DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Amendment
The amendment filed October 06, 2025 has been entered. Claims 50-67 remain pending in the application. Claims 1-49 were previously cancelled. Applicant’s amendments to the claims have overcome the objections and rejections under 35 USC 112 previously set forth in the Non-Final Office Action mailed April 07, 2025.
Claim Objections
Claim 60 is objected to because of the following informalities: there appears to be a typo regarding “wherein the interior cavity of hte tip is defined by a peripheral lip and a base of the tip;” in line 12-13 as opposed to “wherein the interior cavity of hte tip is defined by the peripheral lip and the base of the tip;”. 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 51and 56 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.
Regarding claims 51 and 56, the limitation ‘the base and the plurality of needles are movable relative to the peripheral lip” in Claim 51, lines 4-5 and similarly the limitation “the base and the needles are movable relative to the peripheral lip” in Claim 56 lines 1-2 in combination with the limitation “wherein the peripheral lip and the base form a unitary part” in line 13 of claim 50 is a recitation of new matter. The disclosure as originally filed does not provide support for a tip comprised of a peripheral lip and base that form a unitary part in combination with the base also being movable relative to the peripheral lip as required by claims 51 and 56. Paragraph [0024] discloses “the tip skirt portion 162, the base member 165 and the peripheral lip 164 can be adjustable with respect to each other or can be constructed as a unitary part” (emphasis added), and paragraph [0028] discloses “the plurality of needles 566 and/or base member 565 can be moved with respect to the peripheral lip 564, as shown in FIG. 9.”. However, there is not disclosure of the base being a unitary part with the peripheral lip and also movable relative to the peripheral lip.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 50, 52, 57-60, and 64-67 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Prausnitz et al. (USPN 6743211) in view of Ignon et al. (US 20090192442).
Regarding claim 50, Prausnitz discloses a device (suction device 200 with attached fluid delivery and vacuum pump; Figure 13C; [Col 13, line 66 – Col 14, line 20]) for treating skin, the device comprising:
a fluid delivery conduit (through female luer lock 212) and a suction conduit (through tubing section 214), the suction conduit being configured to be in fluid communication with a suction source (“as tubing section 214 that can be used to connect the device to a vacuum pump of some kind, either manually or power driven.” [Col 14, line 18-20]); and
a tip (body portion 202; Figure 13C), the tip configured to contact skin (Figure 13B for example), the tip comprising: a base (inner surface of body portion 202 having “annular ring holding microneedles” [Col 14, line 13-14]; Figure 13C); a peripheral lip (rim forming outer surface of outer vacuum ring 206), wherein a distal portion of the peripheral lip is configured to contact skin during use (“The suction device 200 includes body portion 202 having an inner vacuum ring 204 and an outer vacuum ring 206, separated by a ring-shaped microneedle array (not shown). The use of coaxial suction rings provides a uniform deformation force on the skin.” [Col 14, lines 5]; Figure 13B, for example), at least one opening (port 208, circular fluidic channel 210, and opening from tubing section 214) along the base (inner surface of body portion 202) in fluid communication with the fluid delivery conduit (“molecules, typically as a fluid, are delivered through a port 208 in the annular ring holding the microneedles, and to the whole ring-shaped array through a circular fluidics channel 210 adjacent the substrate of the microneedles.” [Col 14, lines 12-16]), and a plurality of needles (“a ring-shaped microneedle array” [Col 14, line 3]) extending from the base (Figure 13C); wherein the peripheral lip and the base form a unitary part (Figure 13C);
wherein the base (inner surface of body portion 202) is recessed relative to the distal portion to define an interior tip region (Figure 13C, within outer vacuum ring 206); and
wherein the interior tip region is in fluid communication with the fluid delivery conduit and the suction conduit using the at least one opening along the base (Figure 13C; “The amount of deformation can be controlled by varying the absolute and relative sizes of the annular vacuum rings, and by controlling the amount of vacuum pulled, for example, by a suction pump…molecules, typically as a fluid, are delivered through a port 208 in the annular ring holding the microneedles, and to the whole ring-shaped array through a circular fluidics channel 210 adjacent the substrate of the microneedles. The device shown includes a female Luer lock 212 for attachment to a conventional syringe, as well as tubing section 214 that can be used to connect the device to a vacuum pump of some kind, either manually or power driven.” [Col 14, lines 5-20]).
