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 .
Election/Restriction
Applicant's election with traverse of Species A, claims 1, 3, 8 and 11-14 in the reply filed on 28 August 2026 is acknowledged. The traversal is on the ground(s) that the identification of the common feature is incomplete (remarks p. 2). Applicant reasons that the linking feature is therefore not, as the Office Action frames it, a bare catheter-and-electrode combination. It is the provision of resistance against lateral movement of the intermediate portion of the fistula-forming electrode (remarks p. 3).
Examiner acknowledges that each species recites a different mechanism. Each independent claim 1, 18, 35 and 49 describes a different structure that generates a biasing force.
Applicant contends that Zheng's biasing spring is thus carried by the housing and acts to bias the catheter's treatment portion toward the vessel - not attached to the electrode, and not resisting lateral movement of an intermediate portion of the electrode (remarks p. 5).
This is not found persuasive because Zheng implies that the spring resists lateral movement of the intermediate portion of the fistula-forming electrode (¶ [0155], the biasing mechanism 806 is illustrated as a biasing spring 814 … to bias the treatment portion 808 of the catheter 800). Zheng defines the treatment portion 808 as including at least an electrode (¶ [0155], The treatment portion 808 may include a spring biased electrode 810, such as described above). Figs. 10A and 10B show that the electrode 810 and biasing spring 814 converge at their proximal and distal ends. Zheng further discloses that the electrode 810 and biasing spring 814 move in concert when an external constraint is removed (¶ [0155], Accordingly, retracting of the sheath 804 may deploy both the spring biased electrode 810 and the biasing spring 814 simultaneously). This suggests that the electrode 810 and biasing spring 814 are coupled or influence each other’s movement.
The requirement is still deemed proper and is therefore made final.
Claims 18, 23-24, 26-27, 35, 41-42, 44 and 49-52 are withdrawn from further consideration and claims 1, 3, 8 and 11-14 are examined on their merits.
Claim Rejections - 35 USC § 102 / 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 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 the appropriate paragraphs of 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 –
(a) NOVELTY; PRIOR ART.—A person shall be entitled to a patent unless—
(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention; or
(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
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 of this title, 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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 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 1, 3 and 8 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Zheng; Peng et al. (US 20220280244 A1, published earlier as WO 2020242491 A1).
Regarding claim 1, Zheng discloses a system for forming a fistula (¶ [0001], [0005], [0124], [0127], [0136]);
between two vessels (¶ [0124], Accordingly, while various embodiments are directed to fistula formation between two blood vessels, other vascular treatments are contemplated and possible);
comprising: a first catheter comprising a housing with an opening (¶ [0136], the system may include a first catheter 101 and a second catheter 103; ¶ [0155] FIGS. 10 and 10B illustrate an embodiment of a catheter 800 including a housing 801);
an electrode disposed at least partially within the housing, the electrode comprising a distal portion, a proximal portion and an intermediate portion therebetween for contacting a vessel wall and forming the fistula (¶ [0136], The fistula-forming element 110 may comprise an electrode 106; ¶ [0155], The treatment portion 808 may include a spring biased electrode 810, such as described above); and
a spring attached to at least part of the electrode (¶ [0155], the biasing mechanism 806 is illustrated as a biasing spring 814); and
Zheng teaches the invention substantially as claimed by Applicant but does not explicitly disclose that the spring is configured to provide resistance against lateral movement of the intermediate portion.
However, Zheng implies that the spring resists lateral movement of the intermediate portion of the fistula-forming electrode (¶ [0155], the biasing mechanism 806 is illustrated as a biasing spring 814 … to bias the treatment portion 808 of the catheter 800).
Zheng defines the treatment portion 808 as including at least an electrode (¶ [0155], The treatment portion 808 may include a spring biased electrode 810, such as described above). Figs. 10A and 10B show that the electrode 810 and biasing spring 814 converge at their proximal and distal ends. Zheng further discloses that the electrode 810 and biasing spring 814 move in concert when an external constraint is removed (¶ [0155], Accordingly, retracting of the sheath 804 may deploy both the spring biased electrode 810 and the biasing spring 814 simultaneously). This suggests that the electrode 810 and biasing spring 814 are coupled or influence each other’s movement.
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Zheng does not explicitly disclose that the electrode 810 and biasing spring 814 connect at their ends. However, assembling these components or forming them integrally from a single loop would have been obvious since it will simplify manufacturing and reduce the device’s complexity.
Regarding claims 3 and 8, Zheng does not explicitly disclose that the spring is configured to provide resistance against any force causing radial inward movement of the intermediate portion or that the spring is attached to the distal portion of the electrode. However, the electrode 810 and biasing spring 814 converge at their proximal and distal ends and also move in concert (Figs. 10A and 10B). This suggests that the two components are connected and that the biasing spring 814 will exert a force on electrode 810.
