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 .
Claim Status: Claims 1-31 are pending.
Claim Objections
Claims 1, 13, and 24 are objected to because of the following informalities: there is a grammatical error in the limitation “wherein the first portion and the second portion is separated by sealed air”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
Claim 26 is 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.
Re Claim 26, there are two “claim 26”, and one of the claim 26 depends on itself. Therefore, the claims are indefinite.
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.
Claims 1, 2, 4, 5, 7-10, 13-17, 19-21, 24, and 27-31 are rejected under 35 U.S.C. 103 as being unpatentable over Zenzie et al. (Non-Patent Literature: “Evaluation of Cooling Methods for Laser Dermatology”, Applicant provided a copy on September 3, 2021), hereinafter “Zenzie”, in view of Schomacker et al. (US 2021/0077823), hereinafter “Schomacker”.
Re Claim 1, Zenzie discloses a method for treating a skin lesion comprising:
lowering a temperature of a treatment site comprising the skin lesion to a temperature range sufficient to induce vasoconstriction in a dermis of the treatment site (fig. 3, page 134 discloses that [t]he skin surface temperature is kept fixed at 0.1 degree C; page 131, treatment of port wine stains); and
administering a laser light through a medium to the skin lesion (page 132, fig. 2A and B discloses that laser light must pass through the cooling agent (CA) during treatment. The cooler shown in fig. 2A is designed with liquid flow across the light beam; page 136 discloses parallel cooling) while maintaining the temperature of the treatment site within the temperature range (fig. 3, page 134 discloses that The skin surface temperature is kept fixed at 0.1 degree C; page 131, treatment of port wine stains).
The instant specification discloses that the temperature range of the treatment site sufficient to induce vasoconstriction in a dermis of the treatment site can be between 0 degrees C and 20 degrees C. Zenzie discloses the temperature in the disclosed temperature range.
Zenzie further disclose that the medium includes a first portion and a second portion (page 132, fig. 2A and B discloses that laser light must pass through the cooling agent (CA) during treatment. the top window reads on “first portion” and the bottom window reads on “second portion”), wherein the laser light is transmitted through the first portion and the second portion sequentially (page 132, fig. 2A and B shows that laser light transmits through the top window and the bottom window), the second portion includes a contact surface for contacting the treatment site (page 132, fig. 2A, B, discloses that the bottom window is contacting the skin).
Zenzie discloses that the first portion and the second portion is separated by sealed air (page 132, fig. 2A, B shows liquid flow between the top transparent window and the bottom transparent window; the top window reads on “first portion” and the bottom window reads on “second portion”. Page 131, second column and Page 132, first column discloses that heat can be removed from the cooling agent by using flowing liquid, gas, or spray. The liquid flow area reads on sealed air. Additionally, transparent cooling agent reads on “sealed air”).
Zenzie is silent regarding the second portion having a higher thermal conductivity than the first portion.
Schomacker discloses cooling system for tissue treatment with both tissue and light source cooling (abstract) and teaches a second portion for contacting the treatment site having a higher thermal conductivity than a first portion, wherein the treatment light is transmitted through the first portion and the second portion sequentially (fig. 5, 6, para. [0026], the chilled tip 42 can be configured to include two plates, a sapphire plate for contacting the tissue 38 and a less thermally conductive glass plate with the cooling fluid 30 flowing in channel structure defined between the two plates. The glass plate minimizes condensation on top surface that faces the light source 19).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Zenzie, by configuring the second portion to have a higher thermal conductivity than the first portion, as taught by Schomacker, for the purpose of configuring the first portion to minimize condensation on top surface that faces the light source (para. [0026]).
Re Claim 2, Zenzie discloses that the first portion and the second portion are optically transparent (page 132, fig. 2A indicates transparent window and transparent cooling agent, fig. 12B; the top window reads on “first portion” and the bottom window reads on “second portion”).
Re Claim 4, Zenzie discloses that the lowering the temperature of the treatment site includes contacting the treatment site with the contact surface of the second portion of the medium (page 132, fig. 2A, B, discloses that the bottom window is contacting the skin).
Re Claim 5, Zenzie discloses that the contacting the treatment site with the contact surface of the second portion of the medium includes compressing the surface of the treatment site with the contact surface of the second portion of the medium (page 140, first column discloses that in some applications, compression of the skin by a contact-cooling device is desired).
