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 Amendment
The amendment filed February 20th, 2026 has been entered. Claims 1-9 remain pending in the application. Applicant’s amendments to the claims have overcome some of the objections and rejections previously set forth in the Non-Final Office Action mailed November 20th, 2025.
Response to Arguments
Applicant’s arguments with respect to claims 1-9 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. The claim amendments changed the scope of the claimed invention. See new grounds for rejection below.
Claim Objections
Claim 9 is objected to because of the following informalities:
Claim 9 line 17 recites “warm stimulus state and the cold stimulus is continuous presented from the cold” should read -- warm stimulus state and the cold stimulus is continuously presented from the cold --. 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.
Claims 2, 5 and 6 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 2, 5, and 6 disclose the terms “relatively larger” and “relatively smaller” which are relative terms that render the claims indefinite. The term “relatively larger” and “relatively smaller” are not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear as to what the “relatively larger state” and “relatively smaller state” is referring to regarding the intensity of the warm stimulus and the cold stimulus. Does this mean the temperature is higher or the flow rate is higher in the relatively stronger state, and the temperature is lower and the flow rate is lower in the relatively smaller state? Also it is unclear as to what the states are being compared to with the term “relatively”. Is it relative to the warm stimulus? The cold stimulus? The temperature of the room? Further detail is needed to ascertain as to what the “relatively larger state” and the relatively smaller state are referring to within the claims. Further the specification does not provide any clear description and simply recites the claim language.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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.
Claim(s) 1-6 and 8-9 is rejected under 35 U.S.C. 103 as being unpatentable over Yoon et al. (US 6640051 B1) herein referred to as “Yoon” further in view of Chess et al. (US 20010018603 A1) herein referred to as “Chess”.
Regarding claim 1, Yoon discloses a cold sensation presentation device (thermal treatment apparatus, Figure 1, Col. 3, lines6) comprising: a cold stimulus section configured to give a cold stimulus to a skin in a non-contact manner using cold air (low-temperature radiating second 201 comprises a cryo-pump, the low-temperature is radiated if the cool air is flown into the low-temperature radiating second 201 through hose 209, Col. 3, lines 30-40, Figures 1-2); a warm stimulus section configured to give a warm stimulus to the skin in the non-contact manner (high-temperature radiating section 101 comprising an infrared ray heat lamp or a far-infrared ray lamp, Col. 3, lines 27-29, Figures 1-2); and a control unit comprising a processor and a memory storing instructions that, when executed by the processor (control section 300 is manipulated for the purpose of setting the high-temperature radiating time and the low-temperature radiating time, Col. 4, lines 65-67, hardware can be constructed or a microprocessor to control the on and off cycles of the radiating sections, Col. 4, lines 1-10), cause the control unit to: present the cold sensation by alternately repeating (In the present invention, the high-temperature radiating power and the low-temperature radiating power are turned on/off in turns. For instance, if the high-temperature radiating time is Set to be five Seconds and the low-temperature radiating time is set to be three Seconds the high-temperature radiating Section operates for five Seconds and is turned off. Then, the low-temperature radiating Section operates for three Seconds and is turned off. Subsequently, the high temperature radiating Section once again operates for five Seconds. With these Simple Settings, high temperature and low temperature can be repeatedly irradiated onto the affected parts, Col. 3, lines 56-67): (i) a cold stimulus state in which the warm stimulus is presented at a first intensity (the on-cycle of the low-temperature radiating section is the off-cycle of the high-temperature radiating section (seen as first intensity (i.e., off)), Col. 4, lines 1-10, Figures 1-2); and (ii) a warm stimulus state in which the warm stimulus is presented at a second intensity that is higher than the first intensity (the on-cycle of the high-temperature radiating section be an off-cycle (seen as a second intensity (i.e., on)) for the low-temperature radiating section, Col. 4, lines 1-10).
However Yoon does not explicitly disclose wherein the control unit is configured to keep an intensity of the cold stimulus constant and the cold stimulus is continuously presented from the cold stimulus section throughout both the cold stimulus state and the warm stimulus state.
