and Freeman teaches the claimed device of claim 8 having the ability to be used with an irrigation fluid comprising a biocompatible fluid and an additive, as claimed. In other words, the modified device, of Larsson, Hazut et al, and Freeman, is capable of being used with the irrigation fluid comprising the biocompatible fluid and the additive.
In regards to claim 9, it is recited “wherein the additive is a pharmaceutical agent, an enzyme, a natural product, and/or a venom”. Note: claim 9 is drawn to a device intended to be used with an additive that is a pharmaceutical agent, an enzyme, a natural product, and/or a venom, and thus the additive that is a pharmaceutical agent, an enzyme, a natural product, and/or a venom is not a positively recited structure of the claimed device. The combination of Larsson, Hazut et al, and Freeman teaches the claimed device of claim 9 having the ability to be used with an additive that is a pharmaceutical agent, an enzyme, a natural product, and/or a venom, as claimed. In other words, the modified device, of Larsson, Hazut et al, and Freeman, is capable of being used with the additive that is a pharmaceutical agent, an enzyme, a natural product, and/or a venom.
In regards to claim 10, it is recited “wherein the additive is capable of at least one of lysing cells, making the skin more porous, preventing or inhibiting phagocytosis, creating localized edema, or facilitating the removal of the irrigation fluid”. Note: claim 10 is drawn to a device intended to be used with an additive that is capable of at least one of lysing cells, making the skin more porous, preventing or inhibiting phagocytosis, creating localized edema, or facilitating the removal of the irrigation fluid, and thus the additive that is capable of at least one of lysing cells, making the skin more porous, preventing or inhibiting phagocytosis, creating localized edema, or facilitating the removal of the irrigation fluid is not a positively recited structure of the claimed device. The combination of Larsson, Hazut et al, and Freeman teaches the claimed device of claim 10 having the ability to be used with an additive that is capable of at least one of lysing cells, making the skin more porous, preventing or inhibiting phagocytosis, creating localized edema, or facilitating the removal of the irrigation fluid, as claimed. In other words, the modified device, of Larsson, Hazut et al, and Freeman, is capable of being used with the additive that is capable of at least one of lysing cells, making the skin more porous, preventing or inhibiting phagocytosis, creating localized edema, or facilitating the removal of the irrigation fluid.
In regards to claim 11, it is recited “wherein the biocompatible fluid comprises at least one of saline or water”. Note: claim 11 is drawn to a device intended to be used with a biocompatible fluid comprising at least one of saline or water, and thus the biocompatible fluid comprising at least one of saline or water is not a positively recited structure of the claimed device. The combination of Larsson, Hazut et al, and Freeman teaches the claimed device of claim 11 having the ability to be used with a biocompatible fluid comprising at least one of saline or water, as claimed. In other words, the modified device, of Larsson, Hazut et al, and Freeman, is capable of being used with the biocompatible fluid comprising at least one of saline or water.
In regards to claim 12, it is recited “wherein the irrigation fluid comprises a pressurized fluid”. Note: claim 12 is drawn to a device intended to be used with an irrigation fluid comprising a pressurized fluid, and thus the irrigation fluid comprising a pressurized fluid is not a positively recited structure of the claimed device. The combination of Larsson, Hazut et al, and Freeman teaches the claimed device of claim 12 having the ability to be used with an irrigation fluid comprising a pressurized fluid, as claimed. In other words, the modified device, of Larsson, Hazut et al, and Freeman, is capable of being used with the irrigation fluid comprising a pressurized fluid.
In regards to claim 13, 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]: the delivery can take place through the first needles 15), and a pressure/suction mechanism (21) within an inner section of the housing, the pressure/suction mechanism configured to apply an alternating pressure (paragraph [0060] states “different substances can also be delivered to the wound bed through both needles”; thus, it is understood that pressure is applied by substances delivered through second needles 25) and suction 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]: the delivery can take place through the first needles 15)
applying the alternating pressure (paragraph [0060] states “different substances can also be delivered to the wound bed through both needles”; thus, it is understood that pressure is applied by 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 applying a suction facilitates a flow of the irrigation fluid (paragraph [0060]: suction via the second needles 25)
wherein applying a pressure into the inner section of the housing and onto the skin causes a stop in the flow of the irrigation fluid (paragraph [0060] states “different substances can also be delivered to the wound bed through both needles. Moreover,… the suction via the second needles 25”; from which it is understood that when pressure is applied by substances delivered through second needles 25, suction via the second needles 25 would stop)
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”, wherein applying a suction facilitates a flow of “the at least the portion of the exogenous particles”, and wherein applying a pressure into the inner section of the housing and onto the skin causes a stop in the flow of “the at least the portion of the exogenous particles”, 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), wherein applying a suction facilitates a flow of the irrigation fluid and the at least the portion of the exogenous particles (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, to remove at least a portion of the exogenous particles from the irrigation area, and wherein applying a suction facilitates a flow of the at least the portion of the exogenous particles, as taught by Hazut et al, as such will allow for removing a pigmented section of skin which is relatively inexpensive (paragraphs [[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]). And in the combination of Larsson and Hazut et al, it would be expected wherein applying a pressure onto the skin causes a stop in the flow of the irrigation fluid, of Larsson, the flow of the at least the portion of the exogenous particles, of Hazut et al, would also be stopped, as Hazut et al teaches suction facilitates a flow of the irrigation fluid and at least a portion of the exogenous particles.
