Detailed Action
This is the final office action for US application number 17/398,984. Claims are evaluated as filed on May 12, 2026.
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
Applicant's arguments filed May 12, 2026 have been fully considered but they are not persuasive. The rejections in this office action have been amended to address the amended claims. Examiner asserts that Zipnick, Rumi, Noiles, Picha646, and Picha242 teaches all the newly-amended limitations and are capable of performing the functions as claimed. Examiner directs Applicant to the rejection below for a more in-depth description of the limitations.
With regards to Applicant’s argument that Zipnick does not disclose all the limitations of amended claim 6 (Remarks p. 5-6), Examiner agrees and notes that the below rejections have been amended to reflect the amended scope of the claims.
With regards to Applicant’s argument that none of Zipnick, Rumi, Picha646, and Picha242 disclose all the limitations of the amended claims (Remarks p. 6-7), Examiner notes that Noiles has been included in the below rejections to address the new limitations regarding the divergent prongs.
Election/Restrictions
In the reply filed on September 15, 2025, Applicant elected implant species A)20) of Figs. 13A-13F, the texture species B)4) of Figs. 7D, 20A, 21A, 24 bottom portion, and 25A-25C, and tool species C)2) of Figs. 23A-23C without traverse.
As to claim 11, the limitation of the plurality of outwardly extending divergent prongs separated by a first depressed region comprises at least four prongs separated by a centrally positioned depressed region is not disclosed in reference to the elected species. Further, such appears to be shown only in Figs. 20B-20D, which paragraph 172 discloses is created via the cutting pattern of Fig. 20C, i.e. non-elected texture species B)5) shown in Fig. 20C, as also shown in Figs. 20B and 20D per paragraph 173. Therefore, claim 11 does not read on the elected species.
Claim 12 depends from claim 11 and subsequently does not read on the elected species.
As to claim 8, the limitation of a first plurality of elongated grooves aligned in a first direction and a second plurality of elongated grooves aligned in a second direction, the first and second directions being non-parallel, with the first plurality of grooves intersecting with the second plurality of grooves is not disclosed in reference to the elected species. Further, such appears to be shown only in Figs. 20B-20D, which paragraph 172 discloses is created via the cutting pattern of Fig. 20C, i.e. non-elected texture species B)5) shown in Fig. 20C, as also shown in Figs. 20B and 20D per paragraph 173. Therefore, claim 8 does not read on the elected species.
Claims 9, 10, and 18-20 depend from claim 8 and subsequently do not read on the elected species.
Accordingly, claims 8-12 and 18-20 are withdrawn from further consideration.
Priority
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 16/505,096 and 15/220,090, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. Application No. 16/505,096 and 15/220,090 fail to provide adequate support for at least the “divergent prongs” of claim 1 line 11 and claim 6 line 8, “the main body comprising a silicon nitride material” of claim 2 line 2, claim 7 line 2, and claim 10 line 2.
The disclosure of the prior-filed application, Application No. 63/063,853, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. Application No. 63/063,853 fails to provide adequate support for at least “the main body comprising a silicon nitride material” of claim 2 line 2, claim 7 line 2, and claim 10 line 2.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required:
As to claims 6, 7, and 15-17, the specification appears to lack proper antecedent basis for “a plurality of inverted pyramidal shaped protrusions, each of the pyramidal shaped protrusions having a plurality of outwardly extending divergent prongs and a depressed central region, at least a portion of each of the outwardly extending divergent prongs forming an undercut section proximal to a surface of the plate” of claim 6 lines 6-10. That is, there appears to be no original description of an inverted pyramidal shaped structure, such does not appear to be shown, and such was not originally claimed. Thus, the specification fails to provide proper antecedent basis for “a plurality of inverted pyramidal shaped protrusions, each of the pyramidal shaped protrusions having a plurality of outwardly extending divergent prongs and a depressed central region, at least a portion of each of the outwardly extending divergent prongs forming an undercut section proximal to a surface of the plate” of claim 6 lines 6-10.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “a plurality of inverted pyramidal shaped protrusions, each of the pyramidal shaped protrusions having a plurality of outwardly extending divergent prongs and a depressed central region, at least a portion of each of the outwardly extending divergent prongs forming an undercut section proximal to a surface of the plate” of claim 6 lines 6-10 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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.
