DETAILED ACTION
This Office Action is responsive to the Amendment filed 3 April 2026. Claims 1-
10 and 12-28 are now pending. The Examiner acknowledges the amendments to
claims 1-10 and 12-27, as well as the cancellation of claim 11 and the addition of claim
28.
Response to Amendment
Per MPEP 714 and 37 CFR 1.121(c), “(2) When claim text with markings is required. All claims being currently amended in an amendment paper shall be presented in the claim listing, indicate a status of “currently amended,” and be submitted with markings to indicate the changes that have been made relative to the immediate prior version of the claims. The text of any added subject matter must be shown by underlining the added text. The text of any deleted matter must be shown by strike-through except that double brackets placed before and after the deleted characters may be used to show deletion of five or fewer consecutive characters. The text of any deleted subject matter must be shown by being placed within double brackets if strike-through cannot be easily perceived. Only claims having the status of “currently amended,” or “withdrawn” if also being amended, shall include markings. If a withdrawn claim is currently amended, its status in the claim listing may be identified as “withdrawn—currently amended.”
It is brought to Applicant’s attention that claims 15 and 16 both contain double brackets to apparently indicate deletion of subject matter; however both instances are used to show deletion of more than five consecutive characters, which is impermissible. In such instances, strikethrough should be utilized. Additionally, while claim 6 appears to properly indicate deletion of “2” in line 2, the claim does not properly indicate the addition of number “5” with the requisite underlining of a newly added character. For purposes of examination, claim 6 will be construed as now being dependent upon claim
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 Objections
Claims 1, 13, 16 and 27 are objected to because of the following informalities: at line 7 of claim 1, “to the head;” should apparently read –to the head; and--; at line 11 of claim 1, “energy therapy; and” should apparently read –energy therapy; wherein-- or --energy therapy, wherein--; at line 12 of claim 1, “said controller” should apparently read --said controller is--; at line 3 of claim 13, “20Hz” should apparently read --20 Hz--; at line 7 of claim 26, “to the head;” should apparently read –to the head; and--; at line 11 of claim 26, “energy therapy; and” should apparently read –energy therapy; wherein-- or --energy therapy, wherein--; at line 12 of claim 26, “the controller” should apparently read --the controller is--; at line 10 of claim 27, “to the head;” should apparently read –to the head; and--; at line 14 of claim 27, “energy therapy; and” should apparently read –energy therapy; wherein-- or --energy therapy, wherein--; at line 15 of claim 27, “the controller” should apparently read --the controller is--;. Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “controller” in claims 1, 26 and 27.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
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 4, 7, 10, 12, 13 and 16-19 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.
At line 5 of claim 4, it is unclear what is being combined as line 4 recite "any one of said…pulser stimulators…to combine…” and one of ordinary skill would understand that more than one would be required to achieve a combination (but line for says “any one”).
Further regarding claim 4, based on the grammar of the claim, it is unclear exactly what is being “combined” as recited at line 6.
At line 8 of claim 7, it is unclear if “said plurality of at least one or red and near infrared light sources” is referring to “a second plurality of at least one or red and near infrared light sources” recited at line 3 or “a first plurality of at least one or red and near infrared light sources” recited at line 2 of claim 5, from which claim 7 now depends.
At line 2 of claim 10, it is unclear if “a pair of light sources” is the same as or different than “a first plurality of…light sources” recited at line 2 of claim 5, from which claim 10 now depends.
Claim 16 has been amended to recite “said body comprises one of a torso plate that is an integral part of a chair, the chair comprising the backrest, a seat adjacent the backrest, and legs supporting the seat, a torso plate that comprises one of a hook, a belt and a loop configured for mounting of the torso plate to a back of a chair, and a spinal appliance comprising a support structure that is elongated to span the spinal cord of the wearer”. It is unclear what the “alternatives” are that are being presented in the claim with respect to “said body comprises one of…”. A suggested amendment is to include at least semi-colons which would accurately convey what the claimed alternatives are for the recitation “comprises one of…”. In light of such, it is unclear if “a torso plate” at line 4 is the same as or different than “a torso plate” recited at line 2. For instance, at line 4, “seat, a torso plate” should apparently read –a seat; a torso plate--. And for instance at line 5, “a chair, and” should apparently read --a chair; and--.
