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 § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 1-23 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Independent claims 1 and 20 both require that the elongated body or frame is in the radially expanded state within the body lumen and the first and second portions are engaged with an inner wall of the body lumen (lines 16-18 of Claim 1; lines 15-17 of Claim 20). The claims therefore encompass parts of the human body.
Claims 2-19 and 21-23 are rejected because they depend from claims 1 and 20, respectively.
Claim Rejections - 35 USC § 102
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)(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.
Claims 1-7, 10-12, and 14-23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fulton (US 2011/0282274).
With respect to Claim 1, Fulton teaches a perfusion stent (see the embodiments of Figures 13B-C and 16) implantable within a body lumen, the stent comprising:
a radially compressible and self-expandable elongated body 80/110 (80 in Figures 13B-C; 110 in Figure 16) comprising first and second end portions (the left and right ends of body 80 in Figures 13B-C, adjacent numerals 118 and 119 in Figure 16) and an intermediate portion (the reduced-diameter central portion in Figures 13B-C and the equivalent section of Figure 16) extending from the first end portion to the second end 30 portion;
the first and second end portions having an outer diameter greater than an outer diameter of the intermediate portion when the body is in a radially expanded state (as shown in Figures 13B-C and 16);
a perfusion space (the space outside of the intermediate portion and surrounding veins 51; corresponding to numeral 94 in the other figures 4 and 14, for example) between the first and second end portions and the intermediate portion; - 29 -WO 2015/119705 PCT/US2014/068116
a central lumen (84 in Figures 13B-C and the corresponding main lumen in Figure 16; paragraphs [0083-0085] and [0092-0093]) extending through the first end portion, the intermediate portion, and the second end portion;
a perfusion lumen (83, 86, 88 in Figures 13B-C; 111 and 112 in Figure 16) extending at least partially through the first end portion and having a distal opening in communication with the perfusion space;
5 wherein when the elongated body is in the radially expanded state within the body lumen and the first and second end portions are engaged with an inner wall of the body lumen, the central lumen is fluidly separated from the perfusion space 94 (fluid from the perfusion space will pump through lumen 83/86 and 112 in Figures 13b-C and 16, respectively, while fluid in the central lumen 124 will pump through the central lumen, outside of the perfusion lumen; see Figures 13B-C and 16 and paragraphs ([0083-0085] and [0089-0092]); and
wherein a proximal end of the self-expandable frame is connected to a recovery wire (88 in Figures 13B-C; 115 in Figure 16)
With respect to Claim 2, Fulton teaches that the stent further comprises a retractable sheath (element 81 in Figure 13A [0083-0084]; elements 113 and 121 in Figure 16).
With respect to Claim 3, Fulton teaches that the elongated body elongated body 80/110 (80 in Figures 13B-C; 110 in Figure 16) comprises a self-expandable frame (paragraphs [0083-0085] and [0089-0092]).
With respect to Claim 4, Fulton teaches the perfusion lumen (83, 86, 88 in Figures 13B-C; 111 and 112 in Figure 16) is defined at least partially by a perfusion conduit (83 and 86 in figures 13B-C; 112 in Figure 16) that extends at least partly through the first end portion. The perfusion conduit defines the perfusion lumen.
With respect to Claim 5, Fulton teaches that the elongated body 80/110 comprises an inlet and an outlet (defined at opposing ends of lumen 84 in Figures 13B-C; defined by opposing ends 114 of the central lumen 124 in Figure 16), and further teaches a surface that is non-porous to blood surrounding the central lumen and extending longitudinally from the inlet to the outlet (paragraphs [0084] and [0092]; element 113 in Figure 16). See Figures 13B-C and 16.
With respect to Claim 6, Fulton teaches that the body comprises a cover/liner (113 in Figure 16; paragraph [0084] teaches that the embodiment of Figures 13B-C is also covered) attached to the frame, the cover/liner defining a surface that is non-porous to blood (paragraphs [0083-0085], [0090-0092]).
With respect to Claim 7, Fulton teaches that the frame comprises a braided mesh defining a plurality of angled struts that form first and second end portions of the braided mesh structure (Figures 13B-C and 16; paragraphs [0083-0085] and [0089-0090]).
With respect to Claim 10, Fulton teaches that the cover/liner (113 in Figure 16; paragraph [0084] teaches that the embodiment of Figures 13B-C is also covered) covers the frame (i.e. is located inside, outside, or inside and outside the frame). See Figures 13B-C and 16 and paragraphs [0083-0085] and [0089-0090].
