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 .
Information Disclosure Statement
The information disclosure statement filed 11/29/25 fails to comply with 37 CFR 1.98(a)(1), which requires the following: (1) a list of all patents, publications, applications, or other information submitted for consideration by the Office; (2) U.S. patents and U.S. patent application publications listed in a section separately from citations of other documents; (3) the application number of the application in which the information disclosure statement is being submitted on each page of the list; (4) a column that provides a blank space next to each document to be considered, for the examiner’s initials; and (5) a heading that clearly indicates that the list is an information disclosure statement. The information disclosure statement has been placed in the application file, but the information referred to therein has not been considered.
Claim Objections
Claim 1 is objected to because of the following informalities:
In Lines 5, 6, 8, & 11, the word --different-- should be added before each instance of the word “endplate” in order to keep claim terminology consistent.
In Line 10, the words “thus defined” should be deleted.
Appropriate correction is required.
Claim 2 is objected to because of the following informalities:
In Line 1, the word --different-- should be added before the word “endplate” in order to keep claim terminology consistent.
In Line 2, the words “respect of” should be deleted.
Appropriate correction is required.
Claim 5 is objected to because of the following informalities:
In Line 1, a comma should be added after the number “1”, and the word “plural” should be replaced with the words --a plurality of--.
In Line 2, the words “plural core components” should be replaced with the words --plurality of different core components--.
In Lines 4-5, the limitation “the plural holding space openings of” should be replaced with the limitation --each holding space opening having--.
Appropriate correction is required.
Claim 6 is objected to because of the following informalities:
In Line 2, the word “plural” should be replaced with the words --plurality of-- and the word --different-- should be added after the word “of” at the end of the line.
In Line 3, the words “respect of” should be deleted.
Appropriate correction is required.
Claim 7 is objected to because of the following informalities: In Line 2, the words “plural endplates” should be replaced with the words --plurality of different--. Appropriate correction is required.
Claim 8 is objected to because of the following informalities:
In Line 2, the word “plural” should be replaced with the words --plurality of different--.
In Line 3, the word --the-- should be added before the word “core”.
Appropriate correction is required.
Claim 9 is objected to because of the following informalities:
In Line 2, the word “plural” should be replaced with the words --plurality of different--.
In Line 3, the word --the-- should be added before the word “core”.
Appropriate correction is required.
Claim 10 is objected to because of the following informalities: In Line 2, the word --the-- should be added before the word “endplate”. Appropriate correction is required.
Claim 11 is objected to because of the following informalities:
In Lines 3 & 5, the word “plural” should be replaced with the words --plurality of different--.
In Line 4, the word --different-- should be added before the word “endplates”.
Appropriate correction is required.
Claim 14 is objected to because of the following informalities: In Lines 2, 3, & 5, the word --different-- should be added before each instance of the word “endplates”. Appropriate correction is required.
Claim 16 is objected to because of the following informalities: In Lines 2 & 8-9, the words “plural different endplates” should be replaced with the words --plurality of different endplates--. Appropriate correction is required.
Claim 17 is objected to because of the following informalities:
In Line 1, the word --different-- should be added before the word “endplates”.
In Line 2, the words “respect of” should be deleted.
Appropriate correction is required.
Claim 18 is objected to because of the following informalities:
In Lines 5, 9, & 12, the word --different-- should be added before each instance of the word “endplate” in order to keep claim terminology consistent.
In Line 7, the words “thus defined” should be deleted.
Appropriate correction is required.
Claim 19 is objected to because of the following informalities:
In Lines 6, 8, 15 & 17, the word --different-- should be added before each instance of the word “endplates”.
In Line 13, the words “plural endplates” should be replaced with the words –plurality of different endplates--.
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.
Claims 3-4, 7-11, 14, 16-17 & 19-20 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 3 at Line 4 recites the limitation “the selected superior endplate”. There is insufficient antecedent basis for this limitation. Lines 4-5 further recites “when the superior endplate is in engagement with the core component” which renders the claim indefinite as it is unclear which “superior endplate” is being recited since a plurality of different superior endplates are previously recited in Line 2. For purposes of examination, Lines 3-5 are being interpreted as “the core component top surface configured to face [[facing]] the bottom surface of the selected [[superior]] endplate when one of the superior endplates is selected to be in engagement with the core component.” Appropriate correction is required.
