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 .
Response to Amendment
This Office Action is responsive to the amendment filed on 19 December 2025. As directed by the amendment: claims 1, 2, 4, 5, 10, 13, 14, and 16-19 have been amended, and claims 3, 7-9, 11, 12, and 15 stand withdrawn. Claims 1-20 currently stand pending in the application.
The amendments to the claims are sufficient to overcome the claim objections listed in the previous action, which are accordingly withdrawn. Further claim objections as necessitated by the claim amendments are presented below.
The amendments to the claims are sufficient to overcome the rejections under 35 U.S.C. 112(b) and (d) listed in the previous action, which are accordingly withdrawn. Further rejections under 35 U.S.C. 112(b) and (d) as necessitated by the claim amendments are presented below.
Response to Arguments
Applicant's arguments with respect to the rejections under 35 U.S.C. 102 have been fully considered but they are not persuasive. As to Detweiler ‘061 (US 11,364,061), Applicant contends that the coupling feet 722 (the claimed engagement members) do not attach to the plate at a recessed surface that extends between adjacent plate holes. Claim 1 requires opposed exterior side surfaces that extend between adjacent ones of the plate holes and are inwardly recessed, and the pair of engagement members are configured to extend alongside the opposed exterior side surfaces and are biased against the opposed exterior side surfaces. Examiner respectfully submits that the claim does not require the engagement members to be attached to the recessed part of the side surface. Rather, the opposed exterior side surfaces are interpreted as each comprising the entire longitudinal side surface extending down one longitudinal side of the plate body, with the two side surfaces opposed to each other, with portions of each side surface extending between adjacent ones of the plate holes and inwardly recessed. The pair of engagement members extend alongside and are biased against other portions of the opposed exterior side surfaces as shown in Detweiler ‘061. Even if the claim is interpreted that the pair of engagement members are configured to extend alongside the inwardly recessed portions of the side surfaces, Detweiler ‘061 meets the limitations because the engagement members are alongside, or adjacent to, these recessed portions. The engagement members are alongside the recessed portions by being coupled to portions of the side surfaces that are alongside or next to the recessed portions.
As to claim 13, Applicant contends that the retention mechanism of Detweiler ‘061 is oriented vertically and not bent so as to extend at least partially within the channel. Examiner respectfully submits that Detweiler ‘061 discloses that the retention mechanism 714 is attached to the screw guide body at a distal end (outside of the channel), FIG. 27, while also extending into an inner diameter of the channel (col. 11 / lines 20-22), and therefore must be bent along its length so that its free end extends at least partially within the channel. The term bent is commonly understood to mean curved or not straight along its length. The retention mechanism can also be interpreted as bent at its attachment point to the screw guide body so as to angle into the channel.
As to Detweiler ‘111 (US 2022/0370111), Applicant contends that the Office Action fails to cite that the alleged coupling mechanism 44 couples to the plate at a side surface between adjacent holes, as opposed to the regions of the external surface that defines the holes. Examiner respectfully submits, as above, that the claim does not require the engagement members to be attached to the recessed part of the side surface. Rather, the opposed exterior side surfaces are interpreted as each comprising the entire longitudinal side surface extending down one longitudinal side of the plate body, with the two side surfaces opposed to each other, with portions of each side surface extending between adjacent ones of the plate holes and inwardly recessed. The pair of engagement members extend alongside and are biased against other portions of the opposed exterior side surfaces as shown in Detweiler ‘111. Even if the claim is interpreted that the pair of engagement members are configured to extend alongside the inwardly recessed portions of the side surfaces, Detweiler ‘111 meets the limitations because the engagement members are alongside, or adjacent to, these recessed portions. The engagement members are alongside the recessed portions by being coupled to portions of the side surfaces that are alongside or next to the recessed portions.
As to claim 13, Applicant contends that the retention mechanism of Detweiler ‘111 is oriented vertically and not bent so as to extend at least partially within the channel. Examiner respectfully submits that Detweiler ‘111 discloses that the retention mechanism 46 is attached to the screw guide body at a distal end (outside of the channel), FIG. 4, while also extending into an inner diameter of the channel (par. [0035]), and therefore must be bent along its length so that its free end extends at least partially within the channel. The term bent is commonly understood to mean curved or not straight along its length. The retention mechanism can also be interpreted as bent at its attachment point to the screw guide body so as to angle into the channel.
