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 .
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 1-20 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 recites “the first and second side walls extending parallel to each other between proximal ends and distal ends of the first and second extension tabs” (lines 9-10). It is unclear how the side walls of the tulip extend between proximal and distal ends of the extension tabs, as the extension tabs extend from an end of respective side walls. For examination purposes, this limitation is interpreted as ---the first and second extension tabs extending parallel to each other between proximal and distal ends of the first and second extension tabs---.
Claim 1 recites the limitation "the slot” in line 6. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, this limitation will be interpreted as ---the pocket---.
Claim 5 recites “wherein the support ring includes an interior surface and an exterior surface, the retention spring engaging the exterior surface of the support ring to retain the support ring on the tulip extension”. The instant specification depicts a screw system comprising retention spring 260 that only engages an interior surface 322 of support ring 300 to retain the support ring on the extension tabs of the tulip extension, as illustrated in Figs. 1-20. Thus, it is unclear if the applicant is acting as his or her own lexicographer to specifically define the ring’s exterior surface as the surface defining the internal diameter of the support ring and the interior surface as the surface defining external diameter of the support ring, thus rendering the claim indefinite because the specification does not clearly redefine the term interior/exterior, or if the limitation merely includes a typographical error. In the case of the former, where applicant acts as his or her own lexicographer to specifically define a term of a claim contrary to its ordinary meaning, the written description must clearly redefine the claim term and set forth the uncommon definition so as to put one reasonably skilled in the art on notice that the applicant intended to so redefine that claim term. Process Control Corp. v. HydReclaim Corp., 190 F.3d 1350, 1357, 52 USPQ2d 1029, 1033 (Fed. Cir. 1999). For examination purposes, this limitation is interpreted as ---wherein the support ring includes an interior surface and an exterior surface, the retention spring engaging the interior surface of the support ring to retain the support ring on the tulip extension---.
Claim 16 recites “the first and second side walls extending parallel to each other between proximal ends and distal ends of the first and second extension tabs” (lines 9-10). It is unclear how the side walls of the tulip extend between proximal and distal ends of the extension tabs, as the extension tabs extend from an end of respective side walls. For examination purposes, this limitation is interpreted as ---the first and second extension tabs extending parallel to each other between proximal and distal ends of the first and second extension tabs---.
Claim 16 recites the limitation "the slot” in line 6. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, this limitation will be interpreted as ---the pocket---.
Claim 20 recites “the first and second side walls extending parallel to each other between proximal ends and distal ends of the first and second extension tabs” (lines 9-10). It is unclear how the side walls of the tulip extend between proximal and distal ends of the extension tabs, as the extension tabs extend from an end of respective side walls. For examination purposes, this limitation is interpreted as ---the first and second extension tabs extending parallel to each other between proximal and distal ends of the first and second extension tabs---.
Claim 20 recites the limitation "the slot” in line 6. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, this limitation will be interpreted as ---the pocket---.
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.
Claims 1-5 and 7-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wall (US 2013/0096635 A1).
Regarding claim 1, as best understood (see Examiner’s claim interpretation in view of rejections under 35 U.S.C. 112, noted above), Wall discloses a pedicle screw assembly (see Figs. 1-10) comprising:
a screw body (shown in Figs. 6, 10-11; para. 0014) having a head and a threaded shaft extending from the head (screw body shown to be held in receiver identified by reference numeral “40” is understood to have a head and a threaded shaft extending therefrom, though not explicitly described in the reference);
a tulip (40; Figs. 6, 10-11) having a pocket receiving the head of the screw body, the tulip having a first side wall and a second side wall on opposite sides of the pocket, the tulip having rod openings defined between the first and second side walls configured to receive a rod (tulip receiver labeled with reference numeral “40” in Figs. 6 and 10-11 is understood to have a pocket for the head of a screw and first and second upstanding legs defining opposing side walls defining rod openings);
a set screw received in the pocket to secure the rod in the slot (tulip receiver “40” in Figs. 6 and 10-11 is shown to have internal threading formed on the side walls for receiving a set screw to secure a rod received therein);
a tulip extension (defined by extenders 39; Fig. 6; para. 0032) extending from the tulip (40, as shown; Fig. 6), the tulip extension including a first extension tab extending from the first side wall and a second extension tab extending from the second side wall (as shown, first and second extension tabs 39 extending from respective sidewalls of tulip 40; Fig. 6), the first and second side walls (extension tabs) extending parallel to each other between proximal ends and distal ends of the first and second extension tabs (as shown in at least Fig. 6; recited in Abstract and para. 0033-0035), the tulip extension having a lumen defined between the first and second extensions (lumen defined by internal channel formed between extension tabs 39; Fig. 6), the tulip extension having slots defined between the first and second extensions aligned with the rod openings (see Fig. 6), the tulip extension including a deflectable retention spring along the first extension tab (each extension tab 39 includes a deflectable retention spring at end 32 defined by flexible tongs 36, 37; Figs. 4-10; para. 0036-0037); and
a support ring (collar 10; Figs. 1-3, 6-8; para. 0030) coupled to the distal ends of the first and second extension tabs to support the first and second extension tabs relative to each other (as shown in Figs. 7-10; para. 0043), wherein the support ring interfaces with the retention spring to retain the support ring on the first and second extension tabs (particularly shown in Fig. 9; para. 0035-0043), and wherein the retention spring is releasable from the support ring to allow removal of the support ring from the distal ends of the first and second extension tabs (described in para. 0037-0039, pulling support ring collar 10 is releasable from detents 43 of the support spring defined at distal ends 32 of extension tabs 39; Figs. 1-10).
