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 6/2/2026, to claims 1, 11, 13, 19 acknowledged by Examiner.
Claims 1-20 are now pending.
Response to Arguments
Applicant's arguments filed 6/2/2026 have been fully considered but they are not persuasive. Applicant asserts that Kelly does not provide for supporting a patient from below their head. Examiner disagrees. Kelly provides wherein the helmet 14 (Fig. 1-10) is of close and ergonomic fit to the head of the user enabling supporting of the head therein and recites “The helmet 14 can optionally be of the type having mandibular protection” and “each of these features are intended to retain the cranium of a wearer as closely and as comfortably possible” (Col. 14 lines 15-28), wherein the mandible of the head is on a lower underside thereof, where the helmet being of such close fit and the helmet capable of extending below the patient’s head as seen in Fig. 2 and 4 would provide thus for the helmet being able to provide support to a head placed thereon from under/below the head. Also furthermore, helmet is configured to support the patient head from below the patient head due to being connected to the arm 34 which extends under the head as shown in Fig. 1-6 (wherein the arm 34 provides support between the upper collar 14 and lower collar 12 for thus supporting the head as shown) thus providing support from below the head via this configuration attachment.
Applicant’s arguments with respect to claim(s) 1-20 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. New references have been applied below to some of the argued amended language. See updated rejection below.
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'.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 4-18, 20 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 4 recites “pitching movement… in a sagittal plane” wherein claim 1 as amended also recites “a pitching range of movement in a sagittal plane” wherein as written there is a lack clarity and proper antecedent basis as written. For interpretation purposes, will be read as the same pitching movement in sagittal plane.
Claims 5, 7 rejected as being dependent on claim 4.
Claim 6 recites “during pitching movement” wherein it is unclear if this is the same as “the pitching movement” of claims 4 and 5 or different. Will be interpreted as the same.
Claim 8 recites “a vertical range of movement in a frontal plane” wherein claim 1 as amended also recites “a vertical range of motion in a frontal plane” wherein it is unclear if these are the same thing being that motion and movement are synonyms or if they are somehow different vertical ranges in the same or different frontal planes. For interpretation purposes, will be both read as the same vertical range of movement/motion in the same frontal plane.
Claim 9 recites “during vertical movement” wherein claim 8 already provides “vertical movement”. Thus there is a lack of clarity if this is the same vertical movement or a new vertical movement. Will be interpreted as the same.
Claims 10 recites “limit vertical movement” wherein claim 8 already provides “vertical movement”. Thus there is a lack of clarity if this is the same vertical movement or a new vertical movement. Will be interpreted as the same.
Claim 12 recites the limitation "the pitching movement". There is insufficient antecedent basis for this limitation in the claim.
Claims 13, 15, 18 rejected as being dependent on claim 12.
Claims 14 recites “during pitching movement” wherein it is unclear if this is the same as “the pitching movement” of claim 12 or different. Will be interpreted as the same.
Claim 16 recites the limitation "the pitching range of movement". There is insufficient antecedent basis for this limitation in the claim.
Claim 17 recites “a vertical range of movement in a frontal plane” wherein claim 11 as amended now recites “movement… in a frontal plane” wherein as written there is now a lack of clarity and proper antecedent basis for the frontal plane in claim 17 being the same or different frontal plane as claimed in claim 11. For interpretation purposes, they will be read as the same frontal plane.
Claim 20 recites “the arm includes stops” in line 1; however, claim 19 as amended recites “first adjustable stops… second adjustable stops… third adjustable stops” wherein there is a lack of clarity if the “stops” in claim 20 are the same or different from these “stops” in claim 19. Examiner will interpret them as generally the same.
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 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kelly (US 5930843 A) in further view of LoGuercio (US 20220062018 A1) and Gorsen (US 4827915 A).
Regarding claim 1, Kelly discloses an adjustable orthosis 10 (Fig. 1-9, title helmet and shoulder harness for cervical spine protection thus being an orthosis) comprising:
a lower collar 12 configured to rest on a patient torso (Fig. 1, shoulder harness 12);
an upper collar 14 configured to support a patient head and constrain movement of a patient cervical spine (Fig. 1, helmet 14, Col. 4 lines 15-28, helmet/upper collar 14 is of close and ergonomic fit with head such that it is supporting the head; see Fig. 7 wherein there are limit stops 48b for constraining the head tilt of the head and thus cervical spine, see Fig. 8 wherein ends 64 of the track 62 constrain the total amount of cervical spine rotation);
an arm 34 extending between the lower collar 12 and the upper collar 14 (Fig. 1-3), the arm 34 supporting the upper collar 14 at an elevated position with respect to the lower collar 12 (Fig. 1-3); and
the arm 34 enables movement of the upper collar 14 with respect to the lower collar 12 through a rotational range of movement in a transverse plane (Fig. 1 and 8, the arm 34 slides in the track 58 enabling rotational movement between the two in a transverse plane), a pitching range of movement in a sagittal plane (Fig. 2-7, the arm 34 has pivoting movement in the sagittal plane thereof).