Claim 4 at Line 4 recites the limitation “the selected inferior endplate”. There is insufficient antecedent basis for this limitation. Line 5 further recites “when the inferior endplate is in engagement with the core component” which renders the claim indefinite as it is unclear which “inferior endplate” is being recited since a plurality of different inferior endplates are previously recited in Line 2. For purposes of examination, Lines 3-5 are being interpreted as “the core component bottom surface configured to face [[facing]] the top surface of the selected [[inferior]] endplate when one of the inferior endplates is selected to be in engagement with the core component.” Appropriate correction is required.
Claim 7 recites “wherein the core component is configured and each of the plural endplates is configured for inter-engagement of the core component and each endplate with each other.” which renders the claim indefinite as it is unclear if the claim is reciting that the endplates are configured to inter-engage with the other endplate and the core component, or if the claim is reciting that the core component is configured to inter-engage with each of the endplates distinctly. It does not appear from the drawings that multiple endplates inter-engage with each other without the core component and for purposes of examination, the limitation is being interpreted as “wherein the core component is configured with each endplate
Claim 8 at Line 3 recites the term “the endplate” which renders the claim indefinite as it is unclear which endplate is being recited since a plurality of different endplates are previously recited. For purposes of examination, the term is being interpreted as “the selected endplate”. Appropriate correction is required.
Claim 9 at Line 3 recites the term “the endplate” which renders the claim indefinite as it is unclear which endplate is being recited since a plurality of different endplates are previously recited. For purposes of examination, the term is being interpreted as “the selected endplate”. Appropriate correction is required.
Claim 10 at Line 2 recites the term “endplate” which renders the claim indefinite as it is unclear which endplate is being recited since a plurality of different endplates are previously recited. For purposes of examination, the term is being interpreted as “the selected endplate”. Appropriate correction is required.
Claim 11 at Line 2 recites the limitation “that provide for inter-engagement with one endplate” which renders the claim indefinite as it is unclear which “one endplate” is being recited; is it the previously recited selected endplate or a different endplate or any one endplate? For purposes of examination, Lines 1-3 are being interpreted as “wherein the core component comprises features that provide for inter-engagement with each endplate”. Appropriate correction is required.
Claim 11 at Lines 4-6 recites the limitation “with such inter-engaging features corresponding from endplate to endplate of the plural endplates” which renders the claim indefinite as it is unclear what is meant by “corresponding from endplate to endplate” in this limitation; corresponding in what way? Structurally, in size, in function, etc, or something else? Appropriate correction is required.
Claim 14 at Line 2 recites the limitation “that provide for locking with one endplate” which renders the claim indefinite as it is unclear which “one endplate” is being recited; is it the previously recited selected endplate or a different endplate or any one endplate? For purposes of examination, Lines 1-3 are being interpreted as “wherein the core component comprises features that provide for locking with each endplate”. Appropriate correction is required.
Claim 14 at Lines 4-5 recites the limitation “with such locking features corresponding from endplate to endplate of the plurality of endplates” which renders the claim indefinite as it is unclear what is meant by “corresponding from endplate to endplate” in this limitation; corresponding in what way? Structurally, in size, in function, etc, or something else? Appropriate correction is required.
Claim 16 at Line 6 recites the term “the endplate” which renders the claim indefinite as it is unclear which endplate is being recited since a plurality of different endplates are previously recited. For purposes of examination, the term is being interpreted as “the selected endplate”. Appropriate correction is required.
Claim 17 at Line 3 recites the limitation “each of their second locations” and in Line 4 recites the limitation “the first location”. There is insufficient antecedent basis for the term “second location” and “first location”. For purposes of examination, the limitations are being interpreted as “each of their second surfaces” and “the first surface”, respectively. Appropriate correction is required.
Claim 19 at Line 14 recites the term “the endplate” which renders the claim indefinite as it is unclear which endplate is being recited since a plurality of different endplates are previously recited. For purposes of examination, the term is being interpreted as “the selected endplate”. Appropriate correction is required.
Claim 19 at Lines 14-15 recites the limitation “the endplate features corresponding from endplate to endplate of the plurality of endplates” which renders the claim indefinite as it is unclear what is meant by “corresponding from endplate to endplate” in this limitation; corresponding in what way? Structurally, in size, in function, etc, or something else? Appropriate correction is required.
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.
Claim(s) 19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Krueger (US PG Pub No. 2013/0006357).
