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 .
Response to Arguments
Applicant’s arguments with respect to claim(s) 11-17, 25-30, 34-35, and 38-42 have been considered but are moot in view of the new grounds of rejection.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
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.
Claim 40 and its dependent claims are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 40 has been amended to recite that no portion of the handle assembly circumscribes the plurality of cutting features formed on the reamer head. The disclosure does not have adequate support for this limitation. Appropriate correction is required.
Claims 13, 16, and their dependent claims 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 13 recites “providing torque via a polyaxial joint coupling the shaft to the reamer head.” It is unclear if the polyaxial joint is intended to be the same element as the drive tip of amended claim 11, which recites the same usage as the polyaxial joint. Claim 16 recites a bone-facing side of the reamer head in line 2. It is unclear if this side is intended to be the same element as the cutting side of the reamer head recited in claim 11. Appropriate correction and/or clarification is required.
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.
Claim(s) 11-17, 25-30, 34-35, and 38-42 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ek (Patent No.: US 8,361,159 B2) in view of McCombs et al. (Pub. No.: US 2005/0021037 A1; hereinafter “McCombs”).
Ek teaches the following regarding claim 11: a method of preparing a joint (col. 3, lines 48-58) comprising: exposing a joint space (col. 3, lines 48-58); inserting a reamer head (14, 18) into the joint space (Figs. 1A-2, 6), the reamer head comprising: a first central longitudinal axis (central axis of assembled elements 14, 18); a reverse side (upper sides of elements 14, 18) oriented in a proximal direction with respect to the first central longitudinal axis (Fig. 1A); a cutting side (lower sides of elements 14, 18) oriented in a distal direction with respect to the first central longitudinal axis (Fig. 1A); a plurality of teeth (24, 32) coupled to and projecting away from the cutting side of the reamer head in the distal direction (Figs. 1A-1B); and a socket (38) comprising a plurality of socket surfaces (Figs. 1A-2; col. 6, lines 4-24); and providing torque to the reamer head along a second central longitudinal axis (central axis of element 302) of a shaft (302) that is rotatable about the second central longitudinal axis (Fig. 6; col. 5, lines 16-52; col. 8, lines 31-col. 9, lines 24) and is coupled to the reamer head via a drive tip (306) disposed on a distal end of the shaft (Figs. 6-8) that is receivable within the socket of the reamer head (Fig. 6), the drive tip comprising a plurality of lobes (Fig. 8) configured to transmit torque to the reamer head via rotational engagement of the plurality of lobes with the plurality of socket surfaces to rotate the reamer head about the first central longitudinal axis and prepare a reamed surface of the joint (col. 5, lines 16-52; col. 8, lines 31-col. 9, lines 24; col. 12, lines 8-37), wherein the drive tip is oriented at an oblique angle relative to the first central longitudinal axis of the reamer head as the plurality of lobes rotationally engage the plurality of socket surfaces (Fig. 6; col. 5, lines 16-52; col. 8, lines 31-col. 9, lines 48; col. 12, lines 8-37; col. 13, lines 40-46).
Regarding claims 11, 15-17, 25, 28-30, 34-35, and 38-40, Ek states that its system has been described with reference to excising a portion of an articular surface of a tibial condyle, however its system is suitably be applied to various other articular surfaces. The specific embodiments provided in Ek should only be construed as illustrative but not as limiting (col. 3, lines 48-58; col. 13, lines 40-46). Ek does not explicitly recite that its system is used for preparing a glenoid fossa for shoulder arthroplasty. McCombs teaches that it is well known in the art that reamer and implant systems are applied to a variety of joint locations, including a tibia and a glenoid (paras. 0048-0057), in order to utilize the versatility of the reamer device and to properly treat a particular patient’s anatomy. As shown in their figures, the structures of the shafts of Ek and McCombs will extend alongside a humeral head as the reamer head prepares and is applied to the reamed surface on the glenoid fossa. It would have been obvious to one having ordinary skill in the art to modify the invention of Ek to be applied to a glenoid fossa for shoulder arthroplasty, as taught by McCombs, in order to effectively treat a particular patient. As Ek teaches the same reamer structure recited by the claims, such a modification of the usage of Ek would be made with a reasonable expectation of success.
Ek teaches the following regarding claim 12: the method of claim 11, wherein the second central longitudinal axis is polyaxially obliquely angled relative to the first central longitudinal axis (as element 302 is repositioned within the socket) (Fig. 6; col. 5, lines 16-52; col. 8, lines 31-col. 9, lines 48; col. 12, lines 8-37; col. 13, lines 40-46).