As to Lemoine (US 2009/0312801), Applicant contends that Lemoine discloses that the attachment posts 174 (claimed engagement members) are coupled to the region of the bone plate that defines the plate holes, and not to opposed exterior side surfaces as recited in claim 1. Examiner respectfully submits, as above, that the claim does not require the engagement members to be attached to the recessed part of the side surface. Rather, the opposed exterior side surfaces are interpreted as each comprising the entire longitudinal side surface extending down one longitudinal side of the plate body, with the two side surfaces opposed to each other, with portions of each side surface extending between adjacent ones of the plate holes and inwardly recessed. The pair of engagement members 174 extend alongside and are biased against other portions of the opposed exterior side surfaces as shown in Lemoine. Even if the claim is interpreted that the pair of engagement members are configured to extend alongside the inwardly recessed portions of the side surfaces, Lemoine meets the limitations because the engagement members are alongside, or adjacent to, these recessed portions. The engagement members are alongside the recessed portions by being coupled to portions of the side surfaces that are alongside or next to the recessed portions. In the current rejection, the engagement members do not comprise the alignment posts 160, and arguments directed to this are moot.
Applicant’s arguments with respect to claim 13 as anticipated by Lemoine have been considered but are moot because the new ground of rejection does not rely on any combination of references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Objections
Claims 1, 2, 4-6, 10, 19, and 20 are objected to because of the following informalities: improper antecedence. Appropriate correction is required. The following amendments are suggested:
Claim 1 / line 6: “adjacent ones of the plurality of plate holes”
Claim 1 / line 13: “alongside the opposed exterior side surfaces of the body”
Claim 1 / line 14: “the pair of engagement members”
Claim 1 / line 15: “the pair of engagement members”
Claim 1 / line 18: “coaxial with one of the central hole axes when the guide body is coupled to the bone plate”
Claim 19 / line 5: “center the
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.
Claims 4-6 are rejected under 35 U.S.C. 112(b) 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.
As to claim 4, the limitations “a plurality of side surfaces” and “at least two engagement members” render the claims indefinite because it is unclear if these refer back to the opposed exterior side surfaces and the pair of engagement members previously recited in claim 1 / lines 5 and 12, respectively, or to a different plurality of side surfaces and different at least two engagement members. For examination purposes, the claim will be interpreted as “the opposed exterior side surfaces extend between the outer surface and the bone-facing surface; and the pair of engagement members the opposed exterior side surfaces of the plate body with a coupling force that couples the plate body with the guide body at least against the force of gravity.”
As to claim 5, the limitation “opposed exterior side surfaces” renders the claims indefinite because it is unclear if the limitation refers back to the previously recited opposed exterior side surfaces or to different opposed exterior side surfaces. For examination purposes, the limitation will be interpreted in the former instance. The claim is suggested to be cancelled in view of this rejection and the rejection under 35 U.S.C. 112(d) below.
As to claim 6, the limitation “a spring member” renders the claim indefinite because it is unclear if the limitation refers back to the previously recited spring member (claim 1 / line 14) or to a different spring member. For examination purposes, the limitation will be interpreted in the former instance. For examination purposes, the claim will be interpreted as “wherein the is configured to bias the pair of engagement members…”.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 5 is rejected under 35 U.S.C. 112(d) as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 5 fails to further limit the subject matter of the claim upon which it depends, particularly in view of the rejection of claim 4 under 35 U.S.C. 112(b) and the corresponding claim interpretation. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 2, 4-6, 10, 13, 14, 16, and 18 are rejected under 35 U.S.C. 102(a)(1)/(2) as anticipated by U.S. Patent No. US 11,364,061 to Detweiler et al. (hereinafter, “Detweiler ‘061”).
