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 .
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-5, 7-11, 13, 17-20, 23 and 27-30 have been considered but are moot because the new ground of rejection is necessitated by amendment.
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 1, 2, 4, 5, 9, 10, 13, 17-20, 23 and 31, rejected on the ground of nonstatutory double patenting as being unpatentable over claims 21-26 and 28 of U.S. Patent No. 10,799,365 in view of Errico (US 7,022,139 B2), Clarke (US 10,265,186 B2) and Oster (US 10,500,056 B2).
Regarding claim 1, all of the claimed limitations are disclosed in US Patent No. 10,799,635 B1 except, wherein the flange has a contoured proximally-facing surface, the proximal part has a contoured distal surface that abuts the proximally-facing surface of the flange during multi-axial motion of the implant, and the contoured proximally- facing surface of the flange corresponds to the contoured distal surface of the proximal part. However, Errico (Patent No. 7,022,139 B2) shows the flange has a contoured proximally-facing surface (inward facing surface, Fig. 3x, 108), the proximal part has a contoured distal surface (inward facing surface, Fig. 3x, 208) that abuts the proximally-facing surface of the flange during multi-axial motion of the implant (the ball and socket allows for multiaxial motion and allow for movement up to when the inward faces abut), and the contoured proximally- facing surface of the flange corresponds to the contoured distal surface of the proximal part (Figs 3w and 3x). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the proximally-facing surface of the flange and the distal surface of the proximal part to include contoured surfaces that correspond and abut during multi-axial motion of the implant as taught by Errico in order to allow for consistent and smooth contact of the inward faces during axial movement.
In light of the rejection of claim 1, the table below denotes the patent claims which map to the claims of this case.
Instant Case
2
4
9
10
13
17
19
20
23
Patent No. 10,799,365 B1
22
25
22
22
26
25
24
26
26
Regarding claim 5, all of the claimed limitations are disclosed in US Patent No. 10,799,365 B1 except the contoured surface of the flange is tapered radially and distally. However, Errico discloses the contoured surface of the flange is tapered radially and distally (see annotated Fig. 2h, below). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the surface of the flange to include the contoured surface of the flange is tapered radially and distally as taught by Errico in order to reduce the impact on the flange and possible implant debris. Clarke (Patent No. 10,265,186 B2) teaches the proximal part is tapered radially and proximally (Fig. 3). It would have been obvious to one of ordinary skill in the art to have modified the proximal part to be tapered radially and distally in order to provide an engagement that mimics the physiological area.
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Regarding claim 18, all of the claimed limitations are disclosed in US Patent No. 10,799,365 B1 except wherein the platform of the proximal part includes a distal end surface having a concave curvature. Clarke in US Patent No. 10,265,186 B2 teaches the saddle-shaped platform typically has a concave-convex shape, wherein it has a concave curvature along a longitudinal aspect and a convex curvature along a lateral aspect. It would have been obvious to one having ordinary skill in the art at the time of filing for the proximal surface to have a concave curvature as it provides an engagement that closely mimics the physiological situation and allows for natural flexion-extension articulation (col 10, lines 25-32).
Regarding claim 31, all of the claimed limitations are disclosed in US Patent No. 10,799,365 B1 except the implant includes an insert. Oster in US Patent No. 10,500,056 B2 teaches wherein the implant includes an insert (7, articulating socket element, fig. 1), and the flange extends from the proximal end of the insert (see annotated fig. 3, below), and wherein the insert further includes a shoulder (26, protrusion, fig. 1) for engaging the insert with the distal part (col 6, lines 4-23), and the shoulder is configured to prevent rotation of the insert within the distal part (col 5, line 65 – col 6, line 3). It would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have to include an insert in order to permit restoration without metallosis at a possible luxation (col 6, lines 24-33).
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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 32 and 38 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 32 recites “a portion of the articulating coupling” in lines 3-4 and 5-6. It is unclear if these are the same portions or separate and distinct portions due to the repeated us of “a portion of the articulating coupling”. Examiner interprets “the socket forming a portion of the articulating coupling” in lines 3-4 to be a first portion and “the ball forming a portion of the articulating coupling” to be a second portion. The first and second portions together forming the articulating coupling. It is recommended to amend the claim with ‘first’ and ‘second’ descriptors of the portions of the articulating coupling.
Claim 38 recites “the socket” in line 23. It is unclear what purpose this recitation serves. The socket is initially stated under the articulating coupling in lines 7-10. The recitation of the socket in line 23 offers no further limitation to the socket. The examiner believes its placement is to say the socket is included in the insert.
