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 .
Information Disclosure Statement
The Information Disclosure Statements (IDS) filed 11/03/2023 have been considered by the Examiner.
Response to Arguments
Rejections under 35 USC 102/103
Applicant’s arguments dated 04/20/2026 with respect to claims 1-28 have been considered but are not persuasive. Applicant argues that the previously presented prior art of De Taboada does not teach the amended limitation of varying a light intensity based on the cranial thickness information for each of the target zones. Examiner respectfully disagrees and points to De Taboada paragraphs [0105-0106] in which De Taboada discloses factors which are taken into consideration while determining therapy parameters, wherein the factors include skull thickness. Therefore, the rejection in view of De Taboada is maintained and detailed further below.
With respect to the rejection of claim 2 in view of Tucker, Examiner has considered Applicant’s arguments and found them to be persuasive. Therefore, the rejection under 35 USC 102 in view of Tucker has been withdrawn. However, new grounds of rejection are detailed below in view of De Taboada and Tucker.
Double Patenting
The amended claims dated 04/20/2026 have been considered and successfully overcome the double patenting rejection presented in the previous Office Action dates 11/19/2025 by patentably differentiating the claimed invention from the issued patent in question. The double patenting rejection of the claimed invention is hereby withdrawn.
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 8, 9, 25, and 26 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.
Claims 8, 9, 25, and 26 recites the limitation "the tubular structure”. There is insufficient antecedent basis for this limitation in the claim based on the amended claims dated 04/20/2026.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 2, 12, 13, and 21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by De Taboada (US 20100105977 A1).
Regarding claim 1, De Taboada teaches a traumatic brain injury treatment system, comprising:
(a) a headpiece (see Fig. 1, [0045]; therapy apparatus 10 including cap 60) comprising:
(i) a housing comprising a head cavity (see Fig. 1; cap 60 having a head cavity to be worn by a patient); and
(ii) a light array disposed on an inner surface of the head cavity (see Fig. 1, [0048]; light array 40 positioned on the inside of cap 60);
(b) a controller operably coupled to the light array via a first connection line (see [0087]; programmable controller 126 operably coupled to the light source 40), the controller configured to receive cranial thickness information for a number of target zones of a cranium of a patient (see [0105-0106]; factors which may be used to determine power density to penetrate the target tissue include skull thickness);
and
(c) an energy source operably coupled to the controller via a second connection line (see [0087]; power supply operably connected to the light source 40),
wherein the light array is configured to vary an intensity of a light application delivered to each of the number of target zones by the light array based on the cranial thickness information for each of the number of target zones (see [0105-0106]; calculations of the power density to be applied to the scalp so as to deliver a predetermined power density to the target area of the brain take into account the attenuation of light energy as it propagates through the skin, bone, and brain tissue; factors which may be used during calculations to determine power density to penetrate the target tissue include skill thickness, and the location of the target area of the brain, particularly the depth of the area relative to the surface of the scalp; the power density and other parameters of the applied light are then adjusted according to the results of the calculation).
Regarding claim 2, De Taboada teaches a traumatic brain injury treatment system, comprising:
(a) a headpiece (see Fig. 1, [0045]; therapy apparatus 10 including cap 60) comprising:
(i) a housing (see Fig. 1, [0045]; cap 60) comprising
1) a head cavity defined by the housing (see Fig. 1; cap 60 having a head cavity to be worn by a patient); and
2) an inner surface within the head cavity (see Fig. 1; cap 60 having an inner surface wherein the head resides during use);
(ii) a light array disposed on the inner surface (see Fig. 1, [0048]; light array 40 positioned on the inside of cap 60), wherein the light array comprises a plurality of LED light assemblies (see [0077]; light source 40 comprises LEDs);
(b) a power/communication line coupled to the light array;
(c) a controller coupled to the power/communication line (see [0087]; programmable controller 126 operably coupled to the light source 40), the controller configured to receive cranial thickness information for a number of target zones of a cranium of a patient (see [0105-0106]; factors which may be used to determine power density to penetrate the target tissue include skull thickness); and
(d) an energy source coupled to the power/communication line (see [0087]; power supply operably connected to the light source 40),
wherein the light array is configured to vary a fluence of a light application delivered to target zones by the light array for an amount of time based on the cranial thickness information (see [0105-0106]; calculations of the power density to be applied to the scalp so as to deliver a predetermined power density to the target area of the brain take into account the attenuation of light energy as it propagates through the skin, bone, and brain tissue; factors which may be used during calculations to determine power density to penetrate the target tissue include skill thickness, and the location of the target area of the brain, particularly the depth of the area relative to the surface of the scalp; the power density and other parameters of the applied light are then adjusted according to the results of the calculation).
