DETAILED ACTION
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.
Claim 13 is 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.
Regarding claim 13, “the undercuts” lacks clear antecedent basis, as claim 1, from which claim 13 depends, recites “at least one undercut”, and it is unclear if claim 13 requires multiple undercuts to be configured with the recited radius of curvature, or at least one undercut. For the purpose of examination, the latter is assumed.
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.
Claims 1 and 12-16 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2010/0121327 (Velikov).
Regarding claim 1, Velikov discloses a trochanteric nailing system (10), comprising: a trochanteric nail (14) configured for intramedullary insertion into a femur of a patient to address a hip fracture (see paragraphs [0023] and [0024] and Fig. 1); and a trochanteric nail fixation device (16) operatively connectable to the trochanteric nail (see Fig. 1 and paragraph [0024]), wherein the trochanteric nail fixation device comprises a lag screw (16; see paragraph [0023]) configured to be rotatably advanced into the femur and engage bone matter adjacent to the lag screw in response to torque applied thereto (see paragraph [0053], e.g.), wherein the lag screw has a head (32) and a tip (30) formed at opposite ends of the lag screw and a shaft (36) extending at least partially between the head and the tip (see Fig. 2); a helical thread (46) disposed on the outer surface of the shaft, extending longitudinally at a distal location from the head to terminate at the tip (see Fig. 2), the thread having a root (50’, see Fig. 9) located radially proximal to the outer surface of the shaft, the thread further having thread sides (52’/54’) extending laterally from the root to terminate in a thread crest (56’), whereby the root and the thread crest corresponding to the minor and major diameters of the thread (see Fig. 9), the thread sides corresponding, respectively, to leading and trailing edges of the thread (see Fig. 9); wherein at least one of the thread sides having a facet that extends outwardly and downwardly from a top surface of the thread crest towards the root (see marked-up Fig. 9 below, surface below axis 39’ and above concavity 52’ extending outwardly and downwardly), and a concavity extending inwardly and downwardly toward the root, the concavity forms at least one undercut (see concavity in side 52’ extending inwardly and downwardly, Fig. 9 and paragraph [0037]); wherein the thread is characterized by a predetermined pitch selected relative to the bone matter to enable engagement of the bone matter adjacent the lag screw by the undercut (see paragraphs [0030] and [0031]), whereby, in response to a lateral force in a given force direction on the lag screw after insertion into the femur, the bone matter engages in portions of the undercut located opposite the given force direction to resist the lateral force (see paragraphs [0030], [0031], [0037], and [0042]; bone engaged in concave undercut of thread facilitates resistance of lateral movement of the screw 16).
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Further regarding claim 1, Velikov the embodiment of Figure 9 is silent regarding the top surface of the thread crest being generally parallel to the outer surface of the shaft. However, another embodiment of Velikov discloses a top surface of the crest (56’’) being generally parallel to an outer surface of a shaft (36’’) (see Fig. 10 and paragraph [0038]). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to make the top surface of the crest generally parallel to an outer surface of the shaft, as Velikov suggests a crest angle of 0 degrees is one of many angles suitable for a thread in an nail fixation device (see Velikov, paragraph [0038]).
Regarding claim 12, Velikov discloses wherein the thread comprises a single start thread (see Fig. 2; threading 46 shown as a single start thread with no disclosure of a double threading).
Regarding claim 13, Velikov appears to discloses wherein the major and minor diameters define a thread height and wherein the undercuts are configured with a radius of curvature selected to extend the undercut across a distance of at least 75% of the thread height (see Fig. 9; concavity shown extending across a distance of at least 75% of the thread height). Alternatively, it would have been obvious to have the undercut extend across the recited distance range to optimize the threaded engagement with bone, as it has been held 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. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Additionally, there is no evidence in the record of the criticality of the recited range. See In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.).
Regarding claim 14, Velikov discloses wherein the undercut has an outer undercut tip located proximate to the crest of the thread (see Fig. 9; tip of concavity in side 52’ nearest crest 56’).
Regarding claim 15, Velikov discloses wherein the thread (46) is male (see Fig. 2; thread 46 is an external, male thread).
