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 Objections
Claim 31 is objected to because of the following informalities:
Claim 31, line 14, “threw” should be changed to --through--.
Appropriate correction by Applicant 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 26, 33, 34 and 37-39 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 26, “proximal end” lacks clear antecedent basis.
Claim 33, “proximal end” lacks clear antecedent basis.
Claim 37, “proximal end” lacks clear antecedent basis.
Dependent claims 34, 38 and 39 are rejected because they include the limitations of their respective rejected parent claim(s).
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)(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.
Claims 21, 25-37 and 40 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Seex (2016/0235448; cited by Applicant).
Regarding claim 21, Seex discloses a vertebral stabilization system (Fig. 11) comprising:
a shaft 150 (Fig. 8) with a threaded distal end and a larger diameter proximal end (id.), the distal end of the shaft comprising a first locking mechanism (threads; id.);
a guide assembly 200, 250 (Fig. 11) comprising a channel 210 (Fig. 4) sized to accept at least a portion of the shaft 150 (Figs. 8, 9 and 11) and an opening 258, 260 sized to accept a screw 410 (para. 0061; Fig. 11); and
an implant 100 (Fig. 9) comprising a distal end and a threaded proximal end, wherein the proximal end comprises an orifice 112 with a second locking mechanism (threads; para. 0034) configured to engage with the first locking mechanism (Fig. 9), wherein at least a portion of the shaft 150 can be inserted through the channel 210 and into the orifice (id.), and wherein engagement of the first locking mechanism (threads of the shaft 150; Fig. 8) and the second locking mechanism (threads of orifice 112; para. 0034) draws the implant toward the guide assembly 200, 250 by action of the threads advancing,
wherein the opening 258, 260 and the channel 210 are positioned such that the screw 410 extending through the opening (para. 0061 and Fig. 11) is non-parallel (Fig. 11) with the distal end of the shaft 150 when the first locking mechanism (threads of the shaft 150; Fig. 8) is engaged with the second locking mechanism (threads of orifice 112; para. 0034).
Regarding claim 25, the guide assembly 200, 250 is configured to accept the screw 410 while the first locking mechanism (threads of the shaft 150; Fig. 8) and the second locking mechanism (threads of the orifice 112; para. 0034) are engaged (Fig. 11).
Regarding claim 26, the proximal end of the shaft 150 has a larger diameter than an inner diameter of the channel 210 (Figs. 8-10).
Regarding claim 27, the implant 100 comprises an intervertebral cage (Fig 10; para. 0033).
Regarding claim 28, the implant 100 further comprises a vertebral stabilization plate 170 (Figs. 11 and 15).
Regarding claim 29, the system comprises a screw 410 (Fig. 11; para. 0061) and the screw is engageable with the implant 100 while the first locking mechanism (threads of the shaft 150; Fig. 8) is engaged with the second locking mechanism (threads of the orifice 112; para. 0034) (Fig. 11; para. 0061).
Regarding claim 30, the first locking mechanism (threads of the shaft 150; Fig. 8) is a male thread and the second locking mechanism (threads of the orifice 112; para. 0034; Fig. 8) is a female thread.
Regarding claim 31, Seex discloses a surgical system comprising:
a shaft 150 (Fig. 8) with a threaded distal end and a larger diameter proximal end (id.), the distal end of the shaft comprising a first locking mechanism (threads; id.);
a screw 410 (Fig. 11);
a guide assembly 200, 250 (Fig. 11) comprising a channel 210 (Fig. 4) sized to accept at least a portion of the shaft 150 (Figs. 8, 9 and 11) and an opening 258, 260 sized to accept the screw 410 (para. 0061; Fig. 11); and
an implant 100 (Fig. 9) comprising a distal end and a threaded proximal end, wherein the proximal end comprises an orifice 112 with a second locking mechanism (threads; para. 0034) configured to engage with the first locking mechanism (Fig. 9), wherein at least a portion of the shaft 150 can be inserted through the channel 210 and into the orifice (id.), and wherein engagement of the first locking mechanism (threads of the shaft 150; Fig. 8) and the second locking mechanism (threads of orifice 112; para. 0034) draws the implant toward the guide assembly 200, 250 by action of the threads advancing,
wherein the screw 410 is engageable with the implant 100 (Fig. 9) while the first locking mechanism (threads of the shaft 150; Fig. 8) is engaged with the second locking mechanism (threads of orifice 112; para. 0034) (Fig. 11; para. 0061), and
wherein the guide assembly 200, 250 is configured to accept the screw 410 through the opening 258, 260 while the first locking mechanism and the second locking mechanism are engaged (id.).
