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 .
Priority
This application claims priority from provisional application 62/676635, filed 05/25/2018.
Status of Claims
Claims 1-19, 22, 24-34, 38, and 41 are pending.
Claims 1-16, 29-34, 38, and 41 have been withdrawn from consideration.
Claims 20, 21, 23, 35-37, 39, and 40
Election/Restrictions
Applicant elected Species 5 (Figure 6) with traverse on 05/02/2024.
As confirmed by the applicant claim 41 is directed at the non-elected species comprising the additional extensions shown in Figures 3 and 8. The applicant argues that the specification discloses support for all other features disclosed to be part of the embodiment shown in Figures 6 and 7. This is not persuasive because the support sited is too ambiguous and unclear. The cited support merely says “other aspects of the system described above apply equally … and are incorporated herein by reference”. What counts and does not count as another aspect? Not all of the features are compatible without modification. Additionally what is meant by apply equally? How do they apply equally? What makes one aspect more or less equal than others. How are they incorporated by reference if they are part of the applicant’s invention? Incorporation by reference is typically done when referencing other documents not included in the disclosure. Consistent with the examiner’s reasoning, a proper incorporation by reference needs to be clear as to what specific elements are incorporated. Therefore the claims directed at systems with the additional extensions remain withdrawn as being directed at non-elected species.
Drawings
The drawings filed on 12/22/2024 have not been entered because they include new subject matter not disclosed within the original disclosure. There is no original support for the specific nature of the taper on either component (i.e. where it starts, where it stops, the angle of the taper, how much of the circumference is tapered).
The drawings remain objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the tapers of the recesses (claim 26) and the bushing outer surface with a matching taper (claim 27) must be shown or the feature(s) canceled from the claim(s). 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.
Specification
The previous objection to the disclosure has been withdrawn in view of the applicant’s amendments.
However, only the amendments to [0001] have been entered. The amendments to paragraphs [0067] and [0081] are considered to include new subject matter not supported by the original disclosure. Specifically, [0067] is directed to the new drawings which as described above contains new matter and hasn’t been entered. [0081] defines the armatures as extending parallel to each other and perpendicular to the body. This is considered new matter because there are no original recitations supporting this configuration. The only disclosure addressing they arms is in [0091] which says one arm is shorter and its collar is offset in the Z axis. In view of this disclosure, the singular view of the elected embodiment, and the curved nature of the arms a person of ordinary skill in the art would not be able to determine if the arms are parallel. Curved arms of different lengths don’t bring in uncertainty and fail to ensure the arms are parallel. They also don’t lend themselves to being considered perpendicular to any structure.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 17-19, 22, and 24-28 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Independent claim 1 has been amended to define the armatures as being “substantially parallel and extend substantially perpendicular to the thin plate” which is considered to be new matter. As explained in the specification objection above there is no support within the original disclosure for this configuration. The applicant appears to be relying purely on elected Figure 6. However, Figure 6 only shows one view and does not show the full extent of the curve and offset of the collars. [0091] states one arm is shorter than the other and its collar is offset in the Z axis. If the arms were disclosed as being straight and arranged at the same angle, Figure 6 could possibly support them being substantially parallel. However, they are curved and different lengths. Without a clear side view from the left or right of Figure 6 we cannot determine if the arms are truly parallel to each other. Every figure showing the applicant’s invention in use on a bone shows the arms both twist away from each other. Therefore with the original disclosure it is impossible to determine if the arms are substantially parallel to each other. Furthermore, since the curve of the arms relative to the thin plate is not clearly shown it is impossible to determine if they are substantially perpendicular to the thin plate. Since the arms curve away and about the thin plate it doesn’t appear they could be considered perpendicular. If there was a flattened section disclosed that section could possibly be considered perpendicular, but again we do not have disclosure within the specification or a side view of the elected embodiment which discloses this. Finally, the applicant’s attempt to enter into the specification support for such a configuration lends itself to support that there was no previous support. The amendments stand on their own with regards to the shape of the arms. It was not a clarification of previously disclosed recitations. Therefore this clause is considered to be new matter.
