Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Information Disclosure Statement
1. The information disclosure statement (IDS) submitted on 12/16/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, this submission of the information disclosure statement is being considered by the examiner.
Response to Amendment
2. The amendment filed 12/14/2025 has been entered. Currently, claims 1-14, 16, 18, and 20-24 remain pending in the application. Independent claim 1, claim 4, and new claims 21-24 were amended by the Applicant without the addition of new matter to include further narrowing limitations. Additionally, the abstract was amended to overcome previous specification objections and the dependent claims 15, 17, 19 were cancelled and claims 3-12 and 20 were amended to correct previous claim objections that were set forth in the Non-Final Office Action mailed 09/23/2025. Lastly, new drawing objections, claim objections, and 35 USC 112(B) rejections are recited below.
Response to Arguments
3. Applicant’s amendment to independent claim 1 and 4 is sufficient to overcome the previous 35 USC § 102 and 35 USC § 102 rejection recited in the Non-Final Office Action mailed 09/23/2025.
Applicant’s arguments, see Remarks on Page 3, filed 12/14/2025, with respect to the rejection under 35 USC § 102 and 35 USC § 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, the amended claims have changed the scope of the claims and upon further consideration, a new grounds of rejection is made in view of new and current prior art of the record: Stamper et al. (U.S. Patent Pub. No. 20020151831), Mollo (U.S. Patent No. 4632099), Bode (U.S. Patent No. 5195947), Eastman et al. (U.S. Patent No. 4765317), and Moore (U.S. Patent No. 5063920).
4. Applicant makes the argument that “Bode applies force transfer to the shoulders and not below a cervical region of a spine” (Remarks, Page 2).
In response to Applicant’s argument (Remarks, Page 2), Bode is no longer applied to teach the features of the thoracic-lumbar-sacral orthosis without the shoulder interpretation so Applicant’s argument is moot. Nonetheless, Bode’s rod do attach to the vest at a location closer to the chest such that some force is transferred below on the vest even though other force is also transferred to the shoulders. However, a person’s shoulders, especially when non-shrugged, are configurable positionally below a c7 cervical spinal joint in the apparatus/non-method claims.
5. Overall, Examiner notes that Applicant may further amend the claims to overcome the prior art below by reciting positive limitations such as the –the expansion spring above the horizontal rail to connect with the overhead bar—and/or any differences in the actuator rotation for the spring. Furthermore, any negative limitation such as –not—or –without—recited in the claim may help distinguish from the prior art. Lastly, transitional phrases such as –consisting—in the preamble/body would prevent potential combinations of prior art.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “horizontal rails” in claims 22-24 must be numerically shown or the feature(s) canceled from the claim(s). Additionally, the “thoracic-lumbar-sacral orthosis” second support is not numerically labeled and instead described as the “support connection assembly” rods 110. Ensure proper labeling and description of these claimed structure in the drawing and specification. No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 7 and 21 are objected to because of the following informalities:
In claim 7, line 3 rephrase “them” to read --the--.
In claim 21, rephrase “the system” to read –the halo intrinsic traction system--.
In claim 22, rephrase “the coupler” to read --the rotatable coupler--.
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitations are: “support connection assembly” in claim 4; and “multi-positioning assembly” in claim 21.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. Terms such as “assembly” followed by functional language are generic placeholder for the phrase “means for”. For examination purposes, “support connection assembly” in claim 4 is interpreted as the orthosis uprights (Specification, Paragraph 51) ; and “multi-positioning assembly” in claim 21 is interpreted as overhead bar, anterior-posterior block, rail interface, horizontal rails, anterior-posterior positioner hardware, rotatable coupler, and bottom mount (Specification, Paragraph 47).
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 3-8, 11, 13 and 24 are 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.
Regarding claims 3 and 13, the limitation “wherein: the actuator comprises: a first end in communication with the first support; and a second end in communication with the second support and the spring applies the expansion force pushing the first end away from the second end” is unclear. Although Specification Paragraph 41 and Figure 4A label these first ends 405 and second end 410 of the actuator, these ends in embodiment of Figure 1A and 4B are shown as a superior end 405 which is connected to a superior overhead bar and the inferior end 410 that is connected to an AP block/rail rail/rotatable coupler/mount/and halo first member. Thus, only the inferior end 410 of the actuator in Figure 4A is shown as being in communication with the first support halo in Figures 1A/4B, but the superior end 405 is never shown to be in communication with the second support back orthosis. Therefore, this limitation is unclear from the embodiments of Figure 1A and 4A-4B, unless Applicant is trying to a claim a different embodiment that is never shown and contradictory to the current embodiment as claimed.
Claim 4, lines 10 and 12 recites the limitation "the location". There is insufficient antecedent basis for this limitation in the claim. Rephrase to read --a location--.
Regarding claim 24, the limitation wherein “the overhead bar is further configured to be positioned parallel to the horizontal rails and perpendicular to the rotatable coupler” is unclear. Although explained in Paragraph 47 as the rotatable coupler being vertical/parallel to gravity with half dowel in semi-circular hole of AP block 465, this exact structure is also not shown or numerically labeled. Either way Applicant’s Figures 1A and 4A-4B show horizontal rails oriented in anterior to posterior direction that received the vertical orthosis rods (labeled as 110 in Figure 1A, although that labeling is incorrect as given by drawing objection above). Then the overhead bar 460 is actually shown as oriented in a medial to lateral direction, which is still perpendicular to an anterior posterior axis even though both are on the same horizontal plane. For examination purposes, rephrase “overhead bar is further configured to be positioned parallel to the horizontal rails and perpendicular to the rotatable coupler” to read -overhead bar is further configured to be positioned on same plane as the horizontal rails perpendicular to a plane of the rotatable coupler--.
Claims 5-8 and 11 are rejected for being dependent on an indefinite claim.
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.
Claims 1-14, 16, 18, and 20, as best understood given by the 35 USC 112(B) above, are rejected under 35 U.S.C. 103 as being unpatentable over Stamper et al. (U.S. Patent Pub. No. 20020151831) in view of Mollo (U.S. Patent No. 4632099) and in further view of Bode (U.S. Patent No. 5195947).
Regarding claim 1, Stamper discloses a halo intrinsic traction system 30 (Paragraph 60 and Figure 4, HIT 30 with horizontal bracket 42 receiving a superior end of the orthosis rods 40 and the vertical bracket 42 connecting the horizontal bracket to the halo 32. The inferior ends of the orthosis rods 40 are on the chest and back vest 44,46, extending over the patient’s back including at least the thoracic and lumbar regions thereby forming at least a thoracic-lumbar orthosis 44,46) comprising: a first support 32 configured to attach to a head portion of a patient; a second support 44,46 configured to attach to a body portion of a patient, the body portion being below a cervical region of a spine of the patient (Paragraph 60 and Figure 4, chest and back vest 44,46, thereby forming at least a thoracic-lumbar orthosis 44,46 below spinal joint c7); and a positioning assembly 42, 42 (Paragraph 60 and Figure 4, horizontal rail 42 and vertical mount 42).
However, Stamper fails to explicitly disclose (1) a spring assembly comprising at least a first spring, the spring assembly positioned superior to the first support and configured to generate an expansion force between the first and second supports; (2) the spring assembly is part of an actuation assembly comprising a first actuator.
