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.
Claim 9 is 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 9 recites “the engaging surface” in line 1. It is unclear if this limitation refers to the engaging surface of the shank head or the engaging surface of the head clamp. For examination purposes, claim 9 is interpreted as reciting ---the engaging surface of the head clamp---.
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 1-8, 10-14 and 16-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by McPhee (US 2022/0008103 A1).
Regarding claim 1, McPhee teaches a bone securing system (10; Figs. 1-4; Abstract; para. 0042) comprising:
a shank (12; Fig. 1; para. 0043) that is designed to be secured to bone (designed for insertion in a vertebra; para. 0046), the shank comprising a shank head (16; Fig. 1) and an extension (24; Fig. 1) extending from the shank head, the shank head comprising an engaging surface (defined by the exterior surface of shank head 16, including truncated flat surfaces 28 with curved surfaces formed therebetween; Figs. 1, 5; para. 0047-0048); and
a head assembly (14, 18; Fig. 1; para. 0047) comprising:
an assembly head (seat 18; Fig. 1) defining a central hole (recess 44; Fig. 11; para. 0057) therethrough extending in a proximal direction and in a distal direction that is opposite the proximal direction (as shown in at least Fig. 11), the assembly head defining a channel (62a/b; Fig. 11; para. 0062) transverse to the central hole (as shown in at least Fig. 11), the assembly head comprising tabs (60a/b; Fig. 11; para. 0062) extending in the proximal direction on opposite sides of the channel and the central hole (as shown in at least Fig. 11); and
a head clamp (collet 14; Fig. 1) designed to be positioned at least partially within the central hole (44, as shown, Figs. 1-4 and 11, described in para. 0057), the head clamp being designed to receive the shank head and to clamp onto the shank head to secure the shank head in position at least partially in the assembly head with the extension extending away from the head assembly (as shown in Figs. 1-4, shank head 16 received in lower end of head clamp/collet 14, between claw elements 40a-f identified in Fig. 6, with extension 24 facing away from head assembly 14/18; para. 0053), the head clamp comprising an engaging surface (defined by inner surfaces of claw elements 40a-f, including flat bearing surfaces 26a, 26b formed on respective claw elements 40a, 40d which correspond to flat surfaces 28 of the shank head engaging surface; Figs. 1-6; para. 0053) that is shaped and positioned to engage the engaging surface of the shank head (shown in Figs. 1-3, described in at least para. 0048, 0053) to limit pivotal movement of the shank relative to the head clamp to a movement pattern (the uniaxial tilting pattern schematically shown in Fig. 4, effected by uniaxial head clamp/collet 14, as described in para. 0047 for tilting about axis 30), at least a portion of the engaging surface of the head clamp facing in the distal direction toward the shank head (engaging surface 26a,26b of clamp 14 correspond to and engage engaging surface 28a, 28b of shank 12 so as to enable uniaxial tilting action shown schematically in Fig. 4; also see Figs. 5-6; para. 0047-0048, 0053).
Regarding claim 2, McPhee teaches the bone securing system of claim 1, wherein the engaging surface of the shank head faces away from the extension (see Fig. 1; exterior surface of shank head 28 defining the engaging surface of the shank head faces away from extension 24).
Regarding claim 3, McPhee teaches the bone securing system of claim 1, wherein the head clamp (14; Fig. 1) is designed to be fixed to the assembly head while the head clamp is positioned at least partially within the central hole (as shown in Figs. 2-3, clamp 14 positioned within assembly head 18), and the engaging surface of the head clamp is shaped and positioned to engage the engaging surface of the shank head to limit pivotal movement of the shank relative to the assembly head (as shown in Figs. 1-4, limiting movement of shank 12 relative to assembly head 18 to movement about tilt axis 30; para. 0047).
