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 .
According to the Amendment filed on 1/29/26, Claims 11-20 are canceled, claims 26-35 are added.
Election/Restrictions
Applicant's election with traverse of species 1: fig. 1a in the reply filed on 1/29/26 is acknowledged.
The traversal is on the ground(s) that species of fig. 1a is similar to species of fig. 12a, since Para. [0090] of Applicant's specification teaches "any of the devices described herein may be manufactured utilizing an additive manufacturing process."
This is not found persuasive because the species of fig. 12a comprising a build plate contact surface 995, and the specifications of the present application teaches “The articulating interbody fusion device 1000 may be oriented for additive manufacturing such that a proximal end 400 includes a build plate contact surface 995……………The additive manufacturing process may form the articulating interbody fusion device 1000 starting at the build plate contact surface 995 and proceeding along the vertical printing axis 960” (para. 99), and that means the build plate contact surface is a required for the additive manufacturing process.
And since NO where in the specifications nor the drawings of the present application showing or teaching that the species of figure 1A has a build plate contact surface, therefore, the species of fig. 1a and 12a are distinct and restrictable.
Accordingly, claims 8, 21-25 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected species 2: fig. 12a.
The requirement is still deemed proper and is therefore made FINAL.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 27, 28, 30-31 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Palagi (US 20190328546 A1).
Palagi discloses an articulating interbody fusion device fig. 15 comprising: a body comprising: a plurality of interconnected pores figs. 15-17 (porous via a lattice structure, para 59); and a recess portion 226 comprising a first border portion 209a and a second border portion 209b spaced apart from the first border portion; and an articulating connector 205 configured to be positioned entirely within the recess portion fig. 21; wherein: the articulating connector comprises an aperture 207, fig. 18; the body comprises a post 204, fig. 15, 17 positioned within the aperture; the articulating connector is rotatable relative to the body fig. 13; and after installing and fixing the articulating connector 205 in the recess 226 via the post 204, the articulating connector 205 may be considered irremovable from the body and the post may be considered monolithically formed with the body, wherein the plurality of interconnected pores provides continuous pathways from a first side of the body to an opposing second side of the body figs. 15-17, wherein the articulating connector 205 is formed as a single monolithic piece fig. 15, 18.
Claim(s) 1-6, 9-10, 26, 32-35 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Kim (US 20180289506 A1) .
Kim discloses an articulating interbody fusion device fig. 1 comprising: a body comprising: a plurality of interconnected pores 113, 114; and a recess portion 115, fig. 2 comprising a first border portion and a second border portion spaced apart from the first border portion; and an articulating connector 121 configured to be positioned within the recess portion; wherein: the articulating connector comprises an aperture 124; the body comprises a post 123 positioned within the aperture; the articulating connector is rotatable relative to the body (para. 37); and the articulating connector is irremovable from the body fig. 3-4, wherein the post 123 can be considered monolithically formed with the body fig. 3-4, wherein the post 123 is considered integrated with the body and extends from the first border portion to the second border portion figs 2-4, wherein the articulating connector comprises the aperture 124 and an outer perimeter, wherein the aperture is entirely encircled by the outer perimeter fig. 2, wherein the first border portion and the second border portion lack interconnected pores fig. 2, wherein the plurality of interconnected pores 112, 113, 114 provides continuous pathways from a first side of the body to an opposing second side of the body fig. 1, wherein the articulating connector 121 is formed as a single monolithic piece fig. 2, wherein the articulating connector 121 further comprises: a first stop surface (see modified fig. 2 below) configured to limit rotational movement of the articulating connector at a first position; and a second stop surface (opposite surface) configured to limit rotational movement of the articulating connector at a second position; wherein an angle between the first position and the second position is in a range of 50° to 70° fig. 6, wherein the body further comprises a central aperture 112 extending from a superior surface of the body to an inferior surface of the body fig. 3.
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) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kim in view of Burkhardt (US 20160095718 A1).
Kim fails to teach that the body comprises a modulus of elasticity similar to that of a bone.
Burkhardt teaches a body comprises a modulus of elasticity similar to that of a bone (para. 73) so that the body may conform to bony surfaces, forming a more stable support platform (para. 73).
It would have been obvious to a person of ordinary skill in the art at the time of the invention was made to construct the body of Kim with a modulus of elasticity similar to that of a bone in view of Burkhardt so that the body may conform to bony surfaces, forming a more stable support platform.
Claim(s) 27, 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Baccelli (US 20150012099 A1 ) in view of Palagi.
Baccelli discloses an articulating interbody fusion device fig. 2, 2a, 5 comprising: a body comprising: a recess portion 26 comprising a first border portion 10 and a second border portion 10’ spaced apart from the first border portion; and an articulating connector 9 configured to be positioned entirely within the recess portion fig. 2; wherein: the articulating connector comprises an aperture 18, fig. 2a; the body comprises a post 15’, fig. 2a positioned within the aperture 18; the articulating connector is rotatable relative to the body; and after installing and fixing the articulating connector 9 in the recess 26 via the post 15’, the articulating connector 9 may be considered irremovable from the body and the post may be considered monolithically formed with the body fig. 5, wherein the articulating connector 9 comprises the aperture 18 and an outer perimeter, wherein the aperture is entirely encircled by the outer perimeter fig. 2a.
Baccelli fails to teach that the body comprising: a plurality of interconnected pores.
Palagi teaches a body comprising: a plurality of interconnected pores( figs. 15-17 (porous via a lattice structure, para 59))
It would have been obvious to a person of ordinary skill in the art at the time of the invention was made to modify the body of the fusion device of Baccelli with a plurality of interconnected pores (porous via a lattice structure) in view of Palagi for allowing bone ingrowth inside the fusion device to enhance the spinal stabilization.
Response to Arguments
Applicant's arguments filed have been fully considered but they are not persuasive.
Applicant argues that Kim fails to teach that the articulating connector is irremovable from the body.
Examiner respectfully disagrees, since after installing and fixing the articulating connector 120 of Kim in the recess portion 115 via the post 123 passes through a fastening hole (119) figs 1-2, the articulating connector become irremovable from the body.
Conclusion
THIS ACTION IS MADE FINAL. 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 SAMEH RAAFAT BOLES whose telephone number is (571)270-5537. The examiner can normally be reached 9-5 pm.
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/SAMEH R BOLES/Primary Examiner, Art Unit 3775