Kelly does not disclose wherein the arm enables vertical movement through a vertical range of motion in a frontal plane.
However, LoGuercio teaches an analogous pivot assembly 13 (Fig. 6A, [0020]), having analogous first and second blocks 94/95 for limiting a range of movement and abutting an analogous third block 102 (Fig. 6A and [0018, 0046]), the third block 102 forming an analogous base plate 102 attached to an analogous strut 20 and analogous upper collar 30 (Fig. 1A), having further an analogous lower collar 50 (Fig. 1A), analogous post 51 (Fig. 1A, 5B) pivotally connected to the base plate 102 and analogous strut 20 (Fig. 1A, 6A),
wherein the arm (post 51 and strut 20) enables vertical movement of the upper collar 30 with respect to the lower collar 50 through a vertical range of movement in a frontal plane (Fig. 4C and [0036] the arm length being a vertical movement forward/away from the pivot point, may be adjusted),
the strut 20 includes a channel 26 (Fig. 4C-4D, there is a channel that receives a rail 96);
the base plate 102 includes a rail 91 fit into the channel 26 (Fig. 4C-4D, 7A, [0036]);
wherein, during vertical movement of the upper collar 30 with respect to the lower collar 50, the rail 91 of the base plate 102 slides within the channel 26 of the strut 20 (Fig. 4C-4D, 7A [0036]); and
the post 51 is coupled to the base plate 102 by the analogous inner and outer plates 94/95 (Fig. 5A-5C, inner and outer plates 94/95 have analogous first and second blocks therein), such that movement of the base plate 102 with respect to the strut 20 imparts movement of the post 51 with respect to the strut 20 (Fig. 6A, as the base plate 102 is moved vertically relative to the strut 20, the post 52 thus also moves relative to the strut 20 therein),
stops 100 carried by the base plate 102 which confront the strut 20 to limit vertical movement of the upper collar 30 with respect to the lower collar 50 to within a defined range (Fig. 4C and [0036] the slots 100 function as slots on the base plate 102/rail 91 which locks in the vertical position therein thus limiting within a distinct defined range when locked, the strut 20 contains tooth 34 which locks into slots/stops 100).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the pivot assembly of Kelly to have the vertical movement adjustment structures thus providing vertical movement through a vertical range of motion in a frontal plane as taught by LoGuercio in order to enable the pivot assembly to be better adjusted to the user, wherein Kelly would benefit from improved vertical adjustability by making the vertical distance between the helmet 14 and shoulder harness 12 adjustability thus fitting better to the user (LoGuercio [0036]).
Kelly does not disclose the lower collar comprising first and second lower shells coupled to each other for separation from each other to allow the lower collar to be donned by a patient; the upper collar comprising first and second upper shells coupled to each other for separation from each other to allow the upper collar to be donned by the patient.
However, Gorsen teaches an analogous cervical spine collar (title) (Fig. 1-6) comprising an analogous lower collar 13/15 and an analogous upper collar 12/14 (Fig. 1-6), wherein the lower collar 13/15 comprising first (13) and second (15) lower shells (13/15) coupled to each other (Fig. 1-6) for separation from each other to allow the lower collar to be donned by a patient (Fig. 1-6, Col. 1 lines 11-27 and Col. 2 lines 60-65, the two halves 13/15 of the lower collar may be separated and attached for the donning of the lower collar onto the patient);
the upper collar 12/14 comprising first (12) and second (14) upper shells 12/14 coupled to each other (Fig. 1-6) for separation from each other to allow the upper collar to be donned by the patient (Fig. 1-6, Col. 1 lines 11-27 and Col. 2 lines 60-65, the two halves 12/14 of the upper collar may be separated and attached for the donning of the upper collar onto the patient).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the upper and lower collars of Kelly to comprise first and second shells coupled to each other for separation from each other to allow the upper/lower collar to be donned by a patient as taught by Gorsen in order to provide increased adjustability and faster donning of the invention (Gorsen Col. 2 lines 60-65 and Fig. 1-6).
Regarding claim 2, Kelly in view of LoGuercio and Gorsen discloses the invention of claim 1 above.
Kelly further discloses a track 58 formed in the lower collar 12 (Fig. 1 and 8), the track 58 having opposed first and second ends (Fig. 1 and 8, there are ends therein);
wherein the arm 58 is carried in the track 58 for movement through the rotational range of movement between the first and second ends of the track (Fig. 1-8).
