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.
Claim Objections
Claims 2 and 23 objected to because of the following informalities:
In claim 2, ‘(c) an energy source coupled to the power/communication line’ should read ‘(d) an energy source coupled to the power/communication line’
In claim 23, ‘(i) at least two conductors …’ should read ‘(iI) at least two conductors …’
Appropriate correction is required.
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.
Claim(s) 1, 2, 12, 13, and 21 is/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); 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).
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); and
(c) an energy source coupled to the power/communication line (see [0087]; power supply operably connected to the light source 40).
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(s) 2, 10, 14, and 15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tucker et al (US 20100076529 A1).
Regarding claim 2, Tucker teaches a traumatic brain injury treatment system, comprising:
(a) a headpiece comprising (see Fig. 7, [0045]; phototherapy apparatus 10):
(i) a housing (see Fig. 7, [0045]; canopy 40 supported by headband assembly 70) comprising
1) a head cavity defined by the housing (see 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 Fig. 7; canopy 40 having an inner surface);
(ii) a light array disposed on the inner surface (see 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 [0015]; light generating sources may be LEDs);
(b) a power/communication line coupled to the light array (see [0038]; wire 160 couples to head unit);
(c) a controller coupled to the power/communication line (see 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 [0050]; power for energizing the light array may be supplied by batteries in the hand-held control device 110).
Regarding claim 10, Tucker teaches the traumatic brain injury treatment system of claim 2, 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 [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).
Regarding claim 14, Tucker teaches the traumatic brain injury treatment system of claim 2, wherein the housing further comprises a visor disposed on a front portion of the housing (see Fig. 7; canopy 40 having an extended front portion that may be connected to faceplate 80).
Regarding claim 15, Tucker teaches the traumatic brain injury treatment system of claim 2, wherein the housing further comprises two ear coverings, wherein each of the two ear coverings is disposed on a side of the housing (see Fig. 7, [0036]; headphones 24 which cover a user’s ears are disposed on each side of the housing).
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.
Claim(s) 3-5 and 7-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tucker et al (US 20100076529 A1) in view of Saxena et al (US 20100103694 A1) and Gunesekar et al (US 20180153470 A1).
Regarding claim 3, Tucker teaches the system of claim 2, wherein each of the plurality of LED light assemblies has a tubular structure and an LED (102) disposed at a fixed longitudinal position within the tubular structure (see annotated Fig. 9 below).
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Tucker is silent regarding wherein the tubular structure is substantially transparent and a tension member is coupled to the tubular structure and the inner surface of the housing.
Saxena teaches an LED array wherein each of the plurality of LED light assemblies comprises:
(a) a substantially transparent tubular structure (see Saxena [0023]; light guide 30 may be fabricated of any suitable transparent material); and
(b) an LED light disposed at a fixed longitudinal position with the tubular structure (see Fig. 1, [0022-0023]; LEDs 22 arrayed at a fixed position at an end of light guide 30).
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 Tucker’s phototherapeutic device with the transparent tubular light guides as taught by Saxena. One of ordinary skill in the art would have been motivated to make this modification in order to control the direction, angle, luminance intensity and pattern, distribution, and focus of the LEDs in a light array (Saxena [0005]).
Saxena is silent regarding a tension component coupled to the tubular structure and the inner surface of the housing.
Gunasekar teaches a headpiece (100) having a housing comprising a head cavity with an array of electrodes (140) disposed on the inner surface of the housing (see Gunasekar Figs. 2-3 showing electrodes disposed on the inner surface of the housing) wherein each of the plurality of electrodes has a tension component coupling a tubular element and the inner surface of the housing (see Gunasekar Fig. 8, [0047]; spring element 149 arranged between the housing and the electrode tip).
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 Tucker’s phototherapy device having the tubular light guides of Saxena with a tension element to facilitate coupling to the inside of the housing as taught by Gunasekar. One of ordinary skill in the art would have been motivated to make this modification in order to depress the electrode/light to the user’s scalp and absorb variations in the distance between the housing and the user to facilitate a connection between the therapeutic element and the user at all locations (Gunasekar [0045-0047]).
Regarding claim 4, Tucker, Saxena, and Gunasekar teach the system of claim 3. Tucker is silent regarding wherein each of the plurality of LED light assemblies further comprises a cover disposed on a proximal end of the tubular structure, wherein the tension component is coupled to the tubular structure at the cover.
Gunasekar teaches wherein each of the plurality of electrode assemblies further comprises a cover disposed on a proximal end of the tubular structure, wherein the tension component is coupled to the tubular structure at the cover. See annotated Gunasekar Fig. 8 below.
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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 Tucker’s phototherapy device having the tubular light guides of Saxena with a tension member coupled to a proximal end of a tubular structure as taught by Gunasekar. One of ordinary skill in the art would have been motivated to make this modification in order to to depress the electrode/light to the user’s scalp and absorb variations in the distance between the housing and the user to facilitate a connection between the therapeutic element and the user at all locations (Gunasekar [0045-0047]).
