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 Statement (IDS) filed 09/13/2023 has been considered by the Examiner.
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 and 4-8 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kim et al (KR 20210120549 A).
Regarding claim 1, Kim teaches a transcranial device (see [Abstract, machine translation]; transcranial phototherapy device) for irradiating a cranium of a user, the transcranial device comprising:
a power source (see [Page 5, Paragraph 4, machine translation]; power supply module); and
a headset configured to receive power from the power source (see [Page 5, Paragraphs 2- 4, machine translation]; power supply module is connected to the main body of headset 200), the headset comprising:
a positioning structure (200) comprising one or more irradiation sources (110, 120, 130) and
a control module located on a substrate structure (see [Page 5, Paragraph 2, machine translation]; the main body 200 has a built-in control module 210),
wherein the control module is configured to modify operational characteristics of the one or more irradiation sources (see [Page 5, Paragraphs 1-3, machine translation]; control module 210 controls the operation of the irradiation modules),
the substrate structure comprising:
a central segment (see annotated Fig. 2 below) and
one or more ribs (310) extending longitudinally and outwardly from the central segment,
the one or more ribs include one or more respective proximal ends attached to the central segment; and
one or more respective distal ends located longitudinally at one or more respective predetermined distances from the central segment,
the one or more ribs comprising one or more respective expanded portions (110, 120, 130) at the one or more respective distal ends of the one or more respective ribs (see annotated Fig. 2 below);
wherein the one or more ribs are pliable, such that, the one or more ribs are configured to be bent for locating and fastening the headset onto a head of a user (see [Page 7, Paragraph 7, machine translation]; the connecting link 310 can be freely bent or bent and deformed and may have a flexible structure), using one or more first fastening structures and a second fastening structure (see [Page 4, Paragraph 8, machine translation]; the wearing guide 175 is bent at a certain angle in order to fit securely around the users ear, note that in Fig. 4 it can be seen that there are two wearing guides 175, one for each ear, which may be considered to be a first and second fastening structures).
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Regarding claim 4, Kim teaches the transcranial device as claimed in claim 1, wherein the power source is attached to the positioning structure (see [Page 5, Paragraphs 2- 4, machine translation]; power supply module is connected to the main body of headset 200).
Regarding claim 5, Kim teaches the transcranial device as claimed in claim 1, wherein the one or more irradiation sources are light emitting diodes (see [Page 4, Paragraph 1-3, machine translation]; irradiation modules have an array of light emitting diodes).
Regarding claim 6, Kim teaches the transcranial device as claimed in claim 1, wherein the plurality of irradiation sources is configured to emit electromagnetic radiation of red-light wavelengths (630 nm - 670 nm) and Infrared radiation wavelengths (800 nm - 820 nm) (see [Page 4, Paragraph 3, machine translation]; a plurality of light emitting units emitting light of 660 nm and a plurality of second light emitting diodes emitting light of 810 nm).
Regarding claim 7, Kim teaches the transcranial device as claimed in claim 6, wherein the one or more irradiation sources comprise twenty (20) LEDs configured to emit red light of wavelengths ranging between 630 nm and 670 nm, and twenty (20) LEDs configured to emit infrared radiation of wavelengths ranging between 800 nm and 820 nm. See annotated Fig. 5 below and [Page 4, Paragraph 3, machine translation]).
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It can be appreciated that each of the irradiation units 110, 120, and 130 comprise an array as shown in Fig. 5 having at least 6 diodes emitting each wavelength, so the combined irradiation units comprise at least 20 LEDs configured to emit red light and at least 20 configured to emit infrared radiation.
Regarding claim 8, Kim teaches the transcranial device as claimed in claim 1, wherein the control module is located in the central segment (see [Page 5, Paragraph 2, machine translation]; the main body 200 has a built-in control module 210).
Claim(s) 1, 15, and 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tai (US 20200360712 A1).