Regarding claim 3, Kelly in view of LoGuercio and Gorsen discloses the invention of claim 2 above.
Kelly further discloses first and second stops 64 applicable to the track 58 (Fig. 9 and Col. 5 line 66 – Col. 6 line 8, first and second stops 64 may be applied to the track 58) such that, when the first and second stops 64 are applied to the track 58 between the first and second ends, the first and second stops 64 limit the rotational range of movement to between the first and second stops 64 (Fig. 9, Col. 5 line 66 – Col. 6 line 8, the stops 64 limit the side to side rotational range and may be recessed into the track channel itself thus providing stops between the first and second ends of the track).
Regarding claim 4, Kelly in view of LoGuercio and Gorsen discloses the invention of claim 1 above.
Kelly further discloses wherein the arm 34 further enables pitching movement of the upper collar 14 with respect to the lower collar 12 through a range of movement in a sagittal plane (Fig. 2-7, the arm 34 has pivoting movement in the sagittal plane thereof).
Claim(s) 5-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kelly (US 5930843 A) in further view of LoGuercio (US 20220062018 A1) and Gorsen (US 4827915 A) in view of Gilmour (US 20030199798 A1).
Regarding claims 5-7, Kelly in view of LoGuercio and Gorsen discloses the invention of claim 4 above.
Kelly further discloses a post 34 coupled to the lower collar 12 (Fig. 1-3); a strut 20 coupled to the upper collar 14 (Fig. 1-3); a spindle 28 defining an axis of rotation for the pitching movement (Fig. 1-3, the bolt 28 extends therethrough forming an axis of rotation), wherein the spindle 28 is fixed with respect to the strut 20 (Fig. 2, the bolt 28 attaches to a nut 22 in the strut 20, Col. 4 line 66 – Col. 5 line 11); the post 34 is mounted for rotation on the spindle 28 with respect to the strut 20 (Fig. 1-3).
Kelly does not disclose an inner plate mounted for rotation on the spindle; an outer plate mounted for rotation on the spindle (claim 5);
the inner plate has a first set of teeth and a block outboard of the first set of teeth; the outer plate has a second set of teeth engaged with the first set of teeth, and a second block outboard of the second set of teeth; and the post has a third set of teeth engaged with the second set of teeth (claim 6),
the spindle is carried on a base plate, and the base plate includes a third block; and during pitching movement, the base plate rotates on the strut with respect to the post, and the third block moves between the first and second blocks, wherein the first and second blocks confront the third block to limit rotational movement of the base plate and the strut with respect to the post (claim 7).
However, Gilmour teaches an analogous pivoting joint (Fig. 1-5), having an analogous post 11 (Fig. 1 and [0031]) and an analogous strut 4 (Fig. 1 and [0036]), an analogous spindle 12 (Fig. 1 and [0032] enabling analogous rotational movement between the post 11 and strut 4), wherein there is further an inner plate 21 mounted for rotation on the spindle 12 (Fig. 1, [0034] rotatable about the annular member 11 on the post which is in rotatable attachment to the spindle 12 thus indirectly mounted for rotation on the spindle 12);
an outer plate 20 mounted for rotation on the spindle 12 ((Fig. 1, [0034] rotatable about the annular member 11 on the post which is in rotatable attachment to the spindle 12 thus indirectly mounted for rotation on the spindle 12);
the inner plate 21 has a first set of teeth 32 (Fig. 1-5) and a block 26 outboard of the first set of teeth 32 (Fig. 1-5);
the outer plate 20 has a second set of teeth 31 engaged with the first set of teeth 32 (Fig. 1-5, the teeth 31 and the teeth 32 mate with the teeth 30 on the post 11, thus the first and second teeth 31/32 indirectly engage with each other, [0035]), and a second block 25 outboard of the second set of teeth 31 (Fig. 1-5); and
the post 11 has a third set of teeth 30 engaged with the second set of teeth 31 (Fig. 1 and [0035]),
the spindle 12 is carried on a base plate (Fig. 1, the lower end of the arm 4 is the base plate therein), and the base plate includes a third block 40 (Fig. 1); and during pitching movement, the base plate rotates on the strut 4 with respect to the post 11 (Fig. 1, base plate being the lower end of the strut 4 thus rotates with/on strut 4 as it rotates as well), and the third block 40 moves between the first and second blocks 25/26 (Fig. 1 and [0034, 0036]), wherein the first and second blocks 25/26 confront the third block 40 to limit rotational movement of the base plate and the strut 4 with respect to the post 11 (Fig. 1 and [0036]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the joint of Kelly having static limits of rotation (best seen in Fig. 7) to have the adjustable limits of rotation of the analogous pivot joint of Gilmour in order to provide improved adjustability to the invention of Kelly (Gilmour Fig. 1-5 and [0001-0007]).