Mollo teaches an analogous halo intrinsic traction system 10 (Col. 3, lines 1-35 and Figures 1-2, HIT 10 with first support halo wrapping around head/chin 80 as well as second support thoracic -lumbar -sacral orthosis 30,28,46,48,60,62. Frames 15,16 extend from the halo 80 to the back orthosis 30,28,46,48,60,62. These frames 15,16 at a superior point connect to a horizontal rail 96,98 that then connects to a springs 86,88 that connect to a vertical mount 82,84. These springs 86,88 pull a user’s head superiorly from above) comprising a spring assembly 86,88 comprising at least a first spring 86 , the spring assembly 86,88 positioned superior to the analogous first support 80 and configured to generate an expansion force between the analogous first 80 and analogous second supports 30,28,46,48,60,62.
It would have been obvious for a person having ordinary level of skill in the art before the effective filing date of the claimed invention to modify a positioning assembly of Stamper (modifying the vertical bracket mount 42 connected to the halo 32 as well as the horizontal rail bracket 42 receiving the orthosis rods 40 of Stamper to include a spring positioned therebetween, as taught by the spring 86,88 positioned between the horizontal rail 96,98 and a vertical mount 82,84 of the head halo 80 of Mollo), so that there is a spring assembly comprising a first spring positioned superior to the first support and configured to generate an expansion force between the first and second supports, as taught by Mollo, in order to provide an improved halo intrinsic traction system with a spring pulling the user’s head superiorly from above to provide the traction force for desirable therapy (Mollo, Col. 3, lines 1-35)
However, the combination of Stamper in view of Mollo fails to explicitly disclose (2) the spring assembly is part of an actuation assembly comprising a first actuator.
Bode teaches an analogous halo intrinsic traction system 20 (Col. 2, lines 39-60, Col. 3, lines 61-66, Col. 4, lines 11-40 and Figs. 1 and 3-5, halo intrinsic traction device 20 with first head support 22 and second body vest support 24 with left/first and right/second side body actuators 32,40,50,52, each comprising rods 26 with biasing expansion spring 50 providing counteracting upward force via the annular shoulder 56 of the insert 52 which applies an upward force on the halo 22 at connection point 62 with the halo with respect to the connection point 30 of the actuator with the second body vest support 24. Adjustment of the expansion force is provided by rotating sleeve 40 incrementally relative to scale 58 of insert 52 and locking in place via anti-tampering lock clamp 32 and pinch bolts 64) wherein the analogous spring assembly 50 is part of an actuation assembly 32,40,50,52,58 (Col. 2, lines 39-60, Col. 3, lines 61-66, Col. 4, lines 11-40 and Figs. 1 and 3-5, left/first and right/second side body actuators 32,40,50,52, each comprising rods 26 with biasing expansion spring 50 providing counteracting upward force via the annular shoulder 56 of the insert 52 which applies an upward force on the halo 22 at connection point 62 with the halo with respect to the connection point 30 of the actuator with the second body vest support 24. Adjustment of the expansion force is provided by rotating sleeve 40 incrementally relative to scale 58 of insert 52 and locking in place via anti-tampering lock clamp 32 and pinch bolts 64) comprising a first actuator 32,40,50,52,58.
It would have been obvious for a person having ordinary level of skill in the art before the effective filing date of the claimed invention to modify the spring assembly (Modifying the spring 86,88 between the halo first support 32 and horizontal rail 42 of Stamper in view of Mollo to be within an adjustable actuation assembly with a rotatable lock and scale as taught by Bode) of Stamper in view of Mollo, so that the spring is part of an actuation assembly comprising a first actuator, as taught by Bode, in order to provide an improved halo intrinsic traction system with an enhanced spring operation adjustable via a lock and scale actuation assembly for desirable incremental tension adjustment of the spring therein for desirable controlled therapy (Bode, Col. 2, lines 39-60, Col. 3, lines 61-66, Col. 4, lines 11-40).
Regarding claim 2, the combination of Stamper in view of Mollo in view of Bode discloses the invention as described above and further discloses wherein: the second support 44,46 (Stamper, Paragraph 60 and Figure 4, chest and back vest 44,46, extending over the patient’s back including at least the thoracic and lumbar regions thereby forming at least a thoracic-lumbar orthosis 44,46) comprises a thoracic-lumbar orthosis (TLO) 44,46; and the first actuator (Stamper, Paragraph 60 and Figure 4, rods 40 contacting the horizontal rail 42 and connected to orthosis 44,46. Horizontal rail 42 connected to vertical mount 42 to connect to halo 32; Mollo, Col. 3, lines 1-35 and Figures 1-2, springs 86,88 pull a user’s head superiorly from above to generate expansion force wherein the inferior end of the springs 86,88 connect to a vertical mount 82,84 that then attach to halo 80. The superior end of the springs 86,88 further connect to a horizontal rail 96,98; Bode, Col. 2, lines 39-60, Col. 3, lines 61-66, Col. 4, lines 11-40, spring 50 part of actuator32,40,50,52,58 generate adjustable actuated expansion force) comprises a spring (Mollo, Col. 3, lines 1-35 and Figures 1-2, springs 86,88 pull a user’s head superiorly from above to generate expansion force; Bode, Col. 2, lines 39-60, Col. 3, lines 61-66, Col. 4, lines 11-40, spring 50 part of actuator32,40,50,52,58 generate expansion force) configured to generate the expansion force.
Although Stamper discloses various suitable ways of making and using the support structure 36 with the vest 44,46 and alternative embodiments for the support structure 36 of the vest 44,46 are well known, the combination of Stamper in view of Mollo in view of Bode fails to explicitly disclose thoracic-lumbar orthosis includes a sacral orthosis part forming a thoracic-lumbar-sacral orthosis (TLSO).
Mollo further teaches the analogous thoracic-lumbar orthosis 30,28,46,48,60,62 (Col. 3, lines 1-35 and Figures 1-2, thoracic -lumbar -sacral orthosis 30,28,46,48,60,62 extends across back and below hips without going over shoulders near the cervical spine)includes a sacral orthosis part forming a thoracic-lumbar-sacral orthosis (TLSO) 30,28,46,48,60,62 (Col. 3, lines 1-35 and Figures 1-2, thoracic -lumbar -sacral orthosis 30,28,46,48,60,62) without crossing over a patient’s shoulder.
It would have been obvious for a person having ordinary level of skill in the art before the effective filing date of the claimed invention to modify the thoracic-lumbar orthosis second support of Stamper in view of Mollo in view of Bode, to include a sacral orthosis that forms a thoracic -lumbar-sacral orthosis without crossing over a patient’s shoulder, as taught by Mollo, in order to provide an improved halo intrinsic traction system forming an enhanced orthosis with traction forces traveling even more inferiorly into the hip/sacrum for desirable therapy (Mollo, Col. 3, lines 1-35)
Regarding claim 3, the combination of Stamper in view of Mollo in view of Bode discloses the invention as described above and further discloses wherein: the first actuator (Mollo, Col. 3, lines 1-35 and Figures 1-2, springs 86,88 pull a user’s head superiorly from above to generate expansion force; Bode, Col. 2, lines 39-60, Col. 3, lines 61-66, Col. 4, lines 11-40, spring 50 part of actuator 32,40,50,52,58 generate expansion force) comprises: a first end (Mollo: Col. 3, lines 1-35 and Figures 1-2, inferior end of springs 86,88 in communication with halo 80 so as to pull a user’s head superiorly from above to generate expansion force; Bode, Col. 2, lines 39-60, Col. 3, lines 61-66, Col. 4, lines 11-40, spring 50 part of actuator32,40,50,52,58 generate expansion force) in communication with the first support 32 (Stamper, Paragraph 60 and Figure 4, halo ring 32); and a second end (Mollo: Col. 3, lines 1-35 and Figures 1-2, superior end of springs 86,88 in communication with horizontal rail 96,98, orthosis frames 15,16, and back orthosis 30,28,46,48,60,62 so as to pull a user’s head superiorly from above to generate expansion force) in communication with the second support (Stamper: 44,46 ; Mollo: 30,28,46,48,60,62 ), and the spring (Mollo, Col. 3, lines 1-35 and Figures 1-2, springs 86,88 pull a user’s head superiorly from above to generate expansion force; Bode, Col. 2, lines 39-60, Col. 3, lines 61-66, Col. 4, lines 11-40, spring 50 part of actuator32,40,50,52,58 generate expansion force) applies the expansion force pushing the first end away from the second end.
