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 20 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 20 recites the limitation "a first bony endplate and a second bony endplate" in lines 2-3. It is unclear whether “a first bony endplate” and “a second bony endplate” are referring the first and second bony endplates disclosed in lines 3 and 4 of claim 16, or if they are referring to different bony endplates. For the purpose of examining the claim, “a first bony endplate and a second bony endplate will be interpreted as “the first bony endplate and the second bony endplate”.
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 1-3 and 16-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Butterman et al. (U.S. Patent No.8,057,549 B2; hereinafter “Butterman”).
Regarding claim 1, Butterman discloses an orthopedic implant (see the embodiment of Figure 24) comprising: a plurality of columns (compressible bodies 2022 and adjustment members 2038) oriented to extend between a first bony surface and a second bony surface of a patient (Figure 24), the plurality of columns comprising: a first support column (2038); and a first expandable column (2022) selectively couplable to the first support column (via plates 2024, 2026 and sections 2027), wherein a length of the first expandable column is selectively adjustable (compressible elements 2022 may be springs which can be manipulated by the user, see col.20, ll.30-37).
Regarding claim 2, Butterman further discloses wherein a length of the first support column (2038) is fixed (col.20, ll.4-17).
Regarding claim 3, Butterman further discloses wherein a length of the first support column (2038) is selectively adjustable (col.20, ll.4-17).
Regarding claim 16, Butterman discloses a method of providing an interbody implant (embodiment shown in Figure 24), the method comprising: obtaining an interbody implant comprising: a first surface (top surface 2028) configured to be disposed adjacent to a first bony endplate (Figure 24); a second surface (bottom surface 2028) configured to be disposed adjacent to a second body endplate (Figure 24); and a height extending between the first surface and the second surface, wherein the interbody implant is configured to be selectively disposed in an insertion configuration and a deployed configuration (adjustment members 2038 are telescoping struts such that the height of the device can be varied), and wherein the height is greater in the deployed configuration than in the insertion configuration (col.20, ll.4-17); while the interbody implant is in the insertion configuration (adjustment members 2038 are telescopically adjusted to a smaller height), inserting the interbody implant into an intervertebral space of a spine of a patient; and when the interbody implant is disposed in the intervertebral space of the spine of the patient, toggling the interbody implant from the insertion configuration to the deployed configuration (adjustment members 2038 are telescopically adjusted to a greater height, see col.20, ll.4-17).
Regarding claim 17, Butterman further discloses wherein the toggling the interbody implant from the insertion configuration to the deployed configuration comprises causing an expanding component (adjustment member 2038) of the interbody implant to expand to increase the height of the interbody implant (col.20, ll.4-17).
Regarding claim 18, Butterman further discloses wherein the expanding component (2038) is selectively couplable to a fixed component (locking mechanism disclosed in col.18, ll.20-28), and wherein the toggling the interbody implant from the insertion configuration to the deployed configuration comprises decoupling the expanding component from the fixed component (prior to the height being fixed by the locking mechanism)(col.18, ll.20-28).
Regarding claim 19, Butterman further discloses recoupling the expanding component to the fixed component after toggling the interbody implant from the insertion configuration to the deployed configuration (when the height of the adjustment members 2038 are fixed via the locking mechanism).
Regarding claim 20, Butterman further discloses wherein the interbody implant further comprises: a plurality of columns (compressible bodies 2022 and adjustment members 2038) oriented to extend between a first bony endplate and a second bony endplate of the spine of the patient (Figure 24), the plurality of columns comprising: a first support column (2038); and a first expandable column (2022) selectively couplable to the first support column (via plates 2024, 2026 and sections 2027), wherein a length of the first expandable column is selectively adjustable (compressible elements 2022 may be springs which can be manipulated by the user, see col.20, ll.30-37).
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Claims 11-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Trieu (U.S. Patent No.8,642,060 B2).
Regarding claim 11, Trieu discloses an interbody implant (30) comprising: a first surface (34) configured to be disposed adjacent to a first bony endplate (Figures 26-27); a second surface (44) configured to be disposed adjacent to a second body endplate (Figures 26-27); and a height extending between the first surface and the second surface (see H1 and H2 in Figures 26-27), wherein the interbody implant is configured to be selectively disposed in an insertion configuration (Figure 26) and a deployed configuration (Figure 27), and wherein the height is greater in the deployed configuration than in the insertion configuration (see H1 and H2 in Figures 26-27).
Regarding claim 12, Trieu further discloses wherein the interbody implant (30) comprises an expanding component (55) configured to expand to increase the height of the interbody implant when the interbody implant is toggled from the insertion configuration to the deployed configuration (Figures 26-27).
Regarding claim 13, Trieu further discloses wherein the expanding component (55) of the interbody implant is compressed when the interbody implant is in the insertion configuration (Figure 26).
Regarding claim 14, Trieu further discloses wherein the expanding component (55) comprises an inflatable component (expandable element 55 is an inflatable balloon-like structure) configured to expand when selectively inflated by a user (col.14, ll.62-col.15, ll.10).
Regarding claim 15, Trieu further discloses wherein the first surface is configured to conform to a topology of the first bony endplate (via protrusions 38).
Regarding claim 16, Trieu discloses a method of providing an interbody implant (30), the method comprising: obtaining an interbody implant comprising: a first surface configured to be disposed adjacent to a first bony endplate (34); a second surface configured to be disposed adjacent to a second body endplate (44); and a height extending between the first surface and the second surface (see H1 and H2 in Figures 26-27), wherein the interbody implant is configured to be selectively disposed in an insertion configuration (Figure 26) and a deployed configuration (Figure 27), and wherein the height is greater in the deployed configuration than in the insertion configuration (see H1 and H2 in Figures 26-27); while the interbody implant is in the insertion configuration, inserting the interbody implant into an intervertebral space of a spine of a patient; and when the interbody implant is disposed in the intervertebral space of the spine of the patient, toggling the interbody implant from the insertion configuration to the deployed configuration (col.14, ll.48-col.15, ll.21).
Regarding claim 17, Trieu further discloses wherein the toggling the interbody implant from the insertion configuration to the deployed configuration comprises causing an expanding component (55) of the interbody implant to expand to increase the height of the interbody implant (col.14, ll.48-col.15, ll.21).
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Allowable Subject Matter
Claims 4-10 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.
Claims 4-10 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 1. In particular, none of the cited references teach or suggest wherein the first support column comprises a first outer region, a second outer region, and an inner region, and wherein a stiffness of the inner region is different from at least one of a stiffness of the first outer region and a stiffness of the second outer region, as required by claim 4. Butterman fails to disclose a support column comprising these features.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Reo et al. U.S. Patent No.7,731,753 B2
Jimenez et al. U.S. Publication No.2015/0088258 A1
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/CHRISTINA NEGRELLI/
Examiner, Art Unit 3773
/JACQUELINE T JOHANAS/Primary Patent Examiner, Art Unit 3773