DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Status
A complete action on the merits of claims 1-15 follows below.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 12 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Claim 12 recites the limitation "first and second heating members in line 1. It is unclear if the "first and second heating members" are one of or in addition to the "a heating member in claim 1."
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 1-4, 6, 9-10, and 13-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4-7, and 9 of U.S. Patent No. 9,931,164.
Claims 1-4, 6, 9-10, 13-14 are rejected on the grounds of nonstatutory double patenting as being unpatentable over claims 1, 4-7, and 9 of U.S. Patent No. 9,931,164. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ‘164 patent anticipate the claims of the application. Accordingly, the application claims are not patentably distinct from the patent claims. Here, the more specific patent claims encompass the broader application claims. Claim 1 of the instant application provides for “a proximal member and a distal member" whereas claim 1 of patent '164 requires “a distal blunt rigid surface on the proximal elongate member and a proximal blunt rigid surface on the distal member.” Therefore, the claims of the instant application are merely broader with respect to the distal and proximal members and would therefore be encompassed by the claim language of the patent. Following the rationale in In re Goodman cited in the preceding paragraph, where applicant has once been granted a patent containing a claim for the specific narrow invention, applicant may not obtain a second patent with a claim for the generic or broader invention without first submitting an appropriate terminal disclaimer.
Claim 2 of the instant application is taught by claim 4 of patent ‘164.
Claim 3 of the instant application is taught by claim 4 of patent ‘164.
Claim 4 of the instant application is taught by claim 4 of patent ‘164.
Claim 6 of the instant application is taught by claim 1 of patent ‘164
Claim 9 of the instant application is taught by claim 5 of patent ‘164.
Claim 10 of the instant application is taught by claim 6 of patent ‘164.
Claim 13 of the instant application is taught by claim 7 of patent ‘164.
Claim 14 of the instant application is taught by claim 9 of patent ‘164.
Claim 1 is rejected on the grounds of non-statutory double patenting as being unpatentable over claim 7 of U.S Patent No. 10,751,461 and in further view of Clague (Pub. No. 2004/0082945).
Regarding claim 1, Claim 7 of Patent ‘461 teaches all the limitations expect that it does not teach applying energy to a heating member one of the proximal and distal members to further cut the first and second vessels and shape the aperture, the step of applying energy to the heating member further cauterizing and welding an edge of the aperture in order to create the desired fistula between the first and second vessels.
However, Clague discloses an apparatus comprising electrodes 52, Fig. 6 protruding from wire body 54, Fig. 6 and a cutting electrode at the arteriotomy tool distal cutting head 62, Fig. 6 [0098].
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to provide for a heating member on at the toggle apparatus in order to provide for electrical cutting of tissue in addition to mechanical cutting in order to make a clean incision and inhibit blood loss as taught by Clague ([0024], [0028]-[0029] [0098][0101]).
Claim Rejections - 35 USC § 102
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.
Claim(s) 1,8,9,10, and 12 is/are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Makower (Pub. No. 2004/0073238).