Claim 16 at line 3 recites the limitation "the backrest". There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-5 and 24-28 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Thomas-Benedict (U.S. Pub. No. 2005/0024853). Regarding claim 1, Thomas-Benedict teaches a multi-modal neuro-supportive energy therapy delivery device [0012] comprising:
a body sized and shaped to be worn on an anatomical portion of a wearer, including a head of the wearer (Fig. 9 and [0026]; [0030] - body is comprised of multiple modules connected together to cover a surface region of the patient’s body larger than can be covered by a single module; also see Fig. 19 and [0045] showing integration of multiple modules covering different portions of the body);
a first stimulator of a first type (light stimulation) connected to a controller (light delivery control module), the first stimulator being operative to deliver a first energy exposure sequence [0030] to provide a first energy (light) therapy to the head ([0018]-[0020], [0045] and Figs. 3-4B);
a second stimulator of a second type, different from the first type (magnetic field stimulation), connected to the controller (Figs. 10-11A; [0029]-[0032] and [0035]), the second stimulator being operative to deliver a second energy exposure sequence to provide a second energy (magnetic field) therapy to the head, the second energy therapy being different from the first energy therapy ([0029]-[0032] and [0035]); and
the controller operatively connected to each of said first stimulator and said second stimulator, said controller (light delivery control module) being configured to control each of said first stimulator and said second stimulator to provide a desired therapeutic effect ([0029]-[0030]).
Regarding claim 2, at least one of said first stimulator of said first type and said second stimulator of said second type comprises at least one magnetic pulser stimulator (provision of time-varying magnetic field – [0029] and [0018]).
Regarding claim 3, said controller is configured to cause said at least one magnetic pulser stimulator to deliver energy at a selected point within a therapeutic range of frequencies and intensities ([0030], [0035], [0045]; also see claims 51-52).
Regarding claim 28, at least one of said first stimulator of said first type and said second stimulator of said second type comprises a plurality of magnetic pulser stimulators (provision of time-varying magnetic field sources – [0029] and [0018]).
Regarding claim 4, at least two of said plurality of magnetic pulser stimulators are arranged in at least one of positions and orientations on the body to cause energy delivered by any one of said plurality of magnetic pulser stimulators at an energy level less than a predetermined energy level to combine at a desired physical location to provide a combined energy at said predetermined energy level at the physical location (the magnetic pulser stimulators are oriented in a selected direction such that their resultant energies would combine at the target - [0013]; also see claims 51-52).
Regarding claim 5, the device further comprises a first plurality of at least one of red and near infrared light sources supported on said body ([0012]-[0013], [0027]), said at least one of red and near infrared light sources being configured to emit light at a frequency in a wavelength range of about 660 nm to about 850 nm, said first plurality of at least one of red and near infrared light sources being operatively coupled to said controller [0018], said controller being configured to selectively cause said first plurality of at least one of red and near infrared light sources to emit light to provide a desired therapeutic effect ([0018], [0027], [0030], [0038]).
Regarding claims 24 and 25, said controller is configured to cause operation of said first stimulator and said second stimulator in one of a sequential fashion and a concurrent fashion ([0018] and [0030]).
Regarding claim 26, Thomas-Benedict teaches a multi-modal neuro-supportive energy therapy delivery device [0012] comprising:
a helmet sized and shaped to be worn on a head of a wearer ([0026] and Fig. 9);
a body sized and shaped to be worn adjacent a torso of the wearer ([0030] - body is comprised of multiple modules connected together to cover a surface region of the patient’s body larger than can be covered by a single module; also see Fig. 19 and [0045] showing integration of multiple modules covering different portions of the body; further the “body” can comprise “back support and/or torso support for the user” as disclosed at [0026] and shown in Fig. 19 “neck/shoulder/back pad”);
a first stimulator of a first type (light stimulation) connected to a controller (light delivery control module), the first stimulator being operative to deliver a first energy exposure sequence [0030] to provide a first energy (light) therapy to the head ([0018]-[0020], [0045] and Figs. 3-4B);
a second stimulator of a second type, different from the first type (magnetic field stimulation), connected to the controller (Figs. 10-11A; [0029]-[0032] and [0035]), the second stimulator being operative to deliver a second energy exposure sequence to provide a second energy (magnetic field) therapy to the head, the second energy therapy being different from the first energy therapy ([0029]-[0032] and [0035]); and
the controller operatively connected to each of said first stimulator and said second stimulator, said controller (light delivery control module) being configured to control each of said first stimulator and said second stimulator to provide a desired therapeutic effect ([0029]-[0030]).