Regarding claim 4, McPhee teaches the bone securing system of claim 1, wherein the head assembly is designed to allow pivotal movement of the shank in the movement pattern relative to the head clamp (flat bearing surfaces 26a, 26b formed on respective claw elements 40a, 40d of the head clamp/collet 14 of the head assembly allow pivotal movement of shank 12 in the movement pattern about tilt axis 30 relative to head clamp 14; Figs. 1-6; para. 0047-0048).
Regarding claim 5, McPhee teaches the bone securing system of claim 1, wherein the movement pattern is a uniaxial movement pattern (as described above, uniaxial head clamp/collet 14 provides uniaxial tilting of shank 12 about tilt axis 30; Figs. 4-5; para. 0047-0048).
Regarding claim 6, McPhee teaches the bone securing system of claim 1, wherein the head assembly is designed to be mounted on the shank head without all of the extension being passed into the assembly head (as shown in Figs. 1-4, extension 24 of shank 12 extending out of assembly head 18).
Regarding claim 7, McPhee teaches the bone securing system of claim 1, wherein the head clamp is a collar with a central hole passing therethrough (see Fig. 6, head clamp 14 in the form of a collet/collar with a central hole).
Regarding claim 8, McPhee teaches the bone securing system of claim 7, wherein the engaging surface of the head clamp forms a shape that is at least a portion of a circular shape (engaging surface of head clamp 114 defined by interior surfaces of claw elements 40a-f forms a partially circular shape aside from flat bearing surfaces 26a, 26b; Fig. 6).
Regarding claim 10, McPhee teaches the bone securing system of claim 1, wherein the assembly head (18; Fig. 1) is designed to move proximally into a closed position relative to the head clamp to secure the shank head relative to the head clamp and the assembly head, while still allowing the movement pattern of the shank relative to the head clamp and the assembly head (assembly head 18 is designed to threadably receive set screw 49 to push head clamp/collet 14 downward into an operative position therein, such that assembly head 18 moves upward, i.e. proximally, relative to the head clamp 14 to secure shank head 16 and enable the pivoting movement pattern of shank 12 relative to head clamp 14 and assembly head about tilt axis 30, as described above; Figs. 1-5; para. 0043, 0057, 0061).
Regarding claim 11, McPhee teaches the bone securing system of claim 1, wherein the channel is designed to receive a rod (channel 62a, 62b of assembly head 18 receives rod 22; Figs. 1-4, 11; para. 0062), and the head assembly is designed to secure the rod to the shank (shown in Figs. 3-4), the securing of the rod to the shank applying pressure to lock the shank relative to the head clamp and the assembly head (via collet actuator 20 in the form of set screw 49; Figs. 1-4; para. 0061).
Regarding claim 12, McPhee teaches the bone securing system of claim 1, wherein the head clamp is a first head clamp (head clamp/collet 14 in Figs. 1-4 and 6 is a first uniaxial head clamp), the engaging surface of the first head clamp is a first engaging surface, the movement pattern is a first movement pattern (inner surfaces of claw elements 40a-f of first head clamp 14 define the first engaging surface providing the movement pattern shown in Fig. 4, i.e. a first movement pattern, allowing pivoting of shank 30 about tilt axis 30), and the bone securing system further comprises:
a second head clamp (defined by alternative uniaxial inner collet 14’ depicted in Fig. 7; para. 0054) designed to be positioned at least partially within the central hole instead of the first head clamp (as described in para. 0054), the second head clamp being designed to receive the shank head and to clamp onto the shank head to secure the shank head in position at least partially in the assembly head with the extension extending away from the head assembly (shown in Fig. 8), the second head clamp being shaped differently from the first head clamp to limit movement of the shank to a second movement pattern that is different from the first movement pattern (second head clamp 14’ is shaped slightly differently than first head clamp 14, as shown between Figs. 6 and 7 where bearing surfaces 26 are configured differently in second clamp 14’ to provide the second movement pattern shown in Fig. 8 where shank 12 can pivot about a second axis 30’, the second movement pattern different from the first movement pattern shown in Fig. 4).
