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 .
Response to Amendment
Applicant’s Amendments, filed 2/10/2026, to claims 1, 10-13, 16 acknowledged by Examiner. Additionally, applicant cancelled claim 9, and added claim 21.
Claims 1-8 and 10-21 are now pending.
Previous drawing objections withdrawn.
Previous 101 rejections withdrawn.
Response to Arguments
Applicant's arguments filed 2/10/2026 have been fully considered but they are not persuasive.
Regarding Applicant’s arguments that Harty does not provide for “a back plate having a vertebral void… wherein the vertebral void permits unimpeded imaging of cervical vertebrae when the orthosis is worn”, Examiner disagrees. Firstly, it is noted that the features upon which applicant relies in their arguments (i.e., “enable a full view of the cervical region” and “x-rays and other imaging signals to pass through air or an effectively transparent region (for imaging signals)”) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). The claim language at present is simply “wherein the vertebral void permits unimpeded imaging of cervical vertebrae when the orthosis is worn” wherein Hart directly states in paragraph [0034] “The back of the head support defines an opening 28 through which the cervical region may be observed and treated. This opening 28 ensures that no pressure is applied to the brain stem while a patient is wearing the device”, thus this opening (void) is showing the “cervical region” being where the cervical vertebrae are and thus being an opening that enable observation (thus being imaging, wherein imaging herein could be anything generic from photography to ultrasound echo) and treatment (thus also enabling any form of medical treatment as a genus including medical imaging tools) therein. Also being opening completely aligns with your specification cited as this is a region of air that signals would be capable of passing therethrough to the cervical region for imaging the cervical vertebrae. Applicant’s arguments appear to erroneously refer to the aperture 58 and related to disclosure in Harty, when that aperture 58 was not or cited relied on at all in the rejection or combination between Glazener and Harty.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Also, further it is noted, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
The rejections of claim 13 has been updated as necessitated by the amendments below.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). The arguments against Glazener for the newly amended claim language in claim 13 are insufficient as they don’t appear to actually address Glazener not providing for the newly amened claim language as combined with Monat.
Examiner’s Notes
All references relied up on and not cited in the current Form 892 may be found in previous 892's or IDS'.
Drawings
The drawings were received on 2/10/2026. These drawings are acceptable.
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) 1-4, 10-12, and 16-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Glazener (US 20150202072 A1) in view of Harty (US 20050027222 A1).
Regarding claim 1, Glazener discloses an orthosis 10 for immobilizing a cervical spine (Figures 1-17, cervical orthosis implicitly for immobilizing a spine of the user) comprising:
a forehead band 28 (Fig. 1 and 12);
a back plate 12/20 (Fig. 1, 5, 12; head frame 12 and posterior panel 20), the back plate 12/20 coupled to the forehead band 28 (Fig. 12 and [0044, 0055], strap 28 attached to the head frame 12); and
a torso harness 18/16/22 (Fig. 11, the shoulder straps 16/18 and waist straps 22 forming the torso harness) comprising a back plate stabilizer configured to stabilize a position of the back plate 12/20 relative to the cervical spine (Fig. 4 and [0053] fasteners attaching the torso harness straps to the back plate stabilize the position of the back plate 12/20 to the cervical spine).
Glazener does not disclose the back plate having a vertebral void, wherein the vertebral void permits unimpeded imaging of cervical vertebrae when the orthosis is worn.
However, Harty teaches an analogous head brace 10 (Fig. 1) having an analogous back plate 22 (Fig. 4) having a vertebral void 28 (see [0034] opening 28 enables the cervical region to be observed and treated, stops pressure from being applied to the brain stem), wherein the vertebral void 28 permits unimpeded imaging of cervical vertebrae when the orthosis is worn (Fig. 4 and [0034] the opening 28 enables a full view of the cervical region thus enabling unimpeded imaging of the cervical vertebrae when orthosis of Glazener in view of Hart is worn).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have provided a vertebral void 28 as taught by Harty to the back plate 12 of Glazener in order to ensure no pressure is applied to the brain stem in use and allow the cervical region to be observed and treated while device is in use (Harty [0034]).
Regarding claim 2, Glazener in view of Harty discloses the invention of claim 1 above.
Glazener further discloses the forehead band 28 further comprises: a superior strap 28 (Figure 3, the forehead band 28 is a superior strap by being superiorly on the body; Examiner notes that as written the superior strap and forehead band share structure as this claim is describing what the forehead band is through the use of comprise).