Prausnitz fails to explicitly teach the device comprising a handpiece having a distal end and a proximal end, the handpiece comprising the fluid delivery conduit and the suction conduit; and the tip positioned along the distal end.
Ignon teaches a device (handpiece assembly 100) for treating skin (“FIG. 1 illustrates one embodiment of a handpiece assembly 100 configured for use with a skin treatment system” [0092]), the device comprising: a handpiece (main body portion 110) having a distal end and a proximal end (Figure 2A), the handpiece comprising a fluid delivery conduit (delivery channel 140) and a suction conduit (removal channel 150, waste channel 120, tubing 190), the suction conduit being configured to be in fluid communication with a suction source (“the waste conduit 190 of the handpiece assembly can be placed in fluid communication with a suction source” [0095]); and a tip (tip 160) positioned along the distal end (Figure 1), the tip configured to contact skin (Figure 8F, for example) and an interior tip region (at distal end 161) in fluid communication with the fluid delivery conduit and the suction conduction using at least one opening (removal conduits 168A and delivery stem 164) along a base (Figure 3B).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the device of Prausnitz to include a handpiece having a distal end and a proximal end, wherein the handpiece comprises the fluid delivery conduit and the suction conduit, and the tip poisoned along the distal end of the handpiece based on the teachings of Ignon to enable the user to regulate the flowrate of the treatment material (Ignon [0011]).
Regarding claim 52, modified Prausnitz teaches the device of claim 50, wherein a fluid delivered through the fluid delivery conduit is a liquid, vapor, or gas (“For example, one or more grooves on the outside surface of the microneedles can be used to direct the passage of drug, particularly in a liquid state.” [Col 8, line 20-23]; “molecules, typically as a fluid, are delivered through a port 208 in the annular ring holding the microneedles, and to the whole ring-shaped array through a circular fluidics channel 210 adjacent the substrate of the microneedles.” [Col 14, line 12-16]).
Regarding claim 57, modified Prausnitz teaches the device of claim 50, wherein the handpiece comprises an energy delivery device or an energy contact point, wherein the energy delivery device or the energy contact point is configured to deliver energy to skin (“the microneedle device is used in combination with another mechanism that enhances the permeability of the biological barrier, for example by increasing cell uptake or membrane disruption, using electric fields, ultrasound, chemical enhancers, vacuum viruses, pH, heat and/or light.” [Col 8, lines 10-15]; “Essentially all of the microneedle devices and methods described herein can be adapted to vibrate the microneedles and/or the skin to further facilitate penetration. The vibration can be effected to move the microneedles perpendicular and/or parallel to the surface of the biological barrier, and/or at an orientation thereinbetween. The vibration motion can be induced using known techniques, the most common of which is coupling the microneedle or array thereof to a piezoelectric transducer that can provide the vibratory motion. Such a transducer can be bonded directly to the array or can be bonded to a reservoir, thereby utilizing the acoustic transmission properties of the reservoir contents (e.g., an aqueous drug solution) to transmit vibration to the microneedles.” [Col 17, line 31-44]).
Regarding claim 58, modified Prausnitz teaches the device of claim 57, wherein energy delivered by the energy delivery device or the energy contact point comprises at least one of radio frequency, microwave, and ultrasound (“the microneedle device is used in combination with another mechanism that enhances the permeability of the biological barrier, for example by increasing cell uptake or membrane disruption, using electric fields, ultrasound, chemical enhancers, vacuum viruses, pH, heat and/or light.” [Col 8, lines 10-15]).
