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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on October 9, 2025 and November 6, 2025 has been entered.
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 1-2, 4, 7-12, 14-17, 19-20, 23, and 27-37 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 1 recites “wherein said implant excludes fibrous material and polymeric particulate material”. The structure that corresponds to a “fibrous material” and a “polymeric particulate material” is not clear. The claims recite an implant comprising a polymeric material that can be poly(etheretherketone) (PEEK), where a wear resistant additive or reinforcing additive is required in dependent claims. The wear resistant additive can be carbon, glass, polymeric, ceramic, metallic, or any combination or mixture thereof. The reinforcing additive can be a particulate that is metallic, ceramic, or any combination or mixture thereof. Given these possible added components, it is unclear what shapes/forms in the implant constitute a particulate or fibrous material. Hajaj et al. (previously cited) details a tibial implant employing a composite of PEEK with poly(tetrafluoroethylene) (PTFE) that is an interpenetrating network formed from particles of the two polymers, as detailed by Burris et al. (previously cited) (Hajaj et al. paragraph 38). PTFE is a wear resistant polymer; thus its presence constitutes a wear resistant additive. Burris et al. make the material following the general procedure of Sawyer B (Wear 254 (2003) 573–580 – previously cited), where the particles are milled, blended, and compression molded to a temperature of 360⁰C for 0.3, 3, or 30 hours (see Burris et al. page 411 first column last partial paragraph-second column first full paragraph; Sawyer B page 575 first column last paragraph-second column first paragraph). The feed PEEK particles are 5 mm in diameter and the feed PTFE particles are 25 mm in diameter (see page 411 first column last partial paragraph-second column first partial paragraph). The internal structure of the composite varies depending on the heating duration, as shown below from figure 10 of 20% PEEK in PTFE.
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They detail that the PEEK particles melt and coalesce around the PTFE particles, where the dark regions are the PEEK (see page 414 second column last partial paragraph-page 415 first column first partial paragraph and figure 9-10). The PTFE is described as also melting and flowing, but to a lesser degree than the PEEK (see page 417 first column first full paragraph). It is unclear how many PEEK particles have to coalesce with one another and in what way for the enlarged structure to no longer qualify as a particulate and also not qualify as a fibrous material. PEEK is clearly distributed in the PTFE and many of these regions could be considered particulates within the bulk PTFE. Similarly, several of these regions look like striations that could be considered fibrous in shape, but it is not clear when a structure qualifies as fibrous or ceases to do so. The preparatory routes to yield the claimed implant do not implicitly inform the internal structures that are permissible. The additive manufacturing recited as part of the product-by-process recitation of the instant product is envisioned to include blending and heating of the compositional components which also occur in the molding/injection molding of Hajaj et al., Burris et al., and Sawyer B (see instant claim 1 and 30-31). Example 1 of the instant specification exemplifies making the claimed implant from a particulate polymer material that is compounded with an extruder at a temperature profile of 250⁰C to 410⁰C, which may or may not melt the polymer. The material is then drawn into filaments that are the feedstock to a print head that prints through a nozzle at 410⁰C. Wear-resistant additives are explicitly included in the claimed product and are recited to be carbon, glass, polymeric, ceramic, metallic or any combination. If a wear additive polymer is included in the compounding process, it is not clear which shapes are permissible and which blended final product, if any, qualifies as being devoid of fibrous shapes and polymer particulates. Thus the scope of permitted internal structures of the claimed composite implant that are permitted by the instant claims is not clear.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 1-2, 4, 7-8, 10-11, 19-20, 23, 27-32, 35, and 37 are rejected under 35 U.S.C. 103 as being unpatentable over Metzger et al. (previously cited) in view of Evans et al. (previously cited), Yang et al. (previously cited), and Olalde Graells et al. (previously cited) as evidenced by Abu Baker et al. (previously cited) and Graham (previously cited).
