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 Amendment
This office action is in response to the amendment filed July 5, 2025. As directed by the amendment, claims 1, 7, 9-11, 14 have been amended and claims 21-32 have been added. Claims 2-6, 8, 15-20 have been cancelled.
Election/Restrictions
Newly submitted claims 22, 28-32 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: the claim requires the locking nut to have a generally cylindrical shape rather than a generally frustoconical shape.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 22, 28-32 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
As such, claims 1, 7, 9-14, 21, 23-27 remain under consideration in the instant application.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
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) 1, 7, 9-14, 21, 23-27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lueth et al. (US 2018/0289402), hereinafter “Lueth”.
Regarding claim 1, Lueth discloses an osteosynthesis device (¶179-181) comprising: a support structure (“bone plate” ¶179), means for the fixation of the support structure to the bone material (“screws” ¶85), at least one fixation pin (406) suitable for being implanted in a bone material so as to ensure an at least partial reduction of a bone fracture, and locking means (440) designed to lock in position said at least one fixation pin implanted into said bone material, wherein said support structure comprises a locking aperture (42, FIG. 1) through the support structure's thickness, said locking aperture being centered on an aperture axis and being delimited by an aperture contour (FIG. 1), said locking aperture being adapted to be passed through by said at least one associated fixation pin (¶179), and wherein the locking means of the osteosynthesis device comprises a tightening means (440) designed to be fitted into said locking aperture and to come into abutment against a part of said at least one fixation pin in order to ensure its locking in position (¶179), wherein at least a part of said aperture contour is provided with an aperture thread (¶89), and wherein said tightening means consists of a locking nut (440) centered on a nut axis, said locking nut being delimited by an upper nut part provided with a recess (FIG. 43) adapted for the upper nut part's driving into rotation by means of a suitable tool, for the screwing or unscrewing, a lower nut part located at the opposite of said upper nut part, an outer peripheral envelope comprising a nut thread (at 442, FIG. 1) adapted to cooperate with said aperture thread of said locking aperture, said nut thread extending over the whole or almost the whole height of the outer peripheral envelope, and an inner contour (FIG. 43) delimiting an axial hole adapted for the passage of said at least one fixation pin, said locking nut also comprising a deformable tightening structure (442) adapted to be deformed when said locking nut is screwed into said aperture thread and to come into abutment against a part of said at least one fixation pin housed within said axial hole, wherein said tightening structure comprises a plurality of tightening tabs (between slots) regularly spaced apart over the periphery of said lower nut part, and separated from each other by slots extending in radial planes with respect to said nut axis (FIG. 43), each of said tightening tabs being deformable by bending about a bending axis perpendicular to said nut axis, the different bending axes of said tightening tabs being located in a same plane perpendicular to said nut axis, wherein the slots extend from the lower nut end over part of the height of the locking nut (¶181), wherein the aperture contour of the locking aperture and the outer peripheral envelope of the locking nut are configured so that: both have a generally frustoconical shape (FIGS. 1, 41), except with the aperture contour having a different apex angle than the outer peripheral envelope of the locking nut. It would have been obvious to one having ordinary skill in the art to form the angles differently in order to tighten the locking nut within the aperture. Lueth states that the locking nut “collapses” over the fixation pin when it is threaded into the bone plate (¶179), therefore it is understood that the locking nut is wedged into the locking aperture for the purpose of collapsing/bringing the tightening tabs together.
Regarding claim 7, Lueth discloses the osteosynthesis device according to claim 1, wherein said tightening structure comprises 2 to 4 of the tightening tabs (FIG. 43).
Regarding claims 9-10, Lueth discloses the osteosynthesis device according to claim 21, except wherein the first generally frustoconical shape of threaded portion of the locking aperture reflects an angle between 90 and 110 relative to a central axis of the locking aperture or wherein the first generally frustoconical shape of threaded portion of the locking aperture reflects an angle between 70 and 90 relative to a central axis of the locking aperture. It would have been obvious to one having ordinary skill in the art at the time the invention was made to construct the first generally frustoconical shape of threaded portion of the locking aperture reflecting an angle between 70 and 90 or between 90 and 110 relative to a central axis of the locking aperture, 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.