Regarding claims 8-10, Kelly in view of LoGuercio and Gorsen and Gilmour discloses the invention of claim 5-7 above.
Kelly does not disclose wherein the arm enables vertical movement of the upper collar with respect to the lower collar through a vertical range of movement in a frontal plane (claim 8), the strut includes a channel; the base plate includes a rail fit into the channel; wherein, during vertical movement of the upper collar with respect to the lower collar, the rail of the base plate slides within the channel of the strut; and the post is coupled to the base plate by the inner and outer plates, such that movement of the base plate with respect to the strut imparts movement of the post with respect to the strut (claim 9), stops carried by the base plate which confront the strut to limit vertical movement of the upper collar with respect to the lower collar to within a defined range (claim 10).
However, LoGuercio (as combined in claim 1 as well) teaches an analogous pivot assembly 13 (Fig. 6A, [0020]), having analogous first and second blocks 94/95 for limiting a range of movement and abutting an analogous third block 102 (Fig. 6A and [0018, 0046]), the third block 102 forming an analogous base plate 102 attached to an analogous strut 20 and analogous upper collar 30 (Fig. 1A), having further an analogous lower collar 50 (Fig. 1A), analogous post 51 (Fig. 1A, 5B) pivotally connected to the base plate 102 and analogous strut 20 (Fig. 1A, 6A),
wherein the arm (post 51 and strut 20) enables vertical movement of the upper collar 30 with respect to the lower collar 50 through a vertical range of movement in a frontal plane (Fig. 4C and [0036] the arm length being a vertical movement forward/away from the pivot point, may be adjusted),
the strut 20 includes a channel 26 (Fig. 4C-4D, there is a channel that receives a rail 96);
the base plate 102 includes a rail 91 fit into the channel 26 (Fig. 4C-4D, 7A, [0036]);
wherein, during vertical movement of the upper collar 30 with respect to the lower collar 50, the rail 91 of the base plate 102 slides within the channel 26 of the strut 20 (Fig. 4C-4D, 7A [0036]); and
the post 51 is coupled to the base plate 102 by the analogous inner and outer plates 94/95 (Fig. 5A-5C, inner and outer plates 94/95 have analogous first and second blocks therein), such that movement of the base plate 102 with respect to the strut 20 imparts movement of the post 51 with respect to the strut 20 (Fig. 6A, as the base plate 102 is moved vertically relative to the strut 20, the post 52 thus also moves relative to the strut 20 therein),
stops 100 carried by the base plate 102 which confront the strut 20 to limit vertical movement of the upper collar 30 with respect to the lower collar 50 to within a defined range (Fig. 4C and [0036] the slots 100 function as slots on the base plate 102/rail 91 which locks in the vertical position therein thus limiting within a distinct defined range when locked, the strut 20 contains tooth 34 which locks into slots/stops 100).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the pivot assembly of Kelly to have the vertical movement adjustment structures as taught by LoGuercio in order to enable the pivot assembly to be better adjusted to the user, wherein Kelly would benefit from improved vertical adjustability by making the vertical distance between the helmet 14 and shoulder harness 12 adjustability thus fitting better to the user (LoGuercio [0036]).
Claim(s) 11, 12, 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kelly (US 5930843 A) in further view of Yu (US 20070209667 A1).
Regarding claim 11, Kelly discloses an adjustable orthosis 10 (Fig. 1-9, title helmet and shoulder harness for cervical spine protection thus being an orthosis) comprising:
a lower collar 12 configured to rest on a patient torso (Fig. 1, shoulder harness 12);
an upper collar 14 comprising a posterior shell configured to support a patient head from behind the patient head (Fig. 1, helmet 14, Col. 4 lines 15-28, helmet/upper collar 14 is of close and ergonomic fit with head such that it is supporting the head, see Annotated Fig. 1, wherein the back of the helmet 14 being a posterior shell may support the back of the head);
the posterior shell extending from a base thereof (See Annotated Fig. 1, wherein the helmet 14 has a lower end being a “base” where the back/posterior shell of the helmet 14 extends upwardly from there),
and an other shell (See Annotated Fig. 1, wherein the front extending portion of the helmet is the “other shell” therein), the other shell integrally formed to the posterior shell (See Annotated Fig. 1) and extending forwardly from the posterior shell along the base thereof (See Annotated Fig. 1), wherein the other shell of the upper collar 14 is vertically spaced apart from the lower collar 12 (See Annotated Fig. 1);
an arm 34 extending between the lower collar 12 and the upper collar 14 (Fig. 1-3), the arm 34 supporting the upper collar 14 at an elevated position with respect to the lower collar 12 (Fig. 1-3); and
wherein the arm 34 further enables movement of the upper collar 14 with respect to the lower collar 12 through a range of movement in at least one of a transverse plane, a sagittal plane, and a frontal plane (Fig. 2-7, the arm 34 has pivoting movement in the sagittal plane thereof).
