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 .
The Amendment filed 11/14/2025 has been entered. Claims 8, 9, 11-13, and 21-33 remain pending in this application.
Response to Arguments
Applicant’s arguments, see page 7, filed 11/14/2025, with respect to the rejection(s) of claim(s) 8, 9, 11-13, 21-27, and 29-33 under 35 USC 102 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of the newly amended claims.
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) 8, 9, 11-13, and 21-33 is/are rejected under 35 U.S.C. 103 as being unpatentable over by US Patent No. 6,080,193 to Hochshuler et al. (Hochshuler).
Regarding at least claim 8
Hochshuler teaches a method and apparatus for promoting a spinal fusion between neighboring vertebrae (abstract).
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Hochshuler meets the limitations of an expandable implant, comprising: a base member (engaging plate; 14); an adjustable member (engaging plate; 12) coupled to the base member and movable relative to the base member along at least a first direction between a collapsed position and an expanded position (fig. 12 shows a collapsed/lowered position and fig. 13 shows an expanded/raised position), the adjustable member comprising a top surface (fig. 16 shows a top surface of the adjustable member; 12) and a control channel (slot; 90 and/or 92) extending within the adjustable member (12) (figs. 12-15); a control shaft (connector; 80) at least partially disposed between the base member and the adjustable member (fig. 12 shows the shaft/connector 80 disposed between the base 14 and adjustable member 12), wherein manipulation of the control shaft causes the adjustable member to move relative to the base member between the collapsed position and the expanded position (col. 8, lines 51-58 discloses movement between a lowered/collapsed position and a raised/expanded position); and a control member (pin; 86 and/or 88) coupled to the control shaft (80) (col. 9, lines 17-21 discloses that the pin/control member includes a receiving section 87 having an opening for receiving the connector/shaft 80), the control member (86, 88) received within the control channel (90, 92) such that the control member translates within the adjustable member as the adjustable member moves between the collapsed position and the expanded position (translation of the control member/pin within the channel/slot is shown between the collapsed position of fig. 12 and the expanded position of fig. 13), and the control member (86) configured to provide a first force to the adjustable member to move the adjustable member toward the expanded position and provide a second force to the adjustable member to move the adjustable member toward the collapsed position (col. 9, lines 31-48 discloses delivering torque to the connector/control shaft 80 that is converted into a separation force between the pins/control members 86 that results in movement between the lowered/collapsed position and the raised/expanded position); wherein the control shaft and the control member are fixed relative to the base member along the first direction (fig. 12 and fig. 13 show that the control shaft/connector 80 and the control member/pin are fixed relative to the base 14 along the first direction as claimed).
However, the embodiment of figs. 12-15 of Hochshuler does not teach a central cavity extending through the top surface and into the adjustable member, or that the control channel extends to or is in fluid communication with the central cavity with the adjustable member in at least the expanded position.
Hochshuler also teaches that in an embodiment of the invention, as shown in fig. 3, the faces (15) of the engaging plates (12 and 14) contain a plurality of openings (34), including a central cavity (see annotated fig. 3 below), disposed therein to allow bone development and growth though the engaging plates and between the fusion device (10) and neighboring vertebrae (16 and 18) (col. 6, lines 20-24).
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It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the embodiment of Hochshuler, as shown in figs. 12-15, to include a central cavity extending through the top surface and into the adjustable member, in order to allow bone development and growth though the engaging plates and between the fusion device and neighboring vertebrae, as taught by Hochshuler. The control channel (slot; 90 and/or 92) would extend to the central cavity when the central cavity extends through the top surface and into the adjustable member and would also be in fluid communication with the central cavity with the adjustable member in at least the expanded position, as claimed by applicant.
Regarding at least claim 9
Hochshuler teaches the expandable implant of Claim 8, wherein the base member (12) comprises a first end, a second end, a first side, and a second side (fig. 7 shows a first end 22, a second end 24, a first side 26, and a second side 28), and wherein the first side and the second side are curved between the first end and the second end (col. 5, lines 47-55 discloses curved edges of the base member 12).
Regarding at least claim 11
Hochshuler teaches the expandable implant of Claim 8, wherein the control channel comprises a first control channel (90) and a second control channel (92), and wherein the control member comprises a first control member (86) received in the first control channel and a second control member (88) received in the second control channel (col. 9, lines 15-20 discloses pins/control members received in the pins/channels).
