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 .
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Huebner (2013/0211468) in view of Sesic (6,517,541; cited by Applicant).
Regarding claim 1, Huebner discloses a system for compressing a first bone part and a second bone part separated by a fracture (Figs. 9 and 20; paras. 0044 and 0061), the system comprising:
a nail 710 having an elongate smooth portion 742 and an elongate threaded portion, the elongate smooth portion including a leading end of the nail (annotated Fig. 20, below; n.b. the leading and trailing ends are defined herein as shown in the annotated figure), and the elongate threaded portion including a trailing end of the nail (id.), the elongate threaded portion including a first end (id.) opposite the trailing end (id.) and a thread extending from the first end to the trailing end (id.), wherein the thread has a decreasing pitch from the first end to the trailing end (Fig. 20 and paras. 0038-0040, discussing the pitch decreasing toward the trailing end in section 624, then having an average pitch in section 628 that is less than the average pitch in section 624, and finally having a pitch in section 626 that is again smaller than the pitch in section 624 to generate axial compression).
Huebner disclose the claimed invention except for:
wherein the elongate threaded portion further includes a first aperture and a second aperture extending through a central axis of the nail, wherein a central axis of at least one of the first or second apertures is non-perpendicular to the central axis of the nail;
a first screw sized to be positioned through the first aperture; and
a second screw sized to be positioned through the second aperture,
wherein the first and second apertures are positioned along the elongate threaded portion such that, when the elongate threaded portion of the nail is installed across the fracture separating the first bone part and the second bone part, the first aperture is within the first bone part and the second aperture is within the second bone part.
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Sesic also teaches a nail 1 (e.g., Figs. 8, annotated Fig. 8 below, and Fig. 12A; col. 2, lines 34-37; col. 3, lines 35-37; col. 4, lines 25-28 and 40-42; col. 6, lines 30-39), and discloses providing a plurality of apertures, e.g., four apertures (Fig. 8), through a central axis of the elongated threaded portion of the nail at different angles thereto (Fig. 8; col. 4, lines 40-42; col. 6, lines 33-39) and corresponding screws (id.).
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Thus, within this teaching, Sesic discloses:
an elongate threaded portion (Figs. 8 and 12A) further including at least a first aperture, e.g., 13 (Fig. 8), and a second aperture, e.g., 12 (id.), extending through a central axis of the nail, wherein a central axis of at least one of the first or second apertures is non-perpendicular to the central axis of the nail (Fig. 8; col. 4, lines 40-42; col. 6, lines 33-39);
a first screw sized to be positioned through the first aperture (id.); and
a second screw sized to be positioned through the second aperture (id.),
wherein the first and second apertures are positioned along the elongate threaded portion such that, when the elongate threaded portion of the nail is installed across the fracture separating the first bone part and the second bone part, the first aperture is within the first bone part and the second aperture is within the second bone part (cf., e.g., Figs. 8 and 12A).
Sesic discloses that providing the plurality of apertures and corresponding screws provides additional rotary stability to maintain stability between the fractured bone parts with the purpose of creating optimal conditions for bone healing (col. 2, lines 34-37; col. 3, lines 35-37; col. 4, lines 25-28; col. 4, lines 40-42).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date to configure the elongate threaded portion of the nail of Huebner with a plurality of apertures, e.g., four apertures, and corresponding screws, including:
a first aperture and a second aperture extending through a central axis of the nail, wherein a central axis of at least one of the first or second apertures is non-perpendicular to the central axis of the nail;
a first screw sized to be positioned through the first aperture; and
a second screw sized to be positioned through the second aperture,
wherein the first and second apertures are positioned along the elongate threaded portion such that, when the elongate threaded portion of the nail is installed across the fracture separating the first bone part and the second bone part, the first aperture is within the first bone part and the second aperture is within the second bone part; in view of Sesic, to provide additional rotary stability to maintain stability between the fractured bone parts with the purpose of creating optimal conditions for bone healing.
Regarding claim 2, the nail of the combination comprises a plurality of apertures, including a third aperture extending through the central axis of the nail (annotated Fig. 8, supra; col. 4, lines 40-42; col. 6, lines 33-39).
Regarding claim 3, a central axis of the first aperture is at an angle to a central axis of the third aperture (id.).
Regarding claim 4, Sesic does not explicitly recite an angle between the central axes of the apertures between 10˚ and 40˚. However, Sesic appears to show such an angle (Fig. 8) and explicitly teaches that selection of an angle depends on local biomechanical needs and this contributes to more operative possibilities for free bone fragment stabilization.
Therefore, it would have been further obvious to a person having ordinary skill in the art before the effective filing date to provide the nail of the combination with an angle between the apertures of between 10˚ and 40˚, in view of Sesic, to address the local biomechanical needs of a particular patient, e.g., to make purchase with the most viable portion of bone, and to provide more operative possibilities for free bone fragment stabilization.