Regarding claim 12, De Taboada teaches the traumatic brain injury treatment system of claim 2, wherein the housing comprises a substantially flexible material (see [0047]; the cap 60 may have an inner lining 62 comprising a stretchable or mesh fabric).
Regarding claim 13, De Taboada teaches the traumatic brain injury treatment system of claim 2, wherein the housing comprises a substantially rigid material (see [0047]; the outer shell of cap 60 may be made of a rigid material including metal or plastic).
Regarding claim 21, De Taboada teaches the traumatic brain injury treatment system of claim 2, wherein specific portions of the plurality of LED light assemblies have predetermined, differing radiant intensities depending on a position of the specific portions within the housing (see [0091]; control circuit 200 is configured to adjust the power of the light energy emitted by the light source 40 to generate a predetermined power density at the scalp 30 corresponding to a predetermined energy delivery profile based on the target area of the brain).
Claim Rejections - 35 USC § 103
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 3-9 are rejected under 35 U.S.C. 103 as being unpatentable over De Taboada (US 20100105977 A1).
Regarding claim 3, De Taboada teaches the system of claim 2, where cranial thickness of target areas is used as a factor to determine therapy parameters (De Taboada [0105-0106]) because of its effect on the attenuation of light propagating to the brain from the scalp. It can also be appreciated that De Taboada makes an assumption that only approximately 5% of the light mean is transmitted from the scalp to the brain tissue, through the skull (De Taboada [0071]). This assumption can be appreciated to be based on an averaging of factors which would affect light attenuation, including skull thickness.
Regarding claims 3-7, De Taboada teaches the system of claim 2, where cranial thickness of target areas is used as a factor to determine therapy parameters (De Taboada [0105-0106]) because of its effect on the attenuation of light propagating to the brain from the scalp. De Taboada is silent regarding the exact methodology by which the fluence and/or exposure time is modified based on the skull thickness in the target area being greater or less than the reference thickness.
However, it can be appreciated that De Taboada discloses the general conditions of the claimed invention, wherein the therapy parameters are determined and modulated with respect to the skull thickness at the target site (De Taboada [0044], [0105-0106]). It has been held that when the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. See MPEP 2144.05, In re Aller, 220 F.2d 454. The modification of parameters including power densities and time periods of application may play a key role in achieving efficacious phototherapy at the desired site (De Taboada [0044]).
Regarding claim 8, De Taboada teaches the traumatic brain injury treatment system of claim 3, wherein the tubular structure (50) is disposed adjacent to and tensionably coupled to the inner surface (see Fig. 3, [0051]; element 50 is coupled to the light source 40 and adapted to confirm to the scalp 30, and may be mechanically adjustable so as to adjust the position of the light source relative to scalp 30).
Regarding claim 9, De Taboada teaches the traumatic brain injury treatment system of claim 3, wherein the tubular structure is disposed at least partially within a cavity defined within the inner surface (see Figs, 3. 4A, [0061-0062]; wherein element 50 is disposed inside of the housing 60 wherein the concave inner surface may be considered a cavity and is additionally disposed at least partially in a cavity defined as the space between troughs 74).
Claims 10, 14, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over De Taboada (US 20100105977 A1) in view of Tucker et al (US 20100076529 A1).
