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 .
Claim Rejections - 35 USC § 102
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.
Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Levin; Howard et al. (US 20140012180 A1).
Regarding claim 1, Levin discloses a medical device implantable into a patient (¶ [0002], methods for treating ascites such as by implanting an artificial fistula device to drain ascites fluid; ¶ [0013], a minimally invasively artificial fistula; ¶ [0041] FIG. 1 shows one embodiment of an implanted valved fistula 101; ¶ [0073] FIGS. 7 and 8 illustrate the insertion and implantation of a valved fistula 700);
the medical device comprising: a tube graft defining a lumen (¶ [0044] A tubular element 102 is integral with or attached to the retention element 103; ¶ [0073] FIGS. 7 and 8 … a valved fistula 700 which drains ascites fluid from the peritoneal cavity 702 to the bladder 704); and
an obturator removably seated within the lumen (¶ [0081] FIGS. 14 to 18 sequentially illustrate the attachment of a plug 800 to temporarily seal the passage 726 in the fistula 700, the removal of the plug and the attachment of the drain tube 802 with internal valves 501. The plug 800 has threaded cylinder that mates with a threaded aperture in the fistula 700).
To clarify, Figs. 1-2 illustrate the general placement of a valved fistula, and Figs. 9-18 illustrate further details of the fistula. Fig. 15 illustrates the tube graft (fistula 700) in combination with its removable obturator (plug 800).
Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Anderson; James (US 20130150880 A1).
Regarding claim 1, Anderson discloses a medical device implantable into a patient (¶ [0002], devices and methods for positioning a stent in a created subintimal space of a blood vessel; ¶ [0021] An exemplary recanalization catheter 10 is illustrated at FIG. 1 … A stent 40 may be positioned around a body portion 52 of the balloon structure 20 for delivery to a target location);
the medical device comprising: a tube graft defining a lumen (¶ [0021], A stent 40; ¶ [0027], As used herein, the term "stent" is intended to include stents, covered stents, stent-grafts, grafts and other expandable prosthetic devices for implantation in a body passageway to support the passageway; ¶ [0029] In some embodiments, the stent 40 may include a covering … the covering on the abluminal surface may create a smooth lumen for advancing additional medical devices and medical device structures through the stent 40 once implanted); and
an obturator removably seated within the lumen (¶ [0023], The inflation lumen may be configured for delivering inflation fluid to the balloon structure 20 to inflate the balloon structure 20, or portions thereof, during a medical procedure; ¶ [0042] The inflatable balloon structure 20 may be configured such that the distal cone portion 54, forming the distal anchoring portion 60, and/or the proximal cone portion 56, forming the proximal anchoring portion 62, may be at least partially inflated prior to inflating the body portion 52 sufficiently to radially expand the stent 40 into the expanded configuration).
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 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 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 5 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Levin; Howard et al. (US 20140012180 A1).
Regarding claim 5, Levin discloses that the lumen is about 6 millimeters to about 8 millimeters in diameter (¶ [0013], The fistula is equipped with a one way valve to prevent backflow of fluid from the bladder into the peritoneal cavity; ¶ [0027], Sizes for duckbill valves can range for example from 2.5 mm to 10.0 mm in diameter). Levin’s diameter overlaps the claimed range.
Regarding claim 6, Levin discloses that the tube graft is formed from a thermoplastic polymer (¶ [0050] FIGS. 4A and 4B … a hollow tube 404, e.g., a flexible biocompatible polymer cylinder, which forms the passage)
Levin is silent regarding the obturator’s composition and whether it comprises an elastomer. However, Levin describes other components that comprise an elastomer (¶ [0022] The valved fistula need not withstand much pressure. The valved fistula may include a flexible thin walled tube. The tube may be stretchable and made of a polymer such as silicone rubber; ¶ [0023] The valved fistula may include a silicone duckbill attached to a nitinol self-expanding stent-like retainer with silicone seals).
Levin shows that the obturator (plug 800) occupies the same position as a silicone tube (Figs. 14-17, plug 800 is exchanged for tube 802).
A skilled artisan would have been able to modify Levin by constructing the plug from the same material as the tube, since these components both connect to the graft’s threaded outlet end (¶ [0081], The plug is mounted on the coupling end 709 of the catheter 708; ¶ [0082], An attachment coupling 804 at a distal end of the tube 802 is connected to the coupling end 709 of the fistula 700). Also, silicone rubber is a well-known, commercially available and biocompatible material suitable for constructing Levin’s obturator (plug 800). Therefore, it would have been obvious to modify Levin by constructing the obturator from an elastomer in order to use a commercially available and biocompatible material.
Claims 2-4 are rejected under 35 U.S.C. 103 as being unpatentable over Levin; Howard et al. (US 20140012180 A1) in view of Allen; John J. et al. (US 20130023724 A1).