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) 1, 3-11, 13, 17-20, 23, 31-32 and 34-35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Clarke (US 2017/0224499 A1) in view of Oster (US 2016/0302935 A1) and Errico (US 7,022,139 B2).
Regarding claim 1, Clarke discloses a bone joint implant for a mammalian first carpometacarpal joint (¶ [0001]) comprising: a proximal part (34, proximal part, fig. 4C) configured for translational motion over a trapezium bone (¶ [0101] and ¶ [0109]), a distal part (31, distal part, fig. 4C) for intramedullary engagement with an end of a first metacarpal bone (¶ [0019]), an articulating coupling between the proximal and distal parts (¶ [0034]), wherein the implant is configured for multi-axial motion with translational movement over the trapezium bone and rotation about the articulating coupling (¶ [0109]), a proximal end of the distal part (see annotated fig. 2B, below, Clarke), and a proximally-facing surface of the distal part (see annotated fig. 2B, below, Clarke).
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Clarke fails to teach a flange. However, Oster discloses a bone joint implant that includes a flange (28, collar, fig. 3, Oster), wherein the flange is configured to limit relative rotational motion of the proximal and distal parts about the coupling (examiner takes the stance an articulating coupling range of motion will be reduced due to the flange as it extends the insert and increases the length of the proximal part within the insert, it is inherent to the addition of a flange), and to provide resilience for contact between the proximal and distal parts (The instant application states on page 13, lines 1-3, “the flange 105 … is a resilient polymer which is preferable a polymer, such as ... PEEK”. Oster states in ¶ [0028] the socket element 7 can be made of PEEK. This shows that PEEK is a resilient polymer according to the applicant), wherein the flange has a distally facing surface (see annotated fig. 1, below) and the distally facing surface of the flange contacts a proximally-facing surface of the distal part (fig. 4, Oster). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the bone joint implant of Clarke to include a flange as taught by Oster in order to permit restoration without metallosis at a possible luxation (¶ [0031], Oster).
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Clarke in view of Oster fails to teach the flange has a contoured proximally-facing surfaces and the proximal part has a contoured distal surface that abuts the proximally-facing surface of the flange during multi-axial motion of the implant. However, Errico discloses a bone implant that includes a contoured proximally-facing surface (108, inward facing surface, fig. 3x), the proximal part has a contoured distal surface (208, inward facing surface, fig. 3x) that abuts the proximally-facing surface of the flange during multi-axial motion of the implant (in this case the ball and socket allows for multiaxial motion and allow for movement up to when the inward faces abut), the contoured proximally-facing surface of the flange corresponds to the contoured distal surface of the proximal part (fig. 3w, Errico). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the proximally-facing surface of the flange and the distal surface of the proximal part of Clarke in view of Oster to include contoured surfaces that correspond and abut during multi-axial motion of the implant as taught by Errico in order to allow for consistent and smooth contact of the inward faces during axial movement.
Alternatively regarding claim 1, Clarke discloses a bone joint implant for a mammalian first carpometacarpal joint (¶ [0001]) comprising: a proximal part (34, proximal part, fig. 4C) configured for translational motion over a trapezium bone (¶ [0101] and ¶ [0109]), a distal part (31, distal part, fig. 4C) for intramedullary engagement with an end of a first metacarpal bone (¶ [0019]), an articulating coupling between the proximal and distal parts (¶ [0034]), wherein the implant is configured for multi-axial motion with translational movement over the trapezium bone and rotation about the articulating coupling (¶ [0109]), a proximal end of the distal part (see annotated fig. 2B, below, Clarke), and a proximally-facing surface of the distal part (see annotated fig. 2B, below, Clarke).
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Clarke fails to teach a flange. However, Oster discloses a bone joint implant that includes a flange (28, collar, fig. 3, Oster), wherein the flange is configured to limit relative rotational motion of the proximal and distal parts about the coupling (examiner takes the stance an articulating coupling range of motion will be reduced due to the flange as it extends the insert and increases the length of the proximal part within the insert, it is inherent to the addition of a flange), and to provide resilience for contact between the proximal and distal parts (The instant application states on page 13, lines 1-3, “the flange 105 … is a resilient polymer which is preferable a polymer, such as ... PEEK”. Oster states in ¶ [0028] the socket element 7 can be made of PEEK. This shows that PEEK is a resilient polymer according to the applicant), wherein the flange has a distally facing surface (see annotated fig. 1, below) and the distally facing surface of the flange contacts a proximally-facing surface of the distal part (fig. 4, Oster). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the bone joint implant of Clarke to include a flange as taught by Oster in order to permit restoration without metallosis at a possible luxation (¶ [0031], Oster).
