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 (IDS) submitted on August 29th, 2025 and July 6th 2026 is being considered by the examiner.
Priority
The current application claims benefit of provisional application 63069142, filed on August 23rd 2020. Examiner acknowledges the applicant’s claim for priority.
Claim Objections
Claims 3, 10, and 11 are objected to because of the following informalities:
Claim 3: “the stem cell is CD34-positive stem cell” should read “the stem cell is a CD34-positive stem cell”.
Claim 10: “step a)” should read “step (a)”
Claim 11: “step b)” should read “step (b)”
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 1-20 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 enablement requirement. The claims 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.
In making a determination as to whether an application has met the requirements for enablement under 35 U.S.C. 112(a), the following factors enumerated In re Wands, 8 USPQ2d 1400, at 1404 (CAFC 1988) are considered: (1) the breadth of the claims, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the quantity of experimentation necessary. While it is not essential that every factor be examined in detail, those factors deemed most relevant should be considered.
The claims are directed towards a method of enhancing stem cell production in a subject (claim 1) or of enhancing stem cell production in a subject to treat a disease (claim 17), by placing one or more biophoton generators close to the subject within a distance and keeping the one or more biophoton generators close to the subject daily over a period of time.
Breath of claims: Under broadest reasonable interpretation. Claim 1 encompasses enhancing the production of any type of stem cells (embryonic, adult, hematopoietic, mesenchymal, neural, epithelial, or induced pluripotent [0331-0335]) in any subject by placing any number of biophoton generators (of any kind) within any distance of the subject, over any period of time. Claim 17 further encompasses treating any disease by the same steps. The dependent claims confirm the breadth: 5 minutes to 24 hours per day (claim 7), any time of day (claim 9), a distance to the subject from 1 cm to 20 meters (claim 10), and 2 weeks to 10 years (claim 11).
Nature of the invention, state of the prior art, and predictability: The specification asserts that the biophoton generators operate by producing “life force (Qi or biophoton)” and scalar wave energy “without using any energy”, from a passive mixture of natural stones, sand, metal pieces, and water, and asserts that scalar waves “travel faster than the speed of light” and “seem to transcend space and time”, see [0005]. These asserted mechanisms are inconsistent with generally accepted scientific principles, and there is no established predictable relationship in the art between the presence of such a passive mineral device and mammalian hematopoiesis or stem cell proliferation. The interaction of the purported energy field with biological material is therefore unpredictable. The specification’s proposed biological mechanisms, (e.g. modulation of Wnt/β-catenin and Notch signaling, mitochondrial activation, epigenetic modulation) are presented as assertions “without being bound by the theory” (see [0375-376]) with no data linking the claimed device to any of these pathways.
Direction, guidance, and working example: The sole working example directed to the claimed subject matter is example 96 (“Biophotons Enhancing Stem Cell Production for health and longevity”, see [0541]), an open-label, uncontrolled piolet study in which 15 of 23 enrolled volunteers completed a two-week period using four “Tesla BioHealing Biophoton Generators-A” for at least 8 hours per night, with CD34-posititve cell counts measured by flow cytometry at baseline for two weeks. The study aims no control or placebo and no blinding, and provides no bases for distinguishing the reported changes from normal biological variability in peripheral CD34-positive counts, measurement variability, or placebo-associated behavioral changes (e.g., improved sleep). Moreover, the example tests a single device configuration at a single distance regime and duration, and provides no guidance correlating the claimed parameters (number of generators, device composition, distance up to 20 meters, daily duration, from 5 minutes, treatment period up to 10 years) with the claimed result, much less with treatment of any disease as recited in claim 17.
Quantity of experimentation: Given the breadth of the claims, the absence of a credible, art-recognized mechanism, and the severe deficiencies in guidance and working examples, practice of the claimed methods across their full scope would require undue experimentation.
Accordingly, claims 1 and 17 are not enabled due to severe deficiencies in the amount of guidance and predictability for performing the claimed methods are provided by the art and by the instant specification. Claims 2-16 and 18-20 are also rejected because they depend from claims 1 and 17.
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 1-20 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.
