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 .
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-14) in the reply filed on 12/30/2025 is acknowledged. Claims 15-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group II, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/30/2025.
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.
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 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 McDonough et al. (US Publication No. 2010/0145460 A1).
Regarding Claim 1, McDonough discloses an implant assembly (200, Fig. 3A-B, [0086]) for stabilizing a joint between a superior vertebra and an inferior vertebra [0062], the implant assembly comprising: a bone plate (250, Fig. 3A) comprising: an anterior member comprising: at least one superior fastener aperture (40) formed therein and configured to receive at least one superior fastener (70) therethrough; and at least one inferior fastener aperture (40) formed therein and configured to receive at least one inferior fastener (70) therethrough; a first arm extending from a first end (56) of the anterior member; and a second arm extending from a second end (58) 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 an interbody spacer (220) configured for placement within the cavity of the bone plate (see figure below).
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With regards to the limitations of: at least a portion of the interbody spacer is formed via at least one additive manufacturing process; and at least a portion of the bone plate is formed via at least one subtractive manufacturing process, the structure of McDonough 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 McDonough. 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 Claims 2 and 3, the structure of McDonough 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 McDonough. 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 comprises at least one porous region (one or more vertical openings, windows or channels, [0064]); and the bone plate comprises at least one durable material (e.g. titanium, listed in [0075]). Regarding the methods from which these areas are formed, the structure of McDonough 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 McDonough. 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 further comprises at least one solid region (region which does not contain the one or more vertical openings, windows or channels, e.g. areas which surround these openings/windows/channels described in [0064]). The structure of McDonough 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 McDonough. 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 (220) is configured to be inserted into the cavity of the bone plate (50) from at least one of: a superior direction; an inferior direction; and a posterior direction (spacer can be pushed in from the posterior direction or slid down/up in the superior/inferior directions shown below).
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Regarding Claim 7, further comprising: a locking plate (280, Fig. 3B) 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 [0086].
Regarding Claim 8, McDonough discloses an implant assembly (200, Fig. 3A-B, [0086]) for stabilizing a joint between a superior vertebra and an inferior vertebra [0062], the implant assembly comprising: a bone plate (250, Fig. 3A) comprising: an anterior member comprising: at least one superior fastener aperture (40) formed therein and configured to receive at least one superior fastener (70) therethrough; and at least one inferior fastener aperture (40) formed therein and configured to receive at least one inferior fastener (70) therethrough; a first arm extending from a first end (56) of the anterior member; and a second arm extending from a second end (58) 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
an interbody spacer (220) configured for placement within the cavity of the bone plate (see figure below), the interbody spacer comprising: at least one porous region (one or more vertical openings, windows or channels, [0064]); and at least one solid region (region which does not contain the one or more vertical openings, windows or channels, e.g. areas which surround these openings/windows/channels described in [0064]).
The structure of McDonough 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 McDonough. 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 McDonough 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 McDonough. 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 (220) is configured to be inserted into the cavity of the bone plate (50) from at least one of: a superior direction; an inferior direction; and a posterior direction (spacer can be pushed in from the posterior direction or slid down/up in the superior/inferior directions shown below).
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Regarding Claim 14, further comprising: a locking plate (280, Fig. 3B) 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 [0086].
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over McDonough et al. (US Publication No. 2010/0145460 A1) in view of Milz et al. (US Publication No. 2023/0285162 A1).
Regarding Claim 9, McDonough discloses the assembly as described in the rejection of claim 8 above. McDonough discloses that the spacer can have one or more porous regions (boreholes, openings, windows or channels for receiving bone graft material [0064]) 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 McDonough 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 maintain structural integrity of the spacer.
Conclusion
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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/JACQUELINE T JOHANAS/Primary Patent Examiner, Art Unit 3773