Regarding claim 13, McPhee teaches the bone securing system of claim 12, wherein the first movement pattern is a uniaxial movement pattern (as shown in Fig. 4, described in at least para. 0053), and wherein the second movement pattern is either a different uniaxial movement pattern from the first movement pattern (second movement pattern shown in Fig. 8 is a different uniaxial movement pattern, described in para. 0054), a polyaxial movement pattern, or a monoaxial movement pattern.
Regarding claim 14, McPhee teaches a bone securing system (10; Figs. 1-4; Abstract; para. 0042) comprising:
a shank (12; Fig. 1; para. 0043) designed to be secured to bone (designed for insertion in a vertebra; para. 0046), the shank comprising a shank head (16; Fig. 1) and an extension (24; Fig. 1) extending from the shank head, the shank head comprising an engaging surface that faces away from the extension (defined by the external surface of head 16, including truncated flat surface 28, facing away from extension 24; Figs. 1, 5; para. 0047); and
a head assembly (14, 18; Fig. 1; para. 0047) designed to secure the shank head to a rod (22, as shown; Figs. 1-4; para. 0043), the head assembly comprising an engaging surface (defined by inner surfaces of claw elements 40a-f, including bearing surfaces 26a, 26b formed on respective claw elements 40a, 40d of the collet 14; Figs. 1-4, 11) that is shaped and positioned to engage the engaging surface of the shank head (engaging surface 26a,26b of clamp 14 correspond to and engage engaging surface 28a, 28b of shank 12 so as to enable uniaxial tilting action shown schematically in Fig. 4; also see Figs. 5-6; para. 0047-0048, 0053) to limit pivotal movement of the shank relative to the engaging surface of the head assembly, but to allow some pivotal movement of the shank relative to the engaging surface of the head assembly (as schematically shown in Fig. 4; para. 0047), the engaging surface of the head assembly facing toward the engaging surface of the shank head (as shown in at least Fig. 3).
Regarding claim 16, McPhee teaches the bone securing system of claim 14, wherein the engaging surface of the head assembly forms a shape that is at least a portion of a circular shape (engaging surface of collet 14 of the head assembly, defined by interior surfaces of claw elements 40a-f, forms a partially circular shape aside from flat bearing surfaces 26a, 26b; Fig. 6).
Regarding claim 17, McPhee teaches a method comprising:
selecting a selected head clamp from multiple different available head clamps, the different available head clamps being designed to produce different pivotal movement patterns between head assemblies in which the head clamps are secured and shanks that are secured to the head assemblies using the head clamps, the selected head clamp being designed to produce a selected pivotal movement pattern (selecting a head clamp/collet 14, shown in Figs. 1-4, of several head clamps/collets including at least collet 14 in Fig. 6 producing a first pivotal movement pattern shown in Fig. 4, collet 14’ in Fig. 7 producing a second pivotal movement pattern shown in Fig. 8, a third collet 140 in Fig. 9 for producing a third pivotal movement pattern described in para. 0055 and a fourth collet 140’ in Fig. 10 for producing a fourth pivotal movement pattern described in para. 0056; the movement patterns defined between a head assembly 14/18 and shank 12 head within the head 14 via clamp 16);