MPEP 2163.03 states: An original claim may lack written description support when (1) the claim defines the invention in functional language specifying a desired result but the disclosure fails to sufficiently identify how the function is performed or the result is achieved or (2) a broad genus claim is presented but the disclosure only describes a narrow species with no evidence that the genus is contemplated. See Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1349-50 (Fed. Cir. 2010) (en banc). The written description requirement is not necessarily met when the claim language appears in ipsis verbis in the specification. "Even if a claim is supported by the specification, the language of the specification, to the extent possible, must describe the claimed invention so that one skilled in the art can recognize what is claimed. The appearance of mere indistinct words in a specification or a claim, even an original claim, does not necessarily satisfy that requirement."
The methods recited in claims 1 and 17 are defined by the desired effect enhancing stem cell production in a subject to treat a disease) without providing details about how the effect is achieved (see [0059-0063]; [0210] . The recited active steps of placing one or more biophoton generators close to the subject and keeping them close daily are generic placement steps that do not describe any operative link between the device and stem cell production. Neither the claims not the specification explains how the one or more biophoton generators enhance stem cell production beyond allegations that the invention does so.
Further, the claims present broad genus limitations: “any biophoton generator”, and stem cell type, any disease, and any combination of the recited parameter ranges. In contrast, the disclosure describes at most a single narrow species (four “Biophoton Generators-A” used overnight for two weeks in Example 96, with CD34-positive counts, see [0541]). The disclosure does not provide evidence that the inventors possessed the full genus of the claimed methods, including treatment of any disease by any combination of the recited parameters. Claims 2-16 and 18-20 are also rejected because they depend from claims 1 and 17.
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 scope of the term “one or more biophoton generators” as recited in claims 1 and 17 is unclear. The widely accepted definition of “biophoton” is a photon released by a biological system (e.g. plants, animals, humans). Thus, it is unclear whether the scope of “one or more biophoton generators” includes biological systems (including humans). A “biophoton generator” could also be interpreted as a system that induces biophoton generation in an organism. The specification itself describes biophotons as “the natural energy emitted by biological systems” (see [0375]) and thus does not resolve ambiguity.
The term “close to the subject” in claims 1 and 17 is a relative term which renders the claim indefinite. The term “close to the subject” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, stating only that the generator “can be positioned at any location that is positioned close to the subject” (see [0402]) and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Further, the phrase within a distance” fails to impose any discernable boundary, because every possible position of the generator relative to the subject is “within a distance” if a subject. The distance between the subject and the one or more biophoton generators therefore cannot be determined.
Claim 3 recites the limitation “the stem cell” in line 1. There is antecedent basis for this limitation in the claim, because claims 1 and 2 recite “stem cell production” but do not recite “ a stem cell”. Appropriate correction is required.
Claim 5 recited “better management of chronic condition” which is a relative terms that renders the claim indefinite; the specification does not provide a standard for ascertaining what constitutes :better” management. It is additionally unclear which one or more of the enumerated outcomes joined by “and/or” the method must achieve for the claim to be met.
Regarding claim 17, the preamble recites a method of enhancing stem cell production in a subject “to treat a disease”, but the body of the claim recited no step of treating a disease and no limitation linking the placement steps to the treatment of any disease. It is unclear whether treatment of a disease is a limitation of the claim, and if so, what steps accomplish it. For the purposes of examination, “to treat a disease” will be treated as intended use.
Regarding claim 20, 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).
Claims 2-16 and 18-20 are also rejected because they are dependent on claims 1 and 17.
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.
Claims 8 and 9 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. Claim 8 recites that the use of the one or more biophoton generators “commence at any time of the day”. Claim 9 recites that the biophoton generator “is positioned at any location close to the subject”. Claim 1 places no restriction on the time at which use commences or on the location of the generator. Accordingly, claims 8 and 9 do not further limit claim 1. Applicant may cancel the claims, amend the claims to place the claims in proper dependent form, rewrite the claims in independent form, or present a sufficient showing that the dependent claims comply 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.
Claims 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claims do not fall within at least one of the four categories of patent eligible subject matter because the claimed invention lacks patentable utility and the disclosed invention is inoperative and therefore lacks utility.
With respect to the patentable utility, the methods claimed in claims 1-20 do not have a credible asserted utility. As per claim 1, the method is claimed to enhance stem cell production in a subject. The method is claimed to comprise placing one or more biophoton generators close to the subject and keeping the one or more biophoton generators close to the subject daily over a period of time. However, as per the presented claims and specification, it is unclear how placing the one or more biophoton generators close to the subject prevents or improves the stem cell production. The specification attributes the effect to “life force”, “Qi”, and scalar wave energy generated without electricity by a mixture of natural stones, sand , metal, and water, and asserts properties for scalar waves (including travel faster than the speed of light) that are inconsistent with generally accepted scientific principles, see MPEP 2107.01. The assertions of efficacy in the specification, including Example 96, do not establish a credible utility in view of the mechanism asserted and the absence of any cofounding variables.
