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 .
Response to Arguments
Applicant’s arguments, see “Applicant Arguments/Remarks”, filed 09/10/2025, with respect to the under U.S.C. 102 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made under U.S.C. 103 in view of Tankovich and Hall. The amendments to the claims also require new rejections under U.S.C. 112(b). Specifically, Tankovich does not teach the newly amended subject language, “wherein the indicator particles are enclosed by and released from the release mechanisms”, but does continue to teach the remainder of the claim limitations. The new deficiency in Tankovich is made obvious in light of Hall.
Further, additional consideration has required new objections to the claims, listed in the Objections heading below.
Claim Objections
Claims 5 and 14 are objected to because of the following informalities:
i. Regarding Claim 5, “one or more release mechanism” should be “one or more release mechanisms”.
ii. Further regarding Claim 5, “through the device cool and/or control pain within the portion of the patient's skin during and/or after the treatment procedure” is grammatically incorrect. The limitation should read “through the device to cool and/or control pain within the portion of the patient’s skin during and/or after the treatment procedure”.
iii. Regarding Claim 14, “release mechanism” in line 7 should be “release mechanisms”.
Appropriate correction is required.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 5-21 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent 6050990 awarded to Tankovich et al, hereinafter Tankovich, in view of U.S. Patent Publication 20110098609 awarded to Hall et al, hereinafter Hall.
Regarding Claims 5 and 14, Tankovich teaches or makes obvious a device and method comprising: a transparent hydrogel layer to be applied to a patient's skin prior to application of the treatment procedure through the device cool and/or control pain within the portion of the patient's skin during and/or after the treatment procedure (Col. 23, Lines 21-23, “A hydrogel dressing can be used to cool the skin surface whether the cooled or frozen occlusive dressing is removed during lasing or not”) and a transparent indicator layer with dispersed indicator particles attached thereto and/or embedded within, wherein the indicator particles are configured to change in appearance upon application of treatment procedure through the transparent indicator layer wherein the transparent hydrogel layer is pre-cooled, wherein the transparent indicator layer covers at least a portion of the transparent hydrogel layer (Col. 27, Line 61 to Col. 28, Line 3, “The surface of the composite with the coating of indicator material does not contact the skin surface, but faces away, so that the indicator material can be readily seen by a laser operator. A light beam to be applied to a skin surface is transmitted through the hydrogel composite to a skin surface with which it is in contact. As the light of the light beam strikes the indicator material, the track of the beam causes a photoactivated change of appearance in the indicator material”) wherein the transparent hydrogel layer at least one of cools the patient's epidermis (Col. 23, Lines 21-23, “A hydrogel dressing can be used to cool the skin surface whether the cooled or frozen occlusive dressing is removed during lasing or not”), controls pain in the patient's epidermis (Col. 27, Lines 23-28, “The water imbibed by the hydrogel composite can optionally contain an active agent for alleviating pain, reducing irradiation, etc. During use, laser irradiation will aid in releasing the soothing active agent to the skin surface. Examples of active agents useful for soothing skin are described in Section No. 3 of this application”), and protects the patient's epidermis (Col. 28, Lines 11-15, “When hydrated and placed over a skin surface prior to treatment with a light beam, the exposure-indicating hydrogel composites described herein cool the skin surface by evaporation of water from the hydrogel, and prevent generation of air-borne particles of tissue”). Tankovich does not teach wherein the indicator particles are enclosed by and released from the release mechanisms.
However, in the art of hydrogels (Para. 0003) for laser treatments (Para. 0092), Hall teaches the usage of indicator particles enclosed by a release mechanism which are released by a treatment (Para. 0081, “In addition to thermoresponsive biocompatible polymers, suitable temperature indicating agents also include thermochromic dyes. Thermochromic dyes are chemical compounds showing a change of color (usually from a colorless to a colored form) upon a certain change of chemical or physical environment (typically a change of pH and/or temperature). One or more thermochromic dyes is (are) usually enclosed within microcapsules together with a dissociable salt, a weak acid and/or an appropriate solvent. Other type of mixtures using bases instead of acids are also known in the art. When the solvent is solid, i.e. below its melting temperature, the dye exists in its uncolored form, while when the solvent melts, the salt dissociates, the pH inside the microcapsule lowers, the dye becomes protonated, its chemical structure changes, and its absorption spectrum therefore shifts. A number of suitable thermochromic dyes are known in the art and comprise, but are not limited to, spirolactones, fluorans, spiropyrans, and fulgides. A representative example of a thermochromic spirolactone is crystal violet lactone depicted below in both forms”) to avoid overheating the tissue during treatment (Para. 0007).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Tankovich by Hall, i.e. by using the enclosed temperature-sensitive indicators of Hall in the device of Tankovich, for the predictable purpose of preventing overheating of the tissue as taught in Hall.