Regarding claim 4, Stamper discloses a halo intrinsic traction system 30 (Paragraph 60 and Figure 4, HIT 30 with horizontal bracket 42 receiving a superior end of the orthosis rods 40 and the vertical bracket 42 connecting the horizontal bracket to the halo 32. The inferior ends of the orthosis rods 40 are on the chest and back vest 44,46, extending over the patient’s back including at least the thoracic and lumbar regions thereby forming at least a thoracic-lumbar orthosis 44,46) comprising: a first support 32 configured to attach to a head portion of a patient; a second support 44,46 configured to attach to a body portion of a patient, the body portion being below a cervical region of a spine of the patient (Paragraph 60 and Figure 4, chest and back vest 44,46, thereby forming at least a thoracic-lumbar orthosis 44,46 below spinal joint c7); a support connection assembly 40 configured to physically connect the first 32 and second supports 44,46; and a positioning assembly 42, 42 (Paragraph 60 and Figure 4, horizontal rail 42 and vertical mount 42).
However, Stamper fails to explicitly disclose (1) a spring assembly positioned superior to the first support and configured to generate an expansion force between the first and second supports; wherein: the location of the spring assembly is such that the expansion force is transferred to the first support from above the first support; the location of the second support provides for transfer of the expansion force below the cervical region of the spine; and the spring assembly comprises a first spring; (2) the spring assembly is part of an actuation assembly comprising a first actuator comprising an adjustment actuator configured to adjust a magnitude of the expansion force between the first and second supports.
Mollo teaches an analogous halo intrinsic traction system 10 (Col. 3, lines 1-35 and Figures 1-2, HIT 10 with first support halo wrapping around head/chin 80 as well as second support thoracic -lumbar -sacral orthosis 30,28,46,48,60,62. Frames 15,16 extend from the halo 80 to the back orthosis 30,28,46,48,60,62. These frames 15,16 at a superior point connect to a horizontal rail 96,98 that then connects to a springs 86,88 that connect to a vertical mount 82,84. These springs 86,88 pull a user’s head superiorly from above) comprising a spring assembly 86,88 positioned superior to the analogous first support 80 and configured to generate an expansion force between the analogous first 80 and analogous second supports 30,28,46,48,60,62.; wherein: a location of the spring assembly 86,88 is such that the expansion force is transferred to the first support 80 from above the first support 80; a location of the second support 30,28,46,48,60,62 (Col. 3, lines 1-35 and Figures 1-2, thoracic -lumbar -sacral orthosis 30,28,46,48,60,62 extends across back and below hips without going over shoulders near the cervical spine) without crossing over a patient’s shoulder provides for transfer of the expansion force below the cervical region of the spine; and the spring assembly 86,88comprises a first spring86.
It would have been obvious for a person having ordinary level of skill in the art before the effective filing date of the claimed invention to modify a positioning assembly of Stamper (modifying the vertical bracket mount 42 connected to the halo 32 as well as the horizontal rail bracket 42 receiving the orthosis rods 40 of Stamper to include a spring positioned therebetween, as taught by the spring 86,88 positioned between the horizontal rail 96,98 and a vertical mount 82,84 of the head halo 80 of Mollo), so that there is a spring assembly positioned superior to the first support and configured to generate an expansion force between the first and second supports; wherein: the location of the spring assembly is such that the expansion force is transferred to the first support from above the first support; the location of the second support provides for transfer of the expansion force below the cervical region of the spine; and the spring assembly comprises a first spring, as taught by Mollo, in order to provide an improved halo intrinsic traction system with a spring pulling the user’s head superiorly from above to provide the traction force for desirable therapy (Mollo, Col. 3, lines 1-35)
Additionally, it would have been obvious for a person having ordinary level of skill in the art before the effective filing date of the claimed invention to modify the second support of Stamper, such that a location of the second support without crossing over a patient’s shoulder provides for transfer of the expansion force below the cervical region of the spine , as taught by Mollo, in order to provide an improved halo intrinsic traction system forming an enhanced orthosis with traction forces traveling even more inferiorly into the hip/sacrum for desirable therapy (Mollo, Col. 3, lines 1-35)
However, the combination of Stamper in view of Mollo fails to explicitly disclose (2) the spring assembly is part of an actuation assembly comprising a first actuator comprising an adjustment actuator configured to adjust a magnitude of the expansion force between the first and second supports.
Bode teaches an analogous halo intrinsic traction system 20 (Col. 2, lines 39-60, Col. 3, lines 61-66, Col. 4, lines 11-40 and Figs. 1 and 3-5, halo intrinsic traction device 20 with first head support 22 and second body vest support 24 with left/first and right/second side body actuators 32,40,50,52, each comprising rods 26 with biasing expansion spring 50 providing counteracting upward force via the annular shoulder 56 of the insert 52 which applies an upward force on the halo 22 at connection point 62 with the halo with respect to the connection point 30 of the actuator with the second body vest support 24. Adjustment of the expansion force is provided by rotating sleeve 40 incrementally relative to scale 58 of insert 52 and locking in place via anti-tampering lock clamp 32 and pinch bolts 64) wherein the analogous spring assembly 50 is part of an actuation assembly 32,40,50,52,58 (Col. 2, lines 39-60, Col. 3, lines 61-66, Col. 4, lines 11-40 and Figs. 1 and 3-5, left/first and right/second side body actuators 32,40,50,52, each comprising rods 26 with biasing expansion spring 50 providing counteracting upward force via the annular shoulder 56 of the insert 52 which applies an upward force on the halo 22 at connection point 62 with the halo with respect to the connection point 30 of the actuator with the second body vest support 24. Adjustment of the expansion force is provided by rotating sleeve 40 incrementally relative to scale 58 of insert 52 and locking in place via anti-tampering lock clamp 32 and pinch bolts 64) comprising a first actuator 32,40,50,52,58 comprising an adjustment actuator 32,40,50,52,58 (Col. 2, lines 39-60, Col. 3, lines 61-66, Col. 4, lines 11-40 and Figs. 1 and 3-5, adjustment of the expansion force is provided by rotating sleeve 40 incrementally relative to scale 58 of insert 52 and locking in place via respective locking and unlocking positions of anti-tampering lock clamp 32 and anti-tampering lock pinch bolts 64) configured to adjust a magnitude of the analogous expansion force between the analogous first 22 and analogous second supports 24.
It would have been obvious for a person having ordinary level of skill in the art before the effective filing date of the claimed invention to modify the spring assembly (Modifying the spring 86,88 between the halo first support 32 and horizontal rail 42 of Stamper in view of Mollo to be within an adjustable actuation assembly with a rotatable lock and scale as taught by Bode) of Stamper in view of Mollo, so that the spring is part of an actuation assembly comprising a first actuator comprising an adjustment actuator configured to adjust a magnitude of the expansion force between the first and second supports, as taught by Bode, in order to provide an improved halo intrinsic traction system with an enhanced spring operation adjustable via a lock and scale actuation assembly for desirable incremental tension adjustment of the spring therein for desirable controlled therapy (Bode, Col. 2, lines 39-60, Col. 3, lines 61-66, Col. 4, lines 11-40).