Regarding claim 59, modified Prausnitz teaches the device of claim 57, wherein energy is introduced to skin via the plurality of needles (“Essentially all of the microneedle devices and methods described herein can be adapted to vibrate the microneedles and/or the skin to further facilitate penetration. The vibration can be effected to move the microneedles perpendicular and/or parallel to the surface of the biological barrier, and/or at an orientation thereinbetween. The vibration motion can be induced using known techniques, the most common of which is coupling the microneedle or array thereof to a piezoelectric transducer that can provide the vibratory motion. Such a transducer can be bonded directly to the array or can be bonded to a reservoir, thereby utilizing the acoustic transmission properties of the reservoir contents (e.g., an aqueous drug solution) to transmit vibration to the microneedles.” [Col 17, line 31-44]).
Regarding claim 60, Prausnitz discloses a method for treating skin (Figures 13C: [Col 13, line 66 – Col 14, line 20]), the method comprising:
placing a tip (body portion 202; Figure 13C) of a skin treatment device (suction device 200 with attached fluid delivery and vacuum pump; Figure 13C; [Col 13, line 66 – Col 14, line 20]) against a portion of skin (“the use of coaxial suction rings provides a uniform deformation force on the skin” [Col 14, lines 3-5]; Figure 13B for example);
wherein the tip comprises a base (inner surface of body portion 202 having “annular ring holding microneedles” [Col 14, line 13-14]; Figure 13C) and a peripheral lip (rim forming outer surface outer vacuum ring 206); wherein the peripheral lip and the base are monolithically formed (Figure 13C);
wherein the base comprises a plurality of needles (“a ring-shaped microneedle array” [Col 14, line 3]) configured to engage and penetrate skin (“The relative height of the inner and outer rings, and their height relative to the microneedle array, can be varied to change the skin deformation and consequent pressure onto the microneedle array.” [Col 14, lines 8-11]; see also Figure 13B, for example);
wherein the base comprises a plurality of openings (port 208, circular fluidic channel 210, and opening from tubing section 214) in fluid communication with a suction conduit (through tubing section 214) and a fluid delivery conduit (through female luer lock 212; Figure 13C; “The amount of deformation can be controlled by varying the absolute and relative sizes of the annular vacuum rings, and by controlling the amount of vacuum pulled, for example, by a suction pump…molecules, typically as a fluid, are delivered through a port 208 in the annular ring holding the microneedles, and to the whole ring-shaped array through a circular fluidics channel 210 adjacent the substrate of the microneedles. The device shown includes a female Luer lock 212 for attachment to a conventional syringe, as well as tubing section 214 that can be used to connect the device to a vacuum pump of some kind, either manually or power driven.” [Col 14, lines 5-20]);
activating a suction force in fluid communication with the suction conduit of the handpiece, wherein activating the suction force creates a suction along the tip and within an interior cavity of the tip (“The use of coaxial suction rings provides a uniform deformation force on the skin. The amount of deformation can be controlled by varying the absolute and relative sizes of the annular vacuum rings, and by controlling the amount of vacuum pulled, for example, by a suction pump. The relative height of the inner and outer rings, and their height relative to the microneedle array, can be varied to change the skin deformation and consequent pressure onto the microneedle array…tubing section 214 that can be used to connect the device to a vacuum pump of some kind, either manually or power driven.” [Col 14, lines 3-20], see Figure 13B for example showing suction within interior cavity), wherein the interior cavity of the tip is defined by a peripheral lip and a base of the tip (Figure 13C);
delivering at least one treatment material to the tip via the fluid delivery conduit (through female luer lock 212) and one of the plurality of openings (port 208 and circular fluidic channel 210) in the base (“molecules, typically as a fluid, are delivered through a port 208 in the annular ring holding the microneedles, and to the whole ring-shaped array through a circular fluidics channel 210 adjacent the substrate of the microneedles. The device shown includes a female Luer lock 212 for attachment to a conventional syringe” [Col 14, line 12-17]), wherein the at least one treatment material is continuously delivered to the tip during use due to recessing the plurality of openings relative to an end of each of the needles (Figure 13C, showing that the treatment material can be continuously delivered from the female Luer lock 212 through the port 208 to the microneedles); and
drawing skin within the interior cavity of the tip to cause the needles to penetrate skin (“The suction device 200 includes body portion 202 having an inner vacuum ring 204 and an outer vacuum ring 206, separated by a ring-shaped microneedle array (not shown). The use of coaxial suction rings provides a uniform deformation force on the skin. The amount of deformation can be controlled by varying the absolute and relative sizes of the annular vacuum rings, and by controlling the amount of vacuum pulled, for example, by a suction pump. The relative height of the inner and outer rings, and their height relative to the microneedle array, can be varied to change the skin deformation and consequent pressure onto the microneedle array.” [Col 14, line 1-11]);
wherein activating the suction force results in removing material away from the tip (“The suction may also enhance systemic delivery of drug by increasing blood flow in the area of administration via the microneedles, or may enhance withdrawal of interstitial fluid or blood for analysis/sensing” [Col 13, line 21]).