Claim(s) 6, 7, and 15-17 is/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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
As to claims 6, 7, and 15-17, “a plurality of inverted pyramidal shaped protrusions, each of the pyramidal shaped protrusions having a plurality of outwardly extending divergent prongs and a depressed central region, at least a portion of each of the outwardly extending divergent prongs forming an undercut section proximal to a surface of the plate” of claim 6 lines 6-10 appear to be new matter. That is, there appears to be no original description of an inverted pyramidal shaped structure, such does not appear to be shown, and such was not originally claimed. Thus, “a plurality of inverted pyramidal shaped protrusions, each of the pyramidal shaped protrusions having a plurality of outwardly extending divergent prongs and a depressed central region, at least a portion of each of the outwardly extending divergent prongs forming an undercut section proximal to a surface of the plate” of claim 6 lines 6-10 constitutes new matter.
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.
Claim(s) 6, 7, and 14-17 is/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 pre-AIA the applicant regards as the invention.
Claim(s) 6 is/are unclear with regards to “a plurality of inverted pyramidal shaped protrusions, each of the pyramidal shaped protrusions having a plurality of outwardly extending divergent prongs and a depressed central region, at least a portion of each of the outwardly extending divergent prongs forming an undercut section proximal to a surface of the plate” of claim 6 lines 6-10 and how any shown structure can be reasonably construed to represent an inverted pyramidal shape, how divergent prongs can be reasonably construed to form an inverted pyramidal shape, and how an inverted pyramidal shape could additionally comprise an undercut section as claimed. Examiner is interpreting this as referring to, and suggests amending as, “the plate has a surface pattern comprising
Claim(s) 14 is/are unclear with regards to “the second depressed region is located closer to the first or second plate than the first depressed region” and how the depressed regions can differ in distance relative to the plates that define them, i.e. it is unclear how a portion of a plate can be reasonably considered to be a distance from itself. Examiner is interpreting this broadly as referring to the height difference of the depressions as shown in Fig. 21A and suggests amending to clarify.
Claim(s) 16 is/are unclear with regards to “the pyramidal shaped protrusions includes a necked-down section positioned proximate to the plate” and the intended meaning of “necked-down” and where such is disclosed in addition to the undercut of claim 6 line 9 as well as the purported pyramidal shaped protrusions. Examiner is interpreting this as referring to the narrowing/undercut shape and suggests amending to clarify.
Claim(s) 7, 15, and 17 is/are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, for its/their dependence on one or more rejected base claims.
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 of this title, 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, 3-5, and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zipnick (US 2013/0110248) in view of Rumi et al. (US 2016/0100954, hereinafter “Rumi”) and Noiles (US 4,865,603).
The claimed phrase “formed” is being treated as a product by process limitation; that is the product reasonably appears to be either identical with or only slightly different than a product claimed in a product-by-process claim. As set forth in MPEP 2113, product by process claims are not limited to the manipulation of the recited steps, only the structure implied by the steps. Once a product appearing to be substantially the same or similar is found, a 35 USC 102/103 rejection may be made and the burden is shifted to applicant to show an unobvious difference. MPEP 2113.