Re Claim 7, Zenzie discloses that the laser light has a wavelength between about 300 nm and about 2500 nm (page 137 discloses wavelength of 800 nm).
Re Claim 8, Zenzie discloses that the laser light has a fluence of 0-3000 J/cm2 (page 137 discloses fluence of 50 J/cm2).
Re Claim 9, Zenzie discloses that the temperature range is between 00C and 200C (fig. 3, page 134 discloses that the skin surface temperature is kept fixed at 0.1 degree C).
Re Claim 10, Zenzie discloses that the laser light is a pulsed light (page 137, second column discloses four different pulse durations).
Re Claims 13 and 17, Zenzie discloses a device for treating a skin lesion comprising:
a source for generating a laser light (page 137 discloses diode laser with wavelength, fluence, and pulse duration);
a medium for transmitting the laser light, wherein the medium includes a first portion and a second portion (page 132, fig. 2A and B discloses that laser light must pass through the cooling agent (CA) during treatment. the top window reads on “first portion” and the bottom window reads on “second portion”),
wherein the laser light is transmitted through the first portion and the second portion sequentially (page 132, fig. 2A and B shows that laser light transmits through the top window and the bottom window),
wherein the second portion includes a contact surface for contacting a treatment site comprising the skin lesion (page 132, fig. 2A, B, discloses that the bottom window is contacting the skin; page 131, treatment of port wine stains).
Zenzie discloses that the first portion and the second portion are separated by sealed air (page 132, fig. 2A, B shows liquid flow between the top transparent window and the bottom transparent window; the top window reads on “first portion” and the bottom window reads on “second portion”. Page 131, second column and Page 132, first column discloses that heat can be removed from the cooling agent by using flowing liquid, gas, or spray. The liquid flow area reads on sealed air. Additionally, transparent cooling agent reads on “sealed air”).
Zenzie further discloses that the first portion includes quarts, sapphire, crystal, poly(methyl methacrylate), or polystyrene (page 132, sapphire).
Zenzie is silent regarding that the second portion has a higher thermal conductivity than the first portion.
Schomacker discloses cooling system for tissue treatment with both tissue and light source cooling (abstract) and teaches a second portion for contacting the treatment site having a higher thermal conductivity than a first portion, wherein the treatment light is transmitted through the first portion and the second portion sequentially, wherein the first portion includes quarts, sapphire, crystal, poly(methyl methacrylate), or polystyrene (fig. 5, 6, para. [0026], the chilled tip 42 can be configured to include two plates, a sapphire plate for contacting the tissue 38 and a less thermally conductive glass plate with the cooling fluid 30 flowing in channel structure defined between the two plates. The glass plate minimizes condensation on top surface that faces the light source 19; para. [0026], [0024], discloses chilled tip 42 having glass plate made of quartz or sapphire).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Zenzie, by configuring the second portion to have a higher thermal conductivity than the first portion, wherein the first portion includes quarts, sapphire, crystal, poly(methyl methacrylate), or polystyrene, as taught by Schomacker, for the purpose of configuring the first portion to minimize condensation on top surface that faces the light source (para. [0026]).
Re Claim 14, Zenzie discloses that the laser light has a wavelength between about 300 nm and about 2500 nm (page 137 discloses wavelength of 800 nm).
Re Claim 15, Zenzie discloses that the laser light has a fluence of 0-3000 J/cm2 (page 137 discloses fluence of 50 J/cm2).
Re Claim 16, Zenzie discloses that the first portion and the second portion are optically transparent (page 132, fig. 2A indicates transparent window and transparent cooling agent; the top window reads on “first portion” and the bottom window reads on “second portion”).
Re Claim 19, Zenzie discloses a cooling unit to lower a temperature of the medium to a target temperature range (page 132, fig. 2A and B discloses that laser light must pass through the cooling agent (CA) during treatment. The cooler shown in fig. 2A is designed with liquid flow across the light beam; page 136 discloses parallel cooling; page 132, first column discloses that the configuration allows a CA temperature in the -40 to 0 degree C range to be achieved).
Re Claim 20, Zenzie discloses that the target temperature range of the medium is from - 300C to 00C (page 132, first column discloses that the configuration allows a CA temperature in the -40 to 0 degree C range to be achieved).
