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 .
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.
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on January 4, 2026 is acknowledged.
Claims 14 and 15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on January 4, 2026.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-14 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.
There is no conjunction (presumably “and”, but unknown) between the components forming the list comprising the joint implant in independent claim 1. The word “and” may be placed in line 6 between the description of the first component and the description of the second component in order to overcome this rejection. The shield appears to be claimed as a portion of the second component.
Claim 5 depends directly from claim 1. Claim 5 recites the limitation “the profile” in line 2. There is lack of antecedent basis for this limitation in the claim.
Claim 6 depends directly from claim 1. Claim 6 recites the limitations “the relative rotation” and “the fourth axis”. There is lack of antecedent basis for each of these limitations in the claim. See dependent claim 2 for these limitations.
Claim 8 recites the limitation “the bond shield”. There is lack of antecedent basis for this limitation in the claim. Should the claim recite “bone” shield?
Claim 9 recites the limitation “the range of motion” in line 2. There is lack of antecedent basis for this limitation in the claim.
Claim 11 recites the limitation “recessed” in line 5. There is lack of antecedent basis for this limitation in the claim. Should the claim recite “recesses”?
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 1-4, 9 and 13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Grundei et al. U.S. patent no. 5,702,471 (“Grundei”).
Regarding claim 1, Grundei discloses a joint implant (1) configured to replace an interphalangeal joint (1- col. 3, line 35), comprising: a first component (10, 2), wherein the first component (including 10, 2) comprises a first joint section (including 10) and a first anchoring section (including 2), the first joint section (including 10) including a concave joint surface about a first axis (e.g., figure 1) and the first anchoring section (including 2) extending transverse to the first axis (e.g., figure 1); a second component (including 3, 6, 7, 11, 12), wherein the second component (including 3, 6, 7, 11, 12) comprises a second joint section (including 6) and a second anchoring section (including 3), the second joint section (including 6) including a circumferential surface about a second axis (e.g., figure 1) and the second anchoring section (including 3) extending transverse to the second axis (e.g., figure 1), wherein the circumferential surface comprises a convex joint surface (surface of 6- figure 1) that is configured to act as a hinge joint with the concave joint surface (surface of at least 10- figure 1) of the first joint section (including 10); the second component (including 3, 6, 7, 11, 12) further comprising a bone shield (including 12) arranged between the second joint section (including 6) and the second anchoring section (including 3) (e.g., figure 1), wherein the bone shield (including 12) extends about a third axis and partially covers the circumferential surface of the second joint section (including 6) with a gap being formed between the circumferential surface (of 6) and the bone shield (12) (e.g., figure 1 and 2).
Regarding claim 2, Grundei discloses the second joint section (including 6) is connected to the bone shield (including 12) via a compensation mechanism (7), the compensation mechanism (7) configured to allow relative movement between the second joint section (6) and the bone shield (12) in relation to a fourth axis (e.g., figures 1 and 2; and col. 4, lines 5-15 and 33-35), the fourth axis being transverse to the second axis of the second joint section (e.g., figures 1-2).
Regarding claim 3, Grundei discloses the compensation mechanism (7) comprises a pin and a hole (figure 1), wherein the pin and the hole are configured for a relative movement along and/or about the fourth axis (e.g., figures 1-2; and col. 4, lines 5-15 and 33-35).
Regarding claim 4, Grundei discloses the gap (between 12 and 6) is formed between the circumferential surface of the second joint section and an inner surface of the bone shield by [both] a difference in their profiles [and presence of 5] (e.g., figures 1-2).
Regarding claim 9, Grundei discloses the range of motion of the joint implant in flexion-extension is approximately 90º to 110º (figure 2; and col. 4, lines 24-28).
Regarding claim 13, Grundei discloses the first joint section, the first anchoring section and/or the second anchoring section is made of a metal alloy (col. 1, line 50), and the second joint section (6) is made of a material selected from the group consisting of a metal alloy (col. 3, line 60-65) and a polymer (col. 3, lines 60-61).
Claims 1, 4, 9 and 10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Marne U.S. patent no. 4,213,208.
Regarding claim 1, Marne discloses a joint implant configured to replace an interphalangeal joint (e.g., title, etc.), comprising: a first component (12), wherein the first component (12) comprises a first joint section (12c) and a first anchoring section (12b), the first joint section (12c) including a concave joint surface (col. 3, line 35) about a first axis (figures 1, 2 and 7) and the first anchoring section (12b) extending transverse to the first axis (e.g., figures 1, 2 and 7); a second component (14), wherein the second component (14) comprises a second joint section (18) and a second anchoring section (24), the second joint section (18) including a circumferential surface about a second axis (figures 1-3) and the second anchoring section (24) extending transverse to the second axis (e.g., figures 1-3), wherein the circumferential surface comprises a convex joint surface that is configured to act as a hinge joint with the concave joint surface of the first joint section (e.g., figures 1-3 and 7); the second component (14) further comprising a bone shield (16) arranged between the second joint section (18) and the second anchoring section (14) (e.g., figures 1-2), wherein the bone shield (16) extends about a third axis and partially covers the circumferential surface of the second joint section (18) with a gap being formed between the circumferential surface and the bone shield (e.g., figures 1-3 and 7).
Regarding claim 4, Marne discloses the gap is formed between the circumferential surface of the second joint section (18) and an inner surface of the bone shield (16) [at least] by a difference in their profiles (figures 3 and 7).
Regarding claim 9, Marne discloses the range of motion of the joint implant in flexion-extension is approximately 90º to 110º (e.g., figures).
