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 .
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-4, 6-10, 13-14, 16-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lerman (US 6,368,295 B1).
Regarding claim 1, Lerman discloses a cervical immobilization device (CID) (Figures 1-2), comprising: a front collar comprising: a chest brace (10) configured to extend downward from both shoulders of a patient and rest against a chest of the patient (Figure 1; Col. 4, lines 43-57); an adjustable headband (headband 80 of halo 14) configured to strap around a forehead of the patient (Figures 1-2; Col. 6, lines 39-50); first and second lateral head supports (68 of rigid frame 16, Figure 2) configured to attach and extend vertically downward from the headband, the first and second lateral head supports configured to form a rigid connection to the front collar (Figures 1-2; Col. 4, lines 17-42); and first and second underarm straps (34, 36) each having first and second ends, wherein: the first ends are configured to attach to opposing sides of the chest brace below the patient's shoulders, and the second ends are configured to attach to opposing sides of the CID above the patient's shoulders when the CID is worn by the patient (Figures 1 and 7; Col. 4, lines 59-67).
Regarding claim 2, Lerman discloses wherein the second ends of the first and second underarm straps (34, 36) are configured to attach to the front collar (Figures 1 and 7; Col. 4, lines 59-67).
Regarding claim 3, Lerman discloses wherein the first and second underarm straps are configured to extend under and abut against a floor of the patient's armpits when the CID is worn by the patient (Figures 1 and 7; Col. 4, lines 59-67).
Regarding claim 4, Lerman discloses wherein: the first end of the first underarm strap is configured to attach to a left side of the chest brace and the second end of the first underarm strap is configured to attach to a right side of the CID; and the first end of the second underarm strap is configured to attach to a right side of the chest brace and the second end of the second underarm strap is configured to attach to a left side of the CID (Figures 1 and 7; Col. 4, lines 59-67).
Regarding claim 6, Lerman discloses wherein the front collar further comprises: first and second lateral collar projections (18) integrally attached to opposing upper ends of the chest brace, the first and second lateral collar projections extending vertically upwards therefrom (Figure 1); wherein the first and second lateral collar projections are configured to adjustably attached to the first and second lateral head supports to adjust a distance between the headband and the front collar (Col. 4, lines 17-42).
Regarding claim 7, Lerman discloses a plurality of headband adjustment tabs (64) positioned vertically on the first and second lateral head supports; and a plurality of headband adjustment thru-holes (holes in 60 accommodating 64) positioned vertically on the first and second lateral collar projections, wherein the headband adjustment thru-holes are sized to receive the headband adjustment tabs; wherein one or more of the plurality of headband adjustment tabs mate with one or more of the plurality of headband adjustment thru-holes to provide an adjustable connection between the first and second lateral head supports and the first and second lateral collar projections respectively to enable the adjustment of the distance between the headband and the front collar (Figures 1-2; Col. 5, lines 48-59).
Regarding claim 8, Lerman discloses a plurality of headband adjustment tabs (60 including 64) positioned vertically on the first and second lateral collar projections (Figure 1); and a plurality of headband adjustment thru-holes (holes accommodating fasteners 64) positioned vertically on the first and second lateral head supports (Figure 1-2), wherein the headband adjustment thru-holes are sized to receive the headband adjustment tabs (Figures 1-2; Col. 5, lines 48-59); wherein one or more of the plurality of headband adjustment tabs mate with one or more of the plurality of headband adjustment thru-holes to provide an adjustable connection between the first and second lateral head supports and the first and second lateral collar projections respectively to enable the adjustment of the distance between the headband and the front collar (Figures 1-2; Col. 5, lines 48-59).
Regarding claim 9, Lerman discloses a chin brace (70) removably attached to opposing sides of the front collar (Figures 1-2, insofar as the whole device is attached together); wherein the chin brace is configured to provide additional support to immobilize the patient, when the CID is being worn by the patient (Figures 1-2; Col. 5, lines 60-67); and wherein the chin brace is configured to be the sole component of the CID required to be removed from the CID to enable the patient to be intubated while wearing the CID (Figures 1-2; Col. 5, lines 60-67).
