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 .
Status of Claims
Claims 1-17 are pending and examined below.
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) 1-3, 6, 14, 15, and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2022/0241077 (‘077) in view of US 2012/0209392 (Angibaud)
Regarding claim 1, ‘077 discloses a glenoid implant (Figs. 2 and 19) for implantation into a glenoid of a patient during an orthopaedic surgical procedure (¶0002), comprising:
a baseplate (Fig. 4, 102) comprising a plate with a top surface (Fig. 4, 110) and a bottom surface (Fig. 4, 112), the plate having: (i) a central opening (Fig. 4, 114) extending into the plate from the top surface (see Fig. 4), and (ii) a plurality of screw holes (Fig. 4, 118) extending from the top surface to the bottom surface of the plate (see Fig. 4), the plurality of screw holes being positioned circumferentially around the plate (see Fig. 4, wherein holes 118 are positioned circumferentially around plate 102),
a shaft (Fig. 3, 104) coupled to and extending downwardly away from a center of the bottom surface of the plate (see Fig. 3), the shaft having a number of threads formed in an outer surface thereof (Fig. 3, wherein 104 has outer threads),
an augmentation member (Fig. 22, 200) extending downwardly away from the bottom surface of the plate, the augmentation member having (i) a threaded head positioned in a third screw hole of the plurality of screw holes (see Fig. 22), and (ii) an elongated non-threaded post extending away from its threaded head (Fig. 22, wherein 200 has an elongated non-threaded post)
‘077 discloses a first bone screw and a second bone screw (Fig. 19, peripheral screws 158) which extend downwardly from the bottom surface of the plate and have an elongated threaded shank. However, these screws are fixed to the glenosphere (Fig. 19) and do not teach a head positioned in a second screw hole of the plurality of screw holes.
Angibaud discloses a glenoid implant comprising (Fig. 8) comprising: a first bone screw (Fig. 19, 158) extending downwardly away from the bottom surface of the plate, the first bone screw having (i) a head positioned in a first screw hole of the plurality of screw holes, and (ii) an elongated threaded shank extending away from its threaded head (see Fig. 19) and a second bone screw (Fig. 19, 158) extending downwardly away from the bottom surface of the plate, the second bone screw having (i) a head positioned in a second screw hole of the plurality of screw holes, and (ii) an elongated threaded shank extending away from its threaded head (see Fig. 19), and
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the glenoid implant of ‘077 to be secured with a first bone screw and second bone screw, as taught by Angibaud, in order to optimize fixation for each patient's glenoid morphology and help to restore native glenoid version and native glenoid inclination intraoperatively should the surgeon desire.
Regarding claim 2, ‘077 further discloses wherein the elongated non-threaded post of the augmentation member has a porous structure disposed thereon (Fig. 8, ¶0062, wherein post 206 includes a porous surface to provide sites for bone ingrowth when inserted into a prepared glenoid cavity)
Regarding claim 3, ‘077 discloses first and second bone screws with threaded shanks and an augmentation member with an elongated non-threaded post (see rejection of claim 1) but doesn't explicitly teach or disclose wherein the elongated non-threaded post of the augmentation member is shorter in length than the elongated threaded shanks of the first and second bone screws.