Regarding claim 10, Marne discloses the first joint section (12) comprises on each side of the concave joint surface (12c) along the first axis (figure 7), a support face (i.e., support face from which protuberance 12d extends- figure 7) extending transverse to the first axis (figure 7), each support face (i.e., support face from which protuberance 12d extends- figure 7) including a retaining pin (12d) protruding from the support face (figure 7), and wherein the second joint section (18) comprises, on each side of the circumferential surface (18) an end face extending transverse to the second axis (figure 3), wherein in each end face (figure 3) a retaining groove (18a) is formed between the center of the end face up to the circumferential surface (figure 4), the retaining grooves (18a) extending at an angle to the radial direction relative to the second axis (figures 3 and 4; and col. 3, lines 48-56)
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 5-7 are rejected under 35 U.S.C. 103 as being unpatentable over Marne U.S. patent no. 4,213,208 in view of Mathys U.S. patent no. 3,805,302.
Regarding claims 5-7, as described supra, Marne discloses the invention substantially as claimed. Marne is silent regarding the profile of the circumferential surface in a cross-section along the second axis is faceted. Marnie is further silent regarding along the second axis, the convex joint surface is arranged in a middle portion an in between two tapered sections of the circumferential surface, wherein the tapered sections are configured to limit the relative rotation of the bone shield and the second joint section about the fourth axis, wherein the relative rotation of the bone shield and the second joint section about the fourth axis is limited to about ±2º to ±10º substantially as claimed.
In the same field of endeavor, namely bone implants, Mathys teaches a profile of a circumferential surface in a cross-section along a second axis, wherein the circumferential surface appears faceted (e.g., see at least figure 1). Mathys further teaches that along the second axis, a convex joint surface (22) is arranged in a middle portion and in between two tapered sections (21) of the circumferential surface (figure 1), wherein the tapered sections (21) are configured to limit a relative rotation of the joint surfaces during use of the implant (figures 1-2), wherein the relative rotation is limited (figures 1-2).
It would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the claimed invention to modify the profile of the circumferential surface and corresponding female component of Marne such that a profile of the circumferential surface in a cross-section along a second axis is faceted and such that along the second axis, a convex joint surface (22) is arranged in a middle portion and in between two tapered sections (21) of the circumferential surface (figure 1), wherein the tapered sections (21) are configured to limit a relative rotation of the joint surfaces during use of the implant, as taught and/or suggested by Mathys, in order to enhance the elastic material design, loading and function of the joint. Thus, in the invention of Marne in view of Mathys, as applied above the tapered sections of Marne in view of Mathys are configured to limit the relative rotation of the bone shield and the second joint section about the fourth axis substantially as claimed.
Marne in view of Mathys, as applied above, is simply silent regarding the degree of rotation to which the bone shield and the second joint section are limited. Thus, Marne in view of Mathys, as applied above, is silent regarding the relative rotation of the bone shield and the second joint section about the fourth axis is specifically limited to about ±2º to ±10º substantially as claimed.
It has been held that where “[W]here 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 233, 235 (CCPA 1955). In the present case, Marne and Mathys teach that there is relative rotation of the second joint section during normal finger articulation. It is within routine optimization to discover a range of limiting said rotation to about ±2º to ±10º in order to enable finger rotation about the fourth axis, while preventing undesired level of rotation or instability. Thus, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date to form the invention of Marne in view of Mathys such that the relative rotation of the bone shield and the second joint section about the fourth axis is specifically limited to about ±2º to ±10º in order to provide natural movement of the finger while provided stability with predictable results and a reasonable expectation of success.
Claims 11 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Grundei et al. U.S. patent no. 5,702,471 (“Grundei”) in view of Link et al. WIPO publication no. WO2018/188861 A1 (“Link”) [English version of the document used for translation is US patent no. 11,266,450].
Alternatively, claims 11 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Marne U.S. patent no. 4,213,208 in view of Link et al. WIPO publication no. WO2018/188861 A1 (“Link”) [English version of the document used for translation is US patent no. 11,266,450].
Regarding claims 11 and 12, as described supra, Grundei or Marne discloses the invention substantially as claimed.
Grundei or Marne is silent regarding the first anchoring section and/or the second anchoring section has a plate shape, the surface of the plate having a surface structure with protrusions and/or recesses, wherein the protrusions and/or recesses are oriented in the direction of the first and second axes, and wherein the first anchoring section and/or the second anchoring section has a plasma coating substantially as claimed.
In the same field of endeavor, namely bone implants, Link teaches a first anchoring section and/or the second anchoring section has a plate shape (figures 1a-1b), the surface of the plate having a surface structure with protrusions and/or recesses (figures 1a-1b), wherein the protrusions and/or recesses are oriented in the direction of the first and second axes (figures 1a-1b), and wherein the first anchoring section and/or the second anchoring section has a plasma coating (col. 1, line 62, through col. 2, line 1).
It would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the claimed invention to substitute the bone anchor of the first and/or second section of Grundei and/or Marne with the plate shaped anchoring structure of Link in order to optimize the insertion and/or retention features of the bone anchor with predictable results and a reasonable expectation of success.
Allowable Subject Matter
Claim 8 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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to Applicant's disclosure. In addition to Grundei et al. U.S. patent no. 5,702,471, applied herein above, at least prior art to each of Whelan III U.S. patent no. 4,304,011; Greene et al. U.S. patent no. 4,352,212; and Carignan et al. U.S. patent no. 5,147,386 teaches compensation mechanisms substantially as claimed by Applicant in at least dependent claims 2 and 3 (see at least figures of prior art).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARCIA LYNN WATKINS whose telephone number is (571)270-1456. The examiner can normally be reached Mon. & Tues. 3-8pm and Thurs. 12-6pm.
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/MARCIA L WATKINS/
Primary Examiner, Art Unit 3774