DETAILED ACTION
This is a Non-Final Rejection for Application 18/872,889 filed December 9, 2024. This application is a §371 national stage of International Application No. PCT/US23/70297, filed July 16, 2023. This application claims priority to United States Provisional Patent Application No. 63/390,076 filed on July 18, 2022 and United States Provisional Patent Application No. 63/420,962 filed on October 31, 2022. Claims 1-22, 24, 26 and 34 are currently pending.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 112(b)
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 14, 19-22, 24 and 26 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.
Claim 14 recites the limitation "the aperture of the first bushing" in line 7. There is insufficient antecedent basis for this limitation in the claim. An aperture of the first bushing is not previously recited in claim 14 or the claims it depends from. This rejection may be overcome with language such as “an aperture of the first bushing”.
Claim 19 recites the limitation “a sacral segment that couples to the second vertebral segment via the second joint” in lines 1-2. Claim 19 depends from claim 5 where a third vertebral segment is already coupled to the second vertebral segment via the second joint. There is no disclosure of these features being used together and it is unclear how both features could be present simultaneously as claimed. This rejection may be overcome by amending claim 19 to depend from claim 1.
Claims 20-22, 24 and 26 are rejected for depending from and not curing the deficiencies of claim 19.
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.
Claim(s) 1-11, 13, 15-18 and 34 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2008/0234691 (Schwab) in view of US 2017/0196722 (Murdock).
Regarding claim 1, Schwab discloses a first vertebral segment ([0013] – “The "Flex-Rod", as shown in FIG. 1 in Drawing 1/3, can contain a large number of segments, at least as many as the number of vertebrae being covered by the procedure”; each segment is interpreted as a vertebral segment with the superior most being interpreted as the first.);
a first joint ([0021] – “ An alternative interconnection to the stepped-surface-connection and central wire connectivity between elements of the Flex-Rod as shown in the cross section FIG. 7 in Drawing 3/3 can be accomplished by an interlocking design as, for example, shown in FIG. 8 in Drawing 3/3”; the interlocking feature of the lower segment in Fig. 8 is interpreted as the first joint when the upper segment is the first segment.);
a second vertebral segment that couples to the first vertebral segment via the first joint (The lower segment in Fig. 8 is interpreted as a second vertebral segment that is indirectly coupled to the first segment via the interlocking feature.);
a second joint coupled to the second vertebral segment (While Fig. 8 only shows the first interlocking feature, a second interlocking feature would be disposed on a third vertebral segment and indirectly coupled to the second segment. [0013] – “The "Flex-Rod", as shown in FIG. 1 in Drawing 1/3, can contain a large number of segments, at least as many as the number of vertebrae being covered by the procedure”; here at least three segments are shown.); and
a first bushing between the first and second vertebral segments ([0001] – “A rod is segmented and contains wedge-shaped washers between straight rod segments with either a central internal wire providing the connection or with interlocking surface features between the rod elements”; the pair of washers are interpreted as a first bushing.);
wherein: (a) a sagittal plane intersects the first and second vertebral segments, the first and second joints and the first bushing ([0017] – “FIG. 6 in Drawing 2/3 presents a schematic picture of a Flex-Rod with various curvatures in 2 dimensions. But it is obvious that a combined rotation of a pair of wedge-shaped washers by 90 degrees would allow a curvature of the rod in a plane at a 90 degree angle to the drawing paper or, in other words, in a third dimension. In a more general way, the pairs of washers can be jointly rotated in any desired angle and, subsequently, by going from "opposed rotation" to "equal rotation", a curvature of the Flex-Rod can be obtained in any three-dimensional shape, allowing for the perfect adaptation of the Flex-Rod to the actual or desired shape or curvature of the spine or the structural problem on hand.” A sagittal plane intersects the segments, interlocking features and washers as any desired curvature is obtained.); and
(b) a coronal plane intersects one or more of (b)(i) the first and second vertebral segments, (b)(ii) the first and second joints, (b)(iii) the first bushing, or (b)(iv) combinations thereof (A coronal plane inherently intersects the washers as the washers are 3-dimensional objects and therefore must lie in 3 planes, one of which being a coronal plane when positioned relative to a patient.);
