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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “light sources of said pair of light sources are separated by an angle of about 90 degrees to about 70 degrees relative to a center point of said helmet” (claim 11) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 1-27 are objected to because of the following informalities: at line 1 of claims 1-27, “multi-model” should apparently read --multi-modal--; at line 6 of claim 1, “and” should apparently be deleted; at line 10 of claim 1, “energy therapy;” should apparently read –energy therapy; and--; at line 12 of claim 1, “each of first stimulator” should apparently read --each of said first stimulator--; at line 2 of claim 12, “pair or light sources” should apparently read –pair of light sources--; at line 4 of claim 15, “one or red” should apparently read –one of red--; at line 2 of claim 19, “comprises” should apparently read –comprising--; at line 4 of claim 19, “light sources, and” should apparently read –light sources,--; at line 13 of claim 26, “each of first stimulator” should apparently read --each of said first stimulator--; at line 11 of claim 27, “and” should apparently be deleted; and at line 15 of claim 27, “first energy therapy;” should apparently read –first energy therapy; and--. 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 claim 1.
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 1-27 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.
Claim 1 at line 4 recites the limitation "the controller". There is insufficient antecedent basis for this limitation in the claim.
Claim 1 at line 6 recites the limitation "the head". There is insufficient antecedent basis for this limitation in the claim.
At line 11 of claim 1, it is unclear if “a controller” is the same as or different than “the controller” recited at line 4.
Claim 1 at lines 11-12 recites “a controller operatively connected to each of said first stimulator and said second stimulator”. Based on this recitation, it is unclear if one controller is connected to both the first stimulator and the second stimulator or if each stimulator is connected to a (separate) controller.
Regarding claim 3, it is unclear if “said controller” is referencing “the controller” recited at line 4 of claim 1, or “a controller” recited at line 11 of claim 1.
Claim 4 at line 2 recites the limitation "said plurality of magnetic pulser stimulators". There is insufficient antecedent basis for this limitation in the claim.
The phrases “therapeutic level” and “therapeutic energy level” in claim 4 are relative phrases which render the claim indefinite. The phrase “therapeutic…level” 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. Based on the disclosure, it is unclear what would be considered “a therapeutic level”.
At line 5 of claim 4, it is unclear what is being combined as lines 3-4 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.
Further regarding claim 4, based on the grammar of the claim, it is unclear exactly what is being “combined” are recited at line 5.
Regarding claim 5, it is unclear if “said controller” (line 6) is referencing “the controller” recited at line 4 of claim 1, or “a controller” recited at line 11 of claim 1.
At line 3 of claim 6, it is unclear if “a head” is the same as or different than “the head” recited at line 6 of claim 1.
Regarding claim 7, it is unclear if “said controller” (line 7) is referencing “the controller” recited at line 4 of claim 1, or “a controller” recited at line 11 of claim 1.
Claim 7 at line 4 recites the limitation “a second plurality of at least one of red and near infrared light sources” which implies that a first plurality is previous recited. However, claim 7 does not depend from a claim with previous recites “a first plurality of at least one of red and near infrared light sources” and therefore claim 7 is indefinite.
Claim 9 at line 4 recites the limitation "a head". It is unclear if “a head” is the same as or different than “the head” recited at line 6 of claim 1.
Claim 11 recites “light sources of said pair of light sources are separated by an angle of about 90 degrees to about 70 degrees relative to a center point of said helmet”. Based on the disclosure, it is unclear what constitutes separation “of said pair of light sources…by an angle of about 90 degrees to about 70 degrees relative to a center point of said helmet” given the lack of discussion/definition of a center point of the helmet.
Regarding claim 12, it is unclear if “said controller” is referencing “the controller” recited at line 4 of claim 1, or “a controller” recited at line 11 of claim 1.
Regarding claim 13, it is unclear if “said controller” is referencing “the controller” recited at line 4 of claim 1, or “a controller” recited at line 11 of claim 1.
Claim 15 at line 2 recites the limitation "a helmet…a cap portion…and a visor portion". It is unclear if “a helmet…a cap portion…and a visor portion” are the same as or different than “a helmet…a cap portion…and a visor portion” recited in claims 6 and 9.
Claim 15 at lines 2-3 recites the limitation "said first plurality of at least one or red and near infrared light sources". There is insufficient antecedent basis for this limitation in the claim.
Claim 16 at line 2 recites “a torso plate that is an integral part of a chair adjacent a seat supported on legs”. Based on this recitation, it is unclear if the “chair adjacent a seat” and the “seat supported on legs” are required by the claim or not.
At line 4 of claim 18, it is unclear if “each terminating in a clip” refers only to the plurality of electrical leads or to all 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”.
Claim 19 at line 2 recites “said body a pair of side flaps” which is grammatically unclear.
At line 3 of claim 19, it is unclear if “a first stimulator” is the same as or different than “a first stimulator” recited at line 4 of claim 1.
At line 3 of claim 19, it is unclear if “a second stimulator” is the same as or different than “a second stimulator” recited at line 7 of claim 1.