Re Claim 21, Zenzie discloses that the laser light is a pulsed light (page 137, second column discloses four different pulse durations).
Re Claim 24, Zenzie discloses a system for treating a skin lesion comprising:
a source for generating a laser light (page 137 discloses diode laser with wavelength, fluence, and pulse duration);
a medium for transmitting the laser light, wherein the medium includes a first portion and a second portion (page 132, fig. 2A and B discloses that laser light must pass through the cooling agent (CA) during treatment. the top window reads on “first portion” and the bottom window reads on “second portion”),
wherein the laser light is transmitted through the first portion and the second portion sequentially (page 132, fig. 2A and B shows that laser light transmits through the top window and the bottom window),
the second portion includes a contact surface for contacting a treatment site comprising the skin lesion (page 132, fig. 2A, B, discloses that the bottom window is contacting the skin; page 131, treatment of port wine stains); and
a cooling unit to lower a temperature of the medium to a target temperature range (page 132, fig. 2A and B discloses that laser light must pass through the cooling agent (CA) during treatment. The cooler shown in fig. 2A is designed with liquid flow across the light beam; page 136 discloses parallel cooling; page 132, first column discloses that the configuration allows a CA temperature in the -40 to 0 degree C range to be achieved).
Zenzie discloses that the first portion and the second portion are separated by sealed air (page 132, fig. 2A, B shows liquid flow between the top transparent window and the bottom transparent window; the top window reads on “first portion” and the bottom window reads on “second portion”. Page 131, second column and Page 132, first column discloses that heat can be removed from the cooling agent by using flowing liquid, gas, or spray. The liquid flow area reads on sealed air. Additionally, transparent cooling agent reads on “sealed air”).
Zenzie is silent regarding that the second portion has a higher thermal conductivity than the first portion.
Schomacker discloses cooling system for tissue treatment with both tissue and light source cooling (abstract) and teaches a second portion for contacting the treatment site having a higher thermal conductivity than a first portion, wherein the treatment light is transmitted through the first portion and the second portion sequentially (fig. 5, 6, para. [0026], the chilled tip 42 can be configured to include two plates, a sapphire plate for contacting the tissue 38 and a less thermally conductive glass plate with the cooling fluid 30 flowing in channel structure defined between the two plates. The glass plate minimizes condensation on top surface that faces the light source 19).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Zenzie, by configuring the second portion to have a higher thermal conductivity than the first portion, as taught by Schomacker, for the purpose of configuring the first portion to minimize condensation on top surface that faces the light source (para. [0026]).
Re Claim 27, Zenzie discloses that the laser light has a wavelength between about 300 nm and about 2500 nm (page 137 discloses wavelength of 800 nm).
Re Claim 28, Zenzie discloses that the laser light has a fluence of 0-3000 J/cm2 (page 137 discloses fluence of 50 J/cm2).
Re Claim 29, Zenzie discloses that the first portion and the second portion are optically transparent (page 132, fig. 2A indicates transparent window and transparent cooling agent; the top window reads on “first portion” and the bottom window reads on “second portion”).
Re Claim 30, Zenzie discloses that the target temperature range of the medium is from - 30°C to 00C (page 132, first column discloses that the configuration allows a CA temperature in the -40 to 0 degree C range to be achieved).
Re Claim 31, Zenzie discloses that the laser light is a pulsed light (page 137, second column discloses four different pulse durations).
Claims 3, 11, 12, 18, 22, 23, 25, and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Zenzie et al. (Non-Patent Literature: “Evaluation of Cooling Methods for Laser Dermatology”, Applicant provided a copy on September 3, 2021), hereinafter “Zenzie”, as modified by Schomacker et al. (US 2021/0077823), hereinafter “Schomacker”, and further in view of DeBenedicitis et al. (US 2007/0093798), hereinafter “DeBenedicitis”.
Re Claims 3, 11, and 12, Zenzie as modified by Schomacker discloses the claimed invention substantially as set forth in claim 1.
Zenzie and Schomacker are silent regarding a beam splitter is located between the first portion and the second portion, wherein the beam splitter sends an image of the skin lesion to an image-capturing device; and a controller operatively coupled to the image-capturing device to analyze one or more characteristics of the skin lesion, wherein the controller guides the laser light to treat the skin lesion according to the one or more characteristics.
