DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Objections
Claim 5 and dependents thereof are objected to because of the following informalities: the last two indents of the claims recite “in that the system” and “and in that the system” which are proceeded by “the system comprising.” This does not make grammatical sense and the examiner suggests amending to “wherein” and “and wherein.” Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-4, 7, 11 and 18-21 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 recites the limitation “determining, based on the average skin temperature increase, the skin reflectance as a function of the amount of absorbed energy by the region of the skin of the subject” which lacks sufficient written description.
Claims 2-4 are rejected for their dependence on claim 1.
Claim 7 recites the limitation “determine, based on the average skin temperature increase, the amount of absorbed energy by the region of the skin of the subject” which lacks sufficient written description.
Claim 11 recites the limitation “a pulsed radiation energy control loop wherein the intensity and duration of the pulses of radiation energy are balanced based on the physiologically correlated safety parameters and irradiation parameters” which lacks sufficient written description.
Claim 18 recites the limitation “iv) determining, based on the average skin temperature increase of step iii), the amount of absorbed energy by the region of the skin of the subject” which lacks sufficient written description.
Claims 19-21 are rejected for their dependence on claim 18.
Regarding each of the limitations presented above, the original disclosure does not describe how the skin reflectance, amount of absorbed energy, balancing, and the amount of absorbed energy respectively are determined. The limitations amount to general correlations without an explanation or algorithm disclosed for arriving at the desired result. Original claims may lack written description when the claims define the invention in functional language specifying a desired result but the specification does not sufficiently describe how the function is performed or the result is achieved (MPEP § 2161.01).
Claims 1-4, 7, and 18-21 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Case law holds that applicant’s specification must be “commensurately enabling [regarding the scope of the claims]” Ex Parte Kung, 17 USPQ2d 1545, 1547 (Bd. Pat. App. Inter. 1990). Otherwise undue experimentation would be involved in determining how to practice and use applicant’s invention. The test for undue experimentation as to whether or not all embodiments within the scope of claims 1-4, 7 and 18-21 can be used as claimed and whether claims 1-4, 7 and 18-21 meet the test is stated in Ex parte Forman, 230 USPQ 546, 547 (Bd. Pat. App. Inter. 1986) and In re Wands, 8 USPQ2d 1400, 1404 (Fed.Cir. 1988). Upon applying this test to claims 1-4, 7 and 18-21, it is believed that undue experimentation would be required because:
(a) The breadth of the claims is broad because the claims read on any potential calculation for/to (1) “determining, based on the average skin temperature increase, the skin reflectance as a function of the amount of absorbed energy by the region of the skin of the subject” and (2) “determine, based on the average skin temperature increase, the amount of absorbed energy by the region of the skin of the subject.”
(b) The invention is directed to calculations for determining (1) skin reflectance and (2) the amount of absorbed energy by the region of the skin but the specification fails to describe anything about these calculations.
(c) The prior art does not contain examples of determining (1) “determining, based on the average skin temperature increase, the skin reflectance as a function of the amount of absorbed energy by the region of the skin of the subject” and (2) “determine, based on the average skin temperature increase, the amount of absorbed energy by the region of the skin of the subject.” The closest prior art to the claimed average temperature increase is Iger et al. (US 2022/0203112) which discloses using ratio t/T between time of treatment (t) and temperature of tissue (T) to control a skin rejuvenation system [par. 0314].
(d) The skilled artisan is capable of processing calculations of parameters; however, guidance must be provided relating to how to perform these calculations.
(e) The level of predictability in the art for making the claimed determinations is low since no examples of similar determinations could be found.
(f) There is no direction or guidance presented for making the determinations, merely statements that the determinations are made.
(g) There is an absence of working examples concerning the determinations as the specification and prior art are silent on such determinations.
(h) The quantity of experimentation necessary is great since the claims read on any algorithm for/to (1) “determining, based on the average skin temperature increase, the skin reflectance as a function of the amount of absorbed energy by the region of the skin of the subject” and (2) “determine, based on the average skin temperature increase, the amount of absorbed energy by the region of the skin of the subject” while the specification does not disclose any algorithm or steps
In light of the above factors, it is seen that undue experimentation would be necessary to make and use the invention of claims 1-4, 7, and 18-21.
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, 8 and 12-14 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.
Regarding claim 3, the metes and bounds of the claim cannot be determined by the examiner. It is unclear whether any part of the method or the entire method must be performed before and/or during irradiating the region of the skin.