Regarding claim 5, the nail of the combination includes a plurality of apertures, including a fourth aperture extending through the central axis of the nail (annotated Fig. 8, supra).
Regarding claim 6, a central axis of the second aperture is at an angle to a central axis of the fourth aperture (as exemplified in Fig. 8, these apertures are shown as approximately perpendicular to a central axis of the nail, but Sesic clearly states and includes within its scope each angle being different (col. 4, lines 40-42 and col. 6, lines 33-39).
Regarding claim 7, Sesic does not explicitly recite an angle between the central axes of the apertures between 10˚ and 40˚. However, Sesic appears to show such an angle (Fig. 8) and explicitly teaches that selection of an angle depends on local biomechanical needs and this contributes to more operative possibilities for free bone fragment stabilization.
Therefore, it would have been further obvious to a person having ordinary skill in the art before the effective filing date to provide the nail of the combination with an angle between the apertures of between 10˚ and 40˚, in view of Sesic, to address the local biomechanical needs of a particular patient, e.g., to make purchase with the most viable portion of bone, and to provide more operative possibilities for free bone fragment stabilization.
Regarding claim 8, the third aperture and the fourth aperture are positioned along the elongate threaded portion (annotated Fig. 8, supra) such that, when the elongate threaded portion of the nail is installed across a fracture separating the first bone part and the second bone part (cf. also, e.g., Fig. 12A), the third aperture is capable of being positioned within the first bone part and the fourth aperture is capable of being positioned within the second bone part, if desired, e.g., to provide further stabilization to each bone fragment. It is noted that this limitation is considered to be a statement of intended use for which the nail of the combination is capable.
Regarding claim 9, the device is capable of being used in desired bone parts, including the first part including a first olecranon fragment, and the second bone part includes a distal ulna. With regard to size considerations, it is noted that the nail of Huebner is disclosed as being “useful in, for instance, interphalangeal fusion procedures” (para. 0061). Sesic teaches providing such a nail with apertures and screws for the reasons set forth above. Therefore, the resulting nail of the combination would be expected to be of a generally appropriately small size to be used in a first bone part including an olecranon fragment, and a second part including a distal ulna, as desired. This limitation is considered to be a statement of intended use for which the nail of the combination is capable.
Regarding claim 10, the trailing end of the nail 710 of Huebner, including as modified by Sesic, comprises a notch 30 (Fig. 20 and cf. Fig. 3 and see para. 0061).
Regarding claim 11, a central axis of the first aperture and a central axis of the second aperture are non-perpendicular to the central axis of the nail (as exemplified in Fig. 8, the central axis of the second aperture is shown as approximately perpendicular to a central axis of the nail, but Sesic clearly states and includes within its scope each angle being different, including being non-perpendicular to the central axis of the nail; col. 4, lines 40-42 and col. 6, lines 33-39).
Regarding claim 12, Huebner discloses a nail 710 for compressing a first bone part and a second bone part separated by a fracture (Figs. 9 and 20; paras. 0044 and 0061), the nail comprising:
an elongate smooth portion 742 and an elongate threaded portion, the elongate smooth portion including a leading end of the nail (annotated Fig. 20, supra; n.b. the leading and trailing ends are defined herein as shown in the annotated figure), and the elongate threaded portion including a trailing end of the nail (id.), the elongate threaded portion including a first end (id.) opposite the trailing end (id.) and a thread extending from the first end to the trailing end (id.), wherein the thread has a decreasing pitch from the first end to the trailing end (Fig. 20 and paras. 0038-0040, discussing the pitch decreasing toward the trailing end in section 624, then having an average pitch in section 628 that is less than the average pitch in section 624, and finally having a pitch in section 626 that is again smaller than the pitch in section 624 to generate axial compression).
Huebner disclose the claimed invention except for:
wherein the elongate threaded portion further includes a first aperture and a second aperture extending through a central axis of the nail, wherein a central axis of at least one of the first or second apertures is non-perpendicular to the central axis of the nail; and
wherein the first and second apertures are positioned along the elongate threaded portion such that, when the elongate threaded portion of the nail is installed across the fracture separating the first bone part and the second bone part, the first aperture is within the first bone part and the second aperture is within the second bone part.
Sesic also teaches a nail 1 (e.g., Figs. 8, annotated Fig. 8 supra, and Fig. 12A; col. 2, lines 34-37; col. 3, lines 35-37; col. 4, lines 25-28 and 40-42; col. 6, lines 30-39), and discloses providing a plurality of apertures, e.g., four apertures (Fig. 8), through a central axis of the elongated threaded portion of the nail at different angles thereto (annotated Fig. 8 above; col. 4, lines 40-42; col. 6, lines 33-39) for corresponding screws (id.).