Prausnitz fails to explicitly teach the skin treatment device comprising a handpiece, wherein the tip secured to a distal end of the handpiece; the handpiece comprising the suction conduit and the fluid delivery conduit; wherein activating the suction force results in removing spent treatment material away from the tip.
Ignon teaches a method for treating a skin surface of a patient (“method of treating the skin” [0032]), the method comprising placing a tip (tip 160) of a skin treatment device (handpiece assembly 100) against a portion of the skin, the skin treatment device comprising a handpiece (main body portion 100), wherein the tip secured to a distal end of the handpiece (Figures 1-2B); the handpiece comprising the suction conduit (removal channel 150, waste channel 120, tubing 190) and the fluid delivery conduit (delivery channel 140; Figure 3B); delivering a treatment material to the tip via a fluid delivery conduit (delivery channel 140; “The method includes placing the working end of the skin treatment device against the skin of the patient, translating the working end over the skin to abrade a skin surface, providing a treatment fluid to the skin through an opening in the working end” [0025]), and activating a suction force through a suction conduit (removal channel 150) to result in removing spent treatment material away from the tip (“the method comprises moving the handpiece assembly along a person's skin and activating the suction source to remove a volume of waste materials from the distal end of the tip and to simultaneously deliver a volume of the treatment fluid to the distal end of the tip.” [0032]).
At the time of the invention, it would have been obvious to one having ordinary skill in the art to modify the method of Prausnitz to include the skin treatment device comprising a handpiece, wherein the tip secured to a distal end of the handpiece, wherein the handpiece comprising the suction conduit and the fluid delivery conduit based on the teachings of Ignon to enable the user to regulate the flowrate of the treatment material (Ignon [0011]) and to further modify the method of Prausnitz to include wherein activating the suction force results in removing spent treatment material away from the tip based on the teachings of Ignon to remove debris from the treatment site in order to improve the cleanliness of the method (Ignon [0025]).
Regarding claim 64, modified Prausnitz teaches the method of Claim 60, further comprising delivering energy to the skin (“the microneedle device is used in combination with another mechanism that enhances the permeability of the biological barrier, for example by increasing cell uptake or membrane disruption, using electric fields, ultrasound, chemical enhancers, vacuum viruses, pH, heat and/or light.” [Col 8, lines 10-15]; “Essentially all of the microneedle devices and methods described herein can be adapted to vibrate the microneedles and/or the skin to further facilitate penetration. The vibration can be effected to move the microneedles perpendicular and/or parallel to the surface of the biological barrier, and/or at an orientation thereinbetween. The vibration motion can be induced using known techniques, the most common of which is coupling the microneedle or array thereof to a piezoelectric transducer that can provide the vibratory motion. Such a transducer can be bonded directly to the array or can be bonded to a reservoir, thereby utilizing the acoustic transmission properties of the reservoir contents (e.g., an aqueous drug solution) to transmit vibration to the microneedles.” [Col 17, line 31-44]).
