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 Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
No claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Objections
Claim 36 is objected to because of the following informalities:
in claim 36, line 5: “a” should be inserted before “first shim”.
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.
Claims 21-40 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 21 recites “wherein the measurement device is inverted in the second configuration with respect to the first configuration” in lines 15-16, which appears to be an action step in an apparatus claim. Specifically, the first and second configurations are particular temporal arrangements that the prosthetic knee component system is capable of being in. However, the prosthetic knee component system cannot structurally exist in both configurations at the same time. Thus, the recitation reads an action of the measurement system going from the first configuration into the second configuration. A single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph, because it creates confusion as to when direct infringement occurs. (MPEP 2173.05(p) citing In re Katz Interactive Call Processing Patent Litigation, 639 F.3d 1303, 97 USPQ2d 1737 (Fed. Cir. 2011)).
Alternatively, the claim limitation can be read as permanently requiring the prosthetic knee component system to be in the second configuration, but it is not clear if this interpretation is the intended meaning of the recitation since the claim recites particulars of the first configuration in lines 9-10 (“wherein the first shim is configured for connecting to a right tibia or a right knee joint in a first configuration”) which would suggests that both first and second configurations are possible. This confusion renders claim 21 indefinite.
Claims 22-31 are rejected by virtue of their dependence from claim 21.
Claim 22 recites “a right bone or joint” in line 3, but it is not clear if this recitation is the same as, related to, or different from “a right tibia or a right knee joint” of claim 21, line 10. The use of the indefinite article in the recitation of claim 22, line 3 suggests that they are different, but the similarity in concepts suggests that they are the same. Clarifications is required.
Claim 22 recites “a left bone or joint” in line 5, but it is not clear if this recitation is the same as, related to, or different from “a left tibia or left knee joint” of claim 21, line 14. The use of the indefinite article in the recitation of claim 22, line 5 suggests that they are different, but the similarity in concepts suggests that they are the same. Clarifications is required.
Claim 24 recites “a right bone or joint” in line 3, but it is not clear if this recitation is the same as, related to, or different from “a right tibia or a right knee joint” of claim 21, line 10. The use of the indefinite article in the recitation of claim 24, line 3 suggests that they are different, but the similarity in concepts suggests that they are the same. Clarifications is required.
Claim 24 recites “a left bone or joint” in line 4, but it is not clear if this recitation is the same as, related to, or different from “a left tibia or left knee joint” of claim 21, line 14. The use of the indefinite article in the recitation of claim 24, line 4 suggests that they are different, but the similarity in concepts suggests that they are the same. Clarifications is required.
Claim 31 recites “a right bone or joint” in line 2, but it is not clear if this recitation is the same as, related to, or different from “a right tibia or a right knee joint” of claim 21, line 10. The use of the indefinite article in the recitation of claim 31, line 2 suggests that they are different, but the similarity in concepts suggests that they are the same. Clarifications is required.
Claim 31 recites “a left bone or joint” in line 3, but it is not clear if this recitation is the same as, related to, or different from “a left tibia or left knee joint” of claim 21, line 14. The use of the indefinite article in the recitation of claim 31, line 3 suggests that they are different, but the similarity in concepts suggests that they are the same. Clarifications is required.
Claim 32 recites “wherein the measurement device is inverted in the second system configuration with respect to the first system configuration” in lines 8-9, which appears to be an action step in an apparatus claim. Specifically, the first and second configurations are particular temporal arrangements that the prosthetic knee component system is capable of being in. However, the prosthetic knee component system cannot structurally exist in both configurations at the same time. Thus, the recitation reads an action of the measurement system going from the first configuration into the second configuration. A single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph, because it creates confusion as to when direct infringement occurs. (MPEP 2173.05(p) citing In re Katz Interactive Call Processing Patent Litigation, 639 F.3d 1303, 97 USPQ2d 1737 (Fed. Cir. 2011)).
Alternatively, the claim limitation can be read as permanently requiring the prosthetic knee component system to be in the second configuration, but it is not clear if this interpretation is the intended meaning of the recitation since the claim recites particulars of the first configuration in lines 2-3 (“a first shim configured for connecting to a right bone or joint in a first system configuration”) which would suggests that both first and second configurations are possible. This confusion renders claim 32 indefinite.
Claims 33-35 are rejected by virtue of their dependence from claim 32.
