DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Specification
Amendment to the specification filed 11/27/24 has been accepted.
Claim Objections
Claims 1-15 are objected to because of the following informalities:
Claim 1, line 1 insert “A” before “Vertebral”.
Claims 2-15, line 1, insert “The” before “Device”.
Claim 1, line 11, “by” should be “for”.
For consistency purposes, use consistent naming for all structures:
Claim 1, line 8 and 10, “the rod” should be “the first connection rod”
Claim 2, line 2, “upper bearing surface” should be “upper surface”
Claim 5, line 2-3, “lower surface” should be “lower bearing surface”
Claim 6, line 3, “lower surface” should be “lower bearing surface”
Claim 13, line 2, “the rod” should be “the first connection rod”
Claim 14, line 2, “the rod” should be “the first connection rod”
Claim 8, line 2, remove “namely” for clarity purposes. Applicant can substitute this word with ‘comprising’.
Claim 8, last line, for clarity, “it” should be naming the structure of the second jaw being referred to.
Claim 9, line 3, “these” should be replaced with “the jaws” for clarity purposes.
Appropriate correction is required.
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 1-15 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 1, lines 5-6 refer to “the two threaded portions of the screws”. However the claim previously recited that each screw has a first threaded portion and a second threaded portion. It is unclear if ‘the two threaded portions’ is referring to the first portions, second portions or a combination of all the portions thereby rendering the scope indefinite. For examination purposes, the limitation will be interpreted as “the two second threaded portions of the screws”.
Dependent claims 2-15 are rejected under 112(b) as they contain all the deficiencies of claim 1 from which they depend.
Claims 2, 3, 5, 6, 7 and 8 all refer to “cap-shaped”. It is unclear what the scope of this limitation is because a ‘cap’ is not a standard shape known to one of ordinary skill in the art. Caps can come in many sizes and shapes and so this term is indefinite. The specification does not describe this shape to make one aware of the metes and bounds of this limitation. For examination purposes, any shape will be considered ‘cap-shaped’.
Dependent claims 4, 9-11 are rejected under 112(b) as they contain all the deficiencies of claim 3 from which they depend.
Claims 10 and 11 recite the terms “large” and “small”. These are relative terms which renders the claim indefinite. The terms large and small are not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. As best understood, the terms will be interpreted as relative to one another. “Large cross-section” will be interpreted as “larger cross-section” and “small cross-section” will be interpreted as “smaller cross-section”.
Claim 11 recites “the common center of rotation” in line 7. There is insufficient antecedent basis for this limitation. It is unclear what structure is required to have their centers of rotation be common rendering the scope indefinite. The limitation could be referring to the openings, the jaws, the portions, the securing assemblies, etc. For examination purposes, the limitation “the common centre of rotation being disposed against the small cross-sections of the first and second portions” will be interpreted as referring to small cross-sections of the first and second portions share a common central axis.
Claim 6 recites the limitations of “a first jaw…and a third jaw” and “a second support sleeve”. Claim 6 depends only from claim 1. There is no reference in claims 1 or 6 to a second jaw or a first support sleeve rendering the scope indefinite as to whether three jaws are required and two support sleeves are required in claim 6. It could also be interpreted as merely a naming convention and ‘third’ and ‘second’ having no bearing on the number of total jaws or support sleeves. For examination purposes, the terms ‘third’ and ‘second’ will be interpreted as a naming convention only and not imparting any quantity of the number of jaws or support sleeves to the claim.
Dependent claims 7 are rejected under 112(b) as they contain all the deficiencies of claim 6 from which they depend.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1 (as best understood), 12-13 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lange (US Patent No. 6123706).
Regarding Claim 1, Lange discloses a vertebral stabilization device (Fig. 1), comprising:
- at least two screws (screw 12, Fig. 1, using two screws shown in Fig. 13), each having a first threaded portion (20) to be engaged in a vertebra and a second threaded portion (16) separated from the first threaded portion (20) by a flange (34, Fig. 2) (col. 2; ln. 55-65);
at least one first connection rod (30, Fig. 13) having two opposite ends to connect the two threaded portions of the screws to one another (free ends attached to screws as shown in fig. 13); and
- at least one first securing assembly and one second securing assembly to secure the ends of the rod to the screws (securing assembly is 42+52+14 shown in Fig. 1-2, two assemblies used in Fig. 13 (one per screw)), each securing assembly comprising at least one clip (14+42) which is able to be engaged on the second threaded portion (16) of one of the screws (fig. 2) and arranged to clamp an end of the rod (shown in Fig. 13), and a nut (52) which has a lower bearing surface (54) and which is designed to be screwed on the second threaded portion (16) for clamping the clip against an upper surface of the flange of the screw (fig. 2), each securing assembly being arranged to create a ball-and-socket joint connection between the clip and the second threaded portion (due to concave/convex surfaces, the clip will pivot about the threaded portion, see Fig. 2, col. 4; ln. 65-col. 5; ln. 8).
Regarding Claim 12, wherein the flange (34) is removable (slipped over as separate piece shown in Fig. 1, col. 3; ln. 42-46).
Regarding Claim 13, wherein the rod has a constant cross-section over its entire length (described as smooth round rod in col. 3; ln. 2-3, shown in Fig. 13) .
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) 2-3, 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lange (US Patent No. 6123706) in view of Gradel et al. (FR 2831419 A1).
Regarding Claim 2, Lange discloses the device as described in the rejection of claim 1 above. Lange discloses that the upper bearing surface (40) of the flange (34) is a spherical cap-shaped concave surface (col. 3; ln. 43-54). However, Lange is silent to the lower bearing surface of the nut having an identical spherical cap-shaped concave surface.
