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 . 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 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.
Claim Objections
Claims 9, 10 and 14 are objected to because of the following informalities:
in claim 9, line 4 “the white light” should be amended to recite --the white light lamp--;
in claim 10, line 10 “the horizontal motion” should read --the horizontal moving--;
in claim 14, line 1 “in an organism” should be amended to recite --in a subject--; and
in claim 14, lines 3-4 “delivering a stimulus of 1-100 Hz to a subject by using the device according to claim 1, the deliver is a non-invasive delivery” should be amended to recite --non-invasively delivering a stimulus of 1-100 Hz to the subject using the device according to claim 1--.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
Claims 1-20 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 claim(s) are replete with indefinite language. The examiner has attempted to outline many of the issues below, however, Applicant is advised to review claims for further indefinite language and provide appropriate corrections in the next reply. Due to the indefinite language of the claims, prior art has been applied as best understood by the examiner. A lack of prior art rejection should not be taken as an indication of allowable subject matter.
Regarding claims 1-4, 10, 12, 14, 16 and 20, the repeated use of the phrase "and/or" renders the metes and bounds of the claims indefinite because it is unclear whether the limitation(s) following the phrase are required by the claimed invention. For example, with regards specifically to claim 1, the use of “and/or” renders unclear whether the stimulus generator must generate sound, light flicker, a full-screen visual stimulus, or some combination thereof. For purposes of examination, limitations including the phrase “and/or” have been interpreted as requiring at least one of the listed elements.
Regarding claims 2-5, 7-18 and 20, the repeated use of the term “optionally” renders the metes and bounds of the claims indefinite because it is unclear whether the limitation(s) following the phrase are required by the claimed invention. For purposes of examination, all limitations following the phrase “optionally” have been interpretated as not required by the claim.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claims 2, 4-5, 9-13, 15 and 17-18 recite multiple nested ranges and values in the same claim. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. For purposes of examination, the claims have been interpreted as only requiring the broader range to meet the claimed limitation.
Regarding claims 2, 4-5, 15 and 17-18, the repeated use of the term “preferably” renders the metes and bounds of the claims indefinite because it is unclear whether the limitation(s) following the phrase are required by the claimed invention. For purposes of examination, all limitations following the phrase “preferably” have been interpretated as not required by the claim.
Claim 10 recites the limitation “the display screen” in lines 1-2. There is insufficient antecedent basis for this limitation in the claim because claim 8, from which claim 10 depends, defines the portable device as glasses. It appears claim 10 should be amended to depend from claim 3.
Claim 11 is indefinite because the claim merely recites a use of the system without any active, positive steps delimiting how this use is actually practiced. See MPEP §2173.05(q).
Regarding claim 12, the phrase “treating a subject” renders the claim indefinite because it is unclear whether the limitation is intended to refer to the organism recited in claim 11 or if the claim requires a step of treating in a subject separate from the organism of claim 11.
Claim 18 recites the limitation "the contrast ratio of the grating image" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim or the claims in which claim 18 depends. Additionally, the claim does not define what features of the grating image the contrast ratio is defining.
The phrase “therapeutically effective amount” in claim 19 is a relative term which renders the claim indefinite. The claim does not provide objective boundaries for determining what amount is therapeutically effective and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. See MPEP §2173.05(b).
Claim 19 recites the limitation "the change of the concentration of adenosine within the subject to assess the efficacy of the drug or the medical device" in lines 4-5. There is insufficient antecedent basis for the bolded portions of the limitation in the claim. Additionally, the claim does not identify the reference point for the claimed “change” such as a baseline value, pre-treatment value, untreated control value, or prior measurement. Furthermore, the claim does not provide objective criteria for determining “efficacy” of the drug or medical device.
Claim 20 is indefinite because the claim merely recites a use of the drug or medical device for treatment without any active, positive steps delimiting how this use is actually practiced. See MPEP §2173.05(q).
Claim 6 is rejected due to their dependency on a rejected claim.
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.
Claim 11 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because the is directed to a “use” claim that does not purport to claim a process, machine, manufacture, or composition of matter. Specifically, claim 11 merely recites a use of the device without any active, positive steps delimiting how this use is actually practice, thus fails to properly claim a process. See MPEP §2173.05(q).