wherein: (a) the first bushing includes a superior surface disposed in a first plane of the first bushing and an inferior surface disposed in a second plane of the first bushing ([0015] – “In FIG. 3 in Drawing 1/3, a pair of washers is shown inserted between two rod segments and arranged in an "opposed rotation" arrangement, with their thin and thick ends being 180 degrees opposed to each other relative to the center of the rod, whereby their wedge shapes cancel each other out and leave the rod in a linear, straight configuration. However, when the pair of wedge shaped washers is in an "equal rotation" arrangement, see FIG. 4 in Drawing 2/3, with their thick ends being on the same side of the rod, the wedge function of the two washers of the pair becomes cumulative and the rod will obtain a curvature of 2 times the angle of each of the washers, see FIG. 4 in Drawing 2/3.” The washers include a superior surface and an inferior surface disposed in a first and second plane, respectively.), and
(b) the first plane of the first bushing is not parallel to the second plane of the first bushing (In Fig. 4, the first and second planes are not parallel.).
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Schwab does not directly disclose that the system is an external spinal brace system.
However, Murdock discloses an external spinal brace comprising a plurality of support mechanisms that are analogous to the segments of Schwab. Schwab also discloses that their invention can serve in general structural applications as opposed to an orthopedic spinal implant.
Therefore, it would have been obvious to an artisan of ordinary skill before the effective filing date to use the device of Schwab as an external spinal brace system as taught by Murdock. A skilled artisan would have been motivated to do so because Murdock teaches that an external system is easier to adjust and much less invasive than an implant. A skilled artisan would have a reasonable expectation of success given that all references are analogous and drawn to spinal correction systems.
As a result, Schwab in view of Murdock teaches an external spinal brace system (The device of Schwab is a spinal brace system and may be disposed externally in view of Murdock.).
Regarding claim 2, Schwab in view of Murdock teaches the system according to claim 1, wherein the superior surface directly contacts the first vertebral segment (The superior surface of the washers directly contact the first segment. See Fig. 8.).
Regarding claim 3, Schwab in view of Murdock teaches the system according to claim 2, wherein the inferior surface directly contacts the second vertebral segment (The inferior surface of the washers directly contact the second segment. See Fig. 8.).
Regarding claim 4, Schwab in view of Murdock teaches the system according to claim 1, comprising:
a third vertebral segment that couples to the second vertebral segment via the second joint ([0013] – “The "Flex-Rod", as shown in FIG. 1 in Drawing 1/3, can contain a large number of segments, at least as many as the number of vertebrae being covered by the procedure.” While not shown in Fig. 8, since there are at least three segments as depicted in Fig. 1, the examiner is interpreting the inferior segment to the second segment to be a third vertebral segment that is coupled to the second segment by the second interlocking feature.);
a second bushing between the second and third vertebral segments (While not shown in Fig. 8, since there are at least three segments as depicted in Fig. 1, the examiner is interpreting the inferior washers between the second and third segments to be a second bushing.);
wherein: (a) the second bushing includes a superior surface disposed in a first plane of the second bushing and an inferior surface disposed in a second plane of the second bushing ([0015] – “In FIG. 3 in Drawing 1/3, a pair of washers is shown inserted between two rod segments and arranged in an "opposed rotation" arrangement, with their thin and thick ends being 180 degrees opposed to each other relative to the center of the rod, whereby their wedge shapes cancel each other out and leave the rod in a linear, straight configuration. However, when the pair of wedge shaped washers is in an "equal rotation" arrangement, see FIG. 4 in Drawing 2/3, with their thick ends being on the same side of the rod, the wedge function of the two washers of the pair becomes cumulative and the rod will obtain a curvature of 2 times the angle of each of the washers, see FIG. 4 in Drawing 2/3.” The washers include a superior surface and an inferior surface disposed in a first and second plane, respectively.), and
(b) the first plane of the second bushing is parallel to the second plane of the second bushing (In Fig. 3, the first and second planes are parallel.).