As to claim 1, Detweiler ‘061 discloses a bone plating assembly for bone fixation, comprising: a bone plate (800) having a plate body that has an outer surface and a bone-facing surface opposite the outer surface, FIGS. 31-33, the plate body defining a plurality of plate holes (804) that each extends from the outer surface to the bone-facing surface along a respective central hole axis, wherein the plate body includes opposed exterior side surfaces (each side surface includes the entire longitudinal side surface extending down one longitudinal side of the plate body, with the two side surfaces opposed to each other) that extend between adjacent ones of the plate holes and are inwardly recessed (portions of each side surface extend between adjacent ones of the plate holes and are inwardly recessed); and a guide body (702) having a proximal end and a distal end spaced from each other along a direction, FIG. 27, the distal end having a coupling mechanism (720) that is configured to couple to the bone plate at an orientation of the guide body (col. 11 / lines 52-63), FIGS. 27 and 31-33, the guide body defining at least one channel (712) that extends along a central channel axis and is configured to receive at least one respective bone fastener (806) therein in a pre-loaded position (col. 12 / line 40 – col. 13 / line 4), FIGS. 27 and 33, wherein the coupling mechanism comprises a pair of engagement members (720s on either side of one channel 712) that are configured to extend alongside the opposed exterior side surfaces of the bone plate (the engagement members extend alongside portions of the opposed exterior side surfaces), FIG. 32B, and the guide body comprises a spring member (portion connecting 720 to body 710) configured to apply a biasing force to the engagement members that maintains coupling of the engagement members against the opposed exterior side surfaces of the plate body (col. 12 / line 64 – col. 13 / line 2), wherein the guide body is configured such that the central channel axis is substantially coaxial with the central hole axis when the guide body is connected to the bone plate at the orientation, and wherein the guide body includes a retention mechanism (714) within the at least one channel, FIG. 27, the retention mechanism configured to apply a retention force to the at least one respective bone fastener that retains the at least one respective bone fastener within the at least one channel in the pre-loaded position (col. 12 / line 40 – col. 13 / line 4), FIGS. 27 and 33.
As to claim 2, Detweiler ‘061 discloses the bone plating assembly of claim 1, wherein the retention mechanism comprises a flexible tab (714) defined by a cutout portion (at 715) of the guide body, the flexible tab being biased inward toward the central channel axis (since the tab must be flexed outward to allow the fastener to be pushed through the channel) such that an interior surface of the flexible tab is configured to contact a head of the at least one respective bone fastener (interpreted as language of intended use; fully capable of contacting a head which protrudes outwardly from a rest of the fastener, if the head is positioned adjacently to the tab) to thereby apply the retention force thereto in the pre-loaded position (col. 12 / lines 61-63), FIG. 33.
As to claim 4, Detweiler ‘061 discloses the bone plating assembly of claim 1, wherein: the plate body defines a plurality of side surfaces (each side surface includes the entire longitudinal side surface extending down one side of the plate body, with the two side surfaces opposed to each other) extending between the outer surface and the bone-facing surface; and the coupling mechanism comprises at least two engagement members (720s on either side of one channel 712) that are configured to extend alongside and couple with at least two of the plurality of side surfaces of the plate body with a coupling force that couples the plate body with the guide body at least against the force of gravity (col. 11 / line 52 – col. 12 / line 2).
As to claim 5, Detweiler ‘061 discloses the bone plating assembly of claim 4, wherein the at least two of the plurality of side surfaces are opposed exterior side surfaces of the plate body, FIGS. 31-32B.
As to claim 6, Detweiler ‘061 discloses the bone plating assembly of claim 5, wherein the guide body comprises a spring member (portion connecting 720 to body 710) configured to bias the at least two engagement members toward each other and toward the respective opposed exterior side surfaces of the plate body (col. 12 / line 64 – col. 13 / line 2).
As to claim 10, Detweiler ‘061 discloses the bone plating assembly of claim 1, further comprising a handle (704) that is repeatedly attachable to and detachable from the guide body (col. 12 / lines 3-6), FIGS. 27 and 29, the handle extending from a free end to an attachment end, FIG. 27, the attachment end having a mounting structure configured to attach to and detach from a complementary mounting formation (724) defined along a side of the guide body, the side extending between the proximal and distal ends along the direction, FIG. 27.