Regarding Claim 19 as best understood, Krueger discloses a kit of parts (Paragraph [0206], “Also disclosed are spinal fusion kits that contain key components of the spinal fusion device. In one embodiment, a spinal fusion kit contains modular endplates with different sizes and lordotic angles and modular spacers with different sizes and lordotic angles. In another embodiment, the kit further contains a endplate inserter and a spacer inserter.”) from which selection is made to form an intervertebral fusion device (10, Figs. 1-9, Paragraph [0126]), the kit of parts comprising: a plurality of different endplates (upper and lower endplates 12 & 14, Figs. 1-3B) each of which is configured to be received in an intervertebral space (Paragraphs [0126-0129]) defined between first and second vertebrae (47 & 48, Figs. 4A-4B); and a core component (spacer 24, Figs. 1 & 5-6) capable of inter-engaging with each of the plurality of endplates (Fig. 1) and a selected one of the plurality of endplates (Paragraph [0134]) when the selected endplate and the core component are received in the intervertebral space (Figs. 1 & 4A-4B) (Paragraphs [0126-0131]), wherein each of the plurality of endplates defines a bone graft aperture (opening 26 of 12 & 14, Fig. 2, Paragraph [0126]), the core component defines a bone graft material holding space (central cavity 82, Figs. 5-6, Paragraph [0129]) having a holding space opening in a core component top surface (upper aperture defined through 46, 66, 44, & 69, Figs. 5-6), the core component comprises core component features (enlarged dovetail portions of left and right arms 44 & 46, Figs. 5-7A, Paragraph 0133]) which inter-engage with endplate features (left and right slots 70 formed within inner surfaces of 12 & 14, Figs. 1 & 8A-8B, Paragraph [0133-0134]) of each of the endplates whereby the core component inter-engages with the endplate (Fig. 1), the endplate features corresponding from endplate to endplate of the plurality of endplates (each of 12 & 14 comprise symmetrically arranged slots as seen in Fig. 1 for dovetail engagement with the projections of 24), and the holding space opening is in registration with the bone graft aperture of the selected endplate (Fig. 2) regardless of which of the plurality of endplates is selected and when the core component is moved to its furthest extent in the anterior to posterior direction relative to the selected endplate and when the core component is inter-engaged with the selected endplate (the central cavity 82 is aligned and coaxial with the openings 26 of 12 & 14 vertically along a central axis extending vertically through implant 10 as seen in Figs. 1-2).
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) 1-18 & 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Krueger (US PG Pub No. 2013/0006357).
Regarding Claim 1, Krueger discloses a kit of parts (Paragraph [0206], “Also disclosed are spinal fusion kits that contain key components of the spinal fusion device. In one embodiment, a spinal fusion kit contains modular endplates with different sizes and lordotic angles and modular spacers with different sizes and lordotic angles. In another embodiment, the kit further contains a endplate inserter and a spacer inserter.”) from which selection is made to form an intervertebral fusion device (10, Figs. 1-9, Paragraph [0126]), the kit of parts comprising: a plurality of different endplates (upper and lower endplates 12 & 14, Figs. 1-3B) each of which is configured to be received in an intervertebral space (Paragraphs [0126-0129]) defined between first and second vertebrae (47 & 48, Figs. 4A-4B); and a core component (spacer 24, Figs. 1 & 5-6) configured to engage with each of the plurality of endplates (Fig. 1) and a selected one of the plurality of endplates (Paragraph [0134]) when the selected endplate and the core component are received in the intervertebral space (Figs. 1 & 4A-4B) (Paragraphs [0126-0131]), wherein each of the plurality of endplates defines a bone graft aperture (opening 26 of 12 & 14, Fig. 2, Paragraph [0126]) which is open at top and bottom surfaces of the endplate (top surface of 12 is 16 and bottom surface of 12 is the opposite inner surface 15 of 12; and top surface of 14 is the inner surface 15 of 14 and bottom surface of 14 is 17, Figs. 1, 3A & 8A) and extends between the top and bottom surfaces (Paragraph [0126]), the bone graft apertures being of substantially the same dimensions as one another when the plurality of endplates are in plan view (Fig. 2 depicts the plan view of the implant 10) (Endplates 12 & 14 are substantially similar to one another; Paragraph [0139]), the core component defines a bone graft material holding space (central cavity 82, Figs. 5-6, Paragraph [0129]) having a holding space opening in a core component top surface of the core component (upper aperture defined through 46, 66, 44, & 69, Figs. 5-6).
