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 .
Election/Restrictions
Applicant’s election with traverse of the group including inventions I, II and V (claims 1-14 and 31) in the reply filed on 04/13/2026 is acknowledged.
Examiner notes that Applicant’s Arguments presented in “Applicant Arguments/Remarks Made in Amendment” filed on 04/13/2026 discuss reasons as to why amended claims 1-14 and 31 (Inventions I, II and V) relate to a signal general inventive concept. Examiner notes for the record that inventions I, II and V (claims 1-14 and 31) are no longer considered distinct inventions but rather a single invention.
Claims 15-30 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions III and IV.
Claim Objections
Claim 5 is objected to because of the following informalities. Appropriate correction is required.
In re claim 5
The information being stored on memory in step 10) should match the information being “considered” in step 11). For example, the limitation “10) storing in a memory of the photo-thermal targeted treatment system the safe operating range for the parameters for operating the light source for the first subject at the first treatment location; and 11) when administering the treatment protocol on the first subject at a later time, taking into consideration the parameters so stored in the memory” should read
“10) storing in a memory of the photo-thermal targeted treatment system the safe operating range for the parameters for operating the light source for the first subject at the first treatment location; and 11)when administering the treatment protocol on the first subject at a later time, taking into consideration the safe operating range for the parameters so stored in the memory” or alternatively,
“10) storing in a memory of the photo-thermal targeted treatment system the parameters for operating the light source for the first subject at the first treatment location; and 11)when administering the treatment protocol on the first subject at a later time, taking into consideration the parameters so stored in the memory”
The limitation “11) when administering the treatment protocol on the first subject at a later time, taking into consideration the parameters so stored in the memory”, should read “11) when administering the treatment protocol on the first subject at a later time, taking into consideration the parameters stored in the memory”
Claim Interpretation
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitations are listed below.
In re claim 31, “a cooling unit” .
Because this claim limitation is being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it is being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this limitation interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation to avoid it being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation recite(s) sufficient structure to perform the claimed function so as to avoid it being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 3-10 and 31 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
In re claim 3, the limitation “administering at least one higher-level pulse from the light source above the known pain threshold and below the damage threshold to raise a temperature of the chromophore to its required damage temperature” presents a clarity concern when viewed in combination with the limitation “administering at least one initial laser pulse from the light source at a present power level, the preset power level being below a known threshold” from claim 1. Examiner notes that as written claim 1 implies that the “known pain and damage threshold” is a single threshold value not two separate threshold values. Therefore, for examination purposes, the limitation “administering at least one higher-level pulse from the light source above the known pain threshold and below the damage threshold to raise a temperature of the chromophore to its required damage temperature” will be interpreted as requiring administering at least one higher-level pulse from the light source to raise a temperature of the chromophore to its required damage temperature.
Examiner notes that dependent claims 4-10 inherit the same deficiencies.
In re claim 4, the limitation “further comprising repeating steps 1) through 9) at the first treatment location on a second subject prior to administering the treatment protocol on the second subject” raises a clarity concern when viewed in combination with the limitation “6) administering at least one treatment laser pulse from the light source with a power above the at least one initial laser pulse to raise a temperature of the targeted chromophore to its required damage temperature to effectively target the chromophore in administering a treatment protocol” from claim 1. Specifically, it is unclear how steps 1) through 9) would be administered prior to “the treatment protocol” if step 6) is the step in which the treatment protocol is initiated (see claim 1 which requires “6) administering at least one treatment laser pulse”). For examination purposes, the limitation “further comprising repeating steps 1) through 9) at the first treatment location on a second subject prior to administering the treatment protocol on the second subject” will be interpreted as requiring steps 1) through 9) to be repeated on a second subject.
In re claim 5, there is insufficient antecedent basis for the limitation “the first subject”, for examination purposes the first instance of limitation “the first subject” will be interpreted as “a first subject”.