Regarding claim 5, Tucker, Saxena, and Gunasekar teach the system of claim 3. Tucker is silent regarding wherein the tension component comprises at least one spring.
Gunasekar teaches wherein the tension component comprises at least one spring (see Gunasekar Fig. 8, [0047]; spring element 149).
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 Tucker’s phototherapy device having the tubular light guides of Saxena with a spring to facilitate coupling to the inside of the housing as taught by Gunasekar. One of ordinary skill in the art would have been motivated to make this modification in order to depress the electrode/light to the user’s scalp and absorb variations in the distance between the housing and the user to facilitate a connection between the therapeutic element and the user at all locations (Gunasekar [0045-0047]).
Regarding claim 7, Tucker, Saxena, and Gunasekar teach the system of claim 3. Tucker further teaches wherein the tubular structure is disposed through an opening in the inner surface of the housing (see Tucker Fig. 9 where light generating sources 102 are disposed through openings in the inner facing side 100 of housing 40).
Regarding claim 8, Tucker, Saxena, and Gunasekar teach the system of claim 3. Tucker is silent regarding wherein the tubular structure is disposed adjacent to and tensionably coupled to the inner surface.
Gunasekar teaches wherein the tubular structure is disposed adjacent to and tensionably coupled to the inner surface (see Gunasekar Fig. 8, [0047]; electrode body 142 coupled to band 121 of headpiece device where electrode body 142 is tensionably attached to electrode tip 144 via a spring element 149).
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 Tucker’s phototherapy device having the tubular light guides of Saxena with a tension element to facilitate coupling to the inside of the housing as taught by Gunasekar. One of ordinary skill in the art would have been motivated to make this modification in order to depress the electrode/light to the user’s scalp and absorb variations in the distance between the housing and the user to facilitate a connection between the therapeutic element and the user at all locations (Gunasekar [0045-0047]).
Regarding claim 9, Tucker, Saxena, and Gunasekar teach the system of claim 3. Tucker further teaches wherein the tubular structure is disposed at least partially within a cavity defined within the inner surface (see Tucker Fig. 9 where the light generating sources 102 are disposed within cavities defined within the inner facing side 100 of housing 40).
Claim(s) 6 is/are rejected under 35 U.S.C 103 as being unpatentable over Tucker et al (US 20100076529 A1) in view of Saxena et al (US 20100103694 A1), DeRohan et al (US 20130304140 A1), and Gunesekar et al (US 20180153470 A1).
Regarding claim 6, Tucker in view of Saxena teach the system of claim 3. They are silent regarding wherein the tension component comprises a lever. Gunasekar teaches a tension component comprising at least one spring (see above regarding claim 5), but does not teach the tension component comprising a lever.
However, DeRohan teaches a system for improving contact of stimulation electrodes to a target site (DeRohan, Abstract) using a tension assembly comprising a spring and a lever (see DeRohan Figs. 7A-7B, [0071]; the spring contact probed can incorporate a lever to control how far the spring loaded pins extend through the connector assembly 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 the tension assembly as taught by Gunasekar with an associated lever as taught by DeRohan. One of ordinary skill in the art would have been motivated to make this modification in order to control the positioning and depth of the extending elements and ensure the extending elements return to their unactuated resting position. It can be appreciated that the inclusion of a lever in a tension component would be well understood and obvious to one of ordinary skill in the art, and its inclusion would only require a combination (in the case of the spring and lever/cantilever tension assembly) of prior art elements according to know methods which would yield predictable results of allowing for a variable positioning of the therapeutic elements against a target site.
Claim(s) 11 is/are 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]).
Claim(s) 16-20 and 22 is/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]).
Claim(s) 23 and 24 is/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 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 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 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 [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).
Claim(s) 25 and 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tucker et al (US 20100076529 A1) in view of Saxena et al (US 20100103694 A1), Gunesekar et al (US 20180153470 A1), and Steinle (US 20140160536 A1).
Regarding claims 25 and 26, Tucker in view of Saxena and Gunasekar teach 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 Tucker, Saxena, and Gunasekar 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(s) 27 is/are 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(s) 28 is/are 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:
positioning a treatment system for treatment of a 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),
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]).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
A brief, but non-exhaustive matching of the pending claims and the issued patent are provided below.
Application No. 18/501,663
Pending Claims
U.S. Patent No. 11857801
Issued Claims
1. A traumatic brain injury treatment system, comprising:
(a) a headpiece comprising:
(i) a housing comprising a head cavity; and
(ii) a light array disposed on an inner surface of the head cavity;
(b) a controller operably coupled to the light array via a first connection line; and
(c) an energy source operably coupled to the controller via a second connection line.
