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 .
Information Disclosure Statement
The Information Disclosure Statement filed 08/28/2023 has been considered by the Examiner.
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 1-23 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.
Claim 1 recites the following limitations which lack antecedent basis:
“the electron transport chain” in the preamble, which should read “an electron transport chain”
“the activity of Complex I” in step a. should read “an activity of Complex I”
“the activity of Complex II” in step b. should read “an activity of Complex II”
“the activity of Complex III” in step c. should read “an activity of Complex IIII”
“the activity of Complex IV” in step d. should read “an activity of Complex IV”
Claim 2 recites “the light energy,” however there are four options of light energy in claim 1 and it is unclear which one(s) the dependent claim is referring to.
Claim 3 recites the limitation "the application" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 4 is unclear because it recites “low level laser energy” when the light energy has been claimed as a low level laser energy in the parent claim 2. Claim 4 should read “the low level laser energy” to increase clarity and maintain common terminology.
Claim 5 is unclear as the independent claim recites the different wavelengths of light in the alternative using ‘or’ which indicates only one option. Claim 5 then claims that the device can emit all of the wavelengths previously claimed in the alternative, thus indicating that the method actually required all three of the light wavelengths. The metes and bounds of the claim are unclear.
Claim 6 contradicts claim 1 because claim 1 claims the different wavelengths of light in the alternative using ‘or’ which indicates only one option, while claim 6 claims that more than one wavelength is applied simultaneously.
Claim 7 recites the following limitations which lack antecedent basis:
“the electron transport chain” in the preamble, which should read “an electron transport chain”
“light energy having a violet-blue wavelength” in step d, should read “the light energy having the violet-blue wavelength” to clearly reference the light energy claimed in step a
“light energy having a green wavelength” in step e, should read “the light energy having the green wavelength” to clearly reference the light energy claimed in step b
“light energy having a red wavelength” in step f, should read “the light energy having the red wavelength” to clearly reference the light energy claimed in step c
Claims 8-13 are unclear as they recite “the light energy” in their respective preambles, but there are multiple light energies in the parent claim.
Claim 15 is unclear as it recites “the light energy,” but there are multiple light energies in the parent claim.
Claim 16 recites the limitation "the application" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 17 is unclear because it recites “low level laser energy” when the light energy has been claimed as a low level laser energy in the parent claim 15. Claim 4 should read “the low level laser energy” to increase clarity and maintain common terminology.
Claim 19 recites the limitation “the mitochondrial function” in the preamble. There is insufficient antecedent basis for this limitation in the claim.
Claim 19 steps a and c should read “the patient” instead of “a patient,” as antecedent basis for the patient is established in the preamble.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 2, 5, 7, 15, and 18-21 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rossi et al (US 20200405858 A1).
Regarding claim 1, Rossi teaches a method for increasing activity of one or more complexes in the electron transport chain in a treatment area of a patient (see [0012]; method for stimulating mitochondrial biogenesis with illumination), the method comprising
increasing the activity of Complex IV by applying light energy having a red wavelength externally to the treatment area (see [0048]; cytochrome c oxidase is the primary photoreceptor for the red-NIR wavelength range, 630-900 nm, [0104]; actinic light emitting wavelengths between 200 and 800 nm).
It can be appreciated that claim 1 recites the limitations:
a. increasing the activity of Complex I by applying light energy having a violet- blue wavelength externally to the treatment area of a patient;
b. increasing the activity of Complex II by applying light energy having a violet- blue wavelength externally to the treatment area; or
c. increasing the activity of Complex III by applying light energy having a green wavelength externally to the treatment area;
which are claimed in the alternative, therefore the prior art discussed above satisfies the current claim language.
Regarding claim 2, Rossi teaches the method of claim 1 wherein the light energy is low-level laser energy applied to the treatment area in a continuous sweeping motion (see [0109]; the source of actinic light is in a continuous motion over the treated area for the appropriate time of exposure).
Regarding claim 5, Rossi teaches the method of claim 1 wherein the violet-blue, green, and red wavelengths are emitted from a single light-emitting device (see [0104]; the actinic light may be a LED or plasma arc lamp or laser and will emit wavelength(s) between 200nm and 800nm, the range of possible wavelengths from the single actinic light spanning the spectrum of violet-blue, green, and red light.
