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 .
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the claims at issue are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
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Claim(s) 21, 24 and 29 is/are rejected on the ground of nonstatutory double patenting as being anticipated by claim(s) 7 of U.S. Patent No. 12207849. Although the claims at issue are not identical, they are not patentably distinct from each other because the difference between the application claims and the patent claims lies in the fact that the patent claims include many more elements and are thus much more specific as shown below (note that underlined and/or bolded sections indicate comparable elements):
Invention: 19/001853
US Patent 12207849
21. A set screw assembly having a longitudinal axis for intramedullary fracture fixation devices, comprising: a set screw including a body with an external thread; and a housing including a sidewall defining a cavity for receiving the set screw, wherein a lower portion of the housing comprises a distal end and medial and lateral protrusions extending from opposite sides of the distal end, wherein when the set screw is at least partially disposed within the cavity, the set screw is secured to the housing and rotatable about the longitudinal axis relative to the housing, and wherein a length measured along the longitudinal axis from a proximal end of the housing to an end of the lateral protrusion is longer than a length measured along the longitudinal axis from the proximal end of the housing to an end of the medial protrusion.
7. A set screw assembly having a longitudinal axis for intramedullary fracture fixation devices, comprising: a set screw including a body with an external thread and an elastic member extending from the body, the elastic member having an uncompressed condition and a compressed condition; and a housing including a sidewall and first and second end walls extending from the sidewall in a transverse direction to the longitudinal axis, wherein the sidewall partially surrounds the longitudinal axis, and the combination of the first end wall, the second end wall, and the sidewall defines a cavity sized and configured to receive the set screw, wherein when the elastic member is in the compressed condition, the cavity is configured to allow the set screw to be inserted into the cavity, wherein when the set screw is inserted into the cavity and disposed within the cavity, the cavity is configured such that the elastic member is in the uncompressed condition and that the set screw is secured to the housing and rotatable about the longitudinal axis relative to the housing, and wherein the sidewall of the housing defines an aperture and a portion of the external thread of the set screw extends through the aperture and protrudes outside of the cavity when the set screw is secured to the housing; wherein a lower portion of the housing comprises at least one protrusion extending distally from a distal end of the housing; wherein the at least one protrusion comprises a medial protrusion having a first length and a lateral protrusion having a second length longer than the first length.
24. The set screw assembly of claim 21, wherein the lateral protrusion extends further in a distal direction than the medial protrusion.
Claim 7 (see bolded section)
29. The set screw assembly of claim 21, wherein a portion of the external thread of the set screw extends outside of the cavity when the set screw is secured to the housing.
Claim 7 (see bolded section)
Thus, the invention of US Patent 12207849, claim 7, respectively, are in effect a “species” of the “generic” invention of the application claims. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since the application claims are anticipated by the patent claims, they are not patentably distinct from the patent claims.
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) 21-25, 29 and 31-33 is/are rejected under 35 U.S.C. 102a1as being anticipated by Frank (US 20080294164).
With respect to claim 21, Frank discloses a set screw assembly (180+160, see para. 66, 71) having a longitudinal axis (A2, along 182) for intramedullary fracture fixation devices, comprising: a set screw (180) including a body with an external thread (184); and a housing (160) including a sidewall defining a cavity for receiving the set screw (see fig. 14c below), wherein a lower portion of the housing comprises a distal end (see fig. 9a below) and medial and lateral protrusions extending from opposite sides of the distal end (see fig. 9a below), wherein when the set screw is at least partially disposed within the cavity (see fig. 17b below), the set screw is secured to the housing and rotatable about the longitudinal axis relative to the housing (see para. 75), and wherein a length measured along the longitudinal axis from a proximal end of the housing to an end of the lateral protrusion is longer than a length measured along the longitudinal axis from the proximal end of the housing to an end of the medial protrusion (see fig. 9a below).
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As for claim 22, Frank further discloses the set screw assembly of claim 21, wherein the distal end of the housing is angled obliquely with respect to the longitudinal axis of set screw assembly (see fig. 9a above).