In re claim 8,
The limitation “further comprising repeating steps 1) through 9) at a second treatment location on the first subject during administration of the treatment protocol at the second treatment location” raises a clarity concern when viewed in combination with the limitation “6) administering at least one treatment laser pulse from the light source with a power above the at least one initial laser pulse to raise a temperature of the targeted chromophore to its required damage temperature to effectively target the chromophore in administering a treatment protocol” from claim 1. Specifically, it is unclear how steps 1) through 9) would be administered “during administration of the treatment protocol” if step 6) is the step in which the treatment protocol is initiated (see claim 1 which requires “6) administering at least one treatment laser pulse”). For examination purposes, the limitation “further comprising repeating steps 1) through 9) at a second treatment location on the first subject during administration of the treatment protocol at the second treatment location” will be interpreted as requiring steps 1) through 9) to be repeated at a second treatment location on the first subject.
Regarding the limitation “the first subject” see above (In re claim 5).
In re claim 9,
The limitation “a first treatment location” raises a clarity concern. Specifically, it is unclear if “a first treatment location” is referring to the “first treatment location” described in claims 1, 2 and 3 or a new second “a first treatment location”. For examination purposes the limitation “a first treatment location” will be interpreted as “the first treatment location”.
The limitation “further comprising repeating steps 1) through 9) at a first treatment location on a second subject during administration of the treatment protocol at the second treatment location” raises a clarity concern when viewed in combination with the limitation “6) administering at least one treatment laser pulse from the light source with a power above the at least one initial laser pulse to raise a temperature of the targeted chromophore to its required damage temperature to effectively target the chromophore in administering a treatment protocol” from claim 1. Specifically, it is unclear how steps 1) through 9) would be administered “during administration of the treatment protocol” if step 6) is the step in which the treatment protocol is initiated (see claim 1 which requires “6) administering at least one treatment laser pulse”). For examination purposes, the limitation “further comprising repeating steps 1) through 9) at a second treatment location on the first subject during administration of the treatment protocol at the second treatment location” will be interpreted as requiring steps 1) through 9) to be repeated at the first treatment location on a second subject.
In re claim 10, see above (In re claim 5).
In re claim 11, for substantially the same reasons as described above (In re claim 3) the limitation “9) defining at least one higher-level laser pulse from the light source above the known pain threshold and below the damage threshold to raise a temperature of the chromophore to its required damage temperature” promotes a clarity concern. For examination purposes, the limitation will be interpreted as requiring defining at least one higher-level laser pulse from the light source to raise a temperature of the chromophore to its required damage temperature.
Examiner notes that claims 12-14 inherit the same deficiencies.
In re claim 31, there is insufficient antecedent basis for the limitation “the system”. For examination purposes, “the system” will be interpreted as the “photo-thermal targeted treatment system”.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-14 and 31 are rejected under 35 U.S.C 101 because the claimed invention is directed to a judicial exception, specifically an abstract idea without significantly more.