However, DeBenedictis discloses skin light therapy with treatment cooling (abstract, para. [0041]) and teaches contact cooling device (para. [0072], contact plate 239 and cooling source) and beam splitter (para. [0072], dichroic mirror 232, where the contact plate and dichroic mirror can comprise sapphire, fused silica, borosilicate glass, transparent plastic, or other transparent material). DeBenedictis discloses that the contact plate 239, dichroic mirror 232, and other optical components may have optical coatings applied on one or more sides to increase the efficiency of energy delivery into the skin or to enhance the reflectivity or transmission of the illumination 283 from the illumination source 282. DeBenedictis also discloses beam splitter located between two optical components (fig. 2A, para. [0058], [0072] shows dichroic mirror 232 located between a beam delivery lens 231 and contact plate 239). DeBenedictis discloses that the beam splitter sends an image of the skin lesion to an image-capturing device (para. [0047], [0048], [0059], [0060], fig. 2, positional sensor, dosage evaluation sensor); and a controller operatively coupled to the image-capturing device to analyze one or more characteristics of the skin lesion, wherein the controller guides the laser light to treat the skin lesion according to the one or more characteristics (abstract, para. [0039]-[0041], the feedback loops comprising the controller 115 and/or the scanner control 125 in combination with the positional sensor 180 and/or the dosage evaluation sensor 160 can be used to provide automated control of treatment parameters such as treatment location, treatment zone overlap, treatment energy, treatment depth, treatment power, treatment zone pattern, treatment cooling (including pre-cooling and post-cooling).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Zenzie as modified by Schomacker, by adding a beam splitter located between the first portion and the second portion, wherein the beam splitter sends an image of the skin lesion to an image-capturing device; and a controller operatively coupled to the image-capturing device to analyze one or more characteristics of the skin lesion, wherein the controller guides the laser light to treat the skin lesion according to the one or more characteristics, as taught by DeBenedictis, for the purpose of using positional measurement sensors and dosage evaluation sensors permitting the controller to automatically determine the proper electromagnetic source parameters including pulse timing and pulse frequency (abstract).
Re Claims 18, 22, and 23, Zenzie as modified by Schomacker discloses the claimed invention substantially as set forth in claim 13.
Zenzie and Schomacker are silent regarding a beam splitter is located between the first portion and the second portion, wherein the beam splitter sends an image of the skin lesion to an image-capturing device; and a controller operatively coupled to the image-capturing device to analyze one or more characteristics of the skin lesion, wherein the controller guides the laser light to treat the skin lesion according to the one or more characteristics.
However, DeBenedictis discloses skin light therapy with treatment cooling (abstract, para. [0041]) and teaches contact cooling device (para. [0072], contact plate 239 and cooling source) and beam splitter (para. [0072], dichroic mirror 232, where the contact plate and dichroic mirror can comprise sapphire, fused silica, borosilicate glass, transparent plastic, or other transparent material). DeBenedictis discloses that the contact plate 239, dichroic mirror 232, and other optical components may have optical coatings applied on one or more sides to increase the efficiency of energy delivery into the skin or to enhance the reflectivity or transmission of the illumination 283 from the illumination source 282. DeBenedictis also discloses beam splitter located between two optical components (fig. 2A, para. [0058], [0072] shows dichroic mirror 232 located between a beam delivery lens 231 and contact plate 239). DeBenedictis discloses that the beam splitter sends an image of the skin lesion to an image-capturing device (para. [0047], [0048], [0059], [0060], fig. 2, positional sensor, dosage evaluation sensor); and a controller operatively coupled to the image-capturing device to analyze one or more characteristics of the skin lesion, wherein the controller guides the laser light to treat the skin lesion according to the one or more characteristics (abstract, para. [0039]-[0041], the feedback loops comprising the controller 115 and/or the scanner control 125 in combination with the positional sensor 180 and/or the dosage evaluation sensor 160 can be used to provide automated control of treatment parameters such as treatment location, treatment zone overlap, treatment energy, treatment depth, treatment power, treatment zone pattern, treatment cooling (including pre-cooling and post-cooling).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Zenzie as modified by Schomacker, by adding a beam splitter located between the first portion and the second portion, wherein the beam splitter sends an image of the skin lesion to an image-capturing device; and a controller operatively coupled to the image-capturing device to analyze one or more characteristics of the skin lesion, wherein the controller guides the laser light to treat the skin lesion according to the one or more characteristics, as taught by DeBenedictis, for the purpose of using positional measurement sensors and dosage evaluation sensors permitting the controller to automatically determine the proper electromagnetic source parameters including pulse timing and pulse frequency (abstract).