Glazener does not explicitly describe a superior strap tensioner for adjusting a length of the superior strap.
However, Glazener Figure 13 provides an image of the strap 28 with what appears to be a buckle and hook and loop attachment for adjusting a length of the strap 28. Glazener further provides that the waist straps 22 have a tensioner for adjusting a length of a strap (see [0045] adjustable buckle the enables tightening of strap using hook and loop onto itself).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have understood that the strap 28 of Glazener has a superior strap tensioner for adjusting a length of the superior strap 28 in the form of buckle and hook-and-loop according to Figure 13 of Glazener and the disclosure of other straps within the Glazener (see [0045]).
Regarding claim 3, Glazener in view of Harty discloses the invention of claim 1 above.
Glazener further discloses the back plate 12 further comprises: an extender 14 for changing a length of the back plate 12/20 (See Figures 15-17 and [0048], wherein holes 58 in extender 14 enables the overall length of the back plate being the head frame 20 and posterior panel 20 to be adjusted).
Regarding claim 4, Glazener in view of Harty discloses the invention of claim 1 above.
Glazener further discloses wherein the torso harness 18/16/22 further comprises: a shoulder strap 18; and an abdomen strap 22 (Figures 1-5).
Regarding claim 10, Glazener in view of Harty discloses the invention of claim 1 above.
Glazener further discloses wherein the forehead band 28 is configured to cradle a head of a wearer (Fig. 1-3), wherein the torso harness 18/16/22 is configured to be worn about a torso of the wearer (Fig. 1-3), wherein when the back plate 12/20 in arrangement with the forehead band 28 and the torso harness 18/16/22 is configured to prevent the wearer from performing up/down and side-to-side head movements (See Fig. 1-3 and [0007] wherein the cervical bar 14 has stiffness such that the invention as shown would inhibit up and down movement of the head, and the pads 32 would block side-to-side movement).
Regarding claim 11, Glazener in view of Harty discloses the invention of claim 1 above.
Glazener further discloses wherein the orthosis is configured to immobilize the cervical spine through posterior support along the cervical spine without components resting upon a chest region, which alleviates respiratory problems experienced by wearers of competing products having elements attached to the chest region that exert a downward pressure upon the chest region (Glazener [0011], there is no structure on the chest region enabling free respiration for the user, immobilization occurs through posterior support provided by back plate 20 as seen in Fig. 1-3, see [0055] also: “The pressure/support provided against the wearer's back combined with the restrain of the wearer's head can position the wearer's torso in an upright position”).
Regarding claim 12, Glazener in view of Harty discloses the invention of claim 1 above.
Glazener further discloses wherein the orthosis is configured to immobilize the cervical spine through posterior support along the cervical spine without encircling a neck of a wearer, which alleviates respiratory problems experienced by wearers of competing products having elements that encircle the neck of the wearer (Glazener [0011], there is no structure on the chest region enabling free respiration for the user in addition there is no structure of the invention encircling the neck of the wearer, immobilization occurs through posterior support provided by back plate 20 as seen in Fig. 1-3, see [0055] also: “The pressure/support provided against the wearer's back combined with the restrain of the wearer's head can position the wearer's torso in an upright position”).
Regarding claim 16, Glazener discloses a method for immobilizing a cervical spine via an orthosis 10 (Figures 1-17, cervical orthosis implicitly for immobilizing a spine of the user) said orthosis 10 comprising: a forehead band 28 (Fig. 1-12), a back plate 12/20 (combination of head frame 12 and posterior panel 20 being the “back plate”; Fig. 1-12) connected to the forehead band 28, and a torso harness 16/18/22 (Fig. 1-12),
said method comprising:
securing the forehead band 28 about a forehead of the wearer (Fig. 1-3, see [0013]),
wherein the forehead band 28 is coupled to the back plate 12/20 (Fig. 12, see [0013]);
positioning the back plate 12/20 along a spine of the wearer (Fig. 1 and [0042]); and
placing the torso harness 16/18/22 around a torso of the wearer (Fig. 1-3),
wherein the torso harness 16/18/22 stabilizes a position of the back plate 12/20 relative to the cervical spine of the wearer (Fig. 1-3 and [0050] the torso harness straps lock the back plate 12/20 in relation to the cervical spine of the wearer),
wherein the securing, positioning, and placing prevent the wearer from performing up/down and side-to-side head movements (see [0055] wherein the wearer’s head is restrained into a position thus preventing movements).
