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
There is no claim 11.
The numbering of claims is not in accordance with 37 CFR 1.126 which requires the original numbering of the claims to be preserved throughout the prosecution. When claims are canceled, the remaining claims must not be renumbered. When new claims are presented, they must be numbered consecutively beginning with the number next following the highest numbered claims previously presented (whether entered or not).
Misnumbered claim 12 been renumbered 11.
Misnumbered claim 13 has been renumbered 12.
Misnumbered claim 14 has been renumbered 13.
Misnumbered claim 15 has been renumbered 14.
Misnumbered claim 16 been renumbered 15.
Claim 14 is objected to because of the following informalities: in claim 14, “Wherein” is capitalized. It should be lower case. 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 10-15 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 10 recites the limitation "the lever points" in line 8. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 2-15 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
In claims 2 and 10 the claims states “a spacer comprising a first portion adjacent to a superior vertebral body and a second portion adjacent to an inferior vertebral body” positively claiming the superior and inferior vertebrae. The claims should read “a spacer comprising a first portion configured to be adjacent to a superior vertebral body and a second portion configured to be adjacent to an inferior vertebral body.”
Claims 9 and 15, claim “wherein the first portion is affixed to the superior vertebral body and the second portion is affixed to the inferior vertebral body via two or more fasteners each” again positively claiming the vertebrae. The claims should read “Claims 9 and 16, claim “wherein the first portion is configured to be affixed to the superior vertebral body and the second portion is configured to be affixed to the inferior vertebral body via two or more fasteners each.”
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.
Claim(s) 2-15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Back et al. (US Pub 2011/0202135).
With respect to claim 2, Back et al. discloses an assembly (See figures 5, 9 and 23 below) for aligning vertebral bodies, the assembly comprising: a spacer (fig 9 and 23, 11) comprising a first portion (fig 9, 12) adjacent to a superior vertebral body and a second portion (fig 9, 14) adjacent to an inferior vertebral body, wherein each of the first portion and the second portion comprise a lever point (See fig 9 below); a lever (fig 9, 122) configured to engage each lever point of the first portion and the second portion by applying a force (fig 9, X) in a first direction to the lever point of the first portion and a force in a second, opposing direction (force is shown moving in opposing directions) to the lever point of the second portion to therapeutically align the lever points; and a fastener (fig 5, 20) configured to affix the first portion and the second portion of the spacer once the lever points are therapeutically aligned.
With respect to claim 3, Back et al. discloses wherein the lever is configured to vertically align the lever points (aligns the distraction vertical height of the spacer).
With respect to claim 4, Back et al. discloses wherein the lever points are laterally projecting pins (Fig 9, 204, 205).
With respect to claim 5, Back et al. discloses wherein the laterally projecting pins are configured to be removed once the first portion and the second portion of the spacer are affixed to each other (they are removed as part of the insertion tool).
With respect to claim 6, Back et al. discloses wherein the lever points comprise a recess (paragraph 58, apertures for the tool) in each of the first portion and the second portion of the spacer.
With respect to claim 7, Back et al. discloses wherein one or more of the first portion or the second portion of the spacer comprises an integrated plate (fig 23, 4A and 4B) configured to abut a side surface of the superior vertebral body or the inferior vertebral body.
With respect to claim 8, Back et al. discloses wherein the integrated plate of the one or more of the first portion or the second portion of the spacer is configured to receive one or more fasteners (fig 23 each plate has 2 holes 6 for fasteners) that affixes the integrated plate to the superior vertebral body or the inferior vertebral body.
With respect to claim 9, Back et al. discloses wherein the first portion is affixed to the superior vertebral body and the second portion is affixed to the inferior vertebral body via two or more fasteners each (paragraph 81).
With respect to claim 10, Back et al. discloses an assembly for aligning vertebral bodies, the assembly comprising: a spacer (figs 5, 9 and 23, 11)comprising a first portion (Fig 9, 12) adjacent to a superior vertebral body and a second portion (fig 9, 14) adjacent to an inferior vertebral body, wherein the second portion comprises a lever point (See fig 9 below); a lever (Fig 9, 122) configured to engage the lever point of the second portion and body tissue associated with the superior vertebral body (engages the body indirectly through the first portion) by applying a force (fig 9, X) in a first direction to the lever point and a force in a second, opposing direction (Force X is shown in both directions) to the body tissue of the superior vertebral body to therapeutically align the lever points; and a fastener (fig 5, 20) configured to affix the first portion and the second portion of the spacer once the lever points are therapeutically aligned.
With respect to claim 11, Back et al. discloses wherein the lever is configured to vertically align the lever points (aligns the distraction vertical height of the spacer).
With respect to claim 12, Back et al. discloses wherein the lever points are laterally projecting pins (Fig 9, 204, 205).
With respect to claim 13 Back et al. discloses wherein the laterally projecting pins are configured to be removed once the first portion and the second portion of the spacer are affixed to each other (they are removed as part of the insertion tool).
With respect to claim 14, Back et al. discloses wherein the lever points comprise a recess (paragraph 58, apertures for the tool) in each of the first portion and the second portion of the spacer.
With respect to claim 15, Back et al. discloses wherein the first portion is affixed to the superior vertebral body and the second portion is affixed to the inferior vertebral body via two or more fasteners each (paragraph 81).
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Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 20130197648 A1 discloses a spacer with two portions that are aligned vertically with a lever
US 20080033440 A1 discloses a spacer with two portions that are aligned vertically
US 20070123989 A1 discloses a spacer with two portions that are aligned vertically with a lever
US 20120071978 A1 discloses a spacer with two portions that are aligned vertically
US 20080319481 A1 discloses a spacer with two portions that are aligned vertically
US 20100280616 A1 discloses a spacer with two portions that are aligned vertically with a lever
US 20070219634 A1 discloses a spacer with two portions that are aligned vertically
US 20040148028 A1 discloses a spacer with two portions that are aligned vertically
US 20070260260 A1 discloses a spacer with two portions that are aligned vertically with a lever
US 9351852 B2 discloses a spacer with two portions that are aligned vertically with a lever
US 7909878 B2 discloses a spacer with two portions that are aligned vertically
Any inquiry concerning this communication or earlier communications from the examiner should be directed to STEVEN J COTRONEO whose telephone number is (571)270-7388. The examiner can normally be reached Monday-Friday 9am-5pm EST.
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/S.J.C/Examiner, Art Unit 3773 /EDUARDO C ROBERT/Supervisory Patent Examiner, Art Unit 3773
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