As to claim 13, Detweiler ‘061 discloses a screw guide for connecting to a bone plate (800) having at least one fastener hole (804), comprising: a body (702) having a proximal end and a distal end spaced from each other along a direction, FIG. 27, the distal end having a coupling mechanism (720) configured to couple the body to the bone plate at an orientation (col. 11 / lines 52-63), FIGS. 27 and 31-33, the body defining at least one channel (712) that extends along a central channel axis, the at least one channel configured to receive at least one respective bone fastener (806) therein in a pre-loaded position (col. 12 / line 40 – col. 13 / line 4), FIGS. 27 and 33, wherein the coupling mechanism is configured such that the central channel axis substantially aligns with a central hole axis of the at least one fastener hole when the coupling mechanism is coupled to the bone plate at the orientation, and wherein the body has a flexible retention mechanism (714) that is bent so as to extend at least partially within the at least one channel (the retention mechanism is flexibly bent to extend into the channel to resiliently hold the fastener, col. 11 / lines 20-22), FIG. 27, such that the retention mechanism is configured to apply a retention force to the at least one respective bone fastener that retains the at least one respective bone fastener within the at least one channel in the pre-loaded position (col. 12 / line 40 – col. 13 / line 4), FIGS. 27 and 33.
As to claim 14, Detweiler ‘061 discloses the screw guide of claim 13, wherein the retention mechanism comprises a flexible tab (714) defined by a cutout portion (at 715) of the body, the flexible tab being biased inward toward the central channel axis (since the tab must be flexed outward to allow the fastener to be pushed through the channel) such that an interior surface of the flexible tab is configured to contact a head of the at least one respective bone fastener (interpreted as language of intended use; fully capable of contacting a head which protrudes outwardly from a rest of the fastener, if the head is positioned adjacently to the tab) to thereby apply the retention force thereto in the pre-loaded position (col. 12 / lines 61-63), FIG. 33.
As to claim 16, Detweiler ‘061 discloses the screw guide of claim 13, wherein the coupling mechanism comprises a pair of engagement members (720s on either side of one channel 712) that are configured to extend alongside and clamp against at least two opposed side surfaces of the bone plate (col. 11 / line 52 – col. 12 / line 2).
As to claim 18, Detweiler ‘061 discloses the screw guide of claim 16, wherein the body comprises a spring member (portion connecting 720 to body 710) configured to bias the pair of engagement members toward each other for clamping against respective ones of the at least two opposed side surfaces of the bone plate (col. 12 / line 64 – col. 13 / line 2).
Claims 1, 2, 4-6, 13, 14, and 16-18 are rejected under 35 U.S.C. 102(a)(1)/(2) as anticipated by U.S. Patent Application Publication No. US 2022/0370111 to Detweiler et al. (hereinafter, “Detweiler ‘111).
As to claim 1, Detweiler ‘111 discloses a bone plating assembly for bone fixation, FIGS. 4-5, comprising: a bone plate (14) having a plate body that has an outer surface and a bone-facing surface opposite the outer surface, FIG. 4, the plate body defining a plurality of plate holes (16) that each extends from the outer surface to the bone-facing surface along a respective central hole axis (par. [0037]), wherein the plate body includes opposed exterior side surfaces (each side surface includes the entire longitudinal side surface extending down one longitudinal side of the plate body, with the two side surfaces opposed to each other) that extend between adjacent ones of the plate holes and are inwardly recessed (portions of each side surface extend between adjacent ones of the plate holes and are inwardly recessed); and a guide body (40) having a proximal end and a distal end spaced from each other along a direction, the distal end having a coupling mechanism (44) that is configured to couple to the bone plate at an orientation of the guide body, FIGS. 4-5, the guide body defining at least one channel (48) that extends along a central channel axis and is configured to receive at least one respective bone fastener (12) therein in a pre-loaded position, wherein the coupling mechanism comprises a pair of engagement members (44) that are configured to extend alongside the opposed exterior side surfaces of the bone plate (the engagement members extend alongside portions of the opposed exterior side surfaces), and the guide body comprises a spring member (portion connecting 44 to a rest of body 40) configured to apply a biasing force to the engagement members that maintains coupling of the engagement members against the opposed exterior side surfaces of the plate body (par. [0038]), wherein the guide body is configured such that the central channel axis is substantially coaxial with the central hole axis when the guide body is connected to the bone plate at the orientation, FIG. 5, and wherein the guide body includes a retention mechanism (46) within the at least one channel (described with respect to mechanism 30 in another embodiment, par. [0035]), the retention mechanism configured to apply a retention force to the at least one respective bone fastener that retains the at least one respective bone fastener within the at least one channel in the pre-loaded position (par. [0035]).
