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.
Claims 8 and 13 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 8 recites the limitation "the compliant structure" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
Claim 8 recites the limitation "the first layer" in lines 3-4. There is insufficient antecedent basis for this limitation in the claim.
Claim 13 recites the limitation "the first layer" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102
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) 1-13 is/are rejected under 35 U.S.C. 102a1 as being anticipated by Hyeon (US 20210205091).
With respect to claim 1, Hyeon discloses an interbody implant (1) comprising: a bottom surface (bottom surface of 11, see fig. 1 below), a top surface (top surface of 11, see fig. 1 below), a front surface (at 11a), a rear surface (at 11b) and side surfaces (left and right sides of 11), the surfaces formed integral with respect to each other and constructed and arranged to provide compliance (via springs 12) so that the surface contact area between the implant and a bone surface is increased when compared to a non-compliant implant (see para. 30-35 and also fig. 5).
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As for claim 2, Hyeon further discloses the interbody implant of claim 1 wherein at least the bone contacting surfaces include a first layer (e.g., all on the left side of the implant) of bar springs (12), each bar spring is secured at one distal end to a non-compliant structure (e.g., to frame 11), the uppermost surface of the bar springs providing a surface that can flex and comply with an adjacently positioned bone surface (see fig. 1 above, abstract and para. 27 and 30).
As for claim 3, Hyeon further discloses the interbody implant of claim 2 wherein the bar springs are secured at both ends to the non-compliant structure (see fig. 1 above).
As for claim 4, Hyeon further discloses the interbody implant of claim 2 wherein a second end of each bar spring is secured to a compliant structure (e.g., frame of elastic structure 10, see fig. 4 below and para. 26).
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As for claim 5, Hyeon further discloses the interbody implant of claim 4 wherein the compliant structure is a second layer (e.g., all on the right side of the implant) of bar springs, the second layer of bar springs positioned adjacent (e.g., next to) to the first layer of bar springs (see para. 27 and note that another interpretation of the first and second layers of bar springs can be sets of left and right-side springs, for instance, the first layer could be the springs closest to 11a and the second layer could be the two springs behind them, see fig. 4 below).
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As for claim 6, Hyeon further discloses the interbody implant of claim 1 wherein at least the bone contacting surfaces include bar springs (12), each bar spring is secured at both distal ends to a non-compliant structure (11), the uppermost surface of the bar springs providing a surface that can flex and comply with an adjacently positioned bone surface (see fig. 1 above, abstract and para. 27 and 30).
As for claim 7, Hyeon further discloses the interbody implant of claim 5 wherein both ends of each bar spring are secured to a compliant structure (e.g., frame of 10, see fig. 4 above, para. 26).
As for claim 8, Hyeon further discloses the interbody implant of claim 6 wherein the compliant structure is a second layer of bar springs (see fig. 4 above as demonstrated with claim 5), the second layer of bar springs positioned adjacent to the first layer of bar springs (see fig. 4 above as demonstrated with claim 5).
As for claim 9, Hyeon further discloses the interbody implant of claim 2 wherein each bar spring is formed to include an arch shape (see fig. 1 above).
As for claim 10, Hyeon further discloses the interbody implant of claim 9 wherein each bar spring includes a predetermined spring rate (note that each spring inherently has a spring rate which is known/established, i.e., predetermined, by the surgeon before the procedure).
As for claim 11, Hyeon further discloses the interbody implant of claim 2 including more than one layer of bar springs (see fig. 4 above as demonstrated with claim 5).
As for claim 12, Hyeon further discloses the interbody implant of claim 11 wherein the bar springs are arranged in layers, one layer adjacent to the other (see fig. 4 above as demonstrated with claim 5).
As for claim 13, Hyeon further discloses the interbody implant of claim 12 wherein the distal ends of the first layer of bar springs are connected (via frame 11 and frame 10) to the bar springs of a second layer of bar springs (see fig. 1 and 4 above as demonstrated with claim 5).
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.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hyeon (US 20210205091), as applied to claim 2 above, in view of Roebling (US 20100131009).
As for claim 14, Hyeon does not appear to teach wherein the spring material is selected from the group consisting of polyetheretherketone (PEEK), polyaryletherketone (PEAK) or polyetherimide (PEI).
Roebling, also drawn to spinal implants teaches a variety of known spring materials, including polyetheretherketone (PEEK), polyaryletherketone (PEAK) or polyetherimide (PEI), in order to provide a known material that while transmitting the desired resiliency, also allows the desired biocompatibility as well.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Hyeon wherein the spring material is selected from the group consisting of polyetheretherketone (PEEK), polyaryletherketone (PEAK) or polyetherimide (PEI), in view of Roebling, in order to provide a known material that while transmitting the desired resiliency, also allows the desired biocompatibility as well.
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hyeon (US 20210205091), as applied to claim 2 above, in view of Kim (US 20060149381).
Hyeon does not appear to teach wherein the spring material is titanium.
Kim, also drawn to interbody implants, teaches a variety of known spring materials, including titanium, in order to provide a known material that while transmitting the desired spinal resiliency, also provides strength and resistance to wear, corrosion and biological activity (see para. 75).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Hyeon wherein the spring material is titanium, in view of Kim, as a matter of engineering design choice, in order to provide a known material that while transmitting the desired spinal resiliency, also provides strength and resistance to wear, corrosion and biological activity.
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hyeon (US 20210205091), as applied to claim 12 above, in view of Manassas (US 20020128714).
As for claim 16, Hyeon does not appear to teach wherein each layer is oriented in an angular relationship with respect to an adjacent layer to provide different compliance characteristics.
Manassas, also drawn to interbody implants, teaches different angular arrangements (e.g., symmetric and asymmetric) of springs 200, 300a and 300b (e.g., see fig. 1, 2, 24) in order to provide the desired resistance or support as needed (see para. 94).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Hyeon wherein each layer is oriented in an angular relationship with respect to an adjacent layer to provide different compliance characteristics, in view of Manassas, in order to provide the desired resistance or support as needed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Tara Carter whose telephone number is (571) 272-3402. The examiner can normally be reached on M-F 7am-3pm.
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/TARA ROSE E CARTER/Examiner, Art Unit 3773
/JULIANNA N HARVEY/Primary Examiner, Art Unit 3773
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