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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 13 Feb 2025 has been entered.
This Office Action is responsive to the amendment filed on 01 Dec 2025. As directed by the amendment: claim 1 has been amended, claims 2-101, 149-150, and 152 have been canceled, claims 105-109, 111, 113-121, and 130-148 have been withdrawn, and no claims have been added. Thus, claims 1, 102-104, 110, 112, 122-129, and 151 are presently pending examination.
Response to Arguments
Rejections Under 35 U.S.C. 112(a) – Lack of Written Description and Enablement
Applicant’s arguments, see Remarks, filed 01 Dec 2025, with respect to rejections under 35 U.S.C. 112(a) regarding how the energy converter is “capable of receiving energy from an energy source, converting the energy and emitting therefrom an emitted light of a higher or lower energy than the received energy” have been fully considered and are persuasive in light of the claim amendments. This rejection has been withdrawn.
Applicant's arguments filed 01 Dec 2025 have been fully considered but they are not persuasive.
Applicant argues that “one of ordinary skill, upon reading the present application, and with the understanding of one of ordinary skill in the art would readily understand how the energy augmentation structure of the present invention (particularly the now required¾ wavelength energy augmentation structure) would be administered in the treatment of a patient by triggering cell to cell communication via biophotons” (Remarks, pages 13-14). Examiner respectfully disagrees. The cited portion of the specification on page 13 of the Remarks discloses how one would produce the energy converter and energy augmentation structure, not how they would be used. The statement that “Such an energy augmentator can then be co-administered with the energy converter to the human or animal patient” does not explain how to administer the components, only that it can be done. It would require an unreasonable amount of experimentation for a person of ordinary skill in the art to determine not only which path of administration should be used, but also which of the many examples of energy converters would be effective to “induce a biological change in the second region inside the subject due to a change in biological or chemical activity in the first region through cell to cell communication between the first region and the second region via biophotons”, as recited by claim 1, in order to treat any possible ailment a subject might have.
Applicant further argues:
The Examiner appears to comment at page 9 that the energy converters of the present invention are purely theoretical. Applicant notes that the energy converters are in active use in Applicant's clinical trial for treating cancer (not via cell to cell communication per se, but by conversion of an applied x-ray energy into UV energy to activate, in vivo, a photoactivatable pharmaceutical agent, 8-methoxypsoralen), as well as being used in non-medical uses for curing of adhesives and other resins. As such, they are definitely not theoretical.
(Remarks, page 15)
According to MPEP 716.02(c)(II), “Arguments presented by the applicant cannot take the place of evidence in the record.” Applicant has not presented any experimental data showing that the energy augmentation structures have been shown to be effective in biological environments or produce the biological changes claimed. Claim 1 broadly recites “treating a subject” with a broad group of devices (e.g. the energy converter) without disclosing specifically how this is achieved. Because the prior art does not inform the invention, the breadth of claim 1 is an invitation for a person of ordinary skill in the art to determine what the claimed invention actually is.
Applicant argues:
For those embodiments using an energy converter, one of ordinary skill would readily understand how to select the desired energy converter to emit the wavelength/energy of electromagnetic energy/light to accomplish the desired treatment, based on the wide variety of treatments discussed that can be accomplished via light. Further, the present invention also relates to triggering cell to cell communication between the first region of biological material and the second region inside the subject in accomplishing the treatment.
(Remarks, pages 15-16)
Examiner respectfully disagrees. Claim 1 defines the energy converter by its function of “receiving energy from an energy source, converting the energy and emitting therefrom an emitted light of a higher or lower energy than the received energy”, and “being disposed in a vicinity of the at least one energy augmentation structure”. The structure of the energy converter is not described within the claim. Therefore, the energy converter in claim 1 is directed to anything that can perform the functions described, and the species of energy converters provided in the specification are not representative of the genus claimed.
Applicant further argues
As for the energy augmentation structures, there is also significant disclosure of the types of energy augmentation structures that can be used, as well as implementation structures (see as examples, pages 15-27, 87-120, and 210-213 of the specification as filed). These passages and throughout the specification describe how to create and implement the energy augmentations structures in order to accomplish the invention. As such, the present claimed invention has adequate written description and is adequately enabled to permit one of ordinary skill to perform the invention without undue experimentation.
(Remarks, page 16)
Examiner agrees that the cited portions of the specification disclose how to fabricate the energy augmentation structure. Although page 211 of the specification describes examples of implementation of the energy augmentation structure, this is not reflected in claim 1, as the breadth of “treating a subject” and “inducing a biological change” encompasses any method of bringing the energy augmentation structure adjacent to the targeted region. It is not clear from the specification which kind of implementation of the energy augmentation structures would predictably treat which condition. See MPEP 2164.03.
