DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Reissue Applications
For reissue applications filed before September 16, 2012, all references to 35 U.S.C. 251 and 37 CFR 1.172, 1.175, and 3.73 are to the law and rules in effect on September 15, 2012. Where specifically designated, these are “pre-AIA ” provisions.
For reissue applications filed on or after September 16, 2012, all references to 35 U.S.C. 251 and 37 CFR 1.172, 1.175, and 3.73 are to the current provisions.
Applicant is reminded of the continuing obligation under 37 CFR 1.178(b), to timely apprise the Office of any prior or concurrent proceeding in which Patent No. 8,002,798 is or was involved. These proceedings would include any trial before the Patent Trial and Appeal Board, interferences, reissues, reexaminations, supplemental examinations, and litigation.
Applicant is further reminded of the continuing obligation under 37 CFR 1.56, to timely apprise the Office of any information which is material to patentability of the claims under consideration in this reissue application.
These obligations rest with each individual associated with the filing and prosecution of this application for reissue. See also MPEP §§ 1404, 1442.01 and 1442.04.
Claims 55-64,66,67 and 69-70 are rejected under 35 U.S.C. 251 as being an impermissible recapture of broadened claimed subject matter surrendered in the application for the patent upon which the present reissue is based. In re McDonald, 43 F.4th 1340, 1345, 2022 USPQ2d 745 (Fed. Cir. 2022); Greenliant Systems, Inc. et al v. Xicor LLC, 692 F.3d 1261, 103 USPQ2d 1951 (Fed. Cir. 2012); In re Youman, 679 F.3d 1335, 102 USPQ2d 1862 (Fed. Cir. 2012); In re Shahram Mostafazadeh and Joseph O. Smith, 643 F.3d 1353, 98 USPQ2d 1639 (Fed. Cir. 2011); North American Container, Inc. v. Plastipak Packaging, Inc., 415 F.3d 1335, 75 USPQ2d 1545 (Fed. Cir. 2005); Pannu v. Storz Instruments Inc., 258 F.3d 1366, 59 USPQ2d 1597 (Fed. Cir. 2001); Hester Industries, Inc. v. Stein, Inc., 142 F.3d 1472, 46 USPQ2d 1641 (Fed. Cir. 1998); In re Clement, 131 F.3d 1464, 45 USPQ2d 1161 (Fed. Cir. 1997); Ball Corp. v. United States, 729 F.2d 1429, 1436, 221 USPQ 289, 295 (Fed. Cir. 1984). The reissue application contains claim(s) that are broader than the issued patent claims. The record of the application for the patent family shows that the broadening aspect (in the reissue) relates to claimed subject matter that applicant previously surrendered during the prosecution of the application. Accordingly, the narrow scope of the claims in the patent was not an error within the meaning of 35 U.S.C. 251, and the broader scope of claim subject matter surrendered in the application for the patent cannot be recaptured by the filing of the present reissue application.
There are three steps to determine recapture: 1) determining whether and in what respect, the reissue claims are broader in scope than the patented claims, 2) determining whether the broader aspects of the reissue claims relate to subject matter surrendered in the original prosecution and, 3) determining whether the reissued claims were materially narrowed in other respects, so that the claims may not have been enlarged, and hence, avoid the recapture rule.
Step 1. All of the above claims claim a system for providing access to a spine of a patient with the system comprising a connecting element implantable in a vertabra of the spine and configured to receive an implant, a first and second blade which are discrete from each other each having a distal end forming a docking element securable to the connecting element so that the first and second blades extend proximally from the connecting element along an axis positioned between the first and second blades, the first and second blades being dimensioned such that the proximal end of each of the blades extends proximally through a first incision in the skin of the patient while the distal end is secured to the connecting element and a stabilization member intermediate the proximal and distal ends of the first and second blades, the stabilization member coupling the first and second blades together so as to stabilize the first and second blades in the secured position.
The rejected claims do not claim the blades being detachable from the connecting element.
Step 2. Claim 1 of the ‘798 patent was indicated allowable after an amendment was made on September 17, 2010, which added the claim language, “wherein the first and second blades are independently detachable from the first connecting element such that the first and second blades are independently removable from the patient”. Beginning on the last line of page 19 of the September 17, 2010 response, applicant argued, “Currently amended claim 1 recites, inter alia, that "the first and second blades are independently detachable from the first connecting element such that the first and second blades are independently removable from the patient." In contrast, the contended "blades" (portions of the access tube 12) of Selover are integrally united as part of the access tube 12, and thus they are not "independently detachable" from the pedicle screw 50 "such that the first and second blades are independently removable from the patient," as recited in the claim. The following Office action (December 22, 2010) indicated that claim 1 was allowable.
As claim 1 of the ‘798 patent was allowed after amending the claim to claim that the blades are independently detachable and arguing that such a feature was not found in the prior art, the independently detachable nature of the blades directly led to the allowance of the claims and must therefore remain in all reissue claims.
