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 was filed in this application after appeal to the Patent Trial and Appeal Board, but prior to a decision on the appeal. 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examination under 37 CFR 1.114 and the fee set forth in 37 CFR 1.17(e) has been timely paid, the appeal has been withdrawn pursuant to 37 CFR 1.114 and prosecution in this application has been reopened pursuant to 37 CFR 1.114. Applicant’s submission filed on 05/12/2026 has been entered.
Status of Claims
This office action is responsive to the amendment filed on 05/12/2026. As directed by the amendment: claim 1 has been amended, no additional claims have been cancelled, no new claims have been added, and claims 19-21 remain withdrawn from consideration as being drawn to a non-elected invention. Thus, claims 1, 2, 5, 9-11, 13, 15 and 18 are presently examined in the current Office Action.
Claim Rejections - 35 USC § 112
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 15 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, 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. The parameter set forth in claim 15 can be found on lines 28-29 of independent claim 1. 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.
Examiner’s Notes
It is to be noted that in device/apparatus claims only the claimed structure of the final device bears patentable weight, and intended use/functional language is considered to the extent that it further defines the claimed structure of the final device (see MPEP 2114).
Examiner cites particular columns and line numbers in the references as applied to the claims below for the convenience of the applicant(s). Although the specified citations are representative of the teachings in the art and are applied to the specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested that, in preparing responses, the applicant(s) fully consider the references in entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the examiner.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 2, 5, 9-11, 13, 15 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Jackson (US Patent No. 6,821,298), as previously disclosed, in view of Gotfried (US PG Pub. 2016/0184099), as previously disclosed, and Blain et al. (US PG Pub. 2015/0190242), as previously disclosed, hereinafter Blain.
Regarding claims 1 and 15, Jackson discloses an open wedge implant (301), illustrated in Figures 18-24, comprising an exterior comprising a wedge body (302), a first expandable portion (310); second expandable portion (311) connected to the first expandable portion (310) using an intervening distal attachment (312), wherein the first and second expandable portions (310 & 311, respectively) are separated by a gap (313) that allows movement of the first and second expandable portions during adjustment of the open wedge implant; wherein the intervening distal attachment (312) biases the wedge body (302) in the initial configuration, thereby maintaining an assembled state of the open wedge implant, illustrated in Figures 18, 20, 23 and 24 (Column 11, Line 47 – Column 12, Line 10 & Column 12, Lines 30-32); the exterior comprising a roughened first face (314) and a roughened second face (315), wherein each face comprise repeating surface features (321) that cover and span an entirety of the roughened first face (314) and the roughened second face (315), wherein the roughened first face (314) and the roughened second face (315) contact bone portions exposed during an osteotomy, illustrated in Figures 18, 20, 23 and 24 (Column 11, Lines 51-30 – It is to be noted that thought it isn’t specifically stated that surface features 321 are “machined”, this parameter is deemed to be a product-by-process limitation, and it is important to keep in mind that that though product-by-process claims/limitations are limited by and defined by the process, determination of patentability is based on the product itself; the patentability of a product does not depend on its method of production, and if the product in the product-by-process claim/limitation is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process; see MPEP 2113. Thus, in the instant case, the device of Jackson meets the structural limitation of roughened first face 314 and roughened second face 315 comprising one or more surface features 321, the surface features being capable of performing the intended function of contacting/attaching to bone; thereby meeting the claimed limitation); a proximal opening (PO) within the wedge body (302) comprising a cross-section at a proximal end (CPE) that is larger than at a distal end (CDE) of the wedge body, illustrated in Figure 24 and modified figure 24, below; each of the first and second expandable portions comprising proximal and distal windows (30/220/426) that are vertically aligned to form holes passing through the open wedge implant, illustrated