As to claims 1, 3-5, and 14, Zipnick discloses a hybrid intervertebral cage structure (100, Figs. 1A-1C, ¶s 38, 66, and 70, where ¶66 discloses the tabs/ridges 130 sliding into the receptacles/slots 132 and ¶70 discloses implant assembly movement along A-B shown in Fig. 1A) comprising: a main body (110) comprising a first surface (top surface of 110 as shown in Fig. 1B, Fig. 1B) and a second surface (bottom surface of 110 as shown in Fig. 1B, Fig. 1B) located opposite to the first surface (as defined, Fig. 1B); a first plate (112) disposed on the first surface of the main body (Figs. 1A and 1B); a second plate (114) disposed on the second surface of the main body (Figs. 1A and 1B); and an opening (150) formed at a center portion of the intervertebral cage structure (Figs. 1A-1C) and extending from the first plate to the second plate via the main body (Figs. 1A-1C), wherein at least one of the first and second plates comprise a surface pattern (Figs. 1A-1C) comprising a plurality of outwardly extending teeth (portion between each pair of grooves 140, Figs. 1A-1C), each of the outwardly extending teeth spaced apart by a second depressed region (140, Figs. 1A-1C); wherein the first and second plates comprise titanium (¶58). As to claim 3, Zipnick discloses that the first and second plates include a dovetail connection to the main body (Fig. 1A, ¶s 38, 66, and 70, where ¶66 discloses the tabs/ridges 130 sliding into the receptacles/slots 132 and ¶70 discloses implant assembly movement along A-B shown in Fig. 1A). As to claim 4, Zipnick discloses that the main body comprises Polyether Ether Ketone (PEEK) and the first plate comprises titanium (¶58). As to claim 5, Zipnick discloses that the main body further comprises a plurality of lateral surfaces (Figs. 1A and 1B) extending between the first and second surfaces (Figs. 1A and 1B); and one or more holes (184, 186, 170, ¶s 60 and 67) extend from one of the plurality of lateral surfaces towards the opening (Figs. 1A and 1B).
Zipnick is silent to the second plate connected to the first plate via a bridge element and each of the outwardly extending teeth including a plurality of outwardly extending divergent prongs separated by a first depressed region. As to claim 14, Zipnick is silent to the second depressed region is located closer to the first or second plate than the first depressed region.
Rumi teaches a similar hybrid intervertebral cage structure (10, Figs. 1-5, abstract) comprising: a main body (14, Figs. 1-5) comprising a first surface (top surface of 14 as shown in Fig. 5, Fig. 5) and a second surface (bottom surface of 14 as shown in Fig. 5, Fig. 5) located opposite to the first surface (as defined, Fig. 5); a first plate (upper portion of 12 as shown in Fig. 5A that is shown above 14 in Fig. 1, Figs. 1 and 5A) disposed on the first surface of the main body (Fig. 1); a second plate (lower portion of 12 as shown in Fig. 5A that is shown below 14 in Fig. 1, Figs. 1 and 5A) disposed on the second surface of the main body (Fig. 1), the second plate connected to the first plate via a bridge element (intervening portion of 12 as shown in Figs. 1 and 5A connecting the first plate and the second plate, Figs. 1 and 5A); and an opening (28, Fig. 1) formed at a center portion of the intervertebral cage structure (Fig. 1) and extending from the first plate to the second plate via the main body (Figs. 1 and 3A-4B), wherein at least one of the first and second plates comprise an outwardly extending surface pattern (Figs. 1 and 2) symmetrically distributed over the surface pattern (Figs. 1, 2, and 4A). As to claim 3, Rumi teaches that the first and second plates include a dovetail connection to the main body (protrusions 30, grooved 32, Figs. 1, 3A, 4B, 5A, and 5B, ¶30). As to claim 4, Rumi teaches that the main body comprises Polyether Ether Ketone (PEEK) (¶28) and the first plate comprises titanium (¶28). As to claim 5, Rumi teaches that wherein the main body further comprises a plurality of lateral surfaces (Figs. 1, 3A, and 5B) extending between the first and second surfaces (Figs. 1, 3A, and 5B); and one or more holes (36) extend from one of the plurality of lateral surfaces towards the opening (Figs. 1 and 3A).