Regarding claim 16, Velikov discloses wherein the thread is selected from at least one of a right-hand thread and a left-hand thread (threads have to be either right handed or left handed; thus, thread 46 is at least one of right handed and left-handed).
Claims 2-4 are rejected under 35 U.S.C. 103 as being unpatentable over Velikov in view of U.S. Patent Application Publication No. 2021/0259842 (Feng).
Regarding claim 2, Velikov is silent regarding wherein the threadform comprises two concavities, one on each of the lateral sides of the threadform to create two undercuts, one on each of the leading edge and the trailing edge, and two facets one on each of the leading edge and trailing edge. However, Feng discloses a bone implant device (10-2) having a threadform (11-2), wherein the threadform comprises two undercuts (16-X-A-2 and 12-X-B-2), one on each of a leading edge and trailing edge of the threadform, to create two respective undercuts on each of the leading edge and trailing edge (see Fig. 43 and paragraph [0323]; undercut surfaces can be curved). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the threadform of Velikov to comprise two concavity undercuts, one on each edge of the threadform, as suggested by Feng in order to allow bone to fill undercuts on both sides of the threadworm (see Feng, paragraph [0324]) in order to facilitate keeping the implant device stationary in bone without weakening the bone (see Feng, paragraphs [0002]-[0017]). As Figure 9 of Velikov suggests using an outwardly and downwardly extending facet extending from the crest to help define the concavity, it would have been obvious to include two facets, one on each of the leading edge and trailing edge, to help define each concavity undercut.
Regarding claim 3, Velikov discloses wherein the thread is located to extend longitudinally on the shaft over a predetermined surgical insertion length less than the length of the shaft between the head and the tip (see Fig. 2 of Velikov; thread 46 only extends over a predetermined, partial length of the shaft), while Feng suggests the undercuts extend on the helical thread over the length of the threadform (see Fig. 43 of Feng).
Regarding claim 4, Velikov discloses wherein the surgical length and the thread extending over the surgical length define a lateral profile oriented to oppose the lateral force when applied to the lateral profile (see Figs. 1 and 2 and paragraphs [0030], [0031], [0037], and [0042]; bone engaged in concave undercut of thread facilitates resistance of lateral movement of the screw 16).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Velikov in view of Feng, and further in view of U.S. Patent No. 6,503,252 (Hansson). Regarding claim 5, Velikov is silent regarding wherein the threadform comprises a centerline and comprises a variable cross-sectional width over adjacent courses of the thread, the width increasing from the tip toward the head of the shaft to increase compression of the bone matter during insertion of the lag screw. However, Hansson discloses a bone screw (6) comprising a threadform (16) that comprises a centerline and comprises a variable cross-sectional width over adjacent courses of the thread (variable cross-section width of thread as shown by b1-b8, see Fig. 2 and col. 3, lines 37-48), the width increasing from a tip toward a head of the screw (see Fig. 2 and col. 3, lines 37-48) to increase compression of the bone matter during insertion of the screw (see col. 1, lines 63-67). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the threadform of Velikov to have an increasing, variable width as suggested by Hansson in order to facilitate fixation of the screw and bone fracture by increasing compression of bone matter during insertion of the screw (see Hansson, col. 1, lines 63-67).
Claims 7-9 are rejected under 35 U.S.C. 103 as being unpatentable over Velikov in view of U.S. Patent Application Publication No. 2021/0153911 (Stuart).