in Figures 1, 3, 4, 15-17, 25 and 27 (Column 6, Lines 28-30; Column 10, Lines 49-51 & Column 12, Lines 66-67), and though it is not specifically disclosed that the distal window comprises a pair/two distal windows, this parameter is deemed to be a mere matter of normal design choice, not involving a novel inventive step, a fact that is iterated by the originally filed specification of the current application at hand, which states “It should be understood that the open wedge implant 240 is not to be limited to the number and shapes of the windows and openings illustrated in FIGS. 10-11, but rather any number and shape of the windows and openings may be incorporated into the open wedge implant 240 without limitation” ([0039], Last 4 Lines of the originally filed specification of the current application at hand); thus, it would have been obvious, and well within the capability of one having ordinary skill in the art before the effective filing date of the invention to determine an appropriate number and/or location for the windows in the first and second expandable portions, of the device of Jackson, including having a pair/two distal windows, as opposed to one, in order to allow for bone growth through the first and second expandable portions of the device to fuse the adjacent vertebral bodies, as taught by Jackson (Column 7, Lines 2-5 & Column 9, Lines 8-11), and doing so amounts to a mere matter of duplication of essential working parts/windows of the device, and would not affect or change the intended use/purpose of the device of Jackson, and it has been held that mere duplication of parts involves only routine skill in the art and has no patentable significance unless a new and unexpected result is produced (see MPEP 2144.04); an expander (303) configured to separate the first and second expandable portions so as to increase a proximal thickness and a wedge angle of the wedge body, a flat distal end (344) of the expander contacts a distal surface (DS) of the proximal opening (PO) when the opening wedge implant is placed into the expanded configuration, illustrated in Figures 18, 20, 22-24 and modified figures 20 and 24, below, wherein the proximal opening (PO) comprises a first bevel (332) in the first expandable portion (310) and a second bevel (333) in the second expandable portion (311) which are configured to contact a first taper (1T) and a second taper (2T) in the expander (303), wherein the first and second tapers (1T & 2T) give the expander (303) a distally tapering thickness for separation the first and second expandable portions (310 & 311), illustrated in Figures 18, 20, 22-24 and modified figures 22 and 24, below (Column 11, Line 61 – Column 12, Line 4); wherein the wedge angle of the open wedge implant is proportional to the proximal thickness, such that during the initial configuration the wedge angle comprises a first angle (FA), illustrated in Figure 20 and modified figure 20 below; and during an expanded configuration the wedge angle comprises a second angle (SA), illustrated in Figure 24 and modified figure 24 below, the second angle (SA) being larger than the first angle (FA), illustrated in modified figures 20 and 24, below; a distal channel (DC) that facilitates deflection of the first and second expandable portions (310 & 311), such that a uniform wedge angle is maintained along a longitudinal dimension of the wedge implant, illustrated in Figures 18, 24 and modified figure 24, below (Column 11, Lines 51-55); a proximal screw (304) disposed on a proximal end of the wedge body, configured to move the expander within the wedge body, whereby a wedge angle of the open wedge implant is adjustable by way of turning the proximal screw (304), illustrated in Figures 18-24 (Column 11, Line 60 - Column 12, Line 10 & Column 12, Lines 25-39); wherein the expander (303) comprises a recess (351) to loosely retain a smooth portion (352) of the proximal screw (304), the recess allowing free rotation of the smooth portion while a threaded portion (354) of the proximal screw is rotatably engaged within a threaded channel (322) disposed between the first and second expandable portions (310, 311), illustrated in Figures 18 and 20 (Column 12, Lines 1-10); wherein the expander (303) comprises a countersink (351) that retains a head portion (352) of the proximal screw (304), illustrated in Figures 18 and 20, allowing free rotation of the screw and preventing the expander from becoming disengaged from the screw, the countersink comprising a depth wherein the head portion is positioned substantially within the body of the expander (303); and remains substantially flush with the proximal end of the wedge body; and a proximal socket (355) facilitates engaging and rotating the proximal screw (304), illustrated in Figure 18 (Column 12, Lines 1-10); and though it is not specifically disclosed that the proximal surface of the expander comprises a rounded