Regarding claim 10, De Taboada teaches the traumatic brain injury treatment system of claim 2. De Taboada is silent regarding wherein the housing further comprises two movable side panels hingedly coupled to the housing, wherein the two movable side panels comprise a closed position and an open position
Tucker teaches a treatment system, comprising:
(a) a headpiece comprising (see Tucker Fig. 7, [0045]; phototherapy apparatus 10):
(i) a housing (see Tucker Fig. 7, [0045]; canopy 40 supported by headband assembly 70) comprising
1) a head cavity defined by the housing (see Tucker Fig. 7; head canopy 40 defining a cavity for a head of a user and held in place with headband 70); and
2) an inner surface within the head cavity (see Tucker Fig. 7; canopy 40 having an inner surface);
(ii) a light array disposed on the inner surface (see Tucker Fig. 10, [0048]; light generating sources 102 arranges on the inside of canopy 40), wherein the light array comprises a plurality of LED light assemblies (see Tucker [0015]; light generating sources may be LEDs);
(b) a power/communication line coupled to the light array (see Tucker [0038]; wire 160 couples to head unit);
(c) a controller coupled to the power/communication line (see Tucker Fig. 15, [0038]; hand held controller 110 connected to head unit via wire 160); and
(c) an energy source coupled to the power/communication line (see Tucker [0050]; power for energizing the light array may be supplied by batteries in the hand-held control device 110);
wherein the housing further comprises two movable side panels hingedly coupled to the housing, wherein the two movable side panels comprise a closed position and an open position (see Tucker [0037]; hinge members 27 connect headphones 24, which are regarded as side panels, to arm members 25 which allow the headphones to fold into the head cavity, which is regarded as the closed position, or into an open position for use).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify De Taboada’s brain treatment system with the housing comprising side panels as taught by Tucker. One of ordinary skill in the art would have been motivated to make this modification in order to store the treatment system for convenient storage, packaging, and transport (Tucker [0037]).
Regarding claim 14, De Taboada teaches the treatment system of claim 2. De Taboada is silent regarding wherein the housing further comprises a visor disposed on a front portion of the housing.
Tucker teaches wherein the housing further comprises a visor disposed on a front portion of the housing (see Tucker Fig. 7; canopy 40 having an extended front portion that may be connected to faceplate 80).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify De Taboada’s treatment device with a visor as taught by Tucker. One of ordinary skill in the art would have been motivated to make this modification in order to provide light application to a target portion of the patient’s head by adjusting the positioning of the visor.
Regarding claim 15, De Taboada teaches the treatment system of claim 2. De Taboada is silent regarding wherein the housing further comprises two ear coverings, wherein each of the two ear coverings is disposed on a side of the housing.
Tucker teaches wherein the housing further comprises two ear coverings, wherein each of the two ear coverings is disposed on a side of the housing (see Tucker Fig. 7, [0036]; headphones 24 which cover a user’s ears are disposed on each side of the housing).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify De Taboada’s treatment device with ear covering portions as taught by Tucker. One of ordinary skill in the art would have been motivated to make this modification in order to provide comfort for the user during a treatment period, for example by providing headphones in the ear coverings to allow the user to listen to an audio program during treatment (Tucker [0036]).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over De Taboada (US 20100105977 A1) in view of Lowe et al (US 20110271430 A1).
Regarding claim 11, De Taboada teaches the system of claim 2. De Taboada is silent regarding wherein the housing further comprises a movable rear panel hingedly coupled to the housing, wherein the movable rear panel comprises a closed position and an open position.
Lowe teaches a headpiece having a housing and a head cavity defined by the housing for protecting the wearer’s skull wherein the housing further comprises a movable rear panel hingedly coupled to the housing (see Lowe Fig. 3, [0033]; housing of helmet 35 comprises a back plate 37 that is hingedly attached to the main portion of the housing), wherein the movable rear panel comprises a closed position and an open position (see Lowe [0033]; the hinge allows for the back plate to be moved away from the body of the housing for an ‘open’ position, or towards the body of the housing for a ‘closed’ position).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify De Taboada’s housing system with the hinged rear plate as taught by Lowe. One of ordinary skill in the art would have been motivated to make this modification in order to provide greater ease in donning or removing the headgear due to the housing’s snug fit to a user’s head (Lowe [0033]).
Claims 16-20 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over De Taboada (US 20100105977 A1), hereinafter referred to as De Taboada ‘977, in view of De Taboada et al (US 20100016841 A1), hereinafter referred to as De Taboada ‘841.