Further, while Larsson teaches wherein applying the pressure includes applying a medicament, a liquid, a gas, or different substances onto a surface of the skin (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 the 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). 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 applying the pressure, of the method of Larsson and Hazut et al, to include applying a mechanical force onto a surface of the skin, as taught by Freeman, as such will effect a mechanical, "stripping" action to enable the removal of cells and tissue from the treated surfaces (paragraph [0073]) causing gentle but effective tissue erosion for histological analysis and/or cell culture, affording a method of "enzymatic biopsy" (Abstract).
In regards to claim 15, in the modified method of Larsson, Hazut et al, and Freeman, Larsson teaches forming one or more channels within a portion of the irrigation area (paragraph [0059]: These penetration elements 24 preferably also have a sharp-pointed and/or cutting shape. Their dimensions can be the same as or greater or smaller than those of the first-mentioned penetration elements 14. In particular, their through-channels 25 can have the same internal diameter as, or a greater or smaller internal diameter than, the through-channels 15 of the first penetration elements 14)(paragraph [0051]: continuous channels are created between the hollow space… or drainage tube and the wound bed W), wherein the irrigation fluid is removed through the one or more channels (paragraph [0060]: suction via the second needles 25). However, Larsson does not teach “the at least the portion of the exogenous particles are removed through the one or more channels”, as Larsson instead teaches wound fluid removed through the one or more channels 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 wherein the irrigation fluid and the at least the portion of the exogenous particles are removed through one or more channels (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)(paragraph [0018]: each needle can be… hollow)(paragraph [0033]: suction means 12 coupled to needle 11 via the tube system (not shown) of the skin puncturing device 10). 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 modified method, of Larsson, Hazut et al, and Freeman, with wherein the irrigation fluid and the at least the portion of the exogenous particles are removed through one or more channels, as taught by Hazut et al, as such will allow for removing a pigmented section of skin which is relatively inexpensive (paragraphs [[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 17, in the modified method of Larsson, Hazut et al, and Freeman, Larsson teaches wherein the attaching further comprises using an adhesive material along at least a portion of the housing to attach the housing to the skin (paragraph [0036]: wound cover 3 is preferably secured on the healthy skin surrounding the wound, in particular with an adhesive tape).
In regards to claim 18, in the modified method of Larsson, Hazut et al, and Freeman, Larsson teaches wherein the housing comprises a domed portion (11) to be placed away from the skin and a substantially flat portion (3) to be placed on the skin, wherein the adhesive material is along at least a portion of the substantially flat portion (paragraph [0036]: wound cover 3 is preferably secured on the healthy skin surrounding the wound, in particular with an adhesive tape).
In regards to claim 20, in the modified device of Larsson, Hazut et al, and Freeman, Larsson teaches wherein the at least one fluid injection mechanism (16) and the pressure/suction mechanism (21) are separate.
In regards to claim 21, in the modified method of Larsson, Hazut et al, and Freeman, Larsson teaches wherein the pressure/suction mechanism, within the inner section of the housing, is configured to apply the alternating pressure (paragraph [0060] states “different substances can also be delivered to the wound bed through both needles”; thus, it is understood that pressure is applied by substances delivered through second needles 25) and suction pattern to the irrigation area to facilitate the removal of the irrigation fluid from the irrigation area from the inner section of the housing (paragraph [0060]: suction via the second needles 25). Larsson does not teach the removal of “the at least the portion of the exogenous particles from the irrigation area from the inner section of the housing”, as Larsson instead teaches the method specifically 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 wherein the pressure/suction mechanism is configured to apply the 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 facilitate the removal of the irrigation fluid and the at least the 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 modified method, of Larsson, Hazut et al, and Freeman, with the removal of the at least the 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 (paragraphs [[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 the combination of Larsson, Hazut et al, and Freeman, it would be understood that the at least the portion of the exogenous particles from the irrigation area would be removed “from the inner section of the housing”, as taught by Larsson.
In regards to claim 22, in the modified method of Larsson, Hazut et al, and Freeman, Larsson teaches wherein the at least one fluid injection mechanism (16) and the pressure/suction mechanism (21) are separate.