Krueger does not disclose wherein when the core component is in plan view the holding space opening is of substantially the same dimensions as each of the bone graft apertures, and the holding space opening is substantially coextensive with the bone graft aperture of the selected endplate in plan view and when the core component is engaged with and in registration with the selected endplate. Krueger does disclose in Paragraph [0126] that “As shown in FIG. 2, the outer surfaces 16 and 17 of the endplates 12 and 14 may contain a variety of openings 26 and 30 to allow bone growth through the endplates 12 and 14 and between the adjacent vertebrae 47 and 48 shown in FIGS. 4A and 4B.” A related embodiment of implant 400 depicted in Fig. 10 comprises identical upper and lower endplates 200 and a core component 300 slidably received via a dovetail connection therebetween, similarly to the implant 10 (Paragraph [0143-0144]), wherein the endplates 200 each comprise a central bone graft aperture formed through upper and lower surfaces thereof (Figs. 11-13), and wherein the core component comprises a central bone graft material holding space formed through upper and lower surfaces thereof (Fig. 16), wherein the central bone graft apertures and the central bone graft material holding space are overlapping and aligned vertically along the implant when assembled, although no exact dimensions are disclosed.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the endplates and core components of the kit of Krueger such that the shape and size of the bone graft aperture of each endplate are identical to the shape and size of the bone graft material holding space of each core component as an alternate and functionally equivalent aperture arrangement allowing bone graft to be inserted within and distributed throughout the implant before or after implantation into a spinal surgical site. It would have further been an obvious matter of design choice because the Applicant has not stated that having the bone graft apertures and bone graft material holding spaces be substantially coextensive provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art would have expected Krueger’s implant and the applicant's invention to perform equally well with the apertures and holding spaces taught by Krueger or the claimed "substantially coextensive” apertures and holding spaces because both would perform the same function of enabling bone graft to be inserted and distributed within the implant. Therefore, before the effective filing date it would have been prima facie obvious to modify Krueger to obtain the invention as specified in Claim 1 because such a modification would have been considered a mere design consideration which fails to patentably distinguish over the prior art of Krueger.
Regarding Claim 2, Krueger discloses the claimed invention as stated above in claim 1, and further discloses wherein the plurality of endplates differ from one another in configuration and dimensions (“In one embodiment, a spinal fusion kit contains modular endplates with different sizes and lordotic angles and modular spacers with different sizes and lordotic angles.”, Paragraph [0206]).
Regarding Claim 3 as best understood, Krueger discloses the claimed invention as stated above in claim 1, and further discloses wherein the plurality of different endplates comprise a plurality of different superior endplates (12, Fig. 1) (“In one embodiment, a spinal fusion kit contains modular endplates with different sizes and lordotic angles and modular spacers with different sizes and lordotic angles.”, Paragraph [0206]) and the holding space opening is in the core component top surface (upper aperture defined through 46, 66, 44, & 69, Figs. 5-6), the core component top surface configured to face the bottom surface of the selected endplate when one of the superior endplates is selected to be in engagement with the core component (Figs. 1, 3A).
Regarding Claim 4 as best understood, Krueger discloses the claimed invention as stated above in claim 3, and further discloses wherein the plurality of different endplates further comprises a plurality of different inferior endplates (14) (“In one embodiment, a spinal fusion kit contains modular endplates with different sizes and lordotic angles and modular spacers with different sizes and lordotic angles.”, Paragraph [0206]) and there is a further holding space opening in the core component bottom surface (lower aperture defined through 46, 66, 44, & 69, Figs. 5-6), the core component bottom surface configured to face the top surface of the selected endplate when one of the inferior endplates is selected to be in engagement with the core component (Figs. 1, 3A).
