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 .
Election/Restrictions
Applicant's election with traverse of group I in the reply filed on July 1, 2026 is acknowledged. The traversal is on the ground(s) that manufacturing the apparatus is not materially different from the apparatus itself. This is not found persuasive because manufacturing the apparatus is distinct from the apparatus itself, as the apparatus could be produced by a materially different process.
The requirement is still deemed proper and is therefore made FINAL.
Claim 15 is withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention. As such, claims 1-14, 16-19 are currently pending in the instant application.
Claim Objections
Claims 1-14, 16-19 are objected to because of the following informalities:
Claim 1 should recite “A medical fixation system, comprising…”
Claim 5, line 7 should recite “wherein the through hole”.
Claim 14 should recite “[[A]]The fixation member”.
Claims 16-19 recite “The medical fixation device of [preceding claim]”; however, they should properly recite “The medical fixation system of [preceding claim]” in accordance with antecedent basis. 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 1-14, 16-19 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 1 recites “a breaking point” in line 6. It is unclear from the specification what this refers to.
Claim 1 recites “wherein the through hole extends coaxially to a longitudinal axis”. It is unclear to which longitudinal axis this refers. As best understood, the through hole extends coaxially to its own longitudinal axis, not that of the fixing part; Examiner evaluated the claim as reciting “wherein the through hole extends coaxially to [[a]]its longitudinal axis”.
Claims 13 and 14 should be similarly amended regarding its longitudinal axis.
Claim 8 omits a claim from which it depends. Examiner evaluated the claim as depending from claim 1.
Claim 14 improperly depends from itself; Examiner evaluated the claim as depending from claim 13.
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) 1-5, 7-14, 16-17, 19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Oberli et al. (US 11,179,180), hereinafter, “Oberli”.
Regarding claim 1, Oberli discloses a medical fixation system (2), comprising: a connecting means (8) extending in a longitudinal direction, and a fixing part (4), which is arranged to be brought into engagement with the connecting means in an assembled state, wherein the fixing part has a fixing body (5) and a through hole (6) in the fixing body, which is arranged to at least partially receive the connecting means in the assembled state (FIGS. 1), wherein the through hole extends coaxially to its longitudinal axis (22) and is defined by a wall (FIG. 2D) which extends in a circumferential direction around the longitudinal axis, and wherein the through hole has at least one cavity (28a) formed in the wall, wherein the at least one cavity is designed to accommodate the connecting means in the assembled state, at least in sections (FIGS. 4).
Regarding claim 2, Oberli discloses the medical fixation system according to claim 1, wherein the at least one cavity is produced by milling with a milling tool, the milling tool being moved in the through hole at least in sections in a direction transverse to the longitudinal axis. Oberli is silent regarding the at least one cavity is produced by milling with a milling tool. It is noted that the cavity of Oberli appears to be substantially identical to the cavity claimed, although possibly produced by a different process, therefore the burden is upon the applicant to come forward with evidence establishing an unobvious difference between the two. In re Marosi, 218 USPQ 289 (Fed. Cir. 1983).
Regarding claim 3, Oberli discloses the medical fixation system according to claim 1, wherein the at least one cavity has a concave shape which forms a spatially defined receiving space (FIG. 2A), wherein the receiving space is limited in a circumferential direction (FIG. 2C).
Regarding claim 4, Oberli discloses the medical fixation system according to claim 1 wherein the at least one cavity comprises a first cavity (28a) and the through hole comprises at least one second cavity (28b) formed in the wall and arranged at a distance from the first cavity in a circumferential direction, so that the first cavity and the second cavity are angularly offset from each other and form an offset angle between them, wherein the second cavity is arranged in a direction of the longitudinal axis at a distance from the first cavity, and wherein the offset angle is 40° to 140° (FIG. 2D).
Regarding claim 5, Oberli discloses the medical fixation system according to claim 4, wherein the first cavity and the second cavity are assigned to a first plane (at M, FIG. 2E) which extends perpendicular to a longitudinal axis, so that the first plane runs through the first cavity and the second cavity, wherein the through hole comprises a third cavity (28c) formed in the wall and a fourth cavity (28d) formed in the wall and arranged at a distance from the third cavity in the circumferential direction, wherein the third cavity and the fourth cavity are associated with a second plane (just below M, FIG. 2E) which extends perpendicular to the longitudinal axis, so that the second plane passes through the third cavity and the fourth cavity, and wherein the first plane is spaced apart from the second plane in the direction of the longitudinal axis.
Regarding claim 7, Oberli discloses the medical fixation system according to claim 1 wherein at least one section of the wall is designed as a helical wall, and/or the connecting means has an external thread (FIG. 3A).
Regarding claim 8, Oberli discloses the medical fixation system according to claim 1 wherein the through hole extends from a first side (18) to an opposite second side (20) of the fixing body and has an enlarged inlet section (34) on the first side of the fixing body, and/or the through hole extends from a first side to an opposite second side of the fixing body and has an enlarged outlet section (36) on the second side of the fixing body.
Regarding claim 9, Oberli discloses the medical fixation system according to claim 8, wherein the through hole widens successively from the second side to the first side of the fixing body at an opening angle (at 28, FIG. 2A) with respect to the longitudinal axis thereby providing the enlarged inlet section, wherein the opening angle is 0° to 60° (col. 8 l. 51 – col. 9 l. 4).
