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 .
Claim Rejections - 35 USC § 102/103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
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) 1-8, 10-14, 21-26 is/are rejected under 35 U.S.C. 102((a)(1)) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Gillbride et al. (US Publication No. 2019/0000638 A1).
Regarding Claim 1, Gillbride discloses an implant assembly (2100) (Fig. 15) for stabilizing a joint between a superior vertebra and an inferior vertebra, the implant assembly comprising:
a bone plate (2120) comprising:
an anterior member (2230) comprising:
at least one superior fastener aperture (2240) formed therein and configured to receive at least one superior fastener therethrough; and
at least one inferior fastener aperture (2242) formed therein and configured to receive at least one inferior fastener therethrough [0141-0142];
a first arm (2232) extending from a first end of the anterior member; and
a second arm (2232) extending from a second end of the anterior member, opposite the first arm, to form a cavity intermediate the first arm and the second arm of the bone plate (see figure below);and
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an interbody spacer (2110) configured for placement within the cavity of the bone plate [0140];
wherein: the bone plate comprises at least part of an anterior side, a posterior side, a medial side, and a lateral side of the implant assembly (see figure below).
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The structure of Gillbride appears to be the same as the product set forth in a product-by-process claim although produced by a different process, therefore the claim is anticipated by Gillbride. Alternatively, it would have been obvious to one having ordinary skill in the art to make the components with an additive manufacturing process this is one of a limited number of known manufacturing methods to create products which would produce predictable results of creating desired structure of the components (other methods including casting/moulding, stamping or welding or subtractive methods such as machining). See In re Marosi, 710 F.2d 799, 218 USPQ 289 (Fed. Cir. 1983) and In re Thorpe, 777 F.2d 695, 227 USPQ 964(Fed. Cir. 1985). See also MPEP § 2113.
Regarding Claims 2 and 3, the structure of Gillbride appears to be the same as the product set forth in a product-by-process claim although produced by a different process, therefore the claim is anticipated by Gillbride. Alternatively, it would have been obvious to one having ordinary skill in the art to make the components in an additive or subtractive manufacturing process since these are two of a limited number of known manufacturing methods to create products which would produce predictable results of creating desired structure of the components (other methods including casting/moulding, stamping or welding). See In re Marosi, 710 F.2d 799, 218 USPQ 289 (Fed. Cir. 1983) and In re Thorpe, 777 F.2d 695, 227 USPQ 964(Fed. Cir. 1985). See also MPEP § 2113.
Regarding Claim 4, the interbody spacer (2110) comprises at least one porous region (one or more vertical openings, windows or channels, 2212 shown in Fig. 15 further, these areas are disclosed as retaining bone graft material which is a porous material [0134]); and the bone plate comprises at least one durable material (listed in [0158]). Regarding the methods from which these areas are formed, the structure of Gillbride appears to be the same as the product set forth in a product-by-process claim although produced by a different process, therefore the claim is anticipated by Gillbride. Alternatively, it would have been obvious to one having ordinary skill in the art to make the components in 3D printing or machining manufacturing process since these are two of a limited number of known manufacturing methods to create products which would produce predictable results of creating desired structure of the components (other methods including casting/moulding, stamping or welding). See In re Marosi, 710 F.2d 799, 218 USPQ 289 (Fed. Cir. 1983) and In re Thorpe, 777 F.2d 695, 227 USPQ 964(Fed. Cir. 1985). See also MPEP § 2113.
Regarding Claim 5, the interbody spacer (2110) further comprises at least one solid region (region which does not contain the one or more vertical openings, windows or channels 2216 in Fig. 16C, e.g. areas which surround these openings/windows/channels). The structure of Gillbride appears to be the same as the product set forth in a product-by-process claim although produced by a different process, therefore the claim is anticipated by Gillbride. Alternatively, it would have been obvious to one having ordinary skill in the art to make the components in 3D printing this is one of a limited number of known manufacturing methods to create products which would produce predictable results of creating desired structure of the components (other methods including casting/moulding, stamping or welding or subtractive methods such as machining). See In re Marosi, 710 F.2d 799, 218 USPQ 289 (Fed. Cir. 1983) and In re Thorpe, 777 F.2d 695, 227 USPQ 964(Fed. Cir. 1985). See also MPEP § 2113.
