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, filed March 31, 2026, with respect to the rejection(s) of claims 1, 2, 7, and 9-16 under 35 U.S.C. 102 and claims 3-6 under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made. Please direct attention to rejection below, specifically reference Snider, which teaches the limitations of wherein the support portion is configured to contact a neck of the humerus, the positioning jig having at least one area configured to contact a surface of the humerus, and the area configured to contact the surface of the neck of the humerus is patient-specific, and wherein the portion of the at least one area configured to contact the surface of the head of the humerus is patient-specific.
Applicant has submitted a terminal disclaimer. The double patenting rejection has been withdrawn.
Allowable Subject Matter
Claim 17-20 are allowable over the prior art.
The following is a statement of reasons for the indication of allowable subject matter: The prior art fails to teach or disclose the structural relationship including but not limited to a second portion having a second surface configured to contact a humeral bone surface that is different from the articular surface of the humerus of the specific patient, a first support member extending to a third portion, the third portion having a surface that is complementary to a bicipital groove of the humerus of the specific patient, and a second support member extending to a fourth portion, the fourth portion having a surface that is complementary to a portion of the humerus of the specific patient that is distal to an anatomical neck of the humerus of the specific patient, wherein the second portion defines a resection plane.
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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 1, 2, 7, and 9-16 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Pub. No. 2015/0320430 to Kehres et al. in view of WO 2010/129870 to Snider et al.
As to Claim 1, Kehres discloses a humeral cutting guide (200, Figs. 10-14, [0050]). The guide comprises a support portion (204, Fig. 13, [0054]) comprising at least one area (230) configured to contact a surface distal to a head of a humerus (of 26, Fig. 11, [0054]), the support portion defining a resection surface (234, [0054, 0056]), and a releasable positioning jig (202, Fig. 12, [0050]) configured to be coupled (via 250 and 222/224) to the support portion [0055-0056], the releasable positioning jig having at least one area (215) configured to contact a surface of a head of the humerus (Fig. 14, [0052]).
As to Claim 2, Kehres discloses a humeral cutting guide wherein the support portion (204) defines a plurality of mounting holes (252) each defining a respective longitudinal axis (Fig. 13, [0057]).
As to Claim 7, Kehres discloses a humeral cutting guide wherein the portion of the at least one area configured to contact the surface of the head of the humerus is patient-specific [0029-0030].
As to Claim 9, Kehres discloses a humeral cutting guide wherein the support portion (204) includes a first connection portion (250) and the releasable position jig (202) includes a second connection portion (222/224), the second connection portion configured to mate with the first connection portion [0055-0056].
As to Claim 10, Kehres discloses a humeral cutting guide wherein the first connection portion (250) includes a projection (Fig. 11, [0055-0056]) and the second connection portion (222/224) includes an aperture (Fig. 11, [0055-0056], the aperture sized and configured to receive at least a portion of the projection (Fig. 11, [0055-0056].
As to Claim 11, Kehres discloses a humeral cutting guide wherein the projection (250) is sized and configured to be received in the aperture (222/224) via a slip fit [0055-0056].
As to Claim 12, Kehres discloses a humeral cutting guide wherein the releasable positioning jig includes a base (220) configured to mate with the support portion, and a boss (214) suspended from the base by a projection (Fig. 11, [0050-0051]).
As to Claim 13, Kehres discloses a humeral cutting guide wherein a surface (217) of the boss is patient-specific [0051].
As to Claim 14, Kehres discloses a humeral cutting guide wherein the releasable positioning jig comprises a base (206) having a first side (219), the support portion includes a second side (217, [0051]) that includes the resection surface (234), and the first side of the base (206) is configured to face the second side of the support portion when the releasable positioning jig is mounted to the support portion (seen in Fig. 10).
As to Claim 15, Kehres discloses a humeral cutting guide wherein the at least one area configured to contact the first bone surface (of 26) includes a first area (Fig. 11, [0054]), and the at least one area (215) configured to contact the second bone surface 9Fig. 14, [0052]) includes a second area that is complimentary to a bicipital groove of a humerus [0044].