As to claim 2, Detweiler ‘111 discloses the bone plating assembly of claim 1, wherein the retention mechanism comprises a flexible tab (46) defined by a cutout portion of the guide body, FIG. 4, the flexible tab being biased inward toward the central channel axis (described with respect to mechanism 30 in another embodiment, par. [0035]) such that an interior surface of the flexible tab is configured to contact a head of the at least one respective bone fastener (interpreted as language of intended use) to thereby apply the retention force thereto in the pre-loaded position.
As to claim 4, Detweiler ‘111 discloses the bone plating assembly of claim 1, wherein: the plate body defines a plurality of side surfaces extending between the outer surface and the bone-facing surface; and the coupling mechanism comprises at least two engagement members (44) that are configured to extend alongside and couple with at least two of the plurality of side surfaces of the plate body with a coupling force that couples the plate body with the guide body at least against the force of gravity, FIG. 5.
As to claim 5, Detweiler ‘111 discloses the bone plating assembly of claim 4, wherein the at least two of the plurality of side surfaces are opposed exterior side surfaces of the plate body, FIG. 5.
As to claim 6, Detweiler ‘111 discloses the bone plating assembly of claim 5, wherein the guide body comprises a spring member (portion connecting 44 to a rest of body 40) configured to bias the at least two engagement members toward each other and toward the respective opposed exterior side surfaces of the plate body (par. [0038]).
As to claim 13, Detweiler ‘111 discloses a screw guide for connecting to a bone plate (14) having at least one fastener hole (16), FIGS. 4-5, comprising: a body (40) having a proximal end and a distal end spaced from each other along a direction, the distal end having a coupling mechanism (44) configured to couple the body to the bone plate at an orientation, FIGS. 4-5, the body defining at least one channel (48) that extends along a central channel axis, the at least one channel configured to receive at least one respective bone fastener (12) therein in a pre-loaded position, wherein the coupling mechanism is configured such that the central channel axis substantially aligns with a central hole axis of the at least one fastener hole when the coupling mechanism is coupled to the bone plate at the orientation, FIG. 5, and wherein the body has a flexible retention mechanism (46) that is bent so as to extend at least partially within the at least one channel (described with respect to mechanism 30 in another embodiment, par. [0035]; the retention mechanism is flexibly bent to extend inwardly into the channel to resiliently hold the fastener), such that the retention mechanism is configured to apply a retention force to the at least one respective bone fastener that retains the at least one respective bone fastener within the at least one channel in the pre-loaded position (par. [0035]).
As to claim 14, Detweiler ‘111 discloses the screw guide of claim 13, wherein the retention mechanism comprises a flexible tab (46) defined by a cutout portion of the body, FIG. 4, the flexible tab being biased inward toward the central channel axis (described with respect to mechanism 30 in another embodiment, par. [0035]) such that an interior surface of the flexible tab is configured to contact a head of the at least one respective bone fastener (interpreted as language of intended use) to thereby apply the retention force thereto in the pre-loaded position.
As to claim 16, Detweiler ‘111 discloses the screw guide of claim 13, wherein the coupling mechanism comprises a pair of engagement members (44) that are configured to extend alongside and clamp against at least two opposed side surfaces of the bone plate, FIG. 5.
As to claim 17, Detweiler ‘111 discloses the screw guide of claim 16, wherein the pair of engagement members (44) each comprises a bottom surface (of distal-most tip of 44 in FIG. 5), an interior surface (interior vertical surface of distal prong of 44, adjacent to the distal chamfer) that extends along the direction between a bottom surface of the body and the bottom surface of the respective engagement member, and a chamfer surface (distal chamfer/distal angled surface of 44) that extends from the interior surface to the bottom surface of the respective engagement member, wherein the chamfer surfaces of the pair of engagement members are configured to push the pair of engagement members away from each other as the chamfer surfaces engage the bone plate, FIG. 5.
As to claim 18, Detweiler ‘111 discloses the screw guide of claim 16, wherein the body comprises a spring member (portion connecting 44 to a rest of body 40) configured to bias the pair of engagement members toward each other for clamping against respective ones of the at least two opposed side surfaces of the bone plate (par. [0038]).