Step 1:
Independent claims 1 and 31 are directed to a method and photo-thermal targeted treatment system. Thus, the claims are directed to a statutory category of invention (Step 1: Yes)
Step 2A, Prong 1:
Independent claims 1 and 31 recite the following limitations:
“3) correlation fitting a relationship between the parameters for operating the light source and the skin surface temperature at the first treatment location to be treated” (mathematical calculation)
“4) defining a safe operating range for the parameters for operating the light source in order to avoid pain and thermal damage to the medium at the first treatment location while still effectively targeting the chromophore to be treated” (mathematical calculation and/or mental process)
Dependent claims 2, 6, 7, 11 and 14 recite the following limitations
“wherein… correlation fitting includes estimating the relationship between the parameters for operating the light source, post-pulse cooling and the skin surface temperature at the first treatment location by fitting the skin surface temperature and parameters for operating the light source using data correlations” (mental process and/or mathematical calculation) (claim 2)
“wherein the parameters are established using computational analysis taking into account a-priori knowledge of the correlation from clinical experiment” (mental process and/or mathematical calculation) (claim 2)
“wherein…the safe operating range corresponds to the skin surface temperature between approximately 28 ˚C and 34 ˚C.” (further limiting mental process and/or mathematical calculation of “defining a safe operating range”) (claim 2)
“8) adjusting the safe operating range for the parameters of the light source at the first treatment location to maintain the skin surface temperature below a known pain threshold while simultaneously increasing the peak temperature and depth of the thermal gradient until at a correct depth, wherein the estimating, measuring, and adjusting are updated continuously during a treatment session;” (mental process and/or mathematical calculation) (claim 2) (claim 11)
“10) if the skin surface temperature at the first treatment location reaches a preset threshold temperature, adjusting the parameters of the light source to reduce an effective power incident at the first treatment location.” (mental process) (claim 6)
“wherein defining the safe operating range for the parameters of the light source includes setting at least one of laser power, pulse width, pulse interval, maximum power output, and a skin surface cooling mechanism.” (further limiting mental process and/or mathematical calculation of “defining a safe operating range”) (claim 7) (claim 14)
Regarding the limitations directed to mathematical calculations, under the broadest reasonable interpretation a mathematical calculation is a mathematical operation or an act of calculating using mathematical methods to determine a variable or number. see MPEP 2106.04(a)(2)(I). Examiner notes, as discussed in MPEP 2106.04(a)(2)(I), the claim does not need to recite the word “calculating” in order to be considered a mathematical calculation.
Regarding the limitations directed to mental processes, the courts consider a mental process (thinking) that “can be performed in the human mind, or by a human using a pen and paper” to be an abstract idea. Examiner notes that the courts do not distinguish between claims that recite mental processes performed by humans and claims that recite mental processes performed on a computer.See MPEP 2106.04(a)(2)(III).
For the reasons described above, Examiner asserts that the claims recite a judicial exception, specifically an abstract idea (Step 2A, Prong 1: Yes).
Step 2A, Prong 2:
Independent claims 1 and 31 recite the following additional elements:
“0) cooling a first treatment location” (insignificant extra-solution activity) (claim 1)
“1) administering at least one initial laser pulse from the light source at a preset power level to the first treatment location to be treated, the preset power level being below a known pain and damage threshold” (insignificant extra-solution activity) (claim 1)
“2) measuring a skin surface temperature at the first treatment location to be treated”(insignificant extra-solution activity) (claim 1)
“5) maintaining the skin surface temperature below the known pain and damage threshold while simultaneously increasing a peak temperature and depth of a thermal gradient until the peak temperature and depth of the thermal gradient reaches a desired depth within the medium at the first treatment location to be treated (insignificant extra-solution activity) (claim 1)
“6) administering at least one treatment laser pulse from the light source with a power above the at least one initial laser pulse to raise a temperature of the targeted chromophore to its required damage temperature to effectively target the chromophore in administering a treatment protocol” (insignificant extra-solution activity) (claim 1)
“a cooling unit for providing cooling at a treatment location ” (component used during insignificant extra solution activity ) (claim 31)
“a light source for providing laser pulses” (component used during insignificant extra solution activity) (claim 31)
“a temperature monitoring unit for monitoring a skin surface temperature at the location” (component used during insignificant extra solution activity) (claim 31)