Regarding claim 5, Schwab in view of Murdock teaches the system according to claim 1, comprising:
a third vertebral segment that couples to the second vertebral segment via the second joint ([0013] – “The "Flex-Rod", as shown in FIG. 1 in Drawing 1/3, can contain a large number of segments, at least as many as the number of vertebrae being covered by the procedure.” While not shown in Fig. 8, since there are at least three segments as depicted in Fig. 1, the examiner is interpreting the inferior segment to the second segment to be a third vertebral segment that is coupled to the second segment by the second interlocking feature.);
a second bushing between the second and third vertebral segments (While not shown in Fig. 8, since there are at least three segments as depicted in Fig. 1, the examiner is interpreting the inferior washers between the second and third segments to be a second bushing.);
wherein: (a) the second bushing includes a superior surface disposed in a first plane of the second bushing and an inferior surface disposed in a second plane of the second bushing ([0015] – “In FIG. 3 in Drawing 1/3, a pair of washers is shown inserted between two rod segments and arranged in an "opposed rotation" arrangement, with their thin and thick ends being 180 degrees opposed to each other relative to the center of the rod, whereby their wedge shapes cancel each other out and leave the rod in a linear, straight configuration. However, when the pair of wedge shaped washers is in an "equal rotation" arrangement, see FIG. 4 in Drawing 2/3, with their thick ends being on the same side of the rod, the wedge function of the two washers of the pair becomes cumulative and the rod will obtain a curvature of 2 times the angle of each of the washers, see FIG. 4 in Drawing 2/3.” The washers include a superior surface and an inferior surface disposed in a first and second plane, respectively.), and
(b) the first plane of the second bushing is not parallel to the second plane of the second bushing (In Fig. 4, the first and second planes are not parallel.).
Regarding claim 6, Schwab in view of Murdock teaches the system according to claim 4, wherein the first plane of the first bushing is not parallel to the first plane of the second bushing (In Fig. 6, a first plane of a washer is not parallel to the first plane of another washer. Since the washers can be adjusted such that their angles change, the first plane of the first washer is not parallel to the first plane of the second washer in embodiments.).
Regarding claim 7, Schwab in view of Murdock teaches the system according to claim 5, wherein: the first plane of the first bushing has a first degree of angle in the coronal plane; the first plane of the second bushing has a second degree of angle in the coronal plane; the first degree of angle in the coronal plane is unequal to the second degree of angle in the coronal plane ([0017] – “In a more general way, the pairs of washers can be jointly rotated in any desired angle and, subsequently, by going from "opposed rotation" to "equal rotation", a curvature of the Flex-Rod can be obtained in any three-dimensional shape, allowing for the perfect adaptation of the Flex-Rod to the actual or desired shape or curvature of the spine or the structural problem on hand.” Since the curvature is controlled by the angle of the washers, any degree in three dimensions is obtained including a curvature wherein the first plane of the first washer has a first degree of angle in the coronal plane; the first plane of the second washer has a second degree of angle in the coronal plane; and the first degree of angle in the coronal plane is unequal to the second degree of angle in the coronal plane.).
Regarding claim 8, Schwab in view of Murdock teaches the system according to claim 5, wherein: the first bushing is configured to impart a first degree of scoliosis; the second bushing is configured to impart a second degree of scoliosis; the first and second degrees of scoliosis are unequal to each other ([0017] – “In a more general way, the pairs of washers can be jointly rotated in any desired angle and, subsequently, by going from "opposed rotation" to "equal rotation", a curvature of the Flex-Rod can be obtained in any three-dimensional shape, allowing for the perfect adaptation of the Flex-Rod to the actual or desired shape or curvature of the spine or the structural problem on hand.” Since the curvature is controlled by the angle of the washers, any degree in three dimensions is obtained including a curvature wherein the first washer is configured to impart a first degree of scoliosis; the second washer is configured to impart a second degree of scoliosis; and the first and second degrees of scoliosis are unequal to each other.).