Regarding claim 2, Wall teaches the pedicle screw assembly of claim 1, wherein the retention spring includes a lip protruding outwardly to engage the support ring (see Fig. 9, detents 43 defines a lip protruding outwardly from respective tongs 36, 37 of the retention spring for engaging support ring collar 10; para. 0035).
Regarding claim 3, Wall teaches the pedicle screw assembly of claim 1, wherein the retention spring is coincident with the first extension tab (tongs 36, 37 defining the retention spring are present on each of first and second extension tabs 39; Figs. 6-10).
Regarding claim 4, Wall teaches the pedicle screw assembly of claim 1, wherein the retention spring passes through an opening in the support ring along an interior of the support ring (retention springs defined by tongs 36, 37 on each extension tab 39 pass through a respective opening 21, 22 in support ring 10; Figs. 1-10; para. 0030-0031).
Regarding claim 5, as best understood (see Examiner’s claim interpretation in view of rejections under 35 U.S.C. 112, noted above), Wall teaches the pedicle screw assembly of claim 1, wherein the support ring (10; Figs. 1-3) includes an interior surface and an exterior surface (Figs. 1-3), the retention spring (36, 37; Figs. 5, 9) engaging the exterior (interior) surface of the support ring to retain the support ring on the tulip extension (tongs 36, 37 defining the retention springs engage interior surfaces at channels 21, 22 of support ring 10 to retain ring on extensions 39; Figs. 1-10), the interior surface engaging the first and second extension tabs (see Figs. 7-10).
Regarding claim 7, Wall teaches the pedicle screw assembly of claim 1, wherein the retention spring is a first retention spring, the tulip extension further comprises a second retention spring along the second extension tab (see Figs. 4-10; each of first and second extension tabs 39 has a retention spring defined by deflectable tongs 36, 37).
Regarding claim 8, Wall teaches the pedicle screw assembly of claim 7, wherein the second retention spring is on an opposite side of the lumen as the first retention spring (each retention spring, defined by tongs 36, 37, is defined on opposing extension tabs 39 defining the lumen therebetween; Figs. 4-10).
Regarding claim 9, Wall teaches the pedicle screw assembly of claim 1, wherein the retention spring is deflectable inward into the lumen to release the support ring (described in para. 0038, detents 43 of the tongs 36, 37 defining the retention spring can be depressed inwardly to remove support ring 10; Figs. 1-10).
Regarding claim 10, Wall teaches the pedicle screw assembly of claim 1, wherein the tulip extension includes a collar having a first shoulder along the first extension tab and a second shoulder along the second extension tab, the first and second shoulders forming a seat for the support ring to locate the support ring along the first and second extension tabs, the retention spring holding the support ring on the seat (extension tabs 39 collectively define a collar at distal ends 38, where each extension tab 39 of the tulip extension has two detents 43 defining shoulders forming a seat for support ring 10 as depicted in Fig. 9, so tongs 46, 47 defining the retention spring hold the support ring; Figs. 1-14; para. 0035-0040).
Regarding claim 11, Wall teaches the pedicle screw assembly of claim 1, wherein the first and second tab extensions are removable from the first and second side walls (para. 0039 recites that tab extensions 39 can be removed upon disconnection of support ring collar 10).
