DETAILED ACTION
The following is a Final Office Action on the merits.
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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.
Response to Amendment
Acknowledgment is made to the amendment received 4/27/2026.
Applicant’s amendments are sufficient to overcome the drawings objections set forth in the previous office action.
Applicant’s amendments are sufficient to overcome the 35 USC 112(a) new matter rejections set forth in the previous office action.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 61/712704, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application.
Application No. 61/712704, fails to provide adequate support for “a connector adjustably connected to the handle, the connecter further including a track; and an adjustment knob… configured to couple the track to the handle”.
Accordingly, the claims are given the priority date of 3/14/2013.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “414” has been used to designate both “connection portion” and “second arm” (Par. [0039]).
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to because Fig. 4A-B are shaded and the photographs are hard to see each part.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore:
the limitation of “wherein the track of the connector of the second arm is translatable relative to the adjustment knob and rotatable relative the first arm, to rotationally position the second arm relative the first arm” (claim 30) must be shown or the feature(s) canceled from the claim(s);
the limitation of “the track being configured to be rotatable and slidable relative the connection portion, such that sliding of the track relative the connection portion adjusts a distance between the first arm and the second arm, and rotation of the track relative the connection portion rotates the second arm relative the first arm to rotationally position the second arm relative the first arm (claim 37) must be shown or the feature(s) canceled from the claim(s); and
the limitation of “an adjustment knob including a pin that extends through the track and into the connection portion of the handle; wherein the track of the second arm is configured to translate relative the pin to adjust a distance between the first arm and the second arm and to rotate the connector relative the pin to rotationally position the second arm relative the first arm (claim 44) must be shown or the feature(s) canceled from the claim(s).
Fig. 4A-C illustrate the track 420 and pin 424 of adjustment knob 422, where Fig. 4C illustrates the track 420 specifically only appears to be translatable and not rotatable relative to the first arm. Further, no figure illustrates the second arm being capable of rotational positioning relative to the first arm, and specifically since Fig. 4A-C illustrate the connector 418, connector portion 414 to be solid structural plate or cube elements. While not shown, it is the Examiner’s understanding from the specification and limited detail of the drawings that when the track 420 in Fig. 4C is moved vertically up on the page, this creates a gap between connector 418 and connection portion 414 which could then allow 418 and the track 420 to be rotated in clockwise or counter-clockwise directions to adjust the distance between the arms relative to one another, which can also be interpreted as “rotationally position” the arms relative to one another. The Examiner phoned applicant for clarification and left a voicemail, but no return call was received.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities: amend Par. [0001] to include patent numbers for the priority applications.
Appropriate correction is required.
Claim Objections
Claim 30 is objected to because of the following informalities: amend “relative the” to -relative to- in ll. 8 & 9 (twice). Appropriate correction is required.
Claim 37 is objected to because of the following informalities: amend “relative the” to -relative to- in ll. 7, 8 & 10-11 (three times). Appropriate correction is required.
Claim 44 is objected to because of the following informalities: amend “relative the” to -relative to- in ll. 13 & 15 (twice). Appropriate correction is required.
Claim 49 is objected to because of the following informalities: amend “rotatable” to -rotatably- in ll. 2. Appropriate correction is required.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 30-43 is/are rejected under pre-AIA 35 U.S.C. 102(a)(1) or 102(a)(2) as being anticipated by Sutcu et al. (5,810,805).