Regarding claim 5, the combination of Stamper in view of Mollo in view of Bode discloses the invention as described above and further discloses wherein the adjustment actuator 32,40,50,52,58 (Bode, Col. 2, lines 39-60, Col. 3, lines 61-66, Col. 4, lines 11-40 ) is moveable between a plurality of positions 58 (Bode, Col. 2, lines 39-60, Col. 3, lines 61-66, Col. 4, lines 11-40 and Figs. 1 and 3-5, adjustment of the expansion force is provided by rotating sleeve 40 incrementally relative to scale 58 of insert 52 and locking in place via anti-tampering lock clamp 32 and pinch bolts 64), each position corresponding to a different magnitude of the expansion force between the first 32 (Stamper, Paragraph 60 and Figure 4, halo ring 32)and second (Stamper: 44,46 ; Mollo: 30,28,46,48,60,62 )supports.
Regarding claim 6, the combination of Stamper in view of Mollo in view of Bode discloses the invention as described above and further discloses wherein: the first actuator 32,40,50,52,58 (Bode, Col. 2, lines 39-60, Col. 3, lines 61-66, Col. 4, lines 11-40, adjustment of the expansion force is provided by rotating sleeve 40 incrementally relative to scale 58 of insert 52 and locking in place via respective locking and unlocking positions of anti-tampering lock clamp 32 and anti-tampering lock pinch bolts 64) comprises an anti-tampering lock 32,64 (Bode, Col. 2, lines 39-60, Col. 3, lines 61-66, Col. 4, lines 11-40) configured to transition between a locked and an unlocked position; and the adjustment actuator 32,40,50,52,58 is moveable between the plurality of positions only when the anti-tampering lock is in the unlocked position.
Regarding claim 7, the combination of Stamper in view of Mollo in view of Bode discloses the invention as described above and further discloses wherein each of the plurality of positions 58 (Bode, Col. 2, lines 39-60, Col. 3, lines 61-66, Col. 4, lines 11-40 and Figs. 1 and 3-5, adjustment of the expansion force is provided by rotating sleeve 40 incrementally relative to scale 58 of insert 52 and locking in place via anti-tampering lock clamp 32 and pinch bolts 64) corresponds to a predetermined fixed incremental change in the magnitude of the expansion force between the first 32 (Stamper, Paragraph 60 and Figure 4, halo ring 32)and second (Stamper: 44,46 ; Mollo: 30,28,46,48,60,62 ) supports.
Regarding claim 8, the combination of Stamper in view of Mollo in view of Bode discloses the invention as described above and further discloses wherein: the actuation assembly 32,40,50,52,58 (Bode, Col. 2, lines 39-60, Col. 3, lines 61-66, Col. 4, lines 11-40) further comprises another actuator 32,40,50,52,58 (Stamper, Paragraph 60 and Figure 4, right side attachments 42 to halo; Mollo, Col. 3, lines 1-35 and Figures 1-2, right spring 88 pulls a user’s head superiorly from above to generate expansion force; Bode, Col. 2, lines 39-60, Col. 3, lines 61-66, Col. 4, lines 11-40, right spring 50 is part of right actuator32,40,50,52,58 generate expansion force), and the first actuator 32,40,50,52,58 (Stamper, Paragraph 60 and Figure 4, left side attachments 42 to halo; Mollo, Col. 3, lines 1-35 and Figures 1-2, left spring 86 pulls a user’s head superiorly from above to generate expansion force; Bode, Col. 2, lines 39-60, Col. 3, lines 61-66, Col. 4, lines 11-40, left spring 50 is part of left actuator32,40,50,52,58 generate expansion force) and the other actuators 32,40,50,52,58 are configured to generate differing expansion forces.
Regarding claim 9, the combination of Stamper in view of Mollo in view of Bode discloses the invention as described above. Stamper further discloses wherein the first support 32 Stamper, Paragraph 60 and Figure 4, halo head frame 32) comprises a halo member 32 configured to attach to the head portion of the patient.
Regarding claim 10, the combination of Stamper in view of Mollo in view of Bode discloses the invention as described above but fails to explicitly disclose wherein the halo member is coupled to the first actuator via a rotatable coupler, such that rotation of the rotatable coupler alters a direction of the expansion force applied to the first support relative to the second support.
Bode further teaches wherein the analogous halo member 22 (Col. 2, lines 39-60, Col. 3, lines 61-66, Col. 4, lines 11-40 and Figs. 1 and 3-5, halo worn head support 22 connected at first end 62 to actuator 32,40,50,52 via coupling member 60 that is adjusted three-dimensionally, including rotation along frontal axis, to secure the halo 22 to the support rods 26 and change angle of expansion force of spine and neck) is coupled to the first actuator32,40,50,52,58 (Col. 2, lines 39-60, Col. 3, lines 61-66, Col. 4, lines 11-40 and Figs. 1 and 3-5, left/first and right/second side body actuators 32,40,50,52, each comprising rods 26 with biasing expansion spring 50 providing counteracting upward force via the annular shoulder 56 of the insert 52 which applies an upward force on the halo 22 at connection point 62 with the halo with respect to the connection point 30 of the actuator with the second body vest support 24. Adjustment of the expansion force is provided by rotating sleeve 40 incrementally relative to scale 58 of insert 52 and locking in place via anti-tampering lock clamp 32 and pinch bolts 64) via a rotatable coupler 60, such that rotation of the rotatable coupler alters a direction of the analogous expansion force applied to the analogous first support 22 relative to the analogous second support 24.
It would have been obvious for a person having ordinary level of skill in the art before the effective filing date of the claimed invention to modify a position assembly coupling of the actuator assembly with the halo first support (Modifying a connection of the actuation assembly 32,40,50,52,58 with the superior spring 86,886 of Mollo on the vertical mount 42 of Stamper attached to the halo 32 of Stamper so that there is a rotatable coupler 60 of Bode attached to the halo and mount of the actuator/spring) of Stamper in view of Mollo in view of Bode, so the halo member is coupled to the first actuator via a rotatable coupler, such that rotation of the rotatable coupler alters a direction of the expansion force applied to the first support relative to the second support, as taught by Bode, in order to provide an improved halo intrinsic traction system with an enhanced positioning assembly actuator connection forming a multi-positioning assembly with the halo by allowing for rotatable three-dimensional adjustment across various axis for desirable adjustment during user activity (Bode, Col. 2, lines 39-60, Col. 3, lines 61-66, Col. 4, lines 11-40).
