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 .
Response to Preliminary Amendment
This Office Action is responsive to the amendment filed on 03 Jan 2025. As directed by the amendment: claims 3-5, 8-9, 2-13, 18-20, 22-23, 26-27, and 32 have been amended, claims 6-7, 10-11, 14-15, 21, 24-25, 28, 30-31, and 33-39 have been canceled, and no claims have been added. Thus, claims 1-5, 8-9, 12-13, 16-20, 22-23, 26-27, 29, and 32 are presently pending in this application.
Claim Objections
Claims 12-13 and 26-27 are objected to because of the following informalities:
Claim 12: “step a)” should read “step (a)”
Claim 13: “step b)” should read “step (b)”
Claim 26: “step b)” should read “step (b)”
Claim 27: “step c)” should read “step (c)”
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 1-5, 8-9, 12-13, 16-20, 22-23, 26-27, 29, and 32 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.
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 to a method of preventing or mitigating a side effect of a cancer treatment, or treating cancer in a subject in need therefore, 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.
Under its broadest reasonable interpretation, claim 1 encompasses the prevention or mitigation of any side effect of any cancer treatment by placing any number of biophoton generators (of any kind) within any distance of the subject for any amount of time. The claims are unclear as to how performing the method prevents or mitigates any side effect of any cancer treatment in a subject.
Claims 16 and 29 encompass treating any cancer in a subject by placing any number of biophoton generators (of any kind) within any distance of the subject for any amount of time. The claims are unclear as to how performing the methods treat any kind of cancer in a subject.
The specification provides assertions that performing the claimed methods achieves the claimed results (preventing or mitigating a side effect of a cancer treatment, or treating cancer in a subject) (paragraphs [0318]-[0319], [0321]), but does not specify how the one or more biophoton generators would predictably achieve the claimed results. Therefore, the specification does not enable a person skilled in the art to prevent or mitigate any side effect of any cancer treatment, nor to treat any cancer.
Furthermore, the specification discloses using the method for treating “untreatable cancer” (paragraphs [0119], [0132]). By definition, “untreatable cancer” cannot be treated by any means.
Thus, the claims 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. Practice of the claimed methods would require undue experimentation because the interaction of the energy augmentation structure with biological material is unpredictable.
Claims 2-5, 8-9, 12-13, 17-20, 22-23, 26-27, and 32 are also rejected because they are dependent on claims 1, 16, and 29.
Claims 1-5, 8-9, 12-13, 16-20, 22-23, 26-27, 29, and 32 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, 16, and 29 are defined by the desired effect (preventing or mitigating a side effect of a cancer treatment in a subject, or treating cancer in a subject) without providing details about how the effect is achieved. Neither the claims nor the specification explain how the one or more biophoton generators prevent/mitigate a side effect of cancer or treat cancer beyond allegations that the invention does so.
Claim 1 encompasses the prevention or mitigation of any side effect of any cancer treatment by placing any number of biophoton generators (of any kind) within any distance of the subject for any amount of time. However, the disclosure does not provide evidence that any combination of the parameters recited in claim 1 would predictably prevent or mitigate any side effect of any cancer treatment.
Similarly, claims 16 and 29 encompass treating any cancer in a subject by placing any number of biophoton generators (of any kind) within any distance of the subject for any amount of time. However, the disclosure does not provide evidence that any combination of the parameters recited in claims 16 and 29 would predictably treat any kind of cancer.
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 1-5, 8-9, 12-13, 16-20, 22-23, 26-27, 29, and 32 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, 16, and 29 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 term “close to the subject” in claims 1, 16, and 29 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, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The distance between the subject and the one or more biophoton generators is unclear.
Regarding claims 16 and 29, the term “a subject in need therefore” is unclear as to what qualifies as “in need therefore”. For the purposes of examination, “a subject in need therefore” will be interpreted as “a subject”.
