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 § 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) 1,2, 4-6 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20150305877 A1 (“Gargac”).
Regarding Claim 1, Gargac discloses a baseplate for implantation into a scapula (Figs 2-4, glenoid implant 100, baseplate 108), the baseplate comprising:
a first circular portion (See 8a for upper surface image, see aperture 192);
a second circular portion(See 8a for upper surface image, see aperture 188);
a third circular portion (See 8a for upper surface image, see aperture 176), wherein the first circular portion, the second circular portion, and the third circular portion define an upper surface (See 8a for upper surface image, see three apertures 192, 176, 188 each with circular portions around it that help to define the upper surface);
a projection extending from the third circular portion in a direction away from the upper surface and configured to be received with a scapula aperture created in the scapula (See figure 5 for projection labeled as 160 central protrusion); and
an aperture extending through the projection and configured to receive a bone screw such that a portion of the bone screw extends beyond an end of the projection and into the scapula (See fig 5 for 168 first aperture that extends through central protrusion and receives anchoring member), and wherein the aperture is configured to receive a joint projection of an artificial joint such that the artificial joint is coupled to the baseplate (See fig 2-4 glenosphere 116 artificial joint, see fig 4 for how glenosphere interfaces with the aperture of the baseplate).
Regarding Claim 2, Gargac further discloses the baseplate (Figs 2-4, glenoid implant 100, baseplate 108) of claim 1, wherein the aperture extending through the projection is further configured to receive a sphere projection extending from a sphere such that the sphere is coupled to the baseplate (See fig 2-4 glenosphere 116 artificial joint, see fig 4 for how glenosphere interfaces with the aperture of the baseplate).
Regarding Claim 4, Gargac further discloses the baseplate (Figs 2-4, glenoid implant 100, baseplate 108) of claim 1, wherein the aperture is a central aperture (See 8a for upper surface image, see aperture 176), the bone screw is a central bone screw (See Fig 6 Central anchor member 104), and the baseplate further comprises a first aperture extending through the first circular portion (See 8a for upper surface image, see aperture 192) and a second aperture extending through the second circular portion (See 8a for upper surface image, see aperture 188), the first aperture being configured to receive a first bone screw and the second aperture being configured to receive a second bone screw ([52] for explanation of plurality of holes and [53] for anchoring members 196).
Regarding Claim 5, Gargac further discloses the baseplate (Figs 2-4, glenoid implant 100, baseplate 108) of claim 4, wherein the first aperture (See Fig 6 for cross-sectional view, see aperture 192) is angled away from the central aperture such that the first bone screw is not parallel to the central bone screw ( See Fig 6 aperture 192 is angled from longitudinal axis 212 with bone screws 196 shown at angle as well) and the second aperture (See Fig 6 for cross-sectional view, see aperture 188) is angled away from the central aperture such that the second bone screw is not parallel to the central bone screw( See Fig 6 aperture 188 is angled from longitudinal axis 212 with bone screws 196 shown at angle as well).
Regarding Claim 6, Gargac further discloses The baseplate of claim 1, further comprising an outer ring surrounding an outer edge of the upper surface of the baseplate (See fig 5 for lateral surface 156 and [50] for explanation of lateral surface surrounding the baseplate).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2015/0305877 A1 (“Gargac”) in view of US 2014/0039632 A1 (“Hollis”).
Regarding Claim 3, Gargac discloses the baseplate (Figs 2-4, glenoid implant 100, baseplate 108) of claim 1, wherein the aperture extending through the projection (See fig 5 for 168 first aperture that extends through central protrusion).
Gargac does not teach the use of a morse taper shape of the aperture, however Hollis who teaches another version of a glenoid system teaches:
aperture extending through the projection includes a Morse taper (see [31] for implant attachment means 128 in fig 1 has a female morse taper shape).
It would have been obvious to one of ordinary skill in the art before the effective filing date of
the claimed invention to combine the morse taper shape as taught by Hollis with the glenoid system of Gargac as Hollis teaches of morse taper as being one of the known potential methods to attach glenoid components to the base. Courts have found a conclusion of obviousness is supported in cases of merely applying a known technique to a known device (method, or product) ready for improvement to yield predictable results (see MPEP 2143).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2015/0305877 A1 (“Gargac”) in view of US 2021/0228372 A (“Knox”).
Regarding Claim 7, Gargac further discloses the baseplate of claim 1, wherein the aperture is configured to prevent the joint projection of the artificial joint from extending beyond a predetermined point within the aperture (See figure 5 for projection labeled as 160 central protrusion).
