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 .
Drawings
New corrected drawings in compliance with 37 CFR 1.121(d) are required in this application because the details of the drawings are unclear with shaded/gray-scale drawings provided. Applicant is advised to submit clear black and white drawings and employ the services of a competent patent draftsperson outside the Office, as the U.S. Patent and Trademark Office no longer prepares new drawings. The corrected drawings are required in reply to the Office action to avoid abandonment of the application. The requirement for corrected drawings will not be held in abeyance.
Claim Objections
Claims 14, 24, 28, 31, 35 and 41 are objected to because of the following informalities:
Claim 14, lines 1-2 recite “wherein the first and second expansion assembly” and should be amended to recite “wherein the first and second expansion assemblies”.
Claim 24, lines 11-12 recite “the unexpanded state and the expanded state” and should be amended to recite “the expanded state to the expanded state”.
Claim 28, line 10 recites “configured push apart” and should be amended to recite “configured to push apart”.
Claim 31, line 2 recites “includes in pair pivots” and should be amended to recite “includes a pair of pivots”.
Claim 35, line 2 recites “includes a first locking feature includes” and should be amended to recite “includes a first locking feature which includes”.
Claim 41, lines 2-3 recite “at least a portion of one locking arms” and should be amended to recite “at least a portion of one of the locking arms”.
Appropriate correction 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 2, 5, 7, 10, 11, 17-27, 29 and 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 2 recites the limitation "the second locking feature" in line 2. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examining the claim, “the second locking feature” will be interpreted “the locking region” as disclosed in line 8 of claim 1.
Claim 5 recites the limitation "the second locking feature" in lines 6 and 11. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examining the claim, “the second locking feature” in lines 6 and 11 will be interpreted as “the locking region” as disclosed in line 8 of claim 1.
Claim 7 recites the limitation "the second state" in line 2. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examining the claim, “the second state” will be interpreted as “the expanded state” as disclosed in line 11 of claim 1.
Claim 10 recites the limitation "individual ones of the links" in line 4. It is unclear what “individual ones” is referring to (i.e. a component or feature of the links, each link individually, etc.). For the purpose of examining the claim, “individual ones of the links” will be interpreted as “each link of the plurality of links”.
Claim 17 recites the limitation "the first state" in line 14. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examining the claim, “the first state” will be interpreted as “the unexpanded state” as recited in line 4 of claim 17.
Claim 24 recites the limitation "the locking region" in line 8. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examining the claim, “the locking region” will be interpreted as “the second locking region” as disclosed in line 5.
Claim 25 recites the limitation "the second locking feature" in line 3. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examining the claim, “the second locking feature” will be interpreted as “the second locking region” as disclosed in line 5 of claim 24.
Claim 25 recites the limitation "the first state" in line 3. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examining the claim, “the first state” will be interpreted as “the unexpanded state” as disclosed in lines 6-7 of claim 24.
Claim 26 recites the limitation "the second locking feature" in line 2. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examining the claim, “the second locking feature” will be interpreted as “the second locking region” as disclosed in line 5 of claim 24.
Claim 27 recites the limitation "the second locking feature" in lines 5-6. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examining the claim, “the second locking feature” will be interpreted as “the second locking region” as disclosed in line 5 of claim 24.
Claim 29 recites the limitation "each of the pair of locking arms" in line 1. It is unclear whether it is referring to each locking arm of the pair of locking arms, or if it is referring to multiple pairs of locking arms. For the purpose of examining the claim, “each of the pair of locking arms” will be interpreted as “each locking arm of the pair of locking arms”.
Claim 39 recites the limitation "the second state" in line 1. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examining the claim, “the second state” will be interpreted as “the expanded state” as disclosed in line 11 of claim 28.
Appropriate corrections are required.
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, 2, 4-10, 12, 14-20 and 22-23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Glerum et al.(U.S. Patent No.9,566,168 B2; hereinafter “Glerum”).
Regarding claim 1, Glerum discloses an intervertebral spacer, comprising: a first expansion assembly including a first upper support and a first lower support (see annotated Figure 58 below); a second expansion assembly including a second upper support and a second lower support (see annotated Figure 58 below); a first end body (450) coupled to the first expansion assembly and the second expansion assembly (Figures 64A and 64B), the first end body including a first locking feature (extension 475 comprising prongs 476a, 476b); and a second end body (455) coupled to the first expansion assembly and the second expansion assembly (Figures 64A and 64B), the second end body including a locking region (opening 456) configured to receive the first locking feature when driving apart and expanding the first and second expansion assemblies to move the intervertebral spacer from an unexpanded state (Figure 64A) to an expanded state (Figure 64B), and to cause the first locking feature to couple to the locking region to hold the intervertebral spacer in the expanded state (col.25, ll.26-col.26, ll.18).
Regarding claim 2, Glerum further discloses wherein the first locking feature (475) includes a hooked region (prongs 476a, 476b), wherein the second locking region includes a notch (opening 456), and wherein the hooked region is positioned to contact the notch when the intervertebral spacer is in the expanded state (col.25, ll.26-col.26, ll.18).