Rejections Under 35 U.S.C. 112(b)
Applicant’s arguments, see Remarks, filed 01 Dec 2025, with respect to rejections under 35 U.S.C. 112(b) regarding the antecedent basis issues in claim 1 have been fully considered and are persuasive in light of the claim amendments. This rejection has been withdrawn.
Applicant's arguments filed 01 Dec 2025 regarding the rejections under 35 U.S.C. 112(b) have been fully considered but they are not persuasive.
Regarding claim 1, Applicant argues that “one of ordinary skill would readily understand that the term ‘intensified’ is a relative term meaning that the electric field is intensified when the energy augmentation structure is present, relative to if the energy augmentation structure were not present” (Remarks, page 17). The claim does not include this definition of “intensified” or any basis of comparison of the generated electric field. It is not clear as to how much more “intensified” the electric field is required to be.
Applicant further argues that “The term ‘not in a vicinity of’ or ‘in proximity to’ would be readily understood by one of ordinary skill to indicate that the two items must be close enough to have an effect on the electric field or electromagnetic radiation related to the two items” (Remarks, page 17). Examiner respectfully disagrees. The distance between the energy converter and the energy augmentation structure determines how much larger the intensity of the emitted light is. It is unclear as to how much larger the intensity of the emitted light is required to be.
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, 102-104, 110, 112, 122-129, and 149-152 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.
The written description requirement has several policy objectives. “[T]he ‘essential goal’ of the description of the invention requirement is to clearly convey the information that an applicant has invented the subject matter which is claimed.” In re Barker, 559 F.2d 588, 592 n.4, 194 USPQ 470, 473 n.4 (CCPA 1977). Another objective is to put the public in possession of what the applicant claims as the invention. See Regents of the Univ. of Cal. v. Eli Lilly, 119 F.3d 1559, 1566, 43 USPQ2d 1398, 1404 (Fed. Cir. 1997), cert, denied, 523 U.S. 1089 (1998). "The ‘written description’ requirement implements the principle that a patent must describe the technology that is sought to be patented; the requirement serves both to satisfy the inventor’s obligation to disclose the technologic knowledge upon which the patent is based, and to demonstrate that the patentee was in possession of the invention that is claimed." Capon v. Eshhar, 418 F.3d 1349, 1357, 76 USPQ2d 1078, 1084 (Fed. Cir. 2005). Further, the written description requirement promotes the progress of the useful arts by ensuring that patentees adequately describe their inventions in their patent specifications in exchange for the right to exclude others from practicing the invention for the duration of the patent’s term.
To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See, e.g., Moba, B.V. v. Diamond Automation, Inc., 325 F.3d 1306, 1319, 66 USPQ2d 1429, 1438 (Fed. Cir. 2003); Vas-Cath, Inc. v. Mahurkar, 935 F.2d at 1563, 19 USPQ2d at 1116. An applicant shows possession of the claimed invention by describing the claimed invention with all of its limitations using such descriptive means as words, structures, figures, diagrams, and formulas that fully set forth the claimed invention. Lockwood v. Amer. Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997). Possession may be shown in a variety of ways including description of an actual reduction to practice, or by showing that the invention was “ready for patenting” such as by the disclosure of drawings or structural chemical formulas that show that the invention was complete, or by describing distinguishing identifying characteristics sufficient to show that the applicant was in possession of the claimed invention. See, e.g., Pfaffv. Wells Elecs., Inc., 525 U.S. 55, 68, 119 S.Ct. 304, 312, 48 USPQ2d 1641, 1647 (1998); Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406; Amgen, Inc. v. Chugai Pharm., 927 F.2d 1200, 1206, 18 USPQ2d 1016, 1021 (Fed. Cir. 1991). Importantly, the claimed invention as a whole may not be adequately described where an invention is described solely in terms of a method of its making coupled with its function and there is no described or art recognized correlation or relationship between the structure of the invention and its function. See MPEP 2163.
The claims are directed to inducing a biological change in a second region inside the subject with assistance of an electric field, wherein the electric field is a region of intensified electric field generated by interaction of (i) at least one energy emitter, (ii) at least one energy augmentation structure only, or (iii) at least one energy collector with electromagnetic energy incident thereon, and is in proximity to the first region or the second region. The term “at least one energy augmentation structure” is broadly defined as being “capable of capturing one or more wavelengths of electromagnetic energy, and augmenting at least one property of the one or more wavelengths of electromagnetic energy, wherein the at least one property is selected from the group consisting of intensity, power, associated electrical field, associated magnetic field, wave amplitude, photonic flux, magnetic flux, phase, coherence, and propagation direction” without altering “a length of a wave of the one or more wavelengths of electromagnetic energy”, and encompasses “non-plasmonic structures comprising ¾ wavelength folded resonators”, including known and unknown devices. The claims also require “an energy converter capable of receiving energy from an energy source, converting the energy and emitting therefrom an emitted light of a higher or lower energy than the received energy”, or “at least one energy converter capable of receiving an applied electromagnetic energy, converting the applied electromagnetic energy and emitting therefrom an emitted electromagnetic energy that interacts with the electric field and is shifted in wavelength or energy from the applied electromagnetic energy”.