Regarding claim 16, De Taboada ‘977 teaches the traumatic brain injury treatment system of claim 2. De Taboada ‘977 is silent regarding wherein the plurality of LED light assemblies further comprise a portion of the LED light assemblies disposed adjacent to a front sinus or a mastoid process of a patient's head when the patient's head is disposed within the housing,
wherein the portion of the LED light assemblies disposed adjacent to the front sinus or the mastoid process have a greater radiant intensity or are actuated to radiate for a longer period of time than other LED light assemblies in the plurality of LED light assemblies.
De Taboada ‘841 teaches a light emitting device for providing phototherapy to the brain using a plurality of LED light assemblies,
wherein the plurality of LED light assemblies further comprise a portion of the LED light assemblies disposed adjacent to a front sinus or a mastoid process of a patient's head when the patient's head is disposed within the housing (see De Taboada ‘841 Fig. 16; device housing 420 appears to cover at the user’s forehead at least to the position of their eyes on the front side, which is where a portion of the front sinus is located),
wherein the portion of the LED light assemblies disposed adjacent to the front sinus or the mastoid process have a greater radiant intensity or are actuated to radiate for a longer period of time than other LED light assemblies in the plurality of LED light assemblies (see De Taboada ‘841 [0105]; the power of the light energy emitted can be adjusted in accordance with a selected power density at the subdermal tissue being treated, it can be appreciated that the intensity or duration of radiance would be adjusted when targeting the front sinus located in the forehead, [0126]; each light source 410 has an output emission area positioned to irradiate a corresponding portion of the brain 20 with an efficacious power density and wavelength of light).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify De Taboada ‘977’s system for delivering light to the brain with the plurality of LED light assemblies disposed adjacent to the front sinus having an adjusted radiance intensity as taught by De Taboada ‘841. One of ordinary skill in the art would have been motivated to make this modification in order to effectively irradiate an area of the patient’s brain corresponding to a predetermined structure/location with an efficacious power density (De Taboada ‘841 [0126]).
Regarding claim 17, De Taboada ‘977 in view of De Taboada ‘841 teaches the traumatic brain injury treatment system of claim 16. They are silent regarding wherein the greater radiant intensity ranges from about 15 % to about 50 % greater intensity than the other LED light assemblies in the plurality of LED light assemblies.
However, De Taboada ‘977 teaches various subsurface power densities including 0.01, 0.05, 0.1, 0.5, 1, 5, 10, 15, 20, 30, 40, 50, 60, 70, 80, or 90 mW/cm.sup.2, respectively, depending on the desired clinical performance (De Taboada ‘977 [0078]). Therefore, it can be appreciated that based on the selected power densities, a greater radiant intensity 15-50% greater than other LED light assemblies would be possible. Since the general conditions of the claim having varying radiant intensity ranges are disclosed in the prior art, it has been held that discovering the optimum or workable ranges involves only routine skill in the art. See MPEP 2144.05(II)(A), In Re Aller 105 USPQ 233.
Regarding claim 18, De Taboada ‘977 in view of De Taboada ‘841 teach the traumatic brain injury treatment system of claim 16. De Taboada ‘977 further teaches wherein the greater radiant intensity results from a more powerful LED light or a shorter distance between an LED light and an irradiated surface of the patient's head (see De Taboada ‘977 [0078-0079]; the power of the light emitted can be adjusted in accordance with a selected power density for the target subdermal tissue, and the total power for the device may be provided from a plurality of light sources used in combination, it can be appreciated that in a plurality of light sources having adjustable power levels, some of the light sources may be regarded as more powerful LEDs, [0097]; the apparatus may physically move the light source 40 relative to the scalp).
Regarding claim 19, De Taboada ‘977 teaches the traumatic brain injury treatment system of claim 2. De Taboada ‘977 is silent regarding wherein the plurality of LED light assemblies further comprise a portion of the LED light assemblies disposed adjacent to a sphenoid bone of a patient's head when the patient's head is disposed within the housing,
wherein the portion of the LED light assemblies disposed adjacent to the sphenoid bone have a lesser radiant intensity than other LED light assemblies in the plurality of LED light assemblies.