Regarding at least claim 12
Hochshuler teaches the expandable implant of Claim 11, wherein the first control member (86) and the second control member (88) are threadingly received on the control shaft (col. 9, lines 16-20 discloses that the connector/control shaft is threaded through the receiving sections of the pins/control members).
Regarding at least claim 13
Hochshuler teaches the expandable implant of Claim 8, wherein the base member (12) defines an overall length of the expandable implant in the collapsed position and in the expanded position (the length of the implant is defined by the base member in both the collapsed position shown in fig. 12 and in the expanded position in fig. 13).
Regarding at least claim 21
Hochshuler teaches the expandable implant of Claim 8, wherein the control member (86, 88) is configured to translate within the control channel (90, 92) as the adjustable member moves between the collapsed position and the expanded position (col. 8, lines 51-65 discloses translation of the pin/control member within the slot/control channel as the adjustable member 14 moves between positions). Regarding at least claim 22
Hochshuler teaches the expandable implant of Claim 8, wherein the control member is a first control member (86) of a plurality of control members, the plurality of control members comprising a second control member (88), the first control member and the second control member are coupled to the control shaft (80), wherein the first control member and the second control member are configured to translate away from each other as the adjustable member moves between the collapsed position and the expanded position (col. 9, lines 31-48 discloses translation of the control members/pins away from each other as the adjustable member 14 moves between positions as shown in figs. 12 and 13).
Regarding at least claim 23
Hochshuler teaches the expandable implant of Claim 8, wherein the control member is a first control member (86) of a plurality of control members, the plurality of control members comprising a second control member (88), the first control member and the second control member are coupled to the control shaft (col. 9, lines 18-21 disclose the control shaft/connector 80 being coupled to the control members 86, 88 via receiving sections 87).
Regarding at least claim 24
Hochshuler teaches the expandable implant of Claim 23, wherein manipulation of the control shaft comprises rotation of the control shaft (col. 9, lines 31-48 discloses delivering torque to the connector/control shaft 80, causing rotation, that is converted into a separation force between the pins/control members 86 that results in movement between the lowered/collapsed position and the raised/expanded position).
Regarding at least claim 25
Hochshuler teaches the expandable implant of Claim 24, wherein the rotation of the control shaft causes the first and second control members to translate in opposite directions along the control shaft (col. 9, lines 31-48 discloses delivering torque to the connector/control shaft 80, causing rotation, that is converted into a separation force between the pins/control members 86 that results in movement in angled slots/channels 90, 92 such that the implant moves between the lowered/collapsed position and the raised/expanded position – the angled channels result in translation of the control members/pins in opposite directions along the control shaft 80 as shown in figs. 12 and 13).
Regarding at least claim 26
Hochshuler teaches the expandable implant of Claim 23, wherein the adjustable member (14) includes a first control channel (90) configured to receive the first control member (86) and a second control channel (92) configured to receive the second control member (88).
Regarding at least claim 27
Hochshuler teaches the expandable implant of Claim 26, wherein the first control channel and the second control channel extend in non-parallel directions (fig. 12 shows that the channels/slots extend in non-parallel directions as claimed).
Regarding at least claim 28
Hochshuler teaches the expandable implant of Claim 8, including a control member (86, 88) that includes a portion configured to engage a corresponding portion on the adjustable member (14) when the control member is received within a control channel (90, 92) of the adjustable member, as shown in fig. 13. It is clear from Hochshuler that the control member (86, 88) moves along the channel (90, 92), in a non-rotatable manner since it is coupled to the control shaft (80), to separate the base (12) from the adjustable member (14), and is contemplated to be any connecting element capable of extending from the control shaft into the channel (col. 8, lines 57-65). The control member of Hochshuler is construed to be at least fully capable of engaging a corresponding flat portion on the adjustable member to prevent rotation of the control member within a control channel of the adjustable member. However, Hochshuler does not teach wherein the control member is at least partially rectangular and includes a flat portion.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the shape of the control member such that it is at least partially rectangular and includes a flat portion, since the shape of the control member is a matter of design choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular shape of the control member provides an advantage, is used for a particular purpose, or solves a stated problem (see applicant’s specification at paragraph 0233 which states that any suitable configuration of the control members/channels may be utilized, including an at least partially spherical control member).