Regarding claims 2-4, Levin lacks a braided nylon loop. Allen discloses apparatus, tools and methods for treating pelvic conditions (¶ [0002], [0060], One or more implant devices 10; ¶ [0075] Another embodiment of the anchors 16 and anchor array 16n configuration is provided in FIGS. 22-23. A dual-tipped/barbed anchor 60 is included that flexes about a hinge 62 at the base 18);
comprising a braided nylon loop (¶ [0076] In certain embodiments, the anchors 16, or anchors 60, can be fabricated using a metal injection molding process, or from a molded resin material (e.g., 720FC resin, polycarbonate, PEEK, nylon), with an exemplary Prolene monofilament, or braided, suture 30 threaded therethrough; ¶ [0078], Alternatively, a tag or loop can be included at the free end of the tether 50; ¶ [0114], Further, the anchor 14 can include suture loops. The loops can be tied from the peritoneum side. From the obturator side, the multiple loops or sutures 30 can then be tied around the anchor for fixation; ¶ [0115] In other embodiments, the distal anchor 16 is a wrap-around device adapted to go around the inferior ramus. This, in turn, can reduce or eliminate the chance of pull-out from soft tissue. Sutures, clips, clamps, loops and like devices can be employed to facilitate and affix the wrap-around configuration; ¶ [0120] FIGS. 48-54 depict implants 10 … FIGS. 50-51 show an embodiment having two perineal membrane PM piercing or penetration points, with the implant including a small cinch ring 100 adapted to pull on the members 30 (such as suture, strand, mesh, etc.) to provide the desired adjustment--e.g., along a suture loop).
Allen demonstrates how to grasp and manipulate an implant or obturator with a minimally invasive tool (¶ [0051] FIGS. 43-45 are schematic views of a grasping medial anchor device, and implantation method, in accordance with embodiments of the present invention; ¶ [0110] FIGS. 43-45 are directed to a medial anchor device adapted to puncture through the skin and into the perineal membrane PM or like tissue).
A skilled artisan would have been able to modify Levin with Allen’s braided nylon loop by attaching a braided nylon loop to Levin’s obturator, in order to more easily grasp and manipulate it. Therefore, it would have been obvious to modify Levin with Allen’s braided nylon loop in order to more readily manipulate an implanted obturator.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Levin; Howard et al. (US 20140012180 A1) in view of Griffith; Donald P. (US 5766249 A).
Regarding claim 7, Levin discloses an obturator (¶ [0081] FIGS. 14 to 18 … plug 800); and
further discloses an example of silicone rubber elastomer (¶ [0022], The tube may be stretchable and made of a polymer such as silicone rubber; ¶ [0023] The valved fistula may include a silicone duckbill attached to a nitinol self-expanding stent-like retainer with silicone seals).
Regarding the rationale and motivation to modify Levin’s obturator (plug 800) with the silicone material, see the discussion of claim 6 above.
Levin does not explicitly disclose PTFE. Griffith discloses a tissue bondable cystostomy tube and surgical procedure (col. 1, lines 15-25; col. 3, lines 5-10, cylinder 11);
comprising a thermoplastic polymer that is Polytetrafluoroethylene (PTFE) (col. 3, lines 15-20, The upper portion of the deep implant, 11a, is made of a nonporous material, such as polyurethane, polytetrafluroethylene, or silicone and is uncoated; col. 4, lines 35-45, As shown by the shaded area in FIG. 4, the lower portion of the deep implant cylinder 11b, stabilizing flange 15, and planar disc-like base 13 are coated on their exterior surface with a material suitable for bonding with biological tissue 30 … a polytetrafluoroethylene polymer, such as that sold under the trademark Proplast.RTM.).
Griffith constructs an implant from a commercially available and biocompatible polymer. Griffith’s PTFE also selectively resists or promotes tissue adhesion, based on the polymer’s porosity. One would be motivated to modify Levin with Griffith’s PTFE to construct an implant from commercially available and biocompatible materials, and optionally to prevent or promote tissue adhesion, since Levin calls for adhering tissue to the implant’s middle section (¶ [0083] FIG. 19 … The fistula may include a cylindrical inner structure 730 which may be a mesh of biocompatible material … The exposed mesh may be coated with materials that promote sealing of the tissue of the muscle and membrane on the surface of the mesh). Therefore, it would have been obvious to modify Levin with Griffith’s PTFE in order to construct the implant from commercially available materials and optionally to promote tissue adhesion.
Allowable Subject Matter
Claims 8-10 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following newly cited references fail to teach or suggest a method of percutaneous needle cannulation hemodialysis according to claim 8:
Harrison, Percy US 1205891 A
Carlile; William A. Jr. et al. US 2993616 A
Williamson; Geronimo C. US 4398565 A
Bai; Chao-Liang US 4619643 A
Aebischer; Patrick et al. US 5487739 A
Trerotola; Scott O. et al. US 5591226 A
Greenberg, Roy K. US 20010027338 A1
Gillis, Edward M. et al. US 20010041870 A1
Fogarty; Thomas J. US 6585760 B1
Patel, Umesh H. US 20050182484 A1
Lesh; Michael D. US 20060058891 A1
Huang; Alex et al. US 20070106233 A1
Campbell; Carey V. et al. US 20120310326 A1
Du; Binh T. US D717407 S
Allen; John J. et al. US 20160095586 A1
Smith; Mark S. et al. US 20160199067 A1
Weisse; Charles Winston et al. US 20210402136 A1
Conclusion
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/Adam Marcetich/
Primary Examiner, Art Unit 3781