“a controller for receiving the skin surface temperature as monitored by the temperature monitoring unit and accordingly controlling operating parameters of the cooling unit and the light source” (generic computer component) (claim 31)
Dependent claims 2, 3, 5, 10 and 11 recite the following additional elements:
“wherein: cooling includes directing an air flow on the first treatment location” (further limiting insignificant solution activity of “cooling a first treatment location”) (claim 2)
“7) measuring the skin surface temperature at the first treatment location following administration of the at least one treatment laser pulse”; ” (insignificant extra solution activity, data gathering) (claim 3)
“9) administering at least one higher-level laser pulse from the light source above the known pain threshold and below the damage threshold to raise a temperature of the chromophore to its required damage temperature; and” (insignificant extra--solution activity) (claim 3)
“10) storing in a memory of the photo-thermal targeted treatment system the safe operating range for the parameters for operating the light source for the first subject at the first treatment location” (insignificant solution activity) (claim 5) (claim 10)
“11) when administering the treatment protocol on the first subject at a later time, taking into consideration the parameters so stored in the memory.” (insignificant solution activity) (claim 5) (claim 10)
“7) continuing to track skin surface temperatures at the first treatment location at a refresh rate of 25 Hz to 400 Hz while administering additional laser pulses” (insignificant solution activity, data gathering) (claim 11)
“wherein measuring the skin surface temperature comprises tracking skin surface temperatures at the first treatment location at a refresh rate of 25 HZ to 400Hz while administering the at least one treatment laser pulse (further limiting the insignificant solutionary activity of “measuring the skin surface temperature”) (claim 11)
“9 )defining at least one higher-level laser pulse from the light source above the known pain threshold and below the damage threshold to raise a temperature of the chromophore to its required damage temperature; and” (insignificant solution activity) (claim 11)
The above additional element, with the exception of “a controller”, are examples of insignificant extra solution activity and therefore fail to provide significantly more. Examiner notes that “a controller” fails to provide significantly more because it amounts to merely applying the abstract idea using a generic computer component. (Step 2A, Prong 2: NO)
Step 2B:
The claims do not include any additional elements that amount to significantly more than the judicial exception.
Regarding the limitations “0) cooling a first treatment location”, “a cooling unit for providing cooling at a treatment location”, “wherein: cooling includes directing an air flow on the first treatment location” , see Sakamoto (US 2019/0262072) which discloses a method (Fig. 6) for thermal gradient preconditioning (abstract) that involves cooling a target medium (502) via a cooling unit [0022]. As disclosed by Sakamoto the target medium can be cooled by applying a gaseous fluid such as air [0025]. Thus, the limitations “0) cooling a first treatment location” , “a cooling unit for providing cooling at a treatment location” and “wherein: cooling includes directing an air flow on the first treatment location” are well-understood, routine and conventional (as evidenced by Sakamoto).
Regarding the limitation “a light source for providing laser pulses”, see Sakamoto (US 2019/0262072) which disloses a photo-treatment device (FIG. 1) for thermal gradient preconditioning (abstract). The photo treatment device includes a photo-treatment light source (30) configured to emit pulses of light [0034]. Thus, the limitation “a light source for providing laser pulses” is well-understood, routine and conventional (as evidenced by Sakamoto).
Regarding the limitation “a temperature monitoring unit for monitoring a skin surface temperature at the location”, see Mosher (US 7,251,531) which discloses a device (FIG. 2) for therapeutically heating collagenous tissues of skin (col. 8, lines 51-60). The device includes a temperature monitoring unit (40) for receiving and analyzing temperature signals (col. 9, lines 31-35). Thus, the limitation “a temperature monitoring unit for monitoring a skin surface temperature at the location” is well-understood, routine and conventional (as evidenced by Mosher).
As discussed above, in Step 2A Prong 2 the remaining additional elements amount to no more than applying the abstract idea using generic computer components and insignificant extra solution activity.
Moreover, reconsidering the claim limitations individually and as an ordered combination, the claims fail to meet the requirements for eligibility under 35 U.S.C 101. (Step 2B: NO).
Remaining Claims
Examiner notes that dependent claims 3, 4, 8, and 9 require that the method (specifically steps 1) through 9)) be repeated either on a second subject or at an additional location. Examiner notes that the same 101 analysis preformed above regarding steps 1) through 9) ( from claims 1-3) applies to claims 3, 4, 8 and 9.
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.