Angibaud discloses a glenoid implant (Fig. 8B) wherein the elongated non-threaded post of the augmentation member is shorter in length than the elongated threaded shanks of the first and second bone screws (see Fig. 8B)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the elongated non-threaded post of ‘077 to be shorted than the first and second bone screws, as taught by Angibaud, in order to optimize fixation for each patient's glenoid morphology and help to restore native glenoid version and native glenoid inclination intraoperatively should the surgeon desire (¶0043)
Regarding claim 6, ‘077 further discloses a second embodiment (Fig. 22) wherein the shaft is integral with the plate (¶0047, “In implant system 400, the base plate 402, central screw 404 and coupling member 406, may be integrally connected as a single monobloc construct”)
Regarding claim 14, ‘077 discloses a method of surgically implanting a glenoid implant into a glenoid of a patient’s shoulder during performance of an orthopaedic surgical procedure (Fig. 13), the method comprising:
surgically exposing an outer surface of the glenoid, the outer surface of the glenoid having a bone defect (Fig. 13, 300),
reaming the outer surface of the glenoid so as to form (i) a circular surface in the outer surface of the glenoid (Fig. 13, 302), (ii) a central bore hole that is concentric with the portion of the circular surface (Fig. 13, 304), and (iii) a circular groove that is concentric with the central bore hole (Fig. 13, 306)
inserting a baseplate of the glenoid implant into the central bore hole and circular groove (Fig. 13, 310), the baseplate having a plurality of screw holes (Fig. 4, baseplate 102 has screw holes 118),
aligning a first screw hole of the plurality of screw holes of the baseplate over the bone defect (Fig. 13, 310), and
inserting an augmentation member through the first screw hole such that a bottom surface of a non-threaded post of the augmentation member contacts a bottom surface of the bone defect (Fig. 13, steps 314 and 316)
Regarding claim 15, ‘077 further discloses inserting a first bone screw through a second screw hole of the plurality of screw holes of the baseplate (Figs. 4 and 19, see also ¶0052, wherein screws 154 engage with holes 118 in base plate 102) such that a threaded shank of the first bone screw is threaded into the glenoid (Fig. ¶0052, wherein second threads 158 are threaded into glenoid, see Fig. 18, wherein baseplate is configured in glenoid cavity of scapula), and inserting a second bone screw through a third screw hole of the plurality of screw holes of the baseplate (Figs. 4 and 19, see also ¶0052, wherein screws 154 engage with holes 118 in base plate 102) such that a threaded shank of the second bone screw is threaded into the glenoid (Fig. ¶0052, wherein second threads 158 are threaded into glenoid, see Fig. 18, wherein baseplate is configured in glenoid cavity of scapula)
Regarding claim 17, ‘077 further discloses reaming the glenoid around the bone defect (Fig. 13, 312, see also ¶0081, “a flat surface 344 may be reamed into a portion of the surface 346 of the glenoid cavity 324 within the defect”) prior to insertion of the augmentation member (Fig. 13, wherein step 312 is prior to step 314)
Claim(s) 4 and 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2022/0241077 (‘077) in view of US 2012/0209392 (Angibaud), as applied to claims above, and further in view of US 2021/0077264 (‘264)
Regarding claim 4, ‘077 further discloses the plate of the baseplate further comprises a peripheral ring (Fig. 5, 122) extending downwardly away from, and circumferentially around, the bottom surface of the plate (see Fig. 5), the peripheral ring has an interior surface and an opposite exterior surface (See Fig. 5). Angibaud doesn't explicitly teach or disclose that the exterior surface of the peripheral ring has a number of threads formed therein.
‘264 discloses a glenoid implant (Fig. 1, 100) comprising a peripheral ring (Fig. 2, 132) with an exterior surface (see Fig. 2), and the exterior surface of the peripheral ring has a number of threads formed therein (Fig. 2, wherein 134 and 136 correspond to a number of threads)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the exterior surface of the peripheral ring of ‘077 in view of Angibaud with threads formed therein, as taught by ‘264, in order to increase surface area for better cortical fixation (¶0084)
Regarding claim 5, ‘077 discloses wherein the peripheral ring comprises a plurality of separate arcuate-shaped ring portions (Fig. 5, 122) separated from one another by a gap (Fig. 5, wherein three protrusions 122 are shown separate by a gap)
Claim(s) 7-10, 13, and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2022/0241077 (‘077) in view of US 2012/0209392 (Angibaud) in view of US 2003/0149485 (Tornier)
Regarding claim 7, ‘077 further discloses a locking screw, a glenosphere, and a central opening with a number of threads formed therein (Fig. 4, wherein 114 is threaded) but doesn't explicitly teach or disclose the locking screw has a first number of threads configured to engage the threads of the central opening and a second number of threads configured to engage the threads of the glenosphere. Angibaud doesn't explicitly teach or disclose the locking screw has a first number of threads configured to engage the threads of the central opening and a second number of threads configured to engage the threads of the glenosphere.