Claim 36 recites “wherein the measurement device is inverted in the second configuration with respect to the first configuration” in lines 11-13, which appears to be an action step in an apparatus claim. Specifically, the first and second configurations are particular temporal arrangements that the prosthetic knee component system is capable of being in. However, the prosthetic knee component system cannot structurally exist in both configurations at the same time. Thus, the recitation reads an action of the measurement system going from the first configuration into the second configuration. A single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph, because it creates confusion as to when direct infringement occurs. (MPEP 2173.05(p) citing In re Katz Interactive Call Processing Patent Litigation, 639 F.3d 1303, 97 USPQ2d 1737 (Fed. Cir. 2011)).
Alternatively, the claim limitation can be read as permanently requiring the prosthetic knee component system to be in the second configuration, but it is not clear if this interpretation is the intended meaning of the recitation since the claim recites particulars of the first configuration in lines 9-10 (“wherein the measurement device is configured to (i) measure load applied to the first shim in a first configuration”) which would suggests that both first and second configurations are possible. This confusion renders claim 36 indefinite.
Claim 36 recites “wherein the measurement device is configured to (i) measure load applied to the first shim in a first configuration, and (ii) measure load applied to the second shim in a second configuration” in lines 9-11, but it is not clear how the measurement device measures load since there is no element of the measurement device capable of measuring load. The only elements of the measurement device are the first side and the second side, neither of which is a known element for measuring load. The structure of the measurement device is not clear since its claimed function requires more structure than what is provided in the claim. This ambiguity renders claim 36 indefinite.
Claims 37-40 are rejected by virtue of their dependence from claim 36.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 21, 23-24, 27 and 32-38 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 16-17 of U.S. Patent No. 11,534,316 (the reference patent)(previously cited). Although the claims at issue are not identical, they are not patentably distinct from each other.
Claim 16 or 17 of the reference patent has all the features of claim 21, 23-24, 27 and 32-38 of the present application.
Claims 21, 23, 28-29, 32, 34-38, and 40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 7, and 10-11 of U.S. Patent No. 11,534,316 (the reference patent)(previously cited), in view of U.S. Patent Application Publication No. 2013/0261757 (Claypool)(previously cited).
Claims 1-5, 7, and 10-11 of the reference patent involve a prosthetic knee component system. Claypool teaches that such devices, including their shims, are used in both right and left tibial prosthesis systems (paragraph 0104 and 0135 of Claypool). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the prosthetic knee component system of the reference patent on either or both of the right and left tibias since a placement is required and Claypool teaches suitable places.
Claim 1 or 2 of the reference patent (as modified) has all the features of claim 21, 32, and 34-38 of the present application.
Claim 3 of the reference patent (as modified) has all the features of claim 23 of the present application.
Claim 4 of the reference patent (as modified) has all the features of claim 28 of the present application.
Claim 5 of the reference patent (as modified) has all the features of claim 29 of the present application.
Claim 7 of the reference patent (as modified) has all the features of claim 40 of the present application.
Claim 10 or 11 of the reference patent (as modified) has all the features of claim 21, 23, 32, and 34-38 of the present application.
Claims 32-33 and 36-39 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 16-19 of U.S. Patent No. 10,842,432 (the reference patent)(previously cited), in view of Claypool.
Claims 16-19 of the reference patent involve a knee measurement system. Claypool teaches that such devices, including their shims, are used in both right and left tibial prosthesis systems (paragraph 0104 and 0135 of Claypool). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the knee measurement system of the reference patent on either or both of the right and left tibias since a placement is required and Claypool teaches suitable places.
Claim 16, 17, 18, or 19 of the reference patent (as modified) has all the features of claim 32-33 and 36-39 of the present application.
Claims 32-33 and 36-39 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 20 of U.S. Patent No. 10,842,432 (the reference patent)(previously cited). Although the claims at issue are not identical, they are not patentably distinct from each other.
Claim 20 of the reference patent has all the features of claim 32-33 and 36-39 of the present application.
Claims 32-33 and 36-39 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 10, 11, 14, and 20 of U.S. Patent No. 10,893,955 (the reference patent)(previously cited), in view of Claypool.
Claims 1, 4, 10, 11, 14, and 20 of the reference patent involve a knee measurement system. Claypool teaches that such devices, including their shims, are used in both right and left tibial prosthesis systems (paragraph 0104 and 0135 of Claypool). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the knee measurement system of the reference patent on either or both of the right and left tibias since a placement is required and Claypool teaches suitable places.