Regarding claim 4, Glerum further discloses wherein the first locking feature (450) is a first upper locking feature (476a) configured to couple to a first side of the second end body, the first end body further comprising a first lower locking feature (476b) configured to couple to a second side of the second end body opposite the first side when the intervertebral spacer is in the expanded state (Figure 58).
Regarding claim 5, Glerum further discloses wherein: in the unexpanded state, the first expansion assembly and the second expansion assembly are positioned at least partially between the first end body and the second end body, and the first locking feature is spaced apart from the locking region (see Figure 64A), and in the expanded state, the first end body and the second end body are positioned at least partially between the first expansion assembly and the second expansion assembly, and the first locking feature is coupled to the locking region to at least partially prevent the intervertebral spacer from returning to the unexpanded state (see Figure 64B).
Regarding claim 6, Glerum further discloses wherein in the expanded state, the first upper support and the first lower support are spaced apart from one another, and the second upper support and the second lower support are spaced apart from one another (see Figure 64B).
Regarding claim 7, Glerum further discloses wherein, in the expanded state, the first upper support, the first lower support, the second upper support, and/or the second lower support are angled relative to a longitudinal axis of the intervertebral spacer (see Figure 16 shows wherein the endplates can toggle into an expanded configuration).
Regarding claim 8, Glerum further discloses wherein, in the unexpanded state (Figure 64A), the first locking feature is positioned at least partially between the first expansion assembly and the second expansion assembly (extension 475 is positioned between the assemblies in the unexpanded state, as shown in Figures 64A).
Regarding claim 9, Glerum further discloses wherein the first upper support, the first lower support, the second upper support, and/or the second lower support include a recessed portion defining a locking feature gap (slot 490) in which at least a portion of the first locking feature (angles tongues 495) is positioned when the intervertebral spacer is in the unexpanded state (col.25, ll.38-42).
Regarding claim 10, Glerum further discloses a plurality of links (pins 515) configured to couple the first and second expansion assemblies to the first and second end bodies (pins 515 keep endplates together to provide for even and simultaneous movement of endplate halves, see col.26, ll.58-col.27, ll.5), wherein each link includes a rounded link head (pins 515 are cylindrical), and the first upper support, the first lower support, the second upper support, and/or the second lower support include an expansion slot having a detent configured to receive the rounded link head when the intervertebral spacer is in the expanded state (pins 515 may rest in slots disposed in each portion of upper and lower endplates 480, 485, see col.26, ll.58-col.27, ll.5).
Regarding claim 12, Glerum further discloses wherein the first end body and/or the second end body include a registration tab (tongues 495), wherein the first expansion assembly and/or the second expansion assembly include a registration slot (slots 490), and wherein the registration tab is positioned at least partially within the registration slot when the intervertebral spacer is in the expanded state (col.24, ll.53-col.25, ll.25).
Regarding claim 14, Glerum further discloses wherein the first and second expansion assemblies are mechanically connected (via pins 515) to cause the intervertebral spacer to expand sequentially in different directions (pins 515 keep endplates together to provide for even and simultaneous movement of endplate halves, see col.26, ll.58-col.27, ll.5).
Regarding claim 15, Glerum further discloses wherein the first locking feature (475) is configured to clamp onto the locking region (456)(col.25, ll.62-col.26, ll.18).
Regarding claim16, Glerum further discloses wherein the first locking feature includes barbed locking arms (prongs 476a, 476b).
Regarding claim 17, Glerum discloses a method for implanting an intervertebral spacer between first and second vertebral bodies of a subject’s spine (Figure 1), the method comprising: inserting the intervertebral spacer (embodiment of Figure 58) between the first and second vertebral bodies; and transitioning the intervertebral spacer from an unexpanded state (Figure 64A) toward an expanded state (Figure 64B), wherein transitioning the intervertebral spacer from the unexpanded state toward the expanded state includes––causing a first end body (450) of the intervertebral spacer to move toward a second end body (455) of the intervertebral spacer; causing a first expansion assembly of the intervertebral spacer and a second expansion assembly of the intervertebral spacer (see annotated Figure 58 below) to move radially outward relative to a longitudinal axis of the intervertebral spacer; and causing a first locking feature (475) of the first end body to engage a second locking feature (456) of the second end body to at least partially prevent the intervertebral spacer from returning toward the unexpanded state (col.27, ll.30-57, see also Figures 64A-64B).
Regarding claim 18, Glerum further discloses wherein causing the first expansion assembly of the intervertebral spacer and the second expansion assembly of the intervertebral spacer to move radially outward relative to the longitudinal axis includes causing the first expansion assembly and the second expansion assembly to move away from one another to horizontally expand the intervertebral spacer (col.27, ll.30-57, see also Figures 64A-64B).