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 1 and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Mosher et al. (US 7,251,531), in view of Bean et al. (US 2014/0121631).
In re claim 1, Mosher discloses a method (abstract; FIG. 5, FIG. 8) for determining a suitable set of parameters (col. 16, lines 24-30: “desired treatment time”, “power level”) for operating an energy source (col. 5, lines 13-15: “Radiofrequency (RF) power”) within a thermal targeted treatment system (FIG. 2) for targeting a chromophore (col. 8, lines 47-60: “collagenous tissue of the skin”) embedded in a medium, the method comprising:
0) cooling a first treatment location (130; Examiner notes “first treatment location” is “target tissue”);
1) administering at least one initial energy pulse (140; col. 14, lines 36-38: “apply the initial RF power”, “power is delivered for a fixed amount of time, (preferably 25 seconds)”) from the energy source at a preset power level (col. 14, lines 40-41: “initial power is about 15 Watts to 25 watts”) to the first treatment location to be treated, the preset power level being below a known pain and damage threshold (col. 14, lines 43-47: “initial RF power and time of application are selected to provide minimal tissue heating so as to reduce the likelihood of overheating…”)
2) measuring a skin surface temperature at the first treatment location to be treated (150, shown in greater detail in FIG. 8; Examiner notes “temperature measurement” occurs during step 153 of 150; col. 8, lines 47-60: “collagenous tissue of the skin”);
3) correlation fitting a relationship between the parameters for operating the energy source and the skin surface temperature at the first treatment location to be treated (154; col. 15, lines 62- col. 16, line 15);
4) defining a safe operating range for the parameters for operating the energy source in order to avoid pain and thermal damage to the medium at the first treatment location while still effectively targeting the chromophore to be treated (155);
5) maintaining the skin surface temperature below the known pain and damage threshold while simultaneously increasing a peak temperature and depth of a thermal gradient until the peak temperature and depth of the thermal gradient reaches a desired depth within the medium at the first treatment location to be treated (157; col. 18, lines 25-31: temperature is increased with the goal of reaching “target temperature”); and
6) administering at least one treatment laser pulse from the energy source with a power above the at least one initial energy pulse (163; col. 18, lines 41-44) to raise a temperature of the targeted chromophore to its required damage temperature (163: “target temperature”) to effectively target the chromophore in administering a treatment protocol (163; col. 18, lines: 41-44).
Mosher does not disclose operating a light source within a photo-thermal targeted treatment system and thus lacks:
1) administering at least one initial -laser pulse from the light source
3) correlation fitting a relationship between the parameters for operating the light source
4) defining a safe operating range for the parameters for operating the light source
6) administering at least one treatment laser pulse from the light source with a power above the at least one initial laser pulse
Bean discloses analogous method (Fig. 10) that uses an optical delivery system (Fig. 2: 10 includes “a light emitting device or laser engine”) to deliver laser energy (“Laser pulses”) to a patient’s skin such that the patient’s skin is heated to a desired temperature range (“Temperature profile in the dermal layer of skin”). The method maintains the desired temperature range by controlling pulse energy intensity (“Power”), pulse width (“Pulse width”) and pulse frequency (“Time delay between pulses”; [0080]). As disclosed by Bean, the optical delivery system can be configured to deliver other types of energy like ultrasound or radiofrequency, instead of laser energy [0025].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the energy source of Mosher to be a light source, as taught by Bean. One would have been motivated to make this modification because both radiofrequency and light sources are known types of energy used to treat skin, as evidenced by Bean. Moreover, one of ordinary skill in the art would have the ability to choose the energy source (i.e., radiofrequency or light) that would best meet their needs. Accordingly, such a modification would yield operating a light source within “a photo-thermal targeted treatment system”.
In re claim 31, see above (In re claim 1).