Regarding claim 1, Tai teaches a transcranial device for irradiating a cranium of a user (see Tai Abstract; a phototherapy device including a head cap), the transcranial device comprising:
a power source (see Tai [0017]; power supply 160); and
a headset configured to receive power from the power source (see Tai [0017]; the printed circuit board 120 is disposed at the top of the head cap 110 to provide power to the LEDs 140 via power input 121 and power outputs 122), the headset comprising:
a positioning structure comprising one or more irradiation sources (see Tai Fig. 1, [0015]; phototherapy device 100 including cap 110, printed circuit board 120, and a plurality of flexible circuit boards 130 having a plurality of LEDs 140) and
a control module located on a substrate structure (see Tai Fig. 1, [0018]; control receiving end 123 of the PCB 120),
wherein the control module is configured to modify operational characteristics of the one or more irradiation sources (see Tai [0018]; control signal receiving end 123 receives signal to control the light intensity, illumination position/time and parameter setting of each LED),
the substrate structure comprising:
a central segment (120), and
one or more ribs (130) extending longitudinally and outwardly from the central segment,
the one or more ribs include one or more respective proximal ends attached to the central segment; and
one or more respective distal ends located longitudinally at one or more respective predetermined distances from the central segment (see annotated Tai Fig. 1 below);
the one or more ribs comprising one or more respective expanded portions at the one or more respective distal ends of the one or more respective ribs (see annotated Tai Fig. 1 below, it can be appreciated that the expanded portions at the distal ends of the one or more ribs are being regarded as the expanded length at the distal ends of ribs 132, 133, 134, 136, and 138);
wherein the one or more ribs are pliable, such that, the one or more ribs are configured to be bent for locating and fastening the headset onto a head of a user (see Tai [0019]; the flexible circuit boards 130 can be bent to fit the shape of the head cap 110), using one or more first fastening structures and a second fastening structure (see Tai Fig. 1, [0021]; the flexible circuit boards 130 can be fixed to head cap 110 via fixing plated 130B by way of Velcro, fastener, or belt, it can be appreciated that these fastening structures require a mating structure located on the cap in order to attach the flexible circuit board, which may be considered as a first and second fastening structure).
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Regarding claim 15, Tai teaches the transcranial device as claimed in claim 1, wherein the one or more ribs comprise:
a first rib (132) extending rearwardly from the central segment,
the first rib configured to extend over a frontal bone and an occipital bone of the cranium (see Tai Fig. 4 where the first rib 132 extends down the backside of the head to the location of an occipital bone; Tai Fig. 3; where the origin of the first rib 132 may extend over a part of the frontal bone based on the position of the central segment 120, and [0024]; where the central segment may be located at the top of the head or at a position anterior or posterior to the central point, thereby meeting the limitation that the first rib may be configured to extend over the frontal and occipital bones),
a second rib (138) extending rearwardly and obliquely towards a right side when in use,
the second rib configured to extend over a right parietal bone, a right temporal bone, a right mastoid process and the occipital bone of the cranium (see Tai Fig. 4; second rib 138 extending rearwardly and obliquely towards the right side),
a third rib (136) extending rearwardly and obliquely towards a left side when in use,
the third rib configured to extend over a left parietal bone, a left temporal bone, a left mastoid process and the occipital bone of the cranium (see Tai Fig. 4; third rib 136 extending rearwardly and obliquely towards the left side),
a fourth rib (133) extending laterally towards the right side when in use,
the fourth rib configured to extend over the frontal bone and a right sphenoid bone of the cranium (see Tai Fig. 3, [0022]; illustrating the path of the fifth rib 134 extending laterally toward the left side of the cranium, the right side is not pictured in the figure but can be appreciated to be mirrored on the other side as the arrangement of the ribs is symmetric), and
a fifth rib (134) extending laterally towards the left side when in use (see annotated Tai Fig. 1 below),
the fifth rib configured to extend over the frontal bone and a left sphenoid bone of the cranium (see Tai Fig. 3; illustrating the path of the fifth rib 134 extending laterally toward the left side of the cranium).