Noiles teaches a similar titanium prosthetic device (abstract, col. 4 lines 35-38, col. 9 lines 34-38) comprising: a plate (14) disposed on a first surface (13) of a main body (Figs. 1-3); wherein the plate comprises an outwardly extending surface pattern (Figs. 1-3) comprising a plurality of outwardly extending teeth (between each pair of troughs 10, Figs. 1-3), each of the outwardly extending teeth including a plurality of outwardly extending divergent prongs (portions of each tooth between respective trough 10 and shallow trough 26, Figs. 1-3, i.e. to the left of 24 as shown in Fig. 3 and to the right of 24 as shown in Fig. 3) separated by a first depressed region (26), each of the outwardly extending teeth spaced apart by a second depressed region (10). As to claim 14, Noiles teaches that the second depressed region is located closer to the plate than the first depressed region (Fig. 3).
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the first and second plates as disclosed by Zipnick by adding a bridge as taught by Rumi in order to provide the plates in one piece (Rumi ¶28) and provide the cage with additional strength (Rumi ¶28). One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the titanium plate teeth as disclosed by Zipnick by adding first depressed regions as taught by Noiles in order to provide improved outer surfaces for engagement with bone (Noiles col. 4 lines 10-12) via readily controlled processes (Noiles col. 4 lines 24-25) by providing an outer surface texture into which bone may grow with a sufficient volume for bone ingrowth so that the ratio of ingrown bone to metal at the interface can be at least one to one and can be preferably greater than one to one (Noiles col. 4 lines 14-22).
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zipnick, Rumi, and Noiles in view of Picha et al. (US 2020/0323646, hereinafter “Picha646”).
As to claim 2, the combination of Zipnick, Rumi, and Noiles discloses the invention of claim 1 as well as the main body comprising a polymer such as a polyether ether ketone (PEEK) (¶58) and at least one of the first and second plates comprise a titanium material (¶58).
The combination of Zipnick, Rumi, and Noiles is silent to the main body comprising a silicon nitride material.
Picha646 teaches a similar a hybrid intervertebral cage structure (100, Figs. 1-2, ¶54) comprising: a main body (110, ¶57) comprising a first surface (top surface of 110 as shown in Fig. 1, Fig. 1) and a second surface (bottom surface of 110 as shown in Fig. 1, Fig. 1) located opposite to the first surface (as defined, Fig. 1), the main body comprising one or more of a silicon nitride material, PEEK, etc. (¶57); and an opening (134) formed at a center portion of the intervertebral cage structure (Fig. 1, ¶59) and extending from the first surface to the second surface via the main body (Fig. 1), wherein at least one of the first and second surfaces comprises an outwardly extending surface pattern (Fig. 1) symmetrically distributed over the surface pattern (Fig. 1).
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the PEEK main body as disclosed by the combination of Zipnick, Rumi, and Noiles by adding silicon nitride as taught by Picha646 in order to select a known interbody cage main body material (Picha646 ¶57) to achieved a desired modulus of elasticity (Picha646 ¶55) to well match the modulus of elasticity of the bone (Picha646 ¶43) to exhibit mechanical properties similar to those of the bulk bone of the vertebral bodies adjacent to the implanted cage (Picha646 ¶43).
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zipnick, Rumi, and Noiles in view of Picha et al. (US 2002/0040242, hereinafter “Picha242”).
As to claim 13, the combination of Zipnick, Rumi, and Noiles discloses the invention of claim 1.
The combination of Zipnick, Rumi, and Noiles is silent to a plurality of pyramid shaped protrusions positioned in the second depressed region between the plurality of outwardly extending teeth.