De Taboada ‘841 teaches a system for phototherapy having a plurality of LED light assemblies,
wherein the plurality of LED light assemblies further comprise a portion of the LED light assemblies disposed adjacent to a sphenoid bone of a patient's head when the patient's head is disposed within the housing (see De Taboada ‘841 Fig. 16; device housing 420 appears to cover at least a part of the user’s temple on the forehead, which is where the sphenoid bone is located),
wherein the portion of the LED light assemblies disposed adjacent to the sphenoid bone have a lesser radiant intensity than other LED light assemblies in the plurality of LED light assemblies (see De Taboada ‘841 [0105]; the power of the light energy emitted can be adjusted in accordance with a selected power density at the subdermal tissue being treated, it can be appreciated that an area like the sphenoid bone which is located in an area where light is unlikely to penetrate may have a lower associated light intensity, [0126]; each light source 410 has an output emission area positioned to irradiate a corresponding portion of the brain 20 with an efficacious power density and wavelength of light).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify De Taboada ‘977’s system for delivering light to the brain with the plurality of LED light assemblies disposed adjacent to the sphenoid bone having an adjusted radiance intensity as taught by De Taboada ‘841. One of ordinary skill in the art would have been motivated to make this modification in order to effectively irradiate an area of the patient’s brain corresponding to a predetermined structure/location with an efficacious power density (De Taboada ‘841 [0126]).
Regarding claim 20, De Taboada ‘977 in view of De Taboada ‘841 teach the traumatic brain injury treatment system of claim 19. De Taboada ‘977 further teaches wherein the lesser radiant intensity results from a less powerful LED light or a greater distance between an LED light and an irradiated surface of the patient's head (see De Taboada ‘977 [0078-0079]; the power of the light emitted can be adjusted in accordance with a selected power density for the target subdermal tissue, and the total power for the device may be provided from a plurality of light sources used in combination, it can be appreciated that in a plurality of light sources having adjustable power levels, some of the light sources may be regarded as less powerful LEDs, [0097]; the apparatus may physically move the light source 40 relative to the scalp).
Regarding claim 22, De Taboada ‘977 teaches the traumatic brain injury treatment system of claim 2. De Taboada ‘977 is silent regarding the system further comprising a protective cap having a low absorbance of near infrared wavelengths,
wherein the protective cap is positionable on a patient's head such that the protective cap is disposed between the patient's head and the inner surface of the housing.
De Taboada ‘841 teaches the system further comprising a protective cap having a low absorbance of near infrared wavelengths (see De Taboada ‘841 [0127]; protective cap 430 which is substantially transmissive at the wavelength and reduces back reflection of the light),
wherein the protective cap is positionable on a patient's head such that the protective cap is disposed between the patient's head and the inner surface of the housing (see De Taboada ‘841 [0127]; cap 430 disposed between light sources 410 and the patient’s scalp such that the light passes through the cap before reaching the scalp).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the system for delivering therapeutic light to the brain as taught by De Taboada ‘977 with the protective cap positionable between the patient and the inside of the housing as taught by De Taboada ‘841. One of ordinary skill in the art would have been motivated to make this modification in order to protect the user by inhibiting temperature increases at the scalp caused by the light emitting assemblies (De Taboada ‘841 [0128]).
Claims 23 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over De Taboada (US 20100105977 A1) in view of Ribeiro et al (US 20180056087 A1).
Regarding claim 23, De Taboada teaches the traumatic brain injury treatment system of claim 2, wherein the housing further comprises an electrical arrangement comprising:
a central supply line disposed along a central location within the housing; and a central ground line disposed adjacent to the central supply line (see De Taboada [0038]; hand held unit 110 connects to the head unit 12 via a wire 160 that plugs into the head unit 12 at a designated port, [0050]; hand held unit may supply power to the head unit via a battery or plugging into a standard wall outlet, it can be appreciated that modern power cables are equipped with a supply line and a ground line for electrical safety).
De Taboada is silent regarding a conductor layer disposed within the housing, the conductor layer comprising:
(i) at least two channels defined within the conductor layer; and
(i) at least two conductors, wherein each of the at least two conductors is disposed within a separate one of the at least two channels, wherein the at least two conductors are coupled at a first end to the central supply line or the central ground line and further are coupled at a second end to at least one of the plurality of LED light assemblies.