Re Claims 25 and 26, Zenzie as modified by Schomacker discloses the claimed invention substantially as set forth in claim 24.
Zenzie and Schomacker are silent regarding a beam splitter is located between the first portion and the second portion, wherein the beam splitter sends an image of the skin lesion to an image-capturing device; and a controller operatively coupled to the image-capturing device to analyze one or more characteristics of the skin lesion, wherein the controller guides the laser light to treat the skin lesion according to the one or more characteristics.
However, DeBenedictis discloses skin light therapy with treatment cooling (abstract, para. [0041]) and teaches contact cooling device (para. [0072], contact plate 239 and cooling source) and beam splitter (para. [0072], dichroic mirror 232, where the contact plate and dichroic mirror can comprise sapphire, fused silica, borosilicate glass, transparent plastic, or other transparent material). DeBenedictis discloses that the contact plate 239, dichroic mirror 232, and other optical components may have optical coatings applied on one or more sides to increase the efficiency of energy delivery into the skin or to enhance the reflectivity or transmission of the illumination 283 from the illumination source 282. DeBenedictis also discloses beam splitter located between two optical components (fig. 2A, para. [0058], [0072] shows dichroic mirror 232 located between a beam delivery lens 231 and contact plate 239). DeBenedictis discloses that the beam splitter sends an image of the skin lesion to an image-capturing device (para. [0047], [0048], [0059], [0060], fig. 2, positional sensor, dosage evaluation sensor); and a controller operatively coupled to the image-capturing device to analyze one or more characteristics of the skin lesion, wherein the controller guides the laser light to treat the skin lesion according to the one or more characteristics (abstract, para. [0039]-[0041], the feedback loops comprising the controller 115 and/or the scanner control 125 in combination with the positional sensor 180 and/or the dosage evaluation sensor 160 can be used to provide automated control of treatment parameters such as treatment location, treatment zone overlap, treatment energy, treatment depth, treatment power, treatment zone pattern, treatment cooling (including pre-cooling and post-cooling).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Zenzie as modified by Schomacker, by adding a beam splitter located between the first portion and the second portion, wherein the beam splitter sends an image of the skin lesion to an image-capturing device; and a controller operatively coupled to the image-capturing device to analyze one or more characteristics of the skin lesion, wherein the controller guides the laser light to treat the skin lesion according to the one or more characteristics, as taught by DeBenedictis, for the purpose of using positional measurement sensors and dosage evaluation sensors permitting the controller to automatically determine the proper electromagnetic source parameters including pulse timing and pulse frequency (abstract).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Zenzie et al. (Non-Patent Literature: “Evaluation of Cooling Methods for Laser Dermatology”, Applicant provided a copy on September 3, 2021), hereinafter “Zenzie”, as modified by Schomacker et al. (US 2021/0077823), hereinafter “Schomacker”, and further in view of Anderson et al. (US 2007/0010861), hereinafter “Anderson”.
Re Claim 6, Zenzie as modified by Schomacker discloses the claimed invention substantially as set forth in claim 1.
Zenzie is silent regarding the lowering the temperature of the treatment site includes administering a drug to induce vasoconstriction of the treatment site before administering the laser light.
However, Anderson discloses method for use in the selective disruption of lipid-rich cells by controlled cooling (abstract) and teaches administering a drug to induce vasoconstriction of the treatment site before application of the cooling agent (para. [0070]).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Zenzie as modified by Schomacker, by configuring the lowering the temperature of the treatment site to include administering a drug to induce vasoconstriction of the treatment site before administering the laser light, as taught by Anderson, for the purpose of inducing vasoconstriction (para. [0070]).
Conclusion
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/Benjamin J Klein/Supervisory Patent Examiner, Art Unit 3792
/V.V.H./
Vynn Huh, February 5, 2026Examiner, Art Unit 3792