Kelly does not explicitly recite the other shell configured to support the patient head from below the patient head.
However, Kelly provides wherein the helmet 14 (Fig. 1-10) is of close and ergonomic fit to the head of the user enabling supporting of the head therein and recites “The helmet 14 can optionally be of the type having mandibular protection” and “each of these features are intended to retain the cranium of a wearer as closely and as comfortably possible” (Col. 14 lines 15-28), wherein the mandible of the head is on a lower underside thereof, where the helmet being of such close fit and the helmet capable of extending below the patient’s head as seen in Fig. 2 and 4 would provide thus for the helmet being able to provide support to a head placed thereon from under/below the head. Also furthermore, the other shell is configured to support the patient head from below the patient head due to being connected to the arm 34 which extends under the head as shown in Fig. 1-6 (wherein the arm 34 provides support between the upper collar 14 and lower collar 12 for thus supporting the head as shown) thus providing support from below the head via this configuration attachment.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have known that the helmet 14 other shell (Annotated Fig. 1) would be configured to support the patient head from below the patient head as the close fit of the helmet and mandibular protection thereof would be able to thus be supporting the helmet from below the patient head (Kelly Col. 14 lines 15-28) as well as the other shell connecting to the arm 34 which extends beneath the head and provides support for the head therein (Fig. 1-6).
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Kelly does not disclose the posterior shell terminating at an open top of the posterior shell.
However, Yu teaches an analogous helmet 10 (Fig. 1-3) comprising an analogous posterior shell 12 (Fig. 3A-3B) terminating at an open top 14 of the posterior shell 12 (Fig. 3A-3B and [0044]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the posterior shell of Kelly to terminate at an open top of the posterior shell as taught by Yu in order to provide ventilation in the head helmet/restrainer (Yu [0044]).
Regarding claim 12, Kelly in view of Yu discloses the invention of claim 11 above.
Kelly further discloses the arm 34 comprises: a post 34 coupled to the lower collar 12 (Fig. 1-3);
a strut 20 coupled to the upper collar 14 (Fig. 1-3);
a spindle 28 carried on the strut 20 (Fig. 2, the bolt 28 attaches to a nut 22 in the strut 20, Col. 4 line 66 – Col. 5 line 11);
the spindle 28 defining an axis of rotation for the pitching movement (Fig. 1-3, the bolt 28 extends therethrough forming an axis of rotation), the post 34 is mounted for rotation on the spindle 28 with respect to the strut 20 (Fig. 1-3).
Regarding claim 16, Kelly in view of Yu discloses the invention of claim 11 above.
Kelly further discloses a pitch assembly in the arm 34 (Fig. 7); and
first and second stops 24b applicable to the arm 34 (Fig. 7, there are first and second stops being first and second ends of receptacle 34b the limit the pitch rotation of the arm) such that, when the stops 34b are applied to the pitch assembly, the stops limit the pitching range of movement to between the first and second stops (Fig. 7, the ends of receptacle 34b will abut the ends of the insert 24b thus restricting the motion of the pitch between those stop ends relative to the insert 24b surfaces).
Claim(s) 13-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kelly (US 5930843 A) in further view of Yu (US 20070209667 A1) in view of Gilmour (US 20030199798 A1).
Regarding claims 13-14, Kelly discloses the invention of claim 12 above.
Kelly does not disclose inner and outer plates between the post and the strut;
the inner plate has a first set of teeth and a block outboard of the first set of teeth; the outer plate has a second set of teeth engaged with the first set of teeth, and a second block outboard of the second set of teeth; and the post has a third set of teeth engaged with the second set of teeth (claim 13),
a base plate including a third block; and during pitching movement, the base plate rotates on the strut with respect to the post, and the third block moves between the first and second blocks, wherein the first and second blocks confront the third block to limit rotational movement of the base plate and the strut with respect to the post (claim 14).
