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
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 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) 1-8, 10-13 and 16-17 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 Fonte et al. (US 2016/0184103).
As to claim 1, Fonte et al. discloses an implant comprising a substrate (implant stem) and a porous portion overlapping the substrate (see Fig. 4). The implant is based off a digital design (additive manufacturing 0074) and editing cell size, strut thickness, etc. (see 0055). Fonte et al. teaches an implant having a digitally defined porous structure, including edited pore and strut dimensions.
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The claim further recites steps on how the implant is made. These steps are product by process limitations. "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). Fonte does not employ the identical process, but produces the same implant having the same structural characteristics (substrate plus porous portion overlapping). Therefore, the implant of claim 1 is anticipated by, or obvious over, the product disclosed in Fonte, regardless of the process by which it is made.
As to claims 2-7, the limitations recited in the claims are product by process limitations. "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). Fonte does not employ the identical process, but produces the same implant having the same structural characteristics (substrate plus porous portion overlapping having struts – 0055-0056). Fonte et al. teaches an implant having a digitally defined porous structure, including edited pore and strut dimensions. Therefore, the implant of claim 1 is anticipated by, or obvious over, the product disclosed in Fonte, regardless of the process by which it is made.
As to claim 8, the porous layer and substrate conforms of the shape of the implant (see Fig. 4).
As to claim 10, the substrate is a solid substrate (See Fig. 4).
As to claim 11-13 and 16-17, the limitations recited in the claims are product by process limitations. "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). Fonte does not employ the identical process, but produces the same implant having the same structural characteristics (substrate plus porous portion overlapping). Therefore, the implant of claim 1 is anticipated by, or obvious over, the product disclosed in Fonte, regardless of the process by which it is made.
Claim(s) 1-8, 10-13 and 16-17 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 Dong et al. (US 2007/0150068).
As to claim 1, Dong et al. discloses an implant having a substrate and a porous portion overlapping the substrate (see 0071-72, Fig. 4). The implant replicates trabecular or foam-like structures (See abstract); design of porosity and strut thickness to promote bone ingrowth (see abstract).
The claim further recites steps on how the implant is made. These steps are product by process limitations. "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). Dong et al. does not employ the identical process, but produces the same implant having the same structural characteristics (substrate plus porous portion overlapping). Therefore, the implant of claim 1 is anticipated by, or obvious over, the product disclosed in Dong et al., regardless of the process by which it is made.
As to claims 2-7, the limitations recited in the claims are product by process limitations. "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). Dong et al. does not employ the identical process, but produces the same implant having the same structural characteristics (substrate plus porous portion overlapping having struts – abstract). Therefore, the implant of claim 1 is anticipated by, or obvious over, the product disclosed in Dong et al., regardless of the process by which it is made.
As to claim 8, the porous layer and substrate conforms of the shape of the implant (see Fig. 4).
As to claim 10, the substrate is a solid substrate (See 0071 and Fig. 4).
As to claim 11-13 and 16-17, the limitations recited in the claims are product by process limitations. "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). Dong et al. does not employ the identical process, but produces the same implant having the same structural characteristics (substrate plus porous portion overlapping). Therefore, the implant of claim 1 is anticipated by, or obvious over, the product disclosed in Dong et al., regardless of the process by which it is made.
Claim(s) 1-13 and 16-17 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 Landon et al. (US20120321878).
As to claim 1, Landon discloses an implant comprising a substrate and porous structure overlaying the substrate (see 0074). The implant is based on a digital porous model (See 0071). The strut and pore sizes are modified (see 0021).
The claim further recites steps on how the implant is made. These steps are product by process limitations. "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). Landon et al. does not employ the identical process, but produces the same implant having the same structural characteristics (substrate plus porous portion overlapping). Therefore, the implant of claim 1 is anticipated by, or obvious over, the product disclosed in Landon et al., regardless of the process by which it is made.