Regarding claim 27, Thomas-Benedict teaches a multi-modal neuro-supportive energy therapy delivery device [0012] comprising:
a helmet having a cap portion 103 sized and shaped to be worn on a head of a wearer ([0026] and Fig. 9), and a visor portion extending downwardly from said cap portion (“visor portion” of Fig. 9 extends downward and outwardly from cap portion 103),
said visor portion being movably mounted to said cap portion and being movable between a first position in which the visor portion is positioned to cover a forehead and eyes of the wearer, and a second position in which the visor portion is positioned not to cover the forehead and eyes of the wearer (due to pliable, elastic, stretchable construction of the helmet – [0026]);
a first stimulator of a first type (light stimulation) connected to a controller (light delivery control module), the first stimulator being operative to deliver a first energy exposure sequence [0030] to provide a first energy (light) therapy to the head ([0018]-[0020], [0045] and Figs. 3-4B);
a second stimulator of a second type, different from the first type (magnetic field stimulation), connected to the controller (Figs. 10-11A; [0029]-[0032] and [0035]), the second stimulator being operative to deliver a second energy exposure sequence to provide a second energy (magnetic field) therapy to the head, the second energy therapy being different from the first energy therapy ([0029]-[0032] and [0035]); and
the controller operatively connected to each of said first stimulator and said second stimulator, said controller (light delivery control module) being configured to control each of said first stimulator and said second stimulator to provide a desired therapeutic effect ([0029]-[0030]).
Claim Rejections - 35 USC § 103
18. In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
19. The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
20. Claims 6, 7, 9, 10 and 12-15 are rejected under 35 U.S.C. 103 as being unpatentable over Thomas-Benedict (U.S. Pub. No. 2005/0024853).
Regarding claim 6, Thomas-Benedict teaches that the body comprises a helmet comprising a cap portion sized and shaped to fit on the head of the wearer ([0026] and Fig. 9) (and cover all parts thereof [0019]), wherein a plurality of stimulators is arranged in spaced positions on said cap portion 103 (Fig. 9 and [0026]). While Thomas-Benedict does not disclose explicitly that the plurality of stimulators of this embodiment are magnetic pulser stimulators, Thomas-Benedict makes such obvious as Thomas-Benedict discloses that any of the light delivery elements may be supplemented with one or more time-varying magnetic field sources [0029]-[0030] for the benefit of combining light therapy with time-varying magnetic fields to provide additional effects and benefits [0005] such as stress relief and tissue regeneration [0035].
Regarding claim 7, and in view of its indefinite nature, Thomas-Benedict teaches that the device further comprises a first plurality of at least one of red and near infrared light sources supported on said body ([0012]-[0013], [0027]), said at least one of red and near infrared light sources being configured to emit light at a frequency in a wavelength range of about 660 nm to about 850 nm, said first plurality of at least one of red and near infrared light sources being operatively coupled to said controller [0018], said controller being configured to selectively cause said plurality of at least one of red and near infrared light sources to emit light to provide a desired therapeutic effect ([0018], [0027], [0038], [0045]). While Thomas-Benedict does not disclose explicitly that the helmet further includes a neck portion, sized and shaped to overlie and span a neck of the wearer, the neck portion extending downwardly from said cap portion, wherein the plurality of light sources is supported on the neck portion, Thomas-Benedict makes such obvious as Thomas-Benedict discloses that the helmet may be used with a back support and a torso support [0026], and further be constructed to be worn on the patient’s neck [0025], each of which comprises a plurality of the light sources ([0017] and [0025]), in order to cover substantially all parts of a patient’s body and provide light/magnetic therapy thereto ([0029]-[0030], [0045] and Fig. 19).
Regarding claim 9, said helmet comprises a visor portion extending downwardly from said cap portion (“visor portion” of Fig. 9 extends downward and outwardly from cap portion 103), said visor portion being sized and shaped to cover eyes and a forehead of the wearer when the cap portion is worn on the head of the wearer (due to soft, pliable fabric construction and elasticity of the “helmet” as described at [0026]).