Claim Rejections - 35 USC § 103
Claims 1, 3, 8 and 11-13 are rejected under 35 U.S.C. 103 as being unpatentable over Miller; Gary H. et al. (US 20120302935 A1).
Regarding claim 1, Miller discloses a system for forming a fistula between two vessels (¶ [0005], [0031], [0037], [0091] FIGS. 39A-39C illustrate yet another variation of a catheter (3900) comprising a blade (3902));
comprising: a first catheter comprising a housing with an opening (¶ [0091], a recess (3904) in catheter body (3906));
an electrode disposed at least partially within the housing, the electrode comprising a distal portion, a proximal portion and an intermediate portion therebetween for contacting a vessel wall and forming the fistula (¶ [0091], blade (3902)); and
a spring attached to at least part of the electrode (¶ [0091], a first wire portion (3908) and a second wire portion (3910). First wire portion may be attached to or otherwise engage a translation wire (3912) at connection point (3914)); and
wherein the spring is configured to provide resistance against lateral movement of the intermediate portion (¶ [0091], first wire portion (3908) and second wire portion (3910) may comprise a shape-memory material, and may be configured such that first wire portion (3908) and second wire portion (3910) bias blade (3902) away from translation wire (3912) and toward an extended position, as shown in FIG. 39C).
Miller teaches the invention substantially as claimed by Applicant but does not disclose all features in a single embodiment. This rejection modifies the embodiment of Figs. 39A-39C with the ablation feature described in other embodiments by electrifying the blade 3902 of Figs. 39A-39C. A skilled artisan would have been able to combine these features by delivering electrical energy through the first wire portion 3908, second wire portion 3910 and translation wire 3912. Miller suggests to combine mechanical and electrical cutting techniques (¶ [0008], [0037], These fistula-forming elements may utilize any structure or mechanism capable of cutting, ablating, vaporizing, dissolving, or otherwise removing tissue between adjoining vessels, such as, for example, one or more electrical mechanisms (e.g., one or more electrodes or electrocautery devices), one or more mechanical mechanisms (e.g., one or more cutting blades, lancets, needles, or the like) … combinations thereof or the like; ¶ [0043] The electrode ablation surface may have any shape or size suitable for ablating tissue).
One would be motivated to modify Miller’s embodiments to simultaneously cut and cauterize tissues while forming a fistula. Therefore, it would have been obvious to modify Miller’s embodiments in order to both cut and cauterize tissues during surgery.
Regarding claims 3, 8 and 11-13, Miller discloses a system wherein the spring is configured to provide resistance against any force causing radial inward movement of the intermediate portion (¶ [0091], first wire portion (3908) and second wire portion (3910) bias blade (3902) away from translation wire (3912) and toward an extended position, as shown in FIG. 39C);
wherein the spring is attached to the distal or intermediate portion of the electrode (Figs. 39A-39C, blade 3902 is coupled to first wire portion 3908 and second wire portion 3910 along a length of blade 3902);
wherein the spring is disposed between the housing and the intermediate portion (Figs. 39A-39C, first wire portion 3908 and second wire portion 3910 are arranged inside catheter body 3906 between an outer wall catheter body 3906 and the blade 3902);
wherein the spring comprises a leaf spring (Figs. 39A-39C, first wire portion 3908 and second wire portion 3910 form a curved or arc shape that pushes against blade 3902).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Miller; Gary H. et al. (US 20120302935 A1) in view of Lee, Roberta et al. (US 20020095100 A1).
Regarding claim 14, Miller does not explicitly disclose that the spring is integral with the electrode. However, integrally forming a leaf spring and blade does not necessarily provide patentability (see MPEP 2144.04). Lee discloses an excisional biopsy device (¶ [0002], [0020], [0025], [0081] FIG. 1A, 1B and 1C … excisional biopsy device 100);
including a flattened resilient blade (¶ [0088] The cutting tool 125 may, as shown in FIG. 1C, be configured as a thin ribbon … Such a sharpened leading edge is shown in FIG. 4 at reference numeral 127).
Lee demonstrates how to integrally form a spring with a blade or cutting tool. One would be motivated to modify Miller with Lee’s integral blade or electrode and spring to simplify its manufacture. Therefore, it would have been obvious to modify Miller with Lee’s integrally joined electrode and spring in order to simplify its construction.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Chamness; Dale L. et al. US 3955578 A
Fleischman, Sidney D. US 20010007939 A1
Lee, Roberta et al. US 20020072739 A1
Buehlmann, Eric L. et al. US 20040167511 A1
Daniel; Steven A. et al. US 20060212032 A1
Goldin; Mark et al. US 20080294166 A1
Vetter; James W US 20150201994 A1
Pendleton; Steven L. et al. US 20160271377 A1
Nagale; Sandra et al. US 20170035497 A1
Pate; Thomas D. et al. US 20170202616 A1
Berman; Adam L. et al. US 20200178970 A1
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/Adam Marcetich/
Primary Examiner, Art Unit 3781