Metzger et al. teach a knee implant with a bearing component 14 having an articulating surface as well as a tibial tray component 12 having a bone engaging surface 16 and stem 24, shown below (see paragraphs 4, 18, and 24, and figure 1; instant claim 1).
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They further teach a few envisioned materials to compose tibial tray 12 and PEEK is listed amongst two polymer options (see paragraph 23). They envision two particular polymer materials for bearing 14 and PEEK is one of them (see paragraph 35). Metzger et al. envision employing bone cement to attach the bearing 14 to the tibia (see paragraph 25; instant claim 2). The presence of a bioactive additive or surface porosity is not detailed.
Evans et al. teach of the improved bone integration of PEEK bone implants facilitated by the addition of surface porosity (see abstract page 160 first column second—third full paragraphs). The surface locale permits retention of the desirable bulk mechanical properties of the inert PEEK while encouraging bone attachment (see page 159 second column last paragraph and page 160 first column second full paragraph; instant claim 4). They find successful and superior ingrowth of bone tissue on a PEEK implant surface conferred with a porous surface as compared to a smooth PEEK implant surface (see page 164 first column-second column first partial paragraph). An extrusion process under heat and pressure through a lattice spacing of poragen crystals that are later removed achieves the surface porosity and a contiguous mass (e.g., particle/fiber free structure) (see page 160 first column last full paragraph).
Yang et al. teach pore size gradients employed to encourage bone integration/formation in bone repair applications (see abstract and paragraph 12). Here a two zone configuration provides different pore sizes where a second zone surrounds a first zone (see paragraph 12; instant claim 37). They go on to test the ability of different pore size configurations to encourage bone formation and find that an inner region with 600 to 800 mm pores (large pores) followed by an outer region with 350 to 500 mm pores (small pores) was the best performing, compared to the reverse pore size arrangement or a uniform pore size (see table 2; instant claims 1 and 37).
Olalde Graells et al. teach porous PEEK for bone medical implants (see paragraphs 1-2). They go on to teach blending calcium phosphate bioactive ceramic particles with the PEEK to provide specific desirable biological interactions between adjacent bone tissue and the PEEK material (see paragraphs 25-27). These bioactive ceramic particles are preferably chosen from a set that includes at least one of biphasic calcium phosphate and hydroxyapatite (see paragraphs 25-27). A 1:10 bioactive ceramic to PEEK mass ratio is exemplified (see example 2; instant claim 29). The pore distribution may be in any desired arrangement including a gradient in size (see paragraph 52). The PEEK and bioactive ceramic are mixed in a solvent for the PEEK along with a poragen, then cast into a desired form, solidified, and the poragen removed (see paragraph 13). Thus no polymer particles or fibers are present in the final structure.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select PEEK as the constituent material for both the tibial tray and bearing of Metzger et al. This choice would have been obvious as one of a small number of finite pairings of constituent components amongst those Metzger et al. explicitly detail. PEEK is a wear resistant polymer; thus the articulating surface is composed of a bioinert wear resistant composition (see Graham paragraph 28; instant claim 4). It further would have been obvious to include a porous surface, in light of Evans et al., on the bone contacting surface of the tibial tray with a gradient arrangement in size as detailed by Yang et al. This modification would have been obvious as the application of the same technique to a similar product in order to yield the same improvement (e.g., encourage bone integration while maintaining bulk mechanical properties). The result is a size gradient of particles with “small” and large” sizes as well as one layer of porosity existing below another dissimilar layer of porosity in series (see instant claims 1 and 37). Similarly, it also would have been obvious to include biphasic calcium phosphate alone or in combination with hydroxyapatite, in light of Olalde Graells et al., as the application of the same technique to a similar product in order to yield the same improvement (e.g., encourage bone grown and tissue interaction in porous PEEK). Formation of this porous composite such that polymer particles and fibrous material are absent would have been obvious, given the discussion of Olalde Graells et al. and Evans for generating porosity in bone implants. The hydroxyapatite is both a second bioactive component and a reinforcing ceramic particle (see Abu Baker et al.; instant claims 19-20 and 23). “’[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)….The structure implied by the process steps should be considered when assessing the patentability of product-by-process claims over the prior art, especially where the product can only be defined by the process steps by which the product is made, or where the manufacturing process steps would be expected to impart distinctive structural characteristics to the final product. See, e.g., In re Garnero, 412 F.2d 276, 279, 162 USPQ 221-223 (CCPA 1979)” (see MPEP 2113). Therefore when no structure is implied, the product-by-process recitation does not add any limitations that affect patentability. Instant claims 1, 27-28, 30-32, and 35 recite a product-by-process where the manufacturing steps do not impart any distinctive structural features to the final product that distinguish it from that rendered obvious by the discussed combination of teachings. Thus the products of the modified Metzger et al. teachings meet the limitations of these claims. Therefore claims 1-2, 4, 7-8, 10-11, 19-20, 23, 27-32, 35, and 37 are obvious over Metzger et al. in view of Evans et al., Yang et al., and Olalde Graells et al. as evidenced by Abu Baker et al. and Graham.