Regarding claim 10, and in view of its indefinite nature, while Thomas-Benedict does not disclose explicitly that said visor portion supports a pair of light sources at positions selected to be located in a region of peripheral vision of the wearer of the helmet, Thomas-Benedict makes such obvious as Thomas-Benedict teaches that the helmet is constructed with a plurality of light sources such that not only the head, but regions adjacent the wearer’s head can be radiated [0026] such as the ears [0024] (which would be in a peripheral direction), which would obviate light sources on the visor portion, as well. Thomas-Benedict further supports such given the teaching of light therapy to the back, torso [0026] and other regions of the body in order to cover substantially all parts of a patient’s body and provide light/magnetic therapy thereto ([0029]-[0030], [0045] and Fig. 19).
Regarding claim 12, said pair of light sources are operatively connected to said controller, and wherein said controller is configured to selectively cause said pair of light sources to emit pulses of visible light to provide a desired therapeutic effect ([0012], [0018], [0027], [0036]).
Regarding claim 13, while Thomas-Benedict does not disclose explicitly that said controller is configured to cause said pair of light sources to emit pulses of visible light at a frequency in a range of about 20 Hz to about 50 Hz, Thomas-Benedict makes such obvious as Thomas-Benedict teaches that the light delivery elements can be activated in a pulsed mode for a sequences of selected time intervals, for example, 40 sec per minute with a 10-90% duty cycle for the benefit of stress relief ([0018]-[0019]), obviating the disclosed range of about 20 Hz to about 50 Hz.
Regarding claim 14, said visor portion is movably mounted to said cap portion of said helmet, said visor portion being movable between a first position in which the visor portion is positioned to cover the forehead and eyes of the wearer, and a second position in which the visor portion is not positioned to cover the forehead and eyes of the wearer (due to pliable, elastic, stretchable construction of the helmet – [0026]).
Regarding claim 15, Thomas-Benedict teaches wherein said first plurality of at least one of red and near infrared light sources are at positions located in a region of a forehead of the wearer of the helmet [0026]. While Thomas-Benedict does not disclose explicitly that said visor portion supports the first plurality of at least one of red and near infrared light sources, Thomas-Benedict makes such obvious as Thomas-Benedict teaches that the helmet is constructed with a plurality of at least one of red and near infrared light sources ([0012], [0036] such that not only the head, but regions adjacent the wearer’s head can be radiated [0026], which would obviate light sources on the visor portion, as well. Thomas-Benedict further supports such given the teaching of light therapy to the back, torso [0026] and other regions of the body in order to cover substantially all parts of a patient’s body and provide light/magnetic therapy thereto ([0029]-[0030], [0045] and Fig. 19).
21. Claims 8, 20 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Thomas-Benedict (U.S. Pub. No. 2005/0024853) in view of Becker (U.S. Pub. No. 2022/0001190). Regarding claims 8 and 20, Thomas-Benedict discloses that the cap portion supports multiple stimulators being positioned to be adjacent a respective one of a pair of ears of a wearer of the device (Fig. 9, [0026] and [0024]; however Thomas-Benedict fails to disclose that the stimulators comprise a pair of loudspeakers, said pair of loudspeakers being operatively coupled to said controller, said controller being configured to selectively cause said pair of loudspeakers to provide an audio signal providing a desired therapeutic effect. Becker teaches a device for directing a therapeutic electromagnetic field to a user, wherein the device can be incorporated into wearable components such as clothing, belts or a helmet (see Abstract and [0015]) (as likewise disclosed by Becker). Becker further teaches that a headset may be incorporated into the therapeutic device in order to play audio to a user in conjunction with the frequency pulsing of the magnetic coils [0103], or to synchronize binural beats and/or light therapy to the pulsed electromagnetic field [0118].
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate a pair of loudspeakers for providing synchronize binaural beats with light therapy and a pulsed electromagnetic field as taught by Becker, into one of the plurality of stimulators of a helmet as suggested by Thomas-Benedict, as Thomas-Benedict recognizes the use of various stimulators into wearable components to provide therapeutic energies to a user ([0029]-[0030]) and Becker teaches that adding music therapy contributes to a calm environment, reduces stress and facilitates meditation ([0114] and [0048]).
Regarding claim 21, while Thomas-Benedict and Becker do not explicitly disclose that the controller is configured to cause said plurality of loudspeakers to provide an audio signal comprising tones of at least one Solfeggio frequency, Becker makes such obvious as Becker teaches that that audio programs are downloadable without restriction, as long as the format is compatible with the device (in MP3 format, for instance) ([0120], [0136], [0137], [0114]) and it is well-known that downloadable music (which contains compositions of various voices, instruments, etc.) would comprise tones that would cover at least one Solfeggio frequency (such as 285 Hz).