Regarding claim 19, Glerum further discloses causing vertical expansion of the intervertebral spacer by: causing a first upper support and a first lower support of the first expansion assembly to move away from one another; and causing a second upper support and a second lower support of the second expansion assembly to move away from one another (col.27, ll.30-57, see also Figures 64A-64B).
Regarding claim 20, Glerum further discloses wherein causing vertical expansion of the intervertebral spacer includes causing the vertical expansion after causing horizontal expansion of the intervertebral spacer (col.27, ll.30-57, see also Figures 64A-64B).
Regarding claim 22, Glerum further discloses wherein the first locking feature (475) is a first upper locking feature (prong 476a), and wherein causing the first upper locking feature to engage the second locking feature (456) includes causing at least a portion of the second end body (455) to be positioned between the first upper locking feature and a first lower locking feature (between prongs 476a and 476b) of the first end body (col.25, ll.26-col.26, ll.18).
Regarding claim 23, Glerum further discloses wherein the first upper locking feature and the first lower locking feature are positioned on opposite sides of the first end body (see prongs 476a and 476b in Figure 58).
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Allowable Subject Matter
Claims 3, 11, 13 and 21 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims, and once the claim objections and rejections under 35 U.S.C. 112(b) discussed above have been corrected.
Claim 3 has not been rejected using prior art because no references, or reasonable combination thereof, could be found which disclose, or suggest, the claimed combination of limitations recited in independent claim 1. In particular, none of the cited references teach or suggest wherein the second end body further includes a ramped surface configured to deflect the first locking feature outwardly from the second end body when the intervertebral spacer is moved from the unexpanded state to the expanded state, as required by claim 3.
Claim 11 has not been rejected using prior art because no references, or reasonable combination thereof, could be found which disclose, or suggest, the claimed combination of limitations recited in independent claim 1 and dependent claim 10. In particular, none of the cited references teach or suggest wherein at least one of the plurality of links includes a registration slot configured to mate with a corresponding link lock feature of the first or second end body to at least partially prevent rotational movement of the at least one link relative to the first or second end body, as required by claim 11.
Claim 13 has not been rejected using prior art because no references, or reasonable combination thereof, could be found which disclose, or suggest, the claimed combination of limitations recited in independent claim 1 and dependent claim 12. In particular, none of the cited references teach or suggest wherein the registration slot is configured to at least partially prevent inward horizontal movement of one or more of the upper and lower supports when the registration tab is positioned at least partially within the registration slot, as required by claim 13.
Claim 21 has not been rejected using prior art because no references, or reasonable combination thereof, could be found which disclose, or suggest, the claimed combination of limitations recited in independent claim 17. In particular, none of the cited references teach or suggest wherein causing the first locking feature of the first end body to engage the second locking feature of the second end body includes causing a ramped surface of the second end body to bend the first locking feature outwardly and away from the second end body, as required by claim 21.
Claims 24-45 are allowable, once the claim objections and rejections under 35 U.S.C. 112(b) discussed above have been corrected.
Claims 24-27 in the instant application have not been rejected using prior art because no references, or reasonable combination thereof, could be found which disclose, or suggest, the claimed combination of limitations recited in independent claim 24. In particular, none of the cited references teach or suggest delivery tool operably couplable to the disclosed intervertebral spacer, the tool comprising: a first engagement shaft configured to releasably couple the first end body of the intervertebral spacer to the delivery tool, a second engagement shaft configured to releasably couple the second end body of the intervertebral spacer to the delivery tool, the second engagement shaft including a notch, and an insertion limiter including a stop tab and transitionable between (i) a first position in which the stop tab contacts the notch to at least partially prevent further movement of the second engagement shaft toward the first locking feature of the intervertebral spacer, and (ii) a second position in which the stop tab is spaced apart from the notch to allow the second engagement shaft to move toward a first expansion locking feature, as required by claim 24.
Claims 28-45 in the instant application have not been rejected using prior art because no references, or reasonable combination thereof, could be found which disclose, or suggest, the claimed combination of limitations recited in independent claim 28. In particular, none of the cited references teach or suggest an intervertebral spacer comprising a first clamp linkage assembly rotatably coupled to the first expansion assembly and the second expansion assembly, a second linkage assembly rotatably coupled to the first expansion assembly and the second expansion assembly, and wherein the second linkage assembly is configured to push apart the pair of locking arms when the intervertebral spacer is moved toward an expanded state such that the pair of locking arms lock onto the second expansion assembly to hold the intervertebral spacer in the expanded state as required by claim 28.
Conclusion
Prior art made of record and not relied upon that has been considered pertinent to applicant's disclosure has been cited on the PTO-892, Notice of References Cited.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Christina Negrelli whose telephone number is 571-270-7389. The examiner can normally be reached on Monday-Friday, between 8:00am to 4:00pm. If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Eduardo Robert, 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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/CHRISTINA NEGRELLI/
Examiner, Art Unit 3773
/EDUARDO C ROBERT/Supervisory Patent Examiner, Art Unit 3773
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