As to Claim 16, Kehres discloses a humeral cutting guide further comprising a third area (of 215) configured to be complimentary to a portion of the humerus adjacent to the bicipital groove (patient specific hook 215 capable of mating with protrusion of humeral bone 26, [0052]).
As to Claims 1, 2, 7, and 9-16, Kehres discloses the claimed invention except for wherein the support portion is configured to contact a neck of the humerus, and the area configured to contact the surface of the neck of the humerus is patient-specific.
Snider discloses a bone cutting guide (10, Fig. 1, [0006]) wherein a support portion (46) is configured to contact a neck (24) of a long bone (12, Figs. 1 and 3, [0040, 0042], and the area configured to contact the surface of the neck of the humerus is patient-specific, and wherein the portion of the at least one area configured to contact the surface of the head of the humerus is patient-specific ([0007] describes “wherein the portions of the inner surfaces of the arms, the at least one head underside member and the at least one neck member that are configured in shape to contact at least one portion of the femoral head and femoral neck of the patient are configured in shape using data obtained from the specific patient regarding the shape of the specific patient’s femur”) in order to cause the guide to grip the specific patient's long bone head and neck during formation of the bore in the specific patient's long bone [0007].
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the humeral cutting guide of Kehres with the bone neck contact modification of Snider in order to cause the guide to grip the specific patient's long bone head and neck during formation of the bore in the specific patient's long bone.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Pub. No. 2015/0320430 to Kehres et al. in view of WO 2010/129870 to Snider et al. in view of U.S. Patent Pub. No. 2016/0374697 to Kehres et al. (Kehres 2).
As to Claim 3, Kehres and Snider discloses the claimed invention except for wherein the longitudinal axis defined by a first mounting hole of the plurality of mounting holes is non-parallel with the longitudinal axis defined by a second mounting hole of the plurality of mounting holes.
Kehres 2 discloses a patient specific cutting guide further wherein the longitudinal axis defined by a first mounting hole (644a) of the plurality of mounting holes is non-parallel with the longitudinal axis defined by a second mounting hole (644b) of the plurality of mounting holes (non-parallel configuration described in [0093]) in order to assist in securing the cut guide member to the humeral bone [0093].
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the humeral cutting guide of Kehres and Snider with the mounting hole modification of Kehres 2 in order to assist in securing the cut guide member to the humeral bone.
Claims 4-6 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Pub. No. 2015/0320430 to Kehres et al. in view of WO 2010/129870 to Snider et al. in view of U.S. Patent Pub. No. 2009/0254091 to Long et al.
As to Claims 4-6, Kehres and Snider discloses the claimed invention except for wherein the releasable positioning jig is configured to guide an instrument configured to prepare the humeral bone distal to a resection plane formed with reference to the resection surface of the support portion, wherein the positioning jig is configured to guide a guide pin through the resection plane, and wherein the positioning jig is configured to guide a reamer through the resection plane.
Long discloses a humeral cutting guide (Fig. 1) including a releasable positioning jig (10) with at least one area configured to contact the humeral head (Fig. 1). The releasable positioning jig is configured to guide an instrument (18) configured to prepare the humeral bone distal to a resection plane formed with reference to the resection surface of a support portion [0024-0025, 0033, 0035]. The positioning jig is configured to guide a guide pin (28) through a resection plane (Fig. 1, [0028, 0033]). The positioning jig is configured to guide a reamer (18) through the resection plane [0024-0025, 0033, 0035] in order to provide means for guiding an instrument in a plurality of planes to allow for proper of resection of the humerus [0010-0011].
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the humeral cutting guide of Kehres and Snider with the positioning jig modification of Long in order to provide means for guiding an instrument in a plurality of planes to allow for proper of resection of the humerus.
Conclusion
Applicant's submission of an information disclosure statement under 37 CFR 1.97(c) with the timing fee set forth in 37 CFR 1.17(p) on May 18, 2026 prompted the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 609.04(b). 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 CHRISTOPHER J BECCIA whose telephone number is (571)270-7391. The examiner can normally be reached Mon - Fri 8:30-5:00.
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/CHRISTOPHER J BECCIA/Primary Examiner, Art Unit 3775
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