Regarding Claim 6, Tankovich modified by Hall makes obvious the device of claim 5. Tankovich further teaches wherein the change in appearance assists an operator in appropriate spacing of application of the treatment procedure, wherein the treatment procedure comprises application of at least two laser pulses (Col. 28, Lines 18-23, “Due to a photoactivated appearance change caused by the laser in the indicator coating, such as a color change, these compositions offer the additional advantage of recording the track of the laser over the skin surface to aid the laser operator in keeping track of which areas have been treated, and which have not”).
Regarding Claim 7, Tankovich modified by Hall makes obvious the device of Claim 5. Tankovich further teaches wherein each of the indicator particles comprises a particle size less than or equal to a maximum particle size chosen based on a length of a laser pulse used during the treatment procedure (Col. 26, Lines 23-33, “The indicator material and its pattern of coating should be selected to perform its indicator function while absorbing a minimal amount of light energy. For example, the coating of indicator material can be a partially metallized surface, such as is formed by vacuum evaporation of aluminum or other metal space. It has been found that vapor-deposited metal films, for example of aluminum or vacuum-coated bismuth, change appearance when illuminated by infrared such as is provided by a Nd:YAG laser at a wavelength of about 1 micron”).
Regarding Claim 8, Tankovich modified by Hall makes obvious the device of claim 5. Tankovich further teaches wherein the transparent hydrogel layer is pre-cooled to protect the patient's epidermis from thermal injury by contact cooling (Col. 28, Lines 11-15, “When hydrated and placed over a skin surface prior to treatment with a light beam, the exposure-indicating hydrogel composites described herein cool the skin surface by evaporation of water from the hydrogel, and prevent generation of air-borne particles of tissue”).
Regarding Claim 9, Tankovich modified by Hall makes obvious the device of claim 8. Tankovich further teaches wherein the contact cooling controls pain felt by the patient due to the application of a laser pulse used during the treatment procedure (Col. 27, Lines 23-28, “The water imbibed by the hydrogel composite can optionally contain an active agent for alleviating pain, reducing irradiation, etc. During use, laser irradiation will aid in releasing the soothing active agent to the skin surface. Examples of active agents useful for soothing skin are described in Section No. 3 of this application”).
Regarding Claim 10, Tankovich modified by Hall makes obvious the device of claim 9. Tankovich further teaches wherein the contact cooling lasts for at least three minutes after the application of the laser pulse (Col. 24, Lines 45-48, “A tacky hydrogel will adhere to skin so that the dressing will continue to release the active agents over a period of many hours, for example about 8 to about 24 hours”).
Regarding Claim 11, Tankovich modified by Hall makes obvious the device of claim 5. Tankovich further teaches wherein the transparent indicator layer and/or the transparent hydrogel layer is configured to mitigate a lase plume generated due to the application of a laser pulse used during the treatment procedure (Col. 28, Lines 11-15, “When hydrated and placed over a skin surface prior to treatment with a light beam, the exposure-indicating hydrogel composites described herein cool the skin surface by evaporation of water from the hydrogel, and prevent generation of air-borne particles of tissue”).
Regarding Claim 12, Tankovich modified by Hall makes obvious the device of claim 11. Tankovich further teaches wherein the transparent indicator layer and/or the transparent hydrogel layer acts as a barrier to particles ejected from the patient's skin due to the application of the laser pulse (Col. 28, Lines 11-15, “When hydrated and placed over a skin surface prior to treatment with a light beam, the exposure-indicating hydrogel composites described herein cool the skin surface by evaporation of water from the hydrogel, and prevent generation of air-borne particles of tissue”).