Regarding claim 11, the combination of Stamper in view of Mollo in view of Bode discloses the invention as described above and further discloses wherein: the first support 32 (Stamper, Paragraph 60 and Figure 4, halo ring 32) comprises a halo member 32 (Stamper, Paragraph 60 and Figure 4) configured to attach to the head portion of the patient; the support connection assembly 40(Stamper, Paragraph 60 and Figure 4, rods 40 contacting the horizontal rail 42 and connected to orthosis 44,46; Mollo, Col. 3, lines 1-35 and Figures 1-2, frames 15,16 contacting the horizontal rail 96,98 and connected to orthosis 30,28,46,48,60,62 without direct contact with the springs 86,88 that then extend downward from the horizontal rail 96,98 to the halo 80. Thereby, there is indirect contact through the horizontal rail 96,98 but not direct contact) comprises rods without direct contact with the actuation assembly (Stamper, Paragraph 60 and Figure 4, rods 40 contacting the horizontal rail 42 and connected to orthosis 44,46. Horizontal rail 42 connected to vertical mount 42 to connect to halo 32; Mollo, Col. 3, lines 1-35 and Figures 1-2, springs 86,88 pull a user’s head superiorly from above to generate expansion force wherein the inferior end of the springs 86,88 connect to a vertical mount 82,84 that then attach to halo 80. The superior end of the springs 86,88 further connect to a horizontal rail 96,98; Bode, Col. 2, lines 39-60, Col. 3, lines 61-66, Col. 4, lines 11-40, spring 50 part of actuator32,40,50,52,58 generate adjustable actuated expansion force); the actuation assembly further comprises a second actuator (Stamper, Paragraph 60 and Figure 4, right side attachments 42 to halo; Mollo, Col. 3, lines 1-35 and Figures 1-2, right spring 88 pulls a user’s head superiorly from above to generate expansion force; Bode, Col. 2, lines 39-60, Col. 3, lines 61-66, Col. 4, lines 11-40, right spring 50 is part of right actuator32,40,50,52,58 generate expansion force), ;the first actuator (Stamper, Paragraph 60 and Figure 4, left side attachments 42 to halo; Mollo, Col. 3, lines 1-35 and Figures 1-2, left spring 86 pulls a user’s head superiorly from above to generate expansion force; Bode, Col. 2, lines 39-60, Col. 3, lines 61-66, Col. 4, lines 11-40, left spring 50 is part of left actuator32,40,50,52,58 generate expansion force) is coupled to a first side of the halo member 32 (Stamper, Paragraph 60 and Figure 4, halo ring 32) and the second actuator is coupled to a second side of the halo member 32 (Stamper, Paragraph 60 and Figure 4).
Regarding claim 12, Stamper discloses a method (Paragraph 60 and Figure 4, method of wearing HIT 30 with horizontal bracket 42 receiving a superior end of the orthosis rods 40 and the vertical bracket 42 connecting the horizontal bracket to the halo 32. The inferior ends of the orthosis rods 40 are on the chest and back vest 44,46, extending over the patient’s back including at least the thoracic and lumbar regions thereby forming at least a thoracic-lumbar orthosis 44,46) of treating scoliosis and/or kyphosis in a patient in need thereof, the method comprising: attaching a first support 32to a head portion of a patient; attaching a second support 44,46 to a body portion of the patient, the body portion being below a cervical region of a spine of the patient (Paragraph 60 and Figure 4, chest and back vest 44,46, thereby forming at least a thoracic-lumbar orthosis 44,46 below spinal joint c7); and a positioning assembly 42, 42 (Paragraph 60 and Figure 4, horizontal rail 42 and vertical mount 42).
However, Stamper fails to explicitly disclose (1) a spring positioned superior to the first support, an expansion force transferred to the first support from above the first support, the expansion force between the first and second supports; (2) generating the expansion force with an actuator comprising the spring therein.
Mollo teaches an analogous halo intrinsic traction system 10 (Col. 3, lines 1-35 and Figures 1-2, HIT 10 with first support halo wrapping around head/chin 80 as well as second support thoracic -lumbar -sacral orthosis 30,28,46,48,60,62. Frames 15,16 extend from the halo 80 to the back orthosis 30,28,46,48,60,62. These frames 15,16 at a superior point connect to a horizontal rail 96,98 that then connects to a springs 86,88 that connect to a vertical mount 82,84. These springs 86,88 pull a user’s head superiorly from above) comprising a spring 86,88 positioned superior to the analogous first support 80, generating an expansion force transferred to the analogous first support from above the analogous first support 80, the expansion force between the analogous first 80 and analogous second supports 30,28,46,48,60,62.
It would have been obvious for a person having ordinary level of skill in the art before the effective filing date of the claimed invention to modify a positioning assembly of Stamper (modifying the vertical bracket mount 42 connected to the halo 32 as well as the horizontal rail bracket 42 receiving the orthosis rods 40 of Stamper to include a spring positioned therebetween, as taught by the spring 86,88 positioned between the horizontal rail 96,98 and a vertical mount 82,84 of the head halo 80 of Mollo), so that there is a spring positioned superior to the first support, generating an expansion force transferred to the first support from above the first support, the expansion force between the first and second supports, as taught by Mollo, in order to provide an improved halo intrinsic traction system with a spring pulling the user’s head superiorly from above to provide the traction force for desirable therapy (Mollo, Col. 3, lines 1-35).
However, the combination of Stamper in view of Mollo fails to explicitly disclose (2) generating the expansion force with an actuator comprising the spring therein.
Bode teaches an analogous halo intrinsic traction system 20 (Col. 2, lines 39-60, Col. 3, lines 61-66, Col. 4, lines 11-40 and Figs. 1 and 3-5, halo intrinsic traction device 20 with first head support 22 and second body vest support 24 with left/first and right/second side body actuators 32,40,50,52, each comprising rods 26 with biasing expansion spring 50 providing counteracting upward force via the annular shoulder 56 of the insert 52 which applies an upward force on the halo 22 at connection point 62 with the halo with respect to the connection point 30 of the actuator with the second body vest support 24. Adjustment of the expansion force is provided by rotating sleeve 40 incrementally relative to scale 58 of insert 52 and locking in place via anti-tampering lock clamp 32 and pinch bolts 64) comprises generating the analogous expansion force (Col. 2, lines 39-60, Col. 3, lines 61-66, Col. 4, lines 11-40 and Figs. 1 and 3-5, expansion force between halo 22 and vest 24) with an actuator 32,40,50,52,58 (Col. 2, lines 39-60, Col. 3, lines 61-66, Col. 4, lines 11-40 and Figs. 1 and 3-5, left/first and right/second side body actuators 32,40,50,52, each comprising rods 26 with biasing expansion spring 50 providing counteracting upward force via the annular shoulder 56 of the insert 52 which applies an upward force on the halo 22 at connection point 62 with the halo with respect to the connection point 30 of the actuator with the second body vest support 24. Adjustment of the expansion force is provided by rotating sleeve 40 incrementally relative to scale 58 of insert 52 and locking in place via anti-tampering lock clamp 32 and pinch bolts 64) comprising the analogous spring 50 therein.
It would have been obvious for a person having ordinary level of skill in the art before the effective filing date of the claimed invention to modify the expansion force spring (Modifying the spring 86,88 between the halo first support 32 and horizontal rail 42 of Stamper in view of Mollo to be within an adjustable actuation assembly with a rotatable lock and scale as taught by Bode) of Stamper in view of Mollo, so that the expansion force is generated with an actuator having the spring therein, as taught by Bode, in order to provide an improved halo intrinsic traction system with an enhanced spring operation adjustable via a lock and scale actuation assembly for desirable incremental tension adjustment of the spring therein for desirable controlled therapy (Bode, Col. 2, lines 39-60, Col. 3, lines 61-66, Col. 4, lines 11-40).
Regarding claim 13, the combination of Stamper in view of Mollo in view of Bode discloses the invention as described above and further discloses wherein: the first actuator (Mollo, Col. 3, lines 1-35 and Figures 1-2, springs 86,88 pull a user’s head superiorly from above to generate expansion force; Bode, Col. 2, lines 39-60, Col. 3, lines 61-66, Col. 4, lines 11-40, spring 50 part of actuator 32,40,50,52,58 generate expansion force) comprises: a first end (Mollo: Col. 3, lines 1-35 and Figures 1-2, inferior end of springs 86,88 in communication with halo 80 so as to pull a user’s head superiorly from above to generate expansion force; Bode, Col. 2, lines 39-60, Col. 3, lines 61-66, Col. 4, lines 11-40, spring 50 part of actuator32,40,50,52,58 generate expansion force) in communication with the first support 32 (Stamper, Paragraph 60 and Figure 4, halo ring 32); and a second end (Mollo: Col. 3, lines 1-35 and Figures 1-2, superior end of springs 86,88 in communication with horizontal rail 96,98, orthosis frames 15,16, and back orthosis 30,28,46,48,60,62 so as to pull a user’s head superiorly from above to generate expansion force) in communication with the second support (Stamper: 44,46 ; Mollo: 30,28,46,48,60,62 ), and the spring (Mollo, Col. 3, lines 1-35 and Figures 1-2, springs 86,88 pull a user’s head superiorly from above to generate expansion force; Bode, Col. 2, lines 39-60, Col. 3, lines 61-66, Col. 4, lines 11-40, spring 50 part of actuator32,40,50,52,58 generate expansion force) applies the expansion force pushing the first end away from the second end.