Regarding claim 16, the term “administering a standard cancer treatment to the subject” is unclear as to what the scopes of “administering” and “standard cancer treatment” are.
Claims 2-5, 8-9, 12-13, 17-20, 22-23, 26-27, and 32 are also rejected because they are dependent on claims 1, 16, and 29.
Regarding claim 18, 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).
Claim 23 recites the limitation "biophoton generators" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, claim 23 will be interpreted as “The method of claim 16, wherein the one or more biophoton generators are kept close to the subject for 5 minutes to 24 hours per day”.
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 1-5, 8-9, 12-13, 16-20, 22-23, 26-27, 29, and 32 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 1-5, 8-9, 12-13, 16-20, 22-23, 26-27, 29, and 32 do not have a credible asserted utility.
As per claim 1, the method is claimed to prevent or mitigate a side effect of a cancer treatment 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 mitigates a side effect of a cancer treatment. While assertions to preventing or mitigating a side effect of a cancer treatment in a subject are made in the specification (paragraphs [0443]-[0453]), a specific mechanism of action is not claimed. As such, it is unclear how the claimed method would prevent or mitigate a side effect of a cancer treatment.
Claims 16 and 29 are directed to methods of treating cancer in a subject in need therefore, with similar steps as those recited in claim 1. However, as per the presented claims and specification, it is unclear how placing the one or more biophoton generators close to the subject treats cancer in the subject. While assertions to treating cancer in a subject are made in the specification (paragraphs [0431]-[0442]), a specific mechanism of action is not claimed. As such, it is unclear how the claimed method would treat cancer in a subject.
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 1-5, 8-9, 12-13, 16-20, 22-23, 26-27, 29, and 32 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).
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, 16, and 29 can be interpreted such that the biophoton generators are any living organism, including human beings.
Claims 1-5, 8-9, 12-13, 16-20, 22-23, 26-27, 29, and 32 are 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, 16, and 29 recite processes (methods), which are within the four statutory categories. Therefore, claims 1, 16, and 29 are directed to a statutory category of invention.
Step 2A, Prong 1: 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 2: 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 treatments recited in claims 1, 16, and 29 are not specific to treating cancer or to preventing or mitigating a side effect of a cancer treatment. The presence or generation of biophotons does not specifically treat cancer or mitigate a side effect of cancer treatment.
Furthermore, the claims do not recite any additional elements that integrate the judicial exception into a practical application.
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 1-5, 8-9, 12-13, 16-20, 22-23, 26-27, 29, and 32 are not patent-eligible under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon without significantly more.
Conclusion
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
Ji (CN 107261337 A) discloses a cancer therapeutic apparatus, using physical method to make the metal gold emit thermal radial under the irradiation of the infrared light, the photo-radial to the cancer, the cancer cells into normal cells, help cancer patients to recover soon
Song (CN 101934116 A) discloses a phototherapy device, comprising a lighting unit and a therapy space for containing a therapy bed
Zemmouri et al. (US 20080287932 A1) discloses a kind of device for curing cancer or early symptom of cancer comprising a light source
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
Whitehurst (US 20020029071 A1) discloses a non-coherent light source for use in therapy such as photodynamic therapy (PDT) for treating cancer (paragraph [0046])
Robins (US 20070129776 A1) discloses an external wearable light therapy treatment system for treating tumors (paragraph [0220])
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
Lakhovsky (The Secret of Life, 1939) discloses using an electromagnetic resonator to treat cancer (pages 126-129)
The Novalite 3000 (2006) is a Tesla coil class of therapy devices, creates pulsed electromagnetic fields which deliver vibrational therapy into biological tissue, creating an energetic balance within the body
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTINE SISON whose telephone number is (703)756-4661. The examiner can normally be reached 8 am - 5 pm PT, Mon - Fri.
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/CHRISTINE SISON/Examiner, Art Unit 3796
/LYNSEY C Eiseman/Primary Examiner, Art Unit 3796
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