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 26 and 27 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.
Claims 26 and 27 are rendered indefinite by the description of the recess relative to surfaces of the plate. Specifically, the recess is defined as part of the armature, which in the elected embodiment curves away from the plate. The recesses do not lend themselves to be tapering with respect to surfaces of the plate. Additionally, as explained above, neither of these tapers are shown or consistent with the surfaces shown in the originally filed drawings. The applicant is advised to amend claim 26 to address the tapering with respect to the bushing or armature.
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 17-19, 22 and 24-28 are rejected under 35 U.S.C. 103 as being unpatentable over Buchanan et al (Buchanan) US 2014/0277176 in view of Day et al (Day) US 2015/0112395 A1.
Buchanan discloses the invention substantially as claimed being a surgical assembly 18 (Figures 1-6), comprising:
- a thin plate 24 having first and second sides (top and bottom of 24 Figure 3),
- one or more cylindrical bores 38 40 extending therethrough (Figure 3);
- two or more armatures 26/28 extending from the first or second side of the thin plate (top side of 24 Figure 3);
- wherein the armatures are substantially parallel and extend substantially perpendicular to the thin plate (the armatures of Buchanan both extend away from and about the thin plate in the same manner as the applicant’s invention, in view of the 112 rejections above the armatures of Buchanan read on this limitation as much as the applicant’s own invention)
- wherein each armatures comprising a recess 48/52 having an inner surface
However, Buchanan does not disclose the bushing and corresponding protrusion/notch.
Day teaches the use of a surgical assembly with polyaxially locking structures comprising bushings 518 with protrusions 509 that engage notches 507 of the through holes while maintaining the ability to receive a fastener (Figures 9-19) in the same field of endeavor for the purpose of limiting/allowing for polyaxial rotation within the through holes while permitting it to be locked at the desired orientation.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to combine the bushing with protrusion/notch taught by Day within the through hole of the assembly of Buchanan in order to permit polyaxial rotation of the screw within the through hole during implantation, but lockable at the desired orientation.
18. Buchanan rotation of the fastener beyond a predetermined amount rotates the bushing which urges the outwardly-extending protrusion to engage the notch and lock the position of the bushing relative to the thin plate (Figure 10 and [0057] of Day).
19. Buchanan discloses two or more armatures (Figures 5-6) comprise a first armature 46 having a curved shape and having a first recess 48 offset from an x-axis of the thin plate by about 90 degrees (Figures 5-6), and a second armature 50 having a curved shape and having a second recess 52 offset from the x-axis of the thin plate by about 90 degrees (Figures 5-6).
22. Buchanan discloses the first and second armatures comprise different lengths (shown best in Figure 2).
24. Day discloses the bushings are secured within the recesses by a frictional or interference fit [0008].
25. Day discloses the at least one outwardly-extending protrusion is selectively retractable, thereby allowing the bushing to pivot or rotate freely when the outwardly-extending protrusion is retracted (the bushings of the current invention Figure 2B and Figure 10 depicted in Day are depicted with identical structures and inherently act the same).
26. and 27. Buchanan and Day disclose the recess and bushing taper from a proximal surface of the thin plate to a distal surface of the thin plate (as explained above the original drawings do not depict the claimed tapers, but those of Buchanan and Day have the same degree of taper as the applicant’s own invention and thereby read on these limitations as much as the applicant’s invention).
28. Buchanan discloses the fastener is a cortical bone screw, a cancellous bone screw or a cannulated bone screw.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTOPHER D PRONE whose telephone number is (571)272-6085. The examiner can normally be reached Monday-Friday 10am-6pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie R Tyson can be reached on (571)272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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CHRISTOPHER D. PRONE
Primary Examiner
Art Unit 3774
/Christopher D. Prone/Primary Examiner, Art Unit 3774