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 .
Response to Arguments
Applicant’s arguments with respect to claim(s) 1, 3-5 and 7 have been considered but are moot because of new grounds of rejection over Rioux US 2001/0053916 and Evans et al. US 2004/0144395.
Rioux US 2001/0053916 discloses said insertion hook and said extraction hook positioned on a side of said body toward which said head section is angled (figure 1).
Evans et al. US 2004/0144395 discloses a handle section with a stabilizer piece inside said handle section, said stabilizer piece receiving said first end of said instrument (figures 3B or 4A, needle end is received within the distal end of handle with stabilizer piece for example, with latch mechanism 33, paragraph 0139).
Hasson US 5830232 discloses a needle shaft having an insertion and extraction hook for pushing or pulling a suture (column 5, lines 41-44).
Election/Restrictions
Newly submitted claims 8-15 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: Claim 1 is directed to a suture passer having an insertion hook and extraction hook continuous on one side of the instrument (for example, figure 3, hooks 30, 32). Claim 18 is directed to a different embodiment or species comprising an insertion hook and an extraction hook each being positioned on opposite sides of the instrument (for example, figure 4, hooks 52, 54). Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 8-15 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
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) 1, 3 and 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rioux US 2001/0053916 in view of Evans et al. US 2004/0144395 in view of Hasson US 5830232 and in view of Rousseau et al. US 2013/0139828.
Regarding claims 1 and 3, Rioux discloses a suture passer device (figure 1) comprising, a solid elongated static needle like single unitary instrument 16 having a body with an external surface (shaft 16, figure 1), a first end received by a handle section 14 (proximal end 18 attached to handle 14, paragraph 0031), and a second end with a needle tip 19 (figure 1); said single unitary instrument includes a head section angled away from a central axis of said instrument body (figure 1, curved at portion 24); said single unitary instrument having an opening for inserting or extracting a suture (slot 30 for receiving a suture, paragraph 0036); said insertion and extraction opening positioned on a side of said body toward which said head section is angled (figure 1); said opening in said body having a length larger than said length of said open mouth area (length along slit 34 longer than opening at 32, figure 2).
Evans et al. discloses an instrument for inserting a sling or suture comprising an elongate needle (figure 2) attached to a handle 4 (figure 3A) and with a stabilizer piece inside said handle section (figures 3B or 4A, needle end is received within the distal end of handle with stabilizer piece for example, paragraph 0139 with latch mechanism 33), said stabilizer piece receiving said first end of said instrument (figures 3B, 4A, 4B).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Rioux with a stabilizer piece inside said handle section for receiving the needle, as taught by Evans et al. to provide a releasable mechanism for attaching or releasing the needle from the handle.
Rioux fails to explicitly disclose an insertion hook for securing a suture for insertion and an extraction hook for securing a suture during extraction; said insertion hook and said extraction hook defined by an open mouth area located between said insertion hook and said extraction hook, said open mouth area having a length of 0.5 millimeters to 4 millimeters, and a continuous internal surface extending from the external surface of the body adjacent to said insertion hook to said external surface of the body adjacent to said extraction hook to form an opening in the body of said suture passer device which receives the suture when said suture is placed into said mouth area; said opening in said body having a length larger than said length of said open mouth area; insertion hook securing said suture for delivering an insertion of said suture by said single unitary instrument and said extraction hook securing said suture for extraction of said suture by said single unitary instrument, wherein said insertion hook is located on said instrument at a position proximal to said handle section relative to said extraction hook.
Hasson teaches a needle instrument 67 (figure 6) having an insertion hook for securing a suture for insertion and an extraction hook for securing a suture during extraction (insertion hook at one side of opening 69, extraction hook at opposite side of opening 69, figure 6); said insertion hook and said extraction hook defined by an open mouth area 69 located between said insertion hook and said extraction hook (figure 6), and a continuous internal surface extending from the external surface of the body adjacent to said insertion hook to said external surface of the body adjacent to said extraction hook to form an opening in the body of said suture passer device which receives the suture when said suture is placed into said mouth area (figure 6, continuous internal surface along slot 69 extending along the slot back to the outer surface of the shaft of the instrument 67); said opening in said body having a length larger than said length of said open mouth area (figure 6); insertion hook securing said suture for delivering an insertion of said suture by said single unitary instrument and said extraction hook securing said suture for extraction of said suture by said single unitary instrument (column 5, lines 41-44, slot for receiving a suture can be used to either push or pull the thread through depending on which portion or side of the slot is used thereby configured to secure within the slot in both directions), but fails to explicitly disclose wherein said open mouth area having a length of 0.5 millimeters to 4 millimeters. However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to cause the device to have an open mouth area between a length of 0.5 millimeters to 4 millimeters since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984).
