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 Amendment
This Office Action is responsive to the amendment filed on 01 Dec 2025. As directed by the amendment: claims 1 and 143 have been amended, claims 2-142, 144-203, 218-243, 259-261, 268-281, and 293-295 have been canceled, claims 204-206, 208, 210, 214-217, 244-258, 262-264, 266, 282, 284-292, and 296 have been withdrawn, and no claims have been added. Thus, claims 1, 143, 207, 209, 211-213, 265, 267, and 283 are presently pending examination.
Response to Arguments
Claim Objections
Applicant’s arguments, see Remarks, filed 01 Dec 2025, with respect to the objections to the claims have been fully considered and are persuasive in light of the claim amendments. These objections have been withdrawn.
Rejections Under 35 U.S.C. 112(a) – Lack of Written Description and Enablement
Applicant's arguments filed 01 Dec 2025 have been fully considered but they are not persuasive.
Regarding the written description rejection, Applicant amended claims 1 and 143 to limit the desired effect to wound healing and the target structure to soft tissue and/or cartilage, and argues that doing so overcomes the rejection (Remarks, pages 18-19). 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.
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, page 19). 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 in order to induce any type of wound healing in any soft tissue and/or cartilage.
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 the claims and the rejection of claim 209, have been fully considered and are persuasive in light of the claim amendments. These rejections have been withdrawn.
Applicant's arguments filed 01 Dec 2025 have been fully considered but they are not persuasive.
Applicant argues that “With respect to the Examiner's objection to the terms ‘in a vicinity of’, and ‘remote’, there is nothing indefinite with respect to this term, when read in light of the specification as is required under US patent law. One of ordinary skill would readily understand the meaning of these terms in the claims which relate the relative positions of the energy augmentation structure and the energy converter” (Remarks, pages 17-18). 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, 143, 207, 209, 211-213, 218, 225, 227, 265, 267, and 283 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 direct to modifying a target structure which mediates or is associated with a biological activity by administering to a subject in a vicinity of the target structure, at least one energy augmentation structure. 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 the one or more wavelengths of electromagnetic energy in at least one property … 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 “selected from the group consisting of folded resonators, fractal antennas, and electrical grid patterns”, 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 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. 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.
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. Claim 1 broadly recites “modifying a target structure” 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.
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. Furthermore, the energy conversion structures are purely theoretical.
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, 143, 207, 209, 211-213, 218, 225, 227, 265, 267, and 283 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 for modifying a target structure which mediates or is associated with a biological activity comprising: administering to a subject in a vicinity of the target structure, at least one energy augmentation structure, wherein the at least one energy augmentation structure is (i) a component of at least one energy emitter, (ii) present on its own, or (iii) a component of at least one energy collector, and applying an initiation energy from at least one source to the target structure.
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.
The limitation “an augmented energy contacts the target structure and induces a predetermined change in said target structure in situ” in claim 1 (page 3, lines 21-22) is unclear as to how the augmented energy is related to the at least one energy augmentation structure, the target structure, and the initiation energy.
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, 143, 207, 209, 211-213, 218, 225, 227, 265, 267, and 283 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 term “in a vicinity of” in claim 1 (page 2, line 4; page 3, lines 3 and 18-19) is a relative term which renders the claim indefinite. The term “vicinity” 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 as to how close the at least one energy augmentation structure must be to the target structure, or how close the energy converter or at least one energy converter must be to the at least one energy augmentation structure.
The term “remote” in claim 1 (page 3, lines 5 and 21) is a relative term which renders the claim indefinite. The term “remote” 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.
Claims 207, 209, 211-213, 218, 225, and 227 are also rejected because they are dependent on claim 1.
The term “in a vicinity of” in claim 143 (page 2, line 4; page 3, lines 3 and 18-19) is a relative term which renders the claim indefinite. The term “vicinity” 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 as to how close the at least one energy augmentation structure must be to the target structure, or how close the energy converter or at least one energy converter must be to the at least one energy augmentation structure.
The term “remote” in claim 1 (page 3, lines 5 and 21) is a relative term which renders the claim indefinite. The term “remote” 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.
Claims 265, 267, and 283 are also rejected because they are dependent on claim 143.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer McDonald can be reached at (571) 270-3061. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/CHRISTINE SISON/Examiner, Art Unit 3796
/Jennifer Pitrak McDonald/Supervisory Patent Examiner, Art Unit 3796