Regarding claim 10, Oberli discloses the medical fixation system according to claim 1 wherein a diameter of the through hole is larger, at least in sections, than a diameter of the connecting means so that the connecting means can incline within the through hole (FIG. 1B).
Regarding claim 11, Oberli discloses the medical fixation system according to claim 1 wherein the connecting means is formed as a screw (8) and comprises a shank portion (25) having a first diameter and a first external thread adapted to be engaged with a bone, and a head portion (27) having a second thread adapted to be engaged with the fixing member in the assembled state (FIGS. 4).
Regarding claim 12, Oberli discloses the medical fixation system according to claim 1 wherein the connecting means and the fixing part are formed at least partially from a metallic material (col. 5 l. 62 – col. 6 l. 18).
Regarding claim 13, Oberli discloses a fixation member (4) for a medical fixation system which is adapted to be engaged with a connecting means (8) in an assembled state, wherein the fixation member has a through hole (6) which is arranged to at least partially receive the connecting means in the assembled state, wherein the through hole extends coaxially to its longitudinal axis and is defined by a wall (FIG. 2D), wherein the through hole has at least one cavity (28) in the wall, wherein the at least one cavity is designed to receive the connecting means at least in sections in the assembled state (FIGS. 4).
Regarding claim 14, Oberli discloses the fixation member according to claim 13, which is produced by a method comprising the steps of: insertion of a through hole in a fixing body, wherein the through hole extends coaxially to its longitudinal axis, making a cavity in a wall of the through hole by milling with a milling tool, the milling tool being moved in the through hole at least in sections in a direction transverse to the longitudinal axis. Oberli is silent regarding the method in which the fixation member is produced. It is noted that the fixation member of Oberli appears to be substantially identical to the fixation member claimed, although possibly produced by a different process, therefore the burden is upon the applicant to come forward with evidence establishing an unobvious difference between the two. In re Marosi, 218 USPQ 289 (Fed. Cir. 1983).
Regarding claim 16, Oberli discloses the medical fixation device of claim 8 wherein at least a first section and a second section of the through hole are frustoconical (FIG. 2E), wherein the enlarged inlet section is provided on the first side of the fixing body and the enlarged outlet section is provided on the second side of the fixing part (FIG. 2E).
Regarding claim 17, Oberli discloses the medical fixation device of claim 1 wherein the connecting means is a screw (8).
Regarding claim 19, Oberli discloses the medical fixation device of claim 2 wherein the through hole is symmetrical about the longitudinal axis (FIG. 2E).
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) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Oberli.
Oberli discloses the medical fixation device of claim 11, except wherein the fixing member has a thickness between the first side and the second side which is equal to or greater than 0.5 mm. It would have been obvious to one having ordinary skill in the art at the time the invention was made to construct the fixing member having a thickness between the first side and the second side which is equal to or greater than 0.5 mm, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Allowable Subject Matter
Claim 6 is 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.
The following is a statement of reasons for the indication of allowable subject matter:
Oberli discloses a medical fixation system (2), comprising: a connecting means (8) extending in a longitudinal direction, and a fixing part (4), which is arranged to be brought into engagement with the connecting means in an assembled state, wherein the fixing part has a fixing body (5) and a through hole (6) in the fixing body, which is arranged to at least partially receive the connecting means in the assembled state (FIGS. 1), wherein the through hole extends coaxially to its longitudinal axis (22) and is defined by a wall (FIG. 2D) which extends in a circumferential direction around the longitudinal axis, and wherein the through hole has at least one cavity (28a) formed in the wall, wherein the at least one cavity is designed to accommodate the connecting means in the assembled state, at least in sections (FIGS. 4), wherein the at least one cavity comprises a first cavity (28a) and the through hole comprises at least one second cavity (28b) formed in the wall and arranged at a distance from the first cavity in a circumferential direction, so that the first cavity and the second cavity are angularly offset from each other and form an offset angle between them, wherein the second cavity is arranged in a direction of the longitudinal axis at a distance from the first cavity, and wherein the offset angle is 40° to 140° (FIG. 2D), wherein the first cavity and the second cavity are assigned to a first plane (at M, FIG. 2E) which extends perpendicular to a longitudinal axis, so that the first plane runs through the first cavity and the second cavity, wherein the through hole comprises a third cavity (28c) formed in the wall and a fourth cavity (28d) formed in the wall and arranged at a distance from the third cavity in the circumferential direction, wherein the third cavity and the fourth cavity are associated with a second plane (just below M, FIG. 2E) which extends perpendicular to the longitudinal axis, so that the second plane passes through the third cavity and the fourth cavity, and wherein the first plane is spaced apart from the second plane in the direction of the longitudinal axis.
However, the prior art, alone or in combination, fails to teach wherein the first plane is angularly offset relative to the second plane so that a torsion angle is defined between the first cavity and the third cavity and between the second cavity and the fourth cavity, wherein the torsion angle is 40° to 140°.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OLIVIA C CHANG whose telephone number is (571) 270-5017. The examiner can normally be reached Monday-Friday, 7:30AM-5:00PM.
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, KEVIN TRUONG, at (571) 272-4705. The fax phone number for the organization where this application or proceeding is assigned is 571 -273-8300.
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/OLIVIA C CHANG/Primary Examiner, Art Unit 3775
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