Chess discloses an apparatus for treatment of skin including the ability to subject the skin to temperature modulation and radiation simultaneously (Abstract), wherein the control unit is configured to keep an intensity of the cold stimulus constant and the cold stimulus is continuously presented from the cold stimulus section throughout both the cold stimulus state and the warm stimulus state (the cooling air 11 is introduced into cavity 36 from the delivery device 15 via an in-line coupling 37 at the side of hand piece 35 or other suitable point, as air 11 is introduced into cavity 36, it completely surrounds the delivery device 19 and then exits at the distal end of hand piece 35 onto treatment site 12. The radiation 16 is simultaneously delivered by delivery device 19 through air 11 to treatment site 12, Paragraph [0046], Figures 5-6, Although the present invention contemplates the use of any type of radiation that is useable to treat biologic tissue, the invention will be described herein where source 35 is a laser. For laser embodiments, delivery device 19 may comprise tubing Such as fiber optic cable or other Suitable conveyor of laser radiation, Paragraph [0035], The temperature and/or flow rate of air 11 are controlled by means situated either at compressed air Source 14 or at any Suitable location along its flow toward treatment site 12. In a preferred embodiment, the flow rate is controlled at air source 14 and the temperature is controlled by means of a vortex tube 20, Paragraph [0037]).
It would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to have modified Yoon to incorporate
the teachings of Chess by including wherein the control unit is configured to keep an intensity of the cold stimulus constant and the cold stimulus is continuously presented from the cold stimulus section throughout both the cold stimulus state and the warm stimulus state. The motivation to do so being to vary the temperature of the skin depending on the type of radiation being utilized and what condition is being treated (Chess, Paragraph [0016] and [0048]).
Regarding claim 2, Yoon in view of Chess discloses the cold sensation presentation device according to claim 1.
Yoon further discloses wherein by alternately repeating the cold stimulus state where an intensity of the warm stimulus is relatively small (the on-cycle of the low-temperature radiating section is the off-cycle of the high-temperature radiating section (seen as small intensity of warm stimulus (i.e., off)), Col. 4, lines 1-10, Figures 1-2) and the warm stimulus state where an intensity of the warm stimulus is relatively large (the on-cycle of the high-temperature radiating section be an off-cycle (seen as large intensity of warm stimulus (i.e., on)) for the low-temperature radiating section, Col. 4, lines 1-10).
However Yoon does not explicitly disclose wherein the warm stimulus state where an intensity of the warm stimulus is relatively large in a state of keeping an intensity of the cold stimulus constant while continuously presenting the cold stimulus from the cold stimulus section, the control unit causes a temporal change of a skin temperature in the cold stimulus state and a temporal change of a skin temperature in the warm stimulus state to be different from each other.
Chess discloses wherein the warm stimulus state where an intensity of the warm stimulus is relatively large in a state of keeping an intensity of the cold stimulus constant while continuously presenting the cold stimulus from the cold stimulus section ((the cooling air 11 is introduced into cavity 36 from the delivery device 15 via an in-line coupling 37 at the side of hand piece 35 or other suitable point, as air 11 is introduced into cavity 36, it completely surrounds the delivery device 19 and then exits at the distal end of hand piece 35 onto treatment site 12. The radiation 16 is simultaneously delivered by delivery device 19 through air 11 to treatment site 12, Paragraph [0046], Figures 5-6, Although the present invention contemplates the use of any type of radiation that is useable to treat biologic tissue, the invention will be described herein where source 35 is a laser. For laser embodiments, delivery device 19 may comprise tubing Such as fiber optic cable or other Suitable conveyor of laser radiation, Paragraph [0035], The temperature and/or flow rate of air 11 are controlled by means situated either at compressed air Source 14 or at any Suitable location along its flow toward treatment site 12. In a preferred embodiment, the flow rate is controlled at air source 14 and the temperature is controlled by means of a vortex tube 20, Paragraph [0037]), the control unit causes a temporal change of a skin temperature in the cold stimulus state and a temporal change of a skin temperature in the warm stimulus state to be different from each other (vary the temperature of the skin up or down depending on what kind of radiation is being utilized, Paragraph [0016]).
