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 3 and 17 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 3, line 2, “sidewalls” lacks consistent antecedent basis.
Claim 17, line 2, “sidewalls” lacks consistent antecedent basis.
Appropriate correction is required.
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.
Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Wickham (2016/0022431) in view of Freudenberger (2019/0142606).
Regarding claim 1, Wickham discloses a lateral lumbar (para. 0001, 0009) intervertebral implant 12 (cf. annotated Fig. 1) for implantation in an intervertebral space between vertebrae, the implant comprising:
a body 14 having a tapered front end, an opposed rear end and opposed inner and outer side walls 22, 24 extending between the ends (cf. Fig. 1; para. 0022 and claim 17), the body having an outer perimeter with, e.g., a rectangular configuration (i.e., polygonal with planar sides; para. 0021) defined by the outer side wall 24 and an inner perimeter defined by inner sidewall 22 about an internal chamber 52, the body including:
an upper surface 18 and a lower surface 20, the upper surface 18 defined by a solid upper outer rim defined at the edge of the upper surface 18 and the outer side wall 24 and a spaced apart solid upper inner rim defined at the edge of the upper surface 18 and the inner side wall 22 and the lower surface 20 defined by a solid lower outer rim defined at the edge of the lower surface 20 and the outer side wall 24 and a spaced apart solid lower inner rim defined at the edge of the lower surface 20 and the inner side wall 22 (cf. Fig. 1);
a solid front wall 64 extending at the front end between at least the solid upper outer rim (supra) and the solid lower outer rim (id.);
a solid opposite rear wall (cf. Fig. 2) extending at the rear end between the solid upper outer rim (supra) and the solid lower outer rim (id.);
a plurality of upper solid cross struts 30 connected between the upper outer rim (supra) and the upper inner rim (id.) and arranged in parallel to each other (cf. Fig. 1);
a plurality of lower solid cross struts 30 connected between the lower outer rim (supra) and the lower inner rim (id.) and arranged in parallel to each other (cf. Fig. 1) and
a porous structure (supra; paras. 0019 and 0039) integrally formed (i.e., monolithically formed; para. 0019) with the solid upper rims (supra), the solid lower rims (id.), and each of the solid cross struts 30, the porous structure extending from the body outer perimeter to the body inner perimeter (supra; paras. 0019 and 0039).
Wickham discloses the claimed invention except each of the side walls including at least one solid support strut extending between the upper outer rim and the lower outer rim.
Freudenberger discloses an implant having a single solid strut 165A, 165B extending perpendicularly at an approximate midpoint of each side between an upper outer rim and a lower outer rim to provide additional support and strength where necessary (Fig. 36 and paras. 0085-0088).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to provide the side walls of the implant 12 of Wickham with at least one solid support strut extending between the upper outer rim and the lower outer rim, in view of Freudenberger, to provide additional support and strength where necessary.
It is noted that Wickham discloses at least one window in the side walls (para. 0013 and claim 11); therefore, the reference is compatible with the solid strut which effectively merely creates two windows on each side, thereby maintaining sight and access while providing additional support and strength where necessary.
It is further noted that the porous structure (supra; paras. 0019 and 0039) as taught by Wickham would be integrally formed with the solid struts in the side walls of the implant of the combination similarly with the other structure of the implant (id.).
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Regarding claim 2, the implant of the combination (supra) has a wedge configuration tapering from a thicker height H along the outer edge of one of the side walls to a thinner height h along the outer edge of the other one of the side walls (cf. annotated Fig. 1).
Regarding claim 3, the at least one solid support strut (supra) of each of the sidewalls of the combination (supra) includes a single support strut extending perpendicularly between the upper outer rim and the lower outer rim at an approximate mid-point of the side wall (supra; Fig. 36 and paras. 0085-0088 of Freudenberger).
Regarding claim 4, the at least one solid support strut of the combination (supra) extends perpendicularly relative to the upper outer rim and the lower outer rim (supra; Fig. 36 and paras. 0085-0088 of Freudenberger).
Regarding claim 5, the plurality of upper solid cross struts 30 of the combination are connected perpendicularly between the upper outer rim and the upper inner rim (cf. Fig. 1 of Wickham).