The proposed combination also yields (all mapping directed to Mosher unless indicated otherwise):
a cooling unit (44)
a temperature monitoring unit (40)
a controller (20)
Claims 2-4 and 6-9 are rejected under 35 U.S.C. 103 as being unpatentable over Mosher et al. (US 7,251,531), in view of Bean et al. (US 2014/0121631), in view of Sakamoto et al. (US 2019/0262072), in view of O’Neil et al. (US 2017/0173360).
In re claim 2, the proposed combination yields (all mapping directed to Mosher),
wherein:
wherein cooling includes directing a fluid on the first treatment location (col. 9, lines 40-47; regarding “a fluid” see col. 6, lines 29-32 of US 6,480,746 incorporated by reference)
correlation fitting includes estimating the relationship between the parameters for operating the light source, post-pulse cooling and the skin surface temperature at the first treatment location by fitting the skin surface temperature and parameters for operating the light source using data correlations (154: “measure a temperature rate of change”; col. 15, lines 62- col. 16, line 1) ,
wherein
the parameters are established using computational analysis (155)
The proposed combination does not yield
wherein:
cooling includes directing an airflow on the first treatment location
wherein:
the parameters are established using computational analysis taking into account a-priori knowledge of the correlation from clinical experiments; and
the safe operating range corresponds to the skin surface temperature between approximately 28 ˚C and 34 ˚C.
Sakamoto discloses an analogous method (Fig. 6: 500) that involves providing controlled thermal treatment to a patient’s skin (abstract) where a first step (502) of the method involves precooling the patient’s skin [0048]. As disclosed by Sakamoto, precooling is controlled by a cooling device that a gaseous fluid (such as air or water) coupled to a cooling circuit [0025].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the cooling of the proposed combination to include directing an airflow, as taught by Sakamoto. One would have been motivated to make this modification because the cooling of the proposed combination and cooling taught by Sakamoto are functionally equivalent. Moreover, one of ordinary skill in the art would have the ability to choose the form of cooling that would best meet their needs.
Regarding the limitation “the parameters are established using computational analysis taking into account a-priori knowledge of the correlation from clinical experiments”
O’Neil discloses an analogous method (abstract, Figure 7) focused on controlling an amount of therapeutic energy delivered to a patient’s skin [0167]. As disclosed by O’Neil, the amount of therapeutic energy delivered to the patient’s skin is controlled by adjusting parameters like power and pulse width [0171]. O’Neil further discloses using knowledge from previous experiments to select parameter values that both cause a temperature of the patient’s skin to increase and minimize skin damage (Figure 7; [0173, 0174]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the computational analysis of the proposed combination to involve taking into account a-prior knowledge of the correlation from clinical experiments, as taught by O’Neil. One would have been motivated to make this modification to because doing so would help improve the accuracy of the computational analysis used to establish the parameters.
Regarding the limitation “the safe operating range corresponds to the skin surface temperature between 28 ˚C and 34 ˚C” it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have the safe operating range correspond to the skin surface temperature between 28 ˚C and 34 ˚C, since it has been held that where general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. MPEP 2144.05-II-A.
In re claim 3, the proposed combination yields (all mapping directed to Mosher unless indicated otherwise) further comprising:
7) measuring the skin surface temperature at the first treatment location following administration of the at least one treatment laser pulse (158);
8) adjusting the safe operating range for the parameters of the light source at the first treatment location to maintain the skin surface temperature below a known pain threshold while simultaneously increasing the peak temperature and depth of the thermal gradient until at a correct depth (“No” at 158 is followed by steps 151, 156 and 157 which involves adjusting parameter), wherein the estimating, measuring, and adjusting are updated continuously during a treatment session (FIG. 8; col. 2, lines 57-67); and
9) administering at least one higher-level laser pulse from the light source (163; col. 18, lines: 41-44; regarding limitation “laser” and “light” see above modification (In re claim 1)) above the known pain threshold and below the damage threshold to raise a temperature of the chromophore to its required damage temperature (163: “target temperature” ; col. 18, lines: 41-44; see above section Claim Rejections 35 USC § 112 (In re claim 3));
The proposed combination does not yield:
wherein the method further comprises repeating steps 1) through 9) at a second treatment location.
