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 statements (IDS) submitted on November 7, 2025 and May 29, 2024 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements have been considered by the examiner.
Response to Amendment
Claims 1-37 are pending in the application. Claim 26 has been amended. Claims 1-37 are rejected.
Claim Objections
Claims 18-19 are objected to because of the following informalities: both claims 18 and 19 recite “wherein talar component…”. This is believed to be a typographical error and the claim should read “wherein the talar component…” 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.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 8 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 8 has identical limitations to that of claim 7. Identical or substantially duplicate claims are not permitted. See MPEP §608.01(m). Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claims 36-37 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 36 recites the limitation "the exterior surface of the second end" inline 2-3. There is insufficient antecedent basis for this limitation in the claim. Neither claim 28, nor claim 1 upon which claim 36 depend recite “an exterior surface” or “a second end”. It is noted that claim 34 recites “an exterior surface” in relation to both the top surface of the talar component and the bottom surface of the talar component. None of claims 1, 28, or 34 recite a second end. As can best be understood, the second end appears to be referring to the bone facing bottom surface of the talar component.
For the purposes of examination, this claim is being interpreted as reading: “The prosthetic ankle of claim [[28]] 34, wherein the Zn-Sr alloy comprises a three-dimensional structure extending away from the exterior surface of the bottom surface of the talar component.” Appropriate action is required.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1-5, 22, and 24-27 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by applicant cited Siegler et al (US PG Pub 2016/0008139).
Regarding claim 1, Siegler teaches a prosthetic ankle (see Title) comprising:
a talar component (300) having a top surface (302) and a bottom surface (304) (See paragraph [0070]), wherein the bottom surface is configured to be positioned adjacent to a talus (See paragraphs [0050] and [0080]), wherein the top surface (302) includes a trochlear groove (trough/ valley seen in Fig. 11 where the medial radius and central radius of curvature meet; See also paragraphs [0057], [0068]-[0078]) extending from a posterior side (307) of the talar component to an anterior side (305) of the talar component, wherein the trochlear groove includes a first portion adjacent the posterior side of the talar component and a second portion adjacent the anterior side of the talar component. (See Figs. 8B & 11, paragraphs [0057], [0062] and [0068]-[0078])
Regarding claim 2, Siegler teaches the prosthetic ankle required by claim 1 as set forth above and further teaches wherein the trochlear groove is skewed in a lateral direction as the trochlear groove extends from the posterior side of the talar component to the anterior side of the talar component. (See Figs. 8B and 11; paragraphs [0048] and [0057]).
Regarding claim 3, Siegler teaches the prosthetic ankle required by claim 1 as set forth above and further teaches the top surface (302) of the talar component is skewed superiorly from a medial direction to a lateral direction (See Figs. 8B and 11; paragraph [0062]), and wherein the top surface (302) of the talar component is skewed posteriorly from an anterior direction to a posterior direction. (See Figs. 8B & 11; paragraphs [0050]-[0058] and [0061]-[0074]).
Regarding claim 4, Siegler teaches the prosthetic ankle required by claim 1 as set forth above and further teaches an average radius of curvature of a medial portion of the top surface of the talar component is greater than an average radius of curvature of a lateral portion of the top surface of the talar component. (See paragraphs [0068]-[0071])
Regarding claim 5, Siegler teaches the prosthetic ankle required by claim 4 as set forth above and further teaches the medial portion comprises a portion of the top surface of the talar component that is medial to the trochlear groove, and wherein the lateral portion comprises a portion of the top surface of the talar component that is lateral to the trochlear groove. (See Figs. 8B & 11; paragraphs [0053]-[0057]); [0059]-[0064]).
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Regarding claim 22, Siegler teaches the prosthetic ankle required by claim 1 as set forth above and further teaches wherein the bottom surface (304) includes one or more interosseous fixation elements (spikes 311) extending away from the bottom surface (See Fig. 12), and wherein the one or more interosseous fixation elements are configured to be positioned within the talus (See paragraph [0080]).