Ribiero teaches a wearable micro-led healing apparatus having a conductor layer (see Ribiero Fig. 3, [0034-0036]; flexible light sheet 12 having conductor pathway film 38) comprising:
(i) at least two channels defined within the conductor layer (see Ribiero Fig. 3, [0034]; conductive pathway film 38 having multiple winding channels 36); and
(i) at least two conductors, wherein each of the at least two conductors is disposed within a separate one of the at least two channels (see Ribiero Fig. 3; where winding channels 36 are made up of a copper pathway that can be regarded as the at least two conductors, and coupled to the LEDs 26 to provide a current), wherein the at least two conductors are coupled at a first end to the central supply line or the central ground line and further are coupled at a second end to at least one of the plurality of LED light assemblies (see Ribiero [0035]; the flexible light sheet 12 is operatively connected to a light source controller 34).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the traumatic brain injury treatment system as taught by De Taboada with the conductor layer as taught by Ribeiro. One of ordinary skill in the art would have been motivated to make this modification in order to provide power to the plurality of therapeutic LED light assemblies (Riberio [0034]).
Regarding claim 24, De Taboada in view of Ribiero teach the system of claim 23. De Taboada further teaches wherein the housing comprises at least two light array sections (see Fig. 4B where light sources 40a are spaced apart from one another which may be considered as array sections).
Claims 25 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over De Taboada (US 20100105977 A1) in view of Steinle (US 20140160536 A1).
Regarding claims 25 and 26, De Taboada teaches the system of claim 3. They are silent regarding the system further comprising a lens coupled to a distal end of the tubular structure via a sleeve.
Steinle teaches an illumination assembly having a substantially tubular structure (see Steinle Fig. 4B) further comprising a lens coupled to a distal end of the tubular structure via a sleeve (see Steinle Fig. 4B, [0069]; collar 88 is a generally cylindrical sleeve that is sized to fit about an outer wall of lens 22 which is located distally in relation to radiant surface 70 of LED 21).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the LED assembly as taught by De Taboada with the lens and coupling sleeve of Steinle One of ordinary skill in the art would have been motivated to make this modification in order to reflect any light that would be emitted out of the sides of the lens to exit at the desired distal point toward the target (Steinle [0071]).
Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over De Taboada (US 20100105977 A1) in view of Medendorp et al (US 20170028216 A1).
Regarding claim 27, De Taboada teaches the traumatic brain injury treatment system of claim 2. They are silent regarding wherein the controller comprises a safety module, wherein the safety module has a maximum use time or a maximum use count, wherein the controller is configured to prevent actuation of any of the plurality of LED light assemblies when the maximum use time or the maximum use count has been exceeded.
Medendorp teaches a phototherapy device to be worn on the head of a patient wherein the controller comprises a safety module, wherein the safety module has a maximum use time or a maximum use count, wherein the controller is configured to prevent actuation of any of the plurality of LED light assemblies when the maximum use time or the maximum use count has been exceeded (see Medendorp [0169-0170]; after a specified number of uses of a device, a power supply circuit is arranged to provide at least one conditioned power signal for use by a microcontroller or at least one light emitting device that can reversibly or irreversibly disable the device).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the system for traumatic brain injury treatment as taught by De Taboada with the safety disable protocol as taught by Medendorp. One of ordinary skill in the art would have been motivated to make this modification in order to prevent unauthorized usage of the device beyond an authorized number of treatment cycles (Medendorp [0169]).
Claim 28 is rejected under 35 U.S.C. 103 as being unpatentable over De Taboada (US 20100105977 A1) in view of Jones (US 20140288351 A1).