22. Claims 16-19 are rejected under 35 U.S.C. 103 as being unpatentable over Thomas-Benedict (U.S. Pub. No. 2005/0024853) in view of Djikstra et al. (U.S. Pub. No. 2021/0093879). Regarding claims 16 and 17 (and in view of their indefinite nature), Thomas Benedict teaches wherein said body comprises one of a torso plate/spinal appliance for implantation of the light therapy [0026], however Thomas-Benedict fails to disclose explicitly that the torso plate comprises one of a hook, a belt and a loop configured for mounting of the torso plate to a back of a chair, and a spinal appliance comprising a support structure that is elongated to span the spinal cord of the wearer. Djikstra et al. (hereinafter Djikstra) teaches a wearable device/support structure for the proper alignment of the spine of a patient, wherein the wearable device further comprises light sources and PEMF sources for the therapeutic benefit of the spine of the patient (Abstract, Fig. 2-4, [0052], [0065] and [0082]). Djikstra further teaches that the support structure comprises at least one of a belt, a strap, and a tie sufficient in length to encircle a range of common human torso sizes, and a fastener for securing said at least one of a belt, a strap and a tie in a position encircling a human torso (see straps and adjustable buckles disclosed at [0060]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate a hook, belt or loop as taught by Djikstra, into a torso plate/spinal support structure as taught by Thomas-Benedict, as Thomas-Benedict recognizes the incorporation of a back support and/or torso support to the wearable body [0026] and Djikstra teaches that a wearable back/spine support for therapy purposes would benefit from the use of adjustable strap/buckles to conform the wearable device to various heights/sizes of different users [0060].
Regarding claim 18, each of said first stimulator and said second stimulator of Thomas-Benedict is selected from a group consisting of a plurality of magnetic pulsers ([0029] and [0018]), a plurality of red or near infrared light sources ([0012], [0036]), a plurality of loudspeakers, and a plurality of electrical leads each terminating in an ear clip.
Regarding claim 19, in the embodiment of Fig. 4A of Thomas-Benedict, each of the light delivery wrap components can be construed as a pair of slide flaps (Fig. 4A and [0019]), wherein each of said pair of side flaps comprises at least one of said first stimulator and said second stimulator selected from a group consisting of a plurality of magnetic pulsers ([0029] and [0018]), a plurality of red or near infrared light sources ([0012], [0036]), a plurality of loudspeakers, and a plurality of electrical leads each terminating in an ear clip.
23. Claims 22 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Thomas-Benedict (U.S. Pub. No. 2005/0024853) in view of Gorham (U.S. Pub. No. 2010/0292746).
Regarding claim 22, While Thomas-Benedict does not explicitly disclose a pair of leads operatively coupled to the controller, wherein each lead terminates in an ear clip, Thomas-Benedict teaches each module electronic/electromagnetic unit provided to various portions of the body would be selectively activated with a power supply [0031], which would obviate leads operatively connected to the controller in order to create an electrical connection between the controller and the electronic/electromagnetic modules. Thomas-Benedict further teaches that each modular component includes a mechanism to adhere the module to the selected portion of the patient’s skin or clothes (“adhesive, Velcro, mechanical wrap-around, hooks, etc.), at least the hook of which would constitute an “ear clip”. However, Thomas-Benedict fails to disclose said controller being configured to selectively cause the pair of leads to deliver low voltage microcurrent to provide a desired therapeutic effect. Gorham teaches the application of various types of electrical energy to the body via a portable system, as likewise disclosed by Thomas-Benedict, wherein conductive pads placed in surface contact with biological tissue facilitate treatment of the individual with different treatment modalities, simultaneously or individually [0038], wherein the conductive pads/modules can be used to provide electrical stimulation to the body via low-voltage microcurrent and a range of various outputs, in order to provide greater flexibility in treatment requirements [0041]. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to cause a pair of leads leading to skin treatment modules as taught by Thomas-Benedict, to provide low-voltage microcurrent and a range of various outputs as suggested by Gorham, as Thomas-Benedict also recognizes the treatment of biological tissues via various energy modalities ([0029]-[0031]), and Gorham teaches that low-voltage microcurrent facilities electrical stimulation of biological tissue, and that biological tissue often responds better to varying the electrical output levels during treatment [0041].
