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 23 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 23 recites, “the first face” and “the second face” in lines 1 and 2, respectively. It is unclear which faces applicant is referring to. For examination purposes, the office will interpret this claim to read, “the first face of the first blade” and “the first face of the second blade”, respectively.
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 12-14, 18-25, and 27-31 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bruffey et al. (US 20170095352 A1) (hereon referred to as Bruffey).
Regarding claim 12, Bruffey teaches an interbody spinal fusion device (100) comprising:
a main body (100) with a central cavity (120) extending from a superior portion (facing in FIg. 2) of the main body to an inferior portion (facing away in FIg. 2) of the main body (100);
a mounting blade strut (120) attached between an anterior face of the central cavity and a posterior face of the central cavity (see Fig. 16a); and
a first blade (consisting of one side 230 and 290) and a second blade (other side 230) each rotatably connected to the mounting blade strut (note that the blades and the strut are all configured to rotate, see Para. [0124]).
Regarding claim 13, Bruffey teaches the interbody spinal fusion device of claim 12, wherein the mounting blade strut (210) separates the first blade from the second blade (see Fig. 9a).
Regarding claim 14, Bruffey teaches the interbody spinal fusion device of claim 12, wherein the mounting blade strut (210) further comprises a superior face facing outward to the superior portion of the main body (see labelled diagram of Fig. 14a below) and an inferior face facing outward to the inferior portion of the main body (see labelled diagram of Fig. 14a below).
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Regarding claim 18, Bruffey teaches the interbody spinal fusion device of claim 12, further comprising a drive screw portal (172a) formed through the main body, wherein the drive screw portal aligns with the first blade (see Para. [0110]).
Regarding claim 19, Bruffey teaches the interbody spinal fusion device of claim 18, further comprising a drive screw (192a), wherein the drive screw is drivable through the drive screw portal (172a) to rotate the first blade (see Para. [0120]).
Regarding claim 20, Bruffey teaches the interbody spinal fusion device of claim 19, wherein the drive screw (192a) abuts with a drive surface (290) of the first blade to push the first blade into a deployed position (see Para. [0120]).
Regarding claim 21, Bruffey teaches an interbody spinal fusion device (100, see Fig. 13a) comprising:
a main body (110) with a central cavity (120) that extends through the main body from a superior opening formed on a superior portion (facing in Fig. 2) of the main body to an inferior opening formed on an inferior portion (facing away in Fig. 2) of the main body (110);
a mounting blade strut (210) in the central cavity;
a first blade (230) pivotable on a first face (see labelled diagram of Fig. 14a above) of the mounting blade strut (210);
a second blade (other side 230) pivotable on a second face (see labelled diagram of Fig. 14a above) of the mounting blade strut (120);
a first drive screw portal (172a) formed in a first portion of the main body to align with the first blade (see Fig. 17a), wherein the first drive screw portal extends through the first portion of the main body from a first face (see labelled diagram of Fig. 6b below) of the main body to the central cavity (see Para. [0110]); and
a second drive screw portal (172b) formed in a second portion of the main body to align with the second blade (see Fig. 17a), wherein the second drive screw portal extends through the second portion of the main body from the first face of the main body to the central cavity (see Para. [0110]).
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Regarding claim 22, Bruffey teaches the interbody spinal fusion device of claim 21, wherein the mounting blade strut (210) attaches between an anterior face of the central cavity and a posterior face of the central cavity (see Fig. 16a).
Regarding claim 23, Bruffey teaches the interbody spinal fusion device of claim 21, wherein the first face of the first blade is angled outward to the superior opening of the main body and the second face of the second blade is angled outward to the inferior opening of the main body (see labelled diagram of Fig. 14a above).
Regarding claim 24, Bruffey teaches the interbody spinal fusion device of claim 21, further comprising:
a first drive screw (190a) received in the first drive screw portal (172a) wherein the first drive screw is drivable through the first drive screw portal to push the first blade to be rotated toward a deployed position (see Para. [0120]); and
a second drive screw (190b) received in the second drive screw portal (172b), wherein the second drive screw is drivable through the second drive screw portal to push the second blade to be rotated toward the deployed position (see Para. [0120]).
Regarding claim 25, Bruffey teaches the interbody spinal fusion device of claim 24, wherein an axis of the first drive screw (190a) is parallel to a drive surface (290) of the first blade (230) when the first blade is in the deployed position (see Fig. 16a).
