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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 2/2/2026 has been entered. Claims 1-20 remain pending in this application.
Response to Arguments
Applicant's arguments filed 1/5/2026 have been fully considered but they are not persuasive. With regard to applicant’s argument that the newly amended limitations of claims 1, 9, and 15 are not met by Faulhaber, the examiner disagrees. Upon further consideration, a new rejection is made in view of Faulhaber, which is designed to be positioned between two bones, such as vertebrae (abstract), for the purpose of spacing the bones of the joint, wherein the base member (112) engages a first bone and the adjustable member (102) engages a second bone.
Claim Objections
Claim 12 is objected to because of the following informalities: Claim 12, line 2 recites “the adjustable member” which appears to be referring to – the expandable member –, as recited in claim 9 from which claim 12 depends. Appropriate correction is required.
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)(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.
Claim(s) 1, 2, 6-11, 13-15, 18, and 20 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by US Patent Application Publication No. 2017/0172756 A1 to Faulhaber (Faulhaber).
Regarding at least claim 1
Faulhaber teaches a spacer for separating bones of a joint (abstract).
PNG
media_image1.png
712
506
media_image1.png
Greyscale
Faulhaber meets the limitations of an implant assembly, comprising: an expandable implant (100), the expandable implant comprising a base member (cam frame; 112) and an adjustable member (top endplate; 102) movable relative to the base member such that the expandable implant is movable between a collapsed configuration and an expanded configuration (paragraph 0054 discloses that the endplates move from a collapsed position as shown in fig. 10 to an expanded position shown in fig. 11), wherein the base member comprises a threaded attachment port (opening; 154 is construed to be comprised on the base member 102, at least when the cam frame 112 is assembled as shown in fig. 10) and is configured to engage a first bone (when implanted, the cam frame is configured to engage a first bone – see description of being placed between bony surfaces to separate two bones at [0039]), and wherein the adjustable member is configured to engage a second bone (top endplate is configured to engage a second bone as disclosed in paragraph 0039);
a plate (front plate; 174) configured to be coupled to the expandable implant (fig. 14 shows the plate 174 coupled to the implant 100);
a coupling fastener (non-threaded end of drive screw; 132 as shown in fig. 3 that is secured to cam frame; 112 as disclosed in paragraph 0056) configured to couple the plate to the expandable implant (fig. 16 shows that the drive screw/fastener 132 couples the plate 174 to the implant 100);
and at least one bone screw (222) configured to extend through the plate and into an adjacent portion of bone (paragraph 0058 discloses bone fasteners which may include bone screws and bone shanks for securing the front plate 174 to adjacent tissue, such as vertebral bodies); wherein the threaded attachment port (opening; 154) is configured to receive a threaded end (212) of an installation tool (spacer insertion device; 202) during positioning of the expandable implant (paragraph 0057 discloses the spacer insertion device/tool having a threaded end 212 that threads into a threaded opening 214 of the drive screw 132 so that drive screw may be retained in opening, as shown in fig. 3 and fig. 16 – therefore the opening/port 154 receives the threaded end of the tool/device 202) and to threadingly receive the coupling fastener to couple the plate to the expandable implant (drive screw/coupling fastener extends through plate and into opening/attachment port; 154 as disclosed in paragraph 0056 and shown in fig. 16 thereby coupling the plate; 174 to the implant).
Regarding at least claim 2
Faulhaber also teaches the implant assembly of claim 1, wherein the expandable implant (100) comprises a control assembly (actuation subassembly; 104, particularly threaded portion; 190 of drive screw, drive nut; 113 and rings; 192, 194) configured to control movement of the expandable implant between the collapsed configuration and the expanded configuration (paragraph 0054 discloses controlled movement between a collapsed position to an expanded position), wherein the control assembly comprises first and second control members (drive nut; 113 and rings; 192, 194) received on a control shaft (threaded portion; 190 is construed to be a control shaft because it may threadingly engage the drive nut through bore; 188 so that drive nut may be retained on drive screw; 132 as disclosed in paragraph 0055, such that the drive nut; 113 is rotated via drive nut interface; 218 as shown in fig. 13 causing drive screw and cam frame to move along the longitudinal axis, thereby causing expansion of the implant as disclosed in paragraph 0054).
Regarding at least claim 6
Faulhaber also teaches the implant assembly of claim 2, wherein each of the first and second control members (drive nut; 113 and rings; 192, 194) are configured to provide a first force to the adjustable member to move the adjustable member toward the expanded configuration and provide a second force to the adjustable member to move the adjustable member toward the collapsed configuration (drive nut; 113 and rings; 192, 194 are received on control shaft/threaded portion; 190 via drive nut through bore; 188 to be retained on drive screw; 132 as disclosed in paragraph 0055, such that the drive nut; 113 is rotated via drive nut interface; 218 as shown in fig. 13 causing drive screw and cam frame to move along the longitudinal axis, thereby causing expansion of the implant and more specifically, a first force in a first direction is provided to move the top plate/adjustable member toward the expanded configuration and a second force in a second, opposite direction is proved to move the top plate/adjustable member toward the collapsed configuration as disclosed in paragraph 0054).