Picha242 teaches a similar hybrid intervertebral cage structure (10, Figs. 1, 2, and 10) comprising: a main body (10) having a surface (Figs. 1, 2, and 10), a plate (upper wall as shown in Fig. 2, Fig. 2) disposed on the main body (Figs. 1 and 2); and an opening (22s) formed in the intervertebral cage structure (Figs. 1 and 2) and extending from the surface and through the main body (Figs. 1 and 2), wherein the plate has a surface pattern (Fig. 10) comprising a plurality of first outwardly extending teeth (68, 6), each of the outwardly extending teeth spaced apart by a second depressed region (between each pair of 68/6, Fig. 10); further comprising a plurality of pyramid shaped protrusions (70, Fig. 10; where ¶36 discloses that 34 are pyramidal pillars shown in Figs. 5 and 6 and a comparison of Figs. 6 and 10 shows the same shape is used for 70; thus 70 is disclosed to be pyramid-shaped) positioned in the second depressed region between the plurality of outwardly extending teeth (Fig. 10).
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the second depressed region as disclosed by the combination of Zipnick, Rumi, and Noiles by adding a plurality of pyramid shaped protrusions as taught by Picha242 in order to more effectively mechanically anchor the cage at an early date and affix the cage into the adjoining bone and more effectively reduce, minimize or disrupt fibrous capsule formation around the cage (Picha242 ¶47).
Claim(s) 6, 15, and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zipnick in view of Noiles.
The claimed phrase “formed” is being treated as a product by process limitation; that is the product reasonably appears to be either identical with or only slightly different than a product claimed in a product-by-process claim. As set forth in MPEP 2113, product by process claims are not limited to the manipulation of the recited steps, only the structure implied by the steps. Once a product appearing to be substantially the same or similar is found, a 35 USC 102/103 rejection may be made and the burden is shifted to applicant to show an unobvious difference. MPEP 2113.
As to claims 6, 15, and 16, Zipnick discloses a hybrid intervertebral cage structure (100, Figs. 1A-1C, ¶s 38, 66, and 70, where ¶66 discloses the tabs/ridges 130 sliding into the receptacles/slots 132 and ¶70 discloses implant assembly movement along A-B shown in Fig. 1A) comprising: a main body (110) having a surface (top surface of 110 as shown in Fig. 1B, Fig. 1B); a plate (112) disposed on the surface of the main body (Figs. 1A and 1B); and an opening (150) formed in the intervertebral cage structure (Figs. 1A-1C) and extending from the surface and through main body (Figs. 1A-1C), wherein the plate has a surface pattern (Figs. 1A-1C) comprising a plurality of outwardly extending prongs (between recesses 140s as shown in Figs. 1A-1C, Figs. 1A-1C); at least a portion of each of the outwardly extending prongs forming an undercut section (left and right surface of each as shown in Fig. 1B, Figs. 1A-1C) proximal to a surface of the plate (Figs. 1A-1C) capable of retaining blood, tissue, or bone graft and promoting bone growth (due to the shown shape in Figs. 1A-1C, Figs. 1A-1C, ¶61 discloses these as engaging features that engage with the vertebra or disc tissue). As to claim 15, Zipnick discloses that each of the plurality of outwardly extending divergent prongs includes a flattened tip (Fig. 1B). As to claim 16, Zipnick discloses that each of the pyramidal shaped protrusions includes a necked-down section positioned proximate to the plate (due to the shape of the undercut, Figs. 1A-1C).
Zipnick is silent to the outwardly extending prongs being divergent and having a depressed central region.
Noiles teaches a similar titanium prosthetic device (abstract, col. 4 lines 35-38, col. 9 lines 34-38) comprising: a plate (14) disposed on a surface (13) of a main body (Figs. 1-3); wherein the plate has a surface pattern (Figs. 1-3) comprising a plurality of outwardly extending divergent prongs (between respective trough 10 and shallow trough 26, Figs. 1-3, i.e. to the left of 24 as shown in Fig. 3 and to the right of 24 as shown in Fig. 3) and a depressed central region (26), at least a portion of each of the outwardly extending divergent prongs forming an undercut section (left and right surface of each as shown in Fig. 3, Fig. 3) capable of retaining blood, tissue, or bone graft and promoting bone growth (due to the shown shape in Fig. 3, col. 4 lines 10-22). As to claim 15, Noiles teaches that each of the plurality of outwardly extending divergent prongs includes a flattened tip (Fig. 3). As to claim 16, Noiles teaches that each of the pyramidal shaped protrusions includes a necked-down section positioned proximate to the plate (due to the shown shape in Fig. 3).