Claims 1-2, 4, 7-11, 19-20, 23, 27-32, 35, and 37 are rejected under 35 U.S.C. 103 as being unpatentable over Metzger et al. in view of Evans et al., Yang et al., and Olalde Graells et al. as evidenced by Abu Baker et al. and Graham as applied to claims 1-2, 4, 7-8, 10-11, 19-20, 23-29, 31-32, 35, and 37 above, and further in view of Larsson et al. (previously cited).
Metzger et al. in view of Evans et al., Yang et al., and Olalde Graells et al. as evidenced by Abu Baker et al. and Graham teach the limitations of instant claims 1-2, 4, 7-8, 10-11, 19-20, 23, 27-32, 35, and 37, where the bioactive additive hydroxyapatite is included in the bone/implant interface. A graded concentration of this component is not detailed.
Larsson et al. teach a knee implant composed of a wear resistant material and a bioactive material (see abstract). They teach the presentation of the bioactive as a gradient via a series of layers to easily attach to bone (see abstract and paragraphs 7 and 41; instant claim 9).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to arrange the hydroxyapatite in the surface region of the bone/implant interface of Metzger et al. in view of Evans et al., Yang et al., and Olalde Graells et al. as evidenced by Abu Baker et al. and Graham as a gradient as suggested by Larsson et al. so as to facilitate integration with the bone This modification would have been obvious as the application of the same technique to a similar product in order to yield the same improvement. Therefore claims 1-2, 4, 7-11, 19-20, 23, 27-32, 35, and 37 are obvious over Metzger et al. in view of Evans et al., Yang et al., Olalde et al., and Larsson et al. as evidenced by Abu Baker et al. and Graham
Claims 1-2, 4, 7-11, 19-20, 23-29, 31-32, and 35-37 are rejected under 35 U.S.C. 103 as being unpatentable over Metzger et al. in view of Evans et al., Yang et al., Olalde et al., and Larsson et al. as evidenced by Abu Baker et al. and Graham as applied to claims 1-2, 4, 7-11, 19-20, 23-29, 31-32, 35, and 37 above, and further in view of Van Citters et al. (previously cited).
Metzger et al. in view of Evans et al., Yang et al., Olalde et al., and Larsson et al. as evidenced by Abu Baker et al. teach the limitations of instant claims 1, 4, 7-12, 14-16, 19-28, 31-32, 35, and 37, where bone cement is envisioned to bond the tibial tray to the tibia. The bone cement is not described as polymethyl methacrylate.