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Clarke in view of Oster fails to teach the flange has a contoured proximally-facing surfaces and the proximal part has a contoured distal surface that abuts the proximally-facing surface of the flange during multi-axial motion of the implant. However, Errico discloses a bone implant that includes a contoured proximally-facing surface (58, inward facing surface, Fig. 2g), the proximal part has a contoured distal surface (78, inward facing surface, Fig. 2g) that abuts the proximally-facing surface of the flange during multi-axial motion of the implant (in this case the ball and socket allows for multiaxial motion and allow for movement up to when the inward faces abut), and the contoured proximally- facing surface of the flange corresponds to the contoured distal surface of the proximal part (Fig. 2h). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the proximally-facing surface of the flange and the distal surface of the proximal part of Clarke in view of Oster to include contoured surfaces that correspond and abut during multi-axial motion of the implant as taught by Errico in order to allow for consistent and smooth contact of the inward faces during axial movement.
Regarding claim 3, Clarke in view of Oster fails to teach the contoured surface of the flange is contoured to maximize surface contact with the proximal part. However, Errico further discloses the contoured surface of the flange is contoured to maximize surface contact with the proximal part (due the matching curvatures of both inwardly facing surfaces 108, 208 the surface contact would be maximized). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the bone joint implant of Clarke and Oster to include the contoured surface of the flange is contoured to maximize surface contact with the proximal part as taught by Errico in order to allow for consistent and smooth contact of the inward faces during axial movement.
Regarding claim 4, Clarke fails to teach the flange is annular. However, Oster further discloses the flange is annular (see annotated Fig. 2, below). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the bone joint implant of Clarke to include the flange is annular as taught by Oster in order to permit restoration without metallosis at a possible luxation (¶ [0031], Oster).
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Regarding claim 5, Clarke in view of Oster fails to teach the flange is tapered radially and distally and the abutting surface of the proximal part is tapered radially and proximally. However, Errico further discloses the contoured surface of the flange is tapered radially and distally (see annotated Fig. 2h, below) and the abutting surface of the proximal part is tapered radially and proximally (see annotated Fig. 2h, below). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the bone joint implant of Clarke and Oster to include the contoured surface of the flange is tapered radially and distally and the abutting surface of the proximal part is tapered radially and proximally as taught by Errico in order to allow for consistent and smooth contact of the inward faces during axial movement.
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Regarding claim 7, Clark in view of Oster and Errico fail to teach the flange has a thickness ranging from 0.5 mm to 4.0 mm. However, it would have been obvious to one having ordinary skill in the art at the time the invention was made to make the flange have a thickness ranging from 0.5 mm to 4.0 mm, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art (MPEP 2144.05.II.A)
Regarding claim 8, Clark in view of Oster and Errico fail to teach the flange has a thickness ranging from 1.0 mm to 3.0 mm. However, it would have been obvious to one having ordinary skill in the art at the time the invention was made to make the flange have a thickness ranging from 1.0 mm to 3.0 mm, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art (MPEP 2144.05.II.A)
Regarding claim 9, Clarke fails to teach the flange is of a polymer material. However, Oster further discloses the flange is [[of]] a polymer material (¶ [0028]).Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the bone joint implant of Clarke to include the flange is of a polymer material as taught by Oster in order to permit restoration without metallosis at a possible luxation (¶ [0031], Oster).
Regarding claim 10, Clarke further discloses the components may be manufactured from commonly used orthopedic materials provided that metal on metal contact is avoided. Clarke also provides an example of UHMWHDPE and Titanium being used as the joint parts. However, modified Clarke fails to specifically teach wherein the distal part and the flange (¶ [0028], Oster) is a non-metal material and is different from the material of the proximal part. It would have been obvious to one having ordinary skill in the art at the time of filing to have chosen the distal part and the flange (¶ [0028], Oster) is a non-metal material and is different from the material of the proximal part since it would have been "obvious to try" choosing from the provided examples to avoid metal on metal contact.
Regarding claim 11, Clarke further discloses the flange is configured to provide a cone of motion in the range of 30o to 60o of the distal part about the proximal part. Clarke states the purpose to allow the same range of movement as a natural healthy joint (¶ [0101]). It is known in the art carpometacarpal joints allow 40o-70o range of motion. Thus, if the range of movement is returned to a natural healthy joint, the provided range of motion will be with the limitations of the claims. Further, The phrase “the flange is configured to provide a cone of motion in the range of 300 to 600 of the distal part about the proximal part” is a functional recitation that is not given full patentable weight. The prior art is not required to explicitly disclose the recited function, but merely have the capability of performing [or being manipulated to] the recited function in order to meet the claim requirements. In this case, the flange of Oster in conjunction with the articulation coupling of Clarke is considered to be capable of providing a cone of motion in the range of 300 to 600 of the distal part about the proximal part.