Regarding Claim 5, Krueger discloses the claimed invention as stated above in claim 1, and further discloses a plurality of different core components (24) (“In one embodiment, a spinal fusion kit contains modular endplates with different sizes and lordotic angles and modular spacers with different sizes and lordotic angles.”, Paragraph [0206]), each defining a bone graft material holding space (central cavity 82, Figs. 5-6, Paragraph [0129]) having a holding space opening in a core component top surface (upper aperture defined through 46, 66, 44, & 69, Figs. 5-6). Krueger does not specifically disclose that each holding space opening has substantially the same dimensions in plan view. Kruger discloses that the central cavity 82 is for receiving bone graft or other materials, and Paragraph [0206] states that the modular spacers (24) have different sizes and lordotic angles, but no exact dimensions are disclosed. It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the core components of the kit of Krueger such that size of the bone graft material holding space of each core component and bone graft apertures of each endplate are identical as an obvious matter of design choice because the Applicant has not stated that providing each bone graft material holding space in substantially the same dimensions provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art would have expected Krueger’s implant and the applicant's invention to perform equally well with the apertures and holding spaces taught by Krueger or the claimed holding spaces having "substantially the same dimensions” because both would perform the same function of enabling bone graft to be inserted and distributed within the implant. Therefore, before the effective filing date it would have been prima facie obvious to modify Krueger to obtain the invention as specified in Claim 5 because such a modification would have been considered a mere design consideration which fails to patentably distinguish over the prior art of Krueger.
Regarding Claim 6, Krueger discloses the claimed invention as stated above in claim 5, and further discloses wherein the intervertebral fusion device comprises a selected one of the plurality of different core components (24, Fig. 1), the plurality of core components differing from one another in configuration and dimensions (“In one embodiment, a spinal fusion kit contains … modular spacers with different sizes and lordotic angles.”, Paragraph [0206]).
Regarding Claim 7 as best understood, Krueger discloses the claimed invention as stated above in claim 1, and further discloses wherein the core component is configured for inter-engagement with each endplate (Fig. 1, via 44 & 46 with slots 70 & 70, Paragraph [0133]).
Regarding Claim 8 as best understood, Krueger discloses the claimed invention as stated above in claim 7, and further discloses wherein the core component is configured and each endplate is configured to prevent movement apart of the core component and the selected endplate (based on corresponding dovetail connections between 12, 14 & 24, Paragraphs [0133-0134]) in a direction (top to bottom vertical direction through implant 10) orthogonal to a direction of insertion of the intervertebral fusion device (anterior to posterior insertion direction) into the intervertebral space and orthogonal to a transverse direction (left to right horizontal direction through implant 10).
Regarding Claim 9 as best understood, Krueger discloses the claimed invention as stated above in claim 8, and further discloses wherein the core component is configured and each endplate is configured to prevent movement of the core component and the selected endplate (based on corresponding dovetail connections between 12, 14 & 24, Paragraphs [0133-0134]) relative to each other in the transverse direction (left to right horizontal direction through implant 10).
Regarding Claim 10 as best understood, Krueger discloses the claimed invention as stated above in claim 9, and further discloses wherein the core component and the selected endplate are configured for relative sliding movement in the direction of insertion of the intervertebral fusion device into the intervertebral space (based on corresponding dovetail connections between 12, 14 & 24, the endplates 12 & 14 slidably connect to the core component 24 by sliding the left and right arms 44 & 46 within the corresponding slots 70 along an anterior to posterior direction of insertion, Paragraphs [0133-0134]).
Regarding Claim 11 as best understood, Krueger discloses the claimed invention as stated above in claim 7, and further discloses wherein the core component comprises features (left and right arms 44 & 46, Fig. 1, 5 & 7A) that provide for inter-engagement with each endplate (via corresponding slots 70, Paragraph [0133]), and each endplate comprises features (slots 70, Figs. 1 & 8A-8B, Paragraph [0133]) for inter-engagement with the core component.
Regarding Claim 12 as best understood, Krueger discloses the claimed invention as stated above in claim 1, and further discloses wherein the core component and each endplate are configured to lock together when they are in registration with each other (Fig. 1, via dovetail connections, Paragraph [0133-0134]), to prevent movement in the direction of separation of the first and second vertebrae (top to bottom vertical direction through implant 10).
Regarding Claim 13 as best understood, Krueger discloses the claimed invention as stated above in claim 12, and further discloses wherein the core component and each endplate are configured for relative sliding movement (based on corresponding dovetail connections between 12, 14 & 24, the endplates 12 & 14 slidably connect to the core component 24 by sliding the left and right arms 44 & 46 within the corresponding slots 70 along an anterior to posterior direction of insertion, Paragraphs [0133-0134]), the core component and each endplate configured to lock together (via locking tabs 62, Figs. 5-6, 7A-7C) to prevent movement in a direction opposite the direction of insertion of the intervertebral fusion device into the intervertebral space (Paragraphs [0135, 0138-0139]).
