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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10/03/2025 and 12/23/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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 17 and 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 17 recites the limitation "the data" in line 5. There is insufficient antecedent basis for this limitation in the claim.
Claim 22 recites the limitation "the data" in line 10. There is insufficient antecedent basis for this limitation in the claim.
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.
Claims 17-24 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bonin et al. (Pub. No.: US 2015/0190237).
Consider claim 17, Bonin discloses a patient-specific prosthesis for a fractured long bone of a patient (paragraph [0026], shoulder prosthesis for use in association with repair of one or more fractures of the upper extremity of the humerus 10 (FIG. 2)), the fractured long bone including epiphyseal fragments (paragraph [0048], greater tuberosity 14 separating from the lesser tuberosity 16), the patient-specific prosthesis comprising:
a stem part (paragraph [0027], stem portion 22 with body portion 24) configured so that each epiphyseal fragment can be secured to the stem part at a chosen one of a plurality of securing positions relative to the other epiphyseal fragments (paragraph [0034], Figs. 3, 4, one or more of the suture anchor attachment locations 30 may be defined along various portions of the stem portion 22, the body portion 24 and/or the head portion 26 of the prosthesis 20, wherein proper suture anchor attachment locations 30 (i.e., attachment locations 30a-30e) will result in draping of the sutures S to achieve optimal placement and organization of the sutures S relative to the tuberosity fragments 14, 16 and the humeral shaft 18, see paragraph [0050], Figs. 9, 10), the plurality of securing positions being chosen based on the data so that securing the epiphyseal fragments at the respective chosen securing positions causes a respective patient-specific mechanical stress to be applied onto each epiphyseal fragment by at least one of the other epiphyseal fragments (paragraph [0050], Figs. 9, 10, sutures S may be optimized to help facilitate the application of compression forces to reduce the tuberosity fragments 14, 16 to their proper anatomic position/orientation relative to one another).
Consider claim 18, Bonin discloses wherein the stem part comprises a visible mark indicating the respective chosen securing positions of the epiphyseal fragments on the stem part (paragraph [0035], Fig. 3, the prosthesis 20 may include a plurality of indicia that indicate or mark one or more of the suture anchor attachment locations 30).
Consider claim 19, Bonin discloses wherein the stem part comprises coverable epiphyseal portions (paragraph [0027], Fig. 3, body portion 24), each coverable epiphyseal portion configured to be covered by a specific epiphyseal fragment at the respective chosen securing position (paragraph [0050], Figs. 9, 10, wherein proper suture anchor attachment locations 30 (i.e., attachment locations 30a-30e) will result in draping of the sutures S to achieve optimal placement and organization of the sutures S relative to the tuberosity fragments 14, 16 and the humeral shaft 18).
Consider claim 20, Bonin discloses wherein the visible mark is designed so as to visually delimit the coverable epiphyseal portions from each other (paragraph [0035], indicia may include indents, colors, different materials, or any other suitable indicia for marking one or more of the suture anchor attachment locations 30).
Consider claim 21, Bonin discloses wherein the stem part comprises, for at least one of the epiphyseal fragments, a respective plug for securing the concerned epiphyseal fragment to the stem part (paragraph [0034], Figs. 3, 4, one or more of the suture anchor attachment locations 30 may be defined along various portions of the stem portion 22, the body portion 24 and/or the head portion 26 of the prosthesis 20, wherein proper suture anchor attachment locations 30 (i.e., attachment locations 30a-30e) will result in draping of the sutures S to achieve optimal placement and organization of the sutures S relative to the tuberosity fragments 14, 16 and the humeral shaft 18, see paragraph [0050], Figs. 9, 10), said at least one plug configured to apply mechanical stress onto an epiphyseal fragment when the epiphyseal fragment is secured thereto (paragraph [0050], Figs. 9, 10, sutures S may be optimized to help facilitate the application of compression forces to reduce the tuberosity fragments 14, 16 to their proper anatomic position/orientation relative to one another).