Regarding claim 23, Gorham discloses that the low voltage microcurrent has an amperage of about one millionth of an ampere, and the microcurrent is provided at a frequency in a range of about 10Hz to about 40Hz ([0041] and claim 16).
Response to Arguments
24. Applicant’s arguments filed 3 April 2026 with respect to the objection to the Drawings have been fully considered and are persuasive in light of the amendments.
25. Applicant’s arguments filed 3 April 2026 with respect to the rejection of claims 1-27 under 35 U.S.C. 112(b) have been fully considered and are persuasive, however new grounds of rejection are presented above in light of the amendments.
26. Applicant’s arguments 3 April 2026 with respect to the rejection of claims 1-5 and 24-27 under 35 U.S.C. 102(a)(1) citing Thomas-Benedict (‘853) have been fully considered and are not persuasive. Regarding claims 1 and 26, Applicant contends that Thomas-Benedict does not teach magnetic field sources as a second type of stimulator that deliver their own energy exposure sequences rather that the magnetic field sources are optional supplements to the light therapy modules. However, this argument is not persuasive. Applicant’s attention is directed to paragraphs [0029]-[0030] which discloses that the “light delivery control module controls the light sequences and wavelengths and/or magnetic field frequencies f delivered by a group of two or more ganged-together light delivery modules” [0030]. Applicant also contends that the claimed second stimulator is an independent yet co-equal therapeutic modality, designed to work together with the first stimulator under coordinated control to produce combined therapeutic effect greater than either alone. However, this argument is not persuasive as is noted that claim 1 is not recited in this manner. Applicant also states that “…amended claim 1 requires a controller configured to independently coordinate two different types of stimulators as co-equal modalities”. However, such independent coordination and “co-equal modalities” is not recited, nor is “two elements of a single integrated system under coordinates control” (argued with respect to claim 26). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Applicant further contends that Thomas-Bendict fails to disclose a single controller operatively connected to and configured to control both a first stimulator and a second stimulator of a different type. As previous claims 1, 26 and 27 were unclear with respect to “the controller” and “a controller,” the rejection above now reflects the recitation of a (single) controller in Thomas-Benedict. With respect to claim 27, Applicant contends that the claim further requires “a helmet having a visor portion movably mounted to the cap portion, the visor being movable between a defined first and second portion, via a structural mounting mechanism described in paragraph [00049]” and “a defined visor structure with a mounting mechanism enabling movement between two defined positions”. However, “a mounting mechanism” is not required/recited by the claims. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). In view of the foregoing, the rejection of claims 1-5 and 24-27 under 35 U.S.C. 102(a)(1) citing Thomas-Benedict (‘853) has been maintained.
27. Applicant’s arguments 3 April 2026 with respect to the rejection of claims 6, 7, 9, 10 and 12-15 under 35 U.S.C. 103 citing Thomas-Benedict (‘853) have been fully considered and are not persuasive. Regarding claim 6, Applicant contends that Thomas-Benedict does not disclose that the plurality of stimulators in the helmet embodiment are magnetic pulse stimulators, as Thomas-Benedict discloses that light delivery elements may be supplemented with one or more magnetic fields to provide additional benefits. However, this argument is not persuasive. As indicated above, Applicant’s attention is directed to paragraphs [0029]-[0030] which discloses that the “light delivery control module controls the light sequences and wavelengths and/or magnetic field frequencies f delivered by a group of two or more ganged-together light delivery modules” [0030].
Regarding claim 7, Applicant contends that Thomas-Benedict does not teach a helmet having an integral neck portion specifically configured and positioned to deliver red/NIR light therapy to the cerebellum via the neck portion. However, this argument is not persuasive as claim 7 does not recite red/NIR light therapy being delivered to the cerebellum via the neck portion.