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Regarding claim 20, Tai teaches a transcranial device for irradiating a cranium of a user (see Tai Abstract; a phototherapy device including a head cap), the transcranial device comprising:
a power source (see Tai [0017]; power supply 160); and
a headset configured to receive power from the power source (see Tai [0017]; the printed circuit board 120 is disposed at the top of the head cap 110 to provide power to the LEDs 140 via power input 121 and power outputs 122), the headset comprising:
a positioning structure comprising one or more irradiation sources (see Tai Fig. 1, [0015]; phototherapy device 100 including cap 110, printed circuit board 120, and a plurality of flexible circuit boards 130 having a plurality of LEDs 140) and
a control module located on a substrate structure (see Tai Fig. 1, [0018]; control receiving end 123 of the PCB 120),
wherein the control module is configured to modify operational characteristics of the one or more irradiation sources (see Tai [0018]; control signal receiving end 123 receives signal to control the light intensity, illumination position/time and parameter setting of each LED),
the substrate structure comprising:
a central segment (120), and
one or more ribs (130) extending longitudinally and outwardly from the central segment,
the one or more ribs include one or more respective proximal ends attached to the central segment; and
one or more respective distal ends located longitudinally at one or more respective predetermined distances from the central segment (see annotated Tai Fig. 1 above);
the one or more ribs comprising one or more respective expanded portions at the one or more respective distal ends of the one or more respective ribs (see annotated Tai Fig. 1 below, it can be appreciated that the expanded portions at the distal ends of the one or more ribs are being regarded as the expanded length at the distal ends of ribs 132, 133, 134, 136, and 138);
wherein the one or more ribs are pliable, such that, the one or more ribs are configured to be bent for locating and fastening the headset onto a head of a user (see Tai [0019]; the flexible circuit boards 130 can be bent to fit the shape of the head cap 110), using one or more first fastening structures and a second fastening structure (see Tai Fig. 1, [0021]; the flexible circuit boards 130 can be fixed to head cap 110 via fixing plated 130B by way of Velcro, fastener, or belt, it can be appreciated that these fastening structures require a mating structure located on the cap in order to attach the flexible circuit board, which may be considered as a first and second fastening structure); and
wherein the one or more ribs comprise:
a first rib (132) extending rearwardly from the central segment,
the first rib configured to extend over a frontal bone and an occipital bone of the cranium (see Tai Fig. 4 where the first rib 132 extends down the backside of the head to the location of an occipital bone; Tai Fig. 3; where the origin of the first rib 132 may extend over a part of the frontal bone based on the position of the central segment 120, and [0024]; where the central segment may be located at the top of the head or at a position anterior or posterior to the central point, thereby meeting the limitation that the first rib may be configured to extend over the frontal and occipital bones),
a second rib (138) extending rearwardly and obliquely towards a right side when in use,
the second rib configured to extend over a right parietal bone, a right temporal bone, a right mastoid process and the occipital bone of the cranium (see Tai Fig. 4; second rib 138 extending rearwardly and obliquely towards the right side),
a third rib (136) extending rearwardly and obliquely towards a left side when in use,
the third rib configured to extend over a left parietal bone, a left temporal bone, a left mastoid process and the occipital bone of the cranium (see Tai Fig. 4; third rib 136 extending rearwardly and obliquely towards the left side),
a fourth rib (133) extending laterally towards the right side when in use,
the fourth rib configured to extend over the frontal bone and a right sphenoid bone of the cranium (see Tai Fig. 3, [0022]; illustrating the path of the fifth rib 134 extending laterally toward the left side of the cranium, the right side is not pictured in the figure but can be appreciated to be mirrored on the other side as the arrangement of the ribs is symmetric), and
a fifth rib (134) extending laterally towards the left side when in use (see annotated Tai Fig. 1 above),
the fifth rib configured to extend over the frontal bone and a left sphenoid bone of the cranium (see Tai Fig. 3; illustrating the path of the fifth rib 134 extending laterally toward the left side of the cranium).
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.
Claim(s) 2, 3, 11, 12, and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kim et al (KR 20210120549 A) in view of Lim (US 20200360715 A1)
Regarding claim 2, Kim teaches the transcranial device as claimed in claim 1. Kim is silent regarding wherein the power source comprises one or more rechargeable batteries.
Lim teaches a transcranial device for irradiating the cranium of a user (see Lim Fig. 2, apparatus 100 for transcranial irradiation including headset 102), wherein the power source comprises one or more rechargeable batteries (see Lim [0148]; portable rechargeable power bank 160 having encased batteries).
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 Kim’s transcranial device with a power source comprising rechargeable batteries as taught by Lim. One of ordinary skill in the art would have been motivated to make this modification in order to provide a portable and replenishable source of on-demand power to the device (Lim [0104]).
Regarding claim 3, Kim teaches the transcranial device as claimed in claim 1. Kim is silent regarding wherein the power source comprises a power adaptor comprising an Analog to Digital (AC/DC) converter, the power adaptor configured to receive power from an Alternating Current (AC) based power supply.