Gargac does not teach the use of a gap between the glenosphere and the baseplate, however Knox who teaches a shoulder replacement implant discloses:
such that a gap exists between the upper surface and the artificial joint (See [13] for explanation of gap 1446 between proximal surface of collar 1506 which relates to baseplate of applicant's disclosure and lateral side 1412 of the articular body 1404 which relates to spherical portion see fig 18B).
Knox teaches of that the gap can aid in adjusting or replacing the artificial joint piece (See [32] for use of gap with prying tool). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the gap between the baseplate and the artificial joint as taught by Knox with the glenoid system of Gargac in order to aid in aid in adjusting or replacing the artificial joint piece.
Claim(s) 8,9,11,13 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2015/0305877 A1 (“Gargac”) in view of Official Notice.
Regarding Claim 8, Gargac discloses a baseplate configured to be implanted into a scapula aperture created in a scapula (Figs 2-4, glenoid implant 100, baseplate 108), the baseplate comprising:
a first circular portion (See 8a for upper surface image, see aperture 192);
a second circular portion(See 8a for upper surface image, see aperture 188);
a third circular portion (See 8a for upper surface image, see aperture 176), wherein the first circular portion, the second circular portion, and the third circular portion define an upper surface (See 8a for upper surface image, see three apertures 192, 176, 188 each with circular portions around it that help to define the upper surface);
a projection extending from the third circular portion in a direction away from the upper surface and configured to be received within the scapula aperture created in the scapula (See figure 5 for projection labeled as 160 central protrusion); and
an aperture extending through the projection (See fig 5 for 168 first aperture that extends through central protrusion and receives anchoring member);
a bone screw configured to be inserted into the aperture in the baseplate such that a portion of the bone screw extends beyond an end of the projection and into the scapula (See Fig 6 Central anchor member 104);
and an artificial joint defining an upper joint surface and including a joint projection extending away from the upper joint surface, wherein the joint projection is configured to be received within the aperture is configured such that the artificial joint is coupled to the baseplate. (See fig 2-4 glenosphere 116 artificial joint, see fig 4 for how glenosphere interfaces with the aperture of the baseplate).
Gargac does not disclose the use of a surgical kit; however, the examiner takes Official Notice that surgical kits including surgical implants have long been well known in the art.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include the implant in a surgical kit with the glenoid system taught by Gargac as doing so merely involves combining prior art elements according to known methods to yield predictable results, which courts have found obvious (MPEP 2143).
Regarding Claim 9, Gargac further discloses a sphere having a sphere projection, the projection is configured to be received within the aperture such that the artificial joint is coupled to the baseplate (See fig 2-4 glenosphere 116 artificial joint, see fig 4 for how glenosphere interfaces with the aperture of the baseplate).
Regarding Claim 11, Gargac further discloses wherein the aperture in the baseplate is a central aperture (See fig 5 for 168 first aperture that extends through central protrusion and receives anchoring member), the bone screw is a central bone screw (See Fig 6 Central anchor member 104), and the baseplate further comprises a first aperture extending through the first circular portion (See Fig 6 aperture 192) and a second aperture extending through the second circular portion (See Fig 6 aperture 188), the first aperture being configured to receive a first bone screw and the second aperture being configured to receive a second bone screw (See Fig 6 for anchoring members 196).
Regarding Claim 13, Gargac further discloses wherein the baseplate further comprises an outer ring surrounding an outer edge of the upper surface of the baseplate (See fig 5 for lateral surface 156 and [50] for explanation of lateral surface surrounding the baseplate).
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2015/0305877 A1 (“Gargac”) in view of Official Notice as applied to claim 8 above, and further in view of US 2014/0039632 A1 (“Hollis”).
Gargac discloses wherein the aperture extending through the projection (See fig 5 for 168 first aperture that extends through central protrusion).
Gargac does not teach the use of a morse taper shape of the aperture, however Hollis who teaches another version of a glenoid system teaches:
aperture extending through the projection includes a Morse taper (see [31] for implant attachment means 128 in fig 1 has a female morse taper shape).
Hollis teaches of morse taper as being one of the known potential methods to attach glenoid components to the base (citation to where this is taught).It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the morse taper shape as taught by Hollis with the glenoid system of Gargac in order to securely attach the glenoid components to the base.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2015/0305877 A1 (“Gargac”) in view of Official Notice as applied to claim 11 above, and further in view of US 12,121,451 B2 (“Pressacco”).