With respect to Claims 11 and 12, Fulton teaches that a plurality of radiopaque position markers may be provided at proximal 119 and distal 118 ends of the device (Figure 16; paragraph [0091]).
With respect to Claim 14, Fulton teaches a method of selectively administering a therapeutic agent to an organ of a subject (paragraphs [0003], [0098], and [0101-0102]), the method comprising implanting the stent of claim 1 ([0003], [0098], [0101], and [0102]; Figures 13B-C and 16).
With respect to Claim 15, Fulton teaches that the perfused organ may be the liver 3, which is a visceral organ (paragraphs [0101-0102]; Figures 3-9 and 14).
With respect to Claims 16 and 17, Fulton teaches that the therapeutic agent may be a chemotherapeutic agent that is toxic to the central nervous system (paragraphs [0005], [0062], [0067], [0084], [0101-0104]).
With respect to Claim 18, Fulton teaches that the therapeutic agent perfuses the organ as part of a solution. Additionally or in the alternative, Fulton teaches that the organ is perfused with a solution via a perfusion conduit (83 and 86 in figures 13B-C; 112 in Figure 16) that extends at least partly through the first end portion. See paragraphs [0083-0085] and [0089-0092].
With respect to Claim 19 Fulton teaches that blood is perfused to the organ through a perfusion conduit. See paragraphs [0083-0085] and [0089-0092].
With respect to Claim 20, Fulton teaches a perfusion stent (see the embodiments of Figures 13B-C and 16) implantable within a body lumen, the stent comprising:
a self-expandable frame (paragraphs [0083-0085] and [0089-0092]) comprising Nitinol (for example, see paragraphs [0059], [0078], [0087]; it is implicit that the braided mesh in Figures 13B-C and 16 may also be made of Nitinol) that is expandable from a radially compressed to a radially expanded state (paragraphs [0083-0085] and [0089-0092]), the self-expanding frame comprising first and second end portions (the left and right ends of body 80 in Figures 13B-C, adjacent numerals 118 and 119 in Figure 16) and an intermediate portion (the reduced-diameter central portion in Figures 13B-C and the equivalent section of Figure 16) extending from the first end portion to the second end 30 portion, the first and second end portions having an outer diameter greater than an outer diameter of the intermediate portion when the body is in a radially expanded state (as shown in Figures 13B-C and 16);
a non-porous cover/liner (113 in Figure 16; paragraph [0084] teaches that the embodiment of Figures 13B-C is also covered) attached to the frame, the cover/liner defining a surface that is non-porous to blood (paragraphs [0083-0085], [0090-0092]);
a perfusion space (the space outside of the intermediate portion and surrounding veins 51; corresponding to numeral 94 in the other figures 4 and 14, for example) between the first and second end portions and the intermediate portion; - 29 -WO 2015/119705 PCT/US2014/068116
a central lumen (84 in Figures 13B-C and the corresponding main lumen in Figure 16; paragraphs [0083-0085] and [0092-0093]) extending through the first end portion, the intermediate portion, and the second end portion; and
a perfusion conduit (83, 86, 88 in Figures 13B-C; 111 and 112 in Figure 16) extending at least partially through the first end portion and having a distal opening disposed within the perfusion space, the perfusion conduit defining a perfusion lumen in communication with the perfusion space (paragraphs [0083-0085] and [0092-0093]);
wherein when the frame is in the radially expanded state within the body lumen and the first and second end portions are engaged with an inner wall of the body lumen, the central lumen is fluidly separated from the perfusion space 94 by the non-porous cover/liner (fluid from the perfusion space will pump through lumen 83/86 and 112 in Figures 13b-C and 16, respectively, while fluid in the central lumen 124 will pump through the central lumen, outside of the perfusion lumen; see Figures 13B-C and 16 and paragraphs ([0083-0085] and [0089-0092]).
With respect to Claim 21, Fulton teaches that the frame comprises a braided mesh defining a plurality of angled struts that form first and second end portions of the braided mesh structure (Figures 13B-C and 16; paragraphs [0083-0085] and [0089-0090]).
With respect to Claim 22, teaches that a proximal end of the perfusion conduit (86 in Figures 13B-C; 112 in Figure 16) extends proximally beyond the first end portion of the frame and is configured to be coupled to a catheter that extends outside the body (the perfusion conduit is connected to a filter and a pump outside of the body; paragraphs [0084] and [0092]).
