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(s) 1-10 is/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 1 recites the limitation "the placement instrument" in line 5. There is insufficient antecedent basis for this limitation in the claim. It appears that claim 1 should instead recite “the removal instrument” in order to have sufficient antecedent basis.
Claim 6 recites the limitation "the placement instrument" in line 5. There is insufficient antecedent basis for this limitation in the claim. It appears that claim 5 should instead recite “the removal instrument” in order to have sufficient antecedent basis.
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.
Claim(s) 1-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Keller (U.S. Patent 4,997,432, hereinafter “Keller”) in view of Hawkins et al. (U.S. Pub. No. 2005/0027300 A1, hereinafter “Hawkins”) and in view of Bertagnoli et al. (U.S. Pub. No. 2006/0064107 A1, hereinafter “Bertagnoli”).
Keller discloses, regarding claim 1, a method, the method comprising: securing a multipart prosthetic disc (3-4, see Fig. 1) to a distal end (e.g. end by 24-25 of instrument 23, see Fig. 9) of a instrument (23) by grasping at least a portion of the multipart prosthetic disc (4) between a pair of core arms on the placement instrument (24-25, see Figs. 7-9), the instrument including: an inner shaft (29) connected to the pair of core arms (see Fig. 8); and an outer shaft (28) movable with respect to the inner shaft (see Figs. 8-9) and including an activation mechanism (26-27) for causing the arms to grasp the core (see Fig. 8-9, see lines 58-68 of column 5 and lines 1-2 of column 6), the outer shaft having an axial channel (31, see annotated Fig. 9 below) shaped to slidably engage an outer surface of the pair of core arms (see Figs. 8-9, see also annotated Fig. 9 below, see lines 58-68 of column 5 and lines 1-2 of column 6), such that the pair of core arms are selectively seated within the outer shaft (see Figs. 8-9, see also annotated Fig. 7 below, see lines 58-68 of column 5 and lines 1-2 of column 6).
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Keller discloses, regarding claim 4, wherein the pair of core removal arms are shaped to correspond substantially to an outer perimeter of the core (see Figs. 7-9).
Keller discloses, regarding claim 5, wherein distal motion of the inner shaft within the outer shaft causes the pair of core removal arms causes the two prosthetic disc plates of the intervertebral prosthetic disc to abut an outer housing at the distal end of the outer shaft (see Figs. 7-9, see lines 58-68 of column 5 and lines 1-2 of column 6).
Keller discloses, regarding claim 6, a method, the method comprising: securing a multipart prosthetic disc (3-4, see Fig. 1) to a distal end (e.g. end by 24-25, see Fig. 9) of an instrument (23) by grasping at least a portion of the multipart prosthetic disc between a pair of core arms on the placement instrument (24-25, see Figs. 7-9); and a core instrument handle (26, see Fig. 8) connected to the pair of core arms (see Fig. 8), the handle configured to move the arms with respect to one another to grasp the core (see Figs. 8-9, see lines 58-68 of column 5 and lines 1-2 of column 6).
Regarding claim 8, wherein the pair of core removal arms are shaped to correspond substantially to an outer perimeter of the core (see Fig. 8).
Regarding claim 9, wherein removing the from the intervertebral prosthetic disc includes simultaneously actuating the pair of core removal arms (see Figs. 8-9).
Regarding claim 10, wherein distal motion of the inner shaft within the outer shaft causes the pair of core arms causes the two prosthetic disc plates of the intervertebral prosthetic disc to abut an outer housing at the distal end of the outer shaft (see Figs. 8-9).
Keller fails to disclose, regarding claim 1, a method of removing the core from an intervertebral prosthetic disc, the instrument is a removal instrument the pair of core arms are a pair of core removal arms, wherein the arms are each tapered from a thinnest portion at their distal ends to a thicker portion at some distance from the distal end; inserting the pair of core removal arms between two prosthetic disc plates of the intervertebral prosthetic disc to distract the plates away from one another; and removing the core from the intervertebral prosthetic disc with the removal instrument, and the axial channel shaped to slidably engage the outer surface of the pair of core removal arms at the thicker portion thereof; and regarding claim 6, a method of removing a core from an intervertebral prosthetic disc, the instrument is a removal instrument the pair of core arms are a pair of core removal arms, wherein the arms are each tapered from a thinnest portion at their distal ends to a thicker portion at some distance from the distal end; inserting the pair of core removal arms between two prosthetic disc plates of the intervertebral prosthetic disc to distract the plates away from one another; and removing the core from the intervertebral prosthetic disc with the removal instrument, the removal instrument including: a pair of distraction wedges, each wedge being tapered from a thinnest portion at a distal end of a respective one of the pair of core removal arms to a thicker portion at some distance from the distal end, the thicker portion extending outward along an axis perpendicular to an axial orientation of the pair of removal arms; regarding claim 2, wherein the thicker portion is at least two times as thick as the thinnest; and regarding claim 3, wherein the thicker portion is located a distance from the thinnest portion that corresponds substantially to a diameter or largest dimension of the core; regarding claim 7, wherein the distraction wedge is formed integral with the core removal arms; and regarding claim 9, wherein removing the core from the intervertebral prosthetic disc includes simultaneously actuating the distraction wedge.