Regarding claim 1, Makower teaches a method of creating an arteriovenous (AV) fistula between first and second vessels (The system is used to simultaneously achieve a second opening in an adjacent vessel proximate to the first opening so that an anastomosis channel may be created between the two vessels or conduits for the passage of blood therethrough; [0014]) comprising:
inserting a catheter comprising a proximal member and a distal member in to the first vessel so that the distal member comes into contact with a selected anastomosis site (welding catheter system in Fig. 17 proximal elongate member includes balloon 82 and distal member includes balloon 89 [0096] Fig. 17);
creating an aperture between the first and second vessels ([0096] After an anastomosis channel has been created through interstitial space 29 which exists between cardiac vein 3 and coronary artery 2, a guide wire 51 is inserted through the channel. Fig. 16);
advancing the distal member into the second vessel (Fig 17, distal balloon 89 is advanced entirely into the second vessel 2 and the distal face proximal balloon 82 remains entirely in the first vessel 3. The distal face of proximal balloon 82 contacts a tissue wall of the first vessel 3);
clamping the first and second vessels together using the proximal and distal members (The two balloons may be pulled into a position opposing edges of the opening in the coronary artery 2 and cardiac vein 3; [0096]. The proximal face of distal balloon 89 contacts the tissue wall of second vessel 2); and applying energy to a heating member (intraweld electrodes 83, contralateral welding surfaces 87 and 88, and return electrodes 85 and 84) on one of the proximal and distal members to further cut the first and second vessels and shape the aperture, the step of applying energy to the heating member further cauterizing and welding an edge of the aperture in order to create the desired fistula between the first and second vessels (Makower cuts tissue prior to welding since it would have to create an opening in each of the first vessel and the second vessel. Bipolar RF energy further enlarges the aperture and is used to weld the two vessel openings together without the need for additional mechanical attachment devices. Energy will be delivered either between the contralateral welding surfaces 87 and 88 or between the intraweld electrodes 83 and the return electrodes 85 and 84).
Regarding cliam 8, Makower teaches the limitations of claim 1 as previously rejected. Makower teaches wherein applying energy to the heating member comprises applying RF energy [0096].
Regarding claim 9, Makower discloses the limitations of claim 1 as previously rejected above. Makower discloses wherein the advancing step comprises moving the distal member distally relative to the proximal elongate member so that the distal member is spaced a greater axial distance from the proximal elongate member after the advancing step is performed than it is before the advancing step is performed (when catheter 86 is moved distally the distance between distal member/balloon 96 is spaced axially greater than proximal member/balloon 82 [0096]).
Regarding claim 10, Makower discloses the limitations of claim 9 as previously rejected above. Makower discloses retracting the distal member toward the proximal member to clamp the first and second vessels together (when distal balloon 89 is retracted towards tissue 29 it is spaced a lesser axial distance from the proximal member/balloon 82 [0096]).
Regarding claim 12, Makower teaches the limitations of claim 10 as previously rejected above. Makower discloses wherein the catheter comprises first and second heating members, the first heating member being disposed on the proximal member (87) and the second heating member being disposed on the distal member (88), wherein the first and second heating members are prevented from coming into contact with each other when the distal member is fully retracted (the distal member is capable of being deflated).
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 negatived by the manner in which the invention was made.
Claims 2-5 are rejected under 35 U.S.C. 103 (a) as being unpatentable over Makower (Pub. No. 2004/0073238) in view of Lau (Pub. No. US 2006/0217706).
Regarding claims 2-4, Makower discloses the limitations of claim 1 as previously rejected above. Makower is silent about specifically teaching dispersing heat away from the heating member using a heat spreader (claim 2), wherein the heat spreader comprises a conductive material disposed on one of the proximal and distal members (claim 3), wherein the conductive material is disposed below the heating member (claim 4).
However, Lau teaches an apparatus that includes a pair of movable jaws adapted to heat up to a first temperature (Abstract) and further teaches strips of thermally conductive material 486 extending underneath a heating element 484 (Fig. 24A-C) wherein the thermally conductive material strips absorb some of the heat generated by the heating element 484 [0149].
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to provide a heat spreader beneath the heating member on one of the proximal and distal members for the purposes of absorbing some of the heat generated by the heating element and further enhancing heating of the tissue within the hot-zone [0149].
Regarding claim 5, Makower in view of Lua teaches the limitations of claim 2 as previously rejected above. Makower teaches creating a heat gradient across a face of one of the proximal and distal members to weld the first and second vessels together (Fig. 17 distal and proximal sections each include active and return electrodes, the gradient is minimal at the return electrodes 84, 85 and the gradient is high near active electrodes 87, 88, 83).
Claim 6 are rejected under 35 U.S.C. 103 (a) as being unpatentable over Makower (Pub. No. 2004/0073238).