Lim teaches wherein the power source comprises a power adaptor comprising an Analog to Digital (AC/DC) converter, the power adaptor configured to receive power from an Alternating Current (AC) based power supply (see Lim [0105]; the power supply may be alternating current AC via a power adaptor).
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 Kim’s transcranial device with a power source having a power adaptor comprising an AC/DC converter. One of ordinary skill in the art would have been motivated to make this modification in order to obtain power from a source such as a local electrical grid and adjust the voltage appropriately to power the therapeutic device (Lim [0106]).
Regarding claim 11 Kim teaches the transcranial device as claimed in claim 1. Kim is silent regarding wherein the control module comprises a communication interface configured to wirelessly connect to an external programmable device.
Lim teaches wherein the control module comprises a communication interface configured to wirelessly connect to an external programmable device (see Lim [0118-0120]; the controller assembly works in combination with an external device such as a computer, smartphone, etc. having an interface via a wireless connection).
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 Kim’s transcranial device with a wirelessly connected communication interface as taught by Lim. One of ordinary skill in the art would have been motivated to make this modification in order to provide an interface for the user to input instructions and adjust therapy parameters which can then be wirelessly transmitted to the system controller (Lim [0119]).
Regarding claim 12, Kim teaches the transcranial device as claimed in claim 1. Kim is silent regarding wherein the control module is configured to operate the one or more irradiation sources in pulsating mode with a pulsating frequency of 40 Hz and a peak drive current of 400 mA.
Lim teaches a control module configured to operate the one or more irradiation sources in pulsating mode with a pulsating frequency of 40 Hz (see Lim [0171]; the controller determines the desired therapy parameters including pulse frequency; [0183]; a gamma pulse frequency is preferred for treatment of Alzheimer’s disease, preferably 40 Hz).
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 Kim’s transcranial device with a pulse frequency of 40Hz. One of ordinary skill in the art would have been motivated to make this modification in order to treat diseases including Alzheimer’s disease by helping to remove and prevent plaque accumulations on a patient’s brain (Lim [0182-0183]).
Lim is silent regarding the control module operating with a peak drive current of 400 mA.
However, Lim teaches wherein the control module receives power in the form of an electric current and is able to control and direct the flow of the electric current in dosage, power, and time from the power source to the irradiation units (Lim [0112]).
It would have been obvious to one of ordinary skill in the art to establish an appropriate peak drive current value for safety while using the transcranial device to deliver therapy to a patient. It has been held that "where 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" (In re Aller, 220 F.2d 454). Lim teaches the general conditions of the claim wherein the peak current is controlled and delivered within a safe range.
Regarding claim 19, Kim teaches the transcranial device as claimed in claim 1. Kim is silent regarding the device further comprising a nasal driver for nasal application, the nasal driver configured to operate the one or more irradiation sources with a pulsating frequency of 10 Hz.
Lim teaches a transcranial device further comprising a nasal driver for nasal application (see Lim Fig. 3, [0146]; intranasal therapy unit including nose clip 140 having irradiation lens 142), the nasal driver configured to operate the one or more irradiation sources with a pulsating frequency of 10 Hz (see Lim [0171]; the controller determines the desired therapy parameters including pulse frequency and location of the delivered therapy which may be the scalp, nose, or other areas; [0181]; a pulse frequency of 10 Hz is preferred for treatment of TBIs).
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 Kim’s transcranial device with the nasal driver having a pulse frequency of 10 Hz as taught by Lim. One of ordinary skill in the art would have been motivated to make this modification in order to generate light energy with sufficient power to pass through the nasal cavity into the brain to target areas of the ventral or underside of the brain (Lim [0146]).
Claim(s) 9 and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kim et al (KR 20210120549 A) in view of Alleman et al (US 20120083718 A1).
Regarding claims 9 and 10, Kim teaches the transcranial device as claimed in claim 1, wherein the control module is covered with a protective pad (see [Page 5, Paragraph 2, machine translation]; the main body 200 has a built-in control module 210, it can be appreciated that the main body acts as a protective pad for the control module).
Kim is silent regarding wherein the protective pad is made from a non-conductive material selected from a group consisting of Acrylonitrile Butadiene Styrene (ABS), Polyvinyl Chloride (PVC), High-Density Polyethylene (HDPE), Low-Density Polyethylene (LDPE), and combinations thereof.