Claims 19 and 20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claims as a whole, considering all claim elements both individually and in combination, do not amount to significantly more than an abstract idea that is part of the Mental Processes group identified in the 2019 Revised Patent Subject Matter Eligibility Guidance published in the Federal Register (84 FR 50) on January 7, 2019. A subject matter eligibility analysis is as follows:
Step 1: Claim 19 recites a method which falls within one of the four statutory categories of invention.
Step 2A, Prong One: When analyzed to determine whether the claims recite or are directed to any judicial exception, independent claim 19 recites the limitation of “analyzing the change of the concentration of adenosine within the subject to assess the efficacy of the drug or the medical device”, as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitation in the mind. For example, the step of analyzing in the context of this claim encompasses the user or clinician merely looking adenosine concentration and assessing the efficacy of the drug or the medical device using mental steps or basic critical thinking (including observation, evaluation, judgment, opinion)
Examples of ineligible claims that recite mental process include: a claim to “collecting information, analyzing it, and displaying certain results of the collection and analysis,” wherein the data analysis steps are recited at a high level of generality such that they could practically be performed in the human mind, Electric Power Group, LLC v. Alstom, S.A., 830 F.3d 1350, 1354-55, 119 USPQ2d 1739, 1742 (Fed. Cir. 2016); claims to “comparing BRCA sequences and determining the existence of alterations,” where the claim covers any way of comparing BRCA sequences such that the comparison steps can practically be performed in the human mind, University of Utah Research Foundation v. Ambry Genetics Corp., 774 F.3d 755, 761, 113 USPQ2d 1241, 1244 (Fed. Cir. 2014); and a claim to collecting and comparing known information, which are steps that can be practically performed in the human mind, Classen Immunotherapies, Inc. v. Biogen IDEC, 659 F.3d 1057, 1063, 100 USPQ2d 1492, 1497 (Fed. Cir. 2011).
Step 2A, Prong Two: When analyzing the claim as a whole to determine whether the claim recites additional elements that integrate the abstract idea into a practical application, besides the abstract idea, claim 19 recites “administering a therapeutically effective amount of a drug to the subject or treating the subject with a medical device”. These claimed elements fail to recite any additional element or combination of additional elements that apply, rely on, or use the abstract idea in a manner that imposes a meaningful limitation on the abstract idea and do not integrate the abstract idea into a practical application.
As recited the additional element amounts to insignificant extra-solution activity in the form of mere data gathering using well-understood, routine, and conventional methods. The step is performed in order to gather data for the above cited mental process step and is a necessary precursor for all uses of the recited abstract idea since no generation of analysis in the change of the concentration of adenosine for assessment of the efficacy of the drug or medical device could be carried out without first administering the drug or treatment of with the medical device to the subject. Although this limitation indicates that a treatment is to be administered, it is recited at such a high level of generality and does not provide any information as to how the patient is to be treated, or what the treatment is, but instead covers any possible treatment that a doctor decides to administer to the patient.
Step 2B: When analyzing the claim to evaluate whether the claim as a whole amounts to significantly more than the recited exception, i.e., whether any additional element, or combination of additional elements, adds an inventive concept to the claim. The additional elements of claim 19 are not sufficient to amount to significantly more than the judicial exception because they are recited at a high level of generality, there is no meaningful limitation, such as a particular or unconventional structure that distinguishes the elements from well-known, routine, and/or conventional elements.
In view of the above, claim 19 fails to recite patent-eligible subject matter under 35 U.S.C. 101. Dependent claim 20 fails to add additional elements that integrate the judicial exception, the claim does not require any particular application of the recited analyzing step of claim 19 and is at best the equivalent of merely adding the words “apply it” to the judicial exception.
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 1-5, 6-9 and 11-17 are rejected under 35 U.S.C. 102(a)(1)/102(a)(2) as being anticipated by Barron et al. (US 2021/0275827 A1) (Barron).
Referring to claim 1: Barron teaches a device comprises a stimulus generator (see figure 1, #101) for generating a sound of 1-100 Hz (see paragraphs [0020], [0027], and [0101]; wherein sound is generated at a gamma or beta frequency) and/or for generating a light flicker of 1-100 Hz (see paragraphs [0024] and [0092]; wherein the lights flicker in the theta or gamma frequency) and/or a full-screen visual stimulus (see figure 1, #106/109). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. See MPEP §2114. In this case, Barron teaches all the structural limitations of the claim, specifically a stimulus generator that is fully capable of regulating the release of adenosine in an organism.
