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 .
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after the final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant’s submission filed on 7/9/26 has been entered.
Accordingly, claims 1 and 14 are amended, claims 8-9, 17 are withdrawn.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-4, 12-16, 18-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The new matter issue is “the porosity gradient comprises a continuously increasing average pore diameter in a direction toward both the superior and inferior surfaces” since no where in the specification nor the drawing showing that the porosity gradient comprises a continuously increasing average pore diameter in a direction toward both the superior and inferior surfaces.
Applicant in his remarks filed on 7/9/26, relied on figs 3a and 3b to provide support for the above limitations, however figs 3a and 3b only show a middle portion of small pore diameter and a second portion of large pore diameter (see modified figs 3a and 3b below), and there is NO continuously increasing average pore diameter in a direction toward both the superior and inferior surfaces.
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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 a continuously 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 a continuously increasing average pore diameter in a direction toward both the superior 18 and inferior surfaces 20, (see modified fig. 1 below), 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.
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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 a continuously 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 filed have been fully considered but they are not persuasive.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., ") are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., “Zhang likewise fails to disclose, teach, or suggest a continuously increasing pore diameter within a unitary structural element”) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., “A gradient, as now explicitly recited in the claims, requires a progressive, uninterrupted change in pore diameter with position”) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., “Neither reference contemplates-nor even suggests-the use of a continuous spatial gradient in pore diameter within a single structural frame formed by a pattern of apertures.”) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Applicant argues that “There is no suggestion of a continuous increase in pore diameter toward both surfaces.”
Examiner respectfully disagrees, since Zhang teaches a porosity gradient comprises a continuously increasing average pore diameter in a direction toward both the superior 18 and inferior surfaces 20, (see modified fig. 1 below).
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Conclusion
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Truong can be reached at 571-272-4705. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SAMEH R BOLES/Primary Examiner, Art Unit 3775
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