As discussed above, Bean discloses an analogous method that involves delivering laser energy to a patient’s skin such that the patient’s skin is heated to a desired temperature range (Fig. 10). As disclosed by Bean, laser energy can be delivered to multiple locations on the patient’s skin ([0068]: “user will move the laser into the next position in step 104 and continue treating their skin until all desired skin is treated”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of the proposed combination to comprises repeating steps 1) through 9) at a second treatment location, as taught by Bean. One would have been motivated to make this modification to ensure that the user had the option to treat more than one problematic skin area (Bean, [0051, 0068]).
In re claim 4, the proposed combination does not yield, further comprising: repeating steps 1) through 9) at the first treatment location on a second subject prior to administering the treatment protocol on the second subject.
As discussed above, O’Neil discloses an analogous method (abstract, Figure 7) focused on controlling an amount of therapeutic energy delivered to a patient’s tissue [0167]. As disclosed by O’Neil therapeutic energy is delivered by a handheld device that can be used on multiple patients [0208].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the proposed combination to comprise repeating steps 1) through 9) at the first treatment location on a second subject, as taught by O’Neil. One would have been motivated to make this modification because doing so would ensure that each patient receives an individualized set of suitable parameters.
In re claim 6, the proposed combination yields (all mapping directed to Mosher), further comprising: 10) if the skin surface temperature at the first location reaches a preset threshold temperature (“Yes” at step 158), adjusting the parameters of the light source to reduce an effective power incident at the first treatment location (163; col. 18, lines 41-44: “At 163 the power level may be adjusted (upward or downward)”).
In re claim 7, the proposed combination yields (all mapping directed to Mosher) wherein defining the safe operating range for the parameters of the light source includes setting at least one of
laser power (157, 163: “adjust power level”; regarding “laser” see proposed modification above In re claim 1),
pulse width,
pulse interval,
maximum power output,
and
a skin surface cooling mechanism.
In re claim 8, see above (In re claim 3; Regarding the limitation “during administration of the treatment protocol…” see above section Claim Rejections 35 USC § 112 (In re claim 8))
In re claim 9, see above (In re claim 4; Regarding the limitation “prior to administering the treatment protocol” see above section Claim Rejections 35 USC § 112 (In re claim 9))
Claims 5 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Mosher et al. (US 7,251,531), in view of Bean et al. (US 2014/0121631), in view of Sakamoto et al. (US 2019/0262072), in view of O’Neil et al. (US 2017/0173360), in view of Speelpenning et al. (US 2016/0106505).
In re claim 5, the proposed combination yields (all mapping directed to Mosher),
storing in a memory (FIG. 2: 34) of the photo-thermal targeted treatment system information for operating the light source for the first subject at the first treatment location (col. 9, lines 10-14; regarding “light” source see proposed modification above (In re claim 1)); and
when administering the treatment protocol on the first subject at a later time, taking into consideration the information so stored in memory (col. 9, lines 10-14).
The proposed combination does not yield,
storing in a memory of the photo-thermal targeted treatment system the safe operating range for the parameters for operating the light source for the first subject at the first treatment location; and
when administering the treatment protocol on the first subject at a later time, taking into consideration the parameters so stored in memory.
Speelpenning discloses an analogous photo-thermal targeted treatment system (FIG. 3) used to treat a user’s skin (abstract). As shown in FIG. 3, the photo-thermal targeted treatment system is adapted to store, in the memory, data defining a target operational range [0027]. As disclosed by Speelpenning, storing the target operational range makes helps reduce a “run-in” time when the photo-thermal targeted treatment system is used again at a later time [0027].