Regarding claim 24, Siegler teaches the prosthetic ankle required by claim 1 as set forth above and further teaches the one or more interosseous fixation elements (311) comprise a pair of talar pegs (note there are more than 2 total spikes. Further note Fig. 12 the arrangement of two rows of spikes side-by-side), and wherein each of the pair of talar pegs are angled between 0 and 90 degrees with respect to the bottom surface of the talar component. (See Fig. 12, note the spikes extend directly down and away from the bottom surface of the talar component.
Regarding claim 25, Siegler teaches the prosthetic ankle required by claim 24 as set forth above and further teaches each of the pair of talar pegs (311) are perpendicular to the bottom surface of the talar component. (See Fig. 12)
Regarding claim 26, Siegler teaches the prosthetic ankle required by claim 1 as set forth above and further teaches a bearing surface (200) (See Fig. 16B; paragraph [0087]); and a tibial component (100) having a top (102) surface configured to be positioned adjacent to a tibia (See paragraph [0051]) and a bottom surface (104) configured to be positioned adjacent a top surface of the bearing surface (See paragraphs [0082]-[0084] and [0086]-[0096]).
Regarding claim 27, Siegler teaches the prosthetic ankle required by claim 26 as set forth above and further teaches a bottom surface of the bearing surface is configured to1 substantially match the top surface of the talar component (See paragraph [0087]) such that the bearing surface and tibial component can move relative to one another and frictionally engage one another on the top surface of the bearing surface. (See paragraphs [0086]-[0096])
Claim Rejections - 35 USC § 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 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(s) 6-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over applicant cited Siegler et al (US PG Pub 2016/0008139).
Regarding claim 6, Siegler teaches the prosthetic ankle required by claim 1 as set forth above and further teaches the geometry of the talar top surface varies between the anterior and posterior portions so that the top surface resembles the contours of the top surface of the talus. (See paragraphs [0062]-[0065]). Siegler teaches using multiple frontal plane cross sections to form the top surface geometry to mirror that of a native talus. Siegler further teaches the radius of the anterior end 305 is smaller than the radius of the posterior end 317 and the radii or curvature vary from anterior to posterior to more closely approximate the geometry of a native talus so as to more closely reproduce natural ankle movement while providing stability. (See paragraphs [0057]-[0067]).
Siegler does not expressly teach a diameter of the first portion of the trochlear groove is different from a diameter of the second portion of the trochlear groove. Siegler does, however, teach varying the curvature of the talar top surface from the anterior to posterior sides such that the top surface is more curved near the anterior end and less curved at the posterior end similar to a native talus (See paragraphs [0065]-[0067]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify Siegler such that the trochlear groove (trough/valley) has a different diameter in a first portion of the groove than the diameter of a second portion of the groove since Siegler already expressly contemplates varying the radius of curvature of the surface from anterior to posterior to more closely approximate the shape of a native talus resulting in an implant that provides more natural ankle motion and stability.
Regarding claims 7 and 82, modified Siegler teaches the prosthetic ankle required by claim 6 as set forth above and further teaches the diameter of the first portion of the trochlear groove is greater than the diameter of the second portion of the trochlear groove. (See paragraphs [0062]-[0067]; note that paragraphs [0066]-[0067] state the anterior end is more curved than the posterior end which closely approximates the actual shape of the human talus bone.