Regarding claim 65, modified Prausnitz teaches the method of claim 64, wherein the energy comprises at least one of radio frequency, microwave and ultrasound (“the microneedle device is used in combination with another mechanism that enhances the permeability of the biological barrier, for example by increasing cell uptake or membrane disruption, using electric fields, ultrasound, chemical enhancers, vacuum viruses, pH, heat and/or light.” [Col 8, lines 10-15]).
Regarding claim 66, modified Prausnitz teaches the method of claim 60.
Modified Prausnitz fails to explicitly teach the at least one treatment material comprises at least one of the following: cytokines, soluble collagen, antioxidants, matrix proteins and human growth factors.
Ignon teaches a method for treating a skin surface of a patient (“method of treating the skin” [0032]), the method comprising placing a tip (tip 160) of a skin treatment device (handpiece assembly 100) against a portion of the skin and delivering a treatment material to the tip via a fluid delivery conduit (delivery channel 140; “The method includes placing the working end of the skin treatment device against the skin of the patient, translating the working end over the skin to abrade a skin surface, providing a treatment fluid to the skin through an opening in the working end” [0025]); wherein the at least one treatment material comprises at least one of the following: cytokines, soluble collagen, antioxidants, matrix proteins and human growth factors (“the treatment fluid comprises human growth factors, cytokines, soluble collagen, antioxidants or matrix proteins.” [0018]).
At the time of the invention, it would have been obvious to one having ordinary skill in the art to modify the method of Prausnitz to include wherein the treatment material comprises at least one of cytokines, soluble collagen, antioxidants, matrix proteins and human growth factors based on the teachings of Ignon to facilitate rejuvenation of the skin and improve skin texture (Ignon [0169]).
Regarding claim 67, modified Prausnitz teaches the method of claim 60.
Modified Prausnitz fails to explicitly teach the at least one treatment material comprises a growth factor.
Ignon teaches a method for treating a skin surface of a patient (“method of treating the skin” [0032]), the method comprising placing a tip (tip 160) of a skin treatment device (handpiece assembly 100) against a portion of the skin and delivering a treatment material to the tip via a fluid delivery conduit (delivery channel 140; “The method includes placing the working end of the skin treatment device against the skin of the patient, translating the working end over the skin to abrade a skin surface, providing a treatment fluid to the skin through an opening in the working end” [0025]); wherein the at least one treatment material comprises a growth factor (“the treatment fluid comprises human growth factors, cytokines, soluble collagen, antioxidants or matrix proteins.” [0018]).
At the time of the invention, it would have been obvious to one having ordinary skill in the art to modify the method of Prausnitz to include wherein the treatment material comprises a growth factor based on the teachings of Ignon to facilitate rejuvenation of the skin and improve skin texture (Ignon [0169]).
Claims 51 and 56 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Prausnitz et al. (USPN 6743211) in view of Ignon et al. (US 20090192442) as applied to claims 50 and 61 above, and further in view of Danenberg et al. (US 20080221548).
Regarding claim 51, modified Prausnitz teaches the device of claim 50, wherein, when there is contact between the peripheral lip and skin, the tip is configured to draw skin toward the plurality of needles, toward the interior tip region (“The use of coaxial suction rings provides a uniform deformation force on the skin. The amount of deformation can be controlled by varying the absolute and relative sizes of the annular vacuum rings, and by controlling the amount of vacuum pulled, for example, by a suction pump. The relative height of the inner and outer rings, and their height relative to the microneedle array, can be varied to change the skin deformation and consequent pressure onto the microneedle array.” [Col 14, line 3-11]; see Figure 13B for example).
Modified Prausnitz fails to explicitly teach at least a partial seal formed between the peripheral lip and skin, wherein the base and the plurality of needles are movable relative to the peripheral lip.
Danenberg teaches a device (apparatus 10) for treating the skin comprising a tip (barrel section 18) having a plurality of needles (array of needles 30) extending from a base (valve 38) and a peripheral lip (tip 20); wherein at least a partial seal can be formed between the peripheral lip and skin (“Tip 20 is shaped so that when it is pressed against the skin a hermetic seal is created isolating the interior of the barrel from the outside.” [0041]); and wherein the base and the plurality of needles are movable relative to the peripheral lip (Figures 2A-2B).
