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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore,
The non-parallel axes of claim 2 must be shown or the feature(s) canceled from the claim(s).
The “rectangular area …that does not intersect a proximal or distal edge of the channel within the range of deflection” of claims 8 and 17 must be shown or the feature(s) canceled from the claim(s).
The proximal and distal non-parallel axes of claim 11 must be shown or the feature(s) canceled from the claim(s).
No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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.
Claim(s) 1 – 5, 10 – 15 and 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Grady et al. (US 2012/0330313 A1).
Regarding claim 1, Grady discloses an intramedullary nail (Abstract) comprising:
a shank (ref. 1S, Fig. 1) with a centerline defined along a length thereof (the centerline is considered to be a central longitudinal axis); and
said shank having a channel (Fig. 14, ref. 350) with a channel axis perpendicular to the centerline (see remarked Fig. 14 below), the channel having an obround shape in a first cross-sectional plane perpendicular to the channel axis at the centerline (the first cross-section plane is best shown in the view of Fig. 4 which shows an obround profile in channels refs. 195, 95), and a tapered profile in a second cross-sectional plane containing the channel axis (the view of Fig. 14 is the second cross-section plane and shows the channel having a tapered profile), such that a portion of a proximal edge of the channel within the second cross- sectional plane forms a first angle relative to the channel axis (see remarked Fig. 14 below which shows a proximal portion or lower portion having an acute angle relative to the channel axis) and a distal edge of the channel within the second cross-sectional plane forms a second angle relative to the channel axis that is different from the first angle (see remarked Fig. 14 below which shows a distal portion or upper portion having a second angle that is zero or parallel to the channel axis),
wherein a first opening of the channel at a surface of the shank is a circular opening (see remarked Fig. 14 below which shows the first opening on the left side of the channel being circular), and
wherein a second opening of the channel at the surface of the shank is an obround opening (see remarked Fig. 14 below which shows the second opening on the right side of the channel being elongated and thus obround).
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Regarding claim 2, Grady discloses the intramedullary nail of claim 1, wherein opposed proximal and distal ends of the channel are each defined by a round surface extending along respective non-parallel axes, and opposed sides of the channel are planar and extend between the two round surfaces to define the obround shape (see remarked Figs. 4 and 14 below).
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Regarding claim 3, Grady discloses the intramedullary nail of claim 1, wherein the channel is internally threaded (Fig. 14, paragraph [0073]).
Regarding claim 4, Grady discloses the intramedullary nail of claim 2, wherein the two non-parallel axes each intersect the centerline (see remarked Fig. 14 above).
Regarding claim 5, Grady discloses the intramedullary nail of claim 2, wherein the first angle is non-zero and the second angle is zero (see remarked Fig. 14 above).
Regarding claim 10, Grady discloses the intramedullary nail of claim l, wherein the shank defines a bore extending along the centerline and dividing the channel into two aligned passages (Fig. 2, ref. “CH”).
Regarding claim 11, Grady discloses an intramedullary nail (Abstract) comprising:
a shank (ref. 1S, Fig. 1) with a centerline defined along a length thereof (the centerline is considered to be the central longitudinal axis); and
said shank having a channel (Fig. 14, ref. 350) with a channel axis perpendicular to the centerline (see remarked Fig. 14 below), the channel having an obround shape in a first cross-sectional plane perpendicular to the channel axis at the centerline (the first cross-section plane is best shown in the view of Fig. 4 which shows an obround profile in channels refs. 195, 95 which extends into the channel) and a tapered profile in a second cross-sectional plane containing the channel axis (the view of Fig. 14 is the second cross-section plane and shows the channel having a tapered profile), such that a portion of a proximal edge of the channel within the second cross- sectional plane forrns a first angle relative to the channel axis (see remarked Fig. 14 below which shows a proximal portion or lower portion having an acute angle relative to the channel axis) and a distal edge of the channel within the second cross-sectional plane forms a second angle relative to the channel axis that is different from the first angle (see remarked Fig. 14 below which shows a distal portion or upper portion having a second angle that is zero or parallel to the channel axis),
wherein opposed proximal and distal ends of the channel are each defined by a round surface extending along respective proximal and distal non-parallel axes, and opposed sides of the channel are planar and extend between the two round surfaces to define the obround shape (see remarked Fig. 4 below),
wherein a portion of the round surface of the proximal end of the first channel defines a half of a cylinder centered on the proximal axis (Fig. 4), and
wherein a portion of the round surface of the distal end of the first channel defines a half of a cylinder centered on the distal axis (Fig. 4).
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Regarding claim 12, Grady discloses the intramedullary nail of claim 11, wherein the channel is internally threaded (Fig. 14).
Regarding claim 13, Grady discloses the intramedullary nail of claim 11, wherein an extension portion of the channel defines a circular opening at a surface of the shank (see remarked Fig. 14 above).