Regarding claim 9, modified Siegler teaches the prosthetic ankle required by claim 6 as set forth above but does not expressly teach the diameter of the first portion of the trochlear groove ranges from about 10 mm to about 16 mm, and wherein the diameter of the second portion of the trochlear groove ranges from about 8 mm to about 12 mm. Siegler explicitly states the geometry of the talus component may be variable so as to mimic the natural shape of the talus bone so as to allow stability and smooth motion. (See paragraph [0066])
In applicant’s specification, the variable geometry and size of the trochlear groove is disclosed to be a result effective variable which assists with maintaining medial/lateral stability while allowing proper rotation during dorsiflexion. Siegler also explicitly contemplates varied geometry of the prosthetic talus to closely approximate the natural shape of the bone to provide stability and smooth motion. Further it appears one of ordinary skill in the art would have a reasonable expectation of success in modifying Siegler to have the diameter of the first portion of the trochlear groove ranges from about 10 mm to about 16 mm, and wherein the diameter of the second portion of the trochlear groove ranges from about 8 mm to about 12 mm, as it only involves adjusting the dimension of a component already disclosed to be adjustable. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the size of the first and second portions of the trochlear groove of the implant as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 223, 235 (CCPA 1955). See also MPEP §2144.05
Regarding claim 10, modified Siegler teaches the prosthetic ankle required by claim 6 as set forth above but does not explicitly teach the diameter of the first portion of the trochlear groove is constant, and wherein the diameter of the second portion of the trochlear groove is constant. Siegler teaches the geometry of the talar surface is formed from five different frontal plane cross-sections having specific radii. Siegler further teaches the prosthetic talar component has a close approximation to the natural shape of the bone so as to provide stability and smooth motion and expressly contemplates patient specific sizing (See paragraph [0069]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to having the first and second portions of the trochlear groove each have a constant diameter, or whatever other size and shape was desired or expedient since it is known in the art to have the geometry of the talus implant closely approximate the geometry of a native talus bone so as to provide stability and smooth motion. Further, it is generally known that the size and shape of anatomical structures can vary due to a person’s age, size, genetics and other factors. As stated in MPEP §2144.05(II)(A): “It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions." In re Williams, 36 F.2d 436, 438, 4 USPQ 237 (CCPA 1929).
Regarding claim 11, modified Siegler teaches the prosthetic ankle required by claim 6 as set forth above and further teaches the diameter of the first portion of the trochlear groove is variable, and wherein the diameter of the second portion of the trochlear groove is variable. (See paragraphs [0062]-[0067]. Note Siegler expressly teaches varying the radius along the anterior-posterior direction to more closely approximate the natural talar anatomy so as to improve stability and aid in smooth motion.
Regarding claim 12, modified Siegler teaches the prosthetic ankle required by claim 6 as set forth above and further teaches the first portion of the trochlear groove has a first length, wherein the second portion of the trochlear groove has a second length, and wherein the second length is greater than the first length. It is noted that there are no limitations in the claims which require the first and second portions of the groove to be in relation to any other specific features of the talar component other than the first portion being adjacent the posterior side and the second portion being adjacent the anterior side. Thus, an imaginary line can be drawn anywhere between those two points to divide the trochlear groove into the first and second portions including drawing the line such that the length of the second portion is greater than the length of the first portion.
Claim(s) 13-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over applicant cited Siegler et al (US PG Pub 2016/0008139) as applied to claim 1 above and further in view of Pak et al (US PG Pub 2019/0031032).
Regarding claim 13, Siegler teaches the prosthetic ankle required by claim 1 as set forth above and also teaches the posterior size of the talar component has a first width and the anterior side of the talar component has a second width. Siegler teaches the talar component has a geometry which closely approximates the natural geometry of the human talus bone so as to aid in stability and smooth motion of the joint. (See paragraphs [0066]-[0067]) Siegler also teaches creating various sizes of the implant as well as patient specific customization. (See paragraph [0069]). Siegler does not expressly teach the second width (anterior side) is greater than the first width (posterior side).
Pak teaches an analogous prosthetic ankle featuring a talar component (150) with an anterior edge (156) and a posterior edge (158) connected by medial & lateral side walls (160). Pak teaches the component tapers outward from posterior edge 158 towards anterior edge 156 such that the distance between the sidewalls is greater near the anterior edge. (See Fig. 4; paragraph [0022]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have the implant as taught Siegler have the second width (anterior side) is greater than the first width (posterior side) as taught by Pak since both Siegler and Pak expressly teach having the talar component of the prosthetic ankle closely mimic the geometry of a native talus bone for stability and smooth motion of the implant. Furthermore, a change in shape or form is generally recognized as a matter of design choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration was significant (produced unexpected results). In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966). See also MPEP §2144.04(IV)(B).
