Detailed Action
This is the first office action on the merits for US application number 17/398,984.
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 .
Election/Restrictions
Applicant’s election of 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-23Cin the reply filed on September 15, 2025 is acknowledged, which indicated that claims 1-10 read on the elected species.
Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
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 main body comprising a silicon nitride material” of claim 1 line 3, claim 7 lines 1-2, and claim 10 lines 1-2, and “a superior surface of the plurality of first protrusions is a different shape than a superior surface of the plurality of second protrusions” of claim 8 lines 8-9.
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 1 line 3, claim 7 lines 1-2, and claim 10 lines 1-2.
Claim Objections
Claim(s) 1, 6, and 8 is/are objected to because of the following informalities:
Claim 1 line 1 should read “A hybrid intervertebral cage structure[[,]] comprising:”.
Claim 6 line 1 should read “A hybrid intervertebral cage structure[[,]] comprising:”.
Claim 8 line 1 should read “A hybrid intervertebral cage structure[[,]] comprising:”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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) 7 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) 7 is/are unclear with regards to “the main body comprises a silicon nitride material” in lines 1-2 that is in addition to the “the main body comprising a silicon nitride material” of claim 1 line 3 from which claim 7 depends and where such support can be found in Applicant’s specification for two silicon nitride materials and the intended difference. Claim(s) 7 is/are unclear with regards to “the plate” in line 2 and if such is intended to refer to the first plate or the second plate of claim 1 lines 4 and 5, respectively. Examiner is interpreting this as referring to, and suggests amending as, “7. The hybrid intervertebral cage structure of claim [[5]]6, wherein”.
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(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) 6 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zipnick (US 2013/0110248).
As to claim 6, 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) that comprises a plurality of outwardly extending prongs (between recesses 140s as shown in Figs. 1A-1C, Figs. 1A-1C) having undercut sections (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).
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) 1-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zipnick (US 2013/0110248) in view of Picha et al. (US 2020/0323646, hereinafter “Picha646”) and Rumi et al. (US 2016/0100954, hereinafter “Rumi”).
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 1-5, 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), the main body comprising a polymer such as a polyether ether ketone (PEEK) (¶58); 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 an outwardly extending surface pattern (Figs. 1A-1C) comprising a first plurality of depressions (140s, Figs. 1A-1C) having a first depth (Figs. 1A-1C) that are symmetrically distributed over the surface pattern (Figs. 1A-1C). As to claim 2, Zipnick discloses that the first and second plate comprise a titanium material (¶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 main body comprising a silicon nitride material and the second plate connected to the first plate via a bridge element.
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).
Rumi teaches a similar a 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 2, Rumi teaches that the first and second plate comprise a titanium material (¶28). 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).
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 Zipnick by adding silicon nitride as taught by Picha 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). 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).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zipnick in view of Picha646.
As to claim 7, Zipnick discloses the invention of claim 6 as well as that the main body comprises Polyether Ether Ketone (PEEK) and the plate comprises titanium (¶58).
Zipnick 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 plate has a surface pattern (Fig. 1); wherein . As to claim 7, Picha646 teaches that the main body comprises 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 Zipnick 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) 8 and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zipnick (US 2013/0110248) in view of Picha et al. (US 2002/0040242, hereinafter “Picha242”)).
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 8 and 9, 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 the main body (Figs. 1A-1C), wherein the plate has a surface pattern (Figs. 1A-1C) comprising a plurality of first protrusions (between recesses 140s as shown in Figs. 1A-1C, Figs. 1A-1C), the plurality of first protrusions each having at least one undercut section (Figs. 1A-1C) at a lower end thereof (Figs. 1A and 1B), wherein a superior surface of the plurality of first protrusions has a shape (Figs. 1A-1C). As to claim 9, Zipnick discloses that at least the plurality of first protrusions has a pocket formed at a bottom surface thereof (formed by the undercut as shown in Figs. 1A and 1B, Figs. 1A-1C).
Zipnick is silent to a plurality of second protrusions, wherein the superior surface of the plurality of first protrusions is a different shape than a superior surface of the plurality of second protrusions.
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 protrusions (68, 6) and a plurality of second protrusions (70), the plurality of first protrusions each having at least one undercut section (Fig. 10) at a lower end thereof (Fig. 10), wherein a superior surface of the plurality of first protrusions is a different shape than a superior surface of the plurality of second protrusions (Fig. 10), wherein the plurality of first protrusions comprises a pillar (68) extending from a protrusion (6, Figs. 2 and 10).
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the surface pattern as disclosed by Zipnick by adding the plurality of second protrusions and adding the pillar to the plurality of first 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) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zipnick and Picha242 in view of Picha646.
As to claim 10, the combination of Zipnick and Picha242 discloses the invention of claim 8 as well as that 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 Picha242 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) having 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 plate has a surface pattern (Fig. 1); wherein the main body comprises 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 Picha242 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).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMY R SIPP whose telephone number is (313)446-6553. The examiner can normally be reached on Mon - Thurs 6-4.
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/AMY R SIPP/Primary Examiner, Art Unit 3775