Regarding claim 11, Lueth discloses the osteosynthesis device according to claim 1, wherein said means that allow the fixation of the support structure to the bone material consist of at least one fixation aperture (32) arranged on said support structure, cooperating with a fixation screw (¶86).
Regarding claim 12, Lueth discloses the osteosynthesis device according to claim 11, wherein said support structure is in the form of an osteosynthesis plate comprising a plurality of fixation apertures and a plurality of locking apertures at least some of which are adapted to receive a fixation pin (FIG. 1).
Regarding claim 13, Lueth discloses the osteosynthesis device according to claim 12, wherein said fixation apertures and said locking apertures of the osteosynthesis plate are identical so as to each accommodate either a fixation screw or a fixation pin (FIG. 1).
Regarding claim 14, Lueth discloses the osteosynthesis device according to claim 1, wherein said tightening structure comprises 3 tightening tabs (FIG. 43).
Regarding claim 21, Lueth discloses an osteosynthesis device (¶179-181) comprising: a support structure (“bone plate” ¶179) comprising: a locking aperture (¶179) through the support structure's thickness, the locking aperture having a threaded portion (43, ¶89); a fixation aperture (32) separate from the locking aperture; a fixation pin (406) suitable for being implanted in a bone material; and a locking nut (440, FIGS. 41-43) comprising: external threads that are configured to engage the threaded portion of the locking aperture of the support structure (at 442, FIG. 41); an inner contour delimiting an axial hole configured to receive the fixation pin (FIG. 43); a recess (FIG. 43) on an upper portion of the locking nut, the recess being shaped to accept a corresponding tool to allow rotation of the locking nut with the external threads of the locking nut engaged with the threaded portion of the locking aperture of the support structure (FIG. 43); and slots (442) extending through a lower portion opposite the upper portion, the slots extending through a portion of the external threads and defining a plurality of tightening tabs such that the external threads are present on the tightening tabs (¶181); wherein the threaded portion of the locking aperture has a first generally frustoconical shape (FIG. 1), and the external threads of the locking nut have a second generally frustoconical shape (FIG. 41), and wherein the support structure, the fixation pin, and the locking nut are configured such that rotating the locking nut relative to the support structure with the external threads of the locking nut engaged with the threaded portion of the locking aperture, with the fixation pin present in the axial hole of the locking nut, causes the tightening tabs of the locking nut to tighten onto the fixation pin and to lock the fixation pin in position relative to the support structure (¶179-181). However, Lueth is silent regarding the first and second frustoconical shapes having different apex angles from one another. It would have been obvious to one having ordinary skill in the art to form the angles differently in order to tighten the locking nut within the aperture. Lueth states that the locking nut “collapses” over the fixation pin when it is threaded into the bone plate (¶179), therefore it is understood that the locking nut is wedged into the locking aperture for the purpose of collapsing/bringing the tightening tabs together.
Regarding claim 23, Lueth discloses the osteosynthesis device according to claim 21, wherein said locking nut comprises 2 to 4 of the tightening tabs (FIG. 43).
Regarding claims 24-25, Lueth discloses the osteosynthesis device according to claim 21, except wherein the first generally frustoconical shape of threaded portion of the locking aperture reflects an angle between 90 and 110 relative to a central axis of the locking aperture or wherein the first generally frustoconical shape of threaded portion of the locking aperture reflects an angle between 70 and 90 relative to a central axis of the locking aperture. It would have been obvious to one having ordinary skill in the art at the time the invention was made to construct the first generally frustoconical shape of threaded portion of the locking aperture reflecting an angle between 70 and 90 or between 90 and 110 relative to a central axis of the locking aperture, 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.
Regarding claim 26, Lueth discloses the osteosynthesis device according to claim 21, further comprising a fixation screw (“screws” ¶85) configured to engage with the fixation aperture of the support structure.
Regarding claim 27, Lueth discloses the osteosynthesis device according to claim 26, wherein said support structure is an osteosynthesis plate comprising a plurality of said fixation apertures and a plurality of said locking apertures (FIG. 1).
Response to Arguments
Applicant’s arguments with respect to claim 2 have been considered but are moot because the arguments do not apply to any of the references being used in the current rejection. The newly presented rejection was necessitated by the amendments to the claims of July 5, 2025.
Conclusion
THIS ACTION IS MADE FINAL. 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 extension fee 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 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