Regarding at least claim 29
Hochshuler teaches the expandable implant of Claim 8, wherein the control shaft (80) includes an access port providing fluid communication between an exterior of the expandable implant and the central cavity of the expandable implant (col. 8, lines 44-50 discloses that the connector/control shaft is a drive screw which includes an access port to accept a driver that provides fluid communication between the exterior of the implant and a central cavity through which the connector/control shaft extends).
Regarding at least claim 30
Hochshuler teaches the expandable implant of Claim 8, wherein the base member (12) includes a retention aperture configured to receive a retention pin (col. 6, lines 34-39 discloses a retaining plate 36 that may contain openings, which are construed to be retention apertures, to allow bone ingrowth therethrough and is capable of receiving a retention pin).
Regarding at least claim 31
Hochshuler teaches the expandable implant of Claim 30, wherein the control shaft (connector; 80) includes a groove (threaded portion; 94 of connector/shaft includes at least one groove), the groove configured to receive the retention pin to position the control shaft relative to the base member (12) (the retention pin is not positively recited in claim 30 and is therefore given little to no patentable weight; the threaded portion of the connector is coupled to, receives, greater width section of one of the cam pins which can be construed as a retention pin as disclosed in col. 9, lines 15-21), wherein the engagement between the retention pin and the groove is configured to permit rotational movement of the control shaft and fix the control shaft relative to the base member along the first direction (the control shaft/connector 80 is able to rotate when the threaded portion is engaged to the greater width section of the cam pin, and the engagement between the threaded portion and the cam pin fixes the control shaft/connector 80 to the base 12 along the first direction as claimed).
Regarding at least claim 32
Hochshuler teaches the expandable implant of Claim 8, wherein the control channel comprises a first control channel (90) and the adjustable member comprises a second control channel (92), and wherein the control member comprises a first control member (86) received in the first control channel and a second control member (88) received in the second control channel, wherein the first control channel is at a first angle and the second control channel is at a second angle different than the first angle such that upon manipulation of the control member the first control member is configured to move within the first control channel at a rate that is different than the second control member moving within the second control channel (figs. 13 and 15 show that the angles of the first and second control channels are different such that the first end has a greater height than the second end).
Regarding at least claim 33
Hochshuler teaches the expandable implant of claim 8, wherein the control member comprises a first control member (86) threadingly received on the control shaft (80) and a second control member (88) threadingly received on the control shaft (80), wherein a first pitch of the thread of the control shaft that receives the first control member is different than a second pitch of the thread of the control shaft that receives the second control member, such that a rate of movement of the first control member along the control shaft is different than a rate of the second control member along the control shaft (col. 9, lines 21-30 discloses that the first pin/control member is preferably connected to the threaded portion of the connector/control shaft 80 and the second pin/control member is preferably connected to the unthreaded portion – the threaded and unthreaded portions have a different pitch, such that the rate of movement of the control members is different as shown by the different heights at each end in figs. 13 and 15).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 8 and 9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 6 and 7 of U.S. Patent No. 11,033,403 B2 in view of Hochshuler.
Regarding claim 8, the patent claims also recite an expandable implant, comprising: a base member; an adjustable member coupled to the base member and movable relative to the base member along at least a first direction between a collapsed position and an expanded position, the adjustable member comprising a control channel extending within the adjustable member; a control shaft at least partially disposed between the base member and the adjustable member, wherein manipulation of the control shaft causes the adjustable member to move relative to the base member between the collapsed position and the expanded position; and a control member coupled to the control shaft, the control member received within the control channel such that the control member translates within the adjustable member as the adjustable member moves between the collapsed position and the expanded position, and the control member configured to provide a first force to the adjustable member to move the adjustable member toward the expanded position and provide a second force to the adjustable member to move the adjustable member toward the collapsed position; wherein the control shaft and the control member are fixed relative to the base member along the first direction (see patent claim 6; the control shaft being received in the central cavity of the base member and the control member received on the control shaft is construed to be the same as the control shaft and the control member being fixed relative to the base member along the first direction; the control member moving within the control channel which is included in the adjustable member is construed to be the same as the control member translating within the adjustable member).