Regarding claim 12, Wall teaches the pedicle screw assembly of claim 1, wherein the support ring (10; Figs. 1-2) includes a ring body (11; Fig. 1; para. 0030) surrounding an opening (12; Fig. 1) configured to receive the distal ends of the first and second extension tabs (see Figs. 6-10), the ring body surrounding the first and second extension tabs to prevent opening of the first and second extension tabs relative to each other, the ring body coupled to the first and second extension tabs to support the first and second extension tabs and prevent closing of the first and second extension tabs relative to each other (see Figs. 1-14; para. 0030).
Regarding claim 13, Wall teaches the pedicle screw assembly of claim 12, wherein the ring body (11; Figs. 1-2; para. 0030) includes a first tab channel (21; Fig. 2) along a first side of the opening and a second tab channel (22; Fig. 2) along a second side of the opening, the first tab channel receiving the first tab extension, the second tab channel receiving the second tab extension (see Figs. 6-10).
Regarding claim 14, Wall teaches the pedicle screw assembly of claim 13, wherein the ring body includes tab hooks (24, 25, 26, 27; Fig. 2; para. 0033) defining the first and second tab channels (21, 22, as shown; Fig. 2), the tab hooks capturing the first and second tab extensions in the first and second tab channels to prevent inward movement of the first and second tab extensions (see Figs. 6-10).
Regarding claim 15, Wall teaches the pedicle screw assembly of claim 12, wherein the ring body includes support pads (24, 25, 26, 27; Fig. 2; para. 0033) between the first and second tab channels (21, 22, as shown; Fig. 2), the support pads engaging edges of the first and second tab extensions to prevent inward movement of the first and second tab extensions (see Figs. 6-10).
Regarding claim 16, as best understood (see Examiner’s claim interpretation in view of rejections under 35 U.S.C. 112, noted above), Wall discloses a pedicle screw assembly (see Figs. 1-10) comprising:
a screw body (shown in Figs. 6, 10-11; para. 0014) having a head and a threaded shaft extending from the head (screw body shown to be held in receiver identified by reference numeral “40” is understood to have a head and a threaded shaft extending therefrom, though not explicitly described in the reference);
a tulip (40; Figs. 6, 10-11) having a pocket receiving the head of the screw body, the tulip having a first side wall and a second side wall on opposite sides of the pocket, the tulip having rod openings defined between the first and second side walls configured to receive a rod (tulip receiver labeled with reference numeral “40” in Figs. 6 and 10-11 is understood to have a pocket for the head of a screw and first and second upstanding legs defining opposing side walls defining rod openings);
a set screw received in the pocket to secure the rod in the slot (tulip receiver “40” in Figs. 6 and 10-11 is shown to have internal threading formed on the side walls for receiving a set screw to secure a rod received therein);
a tulip extension (defined by extenders 39; Fig. 6; para. 0032) extending from the tulip (40, as shown; Fig. 6), the tulip extension including a first extension tab extending from the first side wall and a second extension tab extending from the second side wall (as shown, first and second extension tabs 39 extending from respective sidewalls of tulip 40; Fig. 6), the first and second side walls (extension tabs) extending parallel to each other between proximal ends and distal ends of the first and second extension tabs (as shown in at least Fig. 6; recited in Abstract and para. 0033-0035), the tulip extension having a lumen defined between the first and second extensions (lumen defined by internal channel formed between extension tabs 39; Fig. 6), the tulip extension having slots defined between the first and second extensions aligned with the rod openings (see Fig. 6); and
a support ring (collar 10; Figs. 1-3, 6-8; para. 0030) including a ring body (11; Fig. 1; para. 0030) surrounding an opening (12; Fig. 1) configured to receive the distal ends of the first and second extension tabs (see Figs. 6-10), the ring body surrounding the first and second extension tabs to prevent opening of the first and second extension tabs relative to each other, the ring body coupled to the first and second extension tabs to support the first and second extension tabs and prevent closing of the first and second extension tabs relative to each other (see Figs. 1-14; para. 0030).
Regarding claim 17, Wall teaches the pedicle screw assembly of claim 16, wherein the ring body (11; Figs. 1-2; para. 0030) includes a first tab channel (21; Fig. 2) along a first side of the opening and a second tab channel (22; Fig. 2) along a second side of the opening, the first tab channel receiving the first tab extension, the second tab channel receiving the second tab extension (see Figs. 6-10).
Regarding claim 18, Wall teaches the pedicle screw assembly of claim 17, wherein the ring body includes tab hooks (24, 25, 26, 27; Fig. 2; para. 0033) defining the first and second tab channels (21, 22, as shown; Fig. 2), the tab hooks capturing the first and second tab extensions in the first and second tab channels to prevent inward movement of the first and second tab extensions (see Figs. 6-10).