securing a head assembly (14, 18; Fig. 1; para. 0047) on a shank head of a shank in a motion limiting configuration (secured on shank head 16 in Figs. 1-4, in a motion limiting configuration schematically shown in Fig. 4), the shank being designed to be secured in bone (designed for insertion in a vertebra; para. 0046), the head assembly comprising the selected head clamp (14; Figs. 1-4, 6) positioned at least partially in an assembly head in the motion limiting configuration (as shown; Figs. 1-4), the head assembly being configured to secure the shank to a rod (22; Figs. 1-4; para. 0062), the securing of the head assembly comprising receiving at least a portion of the shank head in the selected head clamp (as shown in Figs. 2-3), and the selected head clamp comprising an engaging surface (defined by inner surfaces of claw elements 40a-f, including flat bearing surfaces 26a, 26b formed on respective claw elements 40a, 40d which correspond to flat surfaces 28 of the shank head engaging surface; Figs. 1-6; para. 0053) that is shaped and positioned to engage the engaging surface of the shank head (shown in Figs. 1-3, described in at least para. 0048, 0053) to limit pivotal movement of the shank relative to the selected head clamp to the selected pivotal movement pattern while in the motion limiting configuration (uniaxial tilting movement pattern schematically shown in Fig. 4, effected by selected uniaxial head clamp/collet 14, as described in para. 0047, for limiting tilting of shank to movement about axis 30); and
pivoting the head assembly and the shank relative to each other within the selected pivotal movement pattern while the selected head clamp and the shank are in the motion limiting configuration (as schematically shown in Fig. 4; para. 0047), the pivoting comprising pivoting at least a portion of the engaging surface of the shank head away from at least a portion of the engaging surface of the selected head clamp while the at least a portion of the engaging surface of the shank head and the at least a portion of the engaging surface of the head clamp face toward each other (the pivoting shown in Fig. 4, described in at least para. 0047, is understood to involve pivoting the shank head 16 within the assembled head 18 and selected clamp 14 so that the engaging surface of the shank head pivots away from the assembled head clamp 14 while facing the engaging surface defined within claws 40 of the selected clamp 14; Figs. 1-6).
Regarding claim 18, McPhee teaches the method of claim 17, further comprising locking the shank relative to the head assembly in a locked configuration that inhibits pivoting of the shank and the head assembly relative to each other (locking set screw 49 is threaded into assembly head 18 to push rod 22 and head clamp 14 downward into a locked configuration where pivoting of shank 12 relative to head assembly 14/18 is inhibited; para. 0061).
Regarding claim 19, McPhee teaches the method of claim 17, wherein the securing comprises mounting the head assembly on the shank head with the head assembly in an open position wherein the shank head is moveable into and out of the selected head clamp (open position shown in Fig. 2), and moving the head assembly to a closed position in which the head assembly inhibits movement of the shank head out of the selected head clamp, wherein the motion limiting configuration comprises the head assembly being in the closed position (closed position shown in Figs. 3-4, where set screw 49 has been installed to inhibit movement of shank head 16 out of selected clamp 14, where the motion limiting configuration of Fig. 4 comprises the closed position; para. 0047, 0061).
Regarding claim 20, McPhee teaches the method of claim 17, further comprising securing the shank to a bone, wherein the pivoting is performed while the shank is secured to the bone (where at least para. 0047 describes the pivoting as tilting in a sagittal plane suitable for a coronal imbalance, the pivoting is understood to occur while the shank 12 is secured in a vertebral element; Figs. 1-4).
Claims 1, 7, 9, 14 and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shluzas (US 2006/0276791 A1).