It would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to have modified Yoon to incorporate
the teachings of Chess by including wherein the warm stimulus state where an intensity of the warm stimulus is relatively large in a state of keeping an intensity of the cold stimulus constant while continuously presenting the cold stimulus from the cold stimulus section, the control unit causes a temporal change of a skin temperature in the cold stimulus state and a temporal change of a skin temperature in the warm stimulus state to be different from each other. The motivation to do so being to vary the temperature of the skin depending on the type of radiation being utilized and what condition is being treated (Chess, Paragraph [0016] and [0048]).
Regarding claim 3, Yoon in view of Chess discloses the cold sensation presentation device according to claim 1.
Yoon further discloses wherein after a predetermined time from a state of keeping an intensity of the cold stimulus constant while continuously presenting the cold stimulus, the control unit changes an intensity of at least one of the warm stimulus and the cold stimulus (In the present invention, the high-temperature radiating power and the low-temperature radiating power are turned on/off in turns. For instance, if the high-temperature radiating time is Set to be five Seconds and the low-temperature radiating time is set to be three Seconds the high-temperature radiating Section operates for five Seconds and is turned off. Then, the low-temperature radiating Section operates for three Seconds and is turned off. Subsequently, the high temperature radiating Section once again operates for five Seconds. With these Simple Settings, high temperature and low temperature can be repeatedly irradiated onto the affected parts, Col. 3, lines 56-67).
Regarding claim 4, Yoon in view of Chess discloses the cold sensation presentation device according to claim 1.
However Yoon does not explicitly disclose wherein the control unit keeps an intensity of the cold stimulus constant by keeping a temperature and a flow rate of cold air constant.
Chess discloses wherein the control unit keeps an intensity of the cold stimulus constant by keeping a temperature and a flow rate of cold air constant (the temperature and/or flow rate of air 11 are controlled by means situated either at compressed air source 14 or at any suitable location along its flow toward treatment site 12, in a preferred embodiment, the flow rate is controlled at air source 14 and the temperature is controlled by means of a vortex tube 20, Paragraph [0037]).
It would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to have modified Yoon to incorporate
the teachings of Chess by including wherein the control unit keeps an intensity of the cold stimulus constant by keeping a temperature and a flow rate of cold air constant. The motivation to do so being to control the temperature and flow rate of the air directed towards the skin (Chess, Paragraph [0037]).
Regarding claim 5, Yoon in view of Chess discloses the cold sensation presentation device according to claim 1.
Yoon further discloses wherein the control unit temporally changes an intensity of the warm stimulus from a relatively small state to a relatively large state in the warm stimulus state (the on-cycle of the high-temperature radiating section (seen as a large state intensity in the on state of the warm stimulus state) be an off-cycle (seen as large intensity of warm stimulus (i.e., on)) for the low-temperature radiating section, Col. 4, lines 1-10).
Regarding claim 6, Yoon in view of Chess discloses the cold sensation presentation device according to claim 1.
However Yoon does not explicitly disclose wherein the control unit temporally changes an intensity of the cold stimulus from a relatively small state to a relatively large state in the warm stimulus state.