The same analysis applies to claim 17, which further asserts treatment of a disease. Accordingly, the asserted utility is not credible, and one of ordinary skill in the art would not accept that the disclosed invention is currently capable of the claimed invention.
Claims 1-20 are also rejected under 35 U.S.C. 101 because the claimed invention is 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). The widely accepted definition of “biophoton” is a photon released by a biological system (e.g. plants, animals, humans). Thus, under the broadest reasonable interpretation, claims 1 and 17 can be interpreted such that the biophoton generators are any living organism, including human beings.
Claims 1-20 are also rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon without significantly more. Determination as to whether a claim satisfies the criteria for subject matter eligibility is a stepwise process (MPEP 2016).
Step 1: Does the claim fall within a statutory category of invention?
Claims 1 and 17 recite subject matter within a statutory category as methods. However, it will be shown in the following steps, that claims 1-20 are nonetheless unpatentable under 35 U.S.C. 101.
Step 2A Prong One: Does the claim recite an abstract idea, law of nature, or natural phenomenon?
The claims recite “one or more biophoton generators”. The widely accepted definition of “biophoton” is a photon released by a biological system (e.g. plants, animals, humans). Thus, a “biophoton generator” encompasses any living organism that produces biophotons. Therefore, “one or more biophoton generators” is directed to the natural phenomenon of biophoton generation by living organisms.
Step 2A Prong Two: Does the claim recite additional elements that integrate the judicial exception into a practical application?
This judicial exception is not integrated into a practical application. According to MPEP 2106.04(d)(2)(b), “The treatment or prophylaxis limitation must have more than a nominal or insignificant relationship to the exception(s).”
The steps placed in claims 1 and 17 of placing a generator near a subject and keeping it there daily are generic instructions to expose the subject to the phenomenon; they recite no particular device structure, wavelength, dose, or treatment protocol specific to enhancing stem cell production. Therefore, placing one or more biophoton generators close to a subject does not apply or use the natural phenomenon of biophoton generation in a meaningful way, and the claims do not integrate the phenomenon into a practical application.
Step 2B: Does the claim include additional elements that are sufficient to amount to significantly more than the judicial exception?
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As explained above, the claims do not recite any elements in addition to the one or more biophoton generators. Therefore, claims 1-20 are not patent-eligible under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon without significantly more.
Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Schmidt (US 20230218918 A1) discloses a wearable device that selectively reflects biophotons emitted naturally from the user's body back into the body, achieving beneficial health effects similar to low-level laser therapy without requiring an external laser device
Schuster (DE 102009025982 A1) discloses methods of increasing the intensity and concentration of biophotons
Hwang (KR 20130107078 A) discloses a therapeutic tool and a method of treatment using biophotons, and more particularly, a therapeutic tool and a method of treatment using biophotons provided to enhance the symptom improvement effect of the affected area using biophotons generated from the human body
Yang (DE 202017105616 U1) discloses a container for storing biophotonic water generated by crystal lattice electron transfer and light quantum technology
Bourke et al. (US 20200114164 A1) discloses an in vivo biophoton source and a biophoton stimulator
Song (CN 101934116 A) discloses a phototherapy device, comprising a lighting unit and a therapy space for containing a therapy bed
Banker (US 20160317348 A1) discloses a photo-stimulation scalp therapy system (paragraph [0084])
Dougal (US 20050234383 A1) discloses an apparatus producing, and a method of therapy using, electromagnetic radiation for the treatment of diseases and for the maintenance or improvement of organs or body tissues
Chen et al. (US 20160367672 A1) discloses methods and systems of using a nanoparticle and near infrared radiation to treat, prevent, reduce the likelihood of having, reduce the severity of and/or slow the progression of a condition in a subject
Zhou et al. (US 5814078 A) discloses a method and apparatus utilizing the action of simulated bio-frequency spectrum signals generated upon human beings, animals, plants, and micro-organisms to regulate and improve the status of growth and survival of said organisms
Conclusion
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/R.A.S/Examiner, Art Unit 3792
/AMANDA L STEINBERG/Examiner, Art Unit 3792
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