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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 2/23/26 has been entered.
Election/Restrictions
Claims 1-5 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 6/26/25.
The amendment to claim 1, which add the plug, is not found in the elected species, it is found in the non-elected species of Fig. 30-40; hence the claims have been withdrawn.
Claim Objections
Claims 9 and 10 are objected to because of the following informalities: the claims are dependent on a previously withdrawn claim, “claim 7”. It appears to the examiner that it should be –claim 8—and will be interpreted in this manner in order to advance prosecution. Appropriate correction is required.
Claims 23, 24, and 27 are objected to because of the following informalities: the claims are dependent on a cancelled claim, “claim 21”. It appears to the examiner that it should be –claim 22—and will be interpreted in this manner in order to advance prosecution. Appropriate correction is required.
Claim 26 is objected to because of the following informalities: the claim is dependent on itself, “claim 26”. It appears to the examiner that it should be –claim 22—and will be interpreted in this manner in order to advance prosecution. Appropriate correction is required.
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 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) 8-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over by Coleman et al. (2010/0114128) in view of Kohm et al. (2008/0071376).
Coleman discloses a surgical assembly, comprising: a delivery tool (200) (Fig. 16 and [0086]) including an elongate shaft (224’, 225’) (Fig. 26-30 and [0095]) extending from a distal end thereof (Fig. 26-30 and [0095]), the delivery tool including a first central lumen (lumen of 224’ that holds 225’ as seen in Fig. 27, lumen of 225’ as seen in Fig. 27 that holds suture 131’) therethrough (Fig. 26-30 and [0095]); and a deployable coupler (10, 310, 410) (Fig. 1-30) coupled to a distal end of the elongate shaft (Fig. 26-30 and [0095]) and having a second central lumen (lumen seen in Fig. 1-3 and 5 that holds part 229’ as seen in Fig. 27-29) in communication with the first central lumen of the delivery tool (Fig. 27-29 and [0095]), the deployable coupler having a distal wing (16b) (Fig. 1-5 and [0078-79]) defined by first proximal and distal cuts (see figure below) on a distal region thereof (12b) (Fig. 1) and a proximal wing (16a) (Fig. 1-5 and [0078-79]) defined by second proximal and distal cuts (see figure below) on a proximal region (12a) thereof (Fig. 1), the deployable coupler having a middle region (13) (Fig. 1) between the proximal region and the distal region (Fig. 1); wherein the delivery tool is configured to transform the deployable coupler between a delivery configuration (Fig. 1, 6, and 16-18) in which the elongate shaft is substantially parallel to the distal and proximal wing (Fig. 1, 6, and 16-18) and a deployed configuration (Fig. 4, 5, and 10) in which the elongate shaft is substantially skew to the distal and proximal wing (Fig. 1, 6, and 16-18 and [0079]); wherein the length ratio of the first proximal and distal cuts is substantially equal to 1 (see figure below); wherein the length ratio of the second proximal and distal cuts is substantially greater than 1 (see figure below); wherein the delivery tool and the deployable coupler are configured to move over a guidewire extending through the first and second central lumens (Fig. 27-29 where the device is capable of receiving a guidewire).
It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. Ex parte Masham, 2 USPQ2d 1647 (1987).
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Coleman discloses all the limitations discussed above including that that the slits define the angle of the wings ([0079]), however Coleman does not specify that the angle is based on the ratio of the distal and proximal cuts.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to have a length ratio to define the desired angle, since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Furthermore, the determination of optimum or workable ranges of the slits to achieve desired angle and flexibility of the wings would have been characterize by routine experimentation. See MPEP 2144.05 IIB
Coleman discloses all the limitations discussed above, however Coleman is silent with regards to the deployable coupler having a middle portion between the proximal region and the distal region that has a diameter greater than a diameter of the proximal region and a diameter of the distal region.
Kohm discloses a surgical assembly having an actuator assembly (1500) (Fig. 11 and [0130]) including an elongate shaft (1520) (Fig. 11 and [0130]); and a deployable coupler (200) (Fig. 7) coupled to a distal end of the elongate shaft (Fig. 15-16 and [0131]), the deployable coupler including a proximal region (220) (Fig. 7 and [0118]) having a plurality of proximal slits (221) (Fig. 7) therein configured to form a proximal wing (225, 227, 229) (Fig. 7-9 and [0122-123]) and a distal region (210) (Fig. 7 and [0118]) having a plurality of distal slits (211) (Fig. 7) therein configured to form a distal wing (215, 217, 219) (Fig. 7-9 and [0121]), the deployable coupler including a middle portion (250) (Fig. 7 and [0118-119]) between the proximal region and the distal region that has a diameter greater than a diameter of the proximal region and a diameter of the distal region (Fig. 7 and [0119]).
Kohm further discloses that the middle portion (150) can have a diameter smaller than the diameter of the distal and proximal regions (Fig. 5) or the middle portion (250) can have a diameter larger than the diameter of the distal and proximal regions (Fig. 7 and [0119]).
Therefore, it would have been obvious to one of ordinary skill in the art to modify the middle portion of Coleman to have a larger diameter than the distal and proximal regions, as taught by Kohm, since it has been held that a simple substitution of one known element for another will yield predictable results. KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82, USPQ2d 1385 (2007).
Allowable Subject Matter
Claim 22 is allowed.
The following is an examiner’s statement of reasons for allowance: the art of record when considered alone or in combination neither renders obvious nor anticipates a surgical assembly having an actuator assembly including an elongate shaft; and a deployable coupler having a first tubular portion having a proximal cut and a distal cut having a length ratio of approximately 1:1; a second tubular portion having a proximal cut and a distal cut having a length ratio substantially less than 1:1; a connector portion with a larger diameter than the distal and proximal portions and being a press ring, in conjunction with the rest of the claimed limitations.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Response to Arguments
Applicant's arguments filed 2/10/26 with respect to claim 8 have been fully considered but they are not persuasive.
Applicant argues that Coleman does not teach the central lumens of the elongated shaft and the coupler wherein the delivery tool and the deployable coupler are configured to move over a guidewire extending through the first and second central lumens.
The examiner disagrees, applicant focuses on the embodiment of Fig. 17-19 which does show that both components have the claimed lumen however applicant argues that it is not capable of having a guidewire extend through because of the use of shaft 226. This argument is moot in view of the new grounds of rejection where the examiner has used Fig. 26-30 which does not use shaft 226 and therefore would be able to have the guidewire pass through, as seen in the rejection above.
Furthermore, in response to applicant's argument that the device of Coleman would not be able to have a guidewire pass through, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DIANNE DORNBUSCH whose telephone number is (571)270-3515. The examiner can normally be reached Monday-Wednesday 9 am-3 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached at (571) 272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DIANNE DORNBUSCH/ Primary Examiner, Art Unit 3771