In regards to claim 23, it is recited “wherein the irrigation fluid comprises an anti-clotting drug or other anticoagulant”. Note: claim 23 is drawn to a device intended to be used with an irrigation fluid comprising an anti-clotting drug or other anticoagulant, and thus the irrigation fluid comprising the anti-clotting drug or the other anticoagulant is not a positively recited structure of the claimed device. The combination of Larsson, Hazut et al, and Freeman teaches the claimed device of claim 23 having the ability to be used with an irrigation fluid comprising an anti-clotting drug or other anticoagulant, as claimed. In other words, the modified device, of Larsson, Hazut et al, and Freeman, is capable of being used with the irrigation fluid comprising anti-clotting drug or the other anticoagulant.
In regards to claim 24, in the modified device of Larsson, Hazut et al, and Freeman, Larsson teaches a fluid source containing the irrigation fluid coupled to the at least one fluid injection mechanism (paragraph [0060]: different substances can also be delivered to the wound bed through both needles. Moreover, the delivery can take place through the first needles 15).
In regards to claim 26, in the modified method of Larsson, Hazut et al, and Freeman, Larsson is silent about wherein the irrigation fluid includes an anti-clotting drug or other anticoagulant. Freeman teaches wherein an irrigation fluid includes an anti-clotting drug or other anticoagulant (Abstract: protease solution may be supplemented with… anticoagulants). 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 irrigation fluid, of the modified method of Larsson, Hazut et al, and Freeman, to include an anti-clotting drug or other anticoagulant, as taught by Freeman, as such will decrease the discomfort, erythema, bleeding, risk of infection and scarring traditionally associated with surgical treatment of skin lesions (Abstract).
In regards to claim 27, in the modified method of Larsson, Hazut et al, and Freeman, Larsson teaches wherein a fluid source containing the irrigation fluid is coupled to the at least one fluid injection mechanism (paragraph [0060]: different substances can also be delivered to the wound bed through both needles. Moreover, the delivery can take place through the first needles 15).
Claims 4 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Larsson, Hazut et al, and Freeman, as applied to claims 2 and 15 above, and further in view of Lutski et al (US 2010/0121259).
In regards to claim 4, in the modified device of Larsson, Hazut et al, and Freeman, Larsson teaches wherein the inner section of the housing is configured to suction (paragraph [0060]: suction via the second needles 25) and to form the one or more channels within the portion of the irrigation area (paragraph [0059]: These penetration elements 24 preferably also have a sharp-pointed and/or cutting shape. Their dimensions can be the same as or greater or smaller than those of the first-mentioned penetration elements 14. In particular, their through-channels 25 can have the same internal diameter as, or a greater or smaller internal diameter than, the through-channels 15 of the first penetration elements 14)(paragraph [0051]: continuous channels are created between the hollow space… or drainage tube and the wound bed W). However, Larsson does not specifically teach wherein the inner section of the housing is configured to draw the portion of the irrigation area in the inner section of the housing to form the one or more channels within the portion of the irrigation area. Lutski et al teaches a device (Figure 4G) configured to remove exogenous particles from skin (Abstract: for removing pigment from the skin) wherein an inner section of a housing (suction cup 472) is configured to draw a portion of an irrigation area in the inner section of the housing to form one or more channels within the portion of the irrigation area (Figure 4G)(paragraph [0046]: protruder preferably lifts the portion the skin away from the tissues below. Without wishing to be limited by a single hypothesis, it is believed that lifting the skin causes it to become stretched, hence rendering it more permeable). 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 inner section of the housing, of the modified device of Larsson, Hazut et al, and Freeman, to be configured to draw the portion of the irrigation area in the inner section of the housing to form the one or more channels within the portion of the irrigation area, as taught by Lutski et al, as such will cause the skin to become stretched, hence rendering it more permeable or at least sensitive to the treatment, and with such stretching, it is believed that one or more treatment parameters may be altered, preferably through reduction, including but not limited to reducing the length of each treatment, the total number of treatments, the pressure for each pulse, the frequency of pulses, or the concentration of the drug or other treatment material included in the solution (if any), or a combination thereof (paragraph [0046]).