curvature identical to a curvature of a proximal end of the wedge body, this parameter is deemed to be a mere matter of normal design choice, not involving a novel inventive step, and it would have been obvious, and well within the capability of one having ordinary skill in the art before the effective filing date of the invention to determine an appropriate shape for the proximal surface of the expander and the proximal end of the wedge body, including both having an identical rounded curvature to match the anterior curvature of a vertebral body, and amounts to a mere change in form/shape which is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results (see MPEP 2144.04), and wherein the initial configuration of the wedge implant comprises a wedge angle of approximately 7 degrees, illustrated in Figure 23, and wherein the expanded configuration of the wedge implant comprises a wedge angle of approximately 14 degrees, illustrated in Figure 24 (Column 5, Lines 23-30 – To clarify, Figures 23 and 24 show the wedge implant in an initial configuration and an expanded configuration, respectively; the figures showing respective wedge angles of each state. Since the originally filed specification of the current application at hand does not provide a specific standard for the requisite degree of the term “approximately”, the respective wedge angles shown are considered to be “approximately 7 degrees”, in an initial configuration, and “approximately 14 degrees” in an expanded configuration, thereby meeting the claimed limitation. It is further to be noted that the parameter(s) of initial and expanded wedge angles are considered to be mere matter of normal design choice, not involving a novel and inventive step, and it would be obvious, and well within the capability of one having ordinary skill in the art skill in the art before the effective filing date of the invention to determine appropriate wedge angles, including approximately 7 degrees in an initial configuration of the wedge implant and approximately 14 degrees in an expanded configuration of the wedge implant, as claimed, based on specific patient anatomy and intended use of the device, i.e. location of implantation site and/or type of surgical repair/intervention needed. Moreover, it is also to be noted that in the paragraph [0037], of the originally filed specification of the current application at hand, describes an embodiment of the wedge implant having a wedge angle of approximately 7 degrees in the initial configuration and approximately 14 degrees in the expanded configuration, and further goes on to state that “various shapes and dimensions may be incorporated into various embodiments of the open wedge implant 100 so as to utilize the open wedge implant in osteotomies performed in various bone or bone-joint locations within the patient's body”, thereby further supporting that the notion that the parameter(s) of initial and expanded wedge angles are a mere matter of normal design choice); but Jackson does not specifically disclose the proximal end of the wedge body being wider than the distal end, and the wedge implant comprising a thermoplastic polymer.
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However, Gotfried teaches an orthopedic implant (20), illustrated in Figures 1A and 1B, in the same field of endeavor, comprising a wedge body having a proximal/front end (22) and a distal/rear end (24); wherein the proximal/front end (22) has a width (D7) which is wider than a width (D4) of the distal/rear end (24), illustrated in Figure 1B (Gotfried: [0089]; [0090], Line 1 & [0091], Last 3 lines). Additionally, Blain teaches an orthopedic implant (300), illustrated in Figures 12-14, in the same field of endeavor, having upper and lower structures (302 & 204, respectively) comprising a thermoplastic polymer, i.e. PEEK/PEKK (Blain: [0122], Lines 1-5).
In view of the teachings of Gotfried and Blain, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to adjust the overall shape, of the wedge body of Jackson, such that the proximal end is wider than the distal end, as taught by Gotfried, based on patent need/anatomy and since a change in form/shape is generally recognized as being within the level of ordinary skill in the art (see MPEP 2144.04); and for the wedge body to comprise a thermoplastic polymer, as taught by Blain, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use (see MPEP 2144.07).
Regarding claim 2, Jackson in view of Gotfried and Blain disclose the open wedge implant of claim 1, and inasmuch as only the final device/apparatus bears patentable weight, not the intended use, Jackson in view of Gotfried and Blain disclose all the structural limitations as set forth in the claims of the final open wedge implant, and would be capable of being (i.e. has the physical structure to be able to be) used to perform osteotomies in the feet, and therefore anticipates this claim.