However, Gilmour teaches an analogous pivoting joint (Fig. 1-5), having an analogous post 11 (Fig. 1 and [0031]) and an analogous strut 4 (Fig. 1 and [0036]), an analogous spindle 12 (Fig. 1 and [0032] enabling analogous rotational movement between the post 11 and strut 4), wherein there is further an inner and outer plates 21/20 between the post 11 and strut 4 (Fig. 1, when all combined, the plates 20 and 21 will be between the outer most side of the post 11 and the strut 4);
an inner plate 21 has a first set of teeth 32 (Fig. 1-5) and a block 26 outboard of the first set of teeth 32 (Fig. 1-5);
an outer plate 20 has a second set of teeth 31 engaged with the first set of teeth 32 (Fig. 1-5, the teeth 31 and the teeth 32 mate with the teeth 30 on the post 11, thus the first and second teeth 31/32 indirectly engage with each other, [0035]), and a second block 25 outboard of the second set of teeth 31 (Fig. 1-5); and
the post 11 has a third set of teeth 30 engaged with the second set of teeth 31 (Fig. 1 and [0035]),
a base plate (Fig. 1, the lower end of the arm 4 is the base plate therein) includes a third block 40 (Fig. 1), wherein during pitching movement, the base plate rotates on the strut 4 with respect to the post 11 (Fig. 1, base plate being the lower end of the strut 4 thus rotates with/on strut 4 as it rotates as well), and the third block 40 moves between the first and second blocks 25/26 (Fig. 1 and [0034, 0036]), wherein the first and second blocks 25/26 confront the third block 40 to limit rotational movement of the base plate and the strut 4 with respect to the post 11 (Fig. 1 and [0036]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the joint of Kelly having static limits of rotation (best seen in Fig. 7) to have the adjustable limits of rotation of the analogous pivot joint of Gilmour in order to provide improved adjustability to the invention of Kelly (Gilmour Fig. 1-5 and [0001-0007]).
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kelly (US 5930843 A) in view of Yu (US 20070209667 A1) in view of Nace (US 20090137935 A1).
Regarding claims 15, Kelly in view of Yu discloses the invention of claim 12 above.
Kelly does not disclose bands extending between the post and the strut, the bands imparting a bias therebetween.
However, Nace teaches an analogous pivot assembly (Fig. 1 and 5A) having an analogous strut 32 and post 28 forming an arm being a pivot joint (Fig. 1 and 5A), wherein there are bands 60 extending between the post 28 and the strut 32 (Fig. 1 and 5A, [0038] elastic bands 60, figures show one instance of the elastic band 60 but there are “various elastic bands” for placement thus plural bands), the bands 60 imparting a bias therebetween ([0038, 0045] the elastic bands 60 impart a bias within the pivot joint such that the joint will return to a neutral position and improve alignment of the pivot joint with the user).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have provided the elastic bands 60 as taught by pivot assembly of Nace to the joint/pivot assembly arm 34 of Kelly in order to provide an improved joint that would align the user’s head and shoulders into alignment when not flexing the neck of the user (Nace [0038, 0045]).
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kelly (US 5930843 A) in view of Yu (US 20070209667 A1) in view of Andrews (US 4825476 A).
Regarding claims 17, Kelly in view of Yu discloses the invention of claim 12 above.
Kelly does not disclose the arm enables vertical movement of the upper collar with respect to the lower collar through a vertical range of movement in a frontal plane.
However, Andrews teaches an analogous helmet assembly (Fig. 1-14) having an analogous upper collar 1 (Fig. 2) and lower collar 4 (Fig. 1 and 2) having an analogous arm 6/7 (Fig. 2) for mating the upper and lower collars together, wherein as shown the arm 6/7 forms a vertical channel (Fig. 2 and 7 and Col. 2 lines 47-64) that enables vertical movement of the upper collar with respect to the lower collar through a vertical range of movement in a frontal plane (Col. 3 lines 32-45, up and down movement enabled).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have provided the assembly of Kelly with the construction of Andrews to enable vertical movement while still absorbing impact forces (Andrews Col. 3 lines 32-45).
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kelly (US 5930843 A) in further view of Yu (US 20070209667 A1) in view of Gilmour (US 20030199798 A1), in further view of LoGuercio (US 20220062018 A1).
Regarding claim 18, Kelly in view of Gilmour discloses the invention of claim 14 above.
Kelly in view of Gilmour does not disclose the strut includes a channel; the base plate includes a rail fit into the channel; wherein, during vertical movement of the upper collar with respect to the lower collar, the rail of the base plate slides within the channel of the strut; and the post is coupled to the base plate by the inner and outer plates, such that movement of the base plate with respect to the strut imparts movement of the post with respect to the strut.