Claim 1, 4, 10, 11, 14, or 20 of the reference patent (as modified) has all the features of claim 32-33 and 36-39 of the present application.
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.
Claims 36-37 and 40 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent Application Publication No. 2013/0261757 (Claypool)(previously cited).
With respect to claim 36, Claypool teaches a prosthetic knee component system, comprising:
a measurement device (the sensor plate 820 and the place component 814 of Claypool):
a first side including a first medial surface (the medial surface on the sensor plate 820 of Claypool) and a first lateral surface (the lateral surface on the sensor plate 820 of Claypool), wherein the first side is configured for a right bone or joint and is configured to couple to a first shim (the first shim is not recited as being an element of the claimed system; thus, the combination is not required to teach this particular recitation); and
a second side opposite the first side, the second side including a second medial surface (the medial surface on the place component 814 of Claypool) and a second lateral surface (the lateral surface on the place component 814 of Claypool), wherein the second side is configured for a left bone or joint and is configured to couple to a second shim (the second shim is not recited as being an element of the claimed system; thus, the combination is not required to teach this particular recitation),
wherein the measurement device is configured to (i) measure load applied to the first shim in a first configuration, and (ii) measure load applied to the second shim in a second configuration, wherein the measurement device is inverted in the second configuration with respect to the first configuration (the pressure or force sensors 822 of Claypool are capable of measuring load; the first and second shims (and thus, the first and second configurations and the inversion) are not recited as being elements of the claimed system; thus, the combination is not required to teach these particular recitations).
With respect to claim 37, Claypool teaches the first shim (the top portion 816 of Claypool), wherein the first shim includes a first medial articular surface and a first lateral articular surface configured to align with the first medial surface and the first lateral surface of the first side (see FIG. 25 of Claypool).
With respect to claim 40, Claypool teaches that the measurement device further includes a post (the protrusion with the void 852 of Claypool) extending outward from a first side surface (see FIG. 26B of Claypool); the post extends outward in a direction transverse to (i) a first direction in which the first side faces and (ii) a second direction in which the second side faces (see FIG. 26B of Claypool); and the post is configured to be inserted into a slot of the first shim and/or the second shim (the first and second shims are not recited as being elements of the claimed system; thus, the combination is not required to teach these particular recitations).
Claims 36-37 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent Application Publication No. 2005/0113932 (Kovacevic).
With respect to claim 36, Kovacevic teaches a prosthetic knee component system, comprising:
a measurement device (the lower plate 40 with the strain gauges mounted directly below the support posts 42; paragraph 0036 of Kovacevic):
a first side including a first medial surface (the medial surface on the lower plate 40 of Kovacevic on one side) and a first lateral surface (the lateral surface on the lower plate 40 of Kovacevic on one side), wherein the first side is configured for a right bone or joint and is configured to couple to a first shim (the first shim is not recited as being an element of the claimed system; thus, the combination is not required to teach this particular recitation); and
a second side opposite the first side, the second side including a second medial surface (the medial surface on the lower plate 40 of Kovacevic on another side) and a second lateral surface (the lateral surface on the lower plate 40 of Kovacevic on another side), wherein the second is configured for a left bone or joint and is configured to couple to a second shim (the second shim is not recited as being an element of the claimed system; thus, the combination is not required to teach this particular recitation),
wherein the measurement device is configured to (i) measure load applied to the first shim in a first configuration, and (ii) measure load applied to the second shim in a second configuration, wherein the measurement device is inverted in the second configuration with respect to the first configuration (the strain gauges of Kovacevic are capable of measuring load; the first and second shims (and thus, the first and second configurations and the inversion) are not recited as being elements of the claimed system; thus, the combination is not required to teach these particular recitations).
With respect to claim 37, Kovacevic teaches the first shim (the single plate formed by the lateral and medial plateau plates 36 and 38; paragraph 0039 of Kovacevic), wherein the first shim includes a first medial articular surface and a first lateral articular surface configured to align with the first medial surface and the first lateral surface of the first side (see FIGS. 1-2 and 6 of Kovacevic).
Claim 36-38 and 40 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent Application Publication No. 2013/0261502 (Sherman).