Regarding claim 19, Wall teaches the pedicle screw assembly of claim 16, wherein the ring body includes support pads (24, 25, 26, 27; Fig. 2; para. 0033) between the first and second tab channels (21, 22, as shown; Fig. 2), the support pads engaging edges of the first and second tab extensions to prevent inward movement of the first and second tab extensions (see Figs. 6-10).
Regarding claim 20, as best understood (see Examiner’s claim interpretation in view of rejections under 35 U.S.C. 112, noted above), Wall teaches a pedicle screw assembly (see Figs. 1-10) comprising:
a screw body (shown in Figs. 6, 10-11; para. 0014) having a head and a threaded shaft extending from the head (screw body shown to be held in receiver identified by reference numeral “40” is understood to have a head and a threaded shaft extending therefrom, though not explicitly described in the reference);
a tulip (40; Figs. 6, 10-11) having a pocket receiving the head of the screw body, the tulip having a first side wall and a second side wall on opposite sides of the pocket, the tulip having rod openings defined between the first and second side walls configured to receive a rod (tulip receiver labeled with reference numeral “40” in Figs. 6 and 10-11 is understood to have a pocket for the head of a screw and first and second upstanding legs defining opposing side walls defining rod openings);
a set screw received in the pocket to secure the rod in the slot (tulip receiver “40” in Figs. 6 and 10-11 is shown to have internal threading formed on the side walls for receiving a set screw to secure a rod received therein);
a tulip extension (defined by extenders 39; Fig. 6; para. 0032) extending from the tulip (40, as shown; Fig. 6), the tulip extension including a first extension tab extending from the first side wall and a second extension tab extending from the second side wall (as shown, first and second extension tabs 39 extending from respective sidewalls of tulip 40; Fig. 6), the first and second side walls (extension tabs) extending parallel to each other between proximal ends and distal ends of the first and second extension tabs (as shown in at least Fig. 6; recited in Abstract and para. 0033-0035), the tulip extension having a lumen defined between the first and second extensions (lumen defined by internal channel formed between extension tabs 39; Fig. 6), the tulip extension having slots defined between the first and second extensions aligned with the rod openings (see Fig. 6), the tulip extension including a deflectable retention spring along the first extension tab (each extension tab 39 includes a deflectable retention spring at end 32 defined by flexible tongs 36, 37; Figs. 4-10; para. 0036-0037); and
a support ring (collar 10; Figs. 1-3, 6-8; para. 0030) including a ring body (11; Fig. 1; para. 0030) surrounding an opening (12; Fig. 1) configured to receive the distal ends of the first and second extension tabs (see Figs. 6-10), the ring body surrounding the first and second extension tabs to prevent opening of the first and second extension tabs relative to each other, the ring body coupled to the first and second extension tabs to support the first and second extension tabs and prevent closing of the first and second extension tabs relative to each other (see Figs. 1-14; para. 0030);
wherein the support ring interfaces with the retention spring to retain the support ring on the first and second extension tabs (particularly shown in Fig. 9; para. 0035-0043), and wherein the retention spring is releasable from the support ring to allow removal of the support ring from the distal ends of the first and second extension tabs (described in para. 0037-0039, pulling support ring collar 10 is releasable from detents 43 of the support spring defined at distal ends 32 of extension tabs 39; Figs. 1-10).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Wall (US 2013/0096635 A1), as applied to claim 1 above, further in view of Beyer (US 2022/0401130 A1).
Regarding claim 6, Wall discloses the pedicle screw assembly of claim 1.
Wall also discloses wherein the components of the extender system, i.e. the extension tabs having the retention spring tongs, may be formed of metal (see para. 0029).
However, Wall does not specifically disclose wherein the retention spring is stamped from the first extension tab.
Beyer, in analogous art, teaches wherein screw extender extension tabs “can be manufactured from a single piece of metal material, for example a strip of stainless steel, an can then be stamped […] to have its final U-shape with all the features” (see para. 0031, referencing extender 100 shown in Figs. 1A-2B).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have stamped the profile of Wall’s metal tongs defining the retention spring, as claimed and taught by Beyer, because Beyer recognizes that stamping or cutting metal to form the outline of a screw extension is known in the art (see Beyer, para. 0031-0032).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Other relevant references can be found in the attached PTO-892.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANNA VICTORIA LITTLE whose telephone number is (571)272-6630. The examiner can normally be reached M-F 9a-6p EST.
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, 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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ANNA V. LITTLE/ Examiner, Art Unit 3773 /JACQUELINE T JOHANAS/Primary Patent Examiner, Art Unit 3773