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 claims 1-22 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 12-22 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 12 recites the limitation "the humerus" in line 6. There is insufficient antecedent basis for this limitation in the claim.
For the purpose of examination, the term has been interpreted to read “a humerus”.
Claims 13-22 are rejected under 35 U.S.C. 112(b) as they depend from a rejected base claim and do not rectify the issue at hand.
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, 8-10 and 12-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kehres et al. (US 2015/0320430).
Regarding claim 1, Kehres et al. disclose a resection guide, comprising a superior radial arm (54) having a proximal portion (see figure below or alternatively, see figure below) with at least one bone pin receiving opening (72 or alternatively 86) formed therein and a distal portion (see figure below/see figure below) configured to contact engage a humeral head of a humerus with the distal portion extending from the proximal portion in a direction towards a posterior portion of the humeral head (figures 3-4), and a superior surface (see figure below or alternatively 80) of the proximal portion of the superior radial arm defining a resecting plane of the resection guide (via 78); a guide slot (76) formed on the superior radial arm, the guide slot being defined by a ledge (78 or alternatively see figure below) of the distal portion of the superior radial arm extending over the superior surface of the proximal portion of the superior radial arm, and the guide slot being configured to receive a cutting instrument therethrough and guide the cutting instrument along the resecting plane while cutting the humeral head, keeping the cutting instrument one of parallel or substantially parallel to the resecting plane (¶39, ¶43).
Regarding claim 8, Kehres et al. disclose the at least one bone pin receiving opening includes a longitudinal axis (considered the central longitudinal axis of 86) extending through a length thereof that is substantially parallel to the resecting plane (figures 3-4).
Regarding claim 9, Kehres et al. disclose the at least one bone pin receiving opening formed in the proximal portion of the superior radial arm further comprises a plurality of bone pin receiving openings (86’s) formed in the proximal portion of the superior radial arm, with at least two openings of the plurality of bone pin receiving openings being non-parallel (figure 6).
Regarding claim 10, Kehres et al. disclose a removable extender (90, figure 3) coupled to a proximal end of the proximal portion of the superior radial arm and configured to extend the resecting plane inferiorly, the removable extender including at least one inferior bone pin receiving opening
Regarding claim 12, Kehres et al. disclose a method for resecting a humeral head, comprising: coupling a superior arm (54) of a resection guide to a humeral head such that the superior arm contacts the humeral head at a position between a supraspinatus and a humeral head attachment point of the humeral head (figure 4); passing at least one bone pin (88, figure 3) through a portion of the resection guide and into at least one of the humeral head or the humerus (¶46); and resecting the humeral head using the resection guide to guide a cutting instrument and create a humeral resection surface (¶39, ¶43).
Regarding claim 13, Kehres et al. disclose resecting the humeral head using the resection guide further comprises passing the cutting instrument through a guide slot (76) formed on the superior arm, the guide slot serving to guide the cutting instrument (figures 3-4, ¶43).
Regarding claim 14, Kehres et al. disclose coupling a superior arm (54) of a resection guide to a humeral head further comprises contacting the humeral head at a location that is at least one of at or proximate, emphasis added, to the supraspinatus attachment point on the humeral head (figure 3-4).
Regarding claim 15, Kehres et al. disclose aligning the guide slot (76) to a bicipital groove of the humerus (¶43, figures 3-4).
Regarding claim 16, Kehres et al. disclose aligning a vertical alignment plate (90) of the resection guide with an elongate shaft of the humerus to set a location of the superior arm (figure 3, via 88).
Regarding claim 17, Kehres et al. disclose a vertical guide rod (88) is coupled to at least one of the vertical alignment plate or a handle coupled to the vertical alignment plate, the vertical guide rod extending along the elongate shaft of the humerus in conjunction with aligning the vertical alignment plate of the resection guide with the elongate shaft of the humerus (figure 3).
Regarding claim 18, Kehres et al. disclose passing at least one bone pin (88/¶42) through a portion of the resection guide and into the humeral head occurs such that the at least one bone pin does not pass through soft tissue in the glenohumeral joint space (figure 3).
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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 12 and 19-22 are rejected under 35 U.S.C. 103 as being unpatentable over Stchur (US 2021/0145462) in view of Morvan (US 2019/0015113).
Regarding claim 12, Stchur discloses a method for resecting a humeral head, comprising coupling a superior arm (802) of a resection guide (802 + 806) to a humeral head such that the superior arm contacts the humeral head (¶49, ¶54); passing at least one bone pin (870a, 870b) through a portion of the resection guide and into at least one of the humeral head or the humerus (¶52, ¶54); and resecting the humeral head using the resection guide to guide a cutting instrument and create a humeral resection surface (¶54).
Stchur fails to expressly teach or disclose the coupling of the superior art of the resection guide contacts the humeral head at a position between the supraspinatus and a humeral head attachment point of the humeral head.
Morvan discloses the step of positioning a resection guide (500) such that it contacts the humeral head at a position between the supraspinatus and a humeral head attachment point of the humeral head (¶141) as positioning it in this manner avoids muscular insertion sites and the tissues at the muscular insertion sites may be subject to damage if put under pressure in the surgery or if guide pines are passes therethrough (¶141) and contacting the guide in this manner as it avoids contacting soft tissues (¶141).
Accordingly, it would have been obvious to one of ordinary skill in the art at the time of filing to have constructed the method to have the superior arm of the resection guide contact the humeral head at a position between a supraspinatus and a humeral head attachment point of the humeral head as taught by Morvan as positioning it in this manner avoids muscular insertion sites and the tissues at the muscular insertion sites may be subject to damage if put under pressure in the surgery or if guide pines are passes therethrough and contacting the guide in this manner as it avoids contacting soft tissues. Regarding claim 19, Stchur discloses mating a handle (804) to the resection guide (¶51-52, ¶54); and checking angular alignment with a forearm using the handle (¶54).
Regarding claim 20, Stchur in view of Morvan disclose mating an extender (528 of Morvan) to the superior arm at a proximal end of the superior arm (figure 12 of Morvan); and passing at least one inferior bone pin (536 of Morvan) through a portion of the extender (figure 12 of Morvan) and into the humeral head such that the at least one inferior bone pin does not pass through soft tissue in the glenohumeral joint space (Abstract, ¶141 of Morvan). Regarding claim 21, Stchur in view of Morvan disclose a subscapularis tendon is intact during each of the coupling, passing, and resecting actions (¶141, of Morvan).
Regarding claim 22, Stchur in view od Morvan disclose coupling a superior arm of a resection guide to a humeral head such that the superior arm contacts engages the humeral head further comprises passing the superior arm through a rotator interval proximate to the humeral head (figures 12, 15-16, ¶122, ¶141 of Morvan).
Allowable Subject Matter
Claims 2-7 and 11 are 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.
ConclusionApplicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 MATTHEW JAMES LAWSON whose telephone number is (571)270-7375. The examiner can normally be reached Mon - Fri 6:30-3:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anita Coupe can be reached at 571-270-3614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MATTHEW J LAWSON/Primary Examiner, Art Unit 3619