It would have been obvious to one of ordinary skill in the art to modify the memory of the proposed combination to include storing the safe operating range for the parameters, as taught by Speelpenning. One would have been motivated to make this modification because doing so would reduce the photo-thermal targeted treatment systems run-in time when the photo-thermal targeted treatment system is used again at a later time (Speelpenning, [0027]). Accordingly, such a modification would yield when administering the treatment protocol at a later time, taking into consideration “the parameters” stored in memory.
In re claim 10, see above (In re claim 5; Regarding the limitation “second subject” see proposed modification above (In re claim 9)).
Claims 11-14 are rejected under 35 U.S.C. 103 as being unpatentable over Mosher et al. (US 7,251,531), in view of Bean et al. (US 2014/0121631), in view of Sakamoto et al. (US 2019/0262072), in view of O’Neil et al. (US 2017/0173360), in view of Eisenmann et al. (US 2018/0271597).
In re claim 11, the proposed combination yields (all mapping directed to Mosher unless indicated otherwise),
wherein measuring the skin surface temperature comprises tracking skin surface temperatures at the first treatment location while administering the at least one treatment laser pulse (157, 158; col. 3, lines 17-22) , and
the method further comprising:
7) continuing to track skin surface temperatures at the first treatment location while administering additional laser pulses (157, 158; col. 3, lines 17-22 );
8) adjusting the operating range for the parameters of the light source at the first treatment location, maintaining the skin surface temperature below a known pain threshold while simultaneously increasing a peak temperature and depth of the thermal gradient at the first treatment location until at a desired depth (“No” at 158 is followed by steps 151, 156 and 157 which involves adjusting parameter), wherein estimating, defining, measuring, and adjusting are updated continuously during a treatment protocol (FIG. 8; col. 2, lines 57-67); and
9) defining at least one higher-level laser pulse from the light source above the known pain threshold and below the damage threshold to raise a temperature of the chromophore to its required damage temperature (163; col. 18, lines: 41-44; regarding limitation “laser” and “light” see above modification (In re claim 1); see above section Claim Rejections 35 USC § 112 (In re claim 11)).
The proposed combination does not yield:
wherein measuring the skin surface temperature comprises tracking skin surface temperatures at the first treatment location at a refresh rate of 25 HZ to 400Hz while administering the at least one treatment laser pulse, and
7) continuing to track skin surface temperatures at the first treatment location at a refresh rate of 25 Hz to 400 Hz while administering additional laser pulses;
Eisenmann discloses an analogous photo-thermal targeted treatment system (FIG. 2) used for treating a patient’s skin (abstract). The photo-thermal target treatment system includes one or more infrared imagers (236) that work together with associated processing circuitry to determine a temperature of the patient’s skin that is currently being treated [0044].
It would have been obvious to one of ordinary skill in the art to modify the proposed combination to determine temperature using an infrared camera, as taught by Eisenmann. One would have been motivated to make this modification because the temperature assembly of the proposed combination and infrared camera of Eisenmann are functionally equivalent, that is they both determine skin temperature. Moreover, one or ordinary skill in the art would have the ability to choose the form of temperature measurement that would best meet their needs.
Regarding the limitation “at a refresh rate of 25 Hz to 400 Hz” , it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have the infrared camera of the proposed combination operate at a refresh rate of 25 Hz to 400 Hz since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. MPEP 2144.05-II-A.
In re claim 12, see above (In re claim 3).
In re claim 13, see above (In re claim 4).
In re claim 14, see above (In re claim 7).
Conclusion
The following prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Schomacker et al. (US 2012/0179227) discloses a method of treating subcutaneous fat (abstract) focused on delivering effective treatment without causing intolerable pain to the subject [0002].
Wilkens et al. (US 2003/0004501) discloses a method for treatment of acne and acne scars (abstract).
Contact
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/OLIVIA WALKER/Examiner, Art Unit 3796
/William J Levicky/Primary Examiner, Art Unit 3796
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