However, LoGuercio teaches an analogous pivot assembly 13 (Fig. 6A, [0020]), having analogous first and second blocks 94/95 for limiting a range of movement and abutting an analogous third block 102 (Fig. 6A and [0018, 0046]), the third block 102 forming an analogous base plate 102 attached to an analogous strut 20 and analogous upper collar 30 (Fig. 1A), having further an analogous lower collar 50 (Fig. 1A), analogous post 51 (Fig. 1A, 5B) pivotally connected to the base plate 102 and analogous strut 20 (Fig. 1A, 6A),
wherein the arm (post 51 and strut 20) enables vertical movement of the upper collar 30 with respect to the lower collar 50 through a vertical range of movement in a frontal plane (Fig. 4C and [0036] the arm length being a vertical movement forward/away from the pivot point, may be adjusted),
the strut 20 includes a channel 26 (Fig. 4C-4D, there is a channel that receives a rail 96);
the base plate 102 includes a rail 91 fit into the channel 26 (Fig. 4C-4D, 7A, [0036]);
wherein, during vertical movement of the upper collar 30 with respect to the lower collar 50, the rail 91 of the base plate 102 slides within the channel 26 of the strut 20 (Fig. 4C-4D, 7A [0036]); and
the post 51 is coupled to the base plate 102 by the analogous inner and outer plates 94/95 (Fig. 5A-5C, inner and outer plates 94/95 have analogous first and second blocks therein), such that movement of the base plate 102 with respect to the strut 20 imparts movement of the post 51 with respect to the strut 20 (Fig. 6A, as the base plate 102 is moved vertically relative to the strut 20, the post 52 thus also moves relative to the strut 20 therein).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the pivot assembly of Kelly as combined with Gilmour to have the vertical movement adjustment structures as taught by LoGuercio in order to enable the pivot assembly to be better adjusted to the user, wherein Kelly would benefit from improved vertical adjustability by making the vertical distance between the helmet 14 and shoulder harness 12 adjustability thus fitting better to the user (LoGuercio [0036]).
Claim(s) 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kelly (US 5930843 A) in further view of LoGuercio (US 20220062018 A1) in view of Gilmour (US 20030199798 A1).
Regarding claim 19, Kelly discloses an adjustable orthosis 10 (Fig. 1-9, title helmet and shoulder harness for cervical spine protection thus being an orthosis) comprising:
a lower collar 12 configured to rest on a patient torso (Fig. 1, shoulder harness 12);
an upper collar 14 configured to support a patient head from behind the patient head (Fig. 1, helmet 14 supports a back of the head as shown);
an arm 34 extending between the lower collar 12 and the upper collar 14 (Fig. 1-3), the arm 34 supporting the upper collar 14 at an elevated position with respect to the lower collar 12 (Fig. 1-3) to bias the patient head away from the lower collar (Fig. 1-6, the arm 34 biases the upper collar 14 and lower collar 12 from each other, wherein Col. 14 lines 15-28 provides for the helmet/upper collar 14 have a close fit to retain the head in the helmet, thus the inner material of the helmet 14 holds the head inside and thus is also biased away from the lower collar 12); and
wherein the arm 34 enables movement of the upper collar with respect to the lower collar through a rotational range of movement in a transverse plane (Fig. 1 and 8, the arm 34 slides in the track 58 enabling rotational movement between the two in a transverse plane), through a pitching range of movement in a sagittal plane (Fig. 2-7, the arm 34 has pivoting movement in the sagittal plane thereof);
first adjustable stops limiting the movement within the rotational range (Fig. 9 and Col. 5 line 66 – Col. 6 line 8, first and second stops 64 may be applied to the track 58 which enables the rotational range of motion, stops/caps 64 are removable by screws and thus may be said to be adjustable through removal of the stops);
second stops limiting the movement within the pitching range (Fig. 7, the ends of receptacle 34b will abut the ends of the insert 24b thus restricting the motion of the pitch between those stop ends relative to the insert 24b surfaces being the second adjustable stops therein).
Kelly does not explicitly recite the upper collar configured to support below the patient head.
However, Kelly provides wherein the helmet 14 (Fig. 1-10) is of close and ergonomic fit to the head of the user enabling supporting of the head therein and recites “The helmet 14 can optionally be of the type having mandibular protection” and “each of these features are intended to retain the cranium of a wearer as closely and as comfortably possible” (Col. 14 lines 15-28), wherein the mandible of the head is on a lower underside thereof, where the helmet being of such close fit and the helmet capable of extending below the patient’s head as seen in Fig. 2 and 4 would provide thus for the helmet being able to provide support to a head placed thereon from under/below the head. Also furthermore, helmet is configured to support the patient head from below the patient head due to being connected to the arm 34 which extends under the head as shown in Fig. 1-6 (wherein the arm 34 provides support between the upper collar 14 and lower collar 12 for thus supporting the head as shown) thus providing support from below the head via this configuration attachment.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have known that the helmet 14 would be configured to support the patient head from below the patient head as the close fit of the helmet and mandibular protection thereof would be able to thus be supporting the helmet from below the patient head (Kelly Col. 14 lines 15-28) as well as the other shell connecting to the arm 34 which extends beneath the head and provides support for the head therein (Fig. 1-6).
Kelly does not disclose wherein the arm enables vertical movement through a vertical range of motion in a frontal plane and third adjustable stops limiting the movement within the vertical range.