With respect to claim 36, Sherman teaches a prosthetic knee component system, comprising:
a measurement device (the sensor module 12 of Sherman):
a first side including a first medial surface (the medial surface on the medial side 40 of the one side of Sherman) and a first lateral surface (the lateral surface on the lateral side 38 of the one side of Sherman), wherein the first side is configured for a right bone or joint and is configured to couple to a first shim (one of the shims 504 of Sherman; paragraph 0108 of Sherman; the shims and sensor module 12 are used on a right knee; paragraphs 0059-0060 and 0089 of Sherman); and
a second side opposite the first side, the second side including a second medial surface (the medial surface on the medial side 40 of the other side of Sherman) and a second lateral surface (the lateral surface on the lateral side 38 of the other side of Sherman), wherein the second side is configured for a left bone or joint and is configured to couple to a second shim (another of the shims 504 of Sherman; paragraph 0108 of Sherman; the shims and sensor module 12 are used on a left knee; paragraphs 0059-0060 and 0089 of Sherman),
wherein the measurement device is configured to (i) measure load applied to the first shim in a first configuration, and (ii) measure load applied to the second shim in a second configuration, wherein the measurement device is inverted in the second configuration with respect to the first configuration (the sensor module 12 of Sherman is so capable of measuring load (abstract and paragraph 0056 of Sherman); the sensor module 12 is capable of operating in the inverted position on the left or right knee (paragraph 0059-0060 and 0069 of Sherman)).
With respect to claim 37, Sherman teaches the first shim (one of the shims 504 of Sherman; paragraph 0108 of Sherman), wherein the first shim includes a first medial articular surface and a first lateral articular surface configured to align with the first medial surface and the first lateral surface of the first side (see the surfaces of the shim 504 in FIG. 19 of Sherman).
With respect to claim 38, Sherman teaches the second shim (another of the shims 504 of Sherman; paragraph 0108 of Sherman), wherein the second shim includes a second medial articular surface and a second lateral articular surface configured to align with the second medial surface and the second lateral surface of the second side (see the surfaces of the shim 504 in FIG. 19 of Sherman; the sensor module 12 is capable of operating in the inverted position on the left or right knee (paragraph 0059-0060 and 0069 of Sherman)).
With respect to claim 40, Sherman teaches that the measurement device further includes a post (the adaptor 502 of Sherman) extending outward from a first side surface; the post extends outward in a direction transverse to (i) a first direction in which the first side faces and (ii) a second direction in which the second side faces (see FIGS. 21-22 of Sherman); and the post is configured to be inserted into a slot of the first shim and/or the second shim (the slot in the shim 504 in FIG. 19 of Sherman).
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.
Claims 36-37 are rejected under 35 U.S.C. 103 as being unpatentable over Claypool, in view of U.S. Patent Application Publication No. 2011/0203390 (Tao).
Claypool teaches a prosthetic knee component system, comprising a measurement device (the sensor plate 820 of Claypool) including a plurality of load sensors (the pressure or force sensors 822 of Claypool are capable of measuring load). Claypool teaches that the sensors can be any suitable force or pressure sensor (paragraph 0112 of Claypool). Tao teaches a pressure sensing device that can be arranged in an array and can include a plurality conductive elements 103, 302, 512, 522, 532, 542 located between a plurality of bumps in the plurality of top conversion layers 101, 301, 511, 521, 531, 541 and a plurality of bumps in the plurality of bottom layers 104, 305, 513, 523, 533, 543 (See FIGS. 1, 3A, 5A, 5B, 5C, and 5D of Tao). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the array of pressure sensing devices of Tao as the pressure sensors of Claypool since (1) Claypool teaches be any suitable force or pressure sensor can be used and Tao teaches one such sensor and/or (2) it is a simple substitution of one known element for another to obtain predictable results.
With respect to claim 36, the combination teaches or suggest a prosthetic knee component system, comprising:
a measurement device (the plurality conductive elements 103, 302, 512, 522, 532, 542 of Tao arranged in the array of Claypool mirror the top portion 816 of Claypool; see FIGS. 23B and 25 of Claypool) including:
a first side (one side of the plurality conductive elements 103, 302, 512, 522, 532, 542 of Tao) including a first medial surface and a first lateral surface, wherein the first side is configured for a right bone or joint and is configured to couple to a first shim (the first shim is not recited as being an element of the claimed system; thus, the combination is not required to teach this particular recitation); and
a second side (the other side of the plurality conductive elements 103, 302, 512, 522, 532, 542 of Tao) opposite the first side, the second side including a second medial surface and a second lateral surface, wherein the second side is configured for a left bone or joint and is configured to couple to a second shim (the second shim is not recited as being an element of the claimed system; thus, the combination is not required to teach this particular recitation),
wherein the measurement device is configured to (i) measure load applied to the first shim in a first configuration, and (ii) measure load applied to the second shim in a second configuration, wherein the measurement device is inverted in the second configuration with respect to the first configuration (the plurality conductive elements 103, 302, 512, 522, 532, 542 of Tao are so configured; the first and second shims (and thus, the first and second configurations and the inversion) are not recited as being elements of the claimed system; thus, the combination is not required to teach these particular recitations).