With respect to claims 9 and 14, Applicant contends that the claims required “a defined visor structure with a mounting mechanism enabling movement between two defined positions”. As indicated previously, “a mounting mechanism” is not required/recited by the claims. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
With respect to claim 10, Applicant contends that Thomas-Benedict “does not teach specifically positioning light sources in the peripheral vision region for the purpose of delivering 40Hz flickering light to affect gramma brain waves…Applicant’s claims explain that peripheral vision positioning is specifically chosen to induce deep relaxation and improve member, targeting gamma brain wave activity associated with Alzheimer’s disease”. However, this argument is not persuasive. It is noted that the features upon which applicant relies (i.e., “positioning light sources in the peripheral vision region for the purpose of delivering 40Hz flickering light to affect gramma brain waves” and “to induce deep relaxation and improve member, targeting gamma brain wave activity associated with Alzheimer’s disease”) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Regarding claim 12, Applicant contends that Thomas-Benedict provides no teaching, suggestion, or motivation to emit pulses of visible light from light sources deliberately positioned in the peripheral vision region for neurological intervention. However, Applicant’s attention is drawn to [0012], [0018], [0027], [0036] where Thomas-Benedict discloses the claimed limitation of “said controller is configured to selectively cause said pair of light sources to emit pulses of visible light to provide a desired therapeutic effect”. It is noted that the claim doesn’t require “light sources deliberately positioned in the peripheral vision region for neurological intervention”.
Regarding claim 13, Applicant contends that Thomas-Benedict operates on a timescale of seconds, where the Applicant's claim teaches that the light sources emit pulses of visible light at a frequency in a range of about 20 -50Hz which is on a timescale of millisecond. However, this argument is not persuasive. Thomas-Benedict obviates such a range as Thomas-Benedict is directed to providing stress relief with the therapy, and further that the light delivery elements can be activated in a pulsed mode for a sequences of selected time intervals, for example, 40 sec per minute with a 10-90% duty cycle for the benefit of stress relief [0018], and at interval lengths of 0.1 – 1 sec [0019], obviating the disclosed range of about 20 Hz to about 50 Hz.
Regarding claim 15, Applicant contends that Thomas-Benedict “does not teach visor structure, nor a deliberate positioning of red/NIR light sources to target the forehead region”. However, this argument is not persuasive. While Thomas-Benedict does not disclose explicitly that said visor portion supports the first plurality of at least one of red and near infrared light sources, Thomas-Benedict makes such obvious as Thomas-Benedict teaches that the helmet is constructed with a plurality of at least one of red and near infrared light sources ([0012], [0036] such that not only the head, but regions adjacent the wearer’s head can be radiated [0026], which would obviate the forehead region. In view of the foregoing, the rejection of claims 6, 7, 9, 10 and 12-15 under 35 U.S.C. 103 citing Thomas-Benedict (‘853) has been maintained
28. Applicant’s arguments 3 April 2026 with respect to the rejection of claims 22 and 23 under 35 U.S.C. 103 citing Thomas-Benedict (‘853) have been fully considered and are persuasive, however new grounds of rejection are presented above under 35 U.S.C. 103 citing Thomas-Benedict (‘853) in view of Gorham (‘746) in light of the amendments to claim 22.
29. Applicant’s arguments 3 April 2026 with respect to the rejection of claims 8, 20 and 21 under 35 U.S.C. 103 citing Thomas-Benedict (‘853) in view of Becker have been fully considered and are not persuasive. Regarding claims 8 and 20, Applicant contends that the loudspeakers of Becker are not integrated into any other device as a unified wearable device and it operates on its own separate control rather than being operatively coupled to a single controller that controls other stimulator types, but that Applicant’s loudspeakers “are integrated into the cap portion of a helmet, each positioned adjacent to a respective ear, operatively coupled to the same controller that controls the other stimulators of the multi-modal device”. Applicant also states that the claims require “that the loudspeakers comprise one of two co-equal stimulator types coordinated by a single controller within a unified multi-modal device”.
However, these arguments are not persuasive. The claim states “a pair of loudspeakers supported on said cap portion” and not “integrated…as a unified wearable device” or “that the loudspeakers comprise one of two co-equal stimulator types” as contended by Applicant. Applicant also contends that “there is no teaching or suggestion in Thomas-Benedict that would lead one of ordinary skill in the art to incorporate audio therapy loudspeakers into its light delivery head covering”. However, this argument is not persuasive as Thomas-Benedict is also geared towards inducing various health benefits overall to a user of the modular system [0018]. Regarding claim 21, Applicant contends that Becker’s teaching of downloadable music containing tones covering at least one Solfeggio frequency would not render the claim obvious as
“Solfeggio frequencies are a specific, recognized set of frequencies, historically
associated with healing and well-being. Not all music contains energy concentrated at these specific frequencies, and the Examiner has not provided evidence to support this assertion” and “…Even if some downloadable music incidentally contained spectral energy near a Solfeggio frequency, this is fundamentally different from what claim 21 requires”. However, this argument is not persuasive. First, it is noted that the claim recites “said controller is configured to cause…an audio signal comprising tones of at least one Solfeggio frequency”. This recitation does not limit the claim to a controller which only plays tones of at least one Solfeggio frequency.