Tornier discloses a glenoid implant (Fig. 1) wherein the locking screw (Fig. 1, 3) has a first number of threads configured to engage the threads of the central opening (Fig. 1, 35) and a second number of threads configured to engage the threads of the glenosphere (Fig. 1, wherein threads 31 of locking screw 3 engage threads 14 of glenosphere 14)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the base plate and glenosphere of ‘077 in view of Angibaud with a locking screw having corresponding first and second threads, as taught by Tornier, in order to easily manufacture the parts individually so that they may be later assembled precisely and easily (¶0002).
Regarding claim 8, ‘077 discloses a glenoid implant (Fig. 2) for implantation into a glenoid of a patient during an orthopaedic surgical procedure (¶0002), comprising:
a baseplate comprising a plate (Fig. 4, 102) with a top surface (Fig. 4, 110) and a bottom surface (Fig. 4, 112), the plate having: (i) a central opening extending into the plate from the top surface (Fig. 4, 114), the central opening having a number of threads formed therein (see Fig. 4, wherein 114 is threaded), and (ii) a plurality of screw holes extending from the top surface to the bottom surface of the plate (Fig. 4, wherein screw holes 118 extend through plate 102), the plurality of screw holes being positioned circumferentially around the plate (see Fig. 4, wherein holes 118 are positioned circumferentially),
a shaft (Fig. 3, 104) coupled to and extending downwardly away from a center of the bottom surface of the plate (see Fig. 3), the shaft having a number of threads formed in an outer surface thereof (Fig. 3, wherein 104 has outer threads),
an augmentation member (Fig. 22, 200) extending downwardly away from the bottom surface of the plate, the augmentation member having (i) a threaded head positioned in one of the plurality of screw holes (see Fig. 22), and (ii) an elongated non-threaded post extending away from its threaded head (see Fig. 22)
‘077 doesn't explicitly teach or disclose a pair of bone screws extending downwardly away from the bottom surface of the plate, each of the pair of bone screws having (i) a head positioned in one of the plurality of screw holes, and (ii) an elongated threaded shank extending away from its threaded head
Angibaud discloses a glenoid implant (Fig. 8A-8C) comprising: a pair of bone screws (Fig. 8A, wherein at least two screws 114 are shown) extending downwardly away from the bottom surface of the plate (see Fig. 8A), each of the pair of bone screws having (i) a head positioned in one of the plurality of screw holes (Fig. 8A, wherein head of 114 is positioned in the screw hole, ¶0046, “male spherical head”), and (ii) an elongated threaded shank extending away from its threaded head (Fig. 8A, wherein the extended shank of 114 extends downward toward the bone surface)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the glenoid implant of ‘077 to be secured with a pair of bone screws, as taught by Angibaud, in order to allow for independent optimization of the screw trajectories and a better fixation of the plate onto the patient’s anantomy.
‘077 discloses a glenosphere (Fig. 19, 150) but doesn't explicitly teach or disclose a glenosphere having a number of threads formed therein, and a locking screw having (i) a first number of threads configured to engage the threads of the central opening and (ii) a second number of threads configured to engage the threads of the glenosphere. Angibaurd doesn't explicitly teach or disclose a glenosphere having a number of threads formed therein, and a locking screw having (i) a first number of threads configured to engage the threads of the central opening and (ii) a second number of threads configured to engage the threads of the glenosphere.
Tornier discloses a glenosphere (Fig. 1, 1) having a number of threads formed therein (Fig. 1, 14), and a locking screw (Fig. 1, 3) having (i) a first number of threads configured to engage the threads of the central opening (Fig. 1, wherein threads 35 of locking screw 3 engage threads 25a of the central opening of the baseplate) and (ii) a second number of threads configured to engage the threads of the glenosphere (Fig. 1, wherein threads 31 of locking screw 3 engage threads 14 of the glenosphere 1)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the base plate and glenosphere of ‘077 in view of Angibaurd with a locking screw having corresponding first and second threads, as taught by Tornier, in order to easily manufacture the parts individually so that they may be later assembled precisely and easily (¶0002).