As to claims 2-7, the limitations recited in the claims are product by process limitations. "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). Landon et al. does not employ the identical process, but produces the same implant having the same structural characteristics (substrate plus porous portion overlapping having struts – 0023). Therefore, the implant of claim 1 is anticipated by, or obvious over, the product disclosed in Landon et al., regardless of the process by which it is made.
As to claim 8, the porous layer and substrate conforms of the shape of the implant (see Fig. 26B).
As to claim 9, the porous portion is formed via Boolean intersection (see 0113).
As to claim 10, the substrate is a solid substrate (See 0113).
As to claim 11-13 and 16-17, the limitations recited in the claims are product by process limitations. "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). Landon et al. does not employ the identical process, but produces the same implant having the same structural characteristics (substrate plus porous portion overlapping). Therefore, the implant of claim 1 is anticipated by, or obvious over, the product disclosed in Landon et al., regardless of the process by which it is made.
Claim(s) 1-8, 10-17 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 Li et al. (US 2015/0173903).
As to claim 1, Li et al. discloses an implant comprising a substrate and a porous portion overlapping the substrate (see Fig. 12)
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The claim further recites steps on how the implant is made. These steps are product by process limitations. "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). Li et al. does not employ the identical process, but produces the same implant having the same structural characteristics (substrate plus porous portion overlapping). Therefore, the implant of claim 1 is anticipated by, or obvious over, the product disclosed in Li et al., regardless of the process by which it is made.
As to claims 2-7, the limitations recited in the claims are product by process limitations. "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). Li et al. does not employ the identical process, but produces the same implant having the same structural characteristics (substrate plus porous portion overlapping having struts – abstract). Therefore, the implant of claim 1 is anticipated by, or obvious over, the product disclosed in Li et al., regardless of the process by which it is made.
As to claim 8, the porous layer and substrate conforms of the shape of the implant (see Fig. 12).
As to claim 10, the substrate is a solid substrate (See 0034).
As to claim 11-13 and 16-17, the limitations recited in the claims are product by process limitations. "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). Li et al. does not employ the identical process, but produces the same implant having the same structural characteristics (substrate plus porous portion overlapping). Therefore, the implant of claim 1 is anticipated by, or obvious over, the product disclosed in Li et al., regardless of the process by which it is made.
As to claim 14, the implant is cleaned (see 0044).
As to claim 15, the polymeric liner is applied over the implant (see 502 of Fig. 12).
Response to Arguments
Applicant's arguments filed 12/09/2025 have been fully considered but they are not persuasive. Applicant argues, without citation or explanation, that the applied references do not teach the amended claim limitations, including that: the implant ahs the same structure as a digital implant model; the digital implant model is obtained by editing a digital porous block; and the digital porous model has the same structure as an artificial foam. The newly added limitations describe how a digital porous model is generated and how the implant is manufactured, and therefore constitute product by process language. As previously cited, the patentability of a product by process claim is based on structure of the claimed product, not on the process by which it is made. The applied prior art need only disclose an implant having the same or substantially the same structure, regardless of whether the prior art employs editing and printing steps identical to those recited.
Applicant’s reliance on the phrase “same structure as an artificial foam” is not persuasive. Porous lattice structures disclosed in the applied references are structurally indistinguishable from artificial foam for purposes of implant structure. The claim does not require the foam is a specific material or a particular porous geometry/ method of generating such porous geometry. The claims only require structural equivalence, which is met by the cited references.
Since the amended limitations define the implant by process of digital modeling and printing; do not impose a distinct structural limitation over the prior art, the applied references still teach or render obvious the claimed implant. Applicant has not identified any specific structural feature absent from the prior art; nor any unexpected structural result attributable to the recited process. Therefore, the rejection is maintained.
Conclusion
THIS ACTION IS MADE FINAL. 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.
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/CACHET I. PROCTOR/
Examiner
Art Unit 1715
/CACHET I PROCTOR/Primary Examiner, Art Unit 1715
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