Regarding Claim 13, Tankovich modified by Hall makes obvious the device of claim 12. Tankovich further teaches wherein the particles ejected from the patient's skin due to the application of the laser pulse become embedded within the transparent indicator layer and/or the transparent hydrogel layer (Col. 22, Lines 56-60, “During lasing a short pulse of energy vaporizes some of the contaminant, and a puff of smoke and fragments is produced, which fly off the skin surface as smoke or particles. In the present invention, the hydrogel serves as a blast barrier, to confine the smoke and fragments so formed”).
Regarding Claim 15, Tankovich modified by Hall makes obvious the method of Claim 14. Tankovich further teaches wherein the treatment procedure is a dermatology procedure, wherein the dermatology procedure comprises treatment of at least one or permanent hair removal or skin resurfacing (Col. 55, Lines 49-52, “The methods and devices of this invention provide the advantage of reducing loss of incident light at a skin surface, such as during the period of laser illumination for skin resurfacing, hair removal, or inhibition of hair growth”), or treatment of a scar (Col. 3, Lines 26-30, “Another embodiment of the invention is a method for removal of hypertrophic or keloid scars wherein a scar is coated with a light absorbing contaminant and illuminated with short pulses of light preferentially absorbed by the contaminant for a time sufficient to selectively remove the scar”).
Regarding Claim 16, Tankovich modified by Hall makes obvious the method of Claim 14. Tankovich further teaches wherein the treatment procedure comprises a laser treatment, and wherein the transparent hydrogel layer is used to cool at least a portion of the patient's epidermis as the laser treatment is delivered (Col. 28, Lines 11-15, “When hydrated and placed over a skin surface prior to treatment with a light beam, the exposure-indicating hydrogel composites described herein cool the skin surface by evaporation of water from the hydrogel, and prevent generation of air-borne particles of tissue”).
Regarding Claim 17, Tankovich modified by Hall makes obvious the method of Claim 14. Tankovich further teaches wherein the transparent hydrogel layer is used to cool the at least the portion of the patient's epidermis for a time after the laser treatment is delivered (Col. 28, Lines 11-15, “When hydrated and placed over a skin surface prior to treatment with a light beam, the exposure-indicating hydrogel composites described herein cool the skin surface by evaporation of water from the hydrogel, and prevent generation of air-borne particles of tissue”).
Regarding Claim 18, Tankovich modified by Hall makes obvious the method of claim 17. Tankovich further teaches wherein the time is at least three minutes after the laser treatment is delivered (Col. 24, Lines 45-48, “A tacky hydrogel will adhere to skin so that the dressing will continue to release the active agents over a period of many hours, for example about 8 to about 24 hours”).
Regarding Claim 19, Tankovich modified by Hall makes obvious the method of claim 16. Tankovich further teaches wherein the laser treatment comprises a plurality of laser pulses (Col. 28, Lines 18-23, “Due to a photoactivated appearance change caused by the laser in the indicator coating, such as a color change, these compositions offer the additional advantage of recording the track of the laser over the skin surface to aid the laser operator in keeping track of which areas have been treated, and which have not”).
Regarding Claim 20, Tankovich modified by Hall makes obvious the method of 19. Tankovich further teaches wherein the indicator particles are configured to increase an opacity of the transparent indicator layer by changing a perceivable feature with application of at least one of the plurality of laser pulses to an area of the transparent indicator layer (Col. 28, Lines 18-23, “Due to a photoactivated appearance change caused by the laser in the indicator coating, such as a color change, these compositions offer the additional advantage of recording the track of the laser over the skin surface to aid the laser operator in keeping track of which areas have been treated, and which have not”).