Regarding at least claim 7
Faulhaber also teaches the expandable implant of claim 1, wherein the plate (174) comprises a front side (facing away from the implant) and a rear side (facing toward the implant), wherein the rear side faces the expandable implant and a plurality of projections (blocking screws; 224) extend outward from the rear side and are configured to engage adjacent portions of bone (paragraph 0058 discloses blocking screws/projections extending through the plate to retain bone fasteners 222; fig. 14).
Regarding at least claim 8
Faulhaber also teaches implant assembly of claim 1, wherein the attachment port (154) is provided on a front face on the expandable implant (fig. 16 shows the port on the front face of the implant), and wherein the base member further comprises first and second anti-rotation ports (tool engagements; 134) (fig. 3 shows the tool engagements/anti-rotation ports which the base member; 112 is construed to comprise, at least when the implant is assembled) provided on opposite sides of the attachment port (fig. 16, for example, shows that the anti-rotation ports are on opposite sides of the attachment port), the first and second anti-rotation ports configured to receive portions of the installation tool to prevent rotation of the expandable implant (paragraph 0057 discloses that the engagements/ports engage with portion 206 of the tool and prevent rotation).
Regarding at least claim 9
Similar to the explanation above, Faulhaber meets the limitations of a method of installing an implant assembly, comprising: coupling a tool (insertion device; 202) to a threaded attachment port (opening; 154) of a base member (cam frame; 112) of an expandable implant (spacer; 100); positioning the expandable implant in a desired location using the tool (paragraph 0057 discloses positioning the implant 100 with the device/tool 202 by threading the threaded end 212 into the threaded opening 214 of a drive screw 132 which extends through the opening 186 of the plate and into attachment port 154, as shown in fig. 12); expanding the expandable implant to a desired height, wherein during expansion of the expandable implant the base member (112) is stationary and an expandable member (top plate; 102) moves away from the base member (paragraph 0058 discloses use of a cam frame 112 to drive the endplates apart causing expansion of the implant as shown in fig. 15, during which the frame remains stationary); coupling a plate (174) to the expandable implant by securing a coupling fastener (drive screw; 132) to the plate and the expandable implant (the drive screw 132 is coupled to the plate 174 via opening 186 and to the implant 100 via opening 154 thereby securing the plate 174 to the implant 100); and installing a plurality of bone screws (fasteners; 222) through the plate and into adjacent portions of bone (paragraph 0058 discloses that the fasteners/screws secure the plate to adjacent tissue, such as vertebral bodies); wherein the coupling fastener (132) is received by the threaded attachment port (154) of the expandable implant (100) to couple the plate (174) to the expandable implant (100) (fig. 15 shows that the drive screw/fastener is received in the port/opening 154 to couple the plate to the implant as claimed).
Regarding at least claim 10
Faulhaber also teaches the method of claim 9, wherein coupling the tool (202) to the attachment port (154) comprises threadingly coupling the threaded end (threaded end; 212) of the tool to the threaded attachment port (paragraph 0057).
Regarding at least claim 11
Faulhaber also teaches the method of claim 9, further comprising coupling the tool (202) to a pair of alignment apertures (tool engagements; 134) on opposite sides of the threaded attachment port (154), the pair of alignment apertures configured to enable resistance to rotation of the expandable implant via the tool (paragraph 0057 discloses engaging portions 216 with the tool-engagements 134 that prevents rotation of the implant via the tool).
Regarding at least claim 13
Faulhaber method of claim 9, further comprising inserting projections (blocking screws; 224) on a rear surface of the plate into adjacent portions of bone (fig. 16 shows that the blocking screws/projection are inserted on a rear surface of the plate into adjacent portions of bone).
Regarding at least claim 14
Faulhaber also teaches the method of claim 9, wherein the plate is a single unitary structure (the plate 174 is a single unitary structure, as shown in fig. 17).