Thus, within this teaching, Sesic discloses:
an elongate threaded portion (Figs. 8 and 12A) further including at least a first aperture, e.g., 13 (Fig. 8), and a second aperture, e.g., 12 (id.), extending through a central axis of the nail, wherein a central axis of at least one of the first or second apertures is non-perpendicular to the central axis of the nail (Fig. 8; col. 4, lines 40-42; col. 6, lines 33-39);
wherein the first and second apertures are positioned along the elongate threaded portion such that, when the elongate threaded portion of the nail is installed across the fracture separating the first bone part and the second bone part, the first aperture is within the first bone part and the second aperture is within the second bone part (cf., e.g., Figs. 8 and 12A).
Sesic discloses that providing the plurality of apertures and corresponding screws provides additional rotary stability to maintain stability between the fractured bone parts with the purpose of creating optimal conditions for bone healing (col. 2, lines 34-37; col. 3, lines 35-37; col. 4, lines 25-28; col. 4, lines 40-42).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date to configure the elongate threaded portion of the nail of Huebner with a plurality of apertures, e.g., four apertures, along with corresponding screws, the apertures including:
a first aperture and a second aperture extending through a central axis of the nail, wherein a central axis of at least one of the first or second apertures is non-perpendicular to the central axis of the nail;
wherein the first and second apertures are positioned along the elongate threaded portion such that, when the elongate threaded portion of the nail is installed across the fracture separating the first bone part and the second bone part, the first aperture is within the first bone part and the second aperture is within the second bone part; in view of Sesic, to provide additional rotary stability to maintain stability between the fractured bone parts with the purpose of creating optimal conditions for bone healing.
Regarding claim 13, the nail of the combination comprises a plurality of apertures, including a third aperture extending through the central axis of the nail (annotated Fig. 8, supra; col. 4, lines 40-42; col. 6, lines 33-39).
Regarding claim 14, a central axis of the first aperture is at an angle to a central axis of the third aperture (id.).
Regarding claim 15, Sesic does not explicitly recite an angle between the central axes of the apertures between 10˚ and 40˚. However, Sesic appears to show such an angle (Fig. 8) and explicitly teaches that selection of an angle depends on local biomechanical needs and this contributes to more operative possibilities for free bone fragment stabilization.
Therefore, it would have been further obvious to a person having ordinary skill in the art before the effective filing date to provide the nail of the combination with an angle between the apertures of between 10˚ and 40˚, in view of Sesic, to address the local biomechanical needs of a particular patient, e.g., to make purchase with the most viable portion of bone, and to provide more operative possibilities for free bone fragment stabilization.
Regarding claim 16, the nail of the combination includes a plurality of apertures, including a fourth aperture extending through the central axis of the nail (annotated Fig. 8, supra).
Regarding claim 17, a central axis of the second aperture is at an angle to a central axis of the fourth aperture (as exemplified in Fig. 8, these apertures are shown as approximately perpendicular to a central axis of the nail, but Sesic clearly states and includes within its scope each angle being different (col. 4, lines 40-42 and col. 6, lines 33-39).
Regarding claim 18, Sesic does not explicitly recite an angle between the central axes of the apertures between 10˚ and 40˚. However, Sesic appears to show such an angle (Fig. 8) and explicitly teaches that selection of an angle depends on local biomechanical needs and this contributes to more operative possibilities for free bone fragment stabilization.
Therefore, it would have been further obvious to a person having ordinary skill in the art before the effective filing date to provide the nail of the combination with an angle between the apertures of between 10˚ and 40˚, in view of Sesic, to address the local biomechanical needs of a particular patient, e.g., to make purchase with the most viable portion of bone, and to provide more operative possibilities for free bone fragment stabilization.
Regarding claim 19, the third aperture and the fourth aperture are positioned along the elongate threaded portion (annotated Fig. 8, supra) such that, when the elongate threaded portion of the nail is installed across a fracture separating the first bone part and the second bone part (cf. also, e.g., Fig. 12A), the third aperture is capable of being positioned within the first bone part and the fourth aperture is capable of being positioned within the second bone part, if desired, e.g., to provide further stabilization to each bone fragment. It is noted that this limitation is considered to be a statement of intended use for which the nail of the combination is capable.
Regarding claim 20, the trailing end of the nail 710 of Huebner, including as modified by Sesic, comprises a notch 30 (Fig. 20 and cf. Fig. 3 and see para. 0061).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure (see attached PTO-892).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID C COMSTOCK whose telephone number is (571)272-4710. The examiner can normally be reached M-F 9:00-5:00 PST.
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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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DAVID C. COMSTOCK
Examiner
Art Unit 3773
/DAVID C COMSTOCK/Examiner, Art Unit 3773
/JULIANNA N HARVEY/Primary Examiner, Art Unit 3773