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 .
Election/Restrictions
Applicant's election with traverse of Group I (Claims 1-18) and without traverse for Species A (Figs 1-3) in the reply filed on July 14, 2025 is acknowledged. Applicant did not provide a reason for the traversal for the restriction amongst groups I and II. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 11-13, 16-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 7/14/2025.
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 7-10, 14-15 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 7 recites “wherein the one or more blades are configured to bias to varying degrees along an entire length of the screw assembly in the expanded configuration” which is unclear because looking at Fig 2, paragraph 69 of the current application, the proximal end of the blades, that are fixedly coupled to the support anchor are not biased radially outward. If they were to be radially biased outward, then they would no longer be connected to the support anchor. Clarification is requested. For examination purposes, the examiner will treat “an entire length of the screw assembly” to refer to the length of the blade that is biased outward.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-4, 6-7, 14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shimko US 2012/0010668.
Regarding Claim 1, Shimko discloses a pedicle screw assembly (Figs 1-7), comprising:
a support anchor (#111, Fig 4) having one or more blades (#118) and a channel (as seen in Figs 6-7) with a threaded inner surface (#133, paragraph 31) configured to mate with a threaded shaft (#121, Fig 3-4); and
a retractable shaft (#121) having a distal head portion (#122) and a proximal threaded shaft body (proximal end portion of #121, Figs 3-4, paragraph 31); and
wherein the one or more blades are operatively connected to the retractable shaft, such that the blades are biased radially outwardly from a collapsed configuration (Figs 2, 6) to an expanded configuration upon (Figs 4, 7) lateral movement of the retractable shaft within the support anchor (Figs 6-7, paragraph 31).
Regarding Claim 2, Shimko discloses the distal head portion of the retractable shaft comprises a proximal abutment edge (#125, Figs 6-7, paragraph 30-31).
Regarding Claim 3, Shimko discloses the distal head portion (#122) of the retractable shaft comprises a spear (as seen in Figs 6-7, spear shaped) having a distal point (see Fig below) and the proximal abutment edge (#125).
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Regarding Claim 4, Shimko discloses the proximal abutment edge of the distal head portion is configured to push the one or more blades radially outward as the retractable shaft retracts within the support anchor (as seen in Figs 6-7, paragraph 31).
Regarding Claim 6, Shimko discloses biasing of the blades begins along a distal portion of the screw assembly (as seen in Fig 6) upon retraction of the retractable shaft within the support anchor (as seen in Fig 6-7, paragraph 31).
Regarding Claim 7, Shimko discloses wherein the one or more blades are configured to bias to varying degrees (Fig 4, 7, paragraph 31, the blades bow outward at varying degrees) along an entire length of the screw assembly in the expanded configuration (an entire length of the screw assembly is taken as the length of the blades #118 of the screw assembly, see 112 rejection above).
Regarding Claim 14, Shimko discloses wherein a first blade (one of the blades #118) or first pair of blades are configured to engage with the retractable shaft (Figs 6-7) and begin to expand at first position (paragraph 31, Figs 6-7, where the first position is when the distal head portion is moved slightly proximally) along a travel path of the retractable shaft (Figs 6-7, path of travel is along the longitudinal axis of the shaft); and
wherein a second blade (another one of the blades #118) or second pair of blades are configured to engage with the retractable shaft (Figs 6-7) and begin to expand at a second position (paragraph 31, Figs 6-7, where the first position is when the distal head portion is moved slightly proximally) along the travel path of the retractable shaft (Figs 6-7).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Shimko US 2012/0010668 in view of Li US 6,149,669.
Shimko discloses the claimed invention as discussed above, wherein at least one of the one or more blades has a sloped inner surface (#115, as seen in Figs 6-7), the sloped inner surface being configured to abut the proximal abutment edge of the distal head portion as the retractable shaft travels within the support anchor (Figs 6-7, paragraph 31).
Shimko does not disclose the sloped inner surface terminating in a sharp point along a distal end thereof.
Li discloses a support anchor (#45) with one or more blades (#49) that terminate in a sharp point along a distal end there of (as seen in Figs 1-2, Col 5 lines 45-50) to aid in penetration into bone (Col 5 lines 35-36, 45-50).