Consider claim 22, Bonin discloses a patient-specific prosthesis for a fractured long bone of a patient (paragraph [0026], shoulder prosthesis for use in association with repair of one or more fractures of the upper extremity of the humerus 10 (FIG. 2)), the fractured long bone including at least one viable tuberosity fragment, secured to a muscle of the patient by means of a tendon of the muscle, a damaged articular fragment, initially being part of a damaged joint of the patient, for articulating the long bone with an auxiliary bone of the patient (paragraph [0048], FIG. 2, the upper extremity of the humerus 10 may break into several fragments along multiple fracture lines, with the humeral head 12 separating along a fracture line F1 at or near the anatomical neck, the greater tuberosity 14 separating from the lesser tuberosity 16 along a fracture line F2 at or near the biciptal groove, and/or the humeral shaft 18 separating along a fracture line F3 at or near the surgical neck), wherein the patient-specific prosthesis comprising:
a stem part (paragraph [0027], stem portion 22 with body portion 24) configured for securing the at least one viable tuberosity fragment to the stem part (paragraph [0034], Figs. 3, 4, one or more of the suture anchor attachment locations 30 may be defined along various portions of the stem portion 22, wherein proper suture anchor attachment locations 30 will result in draping of the sutures S to achieve optimal placement and organization of the sutures S relative to the tuberosity fragments 14, 16 and the humeral shaft 18, see paragraph [0050], Figs. 9, 10), and
a head part (paragraph [0034], Fig. 3, head portion 26 of the prosthesis 20) being configured to be secured to the stem part in replacement for the damaged articular fragment (paragraph [0048], prosthetic head portion 26 is attached to the body portion 24, which is in turn attached to the stem portion 22, wherein humeral head 12 is being replaced by the prosthetic head 26, see paragraph [0031], Figs. 2, 3), wherein the stem part includes comprising securing positions configured specifically for the patient based on the data, so that the at least one viable tuberosity fragment and the head part can each be secured to the stem part at a respective securing position (paragraph [0034], Figs. 3, 4, one or more of the suture anchor attachment locations 30 may be defined along various portions of the stem portion 22, the body portion 24 and/or the head portion 26 of the prosthesis 20, wherein proper suture anchor attachment locations 30 (i.e., attachment locations 30a-30e) will result in draping of the sutures S to achieve optimal placement and organization of the sutures S relative to the tuberosity fragments 14, 16 and the humeral shaft 18, see paragraph [0050], Figs. 9, 10), the securing positions being chosen so that securing said at least one viable tuberosity fragment and the head part the securing positions a respective patient-specific mechanical stress to be applied onto each viable tuberosity fragment by the head part (paragraph [0049], Figs. 9, 10, the greater and lesser tuberosity fragments 14, 16 are displaced to their proper anatomic position/orientation about the body portion 24 of the prosthesis 20 beneath the head portion 26 wherein sutures S (with use of attachment location 30e of the head portion 26) may be optimized to help facilitate the application of compression forces to reduce the tuberosity fragments 14, 16 to their proper anatomic position/orientation relative to one another, see paragraph [0050]).