Hasson teaches wherein said insertion hook is located on said instrument at a position proximal to said handle section relative to said extraction hook (figure 6, insertion hook proximal side of opening slot 69, extraction hook is the distal side of opening slot 69).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Rioux with an insertion hook for securing a suture for insertion and an extraction hook for securing a suture during extraction; said insertion hook and said extraction hook defined by an open mouth area located between said insertion hook and said extraction hook, said open mouth area having a length of 0.5 millimeters to 4 millimeters, and a continuous internal surface extending from the external surface of the body adjacent to said insertion hook to said external surface of the body adjacent to said extraction hook to form an opening in the body of said suture passer device which receives the suture when said suture is placed into said mouth area; said opening in said body having a length larger than said length of said open mouth area; insertion hook securing said suture for delivering an insertion of said suture by said single unitary instrument and said extraction hook securing said suture for extraction of said suture by said single unitary instrument, as taught by Hasson to provide a hook that is configured for securing a suture for pushing or inserting a suture with the proximal or insertion side or pulling or extracting a suture with the distal or extraction hook side, through or around tissue as necessary for a procedure.
Rioux fails to disclose at least one of said insertion hook or said extraction hook is marked for visual aid.
Rousseau et al. teaches a suture passing device 100 having an elongated shaft and hook elements within an opening for receiving a suture (filament 200, figure 19a-19c), the shaft having a marker on the device for directional location of the opening 108 (figure 9a) on the shaft 106 relative to the filament or suture (paragraph 0059). Examiner notes that although the explicit hook portions are located within the opening 108 of the shaft, and the visual aid marking is located to position the opening or hooks within the opening adjacent the filament to be grasped (figures 19a, 19b), and further any suitable marker may be present to indicate to the surgeon the directional location of the side opening relative to the suture or filament (paragraph 0059).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Rioux with a visual aid marker on the device at the insertion or extraction hook position surrounding the opening on the shaft or needle, as taught by Rousseau et al., in order to provide relative directional location information of the shaft opening relative to the filament or suture and corresponding hook elements within the opening.
Regarding claim 4, Rioux discloses wherein wherein said body of said instrument has a cylindrical shape (shaft 16, figure 1, paragraph 0031).
Claim(s) 5 and 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rioux US 2001/0053916 in view of Evans et al. US 2004/0144395 in view of Hasson US 5830232 and in view of Rousseau et al. US 2013/0139828 and further in view of Esser US 5,222,977.
Regarding claim 5, Rioux discloses a body 16, but fails to explicitly disclose wherein said body of said instrument has an oval shape.
Esser discloses a suture passer device (figure 1) comprising a needle (figure 3A) having an open mouth and opening (defined by opening 3, figure 3A), having a body 1 (figure 1), the body having a generally circular shape or an ovoid shape cross section at the eye (column 3, line 63-column 4, line 2). Esser further discloses wherein the cross-sectional shape may vary and is not critical (column 3, line 63-64).
Therefore, it would have been an obvious matter of design choice to modify Rioux to have a cylindrical or oval shape, since applicant has not disclosed that having an oval shape or a cylindrical shape solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either design (present invention, paragraph 0008, any other shapes are within the scope of the invention). Furthermore, absent a teaching as to criticality of the oval or cylindrical shape, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement. In re Kuhle, 526 F.2d 553,555,188 USPQ 7, 9 (CCPA 1975). Additionally, since such a modification would have involved a mere change in the form or shape of a component. A change in form or shape is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 149 USPQ 47 (CCPA 1976).
Regarding claim 7, Rioux discloses said instrument includes a head section 44’ angled away from a central axis of said instrument body (figure 4a), but fails to explicitly disclose the head section and the central axis of the instrument body is between 18 and 22 degrees.
Esser discloses a suture passer device (figure 1) comprising a needle having an open mouth and opening (figure 1), and a head section angled away from the central axis of the instrument body (column 4, lines 9-13, curvature of head on the distal end of the shaft), the angle formed between 15 to 45 degrees, which is overlapping in scope, and further discloses the curvature is not critical and may be varied (column 4, lines 13-16).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Moses et al. with a head curvature between 18 and 22 degrees, as taught by Esser, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
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 CHRISTINA C LAUER whose telephone number is (571)270-5418. The examiner can normally be reached Monday-Thursday 7:00 AM-4:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at (571) 272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/C.C.L/Examiner, Art Unit 3771
/BROOKE LABRANCHE/Primary Examiner, Art Unit 3771