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(a)
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 claim(s) 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.
There are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is "undue." These factors include, but are not limited to: (A) The breadth of the claims; (B) The nature of the invention; (C) The state of the prior art; (D) The level of one of ordinary skill; (E) The level of predictability in the art; (F) The amount of direction provided by the inventor; (G) The existence of working examples; and (H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure. In re Wands,858 F.2d 731,737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988)
In the present case, claims 1-20 are rejected based on a lack of enablement means because, based on the evidence regarding each of the above factors, the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention without undue experimentation. Analysis of the factors is as follows:
(A) The breadth of the claims
The claims include subject matter about treating muscular degenerative disease, such as muscular dystrophy (claim 2) with “biophotons” (claims 1-10), producing “biophotons” with a “biophoton generator” (claims 1-10), including an effects of “reduces the subject’s genetic mutations” (claim 3).
The claims are also directed towards subject matter about improving genetic mutation with “biophotons” (claims 11-20), producing “biophotons” with a “biophoton generator” (claims 11-20).
In par. 0025 of the specification, Applicant characterizes the invention as “stationary and portable bioenergy generators to produce life force (Qi, or Biophoton)”. As such, the terms “biophoton”, “life force”, and “Qi” are considered as synonymous.
The methods of claims 1-20 includes methods of subjecting a muscular degenerative disease patient or genetic mutation disorder patient with biophotons, the methods are both performed in the exact same way for both patients, that being to place a biophoton generator “close to the subject within a distance” for any period of time. The claims do not specify what the biophoton generator is.
As disclosed in par. 0075, the biophoton generator is a container holding “fine pieces of natural stone 102 selected from the group of diamond, amethyst, tourmaline, jadestone with any color, and obsidian. The bioenergy generator 100 further includes fine pieces of natural sand 104 selected from the group of white sand, black sand, pink sand, red sand, yellow sand, orange sand, and green sand. The bioenergy generator 100 further includes fine pieces of metal 106 selected from the group of steel, iron, copper, zinc, aluminum, calcium, magnesium, silver, and gold. The bioenergy generator further includes water 108 and a supporting material 110 operable to hold the natural sand, the natural stone, the metal, and the water together as a mixture 111. The supporting material may be a polymer, grout, water, sand, stone, or adhesion material, for example. A container 112 is operable to hold the natural stone 102, the natural sand 104, the metal 106, the water 108, and the supporting material 110.”
(B) The nature of the invention
The nature of the invention includes placing a biogenerator (i.e. container holding pieces of natural stone, natural sand, metal, water as specified in par. 0075) nearby a sick person to treat their disease, specifically muscular degeneration or genetic mutations. For example, as shown in Figure 14, the container is placed by the person’s bed; in Figure 15, the container is set on or under a table; in Figure 16, the container is placed under a chair; in Figure 17, the container is placed in a backpack. The inventor asserts the change in life force level can be monitored by biometer (par. 0009-0010) using the Bovis scale.
(C) The state of the prior art and (D) The level of one of ordinary skill
Qi is recognized as a conceptual tool for guiding holistic health. One of ordinary skill would recognize that biophotons (i.e. Qi, life force) is not considered scientific, since it is not proven to exist based on explainable factors. Bovis biometer involves swinging a pendulum along a scale until the swing alters to cross a line corresponding to the Bovis scale value. One of ordinary skill would recognize it is not considered to be a scientific measurement tool, since it is not based on physics.
(E) The level of predictability in the art
One of ordinary skill in the medical arts (e.g. nurses, doctors) would predict that any changes in health state due to the biophoton generator (i.e. container holding pieces of natural stone, natural sand, metal, water) being placed near the sick person are resulting from coincidence or other factor (e.g. medications, directed behavioral changes, placebo effect, etc). One of ordinary skill would not expect a container holding pieces of natural stone, natural sand, metal, and water to have a specific health effect, beneficial or otherwise.