Regarding claim 6, each of the cross struts 30 of the combination defines a portion of a surface serration (cf. Fig. 1 of Wickham).
Regarding claim 7, all of the solid support struts (supra) and cross struts 30 of the combination are embedded within the porous structure (supra; paras. 0019 and 0039 of Wickham).
Regarding claim 8, the tapered front end (cf. annotated Fig. 1) of the combination includes a solid structure (id.) having an upper sloped portion (id.) and a lower sloped portion (similar to the upper sloped portion and on the underside; cf. annotated Fig. 1) together defining the taper.
Regarding claim 9, the rear end of the implant of the combination is defined substantially by a solid structure (supra; cf. Fig. 2 of Wickham).
Regarding claim 10, the solid structure defined by the rear end of the combination (Fig. 2 of Wickham) includes a recess 74 for receiving an insertion instrument (para. 0032 of Wickham).
Regarding claim 11, Wickham discloses the claimed invention except for a solid secondary rear wall coupled between the upper inner rim and the lower inner rim.
Freudenberger shows that a rear wall 10 (cf. Fig. 34 and para. 0073) extending between upper and lower portions of an implant can have solid surfaces on both the outer and inner sides surrounding a recess 12 for receiving an insertion instrument (id.). This configuration provides additional support and strength where necessary or desired (e.g., for supporting bone or forces from the insertion instrument).
Therefore, it also would have been obvious to a person having ordinary skill in the art before the effective filing date to provide at least a solid secondary rear wall (i.e., a solid surface) extending between the upper inner rim and the lower inner rim, also in view of Freudenberger, to provide additional support and strength were necessary or desired, e.g., for supporting bone or forces from the insertion instrument).
Regarding claim 12, the upper inner rim (supra) and the lower inner rim (id.) are both a closed rim (id.; cf. Fig. 1 of Wickham).
Regarding claim 13, Wickham further teaches a mostly porous structure and modifying the pores and modulus to approximate the modulus of bone and promote bone ingrowth (cf. Fig. 1 and paras. 0010-0014), but does not disclose the porous structure explicitly having a greater than 60% porosity.
Therefore, it also would have been obvious to a person having ordinary skill in the art before the effective filing date to configure the porosity of the implant of the combination to be greater than 60%, e.g., to approximate the modulus of bone and/or promote bone ingrowth. It is further noted that it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 14, the porous structure of the combination has an average pore size of 0.75 mm (750µm; para. 0014 of Wickham), which is between about 300-800 pm.
Regarding claim 15, the porous structure of the combination has an average pore size of 0.75 mm (750µm; para. 0014 of Wickham), which is between about 300-800 pm.
Wickham further teaches a mostly porous structure and modifying the pores and modulus to approximate the modulus of bone and promote bone ingrowth (cf. Fig. 1 and paras. 0010-0014), but does not disclose the porous structure explicitly having a greater than 60% porosity.
Therefore, it also would have been obvious to a person having ordinary skill in the art before the effective filing date to configure the porosity of the implant of the combination to be greater than 60%, in view of Wickham, e.g., to approximate the modulus of bone and/or promote bone ingrowth. It is further noted that it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 16, Wickham discloses a lateral lumbar (para. 0001, 0009) intervertebral implant 12 (cf. annotated Fig. 1) for implantation in an intervertebral space between vertebrae, the implant comprising:
a body 14 having a tapered front end, an opposed rear end and opposed inner and outer side walls 22, 24 extending between the ends (cf. Fig. 1; para. 0022 and claim 17), the body having an outer perimeter with, e.g., a rectangular configuration (i.e., polygonal with planar sides; para. 0021) defined by the outer side wall 24 and an inner perimeter defined by inner sidewall 22 about an internal chamber 52, the body including:
an upper surface 18 and a lower surface 20, the upper surface 18 defined by a solid upper outer rim defined at the edge of the upper surface 18 and the outer side wall 24 and a spaced apart solid upper inner rim defined at the edge of the upper surface 18 and the inner side wall 22 and the lower surface 20 defined by a solid lower outer rim defined at the edge of the lower surface 20 and the outer side wall 24 and a spaced apart solid lower inner rim defined at the edge of the lower surface 20 and the inner side wall 22 (cf. Fig. 1);
a solid front wall 64 extending at the front end between at least the solid upper outer rim (supra) and the solid lower outer rim (id.);
a solid opposite rear wall (cf. Fig. 2) extending at the rear end between the solid upper outer rim (supra) and the solid lower outer rim (id.);
a plurality of upper solid cross struts 30 connected between the upper outer rim (supra) and the upper inner rim (id.) and arranged in parallel to each other (cf. Fig. 1);
a plurality of lower solid cross struts 30 connected between the lower outer rim (supra) and the lower inner rim (id.) and arranged in parallel to each other (cf. Fig. 1) and
a porous structure (supra; paras. 0019 and 0039) integrally formed (i.e., monolithically formed; para. 0019) with the solid upper rims (supra), the solid lower rims (id.), and each of the solid cross struts 30, the porous structure extending from the body outer perimeter to the body inner perimeter (supra; paras. 0019 and 0039), the porous structure being mostly porous and having an average pore size of 0.75 mm (750 µm; para. 0014), which is between 300-800 µm.