At the time of the invention, it would have been obvious to one having ordinary skill in the art to further modify the device of Prausnitz to include at least a partial seal can be formed between the peripheral lip and skin based on the teachings of Danenberg to isolate the targeted area of the skin surface during treatment (Danenberg [0041]) and to further modify the device of Prausnitz to include that the base and the plurality of needles are movable relative to the peripheral lip based on the teachings of Danenberg to allow the device to repeatedly puncture the skin to mechanically damage the skin cells and allow for the eradication of scar tissue from the skin (Danenberg [Abstract], [0022]).
Regarding claim 56, modified Prausnitz teaches the device of claim 50.
Modified Prausnitz fails to explicitly teach the base and the needles are movable relative to the peripheral lip mechanically or pneumatically.
Danenberg teaches a device (apparatus 10) for treating the skin comprising a tip (barrel section 18) having a plurality of needles (array of needles 30) extending from a base (valve 38) and a peripheral lip (tip 20); wherein the base and the needles are movable relative to the peripheral lip mechanically or pneumatically (“Fixedly attached to shaft 26 are cylindrical valve 28 and array of needles 30. As the shaft 26 is moved up and down by the motor, the array of needles 30 is alternately pushed through the outer layer of skin 36 into the dermis and withdrawn from the skin into the tip 20 of barrel 18” [0042]).
At the time of the invention, it would have been obvious to one having ordinary skill in the art to further modify the device of Prausnitz such that the base and the needles are movable relative to the peripheral lip mechanically based on the teachings of Danenberg to allow the device to repeatedly puncture the skin to mechanically damage the skin cells and allow for the eradication of scar tissue from the skin (Danenberg [Abstract], [0022]).
Claims 53 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Prausnitz et al. (USPN 6743211) in view of Ignon et al. (US 2009/0192442) as applied in claim 50 above, and further in view of Mulholland (US 2007/0149991).
Regarding claim 53, modified Prausnitz teaches the device of Claim 50.
Modified Prausnitz fails to explicitly teach wherein the tip is selectively removable from the handpiece.
Mulholland teaches a device (needle-based device 12) for treating a skin ([0014]), the device comprising: a handpiece (hand-held portion 12a) and a tip (needle tip 12b) comprising a plurality of needles (plurality of needles 12d), and wherein the tip is selectively removable from the handpiece (“The tip of the reciprocator device has a screw on tip to which the needle tip attaches.” [0015]).
At the time of the invention, it would have been obvious to one having ordinary skill in the art to modify the device of Prausnitz to include wherein the tip is selectively removable from the handpiece based on the teachings of Mulholland to allow the user to select a working tip having the desired and most effective configuration of the plurality of needles (Mulholland [0016], [0044]).
Claims 54 and 55 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Prausnitz et al. (USPN 6743211) in view of Ignon et al. (US 20090192442) as applied to claim 50 above, and further in view of Chickering III et al. (US 20120041338).
Regarding claim 54, modified Prausnitz teaches the device of claim 50.
Modified Prausnitz fails to explicitly teach the needles are coated with or otherwise include an anti-oxidant or other skin nutrient.
Chickering teaches a device for delivering substances to the skin with needles, wherein the needles are coated with or otherwise include an anti-oxidant or other skin nutrient (“the needles may be coated with a substance that is delivered when the needles are inserted into the skin. For instance, the coating may comprise heparin, an anticoagulant, an anti-inflammatory compound, an analgesic, an anti-histamine compound or a vasodilator to assist with the flow of blood from the skin of the subject.” [0105]).
At the time of the invention, it would have been obvious to one having ordinary skill in the art to modify the device of Prausnitz to include the needles are coated with or otherwise include an anti-oxidant or other skin nutrient based on the teachings of Chickering to allow for localized delivery of the therapeutic agent (Chickering [0105]).
