DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120 as follows:
This application repeats a substantial portion of prior Application No. 17666680, filed 02/08/2022, and adds disclosure not presented in the prior application. Because this application names the inventor or at least one joint inventor named in the prior application, it may constitute a continuation-in-part of the prior application. Should applicant desire to claim the benefit of the filing date of the prior application, attention is directed to 35 U.S.C. 120, 37 CFR 1.78, and MPEP § 211 et seq. The presentation of a benefit claim may result in an additional fee under 37 CFR 1.17(w)(1) or (2) being required, if the earliest filing date for which benefit is claimed under 35 U.S.C. 120, 121, 365(c), or 386(c) and 1.78(d) in the application is more than six years before the actual filing date of the application.
Specifically, independent claim 1 recites the term “buttress” to describe the plate. This was not found in the parent application.
Therefore, the effective filing date for claims 1 – 10 is 07/23/2024.
Response to Arguments
Is it noted that the Remarks, filed 01/02/2026, indicate that the term “buttress” is deleted in claims 1 and 11, however the term is still present in claim 1.
Applicant argues that there is no disclosure in Boriani of creating channels in the vertebra. More specifically, that the cortectomy performed removed the entirety of the vertebrae to create an open space, not a channel. The Office respectfully disagrees. The term “channel” is may be defined as a means or access or a route through which anything passes according to Dictionary.com (see below). Thus, the open space, bound by tissue, is a means of access to the intervertebral space and a route through which the device passes. Therefore, the rejection is maintained.
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Claim Objections
Claim 11 is objected to because of the following informalities: Claim 11, line 8, “first and second oblique channels” should read “first and second channels” because the term “oblique” was deleted in the lines above regarding the channels. Appropriate correction is required.
Drawings
The drawings are objected to under 37 CFR 1.83(a) because they fail to show the anterior surface 165 and at least one screw hole ref. 118 of the plate ref. 114 as described in the specification (paragraph [0053]). Any structural detail that is essential for a proper understanding of the disclosed invention should be shown in the drawing. MPEP § 608.02(d). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claim(s) 1, 3 – 5 and 9 is/are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Boriani et al. (US 6,159,211).
Regarding claim 1, Boriani discloses a method of implanting an oblique corpectomy device (ref. 40) in an intervertebral space between adjacent vertebrae using an antero-lateral approach (Figs. 13 – 14, (6) of the Background/Summary discloses an anterolateral system), the method comprising:
performing a corpectomy to remove a part of an upper vertebral body to create a first channel and a part of a lower vertebral body to create a second channel ((10) of Description discloses a corpectomy and Fig. 14 shows a multilevel corpectomy thus having multiple channels);
using an antero-lateral approach, inserting an oblique corpectomy spacer (ref. 40, Fig. 14) into the first and second oblique channels at an oblique direction relative to a mid-sagittal plane (Fig. 14 shows the spacer implanted at an angle, substantially 45 degrees, to the mid-sagittal plane);
attaching a buttress plate to a side wall of the upper and lower vertebral bodies to prevent the inserted oblique corpectomy spacer from backing out (Fig. 14, ref. 64).
Regarding claim 3, Boriani discloses the method of claim 1, wherein the oblique corpectomy spacer includes first and second lateral surfaces with each having a contact area and inserting the corpectomy spacer includes engaging the contact areas of the first and second lateral surfaces to exposed areas defining the first and second channels of the upper and lower vertebral bodies (Figs. 8 shows lateral surfaces having a contact area with fastener receiving holes, thus Fig. 14 shows the contact area engaged with the plate and fasteners).
Regarding claim 4, Boriani discloses the method of claim 1 wherein inserting the oblique corpectomy spacer including inserting the corpectomy spacer at an angle of about 45 degrees relative to a mid-sagittal plane (Fig. 14).
Regarding claim 5, Boriani discloses the method of claim 1, further comprising attaching the inserted corpectomy spacer to the upper and lower vertebral bodies with first and second screw fasteners, respectively (Fig. 14, ref. 66).
Regarding claim 9, Boriani discloses the method of claim 1, prior to performing a corpectomy, further comprising accessing the intervertebral space using an antero-lateral approach so as to minimize dissection of vessels in front of the vertebral bodies (Boriani discloses the use of anterolateral approach which by applicant’s admission minimizes dissection of vessels).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 2 and 6 – 8 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Boriani et al. (US 6,159,211) in view of Trieu et al. (US 2005/0096744 A1).