Van Citters et al. teach a tibial implant that is anchored in place with polymethylmethacrylate bone (see abstract and paragraphs 8-10; instant claim 36).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to employ polymethyl methacrylate bone cement as the bone cement of Metzger et al. in view of Evans et al., Yang et al., Olalde et al., and Larsson et al. as evidenced by Abu Baker et al. and Graham as is taught by Van Citters et al. This modification would have been obvious as the simple substitution of one known element for another in order to yield a predictable outcome (e.g., specific bone cement vs. generic bone cement). Therefore claims 1-2, 4, 7-11, 19-20, 23, 27-32, and 35-37 are obvious over Metzger et al. in view of Evans et al., Yang et al., Olalde et al., Larsson et al., and Van Citters et al. as evidenced by Abu Baker et al. and Graham
Claims 1-2, 4, 7-8, 10-11, 19-20, 23-29, 31-35, and 37 are rejected under 35 U.S.C. 103 as being unpatentable over Metzger et al. in view of Evans et al., Yang et al., and Olalde Graells et al. as evidenced by Abu Baker et al. and Graham as applied to claims 1-2, 4, 7-8, 10-11, 19-20, 23-29, 31-32, 35, and 37 above, and further in view of Nieminen et al. (previously cited).
Metzger et al. in view of Evans et al., Yang et al., and Olalde Graells et al. as evidenced by Abu Baker et al. and Graham render obvious the limitations of instant claims 1-2, 4, 7-8, 10-11, 19-20, 23-29, 31-32, 35, and 37, where PEEK is employed to make the articulating region of the implant. An annealing treatment is not detailed.
Nieminen et al. teach PEEK based orthopedic implants whose mechanical properties are improved via annealing (see page 378 first column first partial paragraph). Annealing is conducted at 150⁰C (see page 378 first column last partial paragraph-second column first partial paragraph; instant claim 34).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to anneal the PEEK material employed in the modified implant of Metzger et al. so as to confer improved mechanical properties as taught by Nieminen et al. This modification would have been obvious as the application of the same technique to a similar product in order to yield the same improvement. Therefore claims 1-2, 4, 7-8, 10-11, 19-20, 23-29, 31-35, and 37 are obvious over Metzger et al. in view of Evans et al., Yang et al., Olalde et al., and Nieminen et al. as evidenced by Abu Baker et al. and Graham
Claims 1-2, 4, 7-8, 10-12, 14-17, 19-20, 23, 27-32, 35, and 37 are rejected under 35 U.S.C. 103 as being unpatentable over Metzger et al. in view of Evans et al., Yang et al., and Olalde Graells et al. as evidenced by Abu Baker et al. and Graham as applied to claims 1-2, 4, 7-8, 10-11,19-20, 23-29, 31-32, 35, and 37 above, and further in view of McKellop et al. (previously cited).
Metzger et al. in view of Evans et al., Yang et al., and Olalde Graells et al. as evidenced by Abu Baker et al. and Graham teach the limitations of instant claims 1-2, 4, 7-8, 10-11, 19-20, 23, 27-32, 35, and 37. In addition to the PEEK taught by Metzger et al. as the constituent polymer for the bearing, they also teach high molecular weight polyethylene as the other envisioned option (see paragraph 35). The limitations of an osteoconductive additive are met by hydroxyapatite present along with biphasic calcium phosphate (see instant claim 16). A graded concentration of wear resistant additive is not detailed.
McKellop et al. teach a wear resistant articulating/bearing implant surface with a graded degree of wear resistance that decreases from the surface inward that avoids known issues with polyethylene particle debris from polyethylene based orthopedic implants (see abstract, column 1 lines 20-32, column 2 lines 11-30, and column 5 lines 5-16). They go on to detail that the implant component is composed of high molecular weight polyethylene that is crosslinked to varying degrees, depending on depth, where an inner portion remains uncrosslinked to maintain desirable mechanical properties (see column 2 lines 18-34). The crosslinking may occur through the addition of a crosslinking agent at a desired concentration with the polyethylene (see column 2 lines 35-41). The wear resistant additive material is the crosslinked chains of polyethylene which are present at a decreasing concentration amongst uncrosslinked polyethylene chains as one progresses from the surface toward the interior (see column 4 line 56-column 5 line 4).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select high molecular weight polyethylene for the bearing component of the modified implant of Metzger et al. device because it is one of two explicitly envisioned options. It additionally would have been obvious to apply the wear reinforcing modification of McKellop et al. with a gradient of crosslinked polyethylene provided at the articulating surface of such an implant. This modification would have been obvious as the application of the same technique to a similar product in order to yield the same improvement. Therefore claims 1-2, 4, 7-12, 14-17, 19-20, 23, 27-32, 35, and 37 are obvious over Metzger et al. in view of Evans et al., Yang et al., Olalde et al., and McKellop et al. as evidenced by Abu Baker et al. and Graham.