Regarding claim 14, the combination of Stamper in view of Mollo in view of Bode discloses the invention as described above and further discloses adjusting a magnitude (Bode, Col. 2, lines 39-60, Col. 3, lines 61-66, Col. 4, lines 11-40 and Figs. 1 and 3-5, adjustment of the expansion force is provided by rotating sleeve 40 incrementally relative to scale 58 of insert 52 and locking in place via anti-tampering lock clamp 32 and pinch bolts 64) of the expansion force (Stamper, Paragraph 60 and Figure 4, rods 40 contacting the horizontal rail 42 and connected to orthosis 44,46. Horizontal rail 42 connected to vertical mount 42 to connect to halo 32; Mollo, Col. 3, lines 1-35 and Figures 1-2, springs 86,88 pull a user’s head superiorly from above to generate expansion force wherein the inferior end of the springs 86,88 connect to a vertical mount 82,84 that then attach to halo 80. The superior end of the springs 86,88 further connect to a horizontal rail 96,98; Bode, Col. 2, lines 39-60, Col. 3, lines 61-66, Col. 4, lines 11-40, spring 50 part of actuator32,40,50,52,58 generate adjustable actuated expansion force)
Regarding claim 16, the combination of Stamper in view of Mollo in view of Bode discloses the invention as described above and further discloses wherein: the first actuator 32,40,50,52,58 (Bode, Col. 2, lines 39-60, Col. 3, lines 61-66, Col. 4, lines 11-40, adjustment of the expansion force is provided by rotating sleeve 40 incrementally relative to scale 58 of insert 52 and locking in place via respective locking and unlocking positions of anti-tampering lock clamp 32 and anti-tampering lock pinch bolts 64) comprises an anti-tampering lock 32,64 (Bode, Col. 2, lines 39-60, Col. 3, lines 61-66, Col. 4, lines 11-40) configured to transition between a locked and an unlocked position; and the adjustment actuator 32,40,50,52,58 is moveable between the plurality of positions only when the anti-tampering lock is in the unlocked position.
Regarding claim 18, the combination of Stamper in view of Mollo in view of Bode discloses the invention as described above and further discloses at least two different expansion forces (Bode, Col. 1, lines 54-55, Col. 2, lines 39-60, Col. 3, lines 61-66, Col. 4, lines 11-40: adjusting left and right actuator 32,40,50,52,58 with different output different expansion forces in order to balance the halo 22) with the actuator 32,40,50,52,58 (Stamper, Paragraph 60 and Figure 4, left side attachments 42 to halo; Mollo, Col. 3, lines 1-35 and Figures 1-2, left spring 86 pulls a user’s head superiorly from above to generate expansion force; Bode, Col. 2, lines 39-60, Col. 3, lines 61-66, Col. 4, lines 11-40, left spring 50 is part of left actuator32,40,50,52,58 generate expansion force) and another actuators 32,40,50,52,58 (Stamper, Paragraph 60 and Figure 4, right side attachments 42 to halo; Mollo, Col. 3, lines 1-35 and Figures 1-2, right spring 88 pulls a user’s head superiorly from above to generate expansion force; Bode, Col. 2, lines 39-60, Col. 3, lines 61-66, Col. 4, lines 11-40, right spring 50 is part of right actuator32,40,50,52,58 generate expansion force).
Regarding claim 20, the combination of Stamper in view of Mollo in view of Bode discloses the invention as described above but fails to explicitly disclose altering a direction of the expansion force.
Bode further teaches wherein the analogous halo member 22 (Col. 2, lines 39-60, Col. 3, lines 61-66, Col. 4, lines 11-40 and Figs. 1 and 3-5, halo worn head support 22 connected at first end 62 to actuator 32,40,50,52 via coupling member 60 that is adjusted three-dimensionally, including rotation along frontal axis, to secure the halo 22 to the support rods 26 and change angle of expansion force of spine and neck) is coupled to the actuator32,40,50,52,58 (Col. 2, lines 39-60, Col. 3, lines 61-66, Col. 4, lines 11-40 and Figs. 1 and 3-5, left/first and right/second side body actuators 32,40,50,52, each comprising rods 26 with biasing expansion spring 50 providing counteracting upward force via the annular shoulder 56 of the insert 52 which applies an upward force on the halo 22 at connection point 62 with the halo with respect to the connection point 30 of the actuator with the second body vest support 24. Adjustment of the expansion force is provided by rotating sleeve 40 incrementally relative to scale 58 of insert 52 and locking in place via anti-tampering lock clamp 32 and pinch bolts 64) via a rotatable coupler 60, such that rotation of the rotatable coupler alters a direction of the analogous expansion force applied to the analogous first support 22 relative to the analogous second support 24.
It would have been obvious for a person having ordinary level of skill in the art before the effective filing date of the claimed invention to modify a position assembly coupling of the actuator assembly with the halo first support (Modifying a connection of the actuation assembly 32,40,50,52,58 with the superior spring 86,886 of Mollo on the vertical mount 42 of Stamper attached to the halo 32 of Stamper so that there is a rotatable coupler 60 of Bode attached to the halo and mount of the actuator/spring) of Stamper in view of Mollo in view of Bode, so the halo member is coupled to the first actuator via a rotatable coupler, such that rotation of the rotatable coupler alters a direction of the expansion force applied to the first support relative to the second support, as taught by Bode, in order to provide an improved halo intrinsic traction system with an enhanced positioning assembly actuator connection forming a multi-positioning assembly with the halo by allowing for rotatable three-dimensional adjustment across various axis for desirable adjustment during user activity (Bode, Col. 2, lines 39-60, Col. 3, lines 61-66, Col. 4, lines 11-40).
Regarding claim 21, the combination of Stamper in view of Mollo in view of Bode discloses the invention as described above but fails to explicitly disclose the positioning assembly is a multi-positioning assembly, and wherein the first support is coupled to the first actuator via a rotatable coupler, such that rotation of the rotatable coupler alters a direction of the expansion force applied to the first support relative to the second support, thereby the multi-positioning assembly is configured to: secure an anterior-posterior (AP) position, a medial-lateral (ML) position, and a superior-inferior (SI) position of the system; and allow for the expansion force to be translated to the patient’s spine in a desired configuration.
Bode further teaches the analogous positioning assembly 60 (Col. 2, lines 39-60, Col. 3, lines 61-66, Col. 4, lines 11-40 and Figs. 1 and 3-5, rotatable position coupler 60) is a multi-positioning assembly 60; wherein an analogous first support halo member 22 (Col. 2, lines 39-60, Col. 3, lines 61-66, Col. 4, lines 11-40 and Figs. 1 and 3-5, halo worn head support 22 connected at first end 62 to actuator 32,40,50,52 via coupling member 60 that is adjusted three-dimensionally, including rotation along frontal axis, to secure the halo 22 to the support rods 26 and change angle of expansion force of spine and neck) is coupled to the actuator32,40,50,52,58 (Col. 2, lines 39-60, Col. 3, lines 61-66, Col. 4, lines 11-40 and Figs. 1 and 3-5, left/first and right/second side body actuators 32,40,50,52, each comprising rods 26 with biasing expansion spring 50 providing counteracting upward force via the annular shoulder 56 of the insert 52 which applies an upward force on the halo 22 at connection point 62 with the halo with respect to the connection point 30 of the actuator with the second body vest support 24. Adjustment of the expansion force is provided by rotating sleeve 40 incrementally relative to scale 58 of insert 52 and locking in place via anti-tampering lock clamp 32 and pinch bolts 64) via a rotatable coupler 60, such that rotation of the rotatable coupler alters a direction of the analogous expansion force applied to the analogous first support 22 relative to the analogous second support 24, thereby the multi-positioning assembly 60 is configured to: secure an anterior-posterior (AP) position, a medial-lateral (ML) position, and a superior-inferior (SI) position of the analogous halo intrinsic traction system 20; and allow for the analogous expansion force to be translated to the patient’s spine in a desired configuration.