Regarding claim 2, Boriani discloses the method of claim 1, except wherein inserting the oblique corpectomy spacer includes inserting the oblique corpectomy spacer which is at least partially made of flexible elastomer.
Regarding claim 6, Boriani discloses the method of claim 1, except wherein the oblique corpectomy spacer includes an upper and lower parts made of biocompatible plastic, and a middle part disposed between the upper and lower parts and made of an elastomeric material.
Trieu discloses a compressible corpectomy device (Abstract) comprising outer components (refs. 22, 24) composed of a biocompatible plastic (paragraph [0028], e.g. UHMWPE) and an inner core member (ref. 26) composed of a flexible elastomer (paragraph [0032]). 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 spacer of Boriani such that is has outer components formed from a biocompatible plastic and an inner component formed from a flexible elastomer, as taught by Trieu, for the purpose of providing a corpectomy device form of durable components for dampening the affect of dynamic loading on the spine (paragraph [0003]).
Regarding claim 7, Boriani in view of Trieu discloses the method of claim 6, wherein the biocompatible plastic includes PEEK material (Trieu, paragraph [0028]).
Regarding claim 8, Boriani in view of Trieu discloses the method of claim 6, wherein each of the upper and lower parts includes an open graft window suitable for receiving a graft material (Trieu, refs. 49, 54, paragraph [0024]).
Claims 10 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Boriani et al. (US 6,159,211) in view of Ferree (US 2002/0128652 A1).
Regarding claim 10, Boriani discloses the method of claim 1, except wherein performing a corpectomy includes forming the first channel having a first vertical contact surface and an opposite second vertical contact surface of the upper vertebral body.
Ferree teaches a method comprising a corpectomy (Fig. 5I) in which two channel are used on top and bottom vertebrae respectively (Fig. 5I). 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 method of Boriani to include forming a first channel at the bottom vertebrae and a second opposite channel at the upper vertebrae, as taught by Ferree, for the purpose of minimizing exposed tissue from a single large incision and channel.
Claims 11, 13, 14 and 18 - 20 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Castro (US 2010/0324679 A1) in view of Spann (US 2012/0010472 A1).
Regarding claim 11, Castro discloses a method of implanting an oblique corpectomy device in an intervertebral space between adjacent vertebrae capable of using an antero-lateral approach (Abstract), the method comprising:
performing a corpectomy to remove a part of an upper vertebral body to create a first channel and a part of a lower vertebral body to create a second channel (see remarked Fig. 8 below);
inserting an oblique corpectomy spacer (Fig. 8, ref. 190 and Figs. 13 – 18) into the first and second channels;
attaching a plate to a side wall of the upper and lower vertebral bodies by screwing first and second screw fasteners to the upper and lower vertebral bodies, respectively (Figs. 13 – 18 discloses the addition of a plate to the device, refs. 1080, 1100 referred to as “brakes”. The plate includes holes refs. 1086, 1102 to receive a screw for attachment to the vertebra, see paragraph [0083]), to prevent the inserted oblique corpectomy spacer from backing out.
Castro is silent regarding using an antero-lateral approach and wherein the step of inserting the spacer at an oblique direction relative to a mid-sagittal plane.
Spann teaches a surgical method for insertion of an intervertebral device (Abstract), the method using an antero-lateral approach in an oblique direction relative to a mid-sagittal plane (paragraph [0011], Figs. 2A – 3A). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the method of Castro to use an antero-lateral approach such that the spacer is inserted at an oblique direction relative to a mid-sagittal plane, as taught by Spann, for the purpose of minimal disruption to posterior or back muscles.
Regarding claim 13, Castro in view of Spann discloses the method of claim 11, wherein the oblique corpectomy spacer includes first and second lateral surfaces with each having a contact area and inserting the corpectomy spacer includes engaging the contact areas of the first and second lateral surfaces to exposed areas defining the first and second channels of the upper and lower vertebral bodies (see remarked Fig. 15 below).
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Regarding claim 14, Castro in view of Spann discloses the method of claim 11, wherein inserting an oblique corpectomy spacer including inserting the corpectomy spacer at an angle of about 45 degrees relative to a mid- sagittal plane (Spann, paragraph [0110]).
Regarding claim 18, Castro in view of Spann discloses method of claim 11, prior to performing a corpectomy, further comprising accessing the intervertebral space using an antero-lateral approach so as to minimize dissection of vessels in front of the vertebral bodies (Spann discloses accessing the space in an initial step using dilators, Figs. 2b-2a).
