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 .
Response to Arguments
Claims 12, 13, and 18 have been amended. 35 U.S.C. 112 rejection has been withdrawn.
Applicant’s arguments, filed June 23, 2026, with respect to the rejection(s) of claim(s) 1-18 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made. Please direct attention to rejection below, which addresses the amended claims.
Allowable Subject Matter
Claims 1-14 are allowed.
Claims 18 and 26 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
The prior art fails to teach or disclose the limitations including but not limited to wherein the porous structure comprises three types of interconnected pore pathways, a first type of pore pathway having a first cross-sectional geometry, a second type of pore pathway having a second cross-sectional geometry, and a third type of pore pathway having a third cross-sectional geometry, wherein the first, second, and third cross-sectional geometries are each different from one another.
The prior art fails to teach or disclose the limitations including but not limited to wherein the orthopedic implant device has a surface contact area to the endplates of two adjacent vertebrae to prevent linear subsidence while carrying a sufficient volume of bone graft area within the orthopedic implant device to fuel a the natural occurrence of a fusion, the orthopedic implant device having internal voids for bone graft and a variable entry angle, where the variable entry angle maximizes the contact surface area to a vertebral body, and the variable entry angle is gradually decreased to offset an increasing insertion force.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 15 is rejected under 35 U.S.C. 103(a) as being unpatentable over U.S. Patent Pub. No. 2014/0025181 to Vanasse et al. in view of U.S. Patent Pub. No. 2014/0172111 to Lang et al.
As to Claim 15, Vanasse discloses an orthopedic implant device (10, Fig. 1, [0008]). The orthopedic implant device comprises a porous structure [0008-0009, 0022-0023] additively manufactured based on a 3-dimensional model [0026-0029].
As to Claim 15, Vanasse discloses the claimed invention except for wherein the porous structure is formed from a plurality of successively laser-melted metal layers defining complex internal geometries
Lang discloses an orthopedic implant device [0035] wherein a porous structure is formed from a plurality of successively laser-melted metal layers defining complex internal geometries [0026, 0048-0049, 0061] in order to allow for the creation of durable metallic objects that are biocompatible and can directly serve as implant components [0026].
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the orthopedic implant device of Vanasse with the laser-melted metal layer manufacture modification of Lang in order to allow for the creation of durable metallic objects that are biocompatible and can directly serve as implant components.
Claims 16 and 17 are rejected under 35 U.S.C. 103(a) as being unpatentable over U.S. Patent Pub. No. 2014/0025181 to Vanasse et al. in view of U.S. Patent Pub. No. 2014/0172111 to Lang et al. in view of U.S. Patent Pub. No. 2012/0191200 to Choren.
As to Claims 16 and 17, Vanasse and Lang disclose the claimed invention for wherein the orthopedic implant device comprises a porous structure that approximates the shape of a bone and has a modulus of elasticity similar to that of the bone, and wherein the porous structure has a porosity of 15% to 65%, the porous structure has a porosity of 25-35%, and the modulus of elasticity is less than 50 GPa.
Choren discloses an orthopedic implant device [0077]. The implant comprises a porous structure that approximates the shape of a bone [0050, 0053] and has a modulus of elasticity similar to that of the bone [0050, 0051, 0053]. The porous structure has a porosity of 15% to 65% [0098] and the modulus of elasticity is less than 50 GPa [0096] in order to provide an implant with desired characteristics for a particular application [0049].
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the orthopedic implant device of Vanasse and Lang with the porous structure modification of Choren in order to provide an implant with desired characteristics for a particular application.
Claims 19-24 are rejected under 35 U.S.C. 103(a) as being unpatentable over U.S. Patent Pub. No. 2012/0191200 to Choren in view of U.S. Patent Pub. No. 2013/0150970 to Thaiyananthan.
As to Claim 19, Choren discloses a method of treatment [0049-0053]. The method comprises, relative to a mammal, positioning an orthopedic implant device [0077]. The implant comprises a porous structure that approximates the shape of a bone [0050, 0053] and has a modulus of elasticity similar to that of the bone [0050, 0051, 0053]. The method includes
As to Claim 21, Choren discloses a method of treatment further comprising additively manufacturing the orthopedic device along a build direction parallel to a first end plate and a second end plate of the orthopedic device, such that the orthopedic device comprises a plurality of interconnecting pores between the first end plate and the second end plate (additive process using layer-by layer fabrication techniques described in [0092]).