Regarding Claim 12, Gargac further discloses wherein the central bone screw is a locking screw (See Fig 4. for 256 locking screw which is a component of the central bone screw).
Gargac does not teach the use of a locking cap with the bone screws, however Pressacco teaches another version of a shoulder prosthesis including:
a bone screw configured to receive a locking cap (See Fig 1 for locking element 7 which is described as a locking cap in [47]).
Pressacco teaches of the locking cap as a method to prevent the release of the screw (See [50] for locking element purpose). It would have been obvious to one of ordinary skill in the art before the effective filing date of
the claimed invention to combine the locking element as taught by Pressacco with the glenoid system of Gargac in view of Official Notice in order to prevent release of the screw,
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2015/0305877 A1 (“Gargac”) in view of Official Notice as applied to claim 8 above, and further in view of US 2021/0228372 A (“Knox”).
Regarding Claim 14, Gargac further discloses wherein the aperture extending through the projection of the baseplate is configured to prevent the projection of the artificial joint from extending beyond a predetermined point within the aperture (See figure 5 for projection labeled as 160 central protrusion).
Gargac in view of Official Notice does not teach the use of a gap between the glenosphere and the baseplate, however Knox teaches a shoulder replacement implant and discloses:
such that a gap exists between the upper surface and the artificial joint (See [13] for explanation of gap 1446 between proximal surface of collar 1506 which relates to baseplate of applicant's disclosure and lateral side 1412 of the articular body 1404 which relates to spherical portion see fig 18B).
It would have been obvious to one of ordinary skill in the art before the effective filing date of
the claimed invention to combine the gap between the baseplate and the artificial joint as taught by Knox with the glenoid system of Gargac in view of Official Notice as Knox teaches of that the gap can aid in adjusting or replacing the artificial joint piece.
Claim(s) 15-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2015/0305877 A1 (“Gargac”).
Regarding Claim 15, Gargac discloses, A method of performing shoulder surgery (See [107] for preparation of implantation), the method comprising:
removing a central portion of bone from a scapula to create a central scapula aperture (See [107-108] for creation of hole in glenoid size of central protrusion);
removing a first portion of bone from the scapula to create a first scapula aperture (See [108] for shaping the bone to match the distal surface of the baseplate);
removing a second portion of bone from the scapula to create a second scapula aperture (See [108] for shaping the bone to match the distal surface of the baseplate);
inserting a projection of a baseplate into the central scapula aperture, the baseplate further comprising a first circular portion received within the first scapula aperture and a second circular portion received within the second scapula aperture (See [108] for shaping the bone to fit the shape of the distal side of the baseplate and see [113} for full seating the baseplate into the scapula); and
inserting a bone screw through an aperture extending through the projection of the baseplate, such that a portion of the bone screw extends past an end of the projection and into the scapula (See [113] for insertion of screws from proximal end of the baseplate through the baseplate into the scapula).
Although Gargac does not explicitly disclose piercing more holes for the additional screws and other aperture portions of the baseplate, Gargac does disclose the method of piercing a hole to create the central aperture in the scapula and insert the baseplate into the pre-pierced hole as well as the additional bone screws to be screwed through the baseplate. It would have been readily understood by one of ordinary skill in the art that, piercing additional holes for the first and second apertures of the baseplate in the scapula similar to the central aperture as seen in Gargac Fig 10, because it is understood that the scapula can be prepared for bone screws and the baseplate to ensure that the baseplate is fully seated in the scapula and to minimize movement (See [104] for selecting baseplate and screws based off patient anatomy and bone density, and [108] for shaping the scapula to match selected baseplate). It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to create more apertures in the scapula like Gargac’s central aperture to accommodate the second and third screws as courts have found a conclusion of obviousness is supported in cases of merely applying a known technique to a known device (method, or product) ready for improvement to yield predictable results (see MPEP 2143).
Regarding Claim 16, Gargac further discloses, the method (See [107] for preparation of implantation) of claim 15, further comprising inserting a joint projection of an artificial joint into the aperture extending through the projection such that the artificial joint is coupled to the baseplate (See [123-124] for coupling of glenosphere after baseplate connection).
Regarding Claim 17, Gargac further discloses inserting a sphere projection of a sphere into the aperture extending through the projection such that the sphere is coupled to the baseplate(See [123-124] for coupling of glenosphere after baseplate connection).
Claim(s) 18-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2015/0305877 A1 (“Gargac”) as applied to claim 15 above, and further in view of US 2015/0250601 A1 (“Humphrey”).