Regarding claim 8, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
The term “closely resembling” in claim 12 is a relative term which renders the claim indefinite. The term “closely resembling” is 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 what would constitute a pre-defined power setting closely resembling the power setting defined based on the physiological parameters.
Regarding claim 14, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 5-6 and 9-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Liu et al. (US 2012/0226268).
[Claim 5] Liu discloses a system (radiation-based treatment device, #10) for irradiating a region of the skin of a subject with radiation having a wavelength in the range of 300 nm to 1000 nm (wavelength of about 810 nm) [par. 0097], the system comprising:
a radiation emitting unit (radiation engine, #12) configured to emit radiation having a wavelength in the range of 300 nm to 1000 nm (wavelength of about 810 nm), wherein the radiation emitting unit is further configured to direct the radiation emitted to the region of the skin of the subject (treatment area of the skin #40) [pars. 0088, 0097];
a radiation energy source (radiation source, #14) connected to the radiation emitting unit, wherein the radiation energy source is configured to supply an amount of energy to the radiation emitting unit [par. 0088];
a control unit (control system, #18) communicatively connected to the radiation energy source and configured to control the supply of energy to the radiation emitting unit by controlling the radiation energy source [pars. 0147, 0198-0202]; and
a measuring unit for measuring one or more physiological parameters of the subject, wherein the physiological parameters measured comprise at least the temperature of the skin of the subject (temperature sensor, #108) [pars. 0128, 0388],
characterized in that the system further comprises:
an user interface unit (user interface, #28, and user interface control system, #134) communicatively connectable to the control unit [par. 0147], wherein the user interface unit is configured to receive and/or store:
safety parameters, wherein the safety parameters are correlated to the physiological parameters measured and wherein the physiologically correlated safety parameters comprise at least a pre-defined maximum allowable skin temperature (Tmax) (treatment spot overlap i.e. excessive treatment is prevented by adjusting beam parameters if skin temperature or a region of skin temperature begins to heat above a threshold) [pars. 0191, 0201-0202]; and
irradiation parameters, wherein the irradiation parameters are selected from the group consisting of minimum irradiation dose (Dmin) (power or fluence to initiate treatment), maximum irradiation dose (Dmax) (power or fluence that causes excessive treatment) [pars. 0140, 0148], irradiation time (Tirr) (pulse rate frequency) [par. 0198], preferred minimum skin irradiation temperature (Tirr,min) and preferred maximum skin irradiation temperature (Tirr,max) (excessive treatment temperature threshold) [par. 0191], said preferred maximum skin irradiation temperature (Tirr,max) is equal to or lower than said pre-defined maximum allowable skin temperature (Tmax),
wherein system is configured to interrupt or adjust the energy supply to the radiation emitting unit in case the temperature of the skin of the subject exceeds said pre-defined maximum skin temperature (Tmax) (adjusts beam parameters to prevent excessive treatment caused by exceeding the temperature threshold) [pars. 0191, 0201-0202], and
wherein the system is configured to execute a radiation regime (treatment delimiters), wherein the radiation regime comprises a power setting based on which the radiation energy source supplies energy to the radiation emitting unit and wherein the power setting is defined such that one or more of the irradiation parameters are taken into account during irradiation of the region of the skin of a subject [pars. 0386-0388].
[Claim 6] Lui discloses wherein the power setting is defined such that the temperature of the skin of the subject does not exceed the preferred maximum skin irradiation temperature (Tirr,max) (adjusts beam parameters to prevent excessive treatment caused by exceeding the temperature threshold) [pars. 0191, 0201-0202].
[Claim 9] Lui discloses the system is configured to interrupt or adjust the energy supply to the radiation emitting unit in case at least one physiological parameter measured by the measuring unit deviates from the at least one physiologically correlated safety parameter; and/or during execution of the radiation regime, the power setting of the radiation regime is interrupted or adjusted in case at least one of the irradiation parameters is not met (adjusts beam parameters to prevent excessive treatment caused by exceeding the temperature threshold) [pars. 0191, 0201-0202].
[Claim 10] Lui discloses the system further comprises a distance measuring unit (skin-contact sensor, #104) configured to measure the distance of the subject's skin to the radiation emitting unit, and wherein the system is configured to determine whether or not the radiation emitting unit is positioned within a pre-defined preferred distance range (in contact with the skin) [par. 0126], and optionally, wherein the system is configured to interrupt or adjust the energy supply to the radiation emitting unit in case the radiation emitting unit is outside the pre-defined preferred distance range (feedback from skin-contact sensor is provided to control operation of the radiation source) [par. 0142].