Regarding claim 55, modified Prausnitz teaches the device of claim 50.
Modified Prausnitz fails to explicitly teach a fluid-soluble material is positioned along a surface of the needles.
Chickering teaches a device for delivering substances to the skin with needles wherein a fluid-soluble material is positioned along a surface of the needle (“needles may be coated with a substance that is delivered when the needles are inserted into the skin” [0105]; “At least some the skin insertion objects may be at least partially coated by a substance such as a drug, analgesic or agent by using dip or spray coating or other suitable technique. Thus, the substance may be delivered to the skin by the substance dissolving or otherwise detaching from the substance transfer component at or in the skin or other subject site" [0106]).
At the time of the invention, it would have been obvious to one having ordinary skill in the art to modify the device of Prausnitz to include a fluid-soluble material positioned along a surface of the needles based on the teachings of Chickering to allow for localized delivery of the therapeutic agent (Chickering [0105]).
Claims 61-63 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Prausnitz et al. (USPN 6743211) in view of Ignon et al. (US 2009/0192442) as applied in claim 60 above, and further in view of Kochamba (US 20080264926).
Regarding claim 61, modified Prausnitz teaches the method of claim 60.
Modified Prausnitz fails to explicitly teach further comprising moving the plurality of needles relative to the peripheral lip of the tip to further control movement of the needles relative to skin.
Kochamba teaches a method for treating skin (Figures 1-4) comprising: placing a tip (housing 20) of a skin treatment device (device 20) against a portion of the skin (Figure 1), wherein the tip comprises a base (guide block 84) and a peripheral lip (peripheral edge 24) that are monolithically formed (Figure 1); wherein the base comprises a needle (needle 26) configured to engage and penetrate skin (Figures 1-4); further comprising moving the needle relative to the peripheral lip of the tip to further control movement of the needle relative to skin (Figures 1-4: “The suction causes the needle 26 to move through the transverse area 34 and thereby pierce the surface 38 of the cutaneous layer 28” [0074]).
At the time of the invention, it would have been obvious to one having ordinary skill in the art to further modify the method of Prausnitz to include moving the plurality of needles relative to the peripheral lip of the tip based on the teachings of Kochamba to ensure that the treatment material is delivered to the skin only when the suction force has been applied and allow the plurality of needles to be withdrawn from the skin after use (Kochamba [0074-0076], [0083]).
Regarding claim 62, modified Prausnitz teaches the method of claim 61.
Modified Prausnitz fails to explicitly teach wherein the needles are moved relative to the peripheral lip mechanically.
Kochamba teaches a method for treating skin (Figures 1-4) comprising: placing a tip (housing 20) of a skin treatment device (device 20) against a portion of the skin (Figure 1), wherein the tip comprises a base (guide block 84) and a peripheral lip (peripheral edge 24) that are monolithically formed (Figure 1); wherein the base comprises a needle (needle 26) configured to engage and penetrate skin (Figures 1-4); further comprising moving the needle relative to the peripheral lip mechanically (“The device includes a biasing spring 56 for causing the needle 26 to be urged from the transverse area 34. Biasing the needle 26 urges the needle 26 from the transverse area 34.” [0080]; Figures 1-4).
At the time of the invention, it would have been obvious to one having ordinary skill in the art to further modify the method of Prausnitz to include the needles are moved relative to the peripheral lip mechanically based on the teachings of Kochamba to allow the plurality of needles to be withdrawn from the skin after use (Kochamba [0074-0076], [0083]).
Regarding claim 63, modified Prausnitz teaches the method of claim 61.
Modified Prausnitz fails to explicitly teach wherein the needles are moved relative to the peripheral lip pneumatically.