(F) The amount of direction provided by the inventor
The inventor describes the contents of the bioenergy generator as being “activated” and therefore they produce biophotons. The contents become “activated” by proximity to another biophoton generator (e.g. par. 0078 “the ingredients are activated by placing the natural stones, natural sands, safe metal, and water next to a strong biophoton generator”). The inventor does not describe how the ingredients of the bioenergy generator are selected or what mechanism causes them to activate. There is no direction provided to confirm the strength of the activated bioenergy generator.
(G) The existence of working examples
The inventor asserts patients were treated with the bioenergy generators placed nearby to cause dramatic healing effects. For example, curing chronic fatigue syndrome (par. 0094), treatment of back pain (par. 0097), treatment of uncurable cancer (par. 0100), treatment of painful menstruation (par. 0101), treatment of prostate enlargement (par. 0102), treatment of depression (par. 0103), curing virus (par. 0104), treatment of erectile dysfunction (par. 0105), treatment of mental health (par. 0106), treatment of stroke-paralysis (par. 0107). It is also asserted that the biophoton generator increases fermentation to make strawberry wine (par. 0132). However, the scientific data to support such assertions was not included. Similarly, for treatment related to muscular degeneration and genetic mutations specifically (as claimed), anecdotal data is provided (par. 0173-0198, especially par. 0243 Example 41). However, these effects can be explained by other factors, especially for a poorly understood disease such as muscular degeneration which symptoms vary over time. Data relating to genetic mutations (par. 0257), toxins and other harmful factors (par. 0264) but this is not considered to be scientific data since it is not using measurements based on physics. Further, the control variable (the husband’s data, par. 0263-0264) showed the same exact trend as the treatment variable (the wife’s data, par. 0263-0264), indicating that there is no effect from the treatment but rather the changes in the data are a result of something else.
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
There would need to be a very high amount of experimentation to make and use the invention based on the content of the disclosure, since no physics were disclosed to either measure or generate the biophotons and no known way (based on physics) exists to measure or generate biophotons.
For all of these reasons, the specification fails to teach how to make and use the claimed invention in its full scope without undue experimentation.
Claim Rejections - 35 USC § 101 and 35 U.S.C. 112(a)
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 not supported by either a credible asserted utility or a well-established utility.
The claims include subject matter about treating muscular degenerative disease, such as muscular dystrophy (claim 2) with “biophotons” (claims 1-10), producing “biophotons” with a “biophoton generator” (claims 1-10), including an effects of “reduces the subject’s genetic mutations” (claim 3).
The claims are also directed towards subject matter about improving genetic mutation with “biophotons” (claims 11-20), producing “biophotons” with a “biophoton generator” (claims 11-20).
In par. 0025 of the specification, Applicant characterizes the invention as “stationary and portable bioenergy generators to produce life force (Qi, or Biophoton)”. As such, the terms “biophoton”, “life force”, and “Qi” are considered as synonymous.
The subject matter of producing and measuring biophotons does not credibly meet the requirements of scientific rigor because biophotons (if they exist) cannot be reliably measured or generated via any known means based on physics.
Claims 1-20 are also rejected under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph. Specifically, because the claimed invention is not supported by either a credible asserted utility or a well-established utility for the reasons set forth above, one skilled in the art clearly would not know how to use the claimed invention.
Although Qi or Biophoton currently does not exist as a scientifically measurable entity to meet the requirements of patent statutes, it still remains a powerful conceptual tool in guiding physical practice, mental focus, and holistic health (e.g. Tai Chi, Qigong).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Applicant’s related (published) patent applications involving biophotons:
US 20260077208, US 20250332434, US 20250249034, US 20250249033, US 12076338, US 20250241945, US 20250229100, US 20250213881, US 20250177773, US 20250177771, US 20250082956, US 20240335467, US 20230392172, US 20240026389, US 20240043882.
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ANGELA M. HOFFA
Primary Examiner
Art Unit 3799
/Angela M Hoffa/Primary Examiner, Art Unit 3799
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