Chess discloses wherein the control unit temporally changes an intensity of the cold stimulus from a relatively small state to a relatively large state in the warm stimulus state (the cooling air 11 is introduced into cavity 36 from the delivery device 15 via an in-line coupling 37 at the side of hand piece 35 or other suitable point, as air 11 is introduced into cavity 36, it completely surrounds the delivery device 19 and then exits at the distal end of hand piece 35 onto treatment site 12, (seen as providing a strong intensity of cold stimulus during the warm stimulus state (i.e., when radiation is simultaneously delivered), The radiation 16 is simultaneously delivered by delivery device 19 through air 11 to treatment site 12, Paragraph [0046], Figures 5-6, Although the present invention contemplates the use of any type of radiation that is useable to treat biologic tissue, the invention will be described herein where source 35 is a laser. For laser embodiments, delivery device 19 may comprise tubing Such as fiber optic cable or other Suitable conveyor of laser radiation, Paragraph [0035], The temperature and/or flow rate of air 11 are controlled by means situated either at compressed air Source 14 or at any Suitable location along its flow toward treatment site 12. In a preferred embodiment, the flow rate is controlled at air source 14 and the temperature is controlled by means of a vortex tube 20, Paragraph [0037]).
It would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to have modified Yoon to incorporate
the teachings of Chess by including wherein the control unit temporally changes an intensity of the cold stimulus from a relatively small state to a relatively large state in the warm stimulus state. The motivation to do so being to vary the temperature of the skin depending on the type of radiation being utilized and what condition is being treated (Chess, Paragraph [0016] and [0048]).
Regarding claim 8, Yoon in view of Chess discloses the cold sensation presentation device according to claim 1.
Yoon further discloses wherein the cold stimulus section gives the cold stimulus via convection (low-temperature radiating section 201 radiates cool air (i.e., convection), Col. 3, lines 30-40), and the warm stimulus section gives the warm stimulus via radiation (high-temperature radiating section comprises an infrared ray lamp or a far-infrared ray lamp, Col. 3, lines 27-29).
Regarding claim 9, Yoon discloses a non-transitory computer readable medium holding instructions for controlling a computer included in a control unit (For example, a hardware can be constructed So that the on-cycle of the high-temperature radiating Section be an off-cycle of the low-temperature radiating Section and that the on-cycle of the low-temperature radiating Section be an off-cycle of the high-temperature radiating Section. Otherwise, a microcomputer can embody the same layout with a particular Software program. Accordingly, one skilled in the art to which this invention pertains can easily conceive the same layout for operation, Col. 4, lines 1-10), wherein the control unit is configured to control a cold stimulus state provided by a cold stimulus section and a warm stimulus state provided by a warm stimulus section of a cold sensation presentation device (control section 300 is manipulated for the purpose of setting the high-temperature radiating time and the low-temperature radiating time, Col. 4, lines 65-67, hardware can be constructed or a microprocessor to control the on and off cycles of the radiating sections, Col. 4, lines 1-10), wherein the cold stimulus section provides a cold stimulus in a non-contact manner using cold air (low-temperature radiating second 201 comprises a cryo-pump, the low-temperature is radiated if the cool air is flown into the low-temperature radiating second 201 through hose 209, Col. 3, lines 30-40, Figures 1-2), and the warm stimulus section provides that gives a warm stimulus in the non-contact manner (high-temperature radiating section 101 comprising an infrared ray heat lamp or a far-infrared ray lamp, Col. 3, lines 27-29, Figures 1-2), wherein the control unit is configured to execute instructions for presenting the cold sensation by alternately repeating (In the present invention, the high-temperature radiating power and the low-temperature radiating power are turned on/off in turns. For instance, if the high-temperature radiating time is Set to be five Seconds and the low-temperature radiating time is set to be three Seconds the high-temperature radiating Section operates for five Seconds and is turned off. Then, the low-temperature radiating Section operates for three Seconds and is turned off. Subsequently, the high temperature radiating Section once again operates for five Seconds. With these Simple Settings, high temperature and low temperature can be repeatedly irradiated onto the affected parts, Col. 3, lines 56-67); (i) a cold stimulus state in which the warm stimulus is presented at a first intensity (the on-cycle of the low-temperature radiating section is the off-cycle of the high-temperature radiating section (seen as first intensity (i.e., off)), Col. 4, lines 1-10, Figures 1-2) and (ii) a warm stimulus state in which the warm stimulus is presented at a second intensity that is higher than the first intensity (the on-cycle of the high-temperature radiating section be an off-cycle (seen as a second intensity (i.e., on) and higher as it went from off to on) for the low-temperature radiating section, Col. 4, lines 1-10).