With respect to claim 37, the combination teaches or suggest the first shim (the top conversion layers 101, 301, 511, 521, 531, 541 of Tao arranged in the array of Claypool), wherein the first shim includes a first medial articular surface and a first lateral articular surface configured to align with the first medial surface and the first lateral surface of the first side (the top conversion layers 101, 301, 511, 521, 531, 541 of Tao arranged in the array of Claypool mirror the top portion 816 of Claypool; see FIGS. 23B and 25 of Claypool).
Claims 32-33 and 39 are rejected under 35 U.S.C. 103 as being unpatentable over Sherman, in view of Claypool.
Sherman teaches a plurality shims 504 (paragraph 0108 of Sherman). Claypool teaches that shims may come in a plurality of thicknesses (paragraphs 0120-0122 of Claypool). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a plurality of thickness for the shims since it permits flexibility in choosing the correct shim based on the patient’s condition.
With respect to claim 32, the combination teaches or suggest a prosthetic knee component system, comprising:
a first shim configured for connecting to a right bone or joint in a first system configuration (the shim 504 of Sherman of one thickness; paragraph 0108 of Sherman; the shims and sensor module 12 are used on a right knee; paragraphs 0059-0060 and 0089 of Sherman);
a second shim configured for connecting to a left bone or joint in a second system configuration (the shim 504 of Sherman of another thickness; paragraph 0108 of Sherman; the shims and sensor module 12 are used on a left knee; paragraphs 0059-0060 and 0089 of Sherman); and
a measurement device (the sensor module 12 of Sherman) including a plurality of load sensors (the sensors of Sherman; paragraphs 0006, 0008, 0012, 0014, 0016, and 0075-0076 of Sherman), a first side configured to couple to the first shim, and a second side opposite the first side and configured to couple to the second shim (the sensor module is capable of being used with any shim of any thickness on either side),
wherein the measurement device is inverted in the second system configuration with respect to the first system configuration (the sensor module 12 is capable of being used with any shim of any thickness on either side; paragraphs 0059-0060 and 0089 of Sherman).
With respect to claim 33, the combination teaches or suggests that: the first shim includes a first medial articular surface and a first lateral articular surface (see the surfaces of the shim 504 in FIG. 19 of Sherman), the first side of the measurement device includes a first medial surface and a first lateral articular surface (see the surfaces of the sensor module 12 in FIGS. 3-4 of Sherman), the plurality of sensors (the sensors of Sherman; paragraphs 0006, 0008, 0012, 0014, 0016, and 0075-0076 of Sherman) are arranged such that the measurement device is configured to measure loading applied to the first medial articular surface and the first lateral articular surface of the first shim, and the first shim and/or the measurement device are non-symmetric about an anterior-posterior axis such that: the first medial articular surface of the first shim has a different contour than the first lateral articular surface of the first shim (see the asymmetry of the shim 504 in FIG. 19 of Sherman), and/or the first medial surface of the measurement device has a different contour than the first lateral surface of the measurement device (see the asymmetry of the sensor module 12 in FIG. 19 of Sherman).
With respect to claim 39, the combination teaches or suggests the first shim and the second shim (the shim of different thickness of the combination), wherein the first shim is non-symmetric about a first anterior-posterior axis of the first shim (the shim 504 is asymmetric as seen in FIG 19 of Sherman), the second shim is non-symmetric about a second anterior-posterior axis of the second shim (the shim 504 is asymmetric as seen in FIG 19 of Sherman), and the first shim has a different shape than the second shim (the shims have different thicknesses).
Claims 21-27 are rejected under 35 U.S.C. 103 as being unpatentable over Sherman, in view of Claypool.
Sherman teaches a plurality shims 504 (paragraph 0108 of Sherman). Claypool teaches that shims may come in a plurality of thicknesses (paragraphs 0120-0122 of Claypool). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a plurality of thickness for the shims since it permits flexibility in choosing the right shim based on the patient’s condition.