Wickham discloses the claimed invention except each of the side walls including at least one solid support strut extending between the upper outer rim and the lower outer rim.
Freudenberger discloses an implant having a single solid strut 165A, 165B extending perpendicularly at an approximate midpoint of each side between an upper outer rim and a lower outer rim to provide additional support and strength where necessary (Fig. 36 and paras. 0085-0088).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to provide the side walls of the implant 12 of Wickham with at least one solid support strut extending between the upper outer rim and the lower outer rim, in view of Freudenberger, to provide additional support and strength where necessary.
It is noted that Wickham discloses at least one window in the side walls (para. 0013 and claim 11); therefore, the reference is compatible with the solid strut which effectively merely creates two windows on each side, thereby maintaining sight and access while providing additional support and strength where necessary.
It is further noted that the porous structure (supra; paras. 0019 and 0039) as taught by Wickham would be integrally formed with the solid struts in the side walls of the implant of the combination similarly with the other structure of the implant (id.).
Wickham further teaches a mostly porous structure and modifying the pores and modulus to approximate the modulus of bone and promote bone ingrowth (cf. Fig. 1 and paras. 0010-0014), but does not disclose the porous structure explicitly having a greater than 60% porosity.
However, it also would have been obvious to a person having ordinary skill in the art before the effective filing date to configure the porosity to be greater than 60%, in view of Wickham, e.g., to approximate the modulus of bone and/or promote bone ingrowth. It is further noted that it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 17, the at least one solid support structure (supra) of each of the sidewalls of the combination includes a single support strut extending perpendicularly between the upper outer rim and the lower outer rim at an approximate mid-point of the side wall (supra; Fig. 36 and paras. 0085-0088 of Freudenberger).
Regarding claim 18, Wickham discloses the claimed invention except for a solid secondary rear wall coupled between the upper inner rim and the lower inner rim.
Freudenberger shows that a rear wall 10 (cf. Fig. 34 and para. 0073) extending between upper and lower portions of an implant can have solid surfaces on both the outer and inner sides surrounding a recess 12 for receiving an insertion instrument (id.). This configuration provides additional support and strength where necessary or desired (e.g., for supporting bone or forces from the insertion instrument).
Therefore, it also would have been obvious to a person having ordinary skill in the art before the effective filing date to provide at least a solid secondary rear wall (i.e., a solid surface) extending between the upper inner rim and the lower inner rim, in view of Freudenberger, to provide additional support and strength were necessary or desired, e.g., for supporting bone or forces from the insertion instrument).
Regarding claim 19, the upper inner rim (supra) and the lower inner rim (supra) are both a closed rim (cf. Fig. 1 of Wickham).
Regarding claim 20, the at least one solid support strut of the combination (supra) extends perpendicularly relative to the upper outer rim and the lower outer rim (supra; Fig. 36 and paras. 0085-0088 of Freudenberger).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure (see attached PTO-892).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID C COMSTOCK whose telephone number is (571)272-4710. The examiner can normally be reached M-F 9:00-5:00 PST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Eduardo Robert can be reached 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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DAVID C. COMSTOCK
Examiner
Art Unit 3773
/DAVID C COMSTOCK/Examiner, Art Unit 3773
/EDUARDO C ROBERT/Supervisory Patent Examiner, Art Unit 3773
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