Ek teaches the following regarding claim 13: the method of claim 12, wherein providing torque to the reamer head further comprises: providing torque via a polyaxial joint coupling the shaft to the reamer head (Fig. 6; col. 5, lines 16-52; col. 8, lines 31-col. 9, lines 48; col. 12, lines 8-37; col. 13, lines 40-46). For the present examination, the polyaxial joint and the drive tip are being interpreted to be the same elements, as the drive tip will provide a polyaxial joint function.
Ek teaches the following regarding claim 14: the method of claim 11, wherein inserting the reamer head into the joint space further comprises: inserting the reamer head into the joint space along a direction that is nonparallel to the first central longitudinal axis of the reamer head (Figs. 3-4).
Ek teaches the following regarding claim 15: the method of claim 11, further comprising: forming a pilot hole (hole in bone to hold element 27) in the bone.
Ek teaches the following regarding claim 16: the method of claim 15, further comprising: inserting a second shaft (27) that protrudes from a bone-facing side (lower side of element 14) of the reamer head into the pilot hole formed in the bone to guide rotation of the reamer head with respect to the bone (col. 5, lines 16-37). For the purpose of the present examination, the bone-facing side is being interpreted to include part of the same elements as the cutting side.
Ek teaches the following regarding claim 17: the method of claim 11, further comprising: installing an implant (500) on the reamed surface of the bone (col. 13, lines 47-col. 14, lines 40).
Ek teaches the following regarding claim 25: a method of preparing a joint (col. 3, lines 48-58) comprising: exposing a joint space (col. 3, lines 48-58); inserting a reamer (10) into the joint space (Fig. 6), the reamer comprising: a reamer head (14, 18) comprising a socket (38); a handle (16) configured to manipulate a location and orientation of the reamer head with respect to the joint (Fig. 6; col. 4, lines 35-58), wherein the handle is configured to retain the reamer head at a fixed position along a first rotational axis (central axis of assembled elements 14, 18) of the reamer head, with respect to the handle, as the reamer head prepares a reamed surface on the joint (Fig. 6; col. 5, lines 16-52; col. 8, lines 31-col. 9, lines 48; col. 12, lines 8-37; col. 13, lines 40-46); and a shaft (302) comprising a drive tip (306) that is received in the socket to define a polyaxial joint (col. 5, lines 16-52; col. 8, lines 31-col. 9, lines 48; col. 12, lines 8-37; col. 13, lines 40-46) comprising: a plurality of socket surfaces (col. 6, lines 4-24) disposed within the socket of the reamer head (Figs. 1A-1B); a plurality of lobes (Fig. 8) disposed on the drive tip of the shaft (Fig. 8), wherein the plurality of lobes disposed on the drive tip are configured to rotationally engage the plurality of socket surfaces disposed within the socket to transmit torque from the drive tip to the socket along an oblique angle of the drive tip relative to the socket (Fig. 6; col. 5, lines 16-52; col. 8, lines 31-col. 9, lines 48; col. 12, lines 8-37; col. 13, lines 40-46); and applying torque to the shaft to rotate the reamer head via the polyaxial joint and prepare the reamed surface of the joint (Fig. 6; col. 5, lines 16-52; col. 8, lines 31-col. 9, lines 48; col. 12, lines 8-37; col. 13, lines 40-46).
Ek teaches the following regarding claim 26: the method of claim 25, wherein: the shaft comprises a second central longitudinal axis (central axis of element 302); and the first rotational axis is nonparallel to the second central longitudinal axis as the shaft rotates the reamer head via the polyaxial joint (Fig. 6; col. 5, lines 16-52; col. 8, lines 31-col. 9, lines 48; col. 12, lines 8-37; col. 13, lines 40-46).
Ek teaches the following regarding claim 27: the method of claim 25, wherein inserting the reamer into the joint space further comprises: inserting the reamer into the joint space along a direction that is nonparallel to the first rotational axis of the reamer head (Figs. 3-4).
Ek teaches the following regarding claim 28: the method of claim 25, further comprising: forming a pilot hole (hole housing element 27) in the bone (col. 5, lines 16-37).
Ek teaches the following regarding claim 29: the method of claim 28, further comprising: inserting a second shaft (27) protruding from a bone-facing side (lower side of element 14) of the reamer head into the pilot hole formed in the bone to guide rotation of the reamer head with respect to the bone (Figs. 1A-2).
Ek teaches the following regarding claim 30: the method of claim 25, further comprising: installing an implant (500) on the reamed surface of the bone (col. 13, lines 47-col. 14, lines 40).