Step 3. All of the claimed features of current claim 55 were claimed in claims 1-17 of the ‘798 patent. Claim 55 does claim a “stabilization member intermediate the proximal and distal ends of the first and second blades, the stabilization member coupling the first and second blades together so as to stabilize the first and second blades in the secured position.” This was not claimed in the ‘798 patent. However, no stabilization member is discussed in the ‘798 specification. The only discussion of any stabilizing is, “The abutment member 144 helps to stabilize the cannula 142 with respect to the tissues it passes through.” (lines 55 and 56 of column 7). Because of this the stabilization member is seen as the abutment member 144 (as the first and second blades are part of the cannula 142). Original claim 6 claimed, “an abutment member configured to engage the first and second blades to restrict relative motion between the first and second blades.” Therefore patent claim 6 is seen to claim all of the elements of new claim 55 with the exception of the blades being detachable, which is the feature that was added to made to claim allowable during the original prosecution and is therefore the surrender generating limitation which may not be eliminated without invoking recapture of surrendered subject material with no additional structure being claimed.
As such, claims 55-64,66,67 and 69-70 are seen to impermissibly recapture surrender subject matter.
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 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.
5. Claims 55-57 are rejected under 35 U.S.C. 102(b) as being anticipated by Mathews (U.S. Patent 6,206,826). Mathews discloses a device comprising a connecting element (the fusion cage) capable of being implanted in a first vertebra and a first cannula capable of receiving a portion of a spinal fusion rod. The first cannula includes a first blade (a first member 10) and a second blade (a second member 10 diametrically opposite the first member 10), wherein the first and second blades are substantially parallel to each other, can be connected to the first connecting element, and assembled together without out being directly connected to each other (discrete) defining a distal end terminating at the first connecting element such that the device is capable of providing access to the spine when the first connecting implant is implanted in the first vertebra. Mathews discloses a device further comprising an abutment (stabilization) member (50) that engages the blades to restrict relative motion between the blades and is lockable by a locking mechanism (18 and 19) to restrict withdrawal of the abutment member from the blades.
In regard to claim 56, Mathews discloses a device wherein the blades further define a first slot (an opening between two adjacent elements 10) with stabilization member 50 between the blades to maintain the spacing between the blades.
In regard to claim 57, the blades are maintained in a parallel relationship, as seen in figure 18.
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 §§ 706.02(l)(1) - 706.02(l)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 55-75 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 55-59 and 62-77 of U.S. Patent No. RE45,676. Although the claims at issue are not identical, they are not patentably distinct from each other because the current system is designed to perform the earlier claimed method and the earlier claimed method cannot be performed without the current system. Claim 55 of the ‘676 reissue requires implanting a first connecting element through a first incision in the skin of the patient and into a first vertebra of the spine (current claim 55 requires “a connecting element implantable in a vertebra of the spine” and “the first and second blades being dimensioned such that the proximal end of each of the first and second blades extends proximally through a first incision in the skin of the patient”) with a first blade and a second blade coupled to the first connecting element so that each of the first and second blades extend proximally therefrom through the first incision (“a first blade and a second blade”), the first and second blades being positioned adjacent to one another to provide a first longitudinal pathway therealong between the first and second blades; moving an implant into engagement with the first connecting element through at least a portion of the first longitudinal pathway (“each of the first and second blades having a distal end and a proximal end, the distal end of each of the first and second blades forming a docking element discrete from the connecting element and securable to the connecting element in a secured position in which the first and second blades extend proximally from the connecting element along an axis positioned between the first and second blades”); and independently uncoupling the first and second blades from the first connecting element and independently removing the first and second blades from the body of the patient while the first connecting element remains implanted in the first vertebra. Thus, the claims of the ‘676 reissue claim a method that is performed using the current apparatus. Such changes are considered obvious to an ordinary practitioner in the art in that the two sets of claims are not patentably distinct. The same is true of the dependent claims.
Claims 55-75 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 55- 82 of U.S. Patent No. RE47,348. Although the claims at issue are not identical, they are not patentably distinct from each other. The current claims are broader in scope than the earlier claims of the ‘348 patent and would dominate then if allowed without a terminal disclaimer. Both claim a system for providing access to a spine of a patient so an implant can be fastened and including blades to provide the access with the blades stabilized by a stabilization (abutment) member.
As such, a terminal disclaimer should be filed to ensure that the two reissues cannot be independently licensed or sold.