Regarding Claim 18, Gargac further discloses wherein removing the central portion of bone from the scapula to create the central scapula aperture (See [107-108] for creation of hole in glenoid size of central protrusion)
Gargac does not disclose the use of sizers and guides; however, Humphrey teaches methods to orient and implant a shoulder joint prosthesis including:
placing one or more sizers proximate the scapula (See [176-177] for use of sizer or guide as described by Humphrey);
selecting an appropriate sizer from the one or more sizers (See [176-177] for sizer based on patient)
inserting a guide wire through a central aperture of the appropriate sizer (See [177] for inserting pin or K-wire);
removing the appropriate sizer from the scapula (See [177] sizer is removed once pin is in place); and
inserting a drill over the guide wire to create the central scapula aperture (See [177-178] for use of drill and reamer to create appropriately sized hole).
Humphrey teaches of that the components used to place the implant aid in correct orientation and placement. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the use of sizers, guides, pin wires and drills as taught by Humphrey with the glenoid preparation of Gargac in order to facilitate correct orientation and placement.
Regarding Claim 19, Gargac discloses wherein removing the first portion of bone and the second portion of bone (See [108] for shaping the bone to fit the shape of the distal side of the baseplate and see [113} for full seating the baseplate into the scapula).
Gargac does not disclose the use of sizers and guides; however, Humphrey teaches methods to orient and implant a shoulder joint prosthesis including:
selecting a guide (See [176-177] for use of sizer or guide as described by Humphrey);
inserting a guide projection of the guide into the central scapula aperture (See [176-177] for sizer based on patient);
placing a first pin into a first aperture of the guide and a second pin into a second aperture of the guide (See [177] for inserting pin or K-wire); ;
remove the guide from the scapula (See [177] sizer is removed once pin is in place);
insert a reamer over the first pin and create the first scapula aperture (See [177-178] for use of drill and reamer to create appropriately sized hole); and
insert the reamer over the second pin and create the second scapula aperture(See [177-178] for use of drill and reamer to create appropriately sized hole).
It would have been obvious to one of ordinary skill in the art before the effective filing date of
the claimed invention to combine the use of sizers, guides, pin wires and drills as taught by Humphrey with the glenoid preparation of Gargac as Humphrey teaches of that the components used to place the implant aid in correct orientation and placement. Courts have found a conclusion of obviousness is supported in cases of merely applying a known technique to a known device (method, or product) ready for improvement to yield predictable results (see MPEP 2143).
Although Gargac in view of Humphrey does not explicitly disclose piercing more holes for the additional screws and other aperture portions of the baseplate, Gargac does disclose the method of piercing a hole to create the central aperture in the scapula and insert the baseplate into the pre-pierced hole as well as the additional bone screws to be screwed through the baseplate (See [108] for shaping the bone to fit the shape of the distal side of the baseplate and see [113] for full seating the baseplate into the scapula). It would have been readily understood by one of ordinary skill in the art that, piercing additional holes for the first and second apertures of the baseplate in the scapula similar to the central aperture as seen in Gargac Fig 10, because it is understood that the scapula can be prepared for bone screws and the baseplate to ensure that the baseplate is fully seated in the scapula and to minimize movement (See [104] for selecting baseplate and screws based off patient anatomy and bone density, and [108] for shaping the scapula to match selected baseplate). It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to create more apertures in the scapula like Gargac’s central aperture to accommodate the second and third screws as courts have found a conclusion of obviousness is supported in cases of merely applying a known technique to a known device (method, or product) ready for improvement to yield predictable results (see MPEP 2143).
Regarding Claim 20, Gargac does not disclose the use of sizers and guides, however, Humphrey further discloses wherein the guide is selected from a plurality of guides based on the appropriate sizer that was selected (See [176-177] on selecting sizer based on patient anatomy).
It would have been obvious to one of ordinary skill in the art before the effective filing date of
the claimed invention to combine the use of sizers, guides, pin wires and drills as taught by Humphrey with the glenoid preparation of Gargac as Humphrey teaches of that the components used to place the implant aid in correct orientation and placement. Courts have found a conclusion of obviousness is supported in cases of merely applying a known technique to a known device (method, or product) ready for improvement to yield predictable results (see MPEP 2143).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Lukas M Lehman whose telephone number is (571)272-5040. The examiner can normally be reached M-F 7:30-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jerrah C Edwards can be reached at (408)918-7557. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/L.M.L./Patent Examiner, Art Unit 3774
/JERRAH EDWARDS/Supervisory Patent Examiner, Art Unit 3774