Ek teaches the following regarding claim 34: the method of claim 11, further comprising: inserting the reamer head comprising the socket into the joint space (Fig. 6); inserting the shaft comprising the drive tip into the joint space (Fig. 6); and engaging the drive tip with the socket to couple the shaft to the reamer head within the joint space (Fig. 6; col. 5, lines 16-52; col. 8, lines 31-col. 9, lines 48; col. 12, lines 8-37; col. 13, lines 40-46).
Ek teaches the following regarding claim 35: the method of claim 11, wherein the reamer head further comprises: a reamer coupler (200) configured to removably couple with the reamer head (col. 7, lines 4-26).
Ek teaches the following regarding claim 38: the method of claim 25, further comprising: inserting the reamer head comprising the socket into the joint space (Fig. 6); inserting the shaft comprising the drive tip into the joint space (Fig. 6); and engaging the drive tip with the socket to couple the shaft to the reamer head within the joint space (Fig. 6; col. 5, lines 16-52; col. 8, lines 31-col. 9, lines 48; col. 12, lines 8-37; col. 13, lines 40-46).
Ek teaches the following regarding claim 39: the method of claim 25, wherein the reamer further comprises: a reamer coupler (200) configured to removably couple with the reamer head (col. 7, lines 4-26).
Ek teaches the following regarding claim 40: a method of preparing a joint (col. 3, lines 48-58) comprising: exposing a joint space adjacent a bone of the joint (col. 3, lines 48-58); inserting a reamer head (14, 18) into the joint space (Fig. 6), the reamer head comprising a socket (38) defining a plurality of socket surfaces (col. 6, lines 4-24) therein (Figs. 1A-1B) and a plurality of cutting features (24, 27, 32) that are formed on the reamer head (Figs. 1A-2) and configured to remove bone from a surface of the joint as the reamer head rotates about a first central longitudinal axis (central axis of assembled elements 14, 18) of the reamer head (Fig. 6; col. 5, lines 16-52; col. 8, lines 31-col. 9, lines 48; col. 12, lines 8-37; col. 13, lines 40-46); and providing torque to the reamer head along a second central longitudinal axis (central axis of element 302) of a shaft (302) that is rotatable about the second central longitudinal axis (col. 5, lines 16-52; col. 8, lines 31-col. 9, lines 48; col. 12, lines 8-37; col. 13, lines 40-46) and is coupled to the reamer head via a drive tip (306) disposed on a distal end of the shaft (Figs. 6-8) that is receivable within the socket (Fig. 6; col. 5, lines 16-52; col. 8, lines 31-col. 9, lines 48; col. 12, lines 8-37; col. 13, lines 40-46), the drive tip comprising a plurality of lobes (Fig. 8) configured to transmit torque to the reamer head via rotational engagement of the plurality of lobes with the plurality of socket surfaces to rotate the reamer head about the first central longitudinal axis and prepare a reamed surface of the bone (Fig. 6; col. 5, lines 16-52; col. 8, lines 31-col. 9, lines 48; col. 12, lines 8-37; col. 13, lines 40-46), wherein: the drive tip is oriented at an oblique angle relative to the first central longitudinal axis of the reamer head as the plurality of lobes rotationally engage the plurality of socket surfaces (Fig. 6); and a handle assembly (16) associated with the reamer head that is configured to manipulate a location and orientation of the reamer head with respect to the joint (Fig. 6; col. 4, lines 35-58), wherein no portion of the handle assembly circumscribes the plurality of cutting features formed on the reamer head (upon the disassembly of elements 14 and 18) (Figs. 1A-2).
Ek teaches the following regarding claim 41: the method of claim 40, further comprising: inserting the reamer head comprising the socket into the joint space (Fig. 6; col. 5, lines 16-52; col. 8, lines 31-col. 9, lines 48; col. 12, lines 8-37; col. 13, lines 40-46); inserting the shaft comprising the drive tip into the joint space (Fig. 6; col. 5, lines 16-52; col. 8, lines 31-col. 9, lines 48; col. 12, lines 8-37; col. 13, lines 40-46); and engaging the drive tip with the socket to couple the shaft to the reamer head within the joint space (Fig. 6; col. 5, lines 16-52; col. 8, lines 31-col. 9, lines 48; col. 12, lines 8-37; col. 13, lines 40-46).
Ek teaches the following regarding claim 42: the method of claim 40, wherein the reamer head further comprises: a reamer coupler (200) configured to removably couple with the reamer head (col. 7, lines 4-26).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Ann Hu whose telephone number is (571) 272-6652. The examiner can normally be reached on Monday-Friday (9:00 am-5:30 pm EST).
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Jerrah Edwards, at (408) 918-7557. The fax phone number for the organization where this application or proceeding is assigned is (571) 273-8300.
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/ANN HU/Primary Examiner, Art Unit 3774