DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
Regarding the potential duplicate claim, applicant’s cancellation of claim 65 has rendered this issue moot.
Regarding the 103 rejection, applicant's arguments have been fully considered but they are not persuasive. First, applicant argues that the problem to be solved is not when to apply light and cooling relative to each other, but instead is how to design a system for controlled thermal treatment of a sebaceous gland. The examiner respectfully disagrees, as this has already been addressed by the Anderson reference, as detailed in the previous Final mailed 2/10/2025. While Altshuler is silent to the specific treatment of a sebaceous gland/sebum, the examiner has clearly articulated why such a modification would be obvious. Furthermore, applicant’s obvious to try argument has been previously addressed in the examiner’s answer mailed 2/24/2023, specifically pages 8-9, including the examiner’s position related to common sense, considerations of reducing cost and faster operation explicitly taught by Altshuler, routine optimization and criticality/unexpected results. It is noted that applicant’s arguments have never addressed these positions. While the examiner has chosen not to repeat these arguments from the examiner’s answer in the current office action, they are nonetheless maintained as part of the current rejection/position. Applicant is reminded that “the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981)”. The only difference between the claimed invention and the combination of Altshuler and Anderson is that applicant’s claimed invention requires simultaneous application of light and cooling during a preconditioning routine to treat a sebaceous gland, while the combination of Altshuler and Anderson teach the sequential application of light first then cooling during a preconditioning routine to treat a sebaceous gland. The examiner maintains that this difference is obvious, as there is no criticality, unexpected results or functional significance to such a simple/trivial modification in the order of application of light and cooling during preconditioning. It is emphasized that simultaneous application is mentioned in exactly 2 paragraphs in applicant’s specification (0049 and 0058), and Par 0058 makes it abundantly clear that the application can be simultaneous or sequential, with no criticality/importance to either, i.e. these are equivalent options. Furthermore, never once is simultaneous application mentioned specifically in relation to treatment of the sebaceous gland/sebum. Additionally, MPEP 2115 states "inclusion of the material or article worked upon by a structure being claimed does not impart patentability to the claims." Therefore, the examiner disagrees with applicant’s overly narrow interpretation of the problem, in particular that the problem relates to simultaneous application of both light and cooling during a preconditioning routine to specifically treat sebum, as applicant’s themselves have never once identified this problem/issue in either their originally filed specification or any evidence/support/facts provided in their response; see further arguments below. For these reasons, the examiner maintains that simultaneous application of light and cooling during a preconditioning routine to treat sebum is obvious.
Second, applicant argues that the specific simultaneous application of cooling and light during preconditioning routine allows the system to provide controlled thermal treatment of a sebaceous gland in a manner that does not damage surrounding tissue, i.e. does not scar the facial tissue of a human patient. Applicant seemingly recites this as a statement of fact, but provides nothing to support it. As discussed above, the specification never once mentions simultaneous application in relation to the treatment of a sebaceous gland. Furthermore, applicant has provided no facts or evidence, as to how/why this simultaneous application (as compared to sequential application) would provide any better/different/significant results, as it relates to treatment of sebum (or any other chromophore, for that matter). Stated differently, there has been no attempt by applicant to provide any factual evidence/support (other than applicant’s general allegation/opinion) as to how/why simultaneous application of preheating and precooling is patentably significant or different from sequential application, especially considering that applicant themselves disclose both as equal options in their own specification. MPEP 2145 states “Arguments presented by applicant cannot take the place of evidence in the record”. Furthermore, the examiner contends that sequential application of light and cooling during pre-conditioning would result in the same benefits/results, i.e. no damage to surrounding tissue, as this is explicitly taught by Altshuler (“protect the epidermis from thermal damage” Par 0039; “The combination of sections 52 and 58 permits the target to be heated and remain heated prior to irradiation while the epidermis is protected against thermal damage by being cooled prior to irradiation” Par 0047; “It is generally desirable that the time T.sub.2 be roughly equal to the thermal relaxation time of the target, assuming destruction of the target is the desired therapeutic effect, since this results in maximum heating of the target with minimal heating of surrounding tissue” Par 0052). Therefore, it’s abundantly clear from Altshuler and applicant’s own specification that the same benefits/advantages/effects occur for sequential application as compared to simultaneous application. Applicant has provided no facts or evidence to support a different conclusion. For these reasons, the examiner maintains that simultaneous application of light and cooling during a preconditioning routine to treat sebum is obvious.
