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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “radius of curvature” of claims 7 and 20 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 5 is objected to because of the following informalities: claim 5 states “a concave end surface.5”. Appropriate correction is required.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-6, 10-19, and 23-24 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Katrana et al. (US 2019/0105163 A1), “Katrana”.
Regarding claim 1, Katrana teaches
A humeral implant configured for implantation at a distal end portion of a humerus (Fig. 6A, capitellar implant 110 is implanted at trochlea 210 of humerus 202),
the humeral implant (Fig. 6A, capitellar implant 110) comprising: a body portion (Fig. 6A, articulating head 112 and extension portion 111) that is made entirely of pyrocarbon (Fig. 6A, articulating head 112 is formed of biocompatible material such as pyrocarbon [0077]) and comprises:
a first end (Fig. 3E, lateral side 130) and a second end (Fig. 3D, medial side 132);
a side surface that extends between the first end and the second end (Fig. 3B, first and second articulating surfaces 118, 119),
wherein the side surface comprises a concave region that defines a first cross-sectional diameter that is a minimum cross-sectional diameter of the body portion (Fig. 3B, narrowed region 121 comprises smallest diameter of the capitellar implant 110);
wherein the first end having a second cross-sectional diameter that is larger than the first cross-sectional diameter (Fig. 3B, lateral side 130 comprises wider diameter than narrowed region 121); and
wherein the second end having a third cross-sectional diameter that is larger than the first cross-sectional diameter (Fig. 3B, medial side 132 comprises wider diameter than narrowed region 121).
Regarding claim 2, Katrana teaches
wherein when implanted at the distal end portion of the humerus (Fig. 6A, capitellar implant 110 is implanted at trochlea 210 of humerus 202),
the humeral implant (Fig. 3B, capitellar implant 110) presents a contoured profile (Fig. 6D, first and second articulating surfaces 118, 119 are curved) of the side surface (Fig. 3B, first and second articulating surfaces 118, 119) to an ulna or an ulna implant (Fig. 6D, ulna 232),
wherein the contoured profile of the side surface articulates with a portion of the ulna (Fig. 6D, superior articulating surface 164 of coronoid implant 150 engaged with ulna 232 articulates with second articulating surface 119 of capitellar implant 110).
Regarding claim 3, Katrana teaches
wherein the humeral implant consists of the body portion (Fig. 6A, capitellar implant 110 is comprised of articulating head 112 and extension portion 111).
Regarding claim 4, Katrana teaches
wherein the second cross-sectional diameter is larger than the third cross-sectional diameter (Figs. 3A and 3C, humeral engaging surface 120 of lateral side 130 is larger in width than humeral engaging surface 120 if medial side 132).
Regarding claim 5, Katrana teaches
wherein the first end comprises a concave end surface (Figs. 1B,1E and 3E, capitellar implant 10 (formed similarly to capitellar implant 110) comprises medial side 32 (medial side 132) which also comprises a humeral engaging surface that is concave, as well as circular and truncated (i.e, curved/concave) [0072]).5
Regarding claim 6, Katrana teaches
wherein the second end comprises a concave end surface (Figs. 1D and 3D, capitellar implant 10 (formed similarly to capitellar implant 110) comprises humeral engaging surface 20 (humeral engaging surface 120) of lateral side 30 (lateral side 130) that is concave [0072]).
Regarding claim 10, Katrana teaches
wherein the body portion is at least partially made of pyrocarbon or comprises an outer surface of pyrocarbon (Fig. 6A, articulating head 112 is formed of biocompatible material such as pyrocarbon [0077]).
Regarding claim 11, Katrana teaches
wherein the humeral implant is configured to rotate about its longitudinal axis relative to the humerus when implanted (Fig. 6A-D, capitellar implant 110 engages with articulating surface 164 to rotate along a portion of the host trochlea 210 (capitellar implant 110 rotates around line 9-9 of passage 124)).
Regarding claim 12, Katrana teaches
A kit for treating an elbow joint (Fig. 15, kit 333), the kit comprising: a plurality of humeral implants of Claim 1 of different sizes (Fig. 15, kit 333 comprises a plurality of modular articulating heads and different size stems 312A-312F).