Regarding claim 14, Siegler teaches the prosthetic ankle required by claim 1 as set forth above and also teaches a first sidewall positioned between the top surface and the bottom surface of the talar component; and a second sidewall positioned between the top surface and the bottom surface of the talar component. (See Figs. 11-13). Siegler does not expressly teach wherein a minimum width of the bottom surface is greater than a minimum width of the top surface such that each of the first sidewall and the second sidewall are angled inwards from the bottom surface towards the top surface. Siegler teaches the talar component has a geometry which closely approximates the natural geometry of the human talus bone so as to aid in stability and smooth motion of the joint. (See paragraphs [0066]-[0067]) Siegler also teaches creating various sizes of the implant as well as patient specific customization. (See paragraph [0069]).
Pak teaches an analogous prosthetic ankle featuring a talar component (150) with an anterior edge (156) and a posterior edge (158) connected by medial & lateral side walls (160). Pak teaches the component tapers outward from posterior edge 158 towards anterior edge 156 such that the distance between the sidewalls is greater near the anterior edge. (See Fig. 4-6; paragraph [0022]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify Siegler to incorporate the teachings of Pak such that the talar component of the prosthetic ankle has a minimum width of the bottom surface is greater than a minimum width of the top surface such that each of the first sidewall and the second sidewall are angled inwards from the bottom surface towards the top surface since both Siegler and Pak teach the prosthetic talar component should closely mimic the natural geometry of a native talus bone for both stability and smooth movement. It is known that the native talar bone has an inwardly tapering geometry.
Claim(s) 15-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over applicant cited Siegler et al (US PG Pub 2016/0008139) in view of Laughner et al (US PG Pub 2011/0035020)
Regarding claim 15, Siegler teaches the prosthetic ankle required by claim 1 as set forth above but does not expressly teach the interior of the talar implant is hollow.
Laughner teaches an analogous orthopedic implant where the implant has an interior hollow lattice structure in the body of the implant. Laughner teaches having a hollow lattice structure enables a lighter weight implant that enables bone ingrowth which better secures the prosthetic implant. Laughner also teaches the hollow lattice structure enables the ability to tune the stiffness of the device to a person’s particular bone density. (See Fig. 3C; paragraphs [0018]-[0019])
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify Siegler to incorporate the teachings of Laughner such that the interior of the talar component is hollow since it is known that a hollow orthopedic implant is advantageous because it is a lighter weight and allows bone ingrowth which better secures the implant in the desired location.
Regarding claim 16, modified Siegler teaches the prosthetic ankle required by claim 15 as set forth above and further teaches the interior of the talar component includes a lattice structure (See Laughner Fig. 3; paragraph [0018], [0019] and [0033]).
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over applicant cited Siegler et al (US PG Pub 2016/0008139) in view of Laughner et al (US PG Pub 2011/0035020) as applied to claim 15 above and further in view of Wickham (US PG Pub 2016/0038301).
Regarding claim 17, modified Siegler teaches the prosthetic ankle required by claim 15 as set forth above but does not expressly teach the interior of the implant includes alternating solid layers and lattice structure layers3.
Wickham teaches an analogous orthopedic implant comprised of an open porous layer, a solid layer for sealing and an open space or cavity. (See paragraph [0023]-[0025]). Wickham teaches the solid layer adjacent the porous lattice layer gives support while preventing undesired tissue growth into particular inner regions of the implant.
It would have been obvious to one of ordinary skill in the art before the effective filing date to further modify Siegler to include the alternating solid and lattice layers as taught by Wickham so as to ensure tissue ingrowth occurs in the desired locations while preventing it from growing into an undesired location.
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over applicant cited Siegler et al (US PG Pub 2016/0008139) as applied to claim 1 above and further in view of Tuttle (US PG Pub 2019/0350717).
Regarding claim 18, Siegler teaches the prosthetic ankle required by claim 1 as set forth above but does not expressly teach the talar component includes a porous structure positioned adjacent the bottom surface.