Regarding claim 1, Shluzas teaches a bone securing system (10; Figs. 1-4; para. 0014) comprising:
a shank (16; Fig. 1) that is designed to be secured to bone (fastened to vertebrae; para. 0014), the shank comprising a shank head (second end portion 26, including first spherical surface 28 and second part spherical surface 30; Figs. 1-4; para. 0016) and an extension (threaded end portion 22; Figs. 1-3; para. 0016) extending from the shank head (as shown; Figs. 1-3), the shank head comprising an engaging surface (defined by part spherical surface 30; Figs. 1-4); and
a head assembly (40, 60; Figs. 1-4; Abstract) comprising:
an assembly head (housing 40; Figs. 1-4) defining a central hole therethrough extending in a proximal direction and in a distal direction that is opposite the proximal direction (as shown in Figs. 2-4, having a central hole for receiving spacer 60 and shank head 26), the assembly head defining a channel transverse to the central hole (channel defined by passage 42 for receiving rod 12; Figs. 1-4), the assembly head comprising tabs extending in the proximal direction on opposite sides of the channel and the central hole (as shown in Figs. 1-4); and
a head clamp (spacer 60; Figs. 1-4) designed to be positioned at least partially within the central hole (as shown in Figs. 1-4), the head clamp being designed to receive the shank head and to clamp onto the shank head to secure the shank head in position at least partially in the assembly head with the extension extending away from the head assembly (as shown in Figs. 1-4), the head clamp comprising an engaging surface (defined by part spherical surface 62; Figs. 2-4; para. 0018) that is shaped and positioned to engage the engaging surface of the shank head to limit pivotal movement of the shank relative to the head clamp to a movement pattern (engaging surface 62 of clamp 60 engages correspondingly shaped part spherical engaging surface 30 of shank head 26 to limit pivotal movement of shank 16 relative to housing 40 and clamp 60 to a polyaxial movement pattern, e.g. when a user manually moves the shank 16 relative to the housing as described in at least para. 0022; Figs. 1-4), at least a portion of the engaging surface of the head clamp facing in the distal direction toward the shank head (as shown, engaging surface 62 of clamp 60 facing downward, in the distal direction, toward shank head 26; Figs. 2-4).
Regarding claim 7, Shluzas teaches the bone securing system of claim 1, wherein the head clamp is a collar with a central hole passing therethrough (spacer 60 defining the head clamp is shown as a collar with a central hole 66 passing therethrough; Figs. 1-4; para. 0018).
Regarding claim 9, Shluzas teaches the bone securing system of claim 7, wherein the engaging surface is on a shoulder that faces in the distal direction when the head clamp is positioned at least partially in the assembly head (engaging surface 62 of head clamp 60, identified in Figs. 2-3, is on a lower shoulder of the head clamp facing in a downward, distal direction hen head clamp 60 is positioned within assembly head housing 40; para. 0018).
Regarding claim 14, Shluzas teaches a bone securing system (10; Figs. 1-4; para. 0014) comprising:
a shank (16; Fig. 1) designed to be secured to bone (fastened to vertebrae; para. 0014), the shank comprising a shank head (second end portion 26, including first spherical surface 28 and second part spherical surface 30; Figs. 1-4; para. 0016) and an extension (threaded end portion 22; Figs. 1-3; para. 0016) extending from the shank head (as shown; Figs. 1-3), the shank head comprising an engaging surface that faces away from the extension (engaging surface defined by part spherical surface 30; Figs. 1-4); and
a head assembly (40, 60; Figs. 1-4; Abstract) designed to secure the shank head to a rod (12; Figs. 1-4), the head assembly comprising an engaging surface (defined by part spherical surface 62 of spacer 60; Figs. 2-4; para. 0018) that is shaped and positioned to engage the engaging surface of the shank head to limit pivotal movement of the shank relative to the engaging surface of the head assembly, but to allow some pivotal movement of the shank relative to the engaging surface of the head assembly (engaging surface 62 of spacer 60 engages correspondingly shaped part spherical engaging surface 30 of shank head 26 to limit pivotal movement of shank 16 relative to housing 40 and clamp 60 to a polyaxial movement pattern, but allow some pivotal movement when a user manually moves the shank 16 relative to the housing as described in at least para. 0022; Figs. 1-4), the engaging surface of the head assembly facing toward the engaging surface of the shank head (as shown; Figs. 2-4).
Regarding claim 15, Shluzas teaches the bone securing system of claim 14, wherein the engaging surface of the shank head is on an end of the shank head opposite the extension (engaging surface 30 of shank head 26 is on an upper end of the shank head, opposite extension 24; Figs. 1-4).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Other relevant prior art 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
/EDUARDO C ROBERT/Supervisory Patent Examiner, Art Unit 3773
Prosecution Insights