Hawkins discloses an instrument (600, see Fig. 15E) with a pair of core arms (611) for gripping a core of an implant (620’), wherein the instrument is used to remove the core (see paras. [0104]-[0105]) in order to enable the core to be removed and replaced due to damage or the surgeon’s preference (see para. [0105]) or if the evaluated height of the modular implant is determined to be not optimal to remove the core and replace it with a different size core until the correct height has been determined (see para. [0128]).
Bertagnoli discloses an instrument (see Fig. 10) for an intervertebral disc implant having upper and lower plates (22, 32) and a pivot core therebetween (42, see Fig. 10), wherein the instrument includes arms (63) that are tapered from a thinnest portion (64A, see Fig. 13A) at their distal ends (see Fig. 13A) to a thicker portion (63A, see Fig. 13A) at some distance from the distal end (see Fig. 13A), the thicker portion extending outward along an axis perpendicular to an axial orientation of the pair of removal arms (see annotated Fig. 4 below), wherein the thicker portion is located a distance from the thinnest portion that corresponds substantially to a diameter or largest dimension of the core (see annotated Fig. 11 below), the instrument includes arms (63) that are tapered from a thinnest portion (e.g. tapered tip of 64A, see Fig. 13A) at their distal ends (see Fig. 13A) to a thicker portion (e.g. thicker portion of 64A, see Fig. 13A) at some distance from the distal end (see Fig. 13A) and a pair of distraction wedges (64A), each wedge being tapered from a thinnest portion at a distal end of a respective one of the pair of core removal arms (e.g. tapered tip of 63A) to a thicker portion at some distance from the distal end (e.g. thicker portion of 63A), the thicker portion extending outward along an axis perpendicular to an axial orientation of the pair of removal arms (see annotated Fig. 4 below), wherein the distraction wedge is formed integral with the core removal arms (see Fig. 4) in order to form a distraction wedge positioned on the arms / integral with the arms (see Fig. 13A) in order to maintain the proper orientation of the upper part to the lower part during use (see para. [0056]).
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It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the method in Keller to include using the instrument to remove the core from the implant in view of Hawkins in order to enable the core to be removed and replaced due to damage or the surgeon’s preference or if the evaluated height of the modular implant is determined to be not optimal to remove the core and replace it with a different size core until the correct height has been determined. And it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the arms in Keller to form a distraction wedge that is tapered from a thinnest portion at the distal ends to a thicker portion / wedge at some distance from the distal end in view of Bertagnoli in order to maintain the proper orientation of the upper part to lower part during use. Further, since the axial channel in Keller engages the existing arms at a thicker portion, modifying the arms in Keller in view of Bertagnoli would mean that the axial channel would engages the pair of core arms at the modified thicker portion; and since the pair of core arms would be integral with the wedges, wherein removing the from the intervertebral prosthetic disc includes simultaneously actuating the distraction wedge. Keller in view of Bertagnoli fails to explicitly disclose, wherein the thicker portion is at least two times as thick as the thinnest portion and the thicker portion is located a distance from the thinnest portion that corresponds substantially to a diameter or largest dimension of the core. However, since Bertagnoli establishes that the thicknesses of the arms can be lowered or raised to effect, lessor, or greater the holding / distracting forces (see para. [0057]), it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the thicker portion is at least two times as thick as the thinnest portion, since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michelle C. Green whose telephone number is (571)270-7051. The examiner can normally be reached on Monday-Friday between 9am-5pm.
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/M.C.G/ Examiner, Art Unit 3773 /EDUARDO C ROBERT/ Supervisory Patent Examiner, Art Unit 3773
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