Tuttle teaches an analogous prosthetic ankle including a talar component with a porous structure (210) positioned adjacent the bottom surface. (See paragraphs [0061]-[0064]). Tuttle teaches the porous layer promotes tissue (bone) ingrowth. (See paragraph [0003]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify Siegler to incorporate the porous structure adjacent the bottom surface of the talar implant as taught by Tuttle since porous layers are known to aid in bone ingrowth which allows the implant to be stable and incorporated into the body when healed.
Claim(s) 19-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over applicant cited Siegler et al (US PG Pub 2016/0008139) in view of Tuttle (US PG Pub 2019/0350717) as applied to claim 18 above and further in view of Jones (US PG Pub 20180280139).
Regarding claim 19, modified Siegler teaches the prosthetic ankle required by claim 18 as set forth above but does not explicitly teach the talar component includes one or more channels embedded in the porous structure.
Jones teaches an analogous orthopedic (bone) implant featuring a lattice structure with one or more channels (voids) within the lattice/porous implant material. Jones teaches the voids/channels allow for fluid transport and communication with another location in the implant. Jones teaches it is common and beneficial to add fluids such as blood, plasma, or drugs to the surgical site during surgery to increase the rate of recovery (see paragraph [0003]). Jones teaches it is advantageous for such fluids to be uniformly distributed through the implant and channels throughout the lattice structure ensures uniform distribution of fluids.
It would have been obvious to one of ordinary skill in the art before the effective filing date to further modify Siegler to incorporate the channels/voids embedded in the porous structure as taught by Jones so as to ensure any beneficial fluids added during surgery are uniformly distributed throughout the implant which aids in faster recovery.
Regarding claim 20, modified Siegler teaches the prosthetic ankle required by claim 19 above and further teaches the one or more channels are interconnected so that they are each in fluid communication with one another. (See Jones Fig. 9 paragraph [0037]-[0047]).
Regarding claim 21, modified Siegler teaches the prosthetic ankle required by claim 19 above and further teaches at least one channel of the one or more channels extends to the anterior side of the talar component. (See Jones Fig. 9; paragraphs [0037]-[0047]), note that Siegler as modified to include the channels/voids of Jones will also extend throughout the implant.
Claim 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over applicant cited Siegler et al (US PG Pub 2016/0008139) in view of Bolesky et al (US Pat. No. 4,479,271).
Regarding claim 23, Siegler teaches the prosthetic ankle required by claim 22 above but does not explicitly teach an interior of each of the interosseous fixation elements are hollow and include a lattice structure.
Bolesky teaches an analogous orthopedic (bone) implant featuring interosseous fixation elements (stems 13) which are hollow (note bore 15 extends through the stem 13) and include a lattice structure (porous polyethylene – See Col. 4, lines 45-66). Bolesky teaches this arrangement allows for bone ingrowth into the device.
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify Siegler to incorporate the teachings of Bolesky such that the interosseous fixation elements are hollow and include a lattice structure since this arrangement is known in the art to be beneficial for tissue ingrowth at the site of implantation.
Claim(s) 28-33, 36, and 37 is/are rejected under 35 U.S.C. 103 as being unpatentable over applicant cited Siegler et al (US PG Pub 2016/0008139) in view of Peking University (CN 104195368).
Regarding claim 28, Siegler teaches the prosthetic ankle required by claim 1 as set forth above and further teaches the bottom surface (304) of the talar component (300) is configured to be positioned within a bone of a patient (See Paragraph [0080]).
Siegler does not explicitly teach at least a portion of an exterior surface of the bottom surface includes a Zinc-Strontium (Zn-Sr) alloy.
Siegler teaches the talar component may be made of materials “selected from an appropriate material suitable for the surgical environment” including high density, ultra-high molecular weight polyethylene and “metallic alloys that are biocompatible and are also suitable materials from the tibial and talar components.” (See paragraph [0094])
Peking University teaches a Zn-Sr alloy which is advantageous for bone implants because it is biocompatible and promotes new bone growth (See pages 3, 5, 7 of attached translation)
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify Siegler to include at least a portion of an exterior surface of the bottom of the talar component (which is positioned within the bone of a patient) include a Zinc-Strontium (Zn-Sr) alloy as taught by Peking University since Zn-Sr is known to be an advantageous bone implant material which promotes bone growth and remodeling. Furthermore, it is deemed to be within the level of ordinary skill in the art to use a known material. “The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945).” See MPEP §2144.07.