Regarding claim 9, Schwab in view of Murdock teaches the system according to claim 5, wherein: the first plane of the first bushing has a first degree of angle in the sagittal plane; the first plane of the second bushing has a second degree of angle in the sagittal plane; the first degree of angle in the sagittal plane is unequal to the second degree of angle in the sagittal plane ([0017] – “In a more general way, the pairs of washers can be jointly rotated in any desired angle and, subsequently, by going from "opposed rotation" to "equal rotation", a curvature of the Flex-Rod can be obtained in any three-dimensional shape, allowing for the perfect adaptation of the Flex-Rod to the actual or desired shape or curvature of the spine or the structural problem on hand.” Since the curvature is controlled by the angle of the washers, any degree in three dimensions is obtained including a curvature wherein the first plane of the first washer has a first degree of angle in the sagittal plane; the first plane of the second washer has a second degree of angle in the sagittal plane; and the first degree of angle in the sagittal plane is unequal to the second degree of angle in the sagittal plane.).
Regarding claim 10, Schwab in view of Murdock teaches the system according to claim 5, wherein: the first bushing is configured to impart a first degree of lordosis; the second bushing is configured to impart a second degree of lordosis; the first degree of lordosis is unequal to the second degree of lordosis ([0017] – “In a more general way, the pairs of washers can be jointly rotated in any desired angle and, subsequently, by going from "opposed rotation" to "equal rotation", a curvature of the Flex-Rod can be obtained in any three-dimensional shape, allowing for the perfect adaptation of the Flex-Rod to the actual or desired shape or curvature of the spine or the structural problem on hand.” Since the curvature is controlled by the angle of the washers, any degree in three dimensions is obtained including a curvature wherein the first washer is configured to impart a first degree of lordosis; the second washer is configured to impart a second degree of lordosis; the first degree of lordosis is unequal to the second degree of lordosis.).
Regarding claim 11, Schwab in view of Murdock teaches the system according to claim 5, wherein: the first bushing is configured to impart a first degree of kyphosis; the second bushing is configured to impart a second degree of kyphosis; the first degree of kyphosis is unequal to the second degree of kyphosis ([0017] – “In a more general way, the pairs of washers can be jointly rotated in any desired angle and, subsequently, by going from "opposed rotation" to "equal rotation", a curvature of the Flex-Rod can be obtained in any three-dimensional shape, allowing for the perfect adaptation of the Flex-Rod to the actual or desired shape or curvature of the spine or the structural problem on hand.” Since the curvature is controlled by the angle of the washers, any degree in three dimensions is obtained including a curvature wherein the first washer is configured to impart a first degree of kyphosis; the second washer is configured to impart a second degree of kyphosis; the first degree of kyphosis is unequal to the second degree of kyphosis.).
Regarding claim 13, Schwab in view of Murdock teaches the system according to claim 5 wherein: the first bushing includes an aperture that couples the superior surface of the first bushing to the inferior surface of the first bushing (The first washer comprises an aperture that couples the superior surface of the first washer to its inferior surface.);
the aperture has a first maximum width where the aperture interfaces the superior surface of the first bushing (The top of the aperture has a maximum width that interfaces with the superior surface of the first washer.);
the aperture has a second maximum width where the aperture interfaces the inferior surface of the first bushing (The bottom of the aperture has a maximum width that interfaces with the inferior surface of the first washer.).
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Schwab in view of Murdock does not teach the first maximum width is greater than the second maximum width.