Referring to claim 2: Barron further teaches the stimulus generator comprises visual stimulus generator and/or acoustic stimulus generator (see figure 1; paragraphs [0020], [0024]-[0026], [0027], [0091]-[0092], [0099] and [0101]; wherein the visual stimulus is light emitted at various wavelengths in red, infra-red, blue-turquoise spectrum, monochromatic, multiple wavelength or white light).
Referring to claim 3: Barron further teaches the visual stimulus generator comprises a lamp and/or a display screen (see figure 1; paragraphs [0021] and [0024]; wherein the visual stimulus is an LED lamp/LED display screen).
Referring to claim 4: Barron further teaches the lamp emits white light and/or monochromatic light (see figure 1; paragraphs [0020], [0024]-[0026], [0027], [0091]-[0092], [0099] and [0101]; wherein the visual stimulus is light emitted at various wavelengths in red, infra-red, blue-turquoise spectrum, monochromatic, multiple wavelength or white light).
Referring to claims 6-8: Barron further teaches the device comprises mobile phone, tablet, or portable wearable device, wherein the portable wearable device is selected from glasses that includes glasses frame, blinder, mask, hat, headband, helmet, bracelet or watch (see figure 1; paragraphs [0020]-[0023] and [0096]).
Referring to claim 9: Barron further teaches the lamp comprises monochromatic light lamp and white light lamp (see figure 1; paragraphs [0020], [0024]-[0026], [0027], [0091]-[0092], [0099] and [0101]; wherein the visual stimulus is light emitted at various wavelengths in red, infra-red, blue-turquoise spectrum, monochromatic, multiple wavelength or white light).
Referring to claims 11 and 12: Barron teaches the device according to claim 1 above and further teaches a method comprising treating a subject having a neurological disease, cardiovascular disease and/or ophthalmic disease (see paragraphs [0010]-[0015]). Under the principles of inherency, in its normal and usual operation, the device of Barron would necessarily perform the claimed result of promoting the release of adenosine in an organism. See MPEP §2112.02.
Referring to claim 13: Barron further teaches the method comprises treating a subject having a sleep disorder (see paragraphs [0034], [0084] and [0089]).
Referring to claim 14: Barron teaches the device according to claim 1 above and further teaches a method comprising noninvasively delivering a visual and/or acoustic stimulus of 1-100 Hz to a subject (see paragraphs [0020], [0024, [0027], [0092] and [0101]; wherein sound is generated at a gamma or beta frequency; and wherein the lights flicker in the theta or gamma frequency). Under the principles of inherency, in its normal and usual operation, the device of Barron would necessarily perform the claimed result of regulating the release of adenosine in an organism. See MPEP §2112.02.
Referring to claim 15: Barron further teaches the frequency of the visual stimulus is 1-100 Hz (see paragraphs [0024] and [0092]; wherein the lights flicker in the theta or gamma frequency).
Referring to claim 16: Barron further teaches the visual stimulus comprises light flicker stimulus and/or image stimulus (see paragraphs [0024] and [0092]; wherein the lights flicker in the theta or gamma frequency); optionally the light flicker comprises white light and/or monochromatic light (see figure 1; paragraphs [0020], [0024]-[0026], [0027], [0091]-[0092], [0099] and [0101]; wherein the visual stimulus is light emitted at various wavelengths in red, infra-red, blue-turquoise spectrum, monochromatic, multiple wavelength or white light)
Referring to claim 17: Barron further teaches the monochromatic light comprises one or more of ultraviolet light, blue light, green light, red light and near-infrared ray (see figure 1; paragraphs [0020], [0024]-[0026], [0027], [0091]-[0092], [0099] and [0101]; wherein the visual stimulus is light emitted at various wavelengths in red, infra-red, blue-turquoise spectrum, monochromatic, multiple wavelength or white light).
Claims 1-3, 5-6, 11-12, 14-16 and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Faubert et al. (US 2011/0005532 A1) (Faubert).
Referring to claim 1: Faubert teaches a device comprises a stimulus generator (see figure 3, #12; paragraphs [0040]-[0041], [0100]-[0109]) fully capable of generating a sound of 1-100 Hz (see figure 3, #24-5; paragraphs [0059], [0067], and [0100])) and/or fully capable of generating a light flicker of 1-100 Hz (see paragraphs [0100]-[0101]) and/or a full-screen visual stimulus (see figure 3, #24-6; paragraphs [0055] and [0100]-[0101]). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. See MPEP §2114. In this case, Faubert teaches all the structural limitations of the claim, specifically a stimulus generator that is fully capable of regulating the release of adenosine in an organism.
