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 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, 2 and 4-20 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. The examiner was unable to find support in the originally-filed disclosure of providing a first peak wavelength in the range from 600 nm to 640 nm in combination with a second peak wavelength in the range of 650 nm to 670 nm, the specific ranges Applicant sets forth as being critical to patentability. Although paragraph 0028 appears to set forth suitable wavelengths of “the first peak wavelength is in a range of from 620 nm to 640 nm and the second peak wavelength is in a range of from 650 nm to 670 nm,” the range of 600 nm to 640 nm does not appear to be supported.
The remaining claims are rejected by virtue of their dependency.
Claim Rejections - 35 USC § 103
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 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 1-18 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over McMickle (US 2006/0161226, hereinafter “McMickle”) in view of Baird et al. (US 2015/0265846, hereinafter “Baird”), as evidenced by Berns et al. (US 2016/0113941, hereinafter “Berns”), or in the alternative, as obvious over McMickle in view of Baird and Berns.
In regards to claim 1, McMickle teaches a method of modulating nitric oxide in living mammalian tissue (abstract), the method comprising:
impinging light on the tissue (Fig. 3A), including light having a first peak wavelength and light having a second peak wavelength (par. 0034; Fig. 1);
wherein the first peak wavelength and the second peak wavelength are selected to increase nitric oxide production (abstract);
wherein the second peak wavelength differs from the first peak wavelength by at least 10 nanometers (nm) (Fig. 1; e.g., 680 and 700 nm); and
wherein each of the first peak wavelength and the second peak wavelength is in a range of from 600 nm to 700 nm (Fig. 1; e.g., 680 and 700 nm; par. 0034).
McMickle discloses the essential features of the claimed invention including providing hair growth therapy at three wavelengths including 680 nm and 700 nm (par. 0034), but does not expressly disclose wherein the first peak wavelength is in a range of from 600 nm to 640 nm, and the second peak wavelength is in a range of from 650 nm to 670 nm.
However, Baird in the same field of endeavor of light therapy for healing and regrowing hair teaches providing therapy wherein the first peak wavelength is in a range of from 600 nm to 640 nm, and the second peak wavelength is in a range of from 650 nm to 670 nm (par. 0075) to provide the predictable results of synergistically combining wavelengths known to beneficially induce nitric oxide to facilitate healing and decrease follicular apoptosis (McMickle at par. 0030; please note that Baird’s wavelengths fall within the range of wavelengths that McMickle recognizes as effective; and Baird at par. 0075 recognizing these wavelengths are effective for regrowing hair). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify McMickle by providing therapy wherein the first peak wavelength is in a range of from 600 nm to 640 nm and the second peak wavelength is in a range of from 650 nm to 670 nm to provide the predictable results of synergistically combining wavelengths known to beneficially induce nitric oxide to facilitate healing and decrease follicular apoptosis.
Although McMickle teaches that the light therapy increases nitric oxide production in the tissue (par. 0005), McMickle does not expressly and explicitly indicate that this increase is due to at least one of releasing nitric oxide from endogenous stores of nitric oxide and stimulating enzymatic generation of nitric oxide to increase endogenous stores of nitric oxide.
However, Berns discloses that the mechanism of action of light therapy in modulating nitric oxide is releasing nitric oxide from endogenous stores of nitric oxide and stimulating enzymatic generation of nitric oxide to increase endogenous stores of nitric oxide (par. 0036), and so this is necessarily the mechanism that is increasing the nitric oxide in McMickle, and so McMickle’s invention as modified above teaches the claimed subject matter. Alternatively and additionally, Berns in the same field of endeavor of light therapy teaches providing the light therapy in such a way to release nitric oxide from endogenous stores of nitric oxide and/or stimulating enzymatic generation of nitric oxide to increase endogenous stores of nitric oxide to provide the predictable results of therapeutically treating the patient in such a way to utilize known healing pathways of the body itself (pars. 0036-0038). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to further modify McMickle by providing the light therapy in such a way to release nitric oxide from endogenous stores of nitric oxide and/or stimulating enzymatic generation of nitric oxide to increase endogenous stores of nitric oxide to provide the predictable results of therapeutically treating the patient in such a way to utilize known healing pathways of the body itself.
In regards to claim 2, McMickle’s invention as modified above teaches wherein the second peak wavelength differs from the first peak wavelength by at least 25 nm (Baird at par. 0075) to provide the same predictable results as set forth above.
In regards to claim 3, McMickle’s invention as modified above teaches wherein the first peak wavelength is in a range from 620 nm to 640 nm (Baird at par. 0075, “630 nm”) to provide the same predictable results as set forth above.
In regards to claim 4, each of the light having the first peak wavelength and the light having the second peak wavelength comprises incoherent light (par. 0031, LED light; see Applicant’s par. 0116).
In regards to claims 5-7, the method as modified above further comprises impinging light having a third peak wavelength on the tissue in a range of 600 nm to 700 nm (McMickle at pars. 0030, 0034 in addition to the wavelengths provided by Baird above), wherein the third peak wavelength differs from each of the first peak wavelength and the second peak wavelength by at least 10 nm (McMickle at par. 0034, Baird at par. 0075), and produces the effect recited in claim 7 under the same rationale set forth above for claim 1 (see also McMickle at par. 0030) to provide the same predictable results as set forth above for claim 1.
In regards to claim 8, the light having the first peak wavelength comprises a first radiant flux and the light having the second peak wavelength comprises a second radiant flux, and each of the first radiant flux and the second radiant flux is in a range of from 5 mW/cm2 to 60 mW/cm2 (pars. 0027, 0049; the preferred energy of 30 J/cm2 over the preferred duration of 15 minutes is a power of 33.3 mW/cm2).