Regarding claim 7, Rossi teaches a method for increasing activity of one or more complexes in the electron transport chain (see [0012]; method for stimulating mitochondrial biogenesis with illumination), in a treatment area of a patient, the method comprising applying light energy having a red wavelength externally to the treatment area (see [0104]; actinic light emitting wavelengths between 200 and 800 nm),
wherein light energy having a red wavelength increases activity of Complex IV (see [0048]; cytochrome c oxidase is the primary photoreceptor for the red-NIR wavelength range, 630-900 nm).
It can be appreciated that claim 7 recites the limitations:
applying light energy of one or more of the following wavelengths externally to the treatment area:
a. light energy having a violet-blue wavelength;
b. light energy having a green wavelength; and
c. light energy having a red wavelength;
wherein
d. light energy having a violet-blue wavelength increases activity of Complex I or Complex II;
e. light energy having a green wavelength increases activity of Complex Ill; and
f. light energy having a red wavelength increases activity of Complex IV
which are claimed in the alternative, therefore the prior art discussed above satisfies the current claim language.
Regarding claim 15, Rossi teaches the method of claim 7 wherein the light energy is low-level laser energy applied to the treatment area in a continuous sweeping motion (see [0109]; the source of actinic light is in a continuous motion over the treated area for the appropriate time of exposure).
Regarding claim 18, Rossi teaches the method of claim 7 wherein the violet-blue, green, and red wavelengths are emitted from a single light-emitting device (see [0104]; the actinic light may be a LED or plasma arc lamp or laser and will emit wavelength(s) between 200nm and 800nm, the range of possible wavelengths from the single actinic light spanning the spectrum of violet-blue, green, and red light.
Regarding claim 19, Rossi teaches a method for increasing the mitochondrial function in a treatment area of a patient, the method comprising:
a. measuring the mitochondrial function of a patient (see [0054; assaying levels of energy production in the target tissue before undergoing biphotonic treatment)
b. applying a first treatment of light energy at one or more wavelengths (see [0104]; actinic light used to illuminate target tissue having a wavelength between 200nm and 800nm), the one or more wavelengths increasing the activity of one or more complexes in the electronic transport chain (see [0048]; cytochrome c oxidase is the primary photoreceptor for the red-NIR wavelength range);
c. measuring the mitochondrial function of a patient after applying light energy (see [0054]; assaying levels of energy production in the target tissue after biphotonic treatment); and
d. applying a second treatment of light energy at the one or more wavelengths, the one or more wavelengths increasing the activity of one or more complexes in the electronic transport chain until the mitochondrial function is at a desired level (see [0054]; comparing energy levels in untreated vs treated tissue and modulating parameters of the treatment regimen if the energy levels in the treated areas are lower than untreated areas).
Regarding claim 20, Rossi teaches the method of claim 19 wherein the one or more wavelengths are selected from violet-blue, green, and red wavelengths (see [0104]; the actinic light is a light source having a wavelength between 200nm and 800nm which spans the wavelengths corresponding to all of violet-blue, green, and red light).
Regarding claim 21, Rossi teaches the method of claim 19 wherein the light energy is low-level laser energy applied to the treatment area in a continuous sweeping motion (see [0109]; the source of actinic light is in a continuous motion over the treated area for the appropriate time of exposure).
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) 3, 4, 6, 8-14, 16, 17, 22, and 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rossi et al (US 20200405858 A1) in view of Loupis et al (US 20160016001 A1).
Regarding claims 3, 16, and 22 Rossi teaches the method of claims 2, 15, and 21. Rossi is silent regarding wherein the application of laser energy causes no detectable temperature rise of the treated location, although Rossi does teach the light energy to be delivered over in a continuous sweeping motion for a preset period of time, which can be appreciated to reduce the likelihood of raising tissue temperatures due to the lack of a stagnant beam of light on a single point (Rossi [0108-0109]).
Loupis teaches a method of phototherapy via a therapeutic device wherein the application causes no detectable temperature rise of the treated location (see Loupis [0145]; the therapeutic device may have a cooling system including heat sinks, one or more fans, vents, or a shield in order to minimize heating).
It can be appreciated that these precautions are taken by Loupis in order to minimize any heating of the target tissue while the light energy is being delivered. It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the method of increasing activity in the electron transport chain via light energy as taught by Rossi with the heating precautions including a heat sink and/or shield as taught by Loupis. One of ordinary skill in the art would have been motivated to make this modification in order to minimize any discomfort or adverse effects to a user during or after treatment.
Regarding claims 4, 17, and 23 Rossi teaches the method of claims 2, 15, and 21. Rossi is silent regarding wherein low-level laser energy is applied using a hand- held laser device that emits a line of laser light.