Regarding claim 28, De Taboada teaches a method of treating a traumatic brain injury, the method comprising:
receiving cranial thickness information for a number of target zones of a cranium of a patient (see [0105-0106]; factors which may be used to determine power density to penetrate the target tissue include skull thickness); and
positioning a treatment system for treatment onto the patient (see Fig. 1; treatment system 10 positioned on the head of a patient), the treatment system comprising:
(a) a headpiece comprising (see Fig. 1, [0045]; therapy apparatus 10 including cap 60):
(i) a housing (60) comprising
1) a head cavity defined by the housing (see Fig. 1; cap 60 having a head cavity to be worn by a patient); and
2) an inner surface within the head cavity (see Fig. 1; cap 60 having an inner surface wherein the head resides during use);
(ii) a light array disposed on the inner surface (see Fig. 1, [0048]; light array 40 positioned on the inside of cap 60), wherein the light array comprises a plurality of LED light assemblies (see [0077]; light source 40 comprises LEDs);
(b) a power/communication line coupled to the light array;
(c) a controller coupled to the power/communication line (see [0087]; programmable controller 126 operably coupled to the light source 40); and
(d) an energy source coupled to the power/communication line (see [0087]; power supply operably connected to the light source 40); and
e) a measurement device coupled to the controller (see [0092-0096]; programmable controller 126 is responsive to signals from a sensor which may include applied power densities or other parameters of the applied light), and configured to vary an intensity of a light application delivered to target zones by the light array for an amount of time based on the cranial thickness information (see [0105-0106]; calculations of the power density to be applied to the scalp so as to deliver a predetermined power density to the target area of the brain take into account the attenuation of light energy as it propagates through the skin, bone, and brain tissue; factors which may be used during calculations to determine power density to penetrate the target tissue include skill thickness, and the location of the target area of the brain, particularly the depth of the area relative to the surface of the scalp; the power density and other parameters of the applied light are then adjusted according to the results of the calculation).
wherein the measurement device is disposed adjacent to at least one of the plurality of LED light assemblies (see [0095]; a temperature sensor may be coupled to the scalp of a user, which it can be appreciated is adjacent to the LED light assemblies when the device is on the patient’s head),
wherein the positioning the treatment system comprises positioning the headpiece on the patient's head (see [0048]; the light delivery apparatus fits securely over the patient’s head);
actuating at least one of the plurality of LED light assemblies to radiate light toward the patient's scalp (see [0091-0095]; light source driver 220 adjusts and controls the delivery of light from light emitting elements 40 to the users scalp);
receiving data from the measurement device, transmitting information from the measurement device to the controller (see [0093]; the controller is responsive to signals from the sensor);
calculating an appropriate level of applied fluence at the controller based on the information about the at least a portion of the radiated light (see [0093]; the controller uses the signals from the sensor to adjust the treatment parameters to optimize the measured response); and
actuating the at least one of the plurality of LED light assemblies to radiate light at the appropriate level of applied fluence (see [0093]; the controller can provide closed-loop monitoring and adjustment of therapy parameters).
De Taboada is silent regarding wherein the measurement device is a light measurement device. Jones teaches a multispectral therapeutic light source having a light measurement device coupled to the controller and disposed adjacent to at least one of the plurality of LED light assemblies (see Jones [0091]; the control assembly comprises one or more light sensors placed in, on, and/or near the lighted window facing toward the target surface so that when the device is in use the sensor may detect reflected light from the target and provide input to the controller to adjust light intensity and or treatment timing).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the method of treating a traumatic brain injury wherein the controller uses input from a measurement device to adjust therapy parameters as taught by De Taboada with the light measuring device as taught by Jones. One of ordinary skill in the art would have been motivated to make this modification in order to detect reflected light off the target area at various wavelengths and send data to the controller so that the therapy parameters can be adjusted for the most efficacious therapy (Jones [0091]).
Conclusion
The following prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Saxena et al (US 20100103694 A1) which teaches a light guide array.
Hart et al (US 20030167080 A1) which teaches a light therapy device.
Gunasekar et al (US 20180153470 A1) which teaches an electroencephalography headset and system for collecting biosignal data.
Streeter et al (US 20090216301 A1) which teaches low level light therapy for enhancement of neurologic function.
Hamid et al (US 20150297914 A1) which teaches a laser phototherapy device.
Whelan et al (US 20080033412 A1) which teaches a system and method for convergent light therapy having controllable dosimetry.
Sverdlov et al (US 20220387818 A1) which teaches a head wearable light therapy device.
THIS ACTION IS MADE FINAL. 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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/A.J.S./Examiner, Art Unit 3792
/Benjamin J Klein/Supervisory Patent Examiner, Art Unit 3792
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