Consider claim 23, Bonin discloses wherein the head part (paragraph [0034], Fig. 3, head portion 26 of the prosthesis 20) comprises:
a standard cap, comprising an articular surface for forming a prosthetic joint for replacement of the damaged joint of the patient (paragraph [0031], Figs. 3, 4, head 26 includes a generally hemi-spherical shaped outer articulation surface 80, wherein the hemi-spherical articulation surface 80 is intended to cooperate with the natural joint face of the glenoid), and
a securing surface opposed to the articular surface, the securing surface configured to secure the standard cap to the stem part (paragraph [0031], Fig. 4, head 26 further defines a conical or cylindrical-shaped indentation or recess 86 extending outwardly from the surface 82 to receive a correspondingly shaped second end portion 92 of the connector 28 therein); and
a patient-specific insert configured to be interposed between the standard cap and the stem part (paragraph [0031], Fig. 4, connector 28 for connecting head 26 and body 24, wherein the connector 28 includes a neck or intermediate spacer portion 94 extending between the end portions 90, 92) and to apply the respective mechanical stress onto each of said at least one viable tuberosity fragment (paragraph [0049], Figs. 9, 10, the greater and lesser tuberosity fragments 14, 16 are displaced to their proper anatomic position/orientation about the body portion 24 of the prosthesis 20 beneath the head portion 26 wherein sutures S (with use of attachment location 30e of the head portion 26) may be optimized to help facilitate the application of compression forces to reduce the tuberosity fragments 14, 16 to their proper anatomic position/orientation relative to one another, see paragraph [0050]).
Consider claim 24, Bonin discloses wherein the articular surface is convex (paragraph [0031], Figs. 3, 4, head 26 includes a generally hemi-spherical shaped outer articulation surface 80).
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 25, 26 and 29-36 are rejected under 35 U.S.C. 103 as being unpatentable over Bonin in view of Deransart et al. (Pub. No.: WO 2016/094739).
Consider claims 25, 33, Bonin does not specifically disclose wherein the articular surface is concave.
Deransart discloses wherein the articular surface is concave (paragraph [0084], Fig. 9, reverse insert 12 includes a concave proximal surface 54).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to replace the articular surface as disclosed by Bonin with the articular surface as taught by Deransart to provide implantation in a patient's glenoid as part of a reverse prosthesis surgery (Deransart, paragraph [0084).
Consider claim 26, Bonin discloses patient-specific prosthesis (paragraph [0026], shoulder prosthesis for use in association with repair of one or more fractures of the upper extremity of the humerus 10 (FIG. 2)), comprising:
a stem part sized and configured to be inserted into a humeral shaft formed in a long bone of a patient (paragraph [0048], Fig. 9, stem portion 22 is embedded/anchored within the humeral shaft 18), the stem part including:
a coverable diaphyseal portion forming a distal end of the stem part along a first axis (paragraph [0027], stem portion 22 forming a distal end), the coverable diaphyseal portion configured to secure the stem part to the long bone of the patient (paragraph [0034], Figs. 3, 4, one or more of the suture anchor attachment locations 30 may be defined along various portions of the stem portion 22, wherein proper suture anchor attachment locations 30 (i.e., attachment locations 30a-30e) will result in draping of the sutures S to achieve optimal placement and organization of the sutures S relative to the tuberosity fragments 14, 16 and the humeral shaft 18, see paragraph [0050], Figs. 9, 10)), and
a plurality of coverable epiphyseal portions located at a proximal end of the stem part along the first axis (paragraph [0027], Fig. 3, body portion 24 located at proximal end);
wherein the stem part is configured to apply a predetermined mechanical stress to a contact zone of the long bone of the patient when the stem part is inserted into the humeral shaft (paragraph [0050], Figs. 9, 10, sutures S may be optimized to help facilitate the application of compression forces to reduce the tuberosity fragments 14, 16 to their proper anatomic position/orientation relative to one another).
Bonin does not specifically disclose the humeral shaft to include a medullary cavity.
Deransart discloses the humeral shaft to include a medullary cavity (paragraph [0078], medullary canal of a humerus of a patient).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the humeral shaft as disclosed by Bonin with the medullary cavity as taught by Deransart to provide an anchor for the stem of a humerus of a patient (Deransart, paragraph [0078]).
Consider claim 29, the combination of Bonin and Deransart discloses wherein the mechanical stress is applied in a radial direction around the first axis (paragraph [0029], wrapping of sutures about the body 24).
Consider claim 30, the combination of Bonin and Deransart discloses a head part configured to be coupled to the stem part (paragraph [0048], Fig. 3, prosthetic head portion 26 is attached to the body portion 24, which is in turn attached to the stem portion 22).