However, it would have been obvious to reverse the direction of the interlocking feature such that the interlocking features project from the first segment to the second segment as this would require a mere rearrangement of parts that one of ordinary skill in the art would be capable of performing. A rearrangement of parts that does not modify the operation of the device is recognized as being within the level of ordinary skill in the art before the filing date of the claimed invention. In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950).
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As a result of the modification, Schwab in view of Murdock teaches the first maximum width is greater than the second maximum width (Rearranging the interlocking feature results in the same operation but the first maximum width is greater than the second maximum width.).
Regarding claim 15, Schwab in view of Murdock teaches the system according to claim 5, wherein: the first vertebral segment includes a maximum width; the first bushing includes a maximum width; the maximum width of the first vertebral segment is equal to the maximum width of the first bushing (In Fig. 8, the maximum width of the first segment and the washer are equal.).
Regarding claim 16, Schwab in view of Murdock teaches the system according to claim 5, wherein: the first vertebral segment includes a maximum width; the first bushing includes a maximum width (In Fig. 8, the first segment and the washer each have a maximum width.);
the maximum width of the first vertebral segment is unequal to the maximum width of the first bushing (The maximum width of the washer is greater than the maximum width of the first segment at points where the washer includes a small protrusion on its periphery as shown in Fig. 5.).
Regarding claim 17, Schwab in view of Murdock teaches the system according to claim 5 wherein: the first bushing includes a maximum width and the second bushing includes a maximum width; the maximum width of the first bushing is unequal to the maximum width of the second bushing (The maximum width of a washer with small protrusions at opposed points has a greater width than a washer with small protrusion at unopposed points. In an embodiment, the maximum width of the first washer is unequal to the maximum width of the second washer due to the placement of the small protrusion. See Fig. 5.).
Regarding claim 18, Schwab in view of Murdock teaches the system according to claim 5.
Schwab in view of Murdock as applied above does not teach wherein: a first portion of the first joint is included in the first vertebral segment; a second portion of the first joint is included in the second vertebral segment; a third portion of the first joint is included in the first bushing.
However, Murdock further discloses coupling portions 120 that bridge from a first support mechanism to a second support mechanism. [0033] – “In FIG. 3 first coupling portion of the first support mechanism is positioned, during use, in the second coupling opening of the second support mechanism. FIG. 4 depicts a rear view of an enlarged representation of an embodiment of the cut away portions from FIG. 3. Support mechanisms may be formed from lightweight resilient materials that can stand up to the stresses of use and yet not put unwanted stress on the user due to weight.”
Therefore, it would have been obvious to an artisan of ordinary skill before the effective filing date to replace the interlocking feature of Schwab with a coupling portion as taught by Murdock. A skilled artisan would have been motivated to do so because Murdock teaches that the coupling portion inhibits decoupling during use ([0033]). A skilled artisan would have a reasonable expectation of success given that all references are analogous and drawn to spinal correction systems.
As a result of the combination, Schwab in view of Murdock teaches wherein: a first portion of the first joint is included in the first vertebral segment; a second portion of the first joint is included in the second vertebral segment; a third portion of the first joint is included in the first bushing (The coupling portion in view of Murdock is included in the first segment and projects through the washer and coupled within the second segment. The coupling portion would inherently pass through the washer as the washer is between the first and second segments.).
Regarding claim 34, Schwab in view of Murdock teaches the system according to claim 5,wherein the system is configured to provide a torsional force to a patient's spine and a bending force to the patient's spine ([0017] – “In a more general way, the pairs of washers can be jointly rotated in any desired angle and, subsequently, by going from "opposed rotation" to "equal rotation", a curvature of the Flex-Rod can be obtained in any three-dimensional shape, allowing for the perfect adaptation of the Flex-Rod to the actual or desired shape or curvature of the spine or the structural problem on hand.” The device of Schwab is configured to provide a torsional and bending force to a patient’s spine by rotating the washers.).
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2008/0234691 (Schwab) in view of US 2017/0196722 (Murdock), and further in view of US 2019/0076287 (Wilson et al.).