Regarding claim 13, Clarke further discloses the articulating coupling is a ball-and-socket coupling (¶ [0021]).
Regarding claim 17, Clarke further discloses a platform of the proximal part (15, platform, fig. 3A) and a stem of the distal part (see annotated fig. 2B, below).
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Clarke fails to teach the contoured surface of the flange is an annular non-metallic wear surface. However, Oster further discloses the contoured surface of the flange is an annular (see annotated Fig. 2, below) non- metallic wear surface (PEEK, ¶ [0028], Oster) that prohibits contact between a platform of the proximal part and a stem of the distal part during articulation (¶ [0031], the collar prevents metallosis by keeping space between the ball element (6) and the connecting member (16)). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the bone joint implant of Clarke to include the contoured surface of the flange is an annular non-metallic wear surface as taught by Oster in order to permit restoration without metallosis at a possible luxation (¶ [0031], Oster).
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Regarding claim 18, Clarke in view of Oster fails to teach the platform of the proximal part includes a distal end surface having a concave curvature. However, Errico further discloses the platform of the proximal part includes a distal end surface having a concave curvature (see annotated Fig. 3w, below). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the flange of the ball joint implant of Clarke and Oster to include the platform of the proximal part includes a distal end surface having a concave curvature as taught by Errico in order to allow for consistent and smooth contact of the inward faces during axial movement.
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Regarding claim 19, Clarke in view of Oster fail to teach the platform of the proximal part includes a distal end surface having a convex curvature. However, Errico further discloses the platform of the proximal part includes a distal end surface having a convex curvature (see annotated Fig. 3w, below). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the flange of the ball joint implant of Clarke and Oster to include the platform of the proximal part includes a distal end surface having a convex curvature as taught by Errico in order to allow for consistent and smooth contact of the inward faces during axial movement.
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Regarding claim 20, Clarke fails to teach a distal non-metallic wear surface which is spherically shaped. However, Oster further discloses a distal non-metallic wear surface (7, articulating socket element, Fig. 3) which is spherically shaped (31, concave joint surface, Fig. 3). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the bone joint implant of Clarke to include a distal non-metallic wear surface which is spherically shaped as taught by Oster in order to permit restoration without metallosis at a possible luxation (¶ [0031], Oster).
Regarding claim 23, Clarke further discloses the articulating coupling is a ball and socket coupling (¶ [0021]), and the distal part includes the socket of the ball and socket coupling (¶ [0023], 32, socket, Fig. 2B).
Regarding claim 31, Clarke fails to teach an insert. However, Oster further discloses the implant includes an insert (7, articulating socket element, fig. 1), and the flange extends from the proximal end of the insert (see annotated fig. 3, below), and wherein the insert further includes a shoulder (26, protrusion, fig. 1) for engaging the insert with the distal part (¶ [0030]), and the shoulder is configured to prevent rotation of the insert within the distal part (¶ [0029]). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the bone joint implant of Clarke to include an insert as taught by Oster in order to permit restoration without metallosis at a possible luxation (¶ [0031], Oster).
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Regarding claim 32, Clarke further discloses a socket (32, socket, fig. 2B, Clarke) and a proximal rim at a proximal end of the socket (see annotated fig. 2B, below), wherein the proximal part includes a ball (10, ball, fig. 3C), the ball forming a portion of the articulating coupling, wherein the ball engages the socket (fig. 4B), and, the proximal rim engages the ball within the socket (the rim is narrower than the widest part width of the socket, when the ball is in the socket its widest part will collide with the proximal rim maintaining its engagement with the socket).
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Clarke fails to teach a distal rim and groove. However, Oster further discloses the insert includes a distal rim (22, snap-in portion, fig. 3) at a distal end (see annotated fig. 3, below) and a socket (31, concave joint surface, fig. 3) distal of the flange and proximal of the distal rim (fig. 3), the socket forming a portion of the articulating coupling, wherein the distal part includes a groove (21, extended part, fig. 3) for receiving the rim (¶ [0028]), wherein the distal rim engages the groove (¶ [0028]), and wherein the proximally-facing surface of the flange is proximal of the ball when the ball is engaged in the socket (the ball is within the socket and the flange is proximal to the socket, thus the proximal facing surface of the flange will be proximal of the ball).