Regarding at least claim 15
Similar to the explanation above, Faulhaber meets the limitations of an implant assembly, comprising: at least one installation tool (insertion device; 202) comprising a threaded end (212); an expandable implant (spacer; 100), the expandable implant comprising a base member (cam frame; 112) and an adjustable member (top endplate; 102) movable relative to the base member such that the expandable implant is movable between a collapsed configuration and an expanded configuration (paragraph 0054 discloses movement between a collapsed configuration and an expanded configuration), wherein the expandable implant comprises a threaded attachment port (opening; 154), and wherein the adjustable member (top endplate; 102) is rotationally static relative to the base member (cam frame; 112) as the expandable implant moves between the collapsed configuration and the expanded configuration (no rotation occurs to the top endplate or the cam frame during expansion); a plate (front plate; 174) configured to be coupled to the expandable implant via the threaded attachment port (154) (fig. 33 shows that drive screw; 132 couples the implant to the plate via threaded attachment port); a coupling fastener (drive screw; 132) configured to couple the plate to the expandable implant (fig. 33 shows that the screw/fastener is used to couple the plate to the implant); and at least one bone screw (bone fastener; 222) configured to extend through the plate and into an adjacent portion of bone (paragraph 0058 discloses securing the plate to adjacent tissue, such as vertebral bodies); wherein the threaded attachment port (154) is configured to couple with the at least one installation tool (202) during positioning of the expandable implant and to threadingly couple with the coupling fastener (132) to secure the plate to the expandable implant (paragraph 0057 discloses the threaded end 212 of the tool/device 202 threads into a threaded opening 214 of the drive screw 132, as shown in fig. 3, and fig. 16 shows that the drive screw 132 extends through the plate 174 into the port/opening 154 of the implant – therefore the attachment port 154 couples with the tool 202 and the coupling fastener 132, as claimed).
Regarding at least claim 18
Faulhaber also teaches the implant assembly of claim 15, wherein the at least one bone screw (222) comprises a first bone screw and a second bone screw (fig. 18 shows a first and second bone screw); and wherein the plate (174) comprises a first bone screw bore (220) positioned on a first end of the expandable implant when the expandable implant is coupled to the plate (fig. 16 shows a first bore on a first, upper end), and a second bone screw bore (220) positioned on a second end of the expandable implant opposite the first end when the expandable implant is coupled to the plate (fig. 16 shows a second bore on a second, lower end).
Regarding at least claim 20
Faulhaber also teaches the implant assembly of claim 15, wherein the base member (112) comprises the attachment port (154) and first and second anti-rotation ports (tool engagements; 134) on opposite sides of the attachment port (fig. 16 shows that the engagements/ports are on opposite sides of the port 154), the first and second anti-rotation ports configured to receive a tool to resist rotation of the expandable implant (paragraph 0057 discloses engaging ears 216 of the tool into the tool engagements 134 which would result in resisting rotation of the implant).
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) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Faulhaber, as applied to claim 18 above, in view of US Patent Application Publication No. 2013/0345813 A1 to Frank et al. (Frank).
Faulhaber also teaches the implant assembly of claim 18, including blocking screws (first and second blocking screws; 224) that may be rotated to block bone fasteners (screws; 222) and retain bone fasteners (222) in bone fastener receiving holes (220). However, Faulhaber does not teach further comprising a first set screw and a second set screw; wherein the first bone screw and the first set screw are both received in the first bone screw bore, and wherein the second bone screw and the second set screw are both received in the second bone screw bore.
Frank teaches a plate-based fixation system having dual anchors (abstract). More specifically, Frank teaches the use of set screws received within recesses of bone screws, for the purpose of preventing back out once positioned in the bone (paragraph 0040).
It would have been obvious to one having ordinary skill in the art to modify the first and second blocking screws of Faulhaber to be first and second set screws and positioned them such that they are received within the first and second screw bores, respectively, along with the first and second bone screws, in order to prevent back out once the screws are positioned in the bone, as taught by Frank, since this configuration would result in retaining the bone fasteners/screws as intended by Faulhaber.
Allowable Subject Matter
Claims 3-5, 12, and 16-17 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: the prior art does not teach or fairly suggest the combination of elements claimed, particularly including first and second control members that are received on a control shaft and also within first and second control channels of the adjustable member, respectively (see claim 3) OR a control shaft that has a first control member received on its first control thread having a first diameter and a second control member received on its second control thread having a second, smaller diameter (see claims, 5, 12, and 16).
The closest prior art to Faulhaber (US Patent Application Publication No. 2017/0172756 A1) teaches an expandable implant in combination with a plate, as well as a control assembly, which includes a cam frame, cam pins, a drive screw, and a drive nut, for controlling movement of the implant between a collapsed configuration and an expanded configuration. However, Faulhaber does not teach first and second control members that are received on a control shaft and also within first and second control channels of the adjustable member, respectively. Faulhaber also does not teach a threaded control shaft with a first diameter and a second, smaller diameter, for threadingly receiving first and second control members, respectively.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MELISSA A HOBAN whose telephone number is (571)270-5785. The examiner can normally be reached Monday-Friday 8:00AM-5:00PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie Tyson can be reached at 571-272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/M.A.H/Examiner, Art Unit 3774
/SARAH W ALEMAN/Primary Examiner, Art Unit 3774
Prosecution Insights