It would have been obvious for a person having ordinary level of skill in the art before the effective filing date of the claimed invention to modify a position assembly coupling of the actuator assembly with the halo first support (Modifying a connection of the actuation assembly 32,40,50,52,58 with the superior spring 86,886 of Mollo on the vertical mount 42 of Stamper attached to the halo 32 of Stamper so that there is a rotatable coupler 60 of Bode attached to the halo and mount of the actuator/spring) of Stamper in view of Mollo in view of Bode, so the positioning assembly is a multi-positioning assembly, and wherein the first support is coupled to the first actuator via a rotatable coupler, such that rotation of the rotatable coupler alters a direction of the expansion force applied to the first support relative to the second support, thereby the multi-positioning assembly is configured to: secure an anterior-posterior (AP) position, a medial-lateral (ML) position, and a superior-inferior (SI) position of the system; and allow for the expansion force to be translated to the patient’s spine in a desired configuration, as taught by Bode, in order to provide an improved halo intrinsic traction system with an enhanced positioning assembly actuator connection forming a multi-positioning assembly with the halo by allowing for rotatable three-dimensional adjustment across various axis for desirable adjustment during user activity (Bode, Col. 2, lines 39-60, Col. 3, lines 61-66, Col. 4, lines 11-40).
Claims 22-24, as best understood given by the 35 USC 112(B) above, are rejected under 35 U.S.C. 103 as being unpatentable over Stamper et al. (U.S. Patent Pub. No. 20020151831) in view of Mollo (U.S. Patent No. 4632099) in view of Bode (U.S. Patent No. 5195947), as applied to claim 21, and in further view of Eastman et al. (U.S. Patent No. 4765317) and Moore (U.S. Patent No. 5063920).
Regarding claim 22, the combination of Stamper in view of Mollo in view of Bode discloses the invention as described above and further discloses wherein: the actuation assembly 32,40,50,52,58 (Col. 2, lines 39-60, Col. 3, lines 61-66, Col. 4, lines 11-40 and Figs. 1 and 3-5, left/first and right/second side body actuators 32,40,50,52, each comprising rods 26 with biasing expansion spring 50 providing counteracting upward force via the annular shoulder 56 of the insert 52 which applies an upward force on the halo 22 at connection point 62 with the halo with respect to the connection point 30 of the actuator with the second body vest support 24. Adjustment of the expansion force is provided by rotating sleeve 40 incrementally relative to scale 58 of insert 52 and locking in place via anti-tampering lock clamp 32 and pinch bolts 64) further comprises a second actuator 32,40,50,52,58 (Stamper, Paragraph 60 and Figure 4, right side attachments 42 to halo; Mollo, Col. 3, lines 1-35 and Figures 1-2, right spring 88 pulls a user’s head superiorly from above to generate expansion force; Bode, Col. 2, lines 39-60, Col. 3, lines 61-66, Col. 4, lines 11-40, right spring 50 is part of right actuator32,40,50,52,58 generate expansion force); the first support 32 (Stamper, Paragraph 60 and Figure 4, halo ring 32) has horizontal rails (Stamper, Paragraph 60 and Figure 4, horizontal rail 42 for receiving orthosis rods 40; Mollo, Col. 3, lines 1-35 and Figures 1-2 horizontal rail 96,98 that receives orthosis frames 15,16); the multi-positioning assembly (Stamper, Paragraph 60 and Figure 4, positioning assembly comprising vertical mount 42 and horizontal rail 42 for receiving orthosis rods 40; Mollo, Col. 3, lines 1-35 and Figures 1-2, positioning assembly comprising horizontal rail 96,98 that then connects to a springs 86,88 that connect to a vertical mount 82,84; Bode, Col. 2, lines 39-60, Col. 3, lines 61-66, Col. 4, lines 11-40, rotatable coupler 60) comprises: the rotatable coupler 60 (Bode, Col. 2, lines 39-60, Col. 3, lines 61-66, Col. 4, lines 11-40)coupling the first support 32 (Stamper, Paragraph 60 and Figure 4, halo ring 32) to the actuation assembly 32,40,50,52,58 (Bode, Col. 2, lines 39-60, Col. 3, lines 61-66, Col. 4, lines 11-40), such that rotation of the rotatable coupler 60 (Bode, Col. 2, lines 39-60, Col. 3, lines 61-66, Col. 4, lines 11-40) alters a direction of the expansion force; the expansion force is transferred to the first support 32 (Stamper, Paragraph 60 and Figure 4, halo ring 32) via the rotatable coupler 60 (Bode, Col. 2, lines 39-60, Col. 3, lines 61-66, Col. 4, lines 11-40); a bottom mount (Stamper, Paragraph 60 and Figure 4, vertical mount 42 connects with horizontal rail 42; Mollo, Col. 3, lines 1-35 and Figures 1-2, vertical mount 82,84;), wherein the bottom mount interface with the horizontal rails (Stamper, Paragraph 60 and Figure 4, horizontal rail 42 for receiving orthosis rods 40; Mollo, Col. 3, lines 1-35 and Figures 1-2 horizontal rail 96,98 that receives orthosis frames 15,16).
However, the combination of Stamper in view of Mollo in view of Bode fails to explicitly disclose (1) an anterior-posterior (AP) positioning subsystem comprising: an anterior-posterior positioner block; and an anterior-posterior positioner hardware; a rail interface; the AP positioning subsystem and the bottom mount interface with the horizontal rails via the rail interface; (2) an overhead bar configured to transverse a space between the actuation assembly superior to the first support and join force outputs of the first and second actuators; the expansion force is transferred to the first support via the overhead bar.
Eastman teaches an analogous halo intrinsic traction system 10 (Col. 3, lines 20-65, Col. 4, lines 1-60 and Figures 1-3, HIT 10 comprising halo 18, orthosis rods 48,50, mount 16, anterior-posterior positioning block 14, horizontal rail 12 which received orthosis rods 48,50, horizontal rail slots of halo 18, superior to inferior adjustment 62,64, 70,72, medial to lateral adjustment 60,62,64, and hardware 74) wherein the analogous multi-positioning assembly 14, 16, 62,64, 70,72, 60,62,64, 74 comprises an anterior-posterior (AP) positioning subsystem 14, 74, comprising: an anterior-posterior positioner block 14; and an anterior-posterior positioner hardware 74; a rail interface 60,62,64 (Col. 3, lines 20-65, Col. 4, lines 1-60 and Figures 1-3, anterior to posterior adjustment via rail-interface 60,62,64 of AP block 14); the AP positioning subsystem 14, 74 and the analogous bottom mount 16 interface with the analogous horizontal rails 12 via the rail interface 60,62,64.