At line 5 of claim 19, it is unclear if “each terminating in a clip” refers only to the plurality of electrical leads or to all of “a plurality of magnetic pulsers, a plurality of red or near infrared light sources, and a plurality of loudspeakers, and a plurality of electrical leads”.
Claim 20 at lines 2-3 recites the limitation "the plurality of loudspeakers". There is insufficient antecedent basis for this limitation in the claim.
Claim 20 at lines 3-4 recites the limitation "said pair of loudspeakers". There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 20, it is unclear if “said controller” is referencing “the controller” recited at line 4 of claim 1, or “a controller” recited at line 11 of claim 1.
Regarding claim 22, it is unclear if “said controller” is referencing “the controller” recited at line 4 of claim 1, or “a controller” recited at line 11 of claim 1.
Regarding claim 24, it is unclear if “said controller” is referencing “the controller” recited at line 4 of claim 1, or “a controller” recited at line 11 of claim 1.
Regarding claim 25, it is unclear if “said controller” is referencing “the controller” recited at line 4 of claim 1, or “a controller” recited at line 11 of claim 1.
Claim 26 at line 5 recites the limitation "the controller". There is insufficient antecedent basis for this limitation in the claim.
At line 12 of claim 26, it is unclear if “a controller” is the same as or different than “the controller” recited at line 5.
Claim 26 at lines 12-13 recites “a controller operatively connected to each of said first stimulator and said second stimulator”. Based on this recitation, it is unclear if one controller is connected to both the first stimulator and the second stimulator or if each stimulator is connected to a (separate) controller.
Claim 27 at line 9 recites the limitation "the controller". There is insufficient antecedent basis for this limitation in the claim.
At line 16 of claim 27, it is unclear if “a controller” is the same as or different than “the controller” recited at line 9.
Claim 27 at lines 16-17 recites “a controller operatively connected to each of said first stimulator and said second stimulator”. Based on this recitation, it is unclear if one controller is connected to both the first stimulator and the second stimulator or if each stimulator is connected to a (separate) controller.
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 24-27 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-model neuro-supportive energy therapy delivery device [0012] comprising:
a body sized and shaped to be worn on an anatomical portion of a 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);
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
a controller 151 operatively connected to each of said first stimulator and said second stimulator, said controller being configured to control each of said first stimulator and said second stimulator to provide a desired therapeutic effect (Fig. 19 and [0045]).
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 4, and in view of its indefinite nature, 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 therapeutic level to combine at a desired physical location to provide a combined energy at a therapeutic 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] and [0045]; 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], [0038], [0045]).
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-model 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 a 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
a controller 151 operatively connected to each of said first stimulator and said second stimulator, said controller being configured to control each of said first stimulator and said second stimulator to provide a desired therapeutic effect (Fig. 19 and [0045]).
Regarding claim 27, Thomas-Benedict teaches a multi-model 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
a controller 151 operatively connected to each of said first stimulator and said second stimulator, said controller being configured to control each of said first stimulator and said second stimulator to provide a desired therapeutic effect (Fig. 19 and [0045]).
Claim Rejections - 35 USC § 103
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 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.
Claims 6, 7, 9-15, 22 and 23 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 a head of a human ([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, 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 ([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 a head of the wearer (due to soft, pliable fabric construction and elasticity of the “helmet” as described at [0026]).
Regarding claim 10, 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 ([0045] and Fig. 19).
Regarding claim 11, while Thomas-Benedict does not disclose explicitly that light sources of said pair of light sources are separated by an angle of about 90 degrees to about 70 degrees relative to a center point of said helmet, Thomas-Benedict makes such obvious given that the light delivery elements are constructed in a grid-like fashion ([0026], [0024] Figs. 8-9), which would provide 90 degree angles of separation.
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], [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], 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 that the body comprises a helmet comprising a cap portion 103 sized and shaped to fit on a head of a human ([0026] and Fig. 9) (and cover all parts thereof [0019]), and a visor portion joined to said cap portion 103 (“visor portion” of Fig. 9 extends downward and outwardly from cap portion 103), wherein a 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 ([0045] and Fig. 19).
Regarding claim 22, Thomas-Benedict teaches said controller being configured to selectively cause a delivery of low voltage microcurrent from two voltage sources 155A,155B to provide a desired therapeutic effect ([0045] and Fig. 19), however Thomas-Benedict fails to disclose explicitly that a pair of leads terminating in a clip are coupled to the controller. While Thomas-Benedict does not explicitly disclose the leads, it would have been obvious to one of ordinary skill in the art that a lead (comprising a clip) would be obvious between the controller and each of the two voltage sources in order to create an electrical connection between the two components.
Regarding claim 23, the low voltage sources 155A,155B (V1 and V2) are capable of delivering an amperage of about one millionth of an ampere, at a frequency in a range of about 10Hz to about 40Hz due to V1 and V2 being low voltage sources at 5V and 12V, respectively [0045].
50. 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 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).
51. 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, 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 a 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 of each of said pair of side flaps comprises at least one of a first stimulator and a 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]), and a plurality of loudspeakers, and a plurality of electrical leads, each terminating in a clip.
Conclusion
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/CHRISTINE H MATTHEWS/Primary Examiner, Art Unit 3791