With respect to Claim 23, Fulton teaches that a proximal end of the self-expandable frame is connected to a recovery wire (88 in Figures 13B-C; 115 in Figure 16) that extends proximally from the frame.
Claim Rejections - 35 USC § 103
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 9 is 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 Fulton.
With respect to Claim 9, Fulton teaches the perfusion stent of claims 1, 3, and 6 (see above), and further teaches that the cover/liner (113 in Figure 16; paragraph [0084] teaches that the embodiment of Figures 13B-C is also covered) covers the frame, and is adhered thereto such that it remains attached (see Figures 13B-C and 16 and paragraphs [0083-0085] and [0089-0090]).
In the event that applicant does not clearly envisage this interpretation of Fulton, the examiner takes official notice that it is extraordinarily well known in the art to attach a liner to the frame of a stent by adhesive or suturing, thereby ensuring that the liner remains attached to the frame during use. It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant application to modify Fulton’s perfusion stent such that the cover/liner is secured to the frame by adhesive or suturing, as is well-known in the art, in order to provide an art-established means for securing the cover/liner to the frame.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Fulton in view of Marton et al. (WO 2004/028340; provided by Applicant in an IDS). Fulton teaches the perfusion stent of Claims 1, 3, and 6 substantially as claimed (see above), wherein self-expandable frame may be a mesh frame [0084], and teaches that the liner/cover may be a layer/film comprising silicone, a silicone elastomer or other substance that is expansible and resilient to degradation ([0059] and [0084]). Fulton also teaches other embodiments wherein nitinol is explicitly cited as a material that can be used for the mesh frame (for example, see paragraphs [0059], [0078], [0087]) and it is implicit that the braided mesh in Figures 13B-C and 16 may also be made of Nitinol. Fulton, however does not specifically teach that the self-expandable frame comprises a micropatterned Nitinol film in the embodiments of Figures 13B-C and 16.
However, the used of micropatterned Nitinol film covered by a polymeric film is well known in the art of implantable stents. For example, Marton teaches a micropatterned Nitinol film (abstract) that is covered by a polymeric liner [0040], and teaches that this configuration allows the stent material to be high-strength and superelastic (Abstract). It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant application to modify Fulton’s mesh stent to be made of micropatterned Nitinol film and a liner comprising a polymeric film, as suggested by Marton, in order to provide a stent that is durable and superelastic.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Fulton in view of Valley et al. (US 5,795,325).
With respect to Claim 13, Fulton teaches the perfusion stent of claims 1 and 11 (see above), and further teaches that a plurality of position markers may be provided at proximal 119 and distal 118 ends of the device (Figure 16; paragraph [0091]). Fulton, however, teaches that the position markers are radiopaque markers, and therefore does not specifically teach that the markers are a passive or active electromagnetic wave emitter.
Valley teaches a catheter for insertion into the vasculature of a patient, wherein the catheter comprises a metallic or magnetic marker thereon for detecting the position of the catheter tip using a Hall effect proximity detector or magnetometer (Column 34, Lines 53-58). Hall teaches that the use of non-fluoroscopic imaging has the potential for simplifying the catheter placement procedure and the equipment needed in the operating room (Column 34, Lines 49-53). Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant application to modify Fulton’s perfusion stent to have a positioning marker that comprises passive or active electromagnetic wave emitter, as suggested by Valley, in order to provide a well-known alternate means for detecting the position of the stent within the body, and to simplify the catheter placement procedure and the equipment needed in the operating room (Column 34, Lines 49-53).
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 § 2146 et seq. 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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
Claims 1-23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 11,559,055. Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets are drawn to a perfusion stent comprising a radially compressible/expandable elongated body, a perfusion space, a central lumen, a perfusion lumen, wherein when the elongated bod is expanded the central lumen is fluidly separated from the perfusion space within the body, and a proximal end of the elongated body is connected to a recovery wire.
The instant claims are broader than the ‘055 claims because they do not specifically require that the first and second end portions comprise a cylindrical first section and a tapered second section positioned proximal to the first section when in the radially expanded state.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Hochareon (US 2012/0302995) teaches a system and method for localized delivery and removal of a therapeutic substance using a balloon catheter.
Nitzan (US 10,149,684) teaches a system and method for removing fluid from a targeted region of the body.
Anaya Fernandez de Lomana (US 5,505,701) teaches a catheter system for perfusion of a visceral organ.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Philip R Wiest whose telephone number is (571)272-3235. The examiner can normally be reached M-F 9-6 EST.
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/PHILIP R WIEST/Primary Examiner, Art Unit 3781