Claims 1 and 4-6 are rejected under 35 U.S.C. 102(a)(1)/(2) as anticipated by U.S. Patent Application Publication No. US 2009/0312801 to Lemoine et al. (hereinafter, “Lemoine”).
As to claim 1, Lemoine discloses a bone plating assembly for bone fixation, comprising: a bone plate (112) having a plate body that has an outer surface and a bone-facing surface opposite the outer surface, FIG. 2, the plate body defining a plurality of plate holes (118) that each extends from the outer surface to the bone-facing surface along a respective central hole axis (par. [0031]), wherein the plate body includes opposed exterior side surfaces (each side surface includes the entire longitudinal side surface extending down one longitudinal side of the plate body, e.g. from reference numeral 114 at the top of the plate body to reference numeral 114 at the bottom in FIG. 4, with the two side surfaces opposed to each other) that extend between adjacent ones of the plate holes and are inwardly recessed (portions of each side surface extend between adjacent ones of the plate holes and are inwardly recessed); and a guide body (150) having a proximal end and a distal end spaced from each other along a direction, FIG. 4, the distal end having a coupling mechanism (170, 160) that is configured to couple to the bone plate at an orientation of the guide body (par. [0039]), FIG. 4, the guide body defining at least one channel (158) that extends along a central channel axis and is configured to receive at least one respective bone fastener therein in a pre-loaded position (interpreted as language of intended use; a fastener passing through the channel is pre-loaded or loaded prior to insertion into the plate/bone) (par. [0044]), FIG. 3, wherein the coupling mechanism comprises a pair of engagement members (174) that are configured to extend alongside the opposed exterior side surfaces of the bone plate (the engagement members extend alongside portions of the opposed exterior side surfaces), and the guide body comprises a spring member (172) configured to apply a biasing force to the engagement members that maintains coupling of the engagement members against the opposed exterior side surfaces of the plate body (par. [0039]), wherein the guide body is configured such that the central channel axis is substantially coaxial with the central hole axis when the guide body is connected to the bone plate at the orientation (par. [0037]), and wherein the guide body includes a retention mechanism (par. [0056]; the screwdriver is a retention mechanism because it retains the fastener thereon) within the at least one channel (when the screwdriver is advancing the fastener through the channel it is within the channel), the retention mechanism configured to apply a retention force to the at least one respective bone fastener that retains the at least one respective bone fastener within the at least one channel in the pre-loaded position (when the screwdriver retaining the fastener thereon is passing through the channel, the fastener is within the channel in the pre-loaded position which is the loading position prior to insertion into the plate/bone).
As to claim 4, Lemoine discloses the bone plating assembly of claim 1, wherein: the plate body defines a plurality of side surfaces extending between the outer surface and the bone-facing surface, FIG. 4; and the coupling mechanism comprises at least two engagement members (174) that are configured to extend alongside and couple with at least two of the plurality of side surfaces of the plate body with a coupling force that couples the plate body with the guide body at least against the force of gravity (par. [0040]).
As to claim 5, Lemoine discloses the bone plating assembly of claim 4, wherein the at least two of the plurality of side surfaces are opposed exterior side surfaces of the plate body (as interpreted above).
As to claim 6, Lemoine discloses the bone plating assembly of claim 5, wherein the guide body comprises a spring member (172) configured to bias the at least two engagement members (174) toward each other and toward the respective opposed exterior side surfaces of the plate body (par. [0039]).
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.
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 13, 16, and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Lemoine in view of U.S. Patent Application Publication No. US 2022/0125492 to Steffensmeier et al. (hereinafter, “Steffensmeier”).
As to claim 13, Lemoine discloses a screw guide for connecting to a bone plate (112) having at least one fastener hole (118), comprising: a body (150) having a proximal end and a distal end spaced from each other along a direction, FIG. 4, the distal end having a coupling mechanism (170, 160) configured to couple the body to the bone plate at an orientation (par. [0039]), FIG. 4, the body defining at least one channel (158) that extends along a central channel axis, the at least one channel configured to receive at least one respective bone fastener therein in a pre-loaded position (interpreted as language of intended use; a fastener passing through the channel is pre-loaded or loaded prior to insertion into the plate/bone) (par. [0044]), FIG. 3, wherein the coupling mechanism is configured such that the central channel axis substantially aligns with a central hole axis of the at least one fastener hole when the coupling mechanism is coupled to the bone plate at the orientation (par. [0037]).