It would have been obvious for a person having ordinary level of skill in the art before the effective filing date of the claimed invention to modify the horizontal rail and mount of Stamper in view of Mollo in view of Bode (modifying the positioning assembly comprising the horizontal rail bracket 42 receiving the orthosis rods 40 and the vertical bracket 42 connecting the horizontal rail bracket to the halo 32 of Stamper to include an AP-posterior block/rail interface/hardware, as taught by Eastman having the multi-positioning assembly comprising the horizontal rail 12 which receives orthosis rods 48,50 with anterior-posterior positioning block 14 with AP adjustment 60,62,64; superior to inferior adjustment 62,64, 70,72; and hardware 74 of Eastman), so that there is an anterior-posterior (AP) positioning subsystem comprising: an anterior-posterior positioner block; and an anterior-posterior positioner hardware; a rail interface; the AP positioning subsystem and the bottom mount interface with the horizontal rails via the rail interface, as taught by Eastman, in order to provide an improved halo intrinsic traction system with an enhanced rod receiving horizontal rail and mount allowing for with adjustment therefrom for desirable mobility during user active movement (Eastman, Col. 3, lines 20-65, Col. 4, lines 1-60).
However, the combination of Stamper in view of Mollo in view of Bode in view of Eastman fails to explicitly disclose (2) an overhead bar configured to transverse a space between the actuation assembly superior to the first support and join force outputs of the first and second actuators; the expansion force is transferred to the first support via the overhead bar.
Moore teaches an analogous halo intrinsic traction system (Col. 3, lines 45-65, Col. 4, lines 1-25, and Figures 2-3, second support orthosis vest 11 with orthosis rods 21 that are received in horizontal rails 23. The horizontal rails 23 are also attached to halo first support 30 by a mount as well as further superiorly spaced apart by superior rods 22 that are attached to overhead bar 50 and adjustable via a medial to lateral positioner 70) an overhead bar 50 configured to transverse a space between the analogous horizontal rail 23 and analogously superior (Figure 2, centroid axis of cross/horizontal rail 23 is shown as slightly superior to centroid axis of halo 33) to the analogous first support 30 and join force outputs of analogous first (Figures 2-3, rail 23 and mount on left side of halo 32) and analogous second (Figures 2-3, rail 23 and mount on right side of halo 32)side positioning assembly; a similar force (Col. 3, lines 45-65, Col. 4, lines 1-25, and Figures 2-3, forces transferred through rods and onto user) is transferred to the analogous first support 30 via the overhead bar 50.
It would have been obvious for a person having ordinary level of skill in the art before the effective filing date of the claimed invention to modify the horizontal rail in the multi-positioning assembly that receives the orthosis rods as well as couples with the expansion force actuator of Stamper in view of Mollo in view of Bode in view of Eastman, so that the horizontal rail is further connected to an overhead bar configured to transverse a space between the horizontal rail superior to the first support and join force outputs of first and second side positioning assembly; the force is transferred to the first support via the overhead bar, as taught by Moore, (such that in the combination of Stamper in view of Mollo in view of Bode in view of Eastman in view of Moore there is an overhead bar configured to transverse a space between the actuation assembly superior to the first support and join force outputs of the first and second actuators; the expansion force is transferred to the first support via the overhead bar), in order to provide an improved halo intrinsic traction system with an attached medial to lateral extending overhead bar that also allows for medial to lateral adjustment relative to the horizontal rail and superiorly upward for desirable force transfer from the horizontal rail (Moore, Col. 3, lines 45-65 and Col. 4, lines 1-25).
Regarding claim 23, the combination of Stamper in view of Mollo in view of Bode in view of Eastman in view of Moore discloses the invention as described above and further discloses wherein the rotatable coupler 60 (Bode, Col. 2, lines 39-60, Col. 3, lines 61-66, Col. 4, lines 11-40, rotatable coupler 60 mounted to left and right side of halo 22 so as to be rotatable about frontal axis) is: mountable to the first support 32 (Stamper, Paragraph 60 and Figure 4, halo ring 32) and rotatable about a frontal axis; and configured to be oriented perpendicular to the horizontal rails (Stamper, Paragraph 60 and Figure 4, rods 40 contacting the anterior to posterior extending horizontal rail 42 is oriented perpendicular to superior to inferior vertical mount 42; Mollo, Col. 3, lines 1-35 and Figures 1-2, anterior to posterior extending horizontal rail 96,98 for receiving vertical orthosis frames 15,16; Bode, Col. 2, lines 39-60, Col. 3, lines 61-66, Col. 4, lines 11-40 and Figure 1, horizontal rail is one of the plurality of couplers 60 for receiving vertical orthosis rods 26. The horizontal rail of one of the plurality of couplers 60 is further connected perpendicularly via 3D adjustably to the rotatable coupler 60 of the other of the plurality of couplers 60 that is then attached to halo 22. Thereby the rotatable coupler 60 is aligned vertically/gravitationally/superiorly to inferiorly ; Eastman, Col. 3, lines 20-65, Col. 4, lines 1-60 and Figures 1-3, rotatable couplers slot adjustment axis 90,92 are vertically/gravitationally/superiorly-to-inferiorly aligned and perpendicular to axis of horizontal rail 12).
Regarding claim 24, the combination of Stamper in view of Mollo in view of Bode in view of Eastman in view of Moore discloses the invention as described above and further discloses wherein: the overhead bar 50 (Moore, Col. 3, lines 45-65, Col. 4, lines 1-25, and Figures 2-3, horizontal overhead bar 50 in medial to lateral direction is parallel to horizontal cross rail 23 in anterior to posterior direction; Examiner notes that this parallel and perpendicular of the prior art is achieved in as much as that of Applicant’s invention, see also 112b above) is further configured to be positioned on same plane as the horizontal rails (Stamper, Paragraph 60 and Figure 4, rods 40 contacting the anterior to posterior extending horizontal rail 42 is oriented perpendicular to superior to inferior vertical mount 42; Mollo, Col. 3, lines 1-35 and Figures 1-2, anterior to posterior extending horizontal rail 96,98 for receiving vertical orthosis frames 15,16; Bode, Col. 2, lines 39-60, Col. 3, lines 61-66, Col. 4, lines 11-40 and Figure 1, horizontal rail is one of the plurality of couplers 60 for receiving vertical orthosis rods 26. The horizontal rail of one of the plurality of couplers 60 is further connected perpendicularly via 3D adjustably to the rotatable coupler 60 of the other of the plurality of couplers 60 that is then attached to halo 22. Thereby the rotatable coupler 60 is aligned vertically/gravitationally/superiorly to inferiorly ; Eastman, Col. 3, lines 20-65, Col. 4, lines 1-60 and Figures 1-3, rotatable couplers slot adjustment axis 90,92 are vertically/gravitationally/superiorly-to-inferiorly aligned and perpendicular to axis of horizontal rail 12; Moore, Col. 3, lines 45-65, Col. 4, lines 1-25, and Figures 2-3, horizontal overhead bar 50 in medial to lateral direction is parallel to horizontal cross rail 23 in anterior to posterior direction; Examiner notes that this parallel and perpendicular of the prior art is achieved in as much as that of Applicant’s invention, see also 112b above) and perpendicular to a superiorly-to-inferior plane of the rotatable coupler 60 (Bode, Col. 2, lines 39-60, Col. 3, lines 61-66, Col. 4, lines 11-40, rotatable coupler 60 mounted to left and right side of halo 22 so as to be rotatable about frontal axis) to minimize any moment about the first support 32 (Stamper, Paragraph 60 and Figure 4, halo ring 32).
Conclusion
16. 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.
17. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michael Milo whose telephone number is (571)272-6476. The examiner can normally be reached on Mon-Fri 7:00-5:00.
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/MICHAEL MILO/
Art Unit 3786
/ALIREZA NIA/Supervisory Patent Examiner, Art Unit 3786