It would have been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify the sloped inner surface of at least one of the blades to terminate in a sharp point along a distal end there of in view of Li above because this aids in penetration into bone.
Claims 8, 10 are rejected under 35 U.S.C. 103 as being unpatentable over Shimko US 2012/0010668 in view of Oldakowska US 2024/0423685.
Regarding Claim 8, Shimko discloses the one or more blades comprises four blades, each of the four blades being disposed opposite to another (see Fig 5 where there are at least four blades disposed opposite to each other) but does not disclose the blades are along an outer surface of the support anchor.
Oldakowska discloses a screw assembly (Fig 1, 5) comprising a support anchor (#102 and #108), a plurality of blades (#104) movable from a collapsed (Fig 1) and expanded configuration (Fig 6) via a retractable shaft (#106, paragraph 40), the support anchor having a recesses (#114) that receive the plurality of blades (#104, paragraph 37), the blades having a spring element (#118) that biases the blades in the collapsed configuration to keep the blades in the unexpanded configuration which is advantageous for inserting or removal of the screw assembly (paragraph 43).
It would have been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify the blades of Shimko to be separate from the support anchor, where the support anchor has recesses to receive the blades and for the blades to have a spring element in view of Oldakowska above because this configuration biases the blades in the collapsed configuration to keep the blades in the unexpanded configuration which is advantageous for inserting or removal of the screw assembly. The examiner notes that with the modification for the support anchor to have recesses that receive the blades, the blades would be along a portion of the outer surface of the support anchor.
Regarding Claim 10, Shimko discloses the screw assembly is substantially cylindrical when in the contracted configuration (as seen in Fig 2, 4 in Shimko).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Shimko US 2012/0010668 and Oldakowska US 2024/0423685, as applied to claim 8 above, and in further view of Ochoa US 5,716,358.
Shimko as modified discloses the claimed invention as discussed above where the blades has external threads (as seen in Figs 2-6 in Shimko) but does not disclose wherein at least one of the one or more blades has a plurality of pointed projections extending radially therefrom.
Ochoa discloses a fastener (Fig 1-2) with threads (#15), the threads has a plurality of pointed projections (#16, Fig 2) extending radially therefrom (Fig 2, Col 4 lines 55-67) to increase its holding power in bone, making it harder to remove (Col 2 lines 50-55, Col 4 lines 40-50).
It would have been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify Shimko as modified to have the threads of the blades have pointed projections extending radially therefrom, in view of Ochoa above because the projections increase the blades’ holding power in bone, making it harder to remove.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Shimko US 2012/0010668 and Oldakowska US 2024/0423685, as applied to claim 8 above, and in further view of Fisher US 2012/0172934.
Shimko discloses the claimed invention but does not disclose wherein at least one of the one or more blades comprises a non-expandable blade.
Fisher discloses a pedicle screw assembly (Fig 14) comprising support anchor (#2), a plurality of blades (#73, #71), a retractable shaft (“mandrel”, paragraph 94), wherein at least one of the one or more blades comprises a non-expandable blade (#71) due to its shorter length (Fig 14, paragraph 94 where when the retractable shaft is retracted a first distance, the non-expandable blade #71 does not expand) in order to provide desired or preferential degree of deflections for the blades (paragraph 89, 94).
It would have been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify one of the blades of Shimko as modified to have a shorter length such that it is a non-expandable blade in view of Fisher above because this provides a desired or preferential degree of deflections for the blades. The examiner notes that with the modification, the assembly can be expanded with the exception of the non-expandable blade depending on the amount of retraction of the distal head portion. Examiner notes that applicant is not claiming a method nor how the blade is non-expandable.
Conclusion
See PTO-892 for art of cited interest, in particular other screw assemblies with deflectable blades.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAN CHRISTOPHER L MERENE whose telephone number is (571)270-5032. The examiner can normally be reached Mon-Fri 8:30 am - 6pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Eduardo Robert can be reached at 571-272-4719. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JAN CHRISTOPHER L MERENE/ Primary Examiner, Art Unit 3773