Regarding claim 10, Lerman discloses wherein the chin brace is pivotally and adjustably attached to opposing sides of the front collar, to enable a pivot angle between the chin brace and the front collar to be adjusted (Figures 1-4; Col. 5 line 60 to Col. 6, line 25).
Regarding claim 13, Lerman discloses a cervical immobilization device (CID) (Figures 1-2), comprising: a front collar comprising: a chest brace (10) configured to extend downward from both shoulders of a patient and rest against a chest of the patient (Figure 1; Col. 4, lines 43-57); an adjustable headband (headband 80 of halo 14) configured to strap around a forehead of the patient (Figures 1-2; Col. 6, lines 39-50); first and second lateral head supports (68 of rigid frame 16, Figure 2) configured to attach and extend vertically downward from the headband, the first and second lateral head supports configured to form a rigid connection to the front collar (Figures 1-2; Col. 4, lines 17-42); a chin brace (70) removably attached to opposing sides of the front collar (Figures 1-2, insofar as the whole device is attached together); wherein the chin brace is configured to provide additional support to immobilize the patient, when the CID is being worn by the patient (Figures 1-2; Col. 5, lines 60-67); and wherein the chin brace is configured to be the sole component of the CID required to be removed from the CID to enable the patient to be intubated while wearing the CID (Figures 1-2; Col. 5, lines 60-67).
Regarding claim 14, Lerman discloses wherein the chin brace is pivotally and adjustably attached to opposing sides of the front collar, to enable a pivot angle between the chin brace and the front collar to be adjusted (Figures 1-4; Col. 5 line 60 to Col. 6, line 25).
Regarding claim 16, Lerman discloses wherein and first and second underarm straps (34, 36) each having first and second ends, wherein: the first ends are configured to attach to opposing sides of the chest brace below the patient's shoulders, and the second ends are configured to attach to opposing sides of the CID above the patient's shoulders when the CID is worn by the patient (Figures 1 and 7; Col. 4, lines 59-67), and wherein the first and second underarm straps are configured to extend under and abut against a floor of the patient's armpits when the CID is worn by the patient (Figures 1 and 7; Col. 4, lines 59-67).
Regarding claim 17, Lerman discloses wherein: the first end of the first underarm strap is configured to attach to a left side of the chest brace and the second end of the first underarm strap is configured to attach to a right side of the CID; and the first end of the second underarm strap is configured to attach to a right side of the chest brace and the second end of the second underarm strap is configured to attach to a left side of the CID (Figures 1 and 7; Col. 4, lines 59-67).
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.
Claims 5, 11-12, 13, 15, 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Lerman (US 6,368,295 B1) in view of Cowart et al (US 2024/0252339 A1).
Regarding claims 5, 13, and 18, Lerman wherein the front collar further comprises: first and second pieces (at 26) integrally attached to opposing upper ends of the chest brace that extend in a direction toward the shoulders (Figure 1) but does not disclose the first and second pieces are shoulder pieces configured to project over and rest upon the shoulders of the patient to support the front collar thereon. Coward teaches a cervical collar having first and second shoulder pieces (upper ends of 101) configured to project over and rest upon the shoulders of the patient to support the front collar thereon ([0031], Figure 1). It would have been obvious to one of ordinary skill in the art at the time of filing to provide the pieces of Lerman wherein they are shoulder pieces configured to project over and rest upon the shoulders as taught by Cowart for more evenly distributing the weight of the devices.
