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 .
Specification
The disclosure is objected to because of the following informalities: On page 10, line 8, “four about three hours” should be corrected to “for about three hours”.
Appropriate correction is required.
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 2-12 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.
The term “near-infrared” in claim 2 is a relative term which renders the claim indefinite. The term “near-infrared” 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. The wavelengths are rendered indefinite since one of ordinary skill in the art would not be able to provide an exact definition as to what is “near-infrared” and what is not. It is noted that, in claims 3 and 4, the “near-infrared wavelength” is further defined by the claim. Thus, in claims 3 and 4, the use of “near-infrared” is appropriate.
Claim 2 recites the limitation "the cranium" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 2 recites “[…] wherein the light source irradiates light[…]”. The recitation of “irradiates” defines a process. However, the independent claim 1 that claim 2 is dependent from is directed to a product. Therefore, the claim is indefinite since it is directed towards two different statutory categories of inventions.
Claim 3 and 4 are rejected due to their dependency from claim 2.
Claim 5 recites, “the amount of adenosine within the living body.” (line 3). “[…] the living body” lacks antecedent basis.
The term “enhancement” in claim 8 is a relative term which renders the claim indefinite. The term “enhancement” 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. The delta waves are rendered indefinite by the use of “enhancement” since one of ordinary skill in the art would not be able to define such delta waves.
Claim 9 recites the limitation, "the light irradiation" in line 1. There is insufficient antecedent basis for this limitation in the claim. Claim 1, as recited, only mentions a light source for irradiation, not the light irradiation.
Claim 10 recites the limitation "the light wavelength, irradiation intensity, and duration of irradiation" in lines 1 and 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 11 recites, “[a] sleep induction method using the PBM system of claim 1.” However, the claim does not set forth an steps involved in the process of using the PBM system. Therefore, the claim is indefinite. See MPEP 2173.05(q).
Claim 12 recites, “[a] sleep induction device emplying the PBM system of claim 1[…]”. However, the it is unclear if the claim is directed towards a product or process since the claim recites “employing,” but comprises structural limitations. Further, it is unclear if the “light source unit” (line 2) and “control unit” (line 3) recited in claim 12 are the same as those recited in claim 1.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 5-10 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claims 5-10 merely specify intended results from the use of the system and do not further limit the structure of the PBM system of claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 2, 5, and 8 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Regarding claim 2, the claim recites and requires “the cranium.” This is a part of the human skull, and the claim therefore encompasses a human organism.
Regarding claim 5, the claim recites “increasing adenosine within the living body.” This encompasses a human organism, which is directly stated as “the human body.”
Regarding claim 8, the claim recites a “a brain environment.” The brain and the biological environment within the brain, is a part of a human organism.
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.
(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.
Claims 1, 2, 5, 6, 7, 8, 9 and 11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lim (US 20200360715 A1, “Lim”).
Regarding claim 1, the claim is directed to a photobiomodulation (PBM) system intended for inducing sleep and comprising a light source and a control unit. Lim teaches a photobiomodulation (PBM) system (Abstract; “a novel photobiomodulation (PBM) system.”) comprising: a light source for light irradiation (para. [0194]; “the coherent light of the laser light source may be preferred for its greater tissue penetration distance. As a meaningful alternative however, the use of non-coherent LED light at a longer wavelength (preferably in the NIR range) in combination with a longer treatment time may adequately compensate for the loss of maximal tissue penetration distance that can be provided by the coherent light of the laser source.”); and a control unit (controller assembly 108; Fig. 2) for adjusting the output of light (para. [0150]; “Once the user inputs instructions into the system interface 172, instructions are transmitted to the controller assembly 108 which then adjusts the parameters of the light energy being delivered to by the light generating units.”).
Regarding claim 2 and 3, Lim teaches the PBM system according to claim 1 (see above), wherein the light source irradiates light of near-infrared wavelength to the cranium, wherein the wavelength ranges from 650 nm to 1100 nm (para. [0101]; “The light generating unit will be able to deliver therapeutic light at wavelengths that include but are not necessarily limited to the following: (i) in the visible color spectral ranges, the visible red light wavelengths ranging between about 620-780 nm; and (ii) in the non-visible spectral ranges, the near-infrared light wavelengths ranging between about 780-1400 nm.”; Fig. 2 shows the system on the head (cranium) of the user). See MPEP 2131.03(II). 780 nm is taught and within the range of 650 nm to 1100 nm.