Regarding Claim 14 as best understood, Krueger discloses the claimed invention as stated above in claim 12, and further discloses the core component comprises features (left and right arms 44 & 46 of dovetail connections, Figs. 5-6, 7A-7C) that provide for locking with each endplate (via slots 70, Paragraphs [0133-0134], and each of the endplates comprises features (slots 70 of dovetail connections, Figs. 1 & 8A-8B, Paragraph [0133]) for locking with the core component.
Regarding Claim 15, Krueger discloses the claimed invention as stated above in claim 1, and further discloses wherein the bone graft material holding space is defined by walls on at least three of four sides (46, 66, 44, Figs. 5-6), a fourth side of the bone graft material holding space (69) is open at least in part (at notches 51/51, Fig. 5) to define a bone graft port wherethrough bone graft material is injectable into the bone graft material holding space (notches 51 are fully and structurally capable of defining ports where bone graft material can be injected into 82), and a wall of the fourth side (vertical inner wall of 69 defined between each notch 51/51) and which defines the bone graft port lies in a plane (vertical plane defined through vertical wall running between each notch 51, Fig. 5) which is substantially orthogonal to a direction of insertion of the core component into the intervertebral space (vertical plane is orthogonal to the anterior to posterior insertion direction of the implant 10).
Regarding Claim 16 as best understood, Krueger discloses the claimed invention as stated above in claim 1, and further discloses wherein the core component and each endplate is configured such that a first surface on an outer surface of the core component towards a posterior aspect of the core component (rear/trailing end surface of 24, Figs. 1 & 3A) is adjacent or aligned with a second surface on an outer surface of each endplate towards their posterior aspects (rear/trailing end surface of 12 & 14, Figs. 1 & 3A) and when the core component is in registration with the selected endplate to thereby provide a datum towards the posterior aspect from which measurement can be made (rear/trailing end surfaces of 12, 24 & 14 are coplanar when the implant is assembled as seen in Fig. 3A), and whereby there is adjacency or alignment of first and second surfaces regardless of which endplate has been selected (endplates are modular, Paragraph [0206]).
Regarding Claim 17 as best understood, Krueger discloses the claimed invention as stated above in claim 16, and further discloses wherein the plurality of endplates differ from each other in shape and dimensions (“In one embodiment, a spinal fusion kit contains modular endplates with different sizes and lordotic angles and modular spacers with different sizes and lordotic angles.”, Paragraph [0206]), and the plurality of different endplates are configured such that each of their second locations is adjacent or aligns with the first location when the core component and each endplate are in registration (Fig. 1 & 3A).
Regarding Claim 18, Krueger discloses a method of installing an intervertebral fusion device (Paragraphs [0007, 0151-0159]) in an intervertebral space between first and second adjacent vertebrae (47 & 48, Figs. 4A-4B), the method comprising: selecting one (12 or 14, Fig. 1) of a plurality of different endplates (12 & 14, Figs. 1-3B) comprised in a kit of parts (“In one embodiment, a spinal fusion kit contains modular endplates with different sizes and lordotic angles and modular spacers with different sizes and lordotic angles.”, Paragraph [0206]), each configured to be received in an intervertebral space Paragraphs [0126-0129]) defined between first and second vertebrae (Figs. 4A-4B), and each of the plurality of endplates defining a bone graft aperture (opening 26 of 12 & 14, Fig. 2, Paragraph [0126]) which is open at top and bottom surfaces of the endplate extends between the top and bottom surfaces (top surface of 12 is 16 and bottom surface of 12 is the opposite inner surface 15 of 12; and top surface of 14 is the inner surface 15 of 14 and bottom surface of 14 is 17, Figs. 1, 3A & 8A), the bone graft apertures being of substantially the same dimensions as one another when the plurality of endplates are in plan view (Fig. 2 depicts the plan view of the implant 10) (Endplates 12 & 14 are substantially similar to one another; Paragraph [0139]); engaging a core component (spacer 24, Figs. 1 & 5-6) comprised in the kit of parts with the selected endplate to form an intervertebral fusion device (Fig. 1), the core component configured to engage with each of the plurality of endplates (Fig. 1), the core component defining a bone graft material holding (central cavity 82, Figs. 5-6, Paragraph [0129]) having a holding space opening in a core component top surface of the core component (upper aperture defined through 46, 66, 44, & 69, Figs. 5-6); and installing the intervertebral fusion device in the intervertebral space such that the core component engages with the selected endplate when in the intervertebral space (Figs. 4A-4B, Paragraph [0158]).
