Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Objections
Claim 20 is objected to under 37 CFR 1.75 as being a substantial duplicate of claim 19. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
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 2-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 10-34 of U.S. Patent No. 10,245,070. Although the claims at issue are not identical, they are not patentably distinct from each other because both the present application and granted patent disclose a system comprising a cannula, the access cannula comprising a distal end, a proximal end and a lumen extending therebetween, and a telescoping obturator, the telescoping obturator comprising a handle, and a shaft, and a locking mechanism for selectively locking the shaft to the handle at a plurality of longitudinal positions along the length of the shaft. The shaft of the telescoping obturator is positioned relative to the handle of the telescoping obturator so that the shaft extends beyond the distal end of the access cannula.
Claim Rejections - 35 USC § 103
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.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 2-10, 12, and 17-19 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Stouder, Jr. in view of U.S. Patent Pub. No. 2009/0024056 to Bacon et al.
As to Claim 2, Stouder, Jr. discloses a system (Col. 2, Lines 11-21, Lines 56-67) that comprises a cannula (10, Fig. 1) that is configured to be inserted into a portion of a body and adjusted in length (Col. 4, Lines 42-67 – Col. 5, Lines 1-17) based on a depth measurement (Col. 8, Lines 26-35) associated with the portion of the body (Col. 4, Lines 9-36), and an obturator (50, Fig. 7) comprising a handle (54) and a shaft (52) that can be moved relative to the handle (54) to adjust a length of the obturator (Col. 5, Lines 36-67 – Col. 6, Lines 1-8) and a mechanism (relationship between 58 and threads 62 and 64) for restricting motion of the shaft (52) in a plurality of positions relative to the handle (54, Col. 5, Lines 45-50). The obturator (50) is configured for receiving the cannula on the shaft (Col. 5, Lines 1-17) and inserting the cannula into the portion of the body (Col. 5, Lines 8-17, Lines 63-65).
As to Claim 3, Stouder, Jr. discloses a system wherein the cannula (10) comprises an adjustable portion (30) configured to be adjusted in length (Col. 4, Lines 42-59), a head portion (16), and a threaded portion (including 32 and 34) located between the adjustable portion and the head portion (seen in Fig. 6).
As to Claim 4, Stouder, Jr. discloses a system wherein the threaded portion comprises an outer surface and at least one thread formed on the outer surface (outer threads 34).
As to Claim 5, Stouder, Jr. discloses a system wherein the adjustable portion is a separate piece from the threaded portion (separate portions 12 and 30, including threaded portions 32 and 34).
As to Claim 9, Stouder, Jr. discloses a system (embodiment of Figs. 10-13) wherein an element (208) is movable into and out of the at least one recess (178) via rotational motion (Col. 8, Lines 11-12).
As to Claim 12, Stouder, Jr. discloses a system wherein the cannula is configured to be adjusted to a length of 10mm to 300mm. (Col. 8, Lines 26-31).
As to Claim 17, Stouder, Jr. discloses a system wherein the shaft (52) of the obturator (50) comprises a proximal end (54) and a distal end (56), the proximal end being connected to the handle (at 54, Fig. 7), and the distal end forming a blunt end (Fig. 7, Col. 5, Lines 36-50).
As to Claim 18, Stouder, Jr. discloses a system wherein the cannula (10) comprises a thread (42) and the obturator and the cannula are configured for mating such that the obturator (50) can apply a rotational force to the cannula (10) to thread the cannula into the portion of the body (Col. 5, Lines 18-35).
As to Claims 19 and 20, Stouder, Jr. discloses a system wherein the obturator comprises at least one projection (60) that projects distally at a distal end of the handle (Fig. 7) for applying a torque to the cannula (Col. 5, Lines 51-62).