Claypool teaches the use of columns 850 so as to transfer force to sensors (paragraph 0114-0116 of Claypool). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a plurality of columns 850 aligned with the sensors Sherman to the shims of varying thicknesses to Sherman since it more effectively transfers force to the sensors.
With respect to claim 21, the combination teaches or suggests a prosthetic knee component system, comprising:
a measurement device that is non-symmetrical about an anterior-posterior axis of the measurement device (the sensor module 12 of Sherman is asymmetric in FIG. 19 of Sherman), the measurement device including a plurality of load sensors (the sensors of Sherman; paragraphs 0006, 0008, 0012, 0014, 0016, and 0075-0076 of Sherman) and having a first side and a second side, the first side including a first medial surface and a second lateral surface, and the second side including a second medial surface and a second lateral surface (see the surfaces of the sensor module 12 in FIGS. 3-4 of Sherman);
a first shim (the shim 504 of Sherman of one thickness; paragraph 0108 of Sherman) including a first medial articular surface configured to couple to the first medial surface and a plurality of first columns configured to align with the plurality of load sensors on the first side of the measurement device (the columns 850 of Claypool), wherein the first shim is configured for connecting to a right tibia or a right knee joint in a first configuration (the shims and sensor module 12 are used on a left or right knee; paragraphs 0059-0060 and 0089 of Sherman); and
a second shim (the shim 504 of Sherman of another thickness; paragraph 0108 of Sherman) including a second medial articular surface configured to couple to the second medial surface and a plurality of second columns configured to align with the plurality of load sensors on the second side of the measurement device (the columns 850 of Claypool), wherein the second shim is configured for connecting to a left tibia or left knee joint in a second configuration (the shims and sensor module 12 are used on a left or right knee; paragraphs 0059-0060 and 0089 of Sherman), wherein the measurement device is inverted in the second configuration with respect to the first configuration (the sensor module 12 is capable of being used with any shim of any thickness on either side).
With respect to claim 22, the combination teaches or suggests that the first shim and the measurement device are configured to be coupled to form a first prosthetic designed for a right bone or joint, and the second shim and the measurement device are configured to be coupled to form a second prosthetic designed for a left bone or joint (the shims and sensor module 12 are used on a left or right knee; paragraphs 0059-0060 and 0089 of Sherman).
With respect to claim 23, the combination teaches or suggests that the first shim has a first lateral articular surface, and wherein a contour of the first medial articular surface is different from a contour of the first lateral articular surface (see the shape and asymmetry of the shim 504 in FIG. 19 of Sherman).
With respect to claim 24, the combination teaches or suggests that the first side of the measurement device has a shape configured for a first prosthetic designed for a right bone or joint, and the second side of the measurement device has a shape configured for a second prosthetic designed for a left bone or joint (the shims and sensor module 12 are used on a left or right knee; paragraphs 0059-0060 and 0089 of Sherman).
With respect to claim 25, the combination teaches or suggests that: the first shim includes a first lateral articular surface, the second shim includes a second lateral articular surface, the first medial articular surface differs in contour from the first lateral articular surface of the first shim such that the first medial articular surface and the first lateral articular surface are non-symmetrical about the anterior-posterior axis; and the second medial articular surface differs in contour from the second lateral articular surface such that the second medial articular surface and the second lateral articular surface are non-symmetrical about the anterior-posterior axis (see the shape and asymmetry of the shim 504 in FIG. 19 of Sherman).
With respect to claim 26, the combination teaches or suggests that the first side and/or the second side of the measurement device is non-symmetrical about the anterior-posterior axis (see the asymmetry of the sensor module 12 in FIG. 19 of Sherman).
With respect to claim 27, the combination teaches or suggests that: the first shim includes a first lateral articular surface (see the shape and asymmetry of the shim 504 in FIG. 19 of Sherman), the second shim includes a second lateral articular surface (see the shape and asymmetry of the shim 504 in FIG. 19 of Sherman), the plurality of first columns are arranged to define a first triangle provided at the first medial articular surface and a second triangle provided at the first lateral articular surface, and the plurality of second columns are arranged to define a third triangle provided at the second medial articular surface and a fourth triangle provided at the second lateral articular surface (the arrangement of the sensors in FIG. 8 would result in the corresponding the columns 850 of Claypool forming virtual triangles as claimed).