Regarding claims 7-9, Velikov discloses wherein threadform is characterized by a first pitch (see Fig. 2; pitch of thread 46), but is silent regarding wherein the lag screw further comprises at least one flute extending helically with a second pitch, the second pitch being a coarser pitch than the first pitch of the thread to define channels extending through respective thread sides at corresponding radial locations which differ between adjacent courses of the thread (claim 7); further comprising three helical flutes having three corresponding flute starts at angular spaced locations about the shaft (claim 8); and, wherein the three flutes are defined at three, corresponding arcuately spaced locations in a 360 degree turn of the thread (claim 9). However, Stuart discloses a bone implant (700) having a threadform (see paragraph [0066] and Fig. 7) having a first pitch, the implant further comprises at least one flute (770) extending helically with a second pitch (see Fig. 7), the second pitch being a coarser pitch than the first pitch of the thread to define channels extending through respective thread sides at corresponding radial locations which differ between adjacent courses of the thread (see Fig. 7; flutes have a larger pitch than the threading and define channels that extend through the thread at different locations between adjacent courts of the thread); and further comprising three helical flutes (770a-770c) having three corresponding flute starts at angular spaced locations about the shaft (see Fig. 7; spaced starts for each flute 770a-770c); and, wherein the three flutes are defined at three, corresponding arcuately spaced locations in a 360 degree turn of the thread (see Fig. 7; flutes 770a-770c are defined at three arcuately spaced locations in a 360 degree turn of the thread). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the lag screw of Velikov to have three flutes as suggested by Stuart in order to facilitate cutting of bone material and anchoring of the screw in bone.
Claims 10, 11, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Velikov in view of U.S. Patent No. 5,176,681 (Lawes).
Regarding claim 10, Velikov discloses wherein the trochanteric nail further comprises an outer, cylindroid surface (outer surface of nail 14, see Fig. 1) characterized by a longitudinal axis and a cross-sectional diameter (see Fig. 1; nail 14 has a longitudinal axis and a cross-sectional diameter), the nail having portions defining a bore (20) extending transversely and diametrically through the shaft at an angle to the longitudinal axis (see Fig. 1), the bore sized to receive the lag screw therethrough (see paragraph [0024] and Fig. 1).
Further regarding claim 10 and regarding claim 11, Velikov is silent regarding wherein the system further comprises a set screw interconnectable between the nail and the screw, wherein the lag screw is operatively connectable to the trochanteric nail by locking of the set screw to the lag screw after insertion of the lag screw through the bore in the trochanteric nail; wherein the lag screw further comprises at least one set screw groove defined in the lag screw shaft by a pair of radially inwardly extending, opposing groove sidewalls extending longitudinally at a location on the outer surface of the shaft that is proximal to the thread when the lag screw is oriented for insertion (claim 10); and further comprising four of the set screw grooves defined at spaced angular locations on the cylindrical surface of the nail (claim 11). However, Lawes discloses an intertrochaneteric fracture fixation system including a nail (1) and a screw (5), wherein the system further comprises a set screw (4) interconnectable between the nail and the screw, wherein the lag screw is operatively connectable to the trochanteric nail by locking of the set screw to the lag screw after insertion of the lag screw through a bore (2) in the trochanteric nail (see col. 5, line 33 – col. 6, line 19); wherein the lag screw further comprises at least one set screw groove (7) defined in the lag screw shaft by a pair of radially inwardly extending, opposing groove sidewalls (see Fig. 1; sidewalls of groove 7) extending longitudinally at a location on the outer surface of the shaft that is proximal to a thread (6) when the lag screw is oriented for insertion (see Fig. 1); and further comprising four of the set screw grooves defined at spaced angular locations on the cylindrical surface of the nail (see Fig. 1 and col. 3, line 66 – col. 4, line 15). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the system to include a set screw and corresponding set screw grooves as suggested by Lawes in order to facilitate securing of the lag screw against rotation and facilitate final locking of the lag screw in the bone (see Lawes, col. 5, line 33 – col. 6, line 19).
Regarding claim 17, Velikov discloses a trochanteric nailing system (10), comprising: a trochanteric nail (14) configured for intramedullary insertion into a femur of a patient to address a hip fracture (see paragraphs [0023] and [0024] and Fig. 1); and a trochanteric nail fixation device (16) operatively connectable to the trochanteric nail (see Fig. 1 and paragraph [0024]), wherein the trochanteric nail fixation device comprises a lag screw (16; see paragraph [0023]) configured to be rotatably advanced into the femur and engage bone matter adjacent to the lag screw in response to torque applied thereto (see paragraph [0053], e.g.), wherein the lag screw has a head (32) and a tip (30) formed at opposite ends of the lag screw and a shaft (36) extending at least partially between the head and the tip (see Fig. 2); a helical thread (46) disposed on the outer surface of the shaft, extending longitudinally at a distal location from the head to terminate at the tip (see Fig. 2), wherein the trochanteric nail further comprises an outer, cylindroid surface (outer surface of nail 14, see Fig. 1) characterized by a longitudinal axis and a cross-sectional diameter (see Fig. 1; nail 14 has a longitudinal axis and a cross-sectional diameter), the nail having portions defining a bore (20) extending transversely and diametrically through the shaft at an angle to the longitudinal axis (see Fig. 1), the bore sized to receive the lag screw therethrough (see paragraph [0024] and Fig. 1).