However Yoon does not explicitly disclose wherein the device is configured to provide the cold stimulus and the warm stimulus to the skin nor wherein the control unit is further configured to keep an intensity of the cold stimulus constant throughout both the cold stimulus state and the warm stimulus state and the cold stimulus is continuous presented from the cold stimulus section throughout both the cold stimulus state and the warm stimulus state.
Chess discloses wherein the device is configured to provide the stimulus to the skin (vary the temperature of the skin up or down depending on what kind of radiation is being utilized, Paragraph [0016]) and wherein the control unit is further configured to keep an intensity of the cold stimulus constant throughout both the cold stimulus state and the warm stimulus state and the cold stimulus is continuous presented from the cold stimulus section throughout both the cold stimulus state and the warm stimulus state (the cooling air 11 is introduced into cavity 36 from the delivery device 15 via an in-line coupling 37 at the side of hand piece 35 or other suitable point, as air 11 is introduced into cavity 36, it completely surrounds the delivery device 19 and then exits at the distal end of hand piece 35 onto treatment site 12. The radiation 16 is simultaneously delivered by delivery device 19 through air 11 to treatment site 12, Paragraph [0046], Figures 5-6, Although the present invention contemplates the use of any type of radiation that is useable to treat biologic tissue, the invention will be described herein where source 35 is a laser. For laser embodiments, delivery device 19 may comprise tubing Such as fiber optic cable or other Suitable conveyor of laser radiation, Paragraph [0035], The temperature and/or flow rate of air 11 are controlled by means situated either at compressed air Source 14 or at any Suitable location along its flow toward treatment site 12. In a preferred embodiment, the flow rate is controlled at air source 14 and the temperature is controlled by means of a vortex tube 20, Paragraph [0037]).
It would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to have modified Yoon to incorporate
the teachings of Chess by including wherein the device is configured to provide the stimulus to the skin nor wherein the control unit is further configured to keep an intensity of the cold stimulus constant throughout both the cold stimulus state and the warm stimulus state and the cold stimulus is continuous presented from the cold stimulus section throughout both the cold stimulus state and the warm stimulus state. The motivation to do so being to vary the temperature of the skin depending on the type of radiation being utilized and what condition is being treated (Chess, Paragraph [0016] and [0048]).
Claim(s) 7 is rejected under 35 U.S.C. 103 as being unpatentable over Yoon in view of Chess further in view of Diller et al. (WO 2016004295) herein referred to as “Diller” (see attached).
Regarding claim 7, Yoon in view of Chess discloses the cold sensation presentation device according to claim 1.
However Yoon in view of Chess does not explicitly disclose wherein the control unit ends cold sensation presentation by gradually decreasing an intensity of the cold stimulus and an intensity of the warm stimulus or gradually decreasing presentation time of the cold stimulus and presentation time of the warm stimulus.
Diller discloses wherein the control unit ends cold sensation presentation by gradually decreasing an intensity of the cold stimulus and an intensity of the warm stimulus or gradually decreasing presentation time of the cold stimulus and presentation time of the warm stimulus (the time periods may change as the contrast therapy progresses, an example would be using 3-hour time periods for a single round of heating and cooling, followed by 1.5 hour time periods for the next round of heating and cooling and so on (shows a gradual decrease in the presentation time of the cold stimulus and the warm stimulus, Paragraph [0059]).
It would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to have modified Yoon in view of Chess to incorporate the teachings of Diller by including wherein the control unit ends cold sensation presentation by gradually decreasing an intensity of the cold stimulus and an intensity of the warm stimulus or gradually decreasing presentation time of the cold stimulus and presentation time of the warm stimulus. The motivation to do so being to vary the time periods based on the patient’s needs to stimulate blood flow (Diller, Paragraphs [0059]-[0060]).
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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/D.S./Examiner, Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794
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