As for claim 23, Frank further discloses the set screw assembly of claim 21, wherein the distal end of the housing is formed by one or more outwardly tapered surfaces (see fig. 9a above and note the surfaces indicated at the medial and lateral protrusions, e.g., at 178).
As for claim 24, Frank further discloses the set screw assembly of claim 21, wherein the lateral protrusion extends further in a distal direction than the medial protrusion (see fig. 9a above).
As for claim 25, Frank further discloses the set screw assembly of claim 21, wherein the housing and the set screw are cannulated such that the set screw assembly is configured to receive a guide wire (see fig. 6a above and note that these elements are capable of performing this function if one so desires).
As for claim 29, Frank further discloses the set screw assembly of claim 21, wherein a portion of the external thread of the set screw extends outside of the cavity when the set screw is secured to the housing (see fig. 16).
As for claim 31, Frank further discloses the set screw assembly of claim 21, wherein the lateral protrusion comprises a chamfer extending in a lateral-to-medial direction (see fig. 9a, 9b, 14a).
As for claim 32, Frank further discloses the set screw assembly of claim 21, wherein each of the medial and lateral protrusions forms a curved shape when viewed from a medial-and-lateral direction, respectively (see fig. 9a, 9b, 14a, 16).
As for claim 33, Frank further discloses the set screw assembly of claim 32, wherein the curved shape substantially comprises a parabola (see fig. 9a, 9b, 14a, 16).
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) 34-36 and 38-40 is/are rejected under 35 U.S.C. 103 as being unpatentable over Frank (US 20080294164) in view of Prien (WO2016190842A1).
With respect to claims 34-36, Frank teaches an intramedullary fracture fixation device, comprising: an intramedullary nail (102) having a proximal portion (e.g., head) adjacent a proximal end (112) and a distal portion (e.g., tail) adjacent a distal end (114, see para. 67), the proximal portion defining an angulated opening (e.g., to receive 104, see fig. 10), and an axial bore (113) extending through the proximal end of the intramedullary nail and into the angulated opening (see fig. 4), the axial bore having a longitudinal axis (A, see para. 67), an internal threading (115, see para. 75), and at least one slot extending substantially parallel to the longitudinal axis (see fig. 4a, note tool notch); a neck screw (e.g., 142) configured to extend through the angulated opening; and a set screw assembly (180+160) configured to be disposed within the axial bore of the intramedullary nail, the set screw assembly comprising: a housing (160) including an upper portion and a lower portion (see fig. 14c above), the upper portion including a first end wall, a second end wall, and a sidewall collectively defining a cavity (see fig. 14c above), wherein the lower portion of the housing comprises a distal end and medial and lateral protrusions extending from the distal end (see fig. 9a above); and a set screw (180) configured to be partially disposed within the cavity of the housing and having an external threading (see fig. 6a above), wherein when the set screw is partially disposed within the cavity of the housing and the set screw assembly is disposed within the axial bore of the intramedullary nail (see fig. 17b above), the external threading of the set screw is engaged with internal threading of the axial bore such that rotation of the set screw rotates the set screw about the longitudinal axis and relative to the housing and causes the set screw assembly to move along the longitudinal axis (see para. 75), and wherein when the set screw assembly is moved along the longitudinal axis and into contact with the neck screw (see fig. 12); and the lateral protrusion engages the neck screw (see fig. 12).
Frank does not teach the neck screw having an exterior surface with a groove; and the lateral protrusion engages a bottom surface of the groove of the neck screw and the medial protrusion extends partially into groove but does not engage the bottom surface of the groove; wherein the exterior surface of the neck screw defines a plurality of grooves extending in a direction substantially parallel to a longitudinal axis of the neck screw; and wherein the groove defines a rising ramp having a shallow end and a deep end, the rising ramp extending from a rear portion of neck screw toward a front portion of the neck screw.
Prien, also drawn to set screw assemblies and intramedullary nails (see abstract), teaches a neck screw (14) having an exterior surface with a groove (56); and the screw assembly lateral protrusion engages a bottom surface of the groove of the neck screw and the set screw assembly medial protrusion extends partially into groove but does not engage the bottom surface of the groove (see fig. and enlarged fig. 3 below); wherein the exterior surface of the neck screw defines a plurality of grooves (56) extending in a direction substantially parallel to a longitudinal axis of the neck screw (see fig. 7a); and wherein the groove defines a rising ramp having a shallow end and a deep end, (see para. 47, 64) the rising ramp extending from a rear portion of neck screw toward a front portion of the neck screw (see fig. 7a and para. 47 and 64) in order to prevent uncontrolled medial sliding of the neck screw within the intramedullary nail (see para. 47 and 64).