Regarding claim 29, modified Siegler teaches the prosthetic ankle required by claim 28 as set forth above and further teaches the Zn-Sr alloy is Zn-Sr. (See Peking pages 3-4).
Regarding claim 30, modified Siegler teaches the prosthetic ankle required by claim 28 as set forth above. It is noted that the instant claims are drawn to an apparatus, and “"[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original).” A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). See MPEP §2114(II). In the instant case, Peking University already teaches the Zn-Sr alloy promotes bone growth due to zinc assisting with bone formation and remodeling and strontium promoting osteoblastic activity. The recitation that the Zn-Sr alloy “stimulates osteogenesis of one or more mesenchymal stem cells is a functional limitation of the claimed prosthetic ankle apparatus and does not require any additional structural feature of the implant. MPEP §2112.014 states that where the claimed prior art products are identical or substantially identical in structure or composition, the properties or functions of the claimed produce are presumed to be inherent. Thus, the device of Siegler as modified to use the Zn-Sr alloy disclosed by applicant would necessarily also result in the recited function of stimulating osteogenesis of mesenchymal stem cells selected from the group consisting of CD45-, CD45'/CD146+, CD45-CD271+, CD31-44+45-73+90+105|, and CD45-CD34+.
Regarding claim 31, modified Siegler teaches the prosthetic ankle required by claim 28 as set forth above. It is noted that the instant claims are drawn to an apparatus, and “"[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original).” A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). See MPEP §2114(II). In the instant case, the limitation requiring that the Zn-Sr alloy “increases cellular PI3K/Akt, MAPK/Erk, and/or Wnt/B-catenin pathway signaling, thereby promoting anabolic and anticatabolic effects on bone remodeling” recites a biological function or mechanism of the claimed alloy rather than an additional structural limitation of the prosthetic ankle. MPEP §2112.015 states that where the claimed prior art products are identical or substantially identical in structure or composition, the properties or functions of the claimed produce are presumed to be inherent. Thus, the device of Siegler as modified to use the Zn-Sr alloy disclosed by applicant would necessarily also result in the recited biologic function. Absent persuasive evidence that the Zn-Sr alloy as taught by Peking University does not produce the recited signaling response, the functional limitation is considered to be met by the prior art.
Regarding claim 32, modified Siegler teaches the prosthetic ankle required by claim 28 as set forth above and further teaches the Zn-Sr alloy further includes a material selected from the group consisting of tricalcium phosphate (TCP), hydroxyapatite (HA), and Silicon. (See Peking University page 3) Note Peking University states the zinc alloy “also includes trace elements” including “silicon”. It also states the zinc alloy may have a ceramic coating which can be “hydroxyapatite” or tricalcium phosphate.
Regarding claim 33, modified Siegler teaches the prosthetic ankle required by claim 28 as set forth above and further teaches the Zn-Sr alloy includes no more than a trace amount of Magnesium. See Example 1 of Peking on page 6 which expressly states the Zn-Sr composition is formed from pure Zinc and pure Strontium. There is no mention of Magnesium as part of the disclosed alloy, and thus there would be no more than a trace amount as an impurity. Additionally, the trace elements listed on page 3 do not include Magnesium.
Regarding claim 36, modified Siegler teaches the prosthetic ankle required by claim 28 as set forth above and further teaches the Zn-Sr alloy comprises a three-dimensional structure6 extending away from the exterior surface of the second end. Note Peking University teaches the Zn-Sr alloy is sintered to create a porous alloy which is inherently three-dimensional. (See page 4).
Regarding claim 37, modified Siegler teaches the prosthetic ankle required by claim 36 as set forth above and further teaches the three-dimensional structure comprises a scaffold7.
Claims 34 and 35 is/are rejected under 35 U.S.C. 103 as being unpatentable over applicant cited Siegler et al (US PG Pub 2016/0008139) in view of Peking University (CN 104195368) as applied to claim 28 above and further in view of Justin et al (US PG Pub 2018/0250134).