Regarding claim 32, distal portions of the opening 258, 260 and the channel 210 (Fig. 4) are positioned within the guide assembly 200, 250 at non-parallel angles (Fig. 11).
Regarding claim 33, the proximal end of the shaft 150 has a larger diameter than an inner diameter of the channel 210 (Figs. 8-10).
Regarding claim 34, the implant 100 comprises an intervertebral cage (Fig 10; para. 0033).
Regarding claim 35, Seex discloses a surgical system comprising:
a guide assembly 200, 250 (Fig. 11) comprising a channel 210 (Fig. 4) and a screw opening 258, 260 (para. 0061; Fig. 11);
a shaft 150 sized to traverse the channel (Figs. 8, 9 and 11), a distal end of the shaft comprising a first threaded connection (Fig. 8);
a screw 410 (Fig. 11; para. 0061); and
an implant 100 (Fig. 9) comprising an orifice 112 with a second threaded connection therein, the first threaded connection of the shaft 150 engageable with the second threaded connection of the orifice 112 (para. 0034),
wherein engagement of the first threaded connection of the shaft and the second threaded connection of the orifice 112 directly (Fig. 8) or indirectly (e.g., when not fully tightened) connects the implant 100 to the guide assembly 200, 250, and
wherein the guide assembly is positioned whereby at least a portion of the shaft 150 can extend from a distal end of the guide assembly 200, 250 concurrent with the screw 410 extending from the distal end of the guide assembly 200, 250 (Fig. 11; para. 0061).
Regarding claim 36, the channel 210 (Fig. 4) and the screw opening 258, 260 are positioned whereby the screw 410 and the distal end of the shaft 150 are configured to extend from the distal end of the guide assembly 200, 250 at non-parallel angles (Fig. 11).
Regarding claim 37, the proximal end of the shaft 150 has a larger diameter than an inner diameter of the channel 210 (Figs. 8-10).
Regarding claim 40, the implant 100 comprises an intervertebral cage (Fig 10; para. 0033).
Claim Rejections - 35 USC § 103
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 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 22-24, 38 and 39 are rejected under 35 U.S.C. 103 as being unpatentable over Seex (2016/0235448; cited by Applicant) in view of Jones et al. (2009/0105830).
Regarding claim 22, Seex discloses the claimed invention including a fastener 410 (Fig. 11) but does not explicitly recite it being sized and configured to at least partially extend through the orifice 112 (Fig. 9) or it being shearable.
Jones et al. teach that an orthopedic fastener 44 (Fig. 2; para. 0033) may comprise a shearable head 48 that that shears off at the proper torque to ensure proper torque is achieved (id.).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to configure fasteners 410 of Seex with a shearable head 48 that shears off at the proper torque, in view of Jones et al., to ensure that proper torque is achieved. It would have been further obvious to size and configure the threads of the modified fastener 410 to extend through the orifice 112, e.g., to provide further stabilization of the implant via the modified fastener 410.
Regarding claim 23, the modified shearable fastener 410 (supra at claim 22) includes the third locking mechanism, i.e., the threads (Figs. 11 and 12 of Seex).
Regarding claim 24, the modified shearable fastener 410 (supra at claims 22 and 23) comprises a shearable zone at the head 48 (para. 0033 of Jones et al.) which breaks when a shearing force is applied to the head (id.).
Regarding claim 38, Seex discloses the claimed invention including a fastener 410 (Fig. 11) but does not explicitly recite it being sized and configured to at least partially extend through the orifice 112 (Fig. 9) or it being shearable.
Jones et al. teach that an orthopedic fastener 44 (Fig. 2; para. 0033) may comprise a shearable head 48 that that shears off at the proper torque to ensure proper torque is achieved (id.).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to configure fasteners 410 of Seex with a shearable head 48 that shears off at the proper torque, in view of Jones et al., to ensure that proper torque is achieved. It would have been further obvious to size and configure the threads of the modified fastener 410 to extend through the orifice 112, e.g., to provide further stabilization of the implant via the modified fastener 410.
Regarding claim 39, the fastener 410 as modified includes the third locking mechanism, i.e., the threads (Figs. 11 and 12 of Seex). In addition, the modified fastener comprises a shearable zone by head 48 (supra; Fig. 2 of Jones et al. and para. 0033) which breaks when a shearing force is applied to a head of the shearable fastener.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure (see attached PTO-892).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID C COMSTOCK whose telephone number is (571)272-4710. The examiner can normally be reached M-F 9:00-5:00 PST.
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DAVID C. COMSTOCK
Examiner
Art Unit 3773
/DAVID C COMSTOCK/Examiner, Art Unit 3773
/EDUARDO C ROBERT/Supervisory Patent Examiner, Art Unit 3773