Claim 1-2, 4, 7-8, 10-11, 19-20, 23, 27-32, 35, and 37 are rejected under 35 U.S.C. 103 as being unpatentable over Metzger et al. (previously cited) in view of Evans et al. (previously cited), Yang et al. (previously cited), Olalde Graells et al. (previously cited) and Lu et al. (Rapid Prototyping Journal 2010 16(5):365–376) as evidenced by Abu Baker et al. (previously cited) and Graham (previously cited).
Metzger et al. teach a knee implant with a bearing component 14 having an articulating surface as well as a tibial tray component 12 having a bone engaging surface 16 and stem 24, shown below (see paragraphs 4, 18, and 24, and figure 1; instant claim 1).
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They further teach a few envisioned materials to compose tibial tray 12 and PEEK is listed amongst two polymer options (see paragraph 23). They envision two particular polymer materials for bearing 14 and PEEK is one of them (see paragraph 35). Metzger et al. envision employing bone cement to attach the bearing 14 to the tibia (see paragraph 25; instant claim 2). The presence of a bioactive additive or surface porosity is not detailed.
Evans et al. teach of the improved bone integration of PEEK bone implants facilitated by the addition of surface porosity (see abstract page 160 first column second—third full paragraphs). The surface locale permits retention of the desirable bulk mechanical properties of the inert PEEK while encouraging bone attachment (see page 159 second column last paragraph and page 160 first column second full paragraph; instant claim 4). They find successful and superior ingrowth of bone tissue on a PEEK implant surface conferred with a porous surface as compared to a smooth PEEK implant surface (see page 164 first column-second column first partial paragraph). An extrusion process under heat and pressure through a lattice spacing of poragen crystals that are later removed achieves the surface porosity and a contiguous mass (e.g., particle/fiber free structure) (see page 160 first column last full paragraph).
Yang et al. teach pore size gradients employed to encourage bone integration/formation in bone repair applications (see abstract and paragraph 12). Here a two zone configuration provides different pore sizes where a second zone surrounds a first zone (see paragraph 12; instant claim 37). They go on to test the ability of different pore size configurations to encourage bone formation and find that an inner region with 600 to 800 mm pores (large pores) followed by an outer region with 350 to 500 mm pores (small pores) was the best performing, compared to the reverse pore size arrangement or a uniform pore size (see table 2; instant claims 1 and 37).
Olalde Graells et al. teach porous PEEK for bone medical implants (see paragraphs 1-2). They go on to teach blending calcium phosphate bioactive ceramic particles with the PEEK to provide specific desirable biological interactions between adjacent bone tissue and the PEEK material (see paragraphs 25-27). These bioactive ceramic particles are preferably chosen from a set that includes at least one of biphasic calcium phosphate and hydroxyapatite (see paragraphs 25-27). A 1:10 bioactive ceramic to PEEK mass ratio is exemplified (see example 2; instant claim 29). The pore distribution may be in any desired arrangement including a gradient in size (see paragraph 52). The PEEK and bioactive ceramic are mixed in a solvent for the PEEK along with a poragen, then cast into a desired form, solidified, and the poragen removed (see paragraph 13). Thus no polymer particles or fibers are present in the final structure.