Regarding claim 11, Lerman discloses that as applied above but does not disclose wherein the chin brace further comprises first and second forked chin brace end portions, each forked chin brace end portion comprising: a first pivoting chin brace extension pivotally and removably attached to the front collar; and a second adjusting chin brace extension adjustably and removably attached to the front collar. Cowart teaches a cervical collar wherein a chin brace (102) further comprises first and second forked chin brace end portions (211a, 211b), each forked chin brace end portion comprising: a first pivoting chin brace extension pivotally and removably attached to the front collar (portion accommodating 531a,b; Figures 2a and 7c); and a second adjusting chin brace extension (portion having slot 414a, b; Figures 2a, 7c) adjustably and removably attached to the front collar (Figures 2a and 7c; [0034], [0049]). It would have been obvious to one of ordinary skill in the art at the time of filing to provide the device of Lerman having the teachings of Cowart so that the chin support can easily be adjusted.
Regarding claims 12 and 15, Lerman does not disclose each first pivoting chin brace extension includes one of a first tab or a first thru-hole, which is configured to mate with the other of the first tab or the first thru-hole positioned on the front collar, wherein the first tab is configured to pivot within the first thru-hole to enable the chin brace to pivot relative to the front collar; and each second adjusting chin brace extension includes one of a plurality second tabs or a plurality of second thru-holes, which are configured to mate with the other of the plurality of second tabs or the plurality of second thru-holes positioned on the front collar, wherein one or more of the plurality of second tabs mate with one or more of the plurality of second thru-holes to provide an adjustable connection between the second adjusting chin brace extensions and the front collar to enable adjustment of the pivot angle between the chin brace and the front collar.
Cowart teaches each first pivoting chin brace extension (portion accommodating 531a,b; Figure 7c) includes one of a first tab or a first thru-hole (422a,b), which is configured to mate with the other of the first tab or the first thru-hole (531a,b) positioned on the front collar (101) wherein the first tab is configured to pivot within the first thru-hole to enable the chin brace to pivot relative to the front collar ([0034], [0049]); and each second adjusting chin brace extension includes one of a second tab or a second thru-hole (414a, b), which are configured to mate with the other of the second tab or the second thru-hole positioned on the front collar (434a,b; Figures 7b-c), wherein one or more of the second tabs mate with one or more of the second thru-holes to provide an adjustable connection between the second adjusting chin brace extensions and the front collar to enable adjustment of the pivot angle between the chin brace and the front collar ([0034], [0049]). It would have been obvious to one of ordinary skill in the art at the time of filing to provide the device of Lerman having the teachings of Cowart so that the chin support can easily be adjusted. Furthermore, It would have been obvious to one of ordinary skill in the art at the time of filing to provide multiple holes/tabs instead of one since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8.
Regarding claim 19, note the rejection of claims 1, 4 and 6. Lerman does not disclose wherein the front collar further comprises: first and second pieces (at 26) integrally attached to opposing upper ends of the chest brace that extend in a direction toward the shoulders (Figure 1) but does not disclose the first and second pieces are shoulder pieces configured to project over and rest upon the shoulders of the patient to support the front collar thereon. Coward teaches a cervical collar having first and second shoulder pieces (upper ends of 101) configured to project over and rest upon the shoulders of the patient to support the front collar thereon ([0031], Figure 1). It would have been obvious to one of ordinary skill in the art at the time of filing to provide the pieces of Lerman wherein they are shoulder pieces configured to project over and rest upon the shoulders as taught by Cowart for more evenly distributing the weight of the devices.
Regarding claim 20, Lerman discloses a chin brace (70) removably attached to opposing sides of the front collar (Figures 1-2, insofar as the whole device is attached together); wherein the chin brace is configured to provide additional support to immobilize the patient, when the CID is being worn by the patient (Figures 1-2; Col. 5, lines 60-67); and wherein the chin brace is configured to be the sole component of the CID required to be removed from the CID to enable the patient to be intubated while wearing the CID (Figures 1-2; Col. 5, lines 60-67).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
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/KARI K RODRIQUEZ/Primary Patent Examiner, Art Unit 3786