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the outwardly extending prongs as disclosed by Zipnick to be divergent and having a depressed central region therebetween as taught by Noiles in order to provide improved outer surfaces for engagement with bone (Noiles col. 4 lines 10-12) via readily controlled processes (Noiles col. 4 lines 24-25) by providing an outer surface texture into which bone may grow with a sufficient volume for bone ingrowth so that the ratio of ingrown bone to metal at the interface can be at least one to one and can be preferably greater than one to one (Noiles col. 4 lines 14-22).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zipnick and Noiles in view of Picha646.
As to claim 7, the combination of Zipnick and Noiles discloses the invention of claim 6 as well as the main body comprising a polymer such as a polyether ether ketone (PEEK) (¶58) and the plate comprises a titanium material (¶58).
The combination of Zipnick and Noiles is silent to the main body comprising a silicon nitride material.
Picha646 teaches a similar a hybrid intervertebral cage structure (100, Figs. 1-2, ¶54) comprising: a main body (110, ¶57) comprising a surface (top surface of 110 as shown in Fig. 1, Fig. 1); and an opening (134) formed in the intervertebral cage structure (Fig. 1, ¶59) and extending from the surface and through the main body (Fig. 1), wherein the surface comprises an outwardly extending surface pattern (Fig. 1); the main body comprising one or more of a silicon nitride material, PEEK, etc. (¶57)
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the PEEK main body as disclosed by the combination of Zipnick and Noiles by adding silicon nitride as taught by Picha646 in order to select a known interbody cage main body material (Picha646 ¶57) to achieved a desired modulus of elasticity (Picha646 ¶55) to well match the modulus of elasticity of the bone (Picha646 ¶43) to exhibit mechanical properties similar to those of the bulk bone of the vertebral bodies adjacent to the implanted cage (Picha646 ¶43).
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zipnick and Noiles in view of Picha242).
As to claim 17, the combination of Zipnick and Noiles discloses the invention of claim 6.
The combination of Zipnick and Noiles is silent to a plurality of pyramid shaped protrusions positioned in the positioned between the plurality of inverted pyramidal shaped protrusions, i.e. the prongs.
Picha242 teaches a similar hybrid intervertebral cage structure (10, Figs. 1, 2, and 10) comprising: a main body (10) having a surface (Figs. 1, 2, and 10), a plate (upper wall as shown in Fig. 2, Fig. 2) disposed on the main body (Figs. 1 and 2); and an opening (22s) formed in the intervertebral cage structure (Figs. 1 and 2) and extending from the surface and through the main body (Figs. 1 and 2), wherein the plate has a surface pattern (Fig. 10) comprising a plurality of outwardly extending prongs (68, 6), at least a portion of each of the outwardly extending prongs forming an undercut section (Fig. 10); further comprising a plurality of pyramid shaped protrusions (70, Fig. 10; where ¶36 discloses that 34 are pyramidal pillars shown in Figs. 5 and 6 and a comparison of Figs. 6 and 10 shows the same shape is used for 70; thus 70 is disclosed to be pyramid-shaped) positioned in the positioned between the plurality of inverted pyramidal shaped protrusions, i.e. the prongs (between each pair of 68/6, Fig. 10).
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the region between the prongs as disclosed by the combination of Zipnick and Noiles by adding a plurality of pyramid shaped protrusions as taught by Picha242 in order to more effectively mechanically anchor the cage at an early date and affix the cage into the adjoining bone and more effectively reduce, minimize or disrupt fibrous capsule formation around the cage (Picha242 ¶47).
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMY SIPP whose telephone number is (313)446-6553. The examiner can normally be reached on Monday through Thursday, 6:30am-4pm EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Truong can be reached on 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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/AMY R SIPP/Primary Examiner, Art Unit 3775
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