Regarding claim 34, modified Siegler teaches the prosthetic ankle required by claim 28 above and further teaches the top surface of the talar component is configured to8 extend away from the bone after implantation of the talar component in the bone (See Siegler Figs. 8B & 11; paragraphs [0050]-[0058] and [0061]-[0074]). Siegler also teaches the bottom, bone facing surface may be coated with a substance to enhance bony ingrowth. (See paragraph [0085])
Siegler does not explicitly teach an exterior surface of the top surface (joint facing) of the talar component comprises a first material and wherein the exterior surface of the bottom surface (bone facing) of the talar component comprises a second material that is different from the first material.
Justin teaches an analogous implantable joint prosthesis9 which has a porous bone facing surface and an opposing articulating surface where the two surfaces are made of different materials based on their different functions. (See paragraphs [0028], [0046]-[0047] and [0067]-[0068]). Justin teaches the bone facing surface has a porous bone engagement surface to facilitate bone ingrowth while the joint facing articulating surface has a nonporous or hard surface. (See paragraph [0038]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to further modify Siegler in view of Peking to incorporate the teachings of Justin such that the bone facing surface and the articulation surface are made of different materials since the two surfaces have different functions and require different material properties. Specifically, it is desirable for the bone facing surface to promote bone ingrowth while the articulating surface needs to be able to move smoothly within the joint capsule. Furthermore, it is deemed to be within the level of ordinary skill in the art to use a known material. “The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945).” See MPEP §2144.07.
Regarding claim 35, modified Siegler teaches the prosthetic ankle required by claim 34 above and further teaches the second (bone facing) material comprises the Zn-Sr alloy. (As noted above Siegler has been modified to incorporate the Zn-Sr alloy as taught by Peking University). Modified Siegler also teaches the first material comprises a cobalt-chromium (CoCr) alloy (See paragraph [0038] of Justin).
Conclusion
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/R.S.H/Examiner, Art Unit 3774
/BRIAN A DUKERT/Primary Examiner, Art Unit 3774
1 It is noted that the instant claims are drawn to an apparatus, and “"[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original).” A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). See MPEP §2114(II).
2 As noted above the limitations of claims 7 and 8 are identical.
3 MPEP §2111 requires claim limitations be given their “broadest reasonable interpretation in light of the specification”. Additionally, claim terms are given their “plain meaning” unless applicant has provided a special definition. However, it is improper to import claim limitations from the specification into the claims. In the instant case, “alternating solid layers and lattice structure layers” is being interpreted as at least two total layers, one solid and one lattice. It is noted that the claims as presently presented to not positively require more than two total layers.
4 MPEP §2112.01 also states “"Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.”
5 MPEP §2112.01 also states “"Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.”
6 MPEP §2111 requires claim limitations be given their “broadest reasonable interpretation in light of the specification”. Additionally, claim terms are given their “plain meaning” unless applicant has provided a special definition. However, it is improper to import claim limitations from the specification into the claims. In the instant case “three dimensional structure” is quite broad and includes the porous Zn-Sr alloy as described by Peking University.
7 MPEP §2111 requires claim limitations be given their “broadest reasonable interpretation in light of the specification”. Additionally, claim terms are given their “plain meaning” unless applicant has provided a special definition. However, it is improper to import claim limitations from the specification into the claims. In the instant case, Merriam-Webster defines “scaffold” as “a supporting framework”. Since Peking University explicitly describes the porous alloy as advantageous for bone ingrowth, it is deemed to meet the broadest reasonable interpretation of “a scaffold”. It is further noted that applicant has not provided any specific definition for “scaffold” in the specification. Furthermore, porous materials are often referred to in the art as “scaffolds” since the pores allow for tissue ingrowth.
8 It is noted that the instant claims are drawn to an apparatus, and “"[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original).” A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). See MPEP §2114(II).
9 Note paragraph [0045] which states the invention is not limited to knee implants “but may be used in connection with any implant having an articulating component and a bone engagement component.”