The specification describes possible forms of the at least one energy augmentation structure, specifically folded resonators (pages 15-21). The specification further describes energy converters (pages 27-86); however, none of these structures are described in the claims.
The specification also describes treating a subject using known methods in conjunction with the claimed energy augmentation structure to treat a variety of conditions (pages 87-91, 106-114, 118-119, 159-167, 178-187). However, the examples provided do not include evidence of using the claimed energy augmentation structures in vivo, let alone successfully treating a patient’s condition, as the specification relies solely on conjecture. Although the specification discloses details about known biological processes, it does not describe any details of how the energy augmentation structures would be administered to a subject in order to initiate changes in these biological processes.
In order for the written description provision of 35 USC 112, first paragraph to be satisfied, applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the 'written description' inquiry, whatever is now claimed. The skilled artisan cannot envision the detailed structure of the encompassed genus of structures that exhibit the claimed functions. Adequate written description requires more than a mere statement that it is part of the invention.
The art does not remedy the deficiencies of the instant specification. While the art teaches known methods of photobiomodulation (page 88, lines 6-14; pages 160-167), the art does not provide adequate teachings to support the claimed methods of using energy augmentation structures to achieve the same results. The prior art does not provide species of the energy augmentation structure that treats a subject that is representative of the full genus claimed. As explained above, the species of energy augmentation structures disclosed in the specification (the folded resonators) have not been shown to be effective in biological environments, let alone produce the biological changes claimed.
Therefore, the full breadth of the many energy augmentation and energy conversion structures, known or unknown, that perform as instantly claimed do not meet the written description provision of 35 USC 112, first paragraph.
Claims 1, 102-104, 110, 112, 122-129, and 149-152 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 ¶ 1, 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 treating a subject comprising: providing a first region of biological material coupled to the subject, initiating a change in a cellular environment of the cells in the first region; and due to a change in biological or chemical activity of the cells in the first region through cell to cell communication between the first region and the second region via biophotons, inducing a biological change in a second region inside the subject with assistance of an electric field, wherein the electric field is a region of intensified electric field generated by interaction of (i) at least one energy emitter, (ii) at least one energy augmentation structure only, or (iii) at least one energy collector with electromagnetic energy incident thereon, and in proximity to the first region or the second region.
The specification teaches known methods of photobiomodulation (page 88, lines 6-14; pages 160-167). While the specification contemplates using the claimed energy augmentation structures to assist in making the biological changes through photobiomodulation, the specification does not teach/demonstrate how this would be achieved. The specification provides no guidance about how to use the energy augmentation structures to induce a biological change. Furthermore, the specification does not provide any in vivo evidence to support the instantly claimed methods of using the energy augmentation structures to induce a biological change within a subject.
The specification provides examples of photobiomodulation and photostimulation using light directly, but does not specify how the energy augmentation structures would be implemented in these methods beyond the conjecture that “the in situ or ex situ presence of energy augmentators including resonators such as the folded resonators … can affect” the biological change.
The art provides no guidance to enable the instant claims, beyond known methods of photobiomodulation using light to directly induce changes in biological material. The art does not enable methods of using energy augmentation structures to predictably achieve the desired effects of photobiomodulation. There is no evidence of the energy augmentation structures being used to predictably achieve a specific biological change.
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.
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, 102-104, 110, 112, 122-129, and 149-152 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.
Relative Terms
The term “intensified” in claim 1, line 7 is a relative term which renders the claim indefinite. The term “intensified” 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. It is unclear how the electric field is “intensified”, because there is no basis for comparison of the generated electric field.
The term “not in a vicinity of” in claim 1, lines 34 and 45 is a relative term which renders the claim indefinite. The term “in proximity to” 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. In the case of the (i) at least one energy emitter, it is unclear how far the energy converter must be from the at least one energy augmentation structure to cause the required difference in emitted intensity. In the case of the (iii) at least one energy collector, it is unclear how far the at least one energy converter must be from the at least one energy augmentation structure to cause the required different in the at least one augmented property.
Clarity Issues
The limitation “due to a change in biological or chemical activity of the cells in the first region, inducing a biological change in a second region inside the subject with assistance of an electric field” in claim 1, lines 5-6 is unclear as to whether “inducing a biological change” is caused by the “change in biological or chemical activity of the cells in the first region” or by the “assistance of an electric field”. Furthermore, the limitation “assistance of an electric field” is unclear as to how the electric field “assists”.
Claims 102-104, 110, 112, 122-129, and 149-152 are also rejected because they are dependent on claim 1.
Conclusion
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
/Jennifer Pitrak McDonald/Supervisory Patent Examiner, Art Unit 3796