Regarding claim 6, Makower teaches the limitations of claim 1 as previously rejected above. While Makower provides for a desired temperature [0096], Makower is silent about specifically teaching wherein applying energy to the heating member elongates the aperture.
It is the position of the Examiner since the duration of heat application or temperature affects the shape of the aperture, it is a matter of optimization as being result effective variable. Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to use the particular parameter and a desired aperture length, 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 (MPEP 2144.05 (II-A)).
Claims 1, 7-11, 13-15 are rejected under 35 U.S.C. 103 (a) as being unpatentable over LeMole (Patent. No. 5,893,369) and in further view of Clague (Pub. No. 2004/0082945).
Regarding claim 1, LeMole teaches a method of creating an arteriovenous (AV) fistula between first and second vessels (Figs. 19 and 20) comprising:
inserting a catheter comprising a proximal member and a distal member into the first vessel (angled sleeve 48 comprises proximal elongate member 64 and distal member 66 over guidewire 52 in graft 14, Fig. 20) so that the distal member comes into contact with a selected anastomosis site (Figs. 18 illustrate distal member 66 which comes into contact with an anastomosis site);
creating an aperture between the first and second vessels (an aperture is created by the guide wire 52, Fig. 15, then cutting tool 54, Fig. 16 prior to delivery of the distal member. Col. 6, lines 15-35, Col. 10, line 59 The aperture is then enlarged by distal member 66, Fig.18 as it contacts and enters the second vessel 12 as seen in Fig. 18 where part of the opening is pushed back);
advancing the distal member into the second vessel (Fig. 18 the distal member 66 is advanced entirely into vessel 12 );
clamping the first and second vessels together using the proximal and distal members (Fig. 20 illustrates distal member 66 is retracted towards elongate member 64 to clamp tissue);
While LeMole teaches further cutting the vessel (Fig. 20), it does not teach applying energy to a heating member one of the proximal and distal members to further cut the first and second vessels and shape the aperture, the step of applying energy to the heating member further cauterizing and welding an edge of the aperture in order to create the desired fistula between the first and second vessels.
However, Clague discloses an apparatus comprising electrodes 52, Fig. 6 protruding from wire body 54, Fig. 6 and a cutting electrode at the arteriotomy tool distal cutting head 62, Fig. 6 [0098].
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to provide for a heating member on at least one of the distal member and the proximal elongate member in order to provide for electrical cutting of tissue in addition to mechanical cutting in order to make a clean incision and inhibit blood loss as taught by Clague ([0024], [0028]-[0029] [0098][0101]).
Regarding claim 7, LeMole in view of Clague teaches the limitations of claim 1 as previously rejected above. LeMole teaches proximal member moves closer to the distal member (Fig. 20) . Claugue provides for the heating member and therefore as the energy is applied the proximal member in LeMole moves closer to the distal
Regarding claim 8, LeMole in view of Clague teaches the limitations of claim 1 as previously rejected above. Clauge teaches wherein applying energy to the heating member comprises applying RF energy (Clague teaches applying RF energy between a cutting electrode 62 and a ground electrode 52 within an arterial lumen to cut through the wall of an artery [0101].).
Regarding claim 9, LeMole in view of Clague teaches the limitations of claim 1 as previously rejected above. LeMole teaches wherein advancing the distal member comprises moving the distal member distally relative to the proximal member so that the distal member is spaced a greater axial distance from the proximal elongate member after the advancing step is performed than it was before the advancing step is performed (when distal member 66 is entirely advanced in graft 14 it is spaced a greater axial distal from the proximal elongate member 64, Fig. 18).
Regarding claim 10, LeMole in view of Clague teaches the limitations of claim 9 as previously rejected above. LeMole teaches further comprising retracting the distal member toward the proximal member to clamp the first and second vessels together (LeMole teaches when distal member 66 is retracted it grabs cut tissue from the second vessel towards the first vessel, Fig. 20).