Claim Interpretation
Regarding the “consisting essentially of” language that was added to dependent claims 50 and 54, this is being interpreted as “comprising”. MPEP 2111.03 states “for the purposes of searching for and applying prior art under 35 U.S.C. 102 and 103, absent a clear indication in the specification or claims of what the basic and novel characteristics actually are, ‘consisting essentially of’ will be construed as equivalent to ‘comprising’." It is emphasized that there is no clear indication in the specification or claims of what the basic and novel characteristics are, especially as it relates to the light source recited in claims 50 and 54. Additionally, the limitation related to the light source comprising a single laser, it is noted that this language does not preclude additional light sources or lasers. For example, even if the prior art teaches multiple light sources/lasers, one of them is a single laser and therefore reads on the claim language. Stated differently, in the situation where multiple light sources are taught, only one of the light sources is being interpreted as “the light source” and therefore, as long as this light source is a laser, then the light source is a single laser.
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 45-47, 49-53 and 55 are rejected under 35 U.S.C. 103 as being unpatentable over US 2003/0055414 to Altshuler et al. in view of US 2002/0091377 to Anderson et al.
[Claim 45 and 55] Altshuler discloses a system (Figs. 1-5, 8, 9 and 13) for controlled thermal treatment of a target (hair bulb; Par 0013), which contains a chromophore of interest (melanin; Par 0055), embedded in a surrounding medium (skin), the system comprising: a cooling device (thermal element/component 56; Par 0041) configured for applying cooling to a surface of the surrounding medium (“For pre-cooling, it is generally desired to cool the entire epidermis 12 to DE junction 16.” Par 0046); a light source (30; Par 0037) configured to transmit light into the surrounding medium, the target, and the chromophore of interest (Par 0013; when focusing/delivering light to the hair bulb, it is also inherently delivered to melanin, since the melanin is contained with the bulb); a processor (Controls 34) in communication with the cooling device and the light source and configured to control the cooling device and the light source (Par 0038); and a memory (implicit to a processor) having stored thereon instructions that, when executed by the processor, cause the processor to execute a pre-conditioning routine and a photo-treatment routine, wherein the processor, during the pre-conditioning routine, controls the cooling device (pre-cooling) and the light source (pre-heating; Par 0017) to establish a thermal gradient in the surrounding medium, the thermal gradient having a peak temperature at a desired depth (“selected depth”, “target depth”, “desired depth”, e.g. 92, Fig. 8) beneath a surface of the surrounding medium, wherein the desired depth is selected based on a known depth of the target and the chromophore of interest (“An ideal procedure would be to preheat the skin down to the target depth and then to precool to the DE junction, leaving the target depth preheated.” Par 0009; See also Pars 0016-17 and 0046-49), wherein a temperature of the surrounding tissue above and below the desired depth are lower than the peak temperature during the pre-conditioning routine (Based on the preheating a target/desired/selected depth and precooling the surface, as discussed above, inherently the resulting temperatures immediately above and below the desired depth are lower than the peak temperature, as the tissue immediately above has been cooled and the tissue immediately below has not been heated) wherein the processor, during the photo-treatment routine, controls the light source to selectively heat the chromophore of interest by an amount sufficient to exceed a damage threshold of the target at the desired depth (“heat and destroy hair bulb” Par 0035; See also Pars 0054-56 and Abstract) while not exceeding a damage threshold of the surrounding medium at the desired depth (“minimal heating of surrounding tissue”; Par 0052).
For clarity, most of the disclosure of Altshuler focuses on an embodiment where the pre-heating is accomplished by the thermal components (56), i.e. thermoelectric device. However, as pointed out above, Par 0017 explicitly states “alternatively, a low energy radiation source, which can be either the same or different than that used for treatment, can be used to perform the preheating operation”. This makes it abundantly clear that a light source, specifically the same light source that provides the treatment, i.e. light source 30, performs the pre-heating. Therefore, any discussion/disclosure by Altshuler of pre-heating accomplished by thermal components (56) is also applicable to a light source that performs the same function.
Furthermore, Altshuler discusses using a temperature sensor (94) that provides feedback to the controls (34) to “control epidermal temperatures” (Par 0078). The examiner interprets this as a controller specifically programmed/configured to control the light source and the cooling device to provide the pre-heating and pre-cooling routine, specifically pre-heating a target located at a depth within the skin while also applying cooling to the skin surface, implicitly creating a temperature gradient. If applicant disagrees with this interpretation, the examiner contends that this is nothing more than automating a manual activity and it would be obvious to specifically program the controller to provide the preconditioning routine already taught by Altshuler; MPEP 2144.04
Regarding, the limitations of a processor and memory, Altshuler is silent with regards to the specific structure of controls (34). While the controller is more than likely a processor with memory, the reference fails to explicitly teach such a structure. The examiner takes official notice that a processor with memory being programmed to control light therapy devices are pervasive throughout the art and it would be obvious to one of ordinary skill to substitute the nondescript controller taught by Altshuler for a processor with memory, as is conventional and well-known in the art.