However, the patent claims do not recite a central cavity extending through a top surface and into the adjustable member, or that the control channel extends to or is in fluid communication with the central cavity with the adjustable member in at least the expanded position.
Hochshuler teaches a similar implant, including a top surface (15) of the engaging plate (adjustable member; 12) that contains a central cavity (a central one of plurality of openings; 34) disposed therein to allow bone development and growth though the engaging plates and between the fusion device (10) and neighboring vertebrae (16 and 18) (col. 6, lines 20-24).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the implant of the patent claims to include a central cavity extending through the top surface and into the adjustable member, such that the control channel extends to the central cavity when the central cavity extends through the top surface and into the adjustable member and is also in fluid communication with the central cavity with the adjustable member in at least the expanded position, as claimed by applicant, in order to allow bone development and growth though the engaging plates and between the fusion device and neighboring vertebrae, as taught by Hochshuler.
Regarding claim 9, the patent claims also recite the expandable implant of Claim 8, wherein the base member comprises a first end, a second end, a first side, and a second side, and wherein the first side and the second side are curved between the first end and the second end (see patent claim 7).
Claims 8, 11, 23, 24, 26, and 27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of U.S. Patent No. 10,154,911 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Regarding claim 8, the patent claims also recite an expandable implant, comprising: a base member; an adjustable member coupled to the base member and movable relative to the base member along at least a first direction between a collapsed position and an expanded position, the adjustable member comprising a control channel extending into the adjustable member; a control shaft at least partially disposed between the base member and the adjustable member, wherein manipulation of the control shaft causes the adjustable member to move relative to the base member between the collapsed position and the expanded position; and a control member coupled to the control shaft, the control member received within the control channel such that the control member translates within the adjustable member as the adjustable member moves between the collapsed position and the expanded position, and the control member configured to provide a first force to the adjustable member to move the adjustable member toward the expanded position and provide a second force to the adjustable member to move the adjustable member toward the collapsed position; wherein the control shaft and the control member are fixed relative to the base member along the first direction (see patent claim 1; the control shaft being received in the central cavity of the base member and the control member received on the control shaft is construed to be the same as the control shaft and the control member being fixed relative to the base member along the first direction).
However, the patent claims do not recite a central cavity extending through a top surface and into the adjustable member, or that the control channel extends to or is in fluid communication with the central cavity with the adjustable member in at least the expanded position.
Hochshuler teaches a similar implant, including a top surface (15) of the engaging plate (adjustable member; 12) that contains a central cavity (a central one of plurality of openings; 34) disposed therein to allow bone development and growth though the engaging plates and between the fusion device (10) and neighboring vertebrae (16 and 18) (col. 6, lines 20-24).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the implant of the patent claims to include a central cavity extending through the top surface and into the adjustable member, such that the control channel extends to the central cavity when the central cavity extends through the top surface and into the adjustable member and is also in fluid communication with the central cavity with the adjustable member in at least the expanded position, as claimed by applicant, in order to allow bone development and growth though the engaging plates and between the fusion device and neighboring vertebrae, as taught by Hochshuler.
Regarding claim 11, the patent claims also recite the expandable implant of Claim 8 wherein the control channel comprises a first control channel and a second control channel, and wherein the control member comprises a first control member received in the first control channel and a second control member received in the second control channel (see patent claim 2).
Regarding claim 23, the patent claims also recite the expandable implant of Claim 8, wherein the control member is a first control member of a plurality of control members, the plurality of control members comprising a second control member, the first control member and the second control member are coupled to the control shaft (see patent claims 1 and 2).
Regarding claim 24, the patent claims also recite the expandable implant of Claim 23, wherein manipulation of the control shaft comprises rotation of the control shaft (see patent claim 1).
Regarding claim 26, the patent claims also recite the expandable implant of Claim 23, wherein the adjustable member includes a first control channel configured to receive the first control member and a second control channel configured to receive the second control member (see patent claim 2).
Regarding claim 27, the patent claims also recite the expandable implant of Claim 26, wherein the first control channel and the second control channel extend in non-parallel directions (see patent claim 3).
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 MELISSA A HOBAN whose telephone number is (571)270-5785. The examiner can normally be reached Monday-Friday 8:00AM-5:00PM.
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/M.A.H/Examiner, Art Unit 3774
/MELANIE R TYSON/Supervisory Patent Examiner, Art Unit 3774