As to claim 16, Lemoine discloses the screw guide of claim 13, wherein the coupling mechanism comprises a pair of engagement members (174) that are configured to extend alongside and clamp against at least two opposed side surfaces of the bone plate (side surfaces coupled to 174s are opposed side surfaces).
As to claim 18, Lemoine discloses the screw guide of claim 16, wherein the body comprises a spring member (172) configured to bias the pair of engagement members (174) toward each other for clamping against respective ones of the at least two opposed side surfaces of the bone plate (par. [0039]).
As to claim 19, Lemoine discloses the screw guide of claim 18, wherein the coupling mechanism includes two additional engagement members (160) that are positioned between the pair of engagement members (as much as the instant invention), the two additional engagement members being configured to extend alongside and couple with another two side surfaces of the bone plate so as to center the bone plate body at the orientation relative to the bone plate (par. [0037]), FIG. 4.
As to claim 20, Lemoine discloses wherein the at least one channel comprises four channels (four exterior 158s) extending from the proximal end to the distal end of the body along respective central channel axes, FIG. 3, the four channels being arranged in a square pattern.
Lemoine is silent as to wherein the body has a flexible retention mechanism that is bent so as to extend at least partially within the at least one channel, such that the retention mechanism is configured to apply a retention force to the at least one respective bone fastener that retains the at least one respective bone fastener within the at least one channel in the pre-loaded position (claim 13); wherein the retention mechanism comprises four compliant members each defined by the body and each extending within a respective one of the four channels (claim 20).
Steffensmeier teaches a screw guide for connecting to a bone plate (200) having at least one fastener hole, comprising: a body (302 including 311s and 312s) having a proximal end and a distal end spaced from each other along a direction, FIGS. 11-13, the distal end having a coupling mechanism (distal protrusions) configured to couple the body to the bone plate at an orientation, the body defining at least one channel (through 311) that extends along a central channel axis, the at least one channel configured to receive at least one respective bone fastener (114) therein in a pre-loaded position (par. [0055]), FIG. 13, wherein the coupling mechanism is configured such that the central channel axis substantially aligns with a central hole axis of the at least one fastener hole when the coupling mechanism is coupled to the bone plate at the orientation, and wherein the body has a flexible retention mechanism (322) that is bent so as to extend at least partially within the at least one channel (par. [0055]), FIG. 13, such that the retention mechanism is configured to apply a retention force to the at least one respective bone fastener that retains the at least one respective bone fastener within the at least one channel in the pre-loaded position.
As to claim 20, Steffensmeier teaches the screw guide of claim 19, wherein the at least one channel comprises four channels (four of the 311s) extending from the proximal end to the distal end of the body along respective central channel axes, the four channels being arranged in a square pattern, wherein the retention mechanism comprises four compliant members (one of the 322s in each channel) each defined by the body (since the body comprises 312s) and each extending within a respective one of the four channels.
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to include in Lemoine a retention mechanism as taught by Steffensmeier, by including captive elements (Steffensmeier, 312) comprising compliant members (Steffensmeier, 322) in Lemoine’s body, with one captive element (and associated compliant members) received in each of Lemoine’s channels and holding a respective fastener within the compliant members and in the channel in the pre-loaded position, to center the fastener in the channel for accurate driving position and to prevent the fastener from falling out of or through the channel before it is driven into the plate and the bone. The retention mechanism would thus comprise four compliant members (one of the 322s in each of the four channels identified in Lemoine) each defined by the body (since the body comprises the 312s/322s) and each extending within a respective one of the four channels. The retention mechanism is, as taught by Steffensmeier, flexible and bent so as to extend into the respective channel for retaining the fastener therein.
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 TRACY L KAMIKAWA whose telephone number is (571)270-7276. The examiner can normally be reached M-F 10:00-6:30 PM.
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/TRACY L KAMIKAWA/Examiner, Art Unit 3775