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According to the Amendment filed on 3/27/26, Claims 8-9, 17 are withdrawn, claims 5-7, 10-11 are canceled.
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) 1-4, 12-16, 18-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wickham (US 20160038301 A1) in view of Zhang (US 20110071635 A1).
Wickham discloses an intervertebral cage fig. 1 comprising: an outer frame with an outer surface and an open inner core region 62 defining an inner core surface, the outer frame further comprising superior 18 and inferior 20 surfaces and proximal 66 and distal ends; and a porosity gradient fig. 3 within the outer frame with at least a portion of both the outer surface fig. 2 and inner core surface fig. 3 being porous; wherein the outer frame comprises a predefined pattern of apertures that form the porosity gradient within the outer frame fig. 3; wherein the intervertebral cage is shaped fig. 1 to facilitate placement of the intervertebral cage between two vertebrae in an intervertebral disc space fig. 4; and wherein the superior 18 and inferior 20 surfaces are each configured to maintain the intervertebral cage in the intervertebral disc space once inserted therein fig. 4, wherein the outer frame comprises a plurality of layers with a predefined and regular pattern of apertures bonded to each other such that the predefined and regular pattern of apertures in each of the plurality of layers forms the porosity gradient within the outer frame (para. 24 and 28), wherein the outer frame comprises a plurality of bonded layers, each layer having a predefined pattern of apertures prior to bonding such that altogether the predefined pattern of apertures in each layer of the plurality of layers forms the porosity gradient within the outer frame (para. 24 and 28), wherein the porosity gradient extends through the superior and inferior surfaces figs 2-3; wherein the porosity gradient promotes bone ingrowth and fusion between adjacent vertebrae (para. 23); wherein at least one of the anterior wall and posterior wall is not the same length as the pair of side walls fig. 1 and 3, wherein at least a portion of the outer frame is capable of being formed using at least one of the following: 3D printing, electric discharge machining, mechanical machining, etching, chemical etching, and layer-by-layer processes, further comprising at least one aperture between the open inner core region and an exterior surface of the intervertebral cage fig. 1, wherein the superior and inferior surfaces include features 50 intended to increase the friction between the features and an adjacent boney structure, the porosity gradient comprises a first portion with a porosity (that portion near the proximal end), and a second portion with a porosity ( that portion near the distal end) fig. 3.
Wickham fails to teach that the porosity gradient comprises an increasing average pore diameter in a direction toward both the superior and inferior surfaces, wherein the porosity gradient comprises a first portion with a porosity within a range of about 5% by volume to about 30% by volume and a second portion within a range of about 30% by volume to about 90% by volume.
Zhang teaches a porosity gradient comprises an increasing average pore diameter in a direction toward both the superior 18 and inferior surfaces 20, fig. 1, wherein the porosity gradient comprises a first portion 16, fig. 1 (which can be made from polymeric materials such as PEEK or polyethylene terephthalate (PET) (para. 34), which are known in the art by their low porosity) with a porosity within a range of about 5% by volume to about 30% by volume and a second portion 12, 14, 22 and 24 within a range of about 30% by volume to about 90% by volume fig. 1.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to construct the porosity gradient comprises an increasing average pore diameter in a direction toward both the superior and inferior surfaces in view of Zhang in order to provide an effective osteoconductive scaffold for bony ingrowth to enhance the stability of the spinal column.
Also It would have been obvious to one having ordinary skill in the art at the time the invention was made to construct the first portion with a porosity within a range of about 5% by volume to about 30% by volume and the second portion within a range of about 30% by volume to about 90% by volume, since it has been held that discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Wickham fails to teach that the porosity gradient comprises a first portion with a porosity with an average diameter between about 5 m and about 100 and a second portion with a porosity with an average diameter between about 100 m and 1000 m.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to construct the porosity gradient with a first portion with a porosity with an average diameter between about 5 m and about 100 and a second portion with a porosity with an average diameter between about 100 m and 1000 m, since it has been held that discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Response to Arguments
Applicant’s arguments, with respect to the rejection(s) of claim(s) 1-4, 12-16, 18-20 under Wickham 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 in view of Zhang.
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 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
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