As to Claims 2-10, 12, and 17-19, Stouder, Jr. discloses the claimed invention except for a lock for locking the shaft in a plurality of positions relative to the handle, wherein the plurality of positions are predefined positions, wherein the lock comprises an element that is movable into and out of at least one recess on the shaft, wherein the element is movable into and out of the at least one recess via linear motion, wherein the lock comprises a spring for biasing the element into the at least one recess. Bacon
Bacon discloses a system (10, Figs. 1-2, [0035]) including a lock for locking the shaft (48) in a plurality of positions relative to the handle (72, [0041]), wherein a plurality of positions are predefined positions ([0040] describes “The length of the elongated slot 76 can selected such that the range of movement of the throw calibrator 16 corresponds to the range of possible throw distances of a biopsy device.”) A lock [0041] comprises an element (78) that is movable into and out of at least one recess (82) on the shaft (74, Fig. 5, [0041]), wherein the element (78) is movable into and out of the at least one recess via linear motion [0041], wherein the lock comprises a spring (torsion spring 78) for biasing the element into the at least one recess [0041] in order to provide a mechanism for fixing position of the obturator relative to the cannula [0041].
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system of Stouder, Jr. with the lock element modification of Bacon in order to provide a mechanism for fixing position of the obturator relative to the cannula.
Claims 11 and 21 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Stouder, Jr. in view of U.S. Patent Pub. No. 2009/0024056 to Bacon et al. in view of U.S. Patent No. 5,480,389 to McWha et al.
As to Claims 11 and 21, Stouder, Jr. and Bacon disclose the claimed invention except for wherein the lock comprises a button located on the handle, and wherein the obturator comprises at least one key and the cannula comprises at least one keyway for receiving the at least one key, and the at least one key can transfer rotational force from the obturator to the cannula for threading the cannula into the portion of the body.
McWha discloses a system (14) wherein a lock comprises a button (50) located on the handle (51, Col. 9, Lines 17-40), and wherein the obturator (32) comprises at least one key (70 )and the cannula (51) comprises at least one keyway (38) for receiving the at least one key (70, Fig. 4, Col. 9, Lines 42-52), and the at least one key (70) can transfer rotational force from the obturator to the cannula for threading the cannula into the portion of the body (Col. 9, Lines 17-60) in order to allow for the surgeon to selectively lock and release the shaft within the handle (Col. 9, Lines 33-41).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the surgical cannula of Stouder, Jr. and Bacon with the locking mechanism modifications of McWha in order to allow for the surgeon to selectively lock and release the shaft within the handle.
Claims 13-16 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Stouder, Jr. in view of U.S. Patent Pub. No. 2009/0024056 to Bacon et al. in view of U.S. Patent Pub. No. 2005/0277942 to Kullas et al.
As to Claims 13-16, Stouder, Jr. and Bacon disclose the claimed invention except for wherein the shaft of the obturator is configured to receive a guidewire for inserting the cannula into the portion of the body, the system comprising the guidewire, the system comprising a switching stick having at least one measurement marker for obtaining the depth measurement associated with the portion of the body, and wherein the obturator comprises a passage that extends centrally through the obturator for passing the switching stick.
Kullas discloses a cannula system (20) wherein a shaft of an obturator (102) is configured to receive a guidewire (104) for inserting the cannula into the portion of the body [0086], the system comprising the guidewire (104), the system comprising a switching stick (104) having at least one measurement marker (suitable lengths described in [0089]) for obtaining the depth measurement associated with the portion of the body [0089], and wherein the obturator (102) comprises a passage that extends centrally through the obturator for passing the switching stick [0089] in order to facilitate insertion of the system at the surgical site [0087].
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system of Stouder, Jr. and Bacon with the switching stick modifications of Kullas in order to facilitate insertion of the system at the surgical site.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTOPHER J BECCIA whose telephone number is (571)270-7391. The examiner can normally be reached Mon - Fri 8:30-5:00.
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/CHRISTOPHER J BECCIA/Primary Examiner, Art Unit 3775
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