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 filed 10/31/2025 have been fully considered but they are not persuasive. The Applicant contends that Leibinger is directed towards a bone screw used in the osteosynthesis of scaphoid bone fractures; while in contrast, the present application is directed to a humeral repair implant for repair of a fracture of a proximal humerus. Applicant’s arguments rely on language solely recited in preamble recitations in the claim(s). When reading the preamble in the context of the entire claim, the recitation of being a humeral repair implant is not limiting because the body of the claim describes a complete invention and the language recited solely in the preamble does not provide any distinct definition of any of the claimed invention’s limitations. Thus, the preamble of the claim(s) is not considered a limitation and is of no significance to claim construction. See Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See MPEP § 2111.02. In addition, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Leibinger is designed to treat bone fractures and due to its dimensions and mechanical properties, it would be fully capable of being used to help treat fractures in a proximal humerus (Figs. 1-4; paras. 0003-0006, 0012).
The Applicant argues that Leibinger does not disclose a hollow, intramedullary implant with a conical section and perforations. The examiner respectfully disagrees. An intramedullary implant is not presently recited by the claims. Leibinger discloses a hollow body (10) with a conical section (60) and perforations (elements 44), as shown in Figures 1-5.
The Applicant further contends that Leibinger does not disclose a plane of an open end of the conical section that is angled relative to an axis of the operative lower section. The examiner respectfully disagrees. Annotated Figure A, below, shows a plane at the upper open end of the conical section that is angled relative to an axis (14) of the operative lower section. Please also note that the claim language “angled” can refer to any angle including acute, oblique, and right angles.
The Applicant argues that the "slot" in Leibinger does not equate to the claimed “slot” in the implant of the present invention which is a compliance feature that allows for temporary deformation of the lower section of the implant, thereby reducing trauma during axial insertion into the humerus. These deformation features of the slot are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). As presently worded, the claim language fails to structurally distinguish the slot of the present application over the prior art.
Claim Objections
Claim 22 is objected to because of the following informalities: a typographical error in line 1 in the phrase “as claimed claim 16.” Appropriate correction is required.
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 21, 29, 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 21 recites the limitation "the cross-section" in line 1. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
Claim 29 recites “said implant is made from any suitable material including metal, biocompatible plastics material or biodegradable material.” It is unclear if the language “including metal, biocompatible plastics material or biodegradable material” is merely exemplary of the remainder of the claim, and therefore not required, or a required feature of the claims. A broad range or limitation (i.e., “any suitable material”) together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) is indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). Appropriate correction is required.
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.
Claim(s) 16-29 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Leibinger et al. (Pub. No.: US 2016/0310187 A1; hereinafter “Leibinger”).
Leibinger discloses the following regarding claim 16: a humeral repair implant for repair of a fracture of the proximal humerus (Figs. 1-4; paras. 0003-0006, where the shape and usage of the implant allows it to be fully capable of being used in a proximal humerus), said implant (10) comprising: (a) a hollow body (Fig. 1) open at both ends (Figs. 1-4); (b) a conical section (60) configured at its top portion (Fig. 1; interpreted to be the top portion of the hollow body); and (c) an operative lower section (24 and lower, central portion of element 10) extending downwardly from said conical section (Fig. 1); wherein a plurality of perforations (elements 44 located on element 60) are defined in said conical section (Fig. 1), said perforations being configured to communicate between an inside and an outside of said conical section (Figs. 1, 2; para. 0041); and wherein a plane of an open end of the conical section is angled relative to an axis (14) of the operative lower section (please see annotated Figure A, below).
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Figure A.
Leibinger discloses the following regarding claim 17: the humeral repair implant as claimed in claim 16, wherein said operative lower section is tubular (Fig. 1).
Leibinger discloses the following regarding claim 18: the humeral repair implant as claimed in claim 16, wherein said conical section and said operative lower section are separated by a step (indentation and projection at junction between element 60 and the central portion of element 10) (Fig. 1).
Leibinger discloses the following regarding claim 19: the humeral repair implant as claimed in claim 16, wherein said plane of the open end of the conical section is angled at an angle between 15° and 45° (Figure A). In addition, the optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ. It would have been customary for one of ordinary skill to determine the angle orientations needed to achieve the desired results and fit the implantation site. Thus, absent some demonstration of unexpected results from the claimed parameters, the optimization of the ranges of the angle orientations, would have been obvious at the time of applicant's invention in view of the teachings of Leibinger. It is well-established that merely selecting proportions and ranges is not patentable absent a showing of criticality. In re Becket, 33 USPQ 33; In re Russell, 169 USPQ 426.
Leibinger discloses the following regarding claim 20: the humeral repair implant as claimed in claim 16, wherein a cross-section of said conical section perpendicular to an axis of said conical section is circular (Figs. 2, 4, at the circular outer periphery of element 60).
Leibinger discloses the following regarding claim 21: the humeral repair implant as claimed in claim 16, wherein the cross-section of said conical section perpendicular to the axis of said operative lower section is in the form of an isosceles trapezium having rounded vertices (Fig. 2, at the inner chamber of element 60).
Leibinger discloses the following regarding claim 22: the humeral repair implant as claimed claim 16, wherein a slot (12) is configured at a bottom open end extending towards a step (indentation and projection at junction between element 60 and the central portion of element 10) (Fig. 1) between said conical section and said lower section (Fig. 1).
Leibinger discloses the following regarding claim 23: the humeral repair implant as claimed in claim 16, wherein an outside surface of the operative lower section is provided with protruding ridges (28, 56) (Figs. 1, 3).
Leibinger discloses the following regarding claim 24: the humeral repair implant as claimed in claim 16, wherein at least a portion of an outwardly-facing surface of said operative lower section is roughened (via elements 28, 56) (Figs. 1, 3).
Leibinger discloses the following regarding claim 25: the humeral repair implant as claimed in claim 16, wherein at least a portion of an outwardly-facing surface of said conical section is a trabecular surface (Figs. 1, 2; paras. 0003-0006). The phrase “trabecular surface” is being interpreted to mean a surface relating to the trabecular/cancellous bone. Upon implantation, the outwardly-facing surface of the conical section is relating to and/or in contact with a trabecular surface of the bone.
Leibinger discloses the following regarding claim 26: the humeral repair implant as claimed in claim 16, wherein said conical section and said operative lower section are formed of a single curved surface extending from a top to a bottom portion of said implant (Fig. 1).
Leibinger discloses the following regarding claim 27: the humeral repair implant as claimed in claim 26, wherein said operative lower section is provided with perforations (elements 44 located on element 24) communicating between the inside and outside (Figs. 1, 3).
Leibinger discloses the following regarding claim 28: the humeral repair implant as claimed in claim 26, wherein a plurality of serrations (28, 56) facing downwardly are configured on said operative lower section (Figs. 1, 3).
Leibinger discloses the following regarding claim 29: the humeral repair implant as claimed in claim 16, wherein said implant is made from any suitable material including metal, biocompatible plastics material or biodegradable material (paras. 0025, 0050).
Conclusion
Applicant'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 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