Alleman teaches a transcranial device (101) configured to irradiate a target tissue (see Alleman [0274]), wherein the structural shell or supporting members of the headset assembly are constructed from a non-conductive plastic material including Acrylonitrile Butadiene Styrene and Polyethylene (see Alleman [0121]).
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 Kim’s transcranial device having a protective pad for the control module with the non-conductive material as taught by Alleman. One of ordinary skill in the art would have been motivated to make this modification in order to prevent unwanted conduction from the control module or other electronics to the patient.
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tai (US 20200360712 A1) in view of Lin (US 20120251334 A1).
Regarding claim 13, Tai teaches the transcranial device of claim 1. Tai is silent regarding wherein the control module further comprises a four (4) -way Dual In-line Package (DIP) switch configured to allow the user to select an operational state from sixteen (16) preconfigured operational states.
Lin teaches a control system having a 4-way DIP switch which provides 16 setting states for the system (Lin [0020]).
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 Tai’s control module for the transcranial device with a 4-way DIP switch as taught by Lin. One of ordinary skill in the art would have been motivated to make this modification in order to readily modify the state of the control system between 16 preconfigured operational states based on the configurations of the DIP switch. It can be appreciated that the usage of DIP switches for controlling operational states of a system is well known and common in the art.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tai (US 20200360712 A1).
Regarding claim 14, Tai teaches the transcranial device of claim 1 except for wherein the substrate structure is made up of fiberglass and coated with an impermeable solder-resistant material.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to use a fiberglass material coated with an impermeable solder-resistant material, for the purpose of constructing the substrate with a strong yet flexible material to house the irradiation assemblies, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Claim(s) 16-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tai (US 20200360712 A1) in view of Rogers et al (US 20210153594 A1).
Regarding claim 16-18, Tai teaches the transcranial device as claimed in claim 1.
Regarding claims 16 and 17, Tai is silent regarding herein each one of the one or more expanded portions comprises one or more apertures, such that, for locating and fastening the headset onto the head of the user, respective apertures of the one or more expanded portions are configured to be overlapped and fastened using the one or more first fastening structures,
wherein the one or more first fastening structures comprise screws and/or bolts.
Rogers teaches a system for a headborne attachment system wherein one or more expanded portions comprises one or more apertures (see Fig 2, [0098]; expanded side portion 64 and expanded frontal portion 62, which are part of a plurality of rigid plates 14), such that, for locating and fastening the headset onto the head of the user, respective apertures of the one or more expanded portions are configured to be overlapped and fastened using the one or more first fastening structures (see Fig 1, [0096]; rigid plates 14, which comprise side portion 64 and frontal portion 62 are overlapped to connect to one another using a fastener),
wherein the one or more first fastening structures comprise screws and/or bolts (see [0096]; the attachment features may include fasteners such as screws or rivets).
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 Tai’s transcranial device with the system for fastening and positioning onto the head of a user as taught by Rogers. One of ordinary skill in the art would have been motivated to make this modification in order to configure the headgear to sit adjacent to and surround the wearers skull to provide support to the system and keep it in place (Rogers, Abstract).
Regarding claim 18, Tai is silent regarding wherein the central segment comprises a notch, and
the second fastening structure comprises a T-strap with ends provided with loop and hook fasteners, the T-strap comprising:
a head portion, and
a body portion,
wherein the head portion is configured to connect with the notch to loop around the body portion, to fasten the body portion upwardly across a periphery of a forehead of the user, and
wherein a transverse fastening strap is configured to fasten the body portion laterally around the periphery of the forehead.
Rogers teaches wherein the central segment comprises a notch, and
the second fastening structure comprises a T-strap with ends provided with loop and hook fasteners (see Rogers [0096]; the fasteners may include hook and loop attachments), the T-strap comprising:
a head portion, and
a body portion,
wherein the head portion is configured to connect with the notch to loop around the body portion, to fasten the body portion upwardly across a periphery of a forehead of the user, and
wherein a transverse fastening strap is configured to fasten the body portion laterally around the periphery of the forehead. See annotated Fig. 2 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 Tai’s transcranial device with the system for fastening and positioning onto the head of a user as taught by Rogers. One of ordinary skill in the art would have been motivated to make this modification in order to configure the headgear to sit adjacent to and surround the wearers skull to provide support to the system and keep it in place (Rogers, Abstract).
Conclusion
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/A.J.S./Examiner, Art Unit 3792
/Benjamin J Klein/Supervisory Patent Examiner, Art Unit 3792