Glazener does not disclose the back plate being positioned such that a vertebral void in the back plate allows substantially unimpeded imaging of the cervical spine through the vertebral void.
However, Harty teaches an analogous head brace 10 (Fig. 1) having an analogous back plate 22 (Fig. 4) having a vertebral void 28 (see [0034] opening 28 enables the cervical region to be observed and treated, stops pressure from being applied to the brain stem), wherein the back plate 22 being positioned such that a vertebral void 28 in the back plate 22 allows substantially unimpeded imaging of the cervical spine through the vertebral void (see [0034] opening 28 enables the cervical region to be observed and treated, thus explicitly performing the function of providing unimpeded imaging, being “observed”, of the cervical spine).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have provided a vertebral void 28 as taught by Harty to the back plate 12 of Glazener in order to ensure no pressure is applied to the brain stem in use and allow the cervical region to be observed and treated while device is in use (Harty [0034]), and performing the method step of the back plate being positioned such that a vertebral void in the back plate allows substantially unimpeded imaging of the cervical spine through the vertebral void.
Regarding claim 17, Glazener in view of Harty discloses the invention of claim 16 above.
Glazener further discloses adjusting a length of the back plate 12/20 for the wearer via an extender 14 (see [0048], wherein extender 14 can be adjusted to alter the overall length of the back plate 12/20); and locking the extender of the back plate (see [0048], when extender 14 is engaged with the pin 58 then the extender is locked in position).
Claim(s) 5-8 and 19-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Glazener (US 20150202072 A1) in view of Harty (US 20050027222 A1), in further view of Monat (US 20190247218 A1).
Regarding claim 5, Glazener in view of Harty discloses the invention of claim 1 above.
Glazener in view of Harty is silent on a lateral brace hinged to the back plate.
However, Monat teaches an analogous head and neck immobilization brace 100 (title, Fig. 1) comprising an analogous back plate 106 (Fig. 1), wherein there is a lateral brace 112 hinged to the back plate 106 (Fig. 1-5 and [0029], the lateral brace 112 being the two “head immobilization pads” having a hinged connections 124 and 126 connecting the lateral braces 112 to the back plate 106, see Fig. 6 and [0032]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have provided the cervical brace of Glazener with the lateral braces 112 of Monat hinged to the analogous back plate 20 of Glazener in order to provide an increased head support that will reduce the likely hood of further injury of the neck or head during treatment (see Monat [0052]), thus providing an improved cervical orthosis with Glazener in view of Hart.
Regarding claim 6, Glazener in view of Harty and Monat discloses the invention of claim 5 above.
Monat further teaches the lateral brace 112 comprises: two lateral elements 112 configured to be positioned on opposing sides of a head (Fig. 9 of Monat shows device in use on patient where the lateral elements 112 are on opposing sides of a head, further see Fig. 2 and how the lateral braces 112 are configured to be on opposing sides of a head when in use).
Regarding claim 7, Glazener in view of Harty and Monat discloses the invention of claim 6 above.
Monat further teaches wherein each of the two lateral elements 112 comprise: a first temporal segment 112 (Fig. 2, the first temporal segment being the lateral brace pad 112 itself, being a temporal segment by being against a temple of the user when worn); a second temporal segment 128 (Fig. 2 and [0033], spacer 128 being the second temporal segment, being a positioning segment for adjusting the lateral brace 112 adjacent to a temple of a user); and a segment hinge 126 joining the first temporal segment 112 and the second temporal segment 128 (Fig. 2 and [0032]).
Regarding claim 8, Glazener in view of Harty and Monat discloses the invention of claim 7 above.
Monat further teaches wherein the segment hinge 126 and a hinge set 124 between the lateral brace 112 and the back plate 106 (Fig. 2 and [0032]) comprise:
a hinge lock having an open state allowing movement and a closed state inhibiting movement (see [0032,0051] wherein hinges 126 and 124 having locking mechanisms with an “open state”/unlocked state enabling rotation thus movement, and a “closed state”/locked state locking rotation thus inhibiting movement).
Regarding claim 19, Glazener in view of Harty discloses the invention of claim 16 above.
Glazener in view of Harty is silent on wherein the orthosis comprises two lateral elements, the method further comprising: positioning the lateral elements on opposing sides of a head of the wearer; and locking a hinge set between the lateral elements and the back plate to inhibit movement.