Regarding claim 11, LeMole in view of Clague teaches the limitations of claim 10 as previously rejected above. LeMole teaches wherein the advancing step is performed by advancing a tubular structure distally (block handle 70) from an outer tube comprising the proximal elongate member (handle 68 of distal member 64), and retracting the distal member is performed by withdrawing the tubular structure proximally into the outer tube (Fig. 20).
Regarding claim 13, LeMole in view of Claugue teaches the limitations of claim 9 as previously rejected above. While LeMole is silent about specifically teaching wherein the catheter is rotated during the advancing step, it would have been obvious to one having ordinary skill in the art at the time the invention was made to rotate the catheter during the advancing step in order to adjust position of the distal tip, since it has been held that the provision of adjustability, where needed, involves routine skill in the art . In re Stevens, 101 USPQ 284 (CCPA 1954) (MPEP 2144 (VD)).
Regarding claim 14, LeMole in view of Claugue teaches the limitations of claim 1 as previously rejected above. LeMole generally provides that during the retracting step, applying a slight tension to the distal member to seat the distal member against a wall of the second vessel (the vessel and graft walls between the punch 64 and block 66 are sheared off and captured within the punch 64…the block cutting surface 66 is substantially parallel to the surface of the host vessel wall; Col. 10 lines 40-47) and Clague generally teaches seating an electrode against tissue [0098].
Regarding claim 15, LeMole in view of Clague teaches the limitations of claim 2 as previously rejected above. LeMole teaches further comprising a step of capturing tissue cut from the first and second vessels (Fig. 20 illustrates the cavity in elongate member 64 receives cut tissue….the vessel and graft walls between the punch 64 and block 66 are sheared off and captured within the punche 64. The capturing of the sheared wall segments within the punch 64 prevents the sheared tissue from entering into the blood stream and causing subsequent damage; Col. 10 lines 50-55).
Claim 2-4 are rejected under 35 U.S.C. 103 (a) as being unpatentable over LeMole (Patent. No. 5,893,369) in further of Clague (Pub. No. 2004/0082945) and in further view of Lau (Pub. No. US 2006/0217706).
Regarding claim 2, LeMole in view of Clague teaches the limitations of claim 1 as previously rejected above. LeMole is silent about specifically teaching dispersing heat away from the heating member using a heat spreader.
However, Lau teaches an apparatus that includes a pair of movable jaws adapted to heat up to a first temperature (Abstract) and further teaches strips of thermally conductive material 486 extending underneath a heating element 484 (Fig. 24A-C) wherein the thermally conductive material strips absorb some of the heat generated by the heating element 484 [0149].
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to provide a heat spreader beneath the heating member for the purposes of absorbing some of the heat generated by the heating element and further enhancing heating of the tissue within the hot-zone [0149].
Regarding claim 3, LeMole in view of Clague and Lau teaches the limitations of claim 2 as previously rejected above. Lau teaches wherein the heat spreader comprises a conductive material disposed on one of the proximal and distal members (486).
Regarding claim 4, LeMole in view of Clague and Lau teaches the limitations of claim 3 as previously rejected above. Lau teaches wherein the conductive material is disposed below the heating member (Fig. 24A-C).
Conclusion
It is the position of the Examiner that the following references are pertinent:
Dinger (6,699,245)– Fig. 4 provides for heaters 16 and 18 on proximal and distal sections respectively ; see also Figs 7-8
Chanduszko (2005/0192654) – provides for catheter (90), distal member (100) with electrodes (155a,b) and proximal member (127) with electrodes (157a,b); see Fig. 10E , 15 and 16
Any inquiry concerning this communication or earlier communications from the examiner should be directed to YASAMIN EKRAMI whose telephone number is (571)272-9803. The examiner can normally be reached 9:00-5:00.
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/Y.E/Examiner, Art Unit 3794
/JAYMI E DELLA/Primary Examiner, Art Unit 3794