Regarding claim 14, Schwab in view of Murdock teaches the system according to claim 5 wherein: the first vertebral segment includes an aperture having a first maximum width (In Fig. 8, the first segment is shown to include an aperture having a first maximum width.);
the second vertebral segment includes an aperture having a second maximum width that is unequal to the first maximum width of the aperture of the first vertebral segment (In Fig. 8, the second segment is shown to include an aperture having a second maximum width unequal to the first maximum width.).
Schwab in view of Murdock does not teach a rod and the rod is included in the aperture of the first vertebral segment, the aperture of the second vertebral segment, and the aperture of the first bushing.
However, Wilson discloses a back-brace assistive device comprising a series of interconnected vertebrae assemblies 102. The vertebra assemblies 102 are connected by a support component 128 which is interpreted as a rod. [0034] – “the support components may be springs, rods, strips, bungee cords, or any appropriate elastic material that returns to its original shape after deformation.”
Therefore, it would have been obvious to an artisan of ordinary skill before the effective filing date to add a rod through the apertures of Schwab as taught by Wilson. A skilled artisan would have been motivated to do so because Wilson teaches that the rod applies appropriate elasticity the returns to its original shape after deformation. A skilled artisan would have a reasonable expectation of success given that all references are analogous and drawn to spinal correction systems.
As a result of the combination, Schwab in view of Murdock and Wilson teaches a rod and the rod is included in the aperture of the first vertebral segment, the aperture of the second vertebral segment, and the aperture of the first bushing (Wilson provides support for a rod and the rod would be included in the apertures of the first segment and the second segment, which also align with the aperture in the washer.).
Allowable Subject Matter
The following is a statement of reasons for the indication of allowable subject matter.
Claim 12 is indicated as containing allowable subject matter. The closest prior art of record is Schwab. Schwab does not disclose wherein the first bushing includes first, second, third and fourth projections; the first vertebral segment includes first and second voids and the second vertebral segment includes first and second voids; the first projection is included in the first void of the first vertebral segment and the second projection is included in the second void of the first vertebral segment, the third projection is included in the first void of the second vertebral segment and the fourth projection is included in the second void of the second vertebral segment. It would not be obvious to modify Schwab to teach this limitation as the modification would defeat the purpose of Schwab by rendering the interlocking mechanism obsolete. Claim 12 objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claim 19 is indicated as containing allowable subject matter. The closest prior art of record is Schwab. Schwab does not disclose a sacral segment that couples to the second vertebral segment via the second joint; wherein the sacral segment includes first and second ratchets, the first ratchet comprising a first toothed rack and a first spring-loaded finger and the second ratchet comprising a second toothed rack and a second spring-loaded finger; wherein the first toothed rack includes a first outer surface that is curved in the sagittal plane and the second toothed rack includes a second outer surface that is curved in the sagittal plane. This limitation is not taught in the prior art and would therefore not be obvious to add to Schwab. Claim 19 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims. Claims 20-22, 24 and 26 contain allowable subject matter due to their dependence from claim 19.
The examiner notes that in the 112(b) rejection Applicant is encouraged to amended claim 19 to depend from claim 1. Therefore, rewriting claim 1 to include the limitations of claim 19 or rewriting claim 19 to include the limitations of claim 1 would be allowable. However, if Applicant rewrites claim 1 to include the limitations of claim 19, claims 4 and 5 would be rejected under 112(b) for the same reasons that claim 19 is rejected currently.
Conclusion
The following prior art made of record and not relied upon are considered pertinent to
applicant's disclosure.
US 2014/0224849 (Hiemenz et al.)
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Seth Brown whose telephone number is (571)272-5642. The examiner can normally be reached 8:00 AM – 11:00 AM or 1:00 PM – 3:00 PM ET.
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/SETH R. BROWN/Examiner, Art Unit 3786
/RACHAEL E BREDEFELD/Supervisory Patent Examiner, Art Unit 3786