However, Monat teaches an analogous head and neck immobilization brace 100 (title, Fig. 1) comprising an analogous back plate 106 (Fig. 1), a lateral brace 112 (Fig. 1-5 and [0029], the lateral brace 112 being the two “head immobilization pads”) comprising two lateral elements 112 positioned on opposing sides of a head (Fig. 9 of Monat shows device in use on patient where the lateral elements 112 are on opposing sides of a head, further see Fig. 2 and how the lateral braces 112 are configured to be on opposing sides of a head when in use, thus with the method step of: “positioning the lateral elements on opposing sides of a head of the wearer”), the back plate 106 being hinged to each of the lateral elements 112 (Fig. 6 and [0032], the lateral brace 112 being the two “head immobilization pads” having a hinged connections 124 and 126 connecting the lateral braces 112 to the back plate 106), locking a hinge 124/126 set between the lateral elements 112 and the back plate 106 to inhibit movement (see [0032,0051] wherein hinges 126 and 124 having locking mechanisms with an “open state”/unlocked state enabling rotation thus movement, and a “closed state”/locked state locking rotation thus inhibiting movement).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have provided the cervical brace of Glazener with the lateral braces 112 of Monat hinged to the analogous back plate 20 of Glazener, along with their method steps therein, in order to provide an increased head support that will reduce the likely hood of further injury of the neck or head during treatment (see Monat [0052]), thus providing an improved cervical orthosis with Glazener.
Regarding claim 20, Glazener in view of Harty discloses the invention of claim 16 above.
Glazener in view of Harty is silent on wherein the orthosis comprises two lateral elements, wherein each of the two lateral elements comprise: a first temporal segment; a second temporal segment; and a segment hinge joining the first temporal segment and the second temporal segment, the method further comprising: positioning the lateral elements on opposing sides of a head of the wearer; adjusting the first temporal segment and the second temporal segment of each of the lateral elements to encase sides of the head; and locking the segment hinges to inhibit movement of the first and second temporal segments relative to each other.
However, Monat teaches an analogous head and neck immobilization brace 100 (title, Fig. 1) comprising an analogous back plate 106 (Fig. 1), a lateral brace 112 (Fig. 1-5 and [0029], the lateral brace 112 being the two “head immobilization pads”) comprising two lateral elements 112 positioned on opposing sides of a head (Fig. 9 of Monat shows device in use on patient where the lateral elements 112 are on opposing sides of a head, further see Fig. 2 and how the lateral braces 112 are configured to be on opposing sides of a head when in use, thus with the method step of: “positioning the lateral elements on opposing sides of a head of the wearer”),
wherein each of the two lateral elements 112 comprise: a first temporal segment 112 (Fig. 2, the first temporal segment being the lateral brace pad 112 itself, being a temporal segment by being against a temple of the user when worn); a second temporal segment 128 (Fig. 2 and [0033], spacer 128 being the second temporal segment, being a positioning segment for adjusting the lateral brace 112 adjacent to a temple of a user); and a segment hinge 126 joining the first temporal segment 112 and the second temporal segment 128 (Fig. 2 and [0032]),
adjusting the first temporal segment 112 and the second temporal segment 128 of each of the lateral elements 112 to encase sides of the head (Fig. 2 and 9, see [0032]); and
locking the segment hinges to inhibit movement of the first and second temporal segments relative to each other (see [0032,0051] wherein hinges 126 and 124 having locking mechanisms with an “open state”/unlocked state enabling rotation thus movement, and a “closed state”/locked state locking rotation thus inhibiting movement relative to each other).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have provided the cervical brace of Glazener with the lateral braces 112 of Monat hinged to the analogous back plate 20 of Glazener, along with their method steps therein, in order to provide an increased head support that will reduce the likely hood of further injury of the neck or head during treatment (see Monat [0052]), thus providing an improved cervical orthosis with Glazener.
Regarding claim 21, Glazener in view of Harty and Monat discloses the invention of claim 7 above.
Harty further teaches wherein the vertebral void 28 is centrally positioned in the back plate 22 (Fig. 4 of Harty, the void 28 being at the central dotted line alpha therein, thus being centrally positioned) and extends longitudinally along the cervical spine (Fig. 4, extends longitudinally in shape therein, and [0034] provides for the void 28 providing view of the cervical region thus extending longitudinally along the cervical spine therein).
Claim(s) 13 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Glazener (US 20150202072 A1) in view of Monat (US 20190247218 A1).