Loupis teaches low-level laser energy (see Loupis [0096]; irradiating light may be applied by a laser) applied using a hand-held laser device that emits a line of laser light (see Loupis [0063]; the device may be portable and provided with handles).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the method of increasing activity in the electron transport chain via light energy as taught by Rossi with the laser emitting hand-held device as taught by Loupis. One of ordinary skill in the art would have been motivated to make this modification in order to provide portability and freedom of positioning for the device and resulting treatment area (Loupis [0063], [0147]).
Regarding claims 6 and 14, Rossi teaches the method of claims 1 and 7. Rossi is silent regarding wherein more than one of the wavelengths are applied simultaneously, the one or more wavelengths being violet-blue, green, and red wavelengths.
Loupis teaches wherein more than one of the wavelengths are applied simultaneously (see Loupis [0053]; the first, second, and third light sources may emit lights having different wavelengths simultaneously from a single light source or a plurality of light sources), the one or more wavelengths being violet-blue, green, and red wavelengths (see Loupis [0049]; the light source can emit light within the violet and blue range, the green range, and the red range of the electromagnetic spectrum).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the method of increasing activity in the electron transport chain via light energy as taught by Rossi with the simultaneous application of violet-blue, green, and red wavelengths as taught by Loupis. One of ordinary skill in the art would have been motivated to make this modification in order to reap the benefits of the different wavelengths at a single time, including the complimentary benefits of multiple wavelengths providing treatment to the target tissue which may be at various stages of healing/activation (Loupis [0053]).
Regarding claim 8, Rossi teaches the method of claim 7. Rossi is silent regarding wherein the light energy is applied in the following order:
a. light energy having a violet-blue wavelength;
b. light energy having a green wavelength; and
c. light energy having a red wavelength.
Loupis teaches wherein the light energy is applied in the following order:
a. light energy having a violet-blue wavelength (see Loupis [0008]; a first light having a peak wavelength of about 430 to about 500 nm, which encompasses the violet-blue range of about 380nm-495nm);
b. light energy having a green wavelength (see Loupis [0009]; a second light having a peak wavelength of about 480 to about 620 nm, which encompasses the green range of about 495nm-570nm); and
c. light energy having a red wavelength (see Loupis [0022]; a third light having a peak wavelength of about 630 to about 750 nm, which encompasses the red range of about 620nm-750nm).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the method of increasing activity in the electron transport chain via light energy as taught by Rossi by applying the light energy in the order of a violet-blue wavelength, a green wavelength, and a red wavelength as taught by Loupis. One of ordinary skill in the art would have been motivated to make this modification in order to activate various therapeutic effects caused by the light energy at each wavelength, wherein the distances between the subsequent peaks may be due to a Stoke’s shift (Loupis [0004], [0010]).
Regarding claims 9-13, Rossi teaches the method of claim 7. Rossi is silent regarding wherein the light energy is applied in a specified order. Loupis teaches wherein the light energy is applied in the order of: light energy having a violet-blue wavelength; light energy having a green wavelength; and light energy having a red wavelength, as elaborated upon above in relation to claim 8. Loupis is silent regarding wherein the light energy is applied at wavelengths in the following orders:
Green, violet-blue, red (claim 9)
Green, red, violet-blue (claim 10)
Red, violet-blue, green (claim 11)
Violet-blue, red, green (claim 12)
Red, green, violet-blue (claim 13)
However, Loupis does teach changing the order of the applied light energy, in paragraph [0004] where the first light is in the violet spectra and the second light is in the blue spectra and paragraph [0005] where the first light is in the blue spectra and the second light is in the violet spectra. It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to change the order of the applied wavelengths, and try various orders of applying the wavelengths in order to maximize the desired therapeutic results and best utilize the different and complementary therapeutic effects that may be caused by differing wavelengths of light (Rossi [0064]).
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 by routine experimentation only involves routine skill in the art. In re Aller, 105 USPQ 233. See MPEP 2144.05(II)(A). It can be appreciated that the general conditions of claims 9-13 are disclosed in the prior art as there is evidence of applying light at differing wavelengths sequentially in multiple orders to maximize the desired therapeutic effects, so optimizing the order of application through routine experimentation only involves routine skill in the art.
Conclusion
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/A.J.S./Examiner, Art Unit 3792
/ALLEN PORTER/Primary Examiner, Art Unit 3796