Concerning claim 30, as discussed in Col. 6-8, ll. 54-46, illustrated in at least Figs. 1-4 & 12-13, Sutcu et al. disclose a device for forming a fistula between two vessels (scissors instrument can be used as a bipolar electrosurgical cutting device or, with one electrode member exposed, as a monopolar electrosurgical cutting device to form a fistula between two vessels) comprising:
a handle (any of scissor arm 28 and/or finger grip 38);
a first arm fixedly connected to the handle (electrode 14’ comprising distal end portion 14a’ and shaft portion 14b’ can either be movable or fixedly connected to scissor arm 28 or finger grip 38); and
a second arm including a connector adjustably connected to the handle, the connector further including a track (rotatable electrode 12’ comprising distal end portion 12a’ and shaft portion 12b’ includes drive gear 32 of generally cylindrical shape on its proximal end, where drive gear inherently comprises gear teeth taken to be the track); and
an adjustment knob configured to couple the track to the handle (a keying or locking mechanism (not shown) can be provided on the proximal end of the movable electrode member 12’ to key or lock the member in place in the normal operating position thereof wherein gears 32 and 34 are in engagement);
wherein the track of the connector of the second arm is translatable relative the adjustment knob (gear teeth on gear 32 are longitudinally movable when rotatable electrode 12’ axially moves the longitudinal axis) and rotatable relative the first arm (gear teeth on gear 32 are rotatable relative to electrode 14’ when electrode 14’ is rotated), to rotationally position the second arm relative the first arm (rotating electrode 12’ is retracted or extended such that electrode 12’ or electrode 14’ can be used as a scalpel while the other electrode is held in the retracted position and electrode 12’ and 14’ are rotatable relative to one another to enable a coagulation procedure), and at least one of the first arm and the second arm comprises a fistula forming element (either of electrode distal ends 12a’, 14a’ of scissors instrument can be used as a bipolar electrosurgical cutting device or, with one electrode member exposed, as a monopolar electrosurgical cutting device that are capable of forming a fistula between two vessels; Col. 8, ll. 13-25).
Concerning claim 31, Sutcu discloses the fistula forming element (12a’) comprises a rotating blade (12a’) (Col. 4, ll. 63-17; Fig. 1-4).
Concerning claim 32, Sutcu discloses the rotatable blade (12a’) is rotatably connected to a distal portion of the first arm (14b’) by connector (16’) (Fig. 7, ll. 1-24; Fig. 1-2 & 13).
Concerning claim 33, Sutcu discloses the handle comprises a first control (finger grip 32 at end of arm 26) configured to rotate the rotatable blade (12a’) relative to the first arm (14b’) (Fig. 7, ll. 1-30 Fig. 12-13).
Concerning claim 34, Sutcu discloses the adjustment knob (keying or locking mechanism (not shown)) is moveable between a first configuration to lock the second arm (12b’) relative to the first arm (14b’) and a second configuration to allow adjustment of the second arm (12b’) relative to the first arm (14b’) (Col. 7, ll. 53-67).
Concerning claim 35-36, Sutcu discloses the first arm and second arms (14b’, 12b’) are formed from a first rigid material (stainless steel) such that placement of the first arm and second arms (14b’, 12b’) in first and second vessels cause the first and second vessels to conform to a shape of the first arm and second arms (14b’, 12b’) (Col. 9, ll. 56-67).
Concerning claim 37, as discussed in Col. 6-8, ll. 54-46, illustrated in at least Figs. 1-4 & 12-13, Sutcu et al. disclose a device for forming a fistula between two vessels (scissors instrument can be used as a bipolar electrosurgical cutting device or, with one electrode member exposed, as a monopolar electrosurgical cutting device to form a fistula between two vessels) comprising:
a handle (scissor arm 28 and/or finger grip 38) comprising:
a grip portion (finger grip 38); and
a connection portion connected to the grip portion (scissor arm 28);
a first arm connected to the connection portion (electrode 14’ comprising distal end portion 14a’ and shaft portion 14b’ can either be movable or fixedly connected to scissor arm 28 or finger grip 38); and
a second arm including a connector that is connected to the connection portion via a track (rotatable electrode 12’ comprising distal end portion 12a’ and shaft portion 12b’ includes drive gear 32 of generally cylindrical shape on its proximal end, where drive gear inherently comprises gear teeth taken to be the track, which in turn connect to hub 30 which connects to scissor arm 28 such that the drive gear teeth track indirectly connect to scissor arm 28) the track being configured to be rotatable (gear teeth on gear 32 are rotatable relative to electrode 14’ when electrode 14’ is rotated) and slidable relative the connection portion (gear teeth on gear 32 are longitudinally movable when rotatable electrode 12’ axially moves the longitudinal axis), such that sliding of the track relative the connection portion adjusts a distance between the first arm and the second arm (rotating electrode 12’, including gear teeth of gear 32, is retracted or extended such that electrode 12’ or electrode 14’ such that a distance between the distalmost end or proximal most end of each is adjusted), and rotation of the track relative the connection portion rotates the second arm relative the first arm to rotationally position the second arm relative the first arm (rotation of gear teeth of gear 32 relative to scissor arm 28 causes rotation of rotating electrode 12’ relative to electrode 14’ to rotationally position the electrodes 12’, 13’ relative to one another).