Lu et al. teach of the benefit of employing solid freeform fabrication (additive manufacture) for permitting the preparation of a polymeric bone implant with a particular precise porous structure based on a prepared poragen skeleton that is infused with the implant polymer material and then removed (see abstract and age 366 first column).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select PEEK as the constituent material for both the tibial tray and bearing of Metzger et al. This choice would have been obvious as one of a small number of finite pairings of constituent components amongst those Metzger et al. explicitly detail. PEEK is a wear resistant polymer; thus the articulating surface is composed of a bioinert wear resistant composition (see Graham paragraph 28; instant claim 4). It further would have been obvious to include a porous surface, in light of Evans et al., on the bone contacting surface of the tibial tray with a gradient arrangement in size as detailed by Yang et al. This modification would have been obvious as the application of the same technique to a similar product in order to yield the same improvement (e.g., encourage bone integration while maintaining bulk mechanical properties). The result is a size gradient of particles with “small” and large” sizes as well as one layer of porosity existing below another dissimilar layer of porosity in series (see instant claims 1 and 37). Similarly, it also would have been obvious to include biphasic calcium phosphate alone or in combination with hydroxyapatite, in light of Olalde Graells et al., as the application of the same technique to a similar product in order to yield the same improvement (e.g., encourage bone grown and tissue interaction in porous PEEK). Formation of this porous composite such that polymer particles and fibrous material are absent would have been obvious, given the discussion of Olalde Graells et al. and Evans for generating porosity in bone implants. The hydroxyapatite is both a second bioactive component and a reinforcing ceramic particle (see Abu Baker et al.; instant claims 19-20 and 23). Finally the application of additive manufacture to prepare the porous composite would have been obvious in light of Lu et al. as the application of the same technique to a similar product in order to yield the same improvement (e.g., precision pore arrangement). “’[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)….The structure implied by the process steps should be considered when assessing the patentability of product-by-process claims over the prior art, especially where the product can only be defined by the process steps by which the product is made, or where the manufacturing process steps would be expected to impart distinctive structural characteristics to the final product. See, e.g., In re Garnero, 412 F.2d 276, 279, 162 USPQ 221-223 (CCPA 1979)” (see MPEP 2113). Therefore when no structure is implied, the product-by-process recitation does not add any limitations that affect patentability. Instant claims 27-28, 30-32, and 35 recite a product-by-process where the manufacturing steps do not impart any distinctive structural features to the final product that distinguish it from that rendered obvious by the discussed combination of teachings. Thus the products of the modified Metzger et al. teachings meet the limitations of these claims. Therefore claims 1-2, 4, 7-8, 10-11, 19-20, 23, 27-32, 35, and 37 are obvious over Metzger et al. in view of Evans et al., Yang et al., Olalde Graells et al. and Lu et al. as evidenced by Abu Baker et al. and Graham.
Response to Arguments
Applicant's arguments filed October 9, 2025 have been fully considered. In light of the amendment concerning the pore size and gradient, the rejections under 35 USC 112 concerning their recitation are withdrawn. The applicant’s arguments concerning the remaining rejections are unpersuasive.
Regarding the rejection under 35 USC 112(b):
The response does not address the issue raised in regard to the scope of implants that exclude fibrous material and polymeric material, given the explicit inclusion of polymeric components as wear resistant components. It remains unclear where the distinction between fibrous material containing and non-fibrous material containing structures occurs, particularly when a polymer is included as a wear resistant component in the poly(aryl ether ketone) (PAEK). Further, the feedstock detailed for the PAEK based implant starts as particles and it has not been made clear the degree of coalescence and the internal microstructure shapes that are necessary to no longer qualify as “particulates” or fibrous material. This is particularly an issue due to the fact that solid additives (e.g., calcium phosphate, wear additive, and/or reinforcing additive) are required in the PAEK such that the PAEK is located around these components of the composite device.