Regarding claim 5, Jackson in view of Gotfried and Blain disclose the open wedge implant of claim 1, wherein Jackson further teaches the first and second expandable portions (310 & 311, respectively), and the distal attachment (312) comprise a single component of material, illustrated in Figure 18 (Jackson: Column 11, Lines 51-54).
Regarding claims 9-11, Jackson in view of Gotfried and Blain disclose the open wedge implant of claim 1, wherein Jackson further teaches tightening the proximal screw (304) draws the expander (303) distally into the wedge body (302), thereby changing the open wedge implant from the initial configuration characterized by a narrow proximal thickness and a small wedge angle of the open wedge implant, illustrated in Figure 23, to an expanded configuration characterized by a proximal thickness larger than the narrow proximal thickness of the initial configuration, illustrated in Figure 24 (Jackson: Column 12, Lines 27-39).
Regarding claim 13, Jackson in view of Gotfried and Blain disclose the open wedge implant of claim 1, wherein Jackson further teaches the proximal opening (PO) is configured to receive the expander (303), illustrate in Figures 18, 20, 23, 24 and modified figure 24, above, such that the first and second expandable portions increasingly separate as the expander is drawn distally into the proximal opening, illustrated in Figure 24 (Jackson: Column 12, Lines 27-39).
Regarding claim 18, Jackson in view of Gotfried and Blain disclose the open wedge implant of claim 1, wherein Jackson further teaches the proximal screw (304) comprises a proximal socket (355) configured to facilitate engaging and rotating the proximal screw by way of a driver, illustrated in Figure 18 (Jackson: Column 12, Lines 8-10).
Response to Arguments
Applicant's arguments filed 05/12/2026 have been fully considered but they are not persuasive. Applicant argues “there is no motivation to combine the devices as suggested in the Office Action”, specifically pointing to the combination of Jackson and Gotfried and listing multiple differences between the devices of Jackson and Gotfried. Though these differences may be true, they have no impact on how the secondary reference of Gotfried was used in the rejections. The prior art of Gotfried was merely used to teach that it is known, in the art of wedge body orthopedic implants, for a wedge body implant to have a shape such that a proximal/front end is wider than the distal/back end. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to adjust the overall shape/form, of the wedge body implant of Jackson, such that the proximal end is wider than the distal end, as taught by Gotfried, since a change in form/shape is generally recognized as being within the level of ordinary skill in the art (see MPEP 2144.04). Applicant goes on to state that that independent claim 1 has further been amended by adding the parameters of “the first and second tapers give the expander a distally tapering thickness for separating the first and second expandable portions”, “a flat distal end of the expander contacts a distal surface of the proximal opening when the open wedge implant is placed into the expanded configuration”, and “a proximal socket facilitates engaging and rotating the proximal screw”, and therefore overcome the rejection. Examiner respectfully disagrees with Applicant’s assertion. As detailed in the rejection section above, Jackson clearly teaches all three of the above mentioned parameters: the parameter of the first and second tapers (1T & 2T) giving the expander a distally tapering thickness for separating the first and second expandable portions ((310 & 311) can clearly be seen in Figures 18, 22, 24 and modified figures 22 and 24, above; the parameter of the flat distal end (344) of the expander contacting a distal surface (DS) of the proximal opening (PO) when the is in the expanded configuration can clearly be seen in Figures 18, 20, 22, 24 and modified figures 20 and 24, above; and the parameter of a proximal socket (355) facilitating engagement and rotation of the proximal screw (304) is disclosed in Column 12, Lines 1-10 and can also clearly be seen in in Figure 18. Thus, the rejection of independent claim 1 as being unpatentable over Jackson in view of Gotfried and Blain is deemed to be proper since all the structural limitations set forth in the claim are taught.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DINAH BARIA whose telephone number is (571)270-1973. The examiner can normally be reached Monday - Friday 10am - 5pm.
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/DINAH BARIA/Primary Examiner, Art Unit 3774 06/04/2026
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