However, LoGuercio teaches an analogous pivot assembly 13 (Fig. 6A, [0020]), having analogous first and second blocks 94/95 for limiting a range of movement and abutting an analogous third block 102 (Fig. 6A and [0018, 0046]), the third block 102 forming an analogous base plate 102 attached to an analogous strut 20 and analogous upper collar 30 (Fig. 1A), having further an analogous lower collar 50 (Fig. 1A), analogous post 51 (Fig. 1A, 5B) pivotally connected to the base plate 102 and analogous strut 20 (Fig. 1A, 6A),
wherein the arm (post 51 and strut 20) enables vertical movement of the upper collar 30 with respect to the lower collar 50 through a vertical range of movement in a frontal plane (Fig. 4C and [0036] the arm length being a vertical movement forward/away from the pivot point, may be adjusted),
the strut 20 includes a channel 26 (Fig. 4C-4D, there is a channel that receives a rail 96);
the base plate 102 includes a rail 91 fit into the channel 26 (Fig. 4C-4D, 7A, [0036]);
wherein, during vertical movement of the upper collar 30 with respect to the lower collar 50, the rail 91 of the base plate 102 slides within the channel 26 of the strut 20 (Fig. 4C-4D, 7A [0036]); and
the post 51 is coupled to the base plate 102 by the analogous inner and outer plates 94/95 (Fig. 5A-5C, inner and outer plates 94/95 have analogous first and second blocks therein), such that movement of the base plate 102 with respect to the strut 20 imparts movement of the post 51 with respect to the strut 20 (Fig. 6A, as the base plate 102 is moved vertically relative to the strut 20, the post 52 thus also moves relative to the strut 20 therein),
stops 100 carried by the base plate 102 which confront the strut 20 to limit vertical movement of the upper collar 30 with respect to the lower collar 50 to within a defined range (Fig. 4C and [0036] the slots 100 function as slots on the base plate 102/rail 91 which locks in the vertical position therein thus limiting within a distinct defined range when locked, the strut 20 contains tooth 34 which locks into slots/stops 100) (being “third adjustable stops limiting movement within the vertical range” as they enable adjustment of the vertical position thus being “adjustable” stops).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the pivot assembly of Kelly to have the vertical movement adjustment structures thus providing vertical movement through a vertical range of motion in a frontal plane as taught by LoGuercio in order to enable the pivot assembly to be better adjusted to the user, wherein Kelly would benefit from improved vertical adjustability by making the vertical distance between the helmet 14 and shoulder harness 12 adjustability thus fitting better to the user (LoGuercio [0036]).
Kelly does not disclose the second stops are adjustable stops.
However, Gilmour teaches an analogous pitching pivoting joint (Fig. 1-5), an analogous spindle 12 for pitching rotational movement (Fig. 1 and [0032] enabling analogous pitching rotational movement between the post 11 and strut 4), wherein there is further an inner plate 21 mounted for rotation on the spindle 12 (Fig. 1, [0034] rotatable about the annular member 11 on the post which is in rotatable attachment to the spindle 12 thus indirectly mounted for rotation on the spindle 12);
the spindle 12 is carried on a base plate (Fig. 1, the lower end of the arm 4 is the base plate therein), and the base plate includes a third block 40 (Fig. 1); and during pitching movement, the base plate rotates on the strut 4 with respect to the post 11 (Fig. 1, base plate being the lower end of the strut 4 thus rotates with/on strut 4 as it rotates as well), and the third block 40 moves between the first and second blocks/stops 25/26 (Fig. 1 and [0034, 0036], these first and second blocks 25/26 being adjustable stops for the pitching range as they may be moved and adjusted), wherein the first and second blocks 25/26 confront the third block 40 to limit rotational movement of the base plate and the strut 4 with respect to the post 11 (Fig. 1 and [0036]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the joint of Kelly having static limits of rotation (best seen in Fig. 7) to have the adjustable limits/stops of rotation of the analogous pivot joint of Gilmour in order to provide improved adjustability to the invention of Kelly (Gilmour Fig. 1-5 and [0001-0007]).
Regarding claim 20, Kelly in view of LoGuercio and Gilmour discloses the invention of claim 19 above.
Kelly further discloses wherein the arm 34 includes stops 64 to limit the range of movement of the upper collar within a defined range (Fig. 8-9, stops 64 limit the rotational movement thereof in a defined range between the stops 64).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 20040128744 A1 (split lower collar)
US 20130036538 A1 (split lower collar)
US 3756226 A (split collar)
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.
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/KEVIN S ALBERS/Patent Examiner, Art Unit 3786
/RACHAEL E BREDEFELD/Supervisory Patent Examiner, Art Unit 3786
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