Claim 38 is rejected upon the same rationale as applied to claim 30.
Concerning claim 39, Sutcu disclose the second arm is lockable in a position relative to the first arm (Col. 7, ll. 53-67).
Concerning claim 40, Sutcu disclose the first arm (14’) is capable of being inserted into a first vessel and the second arm (12’) is capable of being positioned into a second vessel, and wherein an adjustment of a position of the second arm (12’) relative to the first arm (14’) with the connection portion repositions the second vessel relative to the first vessel (Fig. 5-11).
Claim 41 is rejected upon the same rationale as applied to claim 34.
Claim 42-43 is rejected upon the same rationale as applied to claim 35-36.
Allowable Subject Matter
Claims 44-49 are allowed. As allowable subject matter has been indicated, applicant's reply must either comply with all formal requirements or specifically traverse each requirement not complied with. See 37 CFR 1.111(b) and MPEP § 707.07(a).
The following is a statement of reasons for the indication of allowable subject matter: the prior art, neither alone nor in combination disclose “A device for forming a fistula between two vessels comprising: a handle comprising: a grip portion; and a connection portion connected to the grip portion; a first arm connected to the connection portion; a second arm comprising; a connector adjustably connected to the connection portion of the handle; a track coupled to the connector; and a fistula forming element formed on a distal end of the second arm; and an adjustment knob including a pin that extends through the track and into the connection portion of the handle; wherein the track of the second arm is configured to translate relative the pin to adjust a distance between the first arm and the second arm and to rotate the connector relative the pin the first arm to rotationally position the second arm relative the first arm.”
The closest prior art is regarded as: Sutcu et al. (5,810,805) teaches first and second arm that can be axially positioned and rotationally positioned relative to one another. Orphanos et al. (2016/0317171) teach a control handle for both longitudinally extending and rotationally positioning two arms, but fail to disclose an adjustment knob including a pin that extends through a track of the second arm (Fig. 7A-10D). Grundei (4,898,161) teach a track (16) and a pin (15) that move first and second arms (14, 19) longitudinally (Fig. 1). Miller (2012/0302935) teach a fistula forming device comprising two arms and handle having a connection portion (1506) (Fig. 15D). Sutcu et al., Orphanos et al., Grundei and Miller all fail to disclose “an adjustment knob including a pine that extends through the track and into the connection portion of the handle; wherein the track of the second arm is configured to translate relative the pin to adjust a distance between the first arm and the second arm and to rotate the connector relative the pin the first arm to rotationally position the second arm relative the first arm” in combination with the other limitations of claim 44.
Response to Arguments
Applicant’s arguments have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 JAYMI E DELLA whose telephone number is (571)270-1429. The examiner can normally be reached on M-Th 6:00 am - 4:45 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joanne Rodden can be reached on (303) 297-4276. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JAYMI E DELLA/Primary Examiner, Art Unit 3794
JAYMI E. DELLA
Primary Examiner
Art Unit 3794
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