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It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Frank with the neck screw having an exterior surface with a groove; and the lateral protrusion engages a bottom surface of the groove of the neck screw and the medial protrusion extends partially into groove but does not engage the bottom surface of the groove; wherein the exterior surface of the neck screw defines a plurality of grooves extending in a direction substantially parallel to a longitudinal axis of the neck screw; and wherein the groove defines a rising ramp having a shallow end and a deep end, the rising ramp extending from a rear portion of neck screw toward a front portion of the neck screw, in view of Prien, in order to prevent uncontrolled medial sliding of the neck screw within the intramedullary nail.
As for claim 38, Frank, as modified by Prien, further teaches the device of claim 33, wherein a transverse cross-section of the upper portion of the housing is greater than a transverse cross-section of the lower portion of the housing (see fig. 5E) forming a ledge (key 161) at a junction between the upper and lower portions of the housing (see fig. 5E and also para. 74).
As for claim 39, Frank, as modified by Prien, further teaches the device of claim 36, wherein the proximal portion of the intramedullary nail includes a seat (111) projecting inwardly into the axial bore for contacting the ledge of the housing and limiting distal movement of the housing within the axial bore (see para. 74, fig. 1A).
As for claim 40, Frank, as modified by Prien, further teaches the device of claim 34, wherein the set screw comprises an elastic member (188- see fig. 6a above) having an uncompressed condition and a compressed condition (see para. 75), and the set screw is sized such that insertion of the set screw into the cavity causes the elastic member to contact one of the first or second end walls and transition to the compressed condition (see para. 75).
Reasons for Allowance
The following is a statement of reasons for the indication of allowable subject matter:
The claims in the instant application have not been rejected using prior art because no references, or reasonable combination thereof, could be found which disclose, or suggest, the claimed combination of limitations recited in independent claim 21. In particular, none of the cited references teach or suggest the set screw assembly including wherein the elastic member comprises a cantilever flange having a first end attached to a terminal end of the body and a second end disposed above the terminal end of the body such that a gap is formed between the second end of the cantilever flange and the terminal end of the body, as required by claim 26.
The claims in the instant application have not been rejected using prior art because no references, or reasonable combination thereof, could be found which disclose, or suggest, the claimed combination of limitations recited in independent claim 21. In particular, none of the cited references teach or suggest theset screw assembly including wherein when the elastic member is in the uncompressed condition, the set screw has a length in a direction along the longitudinal axis that is greater than a distance between the first and second end walls, and when the elastic member is in the compressed condition, the length of the set screw in the direction along the longitudinal axis is equal to or less than the distance between the first and second end walls, as required by claims 27-28.
The claims in the instant application have not been rejected using prior art because no references, or reasonable combination thereof, could be found which disclose, or suggest, the claimed combination of limitations recited in independent claim 21. In particular, none of the cited references teach or suggest the set screw assembly including wherein the sidewall of the housing defines a plurality of discrete apertures and a portion of the external thread of the set screw extends through each of the apertures when the set screw is secured to the housing, as required by claim 30.
The claims in the instant application have not been rejected using prior art because no references, or reasonable combination thereof, could be found which disclose, or suggest, the claimed combination of limitations recited in independent claim 34. In particular, none of the cited references teach or suggest wherein a transverse cross-section of the upper portion of the housing is a polygon with at least one vertex positioned within the at least one slot to prevent rotation of the housing relative to the intramedullary nail when the set screw is rotated, as required by claim 37.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Allowable Subject Matter
Claims 26-28, 30 and 37 are 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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: US 20100249781 (see figs. 3 and 7).
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/TARA ROSE E CARTER/Examiner, Art Unit 3773 /EDUARDO C ROBERT/Supervisory Patent Examiner, Art Unit 3773