Regarding claim 9, ‘077 further discloses wherein the elongated non-threaded post of the augmentation member has a porous structure disposed thereon (Fig. 8, ¶0062, wherein post 206 includes a porous surface to provide sites for bone ingrowth when inserted into a prepared glenoid cavity)
Regarding claim 10, ‘077 discloses an augmentation member with an elongated non-threaded post (see rejection of claim 8) but doesn't explicitly teach or disclose wherein the elongated non-threaded post of the augmentation member is shorted in length than the elongated threaded shanks of the pair of bone screws.
Angibaud discloses a glenoid implant (Fig. 8B) wherein the elongated non-threaded post of the augmentation member is shorter in length than the elongated threaded shanks of the first and second bone screws (see Fig. 8B)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the elongated non-threaded post of ‘077 to be shorted than the first and second bone screws, as taught by Angibaud, in order to optimize fixation for each patient's glenoid morphology and help to restore native glenoid version and native glenoid inclination intraoperatively should the surgeon desire (¶0043)
Regarding claim 13, ‘077 further discloses a second embodiment (Fig. 22) wherein the shaft is integral with the plate (¶0047, “In implant system 400, the base plate 402, central screw 404 and coupling member 406, may be integrally connected as a single monobloc construct”)
Regarding claim 16, ‘077 doesn't explicitly teach or disclose inserting a locking screw of the glenoid implant into a central opening in a top surface of the baseplate, and coupling a glenosphere of the glenoid implant to the locking screw. Angibaud doesn't explicitly teach or disclose inserting a locking screw of the glenoid implant into a central opening in a top surface of the baseplate, and coupling a glenosphere of the glenoid implant to the locking screw.
Tornier discloses inserting a locking screw of the glenoid implant into a central opening in a top surface of the baseplate (Fig. 1, see also ¶0068, “screw the screw 3 in the component 2 thanks to the thread 35 and to the tapping 36”), and coupling a glenosphere of the glenoid implant to the locking screw (Fig. 4, see also ¶0061-0062, wherein screw 3 is rotated to joint locking screw 3 and glenosphere 1)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the method of ‘077 in view of Angibaud with steps including inserting a locking screw into a baseplate and coupling a glenosphere to the locking screw, as taught by Tornier, in order to in order to easily manufacture the parts individually so that they may be later assembled precisely and easily (¶0002).
Claim(s) 11 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2022/0241077 (‘077) in view of US 2012/0209392 (Angibaud) in view of US 2003/0149485 (Tornier), as applied to claims above, and further in view of US 2021/0077264 (‘264)
Regarding claim 11, ‘077 further discloses the plate of the baseplate further comprises a peripheral ring (Fig. 5, 122) extending downwardly away from, and circumferentially around, the bottom surface of the plate (see Fig. 5), the peripheral ring has an interior surface and an opposite exterior surface (See Fig. 5). ‘077 doesn't explicitly teach or disclose that the exterior surface of the peripheral ring has a number of threads formed therein. Angibaurd doesn't explicitly teach or disclose that the exterior surface of the peripheral ring has a number of threads formed therein. Tornier doesn't explicitly teach or disclose that the exterior surface of the peripheral ring has a number of threads formed therein.
‘264 discloses a glenoid implant (Fig. 1, 100) comprising a peripheral ring (Fig. 2, 132) with an exterior surface (see Fig. 2), and the exterior surface of the peripheral ring has a number of threads formed therein (Fig. 2, wherein 134 and 136 correspond to a number of threads)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the exterior surface of the peripheral ring of ‘077 in view of Angibaud in view of Tornier with threads formed therein, as taught by ‘264, in order to increase surface area for better cortical fixation (¶0084)
Regarding claim 12, ‘077 discloses wherein the peripheral ring comprises a plurality of separate arcuate-shaped ring portions (Fig. 5, 122) separated from one another by a gap (Fig. 5, wherein three protrusions 122 are shown separate by a gap)
Conclusion
Included below is relevant prior art that was considered but not relied upon for this office action:
WO 2019/053576 – discloses a total shoulder prosthesis
US 2014/0257499 & US 2017/0224492 – discloses a modular glenoid baseplate
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/MAXIMILIAN TOBIAS SPENCER/Examiner, Art Unit 3774
/YASHITA SHARMA/ Primary Patent Examiner, Art Unit 3774