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 .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-19 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The preamble of claims 1 and 9 (“method for stabilizing/fixating vertebral bodies”) recites an intended result, while the body of the claims only recites “providing” device components. It is unclear whether the claim is (a) a method of making/providing a device, (b) a method of using a device to stabilize vertebrae, or (c) a combination of both. Ways of resolving this issue may include: (A) clarify that the claim is a method of making/assembling (and remove the stabilization/use language), or (B) explicitly add steps that perform the stabilization (making it clearly a method of use).
Corrections are required.
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 1-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 and 10-18 of U.S. Patent No. 10,245,155. Although the claims at issue are not identical, they are not patentably distinct from each other.
Independent claim 1 of the patent recites all of the elements of independent claim 1 of the application: a plate member (col.21, ll.65) including an upper rim and a lower rim (col.22, ll.3-5), the plate member further including a first arm and a second arm (col.21, ll.66-67 and col.22, ll.1), the first and second arm each including at least one window (col.22, ll.1-2); a spacer (col.22, ll.25) having first and second lateral sides (col.22, ll.27-28), the first and second lateral sides defining the width of the spacer (col.22, ll.27-28), wherein the spacer attaches to the plate member by engaging the first lateral side of the spacer with the at least one window in the first arm and engaging the second lateral side of the spacer with the at least one window in the second arm (col.22, ll.39-42); a first screw upwardly insertable through an upper screw hole of the upper rim (col.22, ll.17-20); and a second screw downwardly insertable through a lower screw hole of the lower rim (col.22, ll.21-24), wherein protrusions on the spacer are configured to fit in the at least one window of the first arm and the second arm (col.22, ll.39-42).
The difference between independent claim 1 of the patent and independent claim 1 of the application lies in the fact that the application recites "a method for stabilizing vertebral bodies comprising the steps of “providing” the claimed invention of claim 1 of the patent. Thus, claim 1 of the application is anticipated by respective claim 1 of the patent, it is not patentably distinct from claim 1 of the patent.
Furthermore, claims 2-6 of the patent recite all of the elements of dependent claims 2-7 of the application:
Claim 2 of the patent recites "wherein the upper rim of the plate member includes an anterior face and a posterior face, wherein each of the anterior face and the posterior face are straight and non-angled", thus reciting all of the elements of claim 2 of the application.
Claim 3 of the patent recites "wherein the upper rim of the plate member includes an anterior face and a posterior face, wherein each of the anterior face and the posterior face are angled", thus reciting all of the elements of claim 3 of the application.
Claim 4 of the patent recites "wherein the posterior face of the upper rim is angled between 5 and 15 degrees in an anterior direction relative to the longitudinal axis that extends vertically from an upper surface of the spacer to a lower surface of the spacer", thus reciting all of the elements of claim 4 of the application.
Claim 5 of the patent recites "wherein the plate member includes a rotatable locking mechanism"…"to prevent backout of the first screw and the second screw from the plate member", thus reciting all of the elements of claim 5 of the application.
Claim 6 of the patent recites "wherein the plate member includes a knife-like edge for inserting partially into a disc space", thus reciting all of the elements of claim 6 of the application.
Claim 1 (col.22, 11.15-16) of the patent recites "wherein a height of each window is greater than a length of each window", thus reciting all of the elements of claim 7 of the application.
Furthermore, independent claim 10 of the patent recites all of the elements of independent claim 9 of the application: a plate having a body (col.23, II.17); an upper rim extending from the body and a lower rim extending from the body (col.23, ll.22-24), wherein the upper rim includes an upper screw hole extending through the upper rim and having an upper screw hole center axis and the lower rim includes a lower screw hole extending through the lower rim and having a lower screw hole center axis (col.23, ll.24-30); a first screw insertable through the upper screw hole, wherein the first screw is oriented in an upward direction (col.23, ll.38-40); and a second screw insertable through the lower screw hole, wherein the second screw is oriented in a downward direction (col.23, ll.42-44); wherein the body comprises a first window and a second window configured to attach the body to a spacer (col.23, ll.17-21), and wherein the upper screw hole center axis is positioned entirely above an upper surface of the spacer and the lower screw hole center axis is positioned entirely below a lower surface of the spacer (col.24, ll.10-17), wherein protrusions on the spacer are configured to fit in the first window and the second window of the body of the plate (col.24, ll.4-7).