Regarding claim 13, Katrana teaches
wherein the plurality of humeral implants comprises at least four different sizes (Fig. 15, kit 333 comprises a plurality of modular articulating heads and different size stems 312A-312F).
Regarding claim 14, Katrana teaches
An elbow prosthesis comprising: a spool-shaped body (Fig. 3B, capitellar implant 110 comprises articulating head 112 and extension portion 111 and narrowed region 121 which forms spool shape) extending along a longitudinal axis (Fig. 6D, line 9-9 which mirrors length of passage 124)
configured to be positioned at a trochlea portion of a distal humerus (Fig. 6A, capitellar implant 110 is implanted at trochlea 210 of humerus 202),
the spool shaped body is made entirely of pyrocarbon (Fig. 6A, articulating head 112 is formed of biocompatible material such as pyrocarbon [0077]) and
comprises: a first end (Fig. 3D, medial side 132);
a second end (Fig. 3E, lateral side 130); and
a concave surface extending between the first end and the second end (Fig. 3B, first and second articulating surfaces 118, 119 are curved),
the concave surface configured to receive a trochlea groove of an ulna (Fig. 6D, superior articulating surface 164 of coronoid implant 150 engaged with ulna 232 articulates with second articulating surface 119 of capitellar implant 110).
Regarding claim 15, Katrana teaches
wherein the elbow prosthesis consists of the spool shaped member (Fig. 3B, capitellar implant 110 comprises articulating head 112 and extension portion 111 and narrowed region 121 which forms spool shape).
Regarding claim 16, Katrana teaches
wherein the first end of the spool-shaped body comprises a first concave end surface that is concave about the longitudinal axis (Figs. 1D and 3D, capitellar implant 10 (formed similarly to capitellar implant 110) comprises humeral engaging surface 20 (humeral engaging surface 120) of medial side 32 (medial side 132) that is concave about passage 124 [0072]).
Regarding claim 17, Katrana teaches
wherein the second end of the spool-shaped body further comprises a second concave end surface that is concave about the longitudinal axis (Figs. 1B,1E and 3E, capitellar implant 10 (formed similarly to capitellar implant 110) comprises lateral side 30 (lateral side 130) which also comprises a humeral engaging surface that is concave, as well as circular and truncated (i.e, curved/concave) [0072]).
Regarding claim 18, Katrana teaches
wherein the first concave end surface is concave in a first direction (Fig. 3D, humeral engaging surface 120 of medial side 132 is concave facing left), and wherein the second concave end surface is concave in a second direction opposite from the first direction (Fig. 3E, humeral engaging surface 120 of lateral side 130 is concave facing right).
Regarding claim 19, Katrana teaches
wherein the first end of the spool-shaped is at a first end of the elbow prosthesis (Fig. 3B, medial side 132 is on the left side of capitellar implant 110) and the second end of the spool-shaped body is at a second end of the elbow prosthesis (Fig. 3B, lateral side 130 of capitellar implant 110 is on the right side of capitellar implant 110).
Regarding claim 23, Katrana teaches
wherein the spool-shaped body comprises pyrocarbon (Fig. 6A, articulating head 112 is formed of biocompatible material such as pyrocarbon [0077]).
Regarding claim 24, Katrana teaches
wherein the elbow prosthesis is configured to rotate about its longitudinal axis relative to the distal humerus when implanted (Fig. 6A-D, capitellar implant 110 engages with articulating surface 164 to rotate along a portion of the host trochlea 210 (capitellar implant 110 rotates around line 9-9 of passage 124)).
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 7-8 and 20-22 are rejected under 35 U.S.C. 103 as being unpatentable over Katrana et al. (US 2019/0105163 A1), “Katrana” in view of Lenich et al. (US 2018/0116807 A1), “Lenich”.
Regarding claim 7, Katrana teaches the concave region (Fig. 3B, first and second articulating surfaces 118, 119 are curved), but fails to teach wherein the concave region comprises a radius of curvature between 10 mm and 30 mm.
Lenich teaches a capitulum implant wherein the concave region comprises a radius of curvature between 10 mm and 30 mm (Fig. 1d and Table 1, R1 ranges from 8.60 mm to 12.20 mm depending on implant size). In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) (The prior art taught carbon monoxide concentrations of “about 1-5%” while the claim was limited to “more than 5%.” The court held that “about 1-5%” allowed for concentrations slightly above 5% thus the ranges overlapped.) MPEP § 2144.05-I.
