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 .
Specification
The disclosure is objected to because of the following informalities:
The title of the invention as submitted in the Application Data Sheet filed 7/19/2024 is “Method for Using Rail Anchor System for Transjugular Intrahepatic Protosystemic Shunt Procedure”, which appears to contain a spelling error since the Specification filed 7/19/2025 comprises the title “Method for Using Rail Anchor System for Transjugular Intrahepatic Portosystemic Shunt Procedure”. It is recommended that the title of the application be amended to reflect the correct spelling of “Portosystemic”.
PP [0038] and [0039] appears to have an incorrect paragraph break in the middle of a sentence, since PP [0038] ends on “The inner rail may include” and PP [0039] begins with “none or one or more features…”. The paragraph break should be amended such that PP [0038] and [0039] are a singular paragraph, and each of the subsequent paragraph numbers should be amended to reflect this change.
Appropriate correction is required.
Claim Objections
Claims 1, 5-7, 8-11, 13-15, and 17-18 are objected to because of the following informalities:
Claim 1, line 4: “a stiff rail line including inflatable balloon” is missing an article and should be amended to “a stiff rail line including an inflatable balloon” instead.
Claims 8-10: these claims recite “the aperture”, yet claim 7 presents “at least one aperture”. It is recommended that the claims be amended to reflect the language of claim 7, which they depend from, to recite “wherein the at least one aperture” instead.
Claim 11, line 4: “a stiff rail line including inflatable balloon” is missing an article and should be amended to “a stiff rail line including an inflatable balloon” instead.
Claim 17, line 1: “repeated portal venography’s” is grammatically incorrect. It is recommended that the correct plural form of venography be used and the claim be amended to “repeated portal venographies” instead.
Claim 18, line 4: “a stiff rail line including inflatable balloon” is missing an article and should be amended to “a stiff rail line including an inflatable balloon” instead.
Claims 1, 5-7, 9-11, 13-15, and 18: the terms “the stiff rail line”, “the rail line”, and “the rail” are used throughout these claims to refer to the same structure. It is recommended that the naming scheme be standardized such that each and every instance recite “the stiff rail line” instead, as set forth in the early lines of each independent claim.
Appropriate correction is required.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include any reference signs mentioned in the description. 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.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 2 and 15 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 2 and 15 each recite “wherein the stiff rail line includes a lumen sufficiently sized and configured to only allow the passage of a gaseous or liquid substance therethrough”, however there is no support for this limitation in the present specification which only describes “The inner rail 302 may include a balloon catheter for executing wedge venography by discharging a gas or contrast through the balloon catheter while a balloon 402 of the balloon catheter is inflated” (PP [0041]). There is no support for a stiff rail line that is configured to only allow the passage of a gaseous or liquid substance, only that the stiff rail line is able to provide passage to a gas or liquid contrast. It is recommended that the claim be amended to remove the word “only”.
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.
The factual inquiries 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-4, 6-13, and 15-18 are rejected under 35 U.S.C. 103 as being unpatentable over DeCicco et al. (US PGPub 2016/0015422 A1) in view of Naumann et al. (US PGPub 2015/0141836 A1).
With respect to claim 1, DeCicco et al. discloses a method of performing a transjugular intrahepatic portosystemic shunt procedure (abstract), comprising the steps of:
providing a medical device (see Figs. 17-18), comprising:
a stiff rail line (1701) including inflatable balloon (1751 and 1753) positioned proximal to a terminal distal end of the rail line (see Fig. 18, 1751 and 1753 are proximal to the distal end);
providing at least one TIPS needle (1725);
advancing and positioning the rail line (1701) within a targeted area surrounding hepatic vein tissue (see Fig. 6, this device is comparable in method to the embodiment of Figs. 17-18); and
advancing the TIPS needle (1725 in Fig. 18, see comparable needle 404 in Fig. 6) alongside the rail (1701 in Figs. 17-18, 1725 extends alongside an inner surface of 1705) toward the hepatic vein tissue (see Fig. 6, this device is comparable to the embodiment of Figs. 17-18),
wherein the stiffness of the rail line (1701 in Figs. 17-18) is configured to allow the TIPS needle (1725) to advance toward the targeted area (see MPEP 2112.01, see Fig. 6),
wherein the stiffness of the rail line (1701 in Figs. 17-18) is configured to allow a distal end of the TIPS needle (1725) to extend to expose the distal end portion of the TIPS needle (1725) to