In regards to claim 9, the enzymatic generation of nitric oxide is mediated by inducible nitric oxide synthase (iNOS), neuronal nitric oxide synthase (nNOS), and/or endothelial nitric oxide synthase NOS (eNOS) in or proximate to the tissue as being the pathway necessarily present per paragraph 0036 of Berns (iNOS) or obvious in view of Berns under the same rationale set forth for claim 1.
In regards to claim 10, the endogenous stores of nitric oxide comprise nitrosoglutathione, nitrosoalbumin, nitrosohemoglobin, nitrosothiols, nitrosamines, and/or metal nitrosyl complexes in or proximate to the tissue as being the pathway necessarily present per paragraph 0036 of Berns (NO release from metal complexes) or obvious in view of Berns under the same rationale set forth for claim 1.
In regards to claim 11, the light having the first peak wavelength is produced by a first array of light emitting devices, and the light having the second peak wavelength is produced by a second array of light emitting devices (Fig. 1; par. 0034).
In regards to claim 12, the impinging of light having the first peak wavelength is performed during a first time window, the impinging of light having the second peak wavelength is performed during a second time window, and the second time window is at least partially non-overlapping with the first time window (pars. 0036-0037; the LEDs are pulsed on and off, so both wavelengths of light are impinged during a first time window, turned off, and impinged during a second time window for the next pulse; and/or par. 0051, 15 minutes for three times a week with each 15 minute treatment being a time window; there is no requirement of any type of light not being provided during the window).
In regards to claim 13, the second time window is entirely non-overlapping with the first time window (pars. 0036-0037; the LEDs are pulsed on and off, so both wavelengths of light are impinged during a first time window, turned off, and impinged during a second time window for the next pulse; and/or par. 0051, 15 minutes for three times a week).
In regards to claim 14, the impinging of light having the first peak wavelength and the impinging of light having the second peak wavelength are performed during a same time window (pars. 0036-0037).
In regards to claim 15, (a) the impinging of light having the first peak wavelength on the tissue includes impinging more than one discrete pulse of light having the first peak wavelength on the tissue during a first time window, and/or (b) the impinging of light having the second peak wavelength on the tissue includes impinging more than one discrete pulse of light having the second peak wavelength on the tissue during a second time window (par. 0036-0037; “pulsed or continuous radiation or both”).
In regards to claim 16, one of the light having the first peak wavelength or the light having the second peak wavelength is impinged on the tissue as a plurality of discrete pulses, and the other of the light having the first peak wavelength or the light having the second peak wavelength is impinged on the tissue in a steady-state manner not including a plurality of discrete pulses (par. 0036; “different LEDs can be configured to emit pulsed or continuous radiation or alternating pulsed and continuous by programming, for example, an integrated circuit, using a computer, other electrical controlling mechanism or by both”).
In regards to claim 17, the tissue comprises at least one of epithelial tissue, mucosal tissue, bone, connective tissue, muscle tissue, cervical tissue, or dermal tissue (par. 0040; “scalp”).
In regards to claim 18, dermal tissue is a scalp of a patient (par. 0040; “scalp”).
In regards to claim 20, McMickle discloses the essential features of the claimed invention, but does not expressly disclose wherein the tissue is a body cavity of a patient. However, Baird in the same field of endeavor of light therapy for healing teaches providing therapy wherein the tissue is a body cavity of a patient (par. 0069) to provide the predictable results of healing sores in the mouth (par. 0069). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to further modify McMickle by providing therapy wherein the tissue is a body cavity of a patient to provide the predictable results of healing sores in the mouth.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over McMickle and Baird (or McMickle, Baird and Berns) in view of Laurent (US 2008/0125835, hereinafter “Laurent”). McMickle’s modified invention discloses the essential features of the claimed invention including providing a first and second peak wavelength, but does not expressly disclose that the therapy is selected to decrease dihydrotestosterone (DHT) production and at least one of reduce and reverse hair loss. However, Laurent in the same field of endeavor of light therapy for hair loss teaches providing light therapy that is selected to decrease dihydrotestosterone (DHT) production and at least one of reduce and reverse hair loss (par. 0019) to provide the predictable results of increasing energy available to cells so they take in nutrients and chemical fortifications faster, and dispose of indigenous waste bi-products more readily (par. 0019) thereby stimulating hair growth (par. 0020). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to further modify McMickle by providing light therapy that is selected to decrease dihydrotestosterone (DHT) production and at least one of reduce and reverse hair loss to provide the predictable results of increasing energy available to cells so they take in nutrients and chemical fortifications faster, and dispose of indigenous waste bi-products more readily thereby stimulating hair growth.
Response to Arguments
Applicant's arguments filed 4/6/2026 have been fully considered but they are moot in part and not persuasive in part. The previous grounds of rejection in view of McMickle (or McMickle and Berns) are overcome by the claim amendments. However, the rejection is maintained as set forth above in view of Baird. Applicant argued that Baird fails to establish motivation for extracting only two wavelengths from Baird’s four-wavelength combination for the specific purpose of nitric oxide modulation. However, the claims are “comprising” claims that do not exclude other steps or providing other wavelengths. McMickle recognizes at par. 0005 that providing near infrared stimulation in the range of 600-1000 nm induces an increase in nitric oxide production thereby improving hair growth, and Baird teaches more specific wavelengths within that range to provide the same effect of improving hair growth. Accordingly, the examiner respectfully maintains the basis for obviousness as producing no more than predictable results in view of the teachings set forth above. Please also see the new grounds of rejection in view of section 112(a) above.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL W KAHELIN whose telephone number is (571)272-8688. The examiner can normally be reached M-F, 8-5.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Benjamin Klein can be reached at (571)270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL W KAHELIN/Primary Examiner, Art Unit 3792
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