Gradel discloses a spinal rod clamp in the same field of endeavor wherein the nut (8) has a spherical cap-shaped concave surface (8a) for the purpose of clamping down on the top of the clamp (24) at a variant of different angles to generate a polyaxial joint (“The connecting slide 4 further comprises, around the upper entrance 16b of the first passage 16, an upper convex spherical surface 24. The clamping nut 8 has a concave lower spherical surface 8a, with the same curvature as the convex upper spherical surface 24, and adapted to directly receive said convex upper spherical surface 24 when tightening the clamping nut 8.”)
It would have been obvious to one having ordinary skill in the art before the effective filing date to modify the connection between the nut and clip of Lange to be one wherein the nut has the concave spherical surface and the clip has a mating convex spherical surface as taught by Gradel in order to use a substitute polyaxial clamping mechanism known in the art to allow for a predictable polyaxial connection of the clip relative to the screw. Further, it would have been obvious to one having ordinary skill in the art to make the radii of curvature the same in the upper and lower spherical joints since there are only two combinations of radii to try- different radii of curvature or identical and identical radii of curvature would have the predictable result of generating smooth polyaxial movement of the clip relative to the nut and flange of the device.
Regarding Claim 3, Lange discloses the device as described in the rejection of claim 1 above. Lange discloses that the clip has a first jaw (23+42), Fig. 2 having a complementary spherical cap-shaped convex outer surface (45) to bear on the upper surface (40) of the flange (34) (fig. 2). Lange discloses the clip has a second jaw (22) having a spherical outer surface (22) bearing against a complementary lower front surface of a support sleeve of the nut (surface 54). However, Lange is silent to the a spherical outer surface (22) of the second jaw being convex and the lower front surface of a support sleeve of the nut (surface 54) being complementary to that convex surface.
Gradel discloses a spinal rod clamp in the same field of endeavor wherein the nut (8) has a spherical cap-shaped concave surface (8a) for the purpose of clamping down on the top of the clamp (24) at a variant of different angles to generate a polyaxial joint (“The connecting slide 4 further comprises, around the upper entrance 16b of the first passage 16, an upper convex spherical surface 24. The clamping nut 8 has a concave lower spherical surface 8a, with the same curvature as the convex upper spherical surface 24, and adapted to directly receive said convex upper spherical surface 24 when tightening the clamping nut 8.”)
It would have been obvious to one having ordinary skill in the art before the effective filing date to modify the connection between the sleeve of the nut and clip of Lange to be one wherein the nut has the concave spherical surface and the clip has a mating convex spherical surface as taught by Gradel in order to use a substitute polyaxial clamping mechanism known in the art to allow for a predictable polyaxial connection of the clip relative to the screw.
Regarding Claim 9, each clip comprises an elastically deformable portion (hinged end 24, Lange) connecting the jaws such that these are movable against one another between an open position (unclamped) and a closed (clamped) position (co. 2; ln. 65- col. 3; ln. 10, Lange).
Claim(s) 14-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lange (US Patent No. 6123706) in view of Heflin (US Patent No. 10034690 B2).
Regarding Claim 14, Lange discloses the device as described in the rejection of claim 1 above. However, Lange is silent to the rod (30) being curved).
Heflin discloses a spinal rod in the same field of endeavor wherein the rod is curved (col. 8; ln. 12-21, Fig. 27) for the purpose of providing a contoured rod to treat the patient and align with the spinal curvature (shown in Fig. 30-33).
It would have been obvious to one having ordinary skill in the art before the effective filing date to use a curved rod in the system of Lange as taught by Heflin in order to provide a contoured rod to treat the patient and align with spinal curvature.
Regarding Claim 15, Lange discloses the device as described in the rejection of claim 1 above. in Fig. 1, Lange shows the proximal portion of the second threaded section (16) is provided with an end portion designed to enable a rotating connection with a tool for screwing the screw into the vertebra, however, Lange is silent to a breaking piece to be able to separate the end portion from the second threaded portion by breaking.
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Heflin discloses a spinal stabilization device in the same field of endeavor wherein the second (proximal) threaded portion has a breakaway connection (223, Fig. 15) for the purpose of enabling the excess height of the threaded shaft to be broken away from the assembly after installation of the system (col. 7; ln. 1-5).
It would have been obvious to one having ordinary skill in the art before the effective filing date to use a curved rod in the system of Lange as taught by Heflin in order to enable the excess height of the threaded shaft to be broken away from the assembly after installation of the system
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lange (US Patent No. 6123706) in view of Gradel et al. (FR 2831419 A1) in further view of Mack (US Publication No. 2010/0211100 A1).
Regarding Claim 4, Lange in view of Gradel discloses the device as described in the rejection of claim 3 above. However, Lange in view of Gradel is silent to the first support sleeve is distinct from the nut.
Mack discloses a spinal fixation system in the same field of endeavor wherein the nut 17 is distinct from the contoured support sleeve 18 (fig. 10-11) in order to provide a structure which can thread down to clamp a clip 4 onto a rod (fig. 1).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the support sleeve (contoured surface) of the nut of Lange in view of Gradel to be distinct components as taught by Mack in order to provide an alternate clamping arrangement which would predictably apply pressure downwards onto the jaws of the clip.
Allowable Subject Matter
Claims 5-8, 10-11 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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See Form PTO-892.
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/JACQUELINE T JOHANAS/ Primary Patent Examiner, Art Unit 3773