1. A traumatic brain injury treatment system, comprising:
(a) a headpiece comprising:
(i) a housing comprising;
1) a head cavity defined by the housing; and
2) an inner surface within the head cavity; and
(ii) a light array disposed on the inner surface, wherein the light array comprises 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, wherein the portion of the LED light assemblies disposed adjacent to the front sinus or the mastoid process have a different radiant intensity or are actuated to radiate for a different period of time than other LED light assemblies in the plurality of LED light assemblies;
(b) a power/communication line coupled to the light array;
(c) a controller coupled to the power/communication line; and
(c) an energy source coupled to the power/communication line.
2. A traumatic brain injury treatment system, comprising:
(a) a headpiece comprising:
(i) a housing comprising
1) a head cavity defined by the housing; and
2) an inner surface within the head cavity;
(ii) a light array disposed on the inner surface, wherein the light array comprises a plurality of LED light assemblies;
(b) a power/communication line coupled to the light array;
(c) a controller coupled to the power/communication line; and
(c) an energy source coupled to the power/communication line.
1. A traumatic brain injury treatment system, comprising:
(a) a headpiece comprising:
(i) a housing comprising;
1) a head cavity defined by the housing; and
2) an inner surface within the head cavity; and
(ii) a light array disposed on the inner surface, wherein the light array comprises 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, wherein the portion of the LED light assemblies disposed adjacent to the front sinus or the mastoid process have a different radiant intensity or are actuated to radiate for a different period of time than other LED light assemblies in the plurality of LED light assemblies;
(b) a power/communication line coupled to the light array;
(c) a controller coupled to the power/communication line; and
(c) an energy source coupled to the power/communication line.
3. The traumatic brain injury treatment system of claim 2, wherein each of the plurality of LED light assemblies comprises:
(a) a substantially transparent tubular structure;
(b) an LED light disposed at a fixed longitudinal position with the tubular structure; and
(c) a tension component coupled to the tubular structure and the inner surface of the housing.
2. The traumatic brain injury treatment system of claim 1, wherein each of the plurality of LED light assemblies comprises:
(a) a substantially transparent tubular structure;
(b) an LED light disposed at a fixed longitudinal position with the tubular structure; and
(c) a tension component coupled to the tubular structure and the inner surface of the housing.
4. The traumatic brain injury treatment system of claim 3, wherein each of the plurality of LED light assemblies further comprises a cover disposed on a proximal end of the tubular structure, wherein the tension component is coupled to the tubular structure at the cover.
3. The traumatic brain injury treatment system of claim 2, wherein each of the plurality of LED light assemblies further comprises a cover disposed on a proximal end of the tubular structure, wherein the tension component is coupled to the tubular structure at the cover.
5. The traumatic brain injury treatment system of claim 3, wherein the tension component comprises at least one spring.
4. The traumatic brain injury treatment system of claim 2, wherein the tension component comprises at least one spring or a lever.
6. The traumatic brain injury treatment system of claim 3, wherein the tension component comprises a lever.
4. The traumatic brain injury treatment system of claim 2, wherein the tension component comprises at least one spring or a lever.
7. The traumatic brain injury treatment system of claim 3, wherein the tubular structure is disposed through an opening in the inner surface of the housing.
5. The traumatic brain injury treatment system of claim 2, wherein the tubular structure is disposed through an opening in the inner surface of the housing.
8. The traumatic brain injury treatment system of claim 3, wherein the tubular structure is disposed adjacent to and tensionably coupled to the inner surface.
6. The traumatic brain injury treatment system of claim 2, wherein the tubular structure is disposed adjacent to and tensionably coupled to the inner surface.
9. 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.
7. The traumatic brain injury treatment system of claim 2, wherein the tubular structure is disposed at least partially within a cavity defined within the inner surface.
10. The traumatic brain injury treatment system of claim 2, 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.
8. The traumatic brain injury treatment system of claim 1, 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.
11. The traumatic brain injury treatment system of claim 2, 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.
9. The traumatic brain injury treatment system of claim 1, 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.
12. The traumatic brain injury treatment system of claim 2, wherein the housing comprises a substantially flexible material.
10. The traumatic brain injury treatment system of claim 1, wherein the housing comprises a substantially flexible material.
13. The traumatic brain injury treatment system of claim 2, wherein the housing comprises a substantially rigid material.
11. The traumatic brain injury treatment system of claim 1, wherein the housing comprises a substantially rigid material.
14. The traumatic brain injury treatment system of claim 2, wherein the housing further comprises a visor disposed on a front portion of the housing.
12. The traumatic brain injury treatment system of claim 1, wherein the housing further comprises a visor disposed on a front portion of the housing.
15. The traumatic brain injury treatment system of claim 2, wherein the housing further comprises two ear coverings, wherein each of the two ear coverings is disposed on a side of the housing.
13. The traumatic brain injury treatment system of claim 1, wherein the housing further comprises two ear coverings, wherein each of the two ear coverings is disposed on a side of the housing.
16. The traumatic brain injury treatment system of claim 2, wherein the p