Regarding claim 8, Katrana teaches the humeral implant (Fig. 6A, capitellar implant 110), but fails to teach wherein the humeral implant has a length between 15 mm and 25 mm.
Lenich teaches a capitulum implant wherein the humeral implant has a length between 15 mm and 25 mm (Fig. 1d and Table 1, X1 ranges from 17.65 mm to 25.15 mm depending on implant size). In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) (The prior art taught carbon monoxide concentrations of “about 1-5%” while the claim was limited to “more than 5%.” The court held that “about 1-5%” allowed for concentrations slightly above 5% thus the ranges overlapped.) MPEP § 2144.05-I.
Regarding claim 9, Katrana teaches the humeral implant (Fig. 6A, capitellar implant 110), but fails to teach, wherein the humeral implant has a maximum diameter 15 mm and 30 mm.
Lenich teaches a capitulum implant wherein the humeral implant has a maximum diameter 15 mm and 30 mm (Fig. 1d and Table 1, R1 ranges from 8.60 mm to 12.20 mm depending on implant size (i.e., diameter ranges from 17.20 mm to 24.40 mm)). In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) (The prior art taught carbon monoxide concentrations of “about 1-5%” while the claim was limited to “more than 5%.” The court held that “about 1-5%” allowed for concentrations slightly above 5% thus the ranges overlapped.) MPEP § 2144.05-I.
Regarding claim 20, Katrana teaches the concave surface (Fig. 3B, first and second articulating surfaces 118, 119 are curved), but fails to teach wherein the concave surface comprises a radius of curvature between 10 mm and 30 mm.
Lenich teaches a capitulum implant wherein the concave surface comprises a radius of curvature between 10 mm and 30 mm (Fig. 1d and Table 1, R1 ranges from 8.60 mm to 12.20 mm depending on implant size). In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) (The prior art taught carbon monoxide concentrations of “about 1-5%” while the claim was limited to “more than 5%.” The court held that “about 1-5%” allowed for concentrations slightly above 5% thus the ranges overlapped.) MPEP § 2144.05-I.
Regarding claim 21, Katrana teaches the spool-shaped body (Fig. 3B, capitellar implant 110 comprises articulating head 112 and extension portion 111 and narrowed region 121 which forms spool shape), but fails to teach wherein the spool-shaped body comprises a length, measured along the longitudinal axis, between 15 mm and 25 mm.
Lenich teaches a capitulum implant wherein the spool-shaped body comprises a length, measured along the longitudinal axis (Fig. 1d, axis x), between 15 mm and 25 mm (Fig. 1d and Table 1, X1 ranges from 17.65 mm to 25.15 mm depending on implant size). In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) (The prior art taught carbon monoxide concentrations of “about 1-5%” while the claim was limited to “more than 5%.” The court held that “about 1-5%” allowed for concentrations slightly above 5% thus the ranges overlapped.) MPEP § 2144.05-I.
Regarding claim 22, Katrana teaches the spool-shaped body (Fig. 3B, capitellar implant 110 comprises articulating head 112 and extension portion 111 and narrowed region 121 which forms spool shape), but fails to teach wherein the spool-shaped body comprises a maximum diameter between 15 mm and 30 mm.
Lenich teaches a capitulum implant wherein the spool-shaped body comprises a maximum diameter between 15 mm and 30 mm (Fig. 1d and Table 1, R1 ranges from 8.60 mm to 12.20 mm depending on implant size (i.e., diameter ranges from 17.20 mm to 24.40 mm)). In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) (The prior art taught carbon monoxide concentrations of “about 1-5%” while the claim was limited to “more than 5%.” The court held that “about 1-5%” allowed for concentrations slightly above 5% thus the ranges overlapped.) MPEP § 2144.05-I.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US Pat. No. 6767368 B2, US Pat. No. 4378607, US Pat. No. 4242758, and US Pat. No. 4038704.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GABRIELLA GISELLE B RIOS whose telephone number is (703)756-5958. The examiner can normally be reached M-Th 7:30-6:00 EST.
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/G.G.R./Examiner, Art Unit 3774
/THOMAS C BARRETT/SPE, Art Unit 3799