Regarding Claim 6, the interbody spacer (2110) is configured to be inserted into the cavity of the bone plate (2120) from at least one of: a superior direction; an inferior direction [0140] (Fig. 18A-B).
Regarding Claim 7, further comprising: a locking plate (2160, Fig. 23A) couplable with the bone plate, wherein the locking plate is configured to prevent the at least one superior fastener and the at least one inferior fastener from backing out of the implant assembly [0157]].
Regarding Claim 8, Gillbride discloses an implant assembly (2100) (Fig. 15) for stabilizing a joint between a superior vertebra and an inferior vertebra, the implant assembly comprising: a bone plate (2120) comprising:
an anterior member (2230) comprising:
at least one superior fastener aperture (2240) formed therein and configured to receive at least one superior fastener therethrough; and
at least one inferior fastener aperture (2242) formed therein and configured to receive at least one inferior fastener therethrough [0141-0142];
a first arm (2232) extending from a first end of the anterior member, the first arm comprising a first arm projection extending medially from a distal end of the first arm (shown below), the first arm projection comprising a first arm projection tab (2112); and a second arm extending from a second end of the anterior member, opposite the first arm, the second arm comprising a second arm projection extending medially from a distal end of the second arm, the second arm projection comprising a second arm projection tab (2112) (shown below), to form a cavity of the bone plate intermediate the first arm and the second arm of the bone plate (Fig. 17A-D);
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and an interbody spacer (2110) configured for placement within the cavity of the bone plate [0140] (Fig. 18B), the interbody spacer comprising: at least one porous region(one or more vertical openings, windows or channels, 2212 shown in Fig. 15, these areas are disclosed as retaining bone graft material which is a porous material [0134]); and at least one solid region (region which does not contain the one or more vertical openings, windows or channels 2216 in Fig. 16C, e.g. areas which surround these openings/windows/channels);
wherein the interbody spacer comprises a first spacer recess (2111) and a second spacer recess (2111) (Fig. 16A-B) [0139], the first arm projection tab (2112) being configured to be received within the first spacer recess and the second arm projection tab (2112) being configured to be received within the second spacer recess to secure the interbody spacer to the bone plate [0139].
The structure of Gillbride appears to be the same as the product set forth in a product-by-process claim although produced by a different process, therefore the claim is anticipated by Gillbride. Alternatively, it would have been obvious to one having ordinary skill in the art to make the components with an additive manufacturing process this is one of a limited number of known manufacturing methods to create products which would produce predictable results of creating desired structure of the components (other methods including casting/moulding, stamping or welding or subtractive methods such as machining). See In re Marosi, 710 F.2d 799, 218 USPQ 289 (Fed. Cir. 1983) and In re Thorpe, 777 F.2d 695, 227 USPQ 964(Fed. Cir. 1985). See also MPEP § 2113.
Regarding Claims 10-12, the structure of Gillbride appears to be the same as the product set forth in a product-by-process claim although produced by a different process, therefore the claim is anticipated by Gillbride. Alternatively, it would have been obvious to one having ordinary skill in the art to make the components in an additive or subtractive manufacturing process since these are two of a limited number of known manufacturing methods to create products which would produce predictable results of creating desired structure of the components (other methods including casting/moulding, stamping or welding). See In re Marosi, 710 F.2d 799, 218 USPQ 289 (Fed. Cir. 1983) and In re Thorpe, 777 F.2d 695, 227 USPQ 964(Fed. Cir. 1985). See also MPEP § 2113.