[Claim 11] Lui discloses the power setting of the radiation regime is a pulsed radiation energy control loop wherein the intensity and duration of the pulses of radiation energy are balanced (assumed to be selected to produce the desired treatment) based on the physiologically correlated safety parameters and irradiation parameters [pars. 0198-0202].
[Claim 12] Lui discloses the user interface unit comprises a plurality of pre-defined power settings and wherein a pre-defined power setting is selected closely resembling the power setting defined based on the physiological parameters, physiologically correlated safety parameters and/or irradiation parameters provided before or during execution of the radiation regime (treatment delimiters, which are predetermined and programed to control the device for different treatments, may be set or modified by the user interface) [pars. 0386-0388].
[Claim 13] The system of Lui may be used in the treatment of a skin condition or unpleasant sensor experience present on a region of the skin of the subject. This is an intended use. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
[Claim 14] Following the logic presented in claim 13 above, the system of Lui would be capable of treating the skin condition is selected from the group consisting of inflammatory skin conditions and the unpleasant sensory experience selected from the group consisting of pruritus and pain.
[Claim 15] The system of Lui may be used in the treatment of a systemic disorder, wherein the systemic disorder is selected from the group consisting of hypertension, hyperbilirubinemia, Raynaud syndrome, Crigler-Najjar syndrome, pain, depression, Chronic Fatigue Syndrome and Long Covid Rehabilitation. This is an intended use. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
[Claim 16] Lui discloses the system is used for non-therapeutic irradiating a region of the skin of a subject (In some embodiments, device fires an "encouragement pulse" when a stationary condition is detected. For example, a single non-damaging but higher than normal energy pulse (causing discomfort but not damage) or a brief pulse train may be emitted if a stationary condition is detected, to encourage the user to move device) [par. 0190].
[Claim 17] Lui discloses the radiation-emitting device comprises the radiation emitting unit (radiation engine, #12), the radiation energy source (radiation source, #14) connected to the radiation emitting unit and the control unit (control system, #18) connected to the radiation energy source, wherein the measuring unit (temperature sensor, #108) is an integral unit (all within the housing) of the radiation-emitting device, and wherein the radiation-emitting device optionally comprises the user interface unit (user interface, #28, and user interface control system, #134).
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.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Liu et al. (US 2012/0226268) as applied to claim 5 above in view of Hammond et al. (US 2010/0179469).
[Claim 8] Liu discloses receiving feedback from temperature sensors and storing temperature correlated safety parameters (excessive treatment temperature) but does not disclose the physiological parameters measured by the measuring unit are further selected from the group consisting of blood pressure, heart rate, blood oxygen saturation, respiratory rate and skin conductance, and wherein the user interface unit is further configured to receive and/or store physiologically correlated safety parameters.
Hammond discloses an analogous system for irradiating skin with radiation comprising a control module that may be an automatic control module that adjusts the properties of the phototherapy device based upon input from sensors. Such sensors include, but are not limited to, temperature sensors, light emission spectrum sensors, pressure sensors, light intensity sensors, medical sensors (that measure patient parameters such as by contact or noncontact such as, for example, bilirubin levels in the blood, body temperature, skin temperature, heart rate, oxygen level, carbon monoxide level, carbon dioxide level, bilirubin level, skin color, blood content, bodily fluid content, blood sugar content) as well as other sensors known in the art [par. 0016]. The control module can further comprise an input/output (I/O) interface to receive the feedback data from the sensors. Memory can be included in the control module to store commands to generate drive sequences [par. 0070].
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the system of Lui to include sensors for measuring heart rate and blood oxygen saturation and store such measurements as taught by Hammond in order to control the radiation emitted by the system in response to the measurements to prevent discomfort or skin damage.
Note on Prior Art
Prior art is not applied to claims 1-4, 7 and 18-21. However, the rejection under 35 U.S.C. 112(a) for lack of written description and enablement remains.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
(1) Hofvander et al. (US 2022/0202114) discloses an energy-based photo-treatment system for providing real-time skin temperature mapping and dosimetry feedback and adjustment capabilities. Adjustments to increase or decrease laser pulse dosage based on the real-time skin temperature map can be made manually by the operator and/or can be suggested or selected automatically by the photo-treatment system [par. 0044].
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NATHAN J JENNESS whose telephone number is (571)270-5055. The examiner can normally be reached M-F 8:00-5:00 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Edward Lefkowitz can be reached at 571-272-2180. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NATHAN J JENNESS/Supervisory Patent Examiner, Art Unit 3733 30 May 2026
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