As to Claim 22, Choren discloses an orthopedic implant device [0077]. The implant comprises a porous structure additively manufactured based on a 3-dimensional model [0082, 0050-0053]).
As to Claim 23, Choren discloses an orthopedic implant device wherein the porous structure comprises a modulus of elasticity similar to that of a bone [0050, 0051, 0053].
As to Claims 19-24, Choren discloses the claimed invention except for inserting the orthopedic device between a first vertebra and a second vertebra, wherein the orthopedic device comprises a variable entry angle at a leading end of the orthopedic device, the variable entry angle gradually decreasing to offset an increasing insertion force, wherein inserting the orthopedic device comprises inserting the orthopedic device diagonally across an interbody space relative to a sagittal plane and a coronal plane.
Thaiyananthan discloses a method of treatment [0004] including inserting an orthopedic device (10) between a first vertebra and a second vertebra [0048]. The orthopedic device (10, [0033]) comprises a variable entry angle at a leading end of the orthopedic device (at 42, 44, [0033], Figs. 1 and 22), the variable entry angle gradually decreasing (from 42 and 44 to 28, [0033], Figs. 1 and 2) to offset an increasing insertion force [0033]. Inserting the orthopedic device (10) comprises inserting the orthopedic device diagonally (along direction ‘A,’ Fig. 8) across an interbody space relative to a sagittal plane and a coronal plane (Fig. 8, [0048]) in order to facilitate insertion into the surgically prepared intervertebral opening [0033].
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the orthopedic implant device of Choren with the variable entry angle modification of Thaiyananthan in order to facilitate insertion into the surgically prepared intervertebral opening.
Claims 25 and 27 are rejected under 35 U.S.C. 103(a) as being unpatentable over U.S. Patent Pub. No. 2014/0025181 to Vanasse et al. in view of U.S. Patent Pub. No. 2010/0255447 to Biris et al.
As to Claim 25, Vanasse discloses an orthopedic implant device (10, Fig. 1, [0008]). The orthopedic implant device comprises a porous structure [0008-0009, 0022-0023] additively manufactured based on a 3-dimensional model [0026-0029].
As to Claims 25 and 27, Vanasse discloses the claimed invention except for a hydroxyapatite nanoparticle coating applied to at least one surface of the orthopedic implant device.
Biris discloses an orthopedic implant device [0030, 0020] including a hydroxyapatite nanoparticle coating applied to at least one surface of the orthopedic implant device [0021] in order to enhance cell growth on the surface of the implant [0021].
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the orthopedic implant device of Vanasse with the hydroxyapatite nanoparticle coating modification of Biris in order to enhance cell growth on the surface of the implant.
Claim 28 is rejected under 35 U.S.C. 103(a) as being unpatentable over U.S. Patent Pub. No. 2014/0025181 to Vanasse et al. in view of U.S. Patent Pub. No. 2010/0255447 to Biris et al. in view of U.S. Patent Pub. No. 2012/0215313 to Saidha et al.
As to Claim 28, Vanasse and Biris discloses the claimed invention except for wherein orthopedic implant device is an expandable interbody device configured to be implant between two adjacent vertebrae.
Biris discloses an orthopedic implant device (26) wherein orthopedic implant device is an expandable interbody device (26, [0030]) configured to be implant between two adjacent vertebrae (Fig. 1B, [0030, 0054]) in order to allow the implant to have an initial unexpanded configuration having a first footprint width suitable for being inserted into an intervertebral space defined by a pair of adjacent vertebral bodies, and an expanded configuration having a second footprint width that is greater than the first footprint width [0004].
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the orthopedic implant device of Vanasse and Biris with the expandable modification of Saidha in order to allow the implant to have an initial unexpanded configuration having a first footprint width suitable for being inserted into an intervertebral space defined by a pair of adjacent vertebral bodies, and an expanded configuration having a second footprint width that is greater than the first footprint width.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTOPHER J BECCIA whose telephone number is (571)270-7391. The examiner can normally be reached Mon - Fri 8:30-5:00.
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/CHRISTOPHER J BECCIA/Primary Examiner, Art Unit 3775
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