Regarding Claim 13, the interbody spacer (2110) is configured to be inserted into the cavity of the bone plate (2120) from at least one of: a superior direction; an inferior direction [0140] (Fig. 18A-B).
Regarding Claim 14, further comprising: a locking plate (2160, Fig. 23A) couplable with the bone plate, wherein the locking plate is configured to prevent the at least one superior fastener and the at least one inferior fastener from backing out of the implant assembly [0157]].
Regarding Claim 21, the interbody spacer is integrally formed as a single piece comprising the at least one porous region (2212) and the at least one solid region (shown in Fig. 16A-D as an integral single piece).
Regarding Claim 22, Gillbride discloses an implant assembly (2100) (Fig. 15) for stabilizing a joint between a superior vertebra and an inferior vertebra, the implant assembly comprising:
a bone plate (2120) comprising:
an anterior member (2230) comprising:
at least one superior fastener aperture (2240) formed therein and configured to receive at least one superior fastener therethrough; and
at least one inferior fastener aperture (2242) formed therein and configured to receive at least one inferior fastener therethrough [0141-0142];
a first arm (2232) extending from a first end of the anterior member; and
a second arm (2232) extending from a second end of the anterior member, opposite the first arm, to form a cavity intermediate the first arm and the second arm of the bone plate (see figure below);and
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an interbody spacer (2110) configured for placement within the cavity of the bone plate (Fig. 18);
wherein the anterior member further comprises a stop surface (2221, Fig. 17A), and the interbody spacer comprises a spacer tab (2220, Fig. 15 and 16C) configured to abut against the stop surface of the anterior member to position the interbody spacer relative to the bone plate [0135].
Regarding Claim 23, the interbody spacer (2110) is configured to be inserted into the cavity of the bone plate from a superior direction, and wherein the spacer tab (2220) is configured to abut against the stop surface (2221) of the anterior member in response to insertion of the interbody spacer into the cavity from the superior direction to limit movement of the interbody spacer in an inferior direction relative to the bone plate [0135] (Fig. 18A-B).
Regarding Claim 24, further comprising: a locking plate (2160, Fig. 23A) couplable with the bone plate, wherein the locking plate is configured to prevent the at least one superior fastener and the at least one inferior fastener from backing out of the implant assembly [0157]].
Regarding Claim 25, the at least one superior fastener aperture (2240) includes a superior ramp (2244) configured to guide a superior fastener into the superior vertebra, the superior ramp forming a first superior angle with respect to the anterior member [0142] (Fig. 15).
Regarding Claim 26, the interbody spacer further comprises an interbody spacer stop surface on an inferior surface of the interbody spacer, the interbody spacer stop surface configured to engage a corresponding stop surface of the bone plate to further position the interbody spacer relative to the bone plate (shown below) [0140].
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Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gillbride et al. (US Publication No. 2019/0000638 A1) in view of Milz et al. (US Publication No. 2023/0285162 A1).
Regarding Claim 9, Gillbride discloses the assembly as described in the rejection of claim 8 above. McDonough Gillbride that the spacer can have one or more porous regions (boreholes, openings, windows or channels 2212 for receiving bone graft material [0134]) but is silent to the configuration of the spacer having the porous region being a central porous region along with three solid regions.
Milz discloses an intervertebral spacer in the same field of endeavor which describes a central porous region (118, Fig. 1 or alternatively, 215, Fig. 9) for receiving bone graft material [0066] and the two sides and posterior region being solid regions to provide the strength to the spacer [0066, 0070].
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to configure the porous region of the spacer of Gillbride to be central while the two side walls and posterior wall remain solid (three solid regions) as taught by Milz in order to provide a known configuration to accept bone graft material while maintaining structural integrity of the spacer.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-26 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JACQUELINE T JOHANAS whose telephone number is (571)270-5085. The examiner can normally be reached Mon. - Fri. 9:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Eduardo Robert can be reached at 571-272-4719. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JACQUELINE T JOHANAS/Primary Patent Examiner, Art Unit 3773