Regarding claim 19, Castro in view of Spann discloses the method of claim 11, wherein performing a corpectomy includes forming the first channel having a first vertical contact surface and an opposite second vertical contact surface of the upper vertebral body (Castro, Fig. 8)
Regarding claim 20, Castro in view of Spann discloses the method of claim 19, wherein the oblique corpectomy spacer includes first and second lateral surfaces with each having a contact area and inserting the corpectomy spacer includes engaging the contact areas of the first and second lateral surfaces with the first and second vertical contact areas of the upper vertebral body (Castro, Fig. 8).
Claims 12 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Castro (US 2010/0324679 A1) in view of Spann (US 2012/0010472 A1) and in view of Trieu et al. (US 2005/00967 A1).
Regarding claim 12, Castro in view of Spann discloses the method of claim 11, except wherein inserting the oblique corpectomy spacer includes inserting the oblique corpectomy spacer which is at least partially made of flexible elastomer.
Trieu discloses a compressible corpectomy device (Abstract) comprising outer components (refs. 22, 24) composed of a biocompatible plastic (paragraph [0028], e.g. UHMWPE) and an inner core member (ref. 26) composed of a flexible elastomer (paragraph [0032]). 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 spacer of Castro in view of Spann such that the spacer is at least partially made of a flexible elastomer, as taught by Trieu, for the purpose of providing a corpectomy device form of durable components for dampening the effect of dynamic loading on the spine (paragraph [0003]).
Claims 11 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Nehls (US 2012/0065688 A1) in view of Spann (US 2012/0010472 A1).
Regarding claim 11, Nehls discloses a method of implanting an oblique corpectomy device in an intervertebral space between adjacent vertebrae fully capable of using an antero-lateral approach, the method comprising:
performing a corpectomy to remove a part of an upper vertebral body to create a first channel and a part of a lower vertebral body to create a second channel (Fig. 2C shows the removal of parts of the vertebral bodies to create two channels in the adjacent vertebra which form shelves refs. 19a,19b);
inserting an oblique corpectomy spacer (ref. 22a, Fig. 2c) into the first and second channels (Fig. 2C);
attaching a plate (Fig. 2b, ref. 10a) to a side wall of the upper and lower vertebral bodies by screwing first and second screw fasteners to the upper and lower vertebral bodies, respectively, to prevent the inserted oblique corpectomy spacer from backing out (paragraph [0041], ref. 60a-d).
Nehls is silent regarding using an antero-lateral approach and wherein the step of inserting the spacer at an oblique direction relative to a mid-sagittal plane.
Spann teaches a surgical method for insertion of an intervertebral device (Abstract), the method using an antero-lateral approach (paragraph [0011], Figs. 2A – 3A). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the method of Nehls to use an antero-lateral approach such that the spacer is inserted at an oblique direction relative to a mid-sagittal plane, as taught by Spann, for the purpose of minimal disruption to posterior or back muscles.
Claims 15 - 17 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Nehls (US 2012/0065688 A1) in view of Spann (US 2012/0010472 A1) and in view of Trieu et al. (US 2005/0096744 A1).
Regarding claim 15, Nehls in view of Spann discloses the method of claim 11, except wherein the oblique corpectomy spacer includes an upper and lower parts made of biocompatible plastic, and a middle part disposed between the upper and lower parts and made of an elastomeric material.
Trieu discloses a compressible corpectomy device (Abstract) comprising outer components (refs. 22, 24) composed of a biocompatible plastic (paragraph [0028], e.g. UHMWPE) and an inner core member (ref. 26) composed of a flexible elastomer (paragraph [0032]). 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 spacer of Nehls in view of Spann such that is has outer components formed from a biocompatible plastic and an inner component formed from a flexible elastomer, as taught by Trieu, for the purpose of providing a corpectomy device form of durable components for dampening the effect of dynamic loading on the spine (paragraph [0003]).
Regarding claim 16, Nehls in view of Spann and in view of Trieu discloses the method of claim 15, wherein the biocompatible plastic includes PEEK material (Trieu, paragraph [0028]).
Regarding claim 17, Nehls in view of Spann and in view of Trieu discloses the method of claim 15, wherein each of the upper and lower parts includes an open graft window suitable for receiving a graft material (Trieu, refs. 54, 49).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892.
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 TESSA M MATTHEWS whose telephone number is (571)272-8817. The examiner can normally be reached M - F 8am - 1pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Eduardo Robert can be reached at (571) 272-4719. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TESSA M MATTHEWS/Examiner, Art Unit 3773