Consider claim 31, the combination of Bonin and Deransart discloses wherein the head part includes a cap having an articular surface (paragraph [0031], Figs. 3, 4, head 26 includes a generally hemi-spherical shaped outer articulation surface 80).
Consider claim 32, the combination of Bonin and Deransart discloses wherein the articular surface has a convex shape (paragraph [0031], Figs. 3, 4, head 26 includes a generally hemi-spherical shaped outer articulation surface 80).
Consider claim 34, the combination of Bonin and Deransart discloses wherein the cap includes: a trunnion (paragraph [0032], Fig. 4, a trunnion having a conical or cylindrical shaped outer surface 98 sized for receipt within the correspondingly shaped indentation 86 in the head 26); and
a securing surface located at an end of the trunnion, the securing surface configured to secure the cap to the stem part (paragraph [0032], Fig. 4, neck or intermediate spacer portion 94 extending between the end portions 90, 92, wherein the first end portion 90 comprises a connection shaft defining external threads 96 configured for threading engagement within the threaded opening 72 in the body 24).
Consider claim 35, the combination of Bonin and Deransart discloses a patient-specific insert configured to be disposed between the cap and the stem part (paragraph [0031], Fig. 4, connector 28 for connecting head 26 and body 24, wherein the connector 28 includes a neck or intermediate spacer portion 94 extending between the end portions 90, 92).
Consider claim 36, the combination of Bonin and Deransart discloses wherein the patient-specific insert includes: a first surface configured to bear against a border surface of the cap, the border surface surrounding the trunnion and disposed opposite the articular surface (paragraph [0032], Fig, 4, second end portion 92 comprises a trunnion having a conical or cylindrical shaped outer surface 98 sized for receipt within the correspondingly shaped indentation 86 in the head 26); and
a second surface configured to bear against at least one fracture line of a bone fragment (Figs. 9, 10).
Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over the combination of Bonin and Deransart in view of Willoughby (Pat. No.: US 5,873,721).
Consider claim 27, the combination of Bonin and Deransart does not specifically disclose wherein the predetermined mechanical stress is sufficient to avoid osseous necrosis in the long bone.
Willoughby discloses wherein the predetermined mechanical stress is sufficient to avoid osseous necrosis in the long bone (col. 86, lines 48-63, unless healing before the implant-bone interface is loaded, a stress on the system may be the result).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to replace the applied predetermined mechanical stress as disclosed by the combination of Bonin and Deransart with the applied predetermined mechanical stress as taught by Willoughby to prevent cortical cratering and avascular necrosis, resulting in bone loss (Willoughby, col. 86, lines 48-63).
Claim 28 is rejected under 35 U.S.C. 103 as being unpatentable over the combination of Bonin and Deransart in view of Yeh (Pub. No.: US 2016/0310281).
Consider claim 28, the combination of Bonin and Deransart does not specifically disclose wherein the stem part is configured to apply a predetermined mechanical stress to a plurality of contact zones of the long bone of the patient when the stem part is inserted into the medullary cavity.
Yeh discloses wherein the stem part is configured to apply a predetermined mechanical stress to a plurality of contact zones of the long bone of the patient when the stem part is inserted into the medullary cavity (paragraph [0028], external force F acting on the upper portion of the femoral implant will produce a biasing stress acting upon the inner wall of the medullary cavity 41 of the femur 40).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the stem part as disclosed by the combination of Bonin and Deransart to include applying a predetermined mechanical stress as taught by Yeh in response to an external force F acting on the upper portion of the femoral implant (Yeh, paragraph [0028).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GERALD JOHNSON whose telephone number is (571)270-7685. The examiner can normally be reached Monday-Friday 8am-5pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Carey Michael can be reached at (571)270-7235. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Gerald Johnson/
Primary Examiner, Art Unit 3797
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