Kochamba teaches a method for treating skin (Figures 1-4) comprising: placing a tip (housing 20) of a skin treatment device (device 20) against a portion of the skin (Figure 1), wherein the tip comprises a base (guide block 84) and a peripheral lip (peripheral edge 24) that are monolithically formed (Figure 1); wherein the base comprises a needle (needle 26) configured to engage and penetrate skin (Figures 1-4); further comprising moving the needle relative to the peripheral lip of the tip to further control movement of the needles relative to skin pneumatically (“There is a generator device element or means 42 for generating a suction force at the area 34 thereby to urge the cutaneous layer 28 towards the area within the peripheral edge 24 of the housing 22 and thereby provide a stabilizing force to the cutaneous layer 28. The suction causes the needle 26 to move through the transverse area 34 and thereby pierce the surface 38 of the cutaneous layer 28.” [0074]; Figures 1-4).
At the time of the invention, it would have been obvious to one having ordinary skill in the art to further modify the method of Prausnitz to include the needles are moved relative to the peripheral lip pneumatically based on the teachings of Kochamba to ensure that the treatment material is delivered to the skin only when the suction force has been applied and allow the plurality of needles to be withdrawn from the skin after use (Kochamba [0074-0076], [0083]).
Response to Arguments
Applicant’s arguments with respect to claims 50-67 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Regarding the argument that “the cited art and other art of record fails to disclose…a handpiece with microneedles configure dot provide a treatment fluid to a skin surface through openings in the base of the tip connected to the handpiece” (Remarks page 6), the examiner respectfully disagrees. As detailed above with respect to the rejections of claims 50 and 60, Prausnitz, in the embodiment of Figure 13C, discloses a device for treating skin (200 [Col 13, line 66 – Col 14, line 20]), comprising: a tip (202) comprising: a base (inner surface of body portion 202 having “annular ring holding microneedles” [Col 14, line 13-14]); a peripheral lip (rim forming outer surface of outer vacuum ring 206), a plurality of needles (“a ring-shaped microneedle array” [Col 14, line 3]); wherein the peripheral lip and the base form a unitary part (Figure 13C); wherein an interior tip region (within outer vacuum ring 206) is in fluid communication with a fluid delivery conduit (through female luer lock 212) and a suction conduit (through tubing section 214) using a plurality of openings (port 208, circular fluidic channel 210, and opening from tubing section 214) in the base (Figure 13C; “The amount of deformation can be controlled by varying the absolute and relative sizes of the annular vacuum rings, and by controlling the amount of vacuum pulled, for example, by a suction pump…molecules, typically as a fluid, are delivered through a port 208 in the annular ring holding the microneedles, and to the whole ring-shaped array through a circular fluidics channel 210 adjacent the substrate of the microneedles. The device shown includes a female Luer lock 212 for attachment to a conventional syringe, as well as tubing section 214 that can be used to connect the device to a vacuum pump of some kind, either manually or power driven.” [Col 14, lines 5-20]). Prausnitz fails to explicitly teach the device comprising a handpiece having a distal end and a proximal end, the handpiece comprising the fluid delivery conduit and the suction conduit; and the tip positioned along the distal end. Ignon teaches a device for treating skin (100, [0092]), the device comprising: a handpiece (110) having a distal end and a proximal end (Figure 2A), the handpiece comprising a fluid delivery conduit (140) and a suction conduit (150, 120, 190); and a tip (160) positioned along the distal end (Figure 1), an interior tip region (at distal end 161) in fluid communication with the fluid delivery conduit and the suction conduction using at least one opening (removal conduits 168A and delivery stem 164) along a base (Figure 3B). It is maintained that it would have been obvious to one having ordinary skill in the art to modify the device of Prausnitz to include a handpiece having a distal end and a proximal end, wherein the handpiece comprises the fluid delivery conduit and the suction conduit, and the tip poisoned along the distal end of the handpiece based on the teachings of Ignon to enable the user to regulate the flowrate of the treatment material (Ignon [0011]).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LEAH J SWANSON whose telephone number is (571)270-0394. The examiner can normally be reached M-F 9 AM- 5 PM ET.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Sirmons can be reached at (571) 272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/LEAH J SWANSON/Examiner, Art Unit 3783
/KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783