Further regarding claim 17, Velikov is silent regarding wherein the system further comprises a set screw interconnectable between the nail and the screw, wherein the lag screw is operatively connectable to the trochanteric nail by locking of the set screw to the lag screw after insertion of the lag screw through the bore in the trochanteric nail; wherein the lag screw further comprises four set screw grooves defined in the lag screw shaft by respective pairs of radially inwardly extending, opposing groove sidewalls extending longitudinally at a location on the outer surface of the shaft that is proximal to the thread when the lag screw is oriented for insertion; wherein the pair of groove sidewalls taper in the distal direction increase engagement with opposing portions of the set screw when received in a selected one of the set screw grooves. However, Lawes discloses an intertrochaneteric fracture fixation system including a nail (1) and a screw (5), wherein the system further comprises a set screw (4) interconnectable between the nail and the screw, wherein the lag screw is operatively connectable to the trochanteric nail by locking of the set screw to the lag screw after insertion of the lag screw through a bore (2) in the trochanteric nail (see col. 5, line 33 – col. 6, line 19); wherein the lag screw further comprises four set screw grooves (7; see Fig. 1 and col. 3, line 66 – col. 4, line 15) defined in the lag screw shaft by respective pairs of radially inwardly extending, opposing groove sidewalls (see Fig. 1; sidewalls of each groove 7) extending longitudinally at a location on the outer surface of the shaft that is proximal to a thread (6) when the lag screw is oriented for insertion (see Fig. 1); wherein the pair of groove sidewalls taper in the distal direction to increase engagement with opposing portions of the set screw when received in a selected one of the set screw grooves (see claim 34). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the system to include a set screw and corresponding set screw grooves as suggested by Lawes in order to facilitate securing of the lag screw against rotation and facilitate final locking of the lag screw in the bone (see Lawes, col. 5, line 33 – col. 6, line 19 and claim 34).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Velikov in view of U.S. Patent Application Publication No. 2016/0346024 (Overes).
Alternatively regarding claim 12, Overes discloses a threaded bone screw (21 or 40) wherein the thread comprises a single start thread (see paragraph [0021]), and it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to have the thread comprise a single start thread as Overes suggests such a thread is suitable for fixation of a screw in a femoral head (see Fig. 1 and paragraph [0021]).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Velikov in view of Hansson.
Alternatively regarding claim 16, Hansson discloses that a bone screw threading may be right-handed or left-handed depending on whether the screw will be inserted in the right or left leg of a patient (see Hansson, col. 4, lines 22-26). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to have the screw threading be right-handed or left-handed in order to optimize the threading for insertion in the right or left leg (see Hansson, col. 4, lines 22-26).
Allowable Subject Matter
Claim 18 is allowed.
Response to Arguments
Applicant’s arguments with respect to claims 1-5 and 7-16 have been considered but are moot in view of the new grounds of rejection.
Applicant's arguments with respect to claim 17 have been fully considered but they are not persuasive.
Applicant argues on page 11 of the Remarks that Lawes fails to suggest grooves that have sidewalls that taper in the distal direction to increase engagement with opposing portions of a set screw. The Examiner disagrees. As shown in Fig. 4, each of the sidewalls tapers in depth as a respective groove travels in the distal direction. Claim 17 does not require the sidewalls to taper in width such that they converge or diverge from each other; so long as the sidewalls taper in the distal direction, the claim reads on the prior art.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 nonprovisional extension fee (37 CFR 1.17(a)) 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 NICHOLAS J PLIONIS whose telephone number is (571)270-3027. The examiner can normally be reached on Monday - Friday, 9:00 a.m. - 5:00 p.m. EST.
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/NICHOLAS J PLIONIS/Primary Examiner, Art Unit 3773
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