Claims 55-75 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 55-81 of U.S. Patent No. RE46,432. Although the claims at issue are not identical, they are not patentably distinct from each other because the structure of the current claims are required to perform the method of the ‘432 reissue. Claim 55 of the ‘432 reissue requires implanting a first connecting element through a first incision in the skin of the patient and into a first vertebra of the spine (current claim 55 requires “a connecting element implantable in a vertebra of the spine” and “the first and second blades being dimensioned such that the proximal end of each of the first and second blades extends proximally through a first incision in the skin of the patient”) with a first passageway device formed as a single piece with the first connecting element so that the first passageway device extends proximally from the implanted first connecting element through the first incision (“each of the first and second blades having a distal end and a proximal end, the distal end of each of the first and second blades forming a docking element discrete from the connecting element and securable to the connecting element in a secured position in which the first and second blades extend proximally from the connecting element along an axis positioned between the first and second blades”, the forming of the unit as a single piece is seen as obvious integration of disclosed parts), the first passageway device providing a first longitudinal passageway therealong, (“the first and second blades extend proximally from the connecting element along an axis positioned between the first and second blades, the first and second blades being dimensioned such that the proximal end of each of the first and second blades extends proximally through a first incision in the skin of the patient while the distal end of the respective blade is secured to the connecting element when the connecting element is implanted in the vertebra of the spine”); moving an implant into engagement with the first connecting element through at least a portion of the first longitudinal passageway; (above; fracturing a frangible portion between the first passageway device and the first connecting element; and removing the first passageway device from the body of the patient while the first connecting element remains implanted in the first vertebra (above).
Thus, the claims of the ‘432 reissue claim a method that requires the current structure to be performed, while the current structure is designed to perform the earlier claimed method.
Claims 55-75 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 55-79 of U.S. Patent No. RE48376. Although the claims at issue are not identical, they are not patentably distinct from each other because the structure of the current claims are required to perform the method of the ‘376 reissue. Claim 55 of the ‘376 reissue requires: securing a first connecting element to a first vertebra of a spine of a patient's body, ( the current claim 55 requires “a connecting element implantable in a vertebra of the spine and configured to receive an implant”) the first connecting element having a first passageway device formed as a single piece with the first connecting element and extending proximally therefrom, such that the first passageway device extends proximally from the secured first connecting element through a first incision in the skin of the patient, (“the first and second blades extend proximally from the connecting element along an axis positioned between the first and second blades, the first and second blades being dimensioned such that the proximal end of each of the first and second blades extends proximally through a first incision in the skin of the patient while the distal end of the respective blade is secured to the connecting element when the connecting element is implanted in the vertebra of the spine”) the first passageway device defining a first longitudinal passageway therein extending along a central longitudinal axis of the first passageway device; inserting a leading end of a rod into the body of the patient through the first incision in the skin; moving the leading end of the rod underneath an unbroken portion of the skin on a first side of the first passageway device; securing the rod to the first connecting element; fracturing a frangible portion between the first passageway device and the first connecting element(“the first and second blades are independently securable to and independently removable from the connecting element”-cl. 65); and removing the first passageway device from the body of the patient while the first connecting element remains implanted in the first vertebra. The current claim 55 does not include the rod, but claim 58 claims, “the implant being a spinal fusion rod”. Thus, the claims of the ‘376 reissue claim a method that is performed using the current apparatus. Such changes are considered obvious to an ordinary practitioner in the art in that the two sets of claims are not patentably distinct. The same is true of the dependent claims.
Claims 55-75 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 55-72 of U.S. Patent No. RE49432. Although the claims at issue are not identical, they are not patentably distinct from each other as current claim 55 contains all of the claimed elements of claim 55 of the ‘432 reissue and would dominate the other reissue if allowed to issue without a terminal disclaimer. Both claim 55s claim a system for providing access to a spine of a patient, the system comprising a connecting element implantable in a vertabra of the spine and configured to receive an implant and first and second blades each of the first and second blades having a distal end and a proximal end, the distal end of each of the first and second blades forming a docking element securable to the connecting element in a secured position in which the first and second blades extend proximally from the connecting element along an axis positioned between the first and second blades, the first and second blades being dimensioned such that the proximal end of each of the first and second blades extends proximally through a first incision in the skin of the patient while the distal end of the respective blade is secured to the connecting element in the secured position and when the connecting element is implanted in the vertebra of the spine; and a stabilization member intermediate the proximal and distal ends of the first and second blades, the stabilization member coupling the first and second blades together so as to stabilize the first and second blades in the secured position. The earlier claim further defines the stabilization member and specifies that the blades are detachable, making the current claim 55 broader in scope that the earlier patented claim of the ‘432 reissue. Because of this, a terminal disclaimer is required.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM C DOERRLER whose telephone number is (571)272-4807. The examiner can normally be reached M-F, 7-5.
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/WILLIAM C DOERRLER/Reexamination Specialist, Art Unit 3993
Conferees:
/CATHERINE S WILLIAMS/Reexamination Specialist, Art Unit 3993
/EILEEN D LILLIS/SPRS, Art Unit 3993
Prosecution Insights