Regarding claim 13, Glazener discloses an orthosis 10 for immobilizing a cervical spine (Figures 1-17, cervical orthosis implicitly for immobilizing a spine of the user) comprising:
a forehead band 28 (Fig. 1 and 12);
a back plate 12/20 (Fig. 1, 5, 12; head frame 12 and posterior panel 20), the back plate 12/20 being configured to extend from the head to below a C7 vertebrae of the cervical spine (See Fig. 1 and Fig. 4-5, the back plate being the head frame 12 and posterior panel 20 extends from the head of the user to the lower back of the user being below a C7 vertebrae therein); and
a torso harness 18/16/22 (Fig. 11, the shoulder straps 16/18 and waist straps 22 forming the torso harness) comprising a back plate stabilizer that stabilizes a position of the back plate 12/20 relative to the cervical spine (Fig. 4 and [0053] fasteners attaching the torso harness straps to the back plate stabilize the position of the back plate 12/20 to the cervical spine).
Glazener is silent on a lateral brace comprising two lateral elements configured to be positioned on opposing sides of a head, the back plate being hinged to each of the lateral elements.
However, Monat teaches an analogous head and neck immobilization brace 100 (title, Fig. 1) comprising an analogous back plate 106 (Fig. 1), a lateral brace 112 (Fig. 1-5 and [0029], the lateral brace 112 being the two “head immobilization pads”) comprising two lateral elements 112 configured to be positioned on opposing sides of a head (Fig. 9 of Monat shows device in use on patient where the lateral elements 112 are on opposing sides of a head, further see Fig. 2 and how the lateral braces 112 are configured to be on opposing sides of a head when in use), the back plate 106 being hinged to each of the lateral elements 112 (Fig. 6 and [0032], the lateral brace 112 being the two “head immobilization pads” having a hinged connections 124 and 126 connecting the lateral braces 112 to the back plate 106).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have provided the cervical brace of Glazener with the lateral braces 112 of Monat hinged to the analogous back plate 20 of Glazener in order to provide an increased head support that will reduce the likely hood of further injury of the neck or head during treatment (see Monat [0052]), thus providing an improved cervical orthosis with Glazener.
Regarding claim 15, Glazener in view of Monat discloses the invention of claim 13 above.
Monat further teaches wherein each of the two lateral elements 112 comprise: a first temporal segment 112 (Fig. 2, the first temporal segment being the lateral brace pad 112 itself, being a temporal segment by being against a temple of the user when worn); a second temporal segment 128 (Fig. 2 and [0033], spacer 128 being the second temporal segment, being a positioning segment for adjusting the lateral brace 112 adjacent to a temple of a user); and a segment hinge 126 joining the first temporal segment 112 and the second temporal segment 128 (Fig. 2 and [0032]).
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Glazener (US 20150202072 A1) in view of Monat (US 20190247218 A1), in further view of Harty (US 20050027222 A1).
Regarding claim 14, Glazener in view of Monat discloses the invention of claim 13 above.
Glazener and Hart does not disclose the back plate comprising: a vertebral void at least 20 mm wide and of sufficient length to extend from C1 to C7 vertebrae of the cervical spine.
However, Harty teaches an analogous head brace 10 (Fig. 1) having an analogous back plate 22 (Fig. 4) having a vertebral void 28 (see [0034] opening 28 enables the cervical region to be observed and treated, stops pressure from being applied to the brain stem).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have provided a vertebral void 28 as taught by Harty to the back plate 12 of Glazener in order to ensure no pressure is applied to the brain stem in use and allow the cervical region to be observed and treated while device is in use (Harty [0034]).
Glazener in view of Hart is still silent on the vertebral void being at least 20 mm wide and of sufficient length to extend from C1 to C7 vertebrae of the cervical spine.
However, Hart does explicitly disclose the vertebral void 28 enables the cervical region to be observed and treated when worn (see [0034]) wherein this provides implicit sizing that the opening 28 must be of a size to show the cervical region which implicitly includes the C1 to C7 cervical vertebrae. This thus must also include implicitly a neck width of the user being shown by the opening 28.
Examiner further notes that the instant specification fails to provide any criticality to the sizing of the vertebral void outside of enabling a cervical region of the neck being visible.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date have provided the vertebral void opening 28 of Hart to be at least 20 mm wide and of sufficient length to extend from C1 to C7 vertebrae of the cervical spine as a matter of routine optimization since 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." See MPEP § 2144.05, and even further Examiner asserts “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), wherein there does not appear to be any performance difference and function between the vertebral void of the instant specification and the opening 28 of Hart.