Referring to claim 2: Faubert further teaches the stimulus generator comprises visual stimulus generator and/or acoustic stimulus generator (see figure 3; paragraphs [0040]-[0041], [0055], [0100]-[0109]).
Referring to claim 3: Faubert further teaches the visual stimulus generator comprises a lamp and/or a display screen (see figure 3; paragraphs [0055]; wherein the visual stimulus a display screen).
Referring to claim 5: Faubert further teaches the display screen displays a grating image (see figures 13-16; paragraphs [0100]-[0109]); wherein the spatial frequency of the moving grating image is 0.05-30 cycle/deg or 0.05-10 cycle/deg (see paragraph [0104]).
Referring to claim 6: Faubert further teaches the device comprises mobile phone, tablet, or portable wearable device (see figure 3; paragraph [0039]).
Referring to claims 11 and 12: Faubert teaches the device according to claim 1 above and further teaches a method comprising treating a subject having a neurological disease, cardiovascular disease and/or ophthalmic disease (see paragraphs [0071]-[0072]). Under the principles of inherency, in its normal and usual operation, the device of Faubert would necessarily perform the claimed result of promoting the release of adenosine in an organism. See MPEP §2112.02.
Referring to claim 14: Faubert teaches the device according to claim 1 above and further teaches a method comprising noninvasively delivering a visual and/or acoustic stimulus of 1-100 Hz to a subject (see paragraphs [0040]-[0041], [0055] and [0100]-[0109]). Under the principles of inherency, in its normal and usual operation, the device of Faubert would necessarily perform the claimed result of regulating the release of adenosine in an organism. See MPEP §2112.02.
Referring to claim 15: Faubert further teaches the frequency of the visual stimulus is 1-100 Hz (see paragraphs [0100]-[0102]).
Referring to claim 16: Faubert further teaches the visual stimulus comprises light flicker stimulus and/or image stimulus (see figures 13-16; paragraphs [0040]-[0041], [0055] and [0100]-[0109]).
Referring to claim 18: Faubert further teaches the contrast ratio of the grating image is 10%-100% (see figures 13-16; paragraphs [0100]-[0109]); wherein the spatial frequency of the moving grating image is 0.05-30 cycle/degree (see paragraph [0104]).
Claims 19 and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ruf et al. (US 2017/0315140 A1) (Ruf).
Referring to claims 19 and 20: Ruf teaches a method of treating a subject having a disease, wherein the method comprises administering a therapeutically effective amount of a drug to the subject or treating the subject with a medical device, and analyzing the change of the concentration of adenosine within the subject to assess the efficacy of the drug or the medical device, wherein the drug or medical device is used for the treatment of neurological disease, the treatment of cardiovascular disease and/or the improvement of sleep disorder (see paragraphs [0011], [0048]; wherein the disease is a cardiovascular disease and the medical device is an exercise stress test).
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 7-8 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Faubert, as applied to claim 6 above.
Referring to claims 7 and 8: Faubert further teaches the portable wearable device comprising glasses frame (see figure 3, #24-1; paragraph [0055]). In the fifth example, Faubert does not explicitly teach using the glasses for providing visual stimulation that includes grating images (see paragraphs [0100]-[0109]). However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make a simple substitution of the display screen taught in the fifth example of Faubert for glasses like taught by Faubert as an alternative visual stimulation device in order to increase the portability of the system while yielding predictable results in delivering grating image stimulation to the user.
Referring to claim 10: Faubert further teaches the display screen displays a grating image which comprises vertical moving grating, horizontal moving grating and/or flickering raster (see figures 13-16; paragraphs [0100]-[0109]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Petluri et al. (US 2022/0272820 A1); Masko et al. (US 2022/0047866 A1); Ooi et al. (US 2016/0128893 A1); Tedford et al. (US 2016/0067087 A1); Baek et al. (US 2015/0182759 A1); Zao et al. (US 2014/0058483 A1); Patton et al. (US 2004/0024287 A1); Miller et al. (US 6,629,935) each of which teaches a dynamic lighting system.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAYLEE R WILSON whose telephone number is (571)270-7517. The examiner can normally be reached Monday thru Friday 8 AM-5:00 PM ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Boyer Ashley can be reached at (571)272-4502. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KAYLEE R WILSON/Primary Examiner, Art Unit 3700
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