In regards to claim 16, in the modified method of Larsson, Hazut et al, and Freeman, Larsson teaches suctioning with the inner section of the housing (paragraph [0060]: suction via the second needles 25) and to form the one or more channels within the portion of the irrigation area (paragraph [0059]: These penetration elements 24 preferably also have a sharp-pointed and/or cutting shape. Their dimensions can be the same as or greater or smaller than those of the first-mentioned penetration elements 14. In particular, their through-channels 25 can have the same internal diameter as, or a greater or smaller internal diameter than, the through-channels 15 of the first penetration elements 14)(paragraph [0051]: continuous channels are created between the hollow space… or drainage tube and the wound bed W). However, Larsson does not specifically teach drawing the portion of the irrigation area into the inner section of the housing to form the one or more channels within the portion of the irrigation area. Lutski et al teaches a method for removing exogenous particles from skin (Abstract: method for removing pigment from the skin) comprising drawing a portion of an irrigation area into an inner section of a housing (472) to form one or more channels within the portion of the irrigation area (Figure 4G)(paragraph [0046]: protruder preferably lifts the portion the skin away from the tissues below. Without wishing to be limited by a single hypothesis, it is believed that lifting the skin causes it to become stretched, hence rendering it more permeable). 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 modified method, of Larsson, Hazut et al, and Freeman, with drawing the portion of the irrigation area into the inner section of the housing to form the one or more channels within the portion of the irrigation area, as taught by Lutski et al, as such will cause the skin to become stretched, hence rendering it more permeable or at least sensitive to the treatment, and with such stretching, it is believed that one or more treatment parameters may be altered, preferably through reduction, including but not limited to reducing the length of each treatment, the total number of treatments, the pressure for each pulse, the frequency of pulses, or the concentration of the drug or other treatment material included in the solution (if any), or a combination thereof (paragraph [0046]).
Claims 25 and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Larsson, Hazut et al, and Freeman, as applied to claims 1 and 13 above, and further in view of Hoskin et al (US 5,000,752).
In regards to claim 25, in the modified device of Larsson, Hazut et al, and Freeman, Larsson teaches configured to form one or more holes or channels in the skin (paragraph [0059]: penetration elements 24, in particular hollow needles. These penetration elements 24 preferably also have a sharp-pointed and/or cutting shape. Their dimensions can be the same as or greater or smaller than those of the first-mentioned penetration elements 14. In particular, their through-channels 25 can have the same internal diameter as, or a greater or smaller internal diameter than, the through-channels 15 of the first penetration elements 14)(paragraph [0051]: continuous channels are created between the hollow space… or drainage tube and the wound bed W); however, Larsson does not teach a laser or an array of lasers within the housing. Hoskin et al teaches a device (Figures 1-2 and 5) configured to remove exogenous particles from skin (column 3, lines 42-45: the apparatus may also be used for effecting treatment of conditions other than port wine stains, for example in the removal of tattoo marks) comprising a laser or an array of lasers (column 2, lines 37-39: an array of needle assemblies 4. Each needle assembly is coupled by an optical fibre 6 to a laser assembly 10) within a housing (strip 2). 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 modified device, of Larsson, Hazut et al, and Freeman, with a laser or an array of lasers within the housing, as taught by Hoskin et al, as such will allow for effecting treatment of conditions such as in the removal of tattoo marks (column 3, lines 42-45) without the danger of disfiguring or scarring the skin surface (Abstract).
In regards to claim 28, in the modified method of Larsson, Hazut et al, and Freeman, Larsson teaches forming one or more holes or channels in the skin (paragraph [0059]: penetration elements 24, in particular hollow needles. These penetration elements 24 preferably also have a sharp-pointed and/or cutting shape. Their dimensions can be the same as or greater or smaller than those of the first-mentioned penetration elements 14. In particular, their through-channels 25 can have the same internal diameter as, or a greater or smaller internal diameter than, the through-channels 15 of the first penetration elements 14)(paragraph [0051]: continuous channels are created between the hollow space… or drainage tube and the wound bed W); however, Larsson does not teach forming one or more holes or channels in the skin using a laser or an array of lasers provided within the housing. Hoskin et al teaches a method for removing exogenous particles from skin (column 3, lines 42-45: the apparatus may also be used for effecting treatment of conditions other than port wine stains, for example in the removal of tattoo marks) comprising forming one or more holes or channels in the skin using a laser or an array of lasers (column 2, lines 37-39: an array of needle assemblies 4. Each needle assembly is coupled by an optical fibre 6 to a laser assembly 10) provided within a housing (2) (column 3, lines 7-16: the strip 2 is pressed down upon the area requiring treatment to cause the tips 16 to penetrate the upper layer of the skin to the required depth. If the strip 2 is transparent, the proper positioning of the tips can be visually checked. The laser assembly 10 is energised to provide each fibre with 0.5 watts of laser radiation for a period generally of 5 seconds. The tips 16 would then generate overlapping radiation patterns 18 (see FIG. 5) to treat the area causing the port wine stain). 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 modified method, of Larsson, Hazut et al, and Freeman, with forming one or more holes or channels in the skin using a laser or an array of lasers provided within the housing, as taught by Hoskin et al, as such will allow for effecting treatment of conditions such as in the removal of tattoo