Regarding Claim 21, Tankovich teaches a system comprising: a transparent hydrogel configured to be pre-cooled and applied to a portion of a patient's skin prior to a treatment procedure to cool and/or control pain within the portion of the patient's skin during and/or after the treatment procedure (Col. 23, Lines 21-23, “A hydrogel dressing can be used to cool the skin surface whether the cooled or frozen occlusive dressing is removed during lasing or not”); and a treatment device configured to apply the treatment procedure through the transparent hydrogel to the patient's skin, wherein the treatment device comprises a microneedle device, an injection device, and/or an energy delivery device (Col. 27, Lines 58-61, “In use, the exposure-indicating hydrogel composites of this invention are hydrated and placed over a skin surface for laser treatment, with the free surface of the crosslinked polymeric hydrogel layer against the surface of the skin”), and one or more release mechanisms comprising the one or more indicator particles embedded within and/or attached to the transparent hydrogel before and/or after the transparent hydrogel is pre-cooled (Col. 26, Lines 34-39, “The indicator material can also be a photoresponsive pigment, such as iron oxide, rhodamine red, or phthalocyanine blue, printed over the exterior surface of the thermoplastic hydrogel layer in an open-work pattern, such as a pattern of dots 32, intersecting lines 37, or cross-hatched lines 39, as shown in FIG. 19B”), wherein the one or more indicator particles are configured to change a perceivable feature upon application of the treatment procedure through the transparent hydrogel (Col. 26, Lines 44-49, “Bismuth trioxide or bismuth subcarbonate, rather than being "bleached" by the laser energy, are reduced to the metal by the light, resulting in a darkening of the lased area. This phenomenon can be beneficial for blocking exposure of the lased area of skin upon subsequent passes of the laser, if desired.”) and a transparent indicator layer with dispersed indicator particles attached thereto and/or embedded within, wherein the indicator particles are configured to change in appearance upon application of treatment procedure through the transparent indicator layer (Col. 27, Line 61 to Col. 28, Line 3, “The surface of the composite with the coating of indicator material does not contact the skin surface, but faces away, so that the indicator material can be readily seen by a laser operator. A light beam to be applied to a skin surface is transmitted through the hydrogel composite to a skin surface with which it is in contact. As the light of the light beam strikes the indicator material, the track of the beam causes a photoactivated change of appearance in the indicator material”) or to create a shield for a laser plume generated by the treatment procedure (Col. 28, Lines 11-15, “When hydrated and placed over a skin surface prior to treatment with a light beam, the exposure-indicating hydrogel composites described herein cool the skin surface by evaporation of water from the hydrogel, and prevent generation of air-borne particles of tissue”). Tankovich does not teach wherein the indicator particles are enclosed by and released from the release mechanisms.
However, in the art of hydrogels (Para. 0003) for laser treatments (Para. 0092), Hall teaches the usage of indicator particles enclosed by a release mechanism which are released by a treatment (Para. 0081, “In addition to thermoresponsive biocompatible polymers, suitable temperature indicating agents also include thermochromic dyes. Thermochromic dyes are chemical compounds showing a change of color (usually from a colorless to a colored form) upon a certain change of chemical or physical environment (typically a change of pH and/or temperature). One or more thermochromic dyes is (are) usually enclosed within microcapsules together with a dissociable salt, a weak acid and/or an appropriate solvent. Other type of mixtures using bases instead of acids are also known in the art. When the solvent is solid, i.e. below its melting temperature, the dye exists in its uncolored form, while when the solvent melts, the salt dissociates, the pH inside the microcapsule lowers, the dye becomes protonated, its chemical structure changes, and its absorption spectrum therefore shifts. A number of suitable thermochromic dyes are known in the art and comprise, but are not limited to, spirolactones, fluorans, spiropyrans, and fulgides. A representative example of a thermochromic spirolactone is crystal violet lactone depicted below in both forms”) to avoid overheating the tissue during treatment (Para. 0007).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Tankovich by Hall, i.e. by using the enclosed temperature-sensitive indicators of Hall in the device of Tankovich, for the predictable purpose of preventing overheating of the tissue as taught in Hall.
Regarding Claim 23, Tankovich modified by Hall makes obvious the system of Claim 21. Tankovich further teaches wherein the treatment device comprises a laser energy device and wherein the transparent hydrogel is configured to create a shield for a laser plume generated by the treatment procedure (Col. 28, Lines 11-15, “When hydrated and placed over a skin surface prior to treatment with a light beam, the exposure-indicating hydrogel composites described herein cool the skin surface by evaporation of water from the hydrogel, and prevent generation of air-borne particles of tissue”).
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.
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/JLM/
Examiner, Art Unit 3792
/AMANDA L STEINBERG/Examiner, Art Unit 3792