Regarding rejection under 35 USC 103:
The applicant argues that Metzger et al. do not teach a knee implant where polymer is its main material. The claims do not require that a particular proportion of polymer be present via its recitation of "polymeric based" because this term is not defined by the disclosure to have such a limitation. Therefore the prior art is not required to have a particular amount of polymer in its knee implant in order to meet the instant claim limitations. The applicant additionally argues that Metzger et al. do not teach an implant comprising a polymeric material consisting of an instantly recited polymer. To the contrary, Metzger et al. teach the tibial tray of their implant to be made of polymer or metal or a combination of the two, which implies that a polymer material can compose the implant component without the metal. In addition, two particular varieties of polymer are envisioned, one of which is the claimed polyetheretherketone (PEEK). This implies that the polymer of the tibial tray can be only PEEK and this meets the limitations of the instantly claimed knee implant with an articulating surface and bone/implant interface comprising a polymeric material consisting of PEЕК. Further, the recitation of ‘a polymeric material consisting of’ does not limit all components that are polymers in the knee implant. Other components may be present that are composed of polymer, as evidenced by the recitation of instant claim 15 which recites a polymeric wear additive in the implant.
The applicant points to discussions in the disclosure of recognized drawbacks of metal and ceramic knee implants. However, these are not new discoveries made by the applicant nor is the recognition of the mechanical properties and bioinert-ness of PEEK that make it an alternative to such materials. The prior art of record already demonstrates the recognized utility and benefits of selecting PEEK to make orthopedic implants. (see Olalde Graells and Evans).
The applicant also notes drawbacks of polyethylene as a polymer component of orthopedic implants, but provide no evidence that this is an unexpected outcome. They also note a shorter post-operative healing time due to biphasic calcium phosphate as compared to hydroxyapatite as ceramic additives. Again, this has not been shown to be an unexpected outcome and it is not clear that there is evidence of record that shows this outcome. The applicant also discusses the benefit of the claimed pore gradient and pore size in regards to pull off force. As the rejection notes, a preference for a claimed pore size arranged in a gradient was already recognized in the prior art. According to MPEP 2144 IV, "[t]he reason or motivation to modify the reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant. See, e.g., In re Kahn, 441 F.3d 977, 987, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006)." Further, there is no evidence that the increased pull off force that the applicant attained from a gradient pore arrangement as compared to small or large pores was unexpected.
The applicant further argues that their claimed biphasic calcium phosphate yields superior bone integration as compared to hydroxyapatite. No supporting evidence is provided to support this contention occurring to an unexpected extent. Additionally, this difference in performance was already recognized by the prior art (see Arinzeh et al. Biomaterials 2005 26:3631–3638). Thus the difference is not a distinguishing feature of the instant product that would suggest non-obviousness.
The applicant goes onto to argue against references not teaching features for which other references were relied upon to provide, such as arguing against Evans and Olalde Graells for not teaching the claimed pore size when Yang is provided to supply and justify the selection of this feature in accordance with the claims. One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). In addition, the applicant notes a high pore fraction discussed by Evans as compromising mechanical integrity, but this reference still imparts porosity near the implant surface and their discussion is not a teaching that addresses pore sizes arranged in a gradient. Larger pores in a smaller amount can yield the same or a smaller pore fraction/volume then smaller pores in larger amount.
The applicant again notes the similarity in structure between an embodiment of a knee implant made by additive manufacture and cancellous bone that was discussed in the declaration filed April 24, 2025. As the office action mailed July 9, 2025 noted, there are no claim limitations directed toward any of these architectural features or any discussion of this architecture in the disclosure. So while it is a notable outcome, it is not relevant to the claims under examination.
The applicant also argues that Olalde Graells do not teach of the incorporation of biphasic calcium phosphate. This argument mischaracterizes the teachings of the reference which discuss PEEK-type polymers for bone implants and include a small number of envisioned ceramic additive options. One of these options is biphasic calcium phosphate. The applicant can support their contention of this ceramic being unexpectedly superior/critical with evidence, but the record currently still supports the obviousness of its selection.
Conclusion
No claim is allowed.
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/CARALYNNE E HELM/Examiner, Art Unit 1615