Regarding claims 5-9, Lim teaches the PBM system according to claim 1 (see above). Absent evidence to the contrary, Lim’s system is understood to result in the instantly claimed effects when the system is in use.
Regarding claim 10, Lim teaches the PBM system according to claim 1 (see above), wherein the control unit adjusts the light wavelength, irradiation intensity, and duration of irradiation. (para. [0114]; “The central processing unit (“CPU”) of the controller assembly is preferably able to regulate light energy with respect to many different parameters including but not limited to: wavelength, coherency/synchrony, energy (Joules (J)), Power (Watts (W) or milliwatts (mW)) or irradiance (W/cm.sup.2), radiant exposure (J/cm.sup.2), exposure time (seconds), wave type (continuous or pulse), frequency (Hertz (Hz)), duty cycle (percentage), fraction protocol (number of patient treatment sessions), light beam size (area of landed beam), and light beam penetration (delivery) distance.”)
Regarding claim 11, Lim teaches a sleep induction method using the PBM system of claim 1 (see above where Lim teaches the structural limitations of claim 1. Further, in the abstract, Lim teaches “a novel photobiomodulation (PBM) system and method,” explicitly stating that the invention is directed to a method.
Claims 1 and 12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Barron et al. (US 20210275827 A1, “Barron”).
Regarding claim 1, the claim is directed to a photobiomodulation (PBM) system intended for inducing sleep and comprising a light source and a control unit. Barron teaches a photobiomodulation (PBM) system (abstract; “light therapy unit”; Fig. 1), comprising: a light source for light irradiation (para. [0010]; “a plurality of LEDs disposed on said chassis”); and a control unit for adjusting the output of light (para. [0010]; “a controller which controls the operation of said LEDs”).
Regarding claim 12, Barron teaches a sleep induction device employing the PBM system of claim 1 (see above), comprising: a light source unit having at least one LED element (para. [0010; “a plurality of LEDs disposed on said chassis.”) a control unit which adjusts the output of the light source (para. [0010]; “a controller which controls the operation of said LEDs”); an internal chassis on which a plurality of light sources and control units are installed (Abstract; “…a light therapy unit comprising (a) a chassis, (b) a plurality of LEDs disposed on said chassis, and (c) a controller which controls the operation of said LEDs.”; Fig. 3; inward-facing surface 106); and an external chassis (Fig. 3; outward-facing surface 108) on which a charging cord and connection terminals are installed (Fig. 3 and 4 (Fig. 4 is a more detailed drawing of the remote (113) disposed on the external chassis shown in Fig. 4); para. [0028]; “The remote control 113 is further equipped with a headset audio plug-in port 211 for connecting a wired headset 212 to the remote control 113, and a power plug-in port 213 for connecting a power cord 214 to the remote control 113. The power cord 214 may be utilized to power the remote control 113 or to recharge one or more internal batteries contained within the device”).
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.
Claims 3 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Lim (US 20200360715 A1, “Lim”).
Regarding claim 3, Lim teaches the PBM system according to claim 2 (see 102 rejection above), including that the light wavelength can range between about 620-780nm and 780-1400 nm (para. [0101]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that Lim’s device could generate light within the claimed range because Lim’s ranges include the claimed range and specifically 780nm.
Furthermore, regarding claim 4, it would have been obvious to configure Lim’s device to provide light at a wavelength of 850 nm because Lim clearly indicates a range of possible wavelengths that include 850 nm and indicates that wavelengths between 808-1072 nm are therapeutically effective (para. [0175]). Therefore, it would have been obvious to try wavelengths within 808-1072, including 850nm
Conclusion
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/OWEN LEWIS MARSH/Examiner, Art Unit 3796
/Jennifer Pitrak McDonald/Supervisory Patent Examiner, Art Unit 3796