The difference between independent claim 10 of the patent and independent claim 9 of the application lies in the fact that the application recites "a method configured to fixate two adjacent vertebral bodies, comprising the steps of: providing” the claimed invention of claim 10 of the patent. Thus, claim 9 of the application is anticipated by respective claim 10 of the patent, it is not patentably distinct from claim 10 of the patent.
Furthermore, claims 10-18 of the patent recite all of the elements of dependent claims 11- 19 of the application:
Claim 11 of the patent recites "wherein the spacer comprises a C-shaped opening for receiving graft material therein", thus reciting all of the elements of claim 10 of the application.
Claim 12 of the patent recites "wherein the spacer comprises a tapered upper surface and a tapered lowered surface", thus reciting all of the elements of claim 11 of the application.
Claim 13 of the patent recites "wherein the spacer is formed of allograft or PEEK", thus reciting all of the elements of claim 12 of the application.
Claim 14 of the patent recites "wherein the portions of the first and second lateral surfaces extending laterally outward include a first bump out portion and a second bump out portion, respectively, wherein the first hump out portion is securable to the first side arm of the plate member and the second bump out portion is securable to the second side arm of the plate member", thus reciting all of the elements of claim 13 of the application.
Claim 10 (col.23, ll.18-20) recites "wherein the plate includes a first side arm and a second side arm that extend from the body of the plate", and claim 14 recites “wherein the first bump out portion is securable to the first side arm of the plate member and the second bump out portion is securable to the second side arm of the plate member”, thus reciting all of the elements of claim 14 of the application.
Claim 15 of the patent recites "wherein the plate includes a first knife-like edge that extends upwardly and a second knife-like edge that extends downwardly", thus reciting all of the elements of claim 15 of the application.
Claim 16 of the patent recites "wherein the upper rim has a front surface and a back surface, wherein at least one of the front surface and the back surface is angled in an anterior direction", thus reciting all of the elements of claim 16 of the application.
Claim 17 of the patent recites "wherein both the front surface and the back surface of the upper rim are angled in an anterior direction", thus reciting all of the elements of claim 17 of the application.
Claim 18 of the patent recites "wherein the upper rim has a front surface and a back surface, wherein both the front surface and the back surface are non-angled with respect to a vertical axis defined by the spacer", thus reciting all of the elements of claim 18 of the application.
Claim 10 (col.23, II.36-37) of the patent recites "wherein the first window has a height greater than a length of the first window", thus reciting all of the elements of claim 19 of the application.
Claims 1-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 12,303,398. Although the claims at issue are not identical, they are not patentably distinct from each other.
Independent claim 1 of the patent recites all of the elements of independent claim 1 of the application: a spinal system comprising: a plate member including an upper rim and a lower rim, the plate member further including a first arm and a second arm, the first arm and the second arm each including at least one window; a spacer having first and second lateral sides, the first and second lateral sides defining the width of the spacer, wherein the spacer attaches to the plate member by engaging the first lateral side of the spacer with the at least one window in the first arm and engaging the second lateral side of the spacer with the at least one window in the second arm; a first screw upwardly insertable through an upper screw hole of the upper rim; and a second screw downwardly insertable through a lower screw hole of the lower rim, wherein protrusions on the spacer are configured to fit in the at least one window of the first arm and the second arm (see claim 1 of the patent).
The difference between independent claim 1 of the patent and independent claim 1 of the application lies in the fact that the application recites "a method for stabilizing vertebral bodies comprising the steps of: providing” the claimed invention of claim 1 of the patent. Thus, claim 1 of the application is anticipated by respective claim 1 of the patent, it is not patentably distinct from claim 1 of the patent.
Furthermore, claims 2-8 of the patent recite all of the elements of dependent claims 2-8 of the application:
Claim 2 of the patent recites "wherein the upper rim of the plate member includes an anterior face and a posterior face, wherein each of the anterior face and the posterior face are straight and non-angled with respect to a vertical axis defined by the spacer", thus reciting all of the elements of claim 2 of the application.
Claim 3 of the patent recites "wherein the upper rim of the plate member includes an anterior face and a posterior face, wherein at least one of the anterior face and the posterior face are angled with respect to a vertical axis defined by the spacer", thus reciting all of the elements of claim 3 of the application.
Claim 4 of the patent recites "wherein the posterior face of the upper rim is angled between 5 and 15 degrees in an anterior direction relative to a longitudinal axis that extends vertically from an upper surface of the spacer to a lower surface of the spacer", thus reciting all of the elements of claim 4 of the application.
