DETAILED ACTION
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 6 and 16 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.
Claims 6 and 16 recite the limitation "the third through hole" and “the longitudinal axis”. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examining the claims, claim 6 will be interpreted as depending from claim 5 and claim 16 will be interpreted as depending from claim 15.
Appropriate corrections are required.
Claim Rejections - 35 USC § 103
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-20 are under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Garcia et al. (U.S. Publication No.2008/0015701 A1; hereinafter “Garcia”).
Regarding claims 1 and 11, Garcia discloses a multi-piece allograft spacer unit (see the embodiment of Figure 12) comprising: an upper allograft spacer (top member 42), an upper surface (surface with serrations 48), a lower surface (surface of top member 42 that directly contacts bottom member 42), a first through hole (a first opening 58 in top member 42) extending between the upper and lower surfaces, a lower allograft spacer (bottom member 42), a lower surface (surface with serrations 48), an upper surface (surface of bottom member 42 that directly contacts top member 42), a second through hole (a first opening 58 in bottom member 42) extending between the upper and lower surfaces, the upper and lower allograft spacers formed of bone material (para.0072); and a first pin (a first fastener 44) extending through the first through hole, and a second pin (a second fastener 44) extending through the second through hole.
The embodiment of Figure 12 fails to disclose wherein the upper spacer comprises an upper central hole, and wherein the lower spacer comprises a lower central hole. However, Garcia discloses an implant embodiment (Figure 6) having a passage 60 through members 42 wherein bone growth material may be placed to facilitate spinal fusion (para.0069). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify Garcia’s embodiment in Figure 12 to have a central hole extending through the upper and lower spacers in order to allow placement of bone growth material and facilitate spinal fusion (para.0069).
Furthermore, the embodiment of Figure 12 fails to disclose a first blind hole extending upwardly from the lower surface of upper spacer; and a second blind hole extending downwardly from the upper surface of the lower spacer. However, Garcia discloses an alternate embodiment (Fig. 13) wherein the two fasteners securing the implant components together are arranged where one fastener passes upward via a through opening into a blind opening and the other fastener passes downward via a through opening into a blind opening in order to secure the implant components together (see Fig. 13, para.0089 and 0095). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify Garcia’s modified embodiment of Figure 12 (as discussed above) to have the fastener configuration of top down/bottom up into blind holes as taught by Garcia in Fig. 13 in order to provide an alternative suitable type of connection between upper and lower implant members 42 via fasteners 44.
Regarding claims 2 and 12, Garcia further discloses wherein the upper and lower central holes (60) are aligned and together define an allograft hole for receiving allograft material (para.0074).
Regarding claims 3 and 13, Garcia further discloses wherein: the upper allograft spacer (top member 42) includes a third through hole extending between the upper and lower surfaces; the lower allograft spacer (lower member 42) includes a third blind hole extending downwardly from the upper surface; the multi-piece allograft spacer unit further comprises a third pin extending through the third through hole and the third blind hole (see para.0089 and 0095).
Regarding claims 4 and 14, Garcia further discloses wherein the first and third through holes are arranged in a non-parallel manner (openings may be formed at angles other than right angles relative to interface surfaces between implant members, thus being arranged in a non-parallel manner relative to the longitudinal axis of the implant, see para.0086).
Regarding claims 5 and 15, Garcia further discloses wherein: the upper and lower central holes (60) define a longitudinal axis; the first and third through holes are arranged obliquely relative to the longitudinal axis (para.0086).
Regarding claims 6 and 16, Garcia further discloses wherein the first through hole extend downwardly from the upper surface of the upper allograft spacer at the same angle as the third through hole relative to the longitudinal axis (see Figure 12).
Regarding claims 7 and 17, Garcia further discloses wherein each of the upper and lower allograft spacers includes a recess at a first lateral side thereof; and the recesses on the first lateral sides of the upper and lower allograft spacers define a gripping surface slot for receiving an insertion tool (side grooves 46).
Regarding claims 8 and 18, Garcia further discloses wherein: each of the upper and lower allograft spacers includes a recess at a second lateral side thereof opposite the first lateral side; and the recesses on the second lateral sides of the upper and lower allograft spacers define a second gripping surface slot for receiving the insertion too (side grooves 46).
Regarding claims 9 and 19, Garcia further discloses wherein the first and second pins are formed of bone (para.0072).
Regarding claims 10 and 20, Garcia further discloses wherein: the first pin is located near a front portion and the second pin is located near a rear portion (see Figure 12).
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Conclusion
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
/JACQUELINE T JOHANAS/Primary Patent Examiner, Art Unit 3773