Becker is found to make such obvious as Becker teaches that that audio programs are downloadable without restriction, as long as the format is compatible with the device (in MP3 format, for instance) ([0120], [0136], [0137], [0114]) and it is well-known that downloadable music (which contains compositions of various voices, instruments, etc.) would comprise tones that would cover at least one Solfeggio frequency (such as 285 Hz). For instance, downloadable music which contains instruments such as a violin or cello have ranges that cover 285 Hz. Applicant further goes on to explain paragraph [00037] of the instant specification, however limitations from the specification are not read into the claims. In view of the foregoing, the rejection of claims 8, 20 and 21 under 35 U.S.C. 103 citing Thomas-Benedict (‘853) in view of Becker has been maintained.
30. Applicant’s arguments 3 April 2026 with respect to the rejection of claims 16-19 under 35 U.S.C. 103 citing Thomas-Benedict (‘853) in view of Dijkstra have been fully considered and are not persuasive. Regrading claims 16 and 17, Applicant contends that Dijkstra “discloses a standalone wearable spinal alignment device that incidentally incorporates light sources and PEMF sources. It is not a component of a multi-modal neuro-supportive energy therapy device comprising co-equal stimulators of different types coordinated by a single controller as required by Applicant's claim 1”. Again, “a component of a multi-modal neuro-supportive energy therapy device comprising co-equal stimulators of different types coordinated by a single controller” is not recited in claim 1. Further, Thomas-Benedict teaches that recited first and second stimulators as indicated in the rejection above. Applicant further contends that “the Examiner has not articulated a sufficient motivation to combine Thomas-Benedict and Dijkstra. Thomas-Benedict is a phototherapy device focused on light delivery. Dijkstra is a spinal alignment device. The mere fact that both references involve wearable devices with light sources does not provide sufficient motivation to combine them into the specific multi-modal architecture required by Applicant's claims”. However, this argument is not persuasive. For those enumerated reasons, Dijkstra is found to be art analogous with that of Thomas-Benedict (see at least paragraphs [0020]-[0023] of Dijkstra. Further, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992).
Regarding claim 18, Applicant contends that “Neither Thomas-Benedict nor Dijkstra teach loudspeakers or electrical leads terminating in clips as therapeutic stimulator types”. However, this argument is not persuasive. The claim only requires that each of said first stimulator and said second stimulator of Thomas-Benedict is selected from a group consisting of a plurality of magnetic pulsers, a plurality of red or near infrared light sources, a plurality of loudspeakers, and a plurality of electrical leads each terminating in an ear clip. Therefore, the “loudspeakers or electrical leads terminating in clips as therapeutic stimulator types” are not required by the claim. As in indicated in the claim above, Thomas-Benedict discloses a plurality of magnetic pulsers and a plurality of red or near infrared light sources; see citations in the rejection above. Regarding claim 19, Applicant contends that “Applicant's specification at paragraph [00045] describes side flaps 300a, 300b as structural elements positioned adjacent the arms of an occupant seated in a chair, including stimulators connected to the controller for delivering energy therapies to the arms in tandem with the helmet and torso plate. These are purpose-built therapeutic delivery structures extending from a torso-worn body element, whereas Thomas-Benedict teaches modular light delivery wraps for covering a patient's head. Furthermore, as amended, claim 19 requires the side flaps to comprise said first stimulator and said second stimulator, tying back to claim 1's requirement of two co-equal, different stimulator types coordinated by a single controller. Thomas-Benedict's head wraps contain only light delivery elements, not two different co-equal stimulator types as required by Applicant's claims. Dijkstra likewise does not teach or suggest side flaps comprising two different co-equal stimulator types”. Again, this argument relies upon subject matter from the specification and not limitations of the claim itself, and further, claim 1 does not recite “two co-equal…stimulator types”. It would also be unclear as to what “co-equal” imposes here. In view of the foregoing, the rejection of claims 16-19 under 35 U.S.C. 103 citing Thomas-Benedict (‘853) in view of Dijkstra has been maintained.
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.
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/CHRISTINE H MATTHEWS/Primary Examiner, Art Unit 3791
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