Allowable Subject Matter
Claims 28-29 and 34-35 are not rejected over the prior art but are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, and are rejected for double patenting.
Claims 30-31 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter.
With respect to claim 28, the prior art does not teach or suggests that “wherein: the first structural webbing extends between a plurality of columns of the plurality of first columns of the first shim; and wherein the second structural webbing extends between a plurality of columns of the plurality of second columns of the second shim” along with the other features or claim 28.
Claim 29 is allowable by virtue of its dependence from claim 28.
With respect to claim 30, the prior art does not teach or suggest that “further including a third shim and a fourth shim, wherein: the third shim has a different height from the first shim, the fourth shim has a different height from the second shim, the first shim and the third shim are of a first type of shim, and the second shim and the fourth shim are of a second type of shim” along with the other features of claim 30.
Claim 31 is allowable by virtue of its dependence from claim 30.
With respect to claims 34-35, Claypool teaches the use of columns 850 so as to transfer force to sensors (paragraph 0115 of Claypool). But even if this teaching was combined with the teachings of Sherman, the resulting combination would not teach or suggest “the first side [of the measurement device] includes a plurality of first raised regions configured to align with the plurality of first columns, and the second side [of the measurement device] includes a plurality of second raised regions configured to align with the plurality of second columns” along with the other features of claim 34.
Claim 35 is allowably by virtue of its dependence from claim 35.
Response to Arguments
Applicant’s arguments filed on 3/2/2026 have been fully considered.
Claim objections
There are new grounds of claim objections that were necessitated by the claim amendments filed on 3/2/2026.
35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph
There are new grounds of claim rejections under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, that were necessitated by the claim amendments filed on3/2/2026.
Double patenting rejection
The Applicant asserts:
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This argument is not persuasive. The Applicant has provided no cogent reason for withdrawing the rejections other than some vague “amendments introduce features”. Since the Examiner has no particular arguments to address and the respective claims of the respective patents include the respective features of the claims, the double patenting rejections are maintained.
Prior art rejection based on Claypool
With respect to the rejection of claim 36, the Applicant asserts that claim 36 includes similar recitations to those discussed above with respect to claim 32 and Claypool does not anticipate claim 36. The Applicant’s arguments with respect to the rejection of claim 32 over Claypool relies upon the fact that the prosthesis of Claypool includes a sensor plate 820 that is not inverted into a second system configuration. This argument is not persuasive. The pressure or force sensors 822 of Claypool are capable of measuring load. The first and second shims of claim 36 are not recited as being elements of the claimed system. As a result, the first and second configurations and the inversion are not required by the claimed system. Claypool teaches the claimed structure of the first and second sides of measurement device, which is all that is required by the claim.
Prior art rejection based on Kovacevic
With respect to the rejection of claim 36, the Applicant asserts that claim 36 includes similar recitations to those discussed above with respect to claim 32 and Kovacevic does not anticipate claim 36. The Applicant’s arguments with respect to the rejection of claim 32 over Kovacevic relies upon the fact that the prosthesis of Kovacevic includes a lower plate 40 that cannot be inverted in a second configuration with respect to a first configuration. This argument is not persuasive. The strain gauges of Kovacevic are capable of measuring load. The first and second shims of claim 36 are not recited as being elements of the claimed system. As a result, the first and second configurations and the inversion are not required by the claimed system. Kovacevic teaches the claimed structure of the first and second sides of measurement device, which is all that is required by the claim.
Prior art rejection based on Claypool and Tao
With respect to the rejection of claim 36, the Applicant asserts that Claypool and Tao do not teach the inversion of the measurement device into the second system configuration. This argument is not persuasive. The plurality conductive elements 103, 302, 512, 522, 532, 542 of Tao are capable of measuring load. The first and second shims of claim 36 are not recited as being elements of the claimed system. As a result, the first and second configurations and the inversion are not required by the claimed system. The combination based on Claypool and Tao teaches the claimed structure of the first and second sides of measurement device, which is all that is required by the claim.
Prior art rejections based on Sherman
There are new grounds of claim rejections based on Sherman.
Conclusion
Applicant’s amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW KREMER whose telephone number is (571)270-3394. The examiner can normally be reached Monday - Friday 8 am to 6 pm; every other Friday off.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JACQUELINE CHENG can be reached at (571) 272-5596. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MATTHEW KREMER/Primary Examiner, Art Unit 3791
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