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Glazener (US 20150202072 A1) in view of Harty (US 20050027222 A1), in further view of Garth (US 5360393 A).
Regarding claim 18, Glazener in view of Harty discloses the invention of claim 16 above.
Glazener in view of Harty does not disclose gluing skin under the forehead band using an adhesive on an interior of the forehead band.
However, Garth teaches an analogous head immobilization device (title) having an analogous forehead strap 4 (Fig. 4) and an analogous back plate 6 (Fig. 4), wherein forehead band includes an adhesive on an interior of the forehead band for gluing to the skin of the user under the forehead band (Col. 3 line 30 – Col. 4 line 12).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to having provided the invention of Glazener in view of Harty with the method step of gluing skin under the forehead band using an adhesive on an interior of the forehead band as taught by Garth in order to ensure the user’s head stays immobilized by the forehead when in use by ensuring the forehead band does not fall off during treatment (Garth Col. 2 lines 1-7).
Claim(s) 13-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Monat (US 20190247218 A1) in view of Nagata (US 5575763 A).
Regarding claim 13, Monat discloses an orthosis (Fig. 1-13) for immobilizing a cervical spine (title, immobilizes head and neck which contains the cervical spine) comprising:
a lateral brace 112 comprising two lateral elements 112 configured to be positioned on opposing sides of a head (Fig. 2 and 9);
a back plate 106, the back plate being hinged to each of the two lateral elements 112 (Fig. 2 and 124/126 are hinges [0032]), the back plate being configured to extend below a C7 vertebrae of the cervical spine (Fig. 2, back plate 106 is clearly capable of extending below a C7 vertebrae);
a torso harness 108 comprising a back plate stabilizer 108 that stabilizes a position of the back plate 106 relative to the cervical spine (Fig. 2, the straps 108 stabilize and attach the back plate 106 to the body of the user thus relative to the cervical spine of the user).
Monat does not disclose the back plate being configured to extend from the head to below a C7 vertebrae of the cervical spine.
However, Nagata teaches an analogous cervical/spine orthosis (Fig. 1-9) comprising an analogous back plate 2a/2c having an analogous vertebral void (Fig. 9), wherein back plate 2a/2c being configured to extend from the head to below a C7 vertebrae of the cervical spine (Fig. 9) (see abstract, “An occipital region brace portion extends further upward from the upper end of each of the rear supporting portions so as to brace the occipital region”, the occipital region 2c being at the head and as shown in Fig. 9 goes below the C7 vertebrae).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the back plate 106 to have the back plate portion 2a/2c structures as taught by Nagata for providing support to the occipital region of the head (Nagata Abstract).
Regarding claim 14, Monat in view of Nagata discloses the invention of claim 13 above.
Monat as modified by Nagata further discloses the back plate 106 comprising: a vertebral void at least 20 mm wide and of sufficient length to extend from C1 to C7 vertebrae of the cervical spine (Fig. 2 and 9, there is a complete void of structure wherein the cervical spine is located relative to the back plate 106, wherein this void is more than 20 mm in width as the neck width of the invention is approximately 7.7 inches [0027] as seen in Figure 5, and length of the C1 to C7 vertebrae, as there is no structure containing the void thus the void being that length therein, and additional structures taught from Nagata provides for the C1 to C7 vertebrae being seen).
Regarding claim 15, Monat in view of Nagata discloses the invention of claim 13 above.
Monat further discloses wherein each of the two lateral elements 112 comprise: a first temporal segment 112 (Fig. 2, the first temporal segment being the lateral brace pad 112 itself, being a temporal segment by being against a temple of the user when worn); a second temporal segment 128 (Fig. 2 and [0033], spacer 128 being the second temporal segment, being a positioning segment for adjusting the lateral brace 112 adjacent to a temple of a user); and a segment hinge 126 joining the first temporal segment 112 and the second temporal segment 128 (Fig. 2 and [0032]).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KEVIN S ALBERS whose telephone number is (571)272-0139. The examiner can normally be reached Monday-Friday 7:30 am to 5:00 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rachael Bredefeld can be reached at (571) 270-5237. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/KEVIN S ALBERS/Patent Examiner, Art Unit 3786
/RACHAEL E BREDEFELD/Supervisory Patent Examiner, Art Unit 3786