Altshuler is discussed above, but fails to explicitly disclose simultaneously applying cooling and heating during the pre-conditioning routine. However, the examiner contends that commonsensically there are only three possible options, pre-heating before pre-cooling, pre-cooling before pre-heating or both at the same time. Therefore, based on the fact that there are only three options for the order of pre-heating and pre-cooling, it would have been obvious to try any of these options, including simultaneous application of light (for heat) and cooling, as this is merely choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success, as a matter of routine experimentation, especially considering that applicant has no criticality, unexpected results or functional significance/importance to such simultaneous application (as compared to sequential application).
Altshuler is discussed above, including explicitly teaching the treatment of “various dermatological conditions” (Pars 0011 and 0039), but fails to explicitly teach targeting the sebaceous gland/sebum. Anderson, in the same field of endeavor, makes it clear that it is known to use light to target a specific chromophore, including melanin or sebum, to treat a desired dermatological condition (Pars 0003, 0043, 0086-87). Therefore, it would have been obvious to modify Altshuler to specifically target any known chromophore/target, including sebum/sebaceous gland, in order to treat a desired dermatological condition, specifically acne, as taught by Anderson.
[Claims 46 and 47] Par 0068 discloses “a wavelength which preferentially targets melanin”. Melanin is a well-known chromophore. Furthermore, it is abundantly clear that the hair bulb (which is the target of the laser treatment) contains melanin (Par 0055) and therefore melanin is also the target of the pre-heating. It is abundantly clear, as pointed out above, that the target (including the chromophore) is heated to a temperature greater than the surrounding tissue (Par 0009, 0016-17 and 0046-49).
In terms of the combination, Anderson explicitly teaches “The teachings of this invention may also be used for other dermatological treatments and for certain subdermal treatments, such as fat removal, acne (sebaceous gland) treatment or for other medical procedures normally performed by selectively applying EMR of an appropriate wavelength to a selected treatment area” (Par 0043) and “applied radiation is at a wavelength selectively absorbed by fat, the sebaceous gland, which primarily contains fat or lipid” (Par 0086). Therefore, both Altshuler and Anderson disclose the general concept of selecting/choosing a wavelength that is specifically/selectively absorbed by a chromophore, and Anderson explicitly teaches wavelengths that specifically target the sebum in the sebaceous gland.
[Claim 49] Altshuler discloses applying cooling during the treatment (Par 0083). As discussed in relation to claim 45 (above), it is clear that the controls (34; interpreted as a processor) control the cooling device (“Temperature sensor line 94 connects to controls 34 and may be utilized to control epidermal temperatures”)
[Claims 50-51] Altshuler discloses a single pulsed laser source (30, Pars 0037-38; Fig. 1)
[Claim 52] Altshuler discloses a thermally conductive material (52, 54 or 58) coupled to a cooling circuit (56); See Pars 0041-42.
[Claim 53] Altshuler discloses that the selected depth may be 1 mm to 5 mm (Par 0013). Additionally, the examiner takes the position that the desired depth is based on the target chromophore, i.e. sebum/sebaceous gland/acne, which is known to exist in the dermis and is generally located 1 to 2 mm below the surface of the skin. Therefore, it would have been obvious to select the desired depth to be any depth where acne exists, including 1-2 mm.
Claims 48 and 54 are rejected under 35 U.S.C. 103 as being unpatentable over Altshuler and Anderson as applied to claims 45 and 65 above, and further in view of 2004/0147984 to Altshuler (‘414 Altshuler).
Altshuler and Anderson are discussed above, but fail to explicitly teach the claimed wavelengths used for targeting sebum/sebaceous gland. However, in the same field of endeavor, ‘414 Altshuler discloses “For sebaceous gland treatment, the wavelength can be in the range 900-1850 nm, preferable around peaks of lipid absorption as 915 nm, 1208 nm, 1715 nm.” (Par 0101). It is noted that 1715 nm is a specific example within applicant’s claimed ranges and therefore anticipate the claim language. Therefore, it would have been obvious to one of ordinary skill in the art to modify the device taught by Altshuler and Anderson with the wavelengths taught by ‘414 Altshuler, as these are known wavelengths for targeting and treating the sebaceous glad.
Conclusion
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Lynsey C Eiseman whose telephone number is (571)270-7035. The examiner can normally be reached Monday-Thursday and alternating Fridays 7 to 4 EST.
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/LYNSEY C Eiseman/Primary Examiner, Art Unit 3796