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Regarding claim 34, Clarke fails to teach the flange is configured to determine a range of motion. However, Oster further discloses the flange (28, collar, fig. 3) is configured to determine a first range of motion (The phrase “the flange is configured to determine a first range of motion” is a functional recitation that is not given full patentable weight. The prior art is not required to explicitly disclose the recited function, but merely have the capability of performing [or being manipulated to] the recited function in order to meet the claim requirements. In this case, the flange is considered to be capable of determining a first range of motion.), and the implant has a second range of motion greater than the first range of motion (A flange increases the depth of the socket and would reduce the range of motion, an insert with no flange or a thinner flange would decrease the depth of the socket and increase the range of motion. Further, the translation motion over the trapezium bone as provided by the implant of Clarke in addition to the cone of motion provided by the ball and socket would increase the range of motion). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the bone joint implant of Clarke to include the flange is configured to determine a first range of motion as taught by Oster in order to permit restoration without metallosis at a possible luxation (¶ [0031], Oster).
Regarding claim 35, Clarke fails to teach the thickness of the flange is selected to limit the range of relative motion of the flange. However, Oster further discloses a thickness of the flange is selected to limit the range of relative motion of the flange (The phrase “a thickness of the flange is selected to limit the range of relative motion of the flange” is intended use. The prior art flange of Oster inherently has a thickness and limits to some extent the range of motion. “Selected” is a mental process. Since the prior art uses a flange with a thickness that limits range of motion, it has been “selected”).
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Clarke (US 2017/0224499 A1) in view of Oster (US 2016/0302935 A1) and Errico (US 7,022,139 B2) as applied to claim 1 above, and further in view of Hunter (US 20060259150 A1).
Regarding claim 2, Clarke in view of Oster and Errico fails to teach the flange is of a material which is more resilient than a material of the proximal part which it contacts. However, Hunter discloses a joint implant that includes the flange (inner lining, Fig. 2, 8, made of UHMWPE) is of a material which is more resilient than a material of the proximal part (joint stem, Fig. 2, 2, made of metal) which it contacts (¶ [0039]). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the bone joint implant of Clarke, Oster and Errico to include the flange is of a material which is more resilient than a material of the proximal part which it contacts as taught by Hunter in order to generate less frictional torque and wear when articulation (¶ [0039, Hunter).
Claim(s) 37 is/are rejected under 35 U.S.C. 103 as being unpatentable over Clarke (US 2017/0224499 A1) in view of Oster (US 2016/0302935 A1) and Errico (US 7,022,139 B2) as applied to claim 1 above, and further in view of Vanasse (US 2011/0184527 A1).
Regarding claim 37, Clarke fails to teach an insert. However, Oster further discloses the flange is connected to an insert (7, articulating socket element, fig. 1). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the bone joint implant of Clarke to include an insert as taught by Oster in order to permit restoration without metallosis at a possible luxation (¶ [0031], Oster).
Clarke in view of Oster and Errico fails to teach the insert is removably attached and one of a plurality of inserts. However, Vanasse discloses an interphalangeal joint that includes the insert is removably attached to the proximal part (¶ [0007]), wherein the insert is one of a plurality of inserts (fig. 12) each having a flange of a different thickness (¶ [0067]). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the bone joint implant of Clarke, Oster and Errico to include the insert is removably attached and one of a plurality of inserts as taught by Vanasse in order to accommodate joints of different sizes (¶ [0067], Vanasse).
Allowable Subject Matter
Claims 27-30 allowed. The following is a statement of reasons for the indication of allowable subject matter: The closest prior art, Clarke (US 2017/0224499 A1), does not disclose or suggest a buffer surface wherein the buffer surface is a continuous surface having a first portion with a first width and a second portion with a second width and wherein the first width is greater than the second width. Claims 28-30 depend from claim 27.
Claim 33 objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including 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: The closest prior art, Clarke (US 2017/0224499 A1), does not disclose or suggest the full range of motion of the implant is 800.
Claim 36 objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. The prior art fails to teach alone or in combination the flange has a larger width above an abduction-adduction plane than below the abduction-adduction plane.
Claim 38 would be allowable if rewritten or amended 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. The following is a statement of reasons for the indication of allowable subject matter: The closest prior art, Clarke (US 2017/0224499 A1), does not disclose or suggest the flange having a larger width on a first side of an abduction-adduction plane than on a second side of the abduction-adduction plane.
Conclusion
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/T.M.D./Examiner, Art Unit 3774
/JERRAH EDWARDS/Supervisory Patent Examiner, Art Unit 3774