Krueger does not disclose wherein when the core component is in plan view the holding space opening is of substantially the same dimensions as each of the bone graft apertures, and the holding space opening is substantially coextensive with the bone graft aperture of the selected endplate in plan view and when the core component is engaged with and in registration with the selected endplate. Krueger does disclose in Paragraph [0126] that “As shown in FIG. 2, the outer surfaces 16 and 17 of the endplates 12 and 14 may contain a variety of openings 26 and 30 to allow bone growth through the endplates 12 and 14 and between the adjacent vertebrae 47 and 48 shown in FIGS. 4A and 4B.” A related embodiment of implant 400 depicted in Fig. 10 comprises identical upper and lower endplates 200 and a core component 300 slidably received via a dovetail connection therebetween, similarly to the implant 10 (Paragraph [0143-0144]), wherein the endplates 200 each comprise a central bone graft aperture formed through upper and lower surfaces thereof (Figs. 11-13), and wherein the core component comprises a central bone graft material holding space formed through upper and lower surfaces thereof (Fig. 16), wherein the central bone graft apertures and the central bone graft material holding space are overlapping and aligned vertically along the implant when assembled, although no exact dimensions are disclosed.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the endplates and core components of the kit used in the method of Krueger such that the shape and size of the bone graft aperture of each endplate are identical to the shape and size of the bone graft material holding space of each core component as an alternate and functionally equivalent aperture arrangement allowing bone graft to be inserted within and distributed throughout the implant before or after implantation into a spinal surgical site. It would have further been an obvious matter of design choice because the Applicant has not stated that having the bone graft apertures and bone graft material holding spaces be substantially coextensive provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art would have expected Krueger’s implant and the applicant's invention to perform equally well with the apertures and holding spaces taught by Krueger or the claimed "substantially coextensive” apertures and holding spaces because both would perform the same function of enabling bone graft to be inserted and distributed within the implant. Therefore, before the effective filing date it would have been prima facie obvious to modify Krueger to obtain the invention as specified in Claim 18 because such a modification would have been considered a mere design consideration which fails to patentably distinguish over the prior art of Krueger.
Regarding Claim 20 as best understood, Krueger discloses the claimed invention as stated above in claim 19, except wherein the holding space opening is substantially coextensive with the bone graft aperture of the selected endplate in plan view and when the core component is inter-engaged with the selected endplate and when the core component is moved to its furthest extent in the anterior to posterior direction relative to the selected endplate. Krueger does disclose in Paragraph [0126] that “As shown in FIG. 2, the outer surfaces 16 and 17 of the endplates 12 and 14 may contain a variety of openings 26 and 30 to allow bone growth through the endplates 12 and 14 and between the adjacent vertebrae 47 and 48 shown in FIGS. 4A and 4B.” A related embodiment of implant 400 depicted in Fig. 10 comprises identical upper and lower endplates 200 and a core component 300 slidably received via a dovetail connection therebetween, similarly to the implant 10 (Paragraph [0143-0144]), wherein the endplates 200 each comprise a central bone graft aperture formed through upper and lower surfaces thereof (Figs. 11-13), and wherein the core component comprises a central bone graft material holding space formed through upper and lower surfaces thereof (Fig. 16), wherein the central bone graft apertures and the central bone graft material holding space are overlapping and aligned vertically along the implant when assembled, although no exact dimensions are disclosed.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the endplates and core components of the kit of Krueger such that the shape and size of the bone graft aperture of each endplate are identical to the shape and size of the bone graft material holding space of each core component as an alternate and functionally equivalent aperture arrangement allowing bone graft to be inserted within and distributed throughout the implant before or after implantation into a spinal surgical site. It would have further been an obvious matter of design choice because the Applicant has not stated that having the bone graft apertures and bone graft material holding spaces be substantially coextensive provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art would have expected Krueger’s implant and the applicant's invention to perform equally well with the apertures and holding spaces taught by Krueger or the claimed "substantially coextensive” apertures and holding spaces because both would perform the same function of enabling bone graft to be inserted and distributed within the implant. Therefore, before the effective filing date it would have been prima facie obvious to modify Krueger to obtain the invention as specified in Claim 1 because such a modification would have been considered a mere design consideration which fails to patentably distinguish over the prior art of Krueger.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
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/JESSICA WEISS/Primary Examiner, Art Unit 3775