Claim 5 of the patent recites “wherein the plate member includes a rotatable locking mechanism designed to prevent backout of the first screw and the second screw from the plate member", thus reciting all of the elements of claim 5 of the application.
Claim 6 of the patent recites "wherein the plate member includes a stabilizer for inserting partially into a disc space", thus reciting all of the elements of claim 6 of the application.
Claim 7 of the patent recites "wherein a height of each window is greater than a length of each window", thus reciting all of the elements of claim 7 of the application.
Claim 8 of the patent recites “further comprising a graft opening, the graft opening being defined by the plate member and the spacer”, thus reciting all of the elements of claim 8 of the application.
Independent claim 9 of the patent recites all of the elements of independent claim 9 of the application: A plate configured to fixate two adjacent vertebral bodies, the plate comprising: a body; an upper rim extending from the body and a lower rim extending from the body, wherein the upper rim includes an upper screw hole extending through the upper rim and having an upper screw hole center axis and the lower rim includes a lower screw hole extending through the lower rim and having a lower screw hole center axis; a first screw insertable through the upper screw hole, wherein the first screw is oriented in an upward direction; and a second screw insertable through the lower screw hole, wherein the second screw is oriented in a downward direction; wherein the body comprises a first window and a second window configured to attach the body to a spacer, and wherein the upper screw hole center axis is positioned entirely above an upper surface of the spacer and the lower screw hole center axis is positioned entirely below a lower surface of the spacer, wherein protrusions on the spacer are configured to fit in the first window and the second window of the body of the plate (see claim 9 of the patent).
The difference between independent claim 9 of the patent and independent claim 9 of the application lies in the fact that the application recites "A method configured to fixate two adjacent vertebral bodies, comprising the steps of: providing” the claimed invention of claim 9 of the patent. Thus, claim 9 of the application is anticipated by respective claim 9 of the patent, it is not patentably distinct from claim 9 of the patent.
Furthermore, claims 10-19 of the patent recite all of the elements of dependent claims 10-19 of the application:
Claim 10 of the patent recites "a graft opening, the graft opening being defined by the plate and the spacer", thus reciting all of the elements of claim 10 of the application.
Claim 11 of the patent recites "wherein the spacer comprises a tapered upper surface and a tapered lowered surface", thus reciting all of the elements of claim 11 of the application.
Claim 12 of the patent recites "wherein the spacer is formed of allograft or PEEK", thus reciting all of the elements of claim 12 of the application.
Claim 13 of the patent recites " wherein the spacer comprises a first bump out portion and a second bump out portion, wherein the first bump out portion is securable to a first arm of the plate and the second bump out portion is securable to a second arm of the plate member", thus reciting all of the elements of claim 13 of the application.
Claim 14 of the patent recites “wherein the first arm comprises the first window configured to receive the first bump out portion of the spacer and the second arm comprises the second window configured to receive the second bump out portion of the spacer", thus reciting all of the elements of claim 14 of the application.
Claim 15 of the patent recites “wherein the plate includes a stabilizer that extends upwardly and a second stabilizer that extends downwardly", thus reciting all of the elements of claim 15 of the application.
Claim 16 of the patent recites “wherein the upper rim has a front surface and a back surface, wherein at least one of the front surface and the back surface is angled in an anterior direction", thus reciting all of the elements of claim 16 of the application.
Claim 17 of the patent recites “wherein both the front surface and the back surface of the upper rim are angled in an anterior direction", thus reciting all of the elements of claim 17 of the application.
Claim 18 of the patent recites “wherein the upper rim has a front surface and a back surface, wherein both the front surface and the back surface are non-angled with respect to a vertical axis defined by the spacer", thus reciting all of the elements of claim 18 of the application.
Claim 19 of the patent recites “wherein the first window has a height greater than a length of the first window", thus reciting all of the elements of claim 19 of the application.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Seifert et al. U.S. Publication No.2011/0251689 A1
Spangler et al. U.S. Publication No.2016/0095714 A1
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Christina Negrelli whose telephone number is 571-270-7389. The examiner can normally be reached on Monday-Friday, between 8:00am to 4:00pm. If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Eduardo Robert, 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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/CHRISTINA NEGRELLI/
Examiner, Art Unit 3773
/EDUARDO C ROBERT/Supervisory Patent Examiner, Art Unit 3773