Regarding claim 14, Grady discloses the intramedullary nail of claim 11, wherein the two non-parallel proximal and distal axes each intersect the centerline (see remarked Fig. 14 below).
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Regarding claim 15, Grady discloses the intramedullary nail of claim 11, wherein the first angle is non-zero and the second angle is zero (see remarked Fig. 14 above).
Regarding claim 20, Grady discloses the intrarnedullary nail of claim 1, wherein the shank defines a bore extending along the centerline and dividing the channel into two aligned passages. (Fig. 2, ref. “CH”).
Claim Rejections - 35 USC § 103
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 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) 6 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Grady et al. (US 2012/0330313 A1) in view of Mutchler (US 2006/0095039 A1).
Regarding claim 6, Grady discloses the intramedullary nail of claim 1, except wherein the obround opening feeds into the channel, and at least part of a perimeter of the obround opening is chamfered.
Regarding claim 16, Grady discloses the intramedullary nail of claim l1, wherein the nail includes an obround opening in the shank that feeds into the channel (Figs. 14, 4), but is silent that at least part of a perimeter of the obround opening is chamfered.
Mutchler teaches an analogous intramedullary nail (Abstract) comprising a channel (ref. 152, paragraph [0105]), and at least part of a perimeter of the channel is chamfered (paragraph [0105], Fig. 2). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify at least part of a perimeter of the obround opening to be chamfered, as taught by Mutchler, for the purpose of better guiding a fastener into the channel (paragraph [0105]).
Claim(s) 7 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Grady et al. (US 2012/0330313 A1).
Regarding claim 7, Grady discloses the intramedullary nail of claim 2, except wherein an angle between the two non- parallel axes is between 3° and 7°.
Regarding claim 17, Grady discloses the intramedullary nail of claim 11, except wherein an angle between the two non- parallel proximal and distal axes is between 3 and 7 degrees.
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 channel of Grady such that the angle between the two non-parallel axes is between 3 and 7 degrees to balance a wide enough opening to receive a fastener and guide it without infringing upon the insertion of the fastener and 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.
Claim(s) 8, 9, 18 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Grady et al. (US 2012/0330313 A1) in view of Philips (US 2002/0111629 A1).
Regarding claim 8, Grady discloses the intramedullary nail of claim 1, except wherein: the shank is capable of elastic deformation across a range of deflection on the second cross-sectional plane,
a ratio of a distance travelled by a distal tip of the shank between opposite ends of the range of deflection to a total length of the nail being at least 1:30; and
a rectangular area exists on the second cross-sectional plane that does not intersect a proximal or distal edge of the channel at any position of the shank within the range of deflection.
Regarding claim 18, Grady discloses the intramedullary nail of claim 11, except wherein: the shank is capable of elastic deformation across a range of deflection on the second cross-sectional plane,
a ratio of a distance travelled by a distal tip of the shank between opposite ends of the range of deflection to a total length of the nail being at least 1:30; and
a rectangular area exists on the second cross-sectional plane that does not intersect a proximal or distal edge of the channel at any position of the shank within the range of deflection.
Phillips teaches an analogous intramedullary nail (Abstract, Fig. 2) wherein a shank (ref. 22) is capable of elastic deformation across a range of deflection on the second cross-sectional plane (paragraph [0029]) to permit accurate placement within the surgical site (paragraph [0029]). 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 nail of Grady to include the elasticity, as taught by Phillips, for the purpose of better accurate placement of the nail. Please note that Phillips teaches both distal and proximal bending (Fig. 3), in the case of the opposing end being bent relative to the end comprising the channel, then a rectangular area exists on the second cross-sectional plane that does not intersect a proximal or distal edge of the channel at any position of the shank within the range of deflection.
Regarding the limitation of a ratio of a distance travelled by a distal tip of the shank between opposite ends of the range of deflection to a total length of the nail being at least 1:30. 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 elasticity/bending and the length of the nail such that a ratio of a distance travelled by a distal tip of the shank between opposite ends of the range of deflection to a total length of the nail being at least 1:30, 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.
Regarding claim 9, Grady in view of Philips discloses the intramedullary nail of claim 8, except wherein the ratio of the range of deflection of the distal tip of the shank to the total length of the nail is 1:24.
Regarding claim 19, Grady in view of Philips discloses the intramedullary nail of claim 18, except wherein the ratio of the range of deflection of the distal tip of the shank to the total length of the nail is 1:24.
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 elasticity/bending and the length of the nail such that a ratio of a distance travelled by a distal tip of the shank between opposite ends of the range of deflection to a total length of the nail being at least 1:24, 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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892 which list the prior art used in the current rejection.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TESSA M MATTHEWS whose telephone number is (571)272-8817. The examiner can normally be reached M - F 8am - 1pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Eduardo Robert can be reached at (571) 272-4719. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TESSA M MATTHEWS/ Examiner, Art Unit 3773