Regarding claim 27, Bruffey teaches the interbody spinal fusion device of claim 21, wherein the first blade pivots to extend from the superior opening parallel to the first face of the mounting blade strut and the second blade pivots to extend from the inferior opening parallel to the second face of the mounting blade strut (see labelled diagram of Fig. below).
Regarding claim 28, Bruffey teaches the interbody spinal fusion device of claim 21, wherein the first face of the mounting blade strut and the second face of the mounting blade strut are on opposing faces of the mounting blade strut (see labelled diagram of Fig. 14a below).
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Regarding claim 29, Bruffey teaches an interbody spinal fusion device (100, see Fig. 13a) comprising:
a main body (110) with a central cavity (120) that extends through the main body from a superior opening formed on a superior portion (facing in Fig. 2) of the main body to an inferior opening formed on an inferior portion (facing away in Fig. 2) of the main body (110);
a mounting blade strut (210) attached between an anterior face of the central cavity and a posterior face of the central cavity (see Fig. 16a);
a first blade (230) pivotable on a superior face of the mounting blade strut (210);
a second blade (other 230) pivotable on an inferior face of the mounting blade strut (210);
a first drive screw portal (172a) formed in a first portion of the main body to align with the first blade (see Fig. 17a), wherein the first drive screw portal (172) extends through the first portion of the main body (110) from a first face of the main body to the central cavity (see Para. [0110]); and
a second drive screw portal (172b) formed in a second portion of the main body to align with the second blade (see Fig. 17a), wherein the second drive screw portal extends through the second portion of the main body from the first face of the main body to the central cavity (see Para. [0110]).
Regarding claim 30, Bruffey teaches the interbody spinal fusion device of claim 29, a first drive screw (190a) received in the first drive screw portal (172a), wherein the first drive screw (190a) is drivable through the first drive screw portal to push the first blade to be rotated toward a deployed position (see Para. [0120]).
Regarding claim 31, Bruffey teaches the interbody spinal fusion device of claim 30, wherein an axis of the first drive screw (190a) is parallel to a drive surface (edge of blade 230, see labelled diagram of Fig. 15b below) of the first blade (230) when the first blade is in the deployed position (see labelled diagram of Fig. 15b below).
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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.
Claims 15-17 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Bruffey as outlined the rejection of claims 12, 14, and 21 above, and further in view of Patel et al. (US 20110035007 A1) (hereon referred to as Patel).
Bruffey teaches an interbody spinal fusion device as outlined in the rejection of claims 12, 14, and 21 above, however fails to teach the device further comprising a first blade attachment portal formed in the superior face of the mounting blade strut and a second blade attachment portal formed in the inferior face of the mounting blade strut (claim 15), wherein the first blade is attached to the first blade attachment portal and the second blade is attached to the second blade attachment portal (claim 16), further comprising an attachment means configured to attach the first blade to the blade mounting strut (claim 17), and wherein the first blade is pivotable independent of the second blade (claim 26).
Patel teaches an interbody fusion device (100), wherein the device consists of a body (105), a mounting blade strut (180), a first blade (110) and a second blade (115), and a first (145) and second (190) blade attachment portal. The device further comprises the first and second blades attached to their respective blade attachment portals (see Para. [0041]), and an attachment means (165) configured to attach the first blade to the blade mounting strut (see Para. [0041]), and wherein the two blades are capable of independent rotation (see Para. [0039], noting that the blades are configured for rotation in separate directions, thereby creating independent movement between the two).
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the spinal fusion device of Bruffey to have a first and second blade attachment portal (claim 15) as taught by Patel, along with corresponding attachment between the first and second blades (claim 16), and an attachment means connecting the first blade to the mounting strut (claim 17), as this would enable rotation of the blades in opposite directions (see Para. [0037]), and furthermore to modify the blade system as taught by Patel such that the first blade is pivotable independent of the second blade (claim 26), as this would likewise allow for opposite movement of the blades in order to better enable gripping of the surrounding tissue by the device (see Para. [0039]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See form PTO-892.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HOLLY J LANE whose telephone number is (703)756-4702. The examiner can normally be reached Monday-Friday 9:00am-5:00pm.
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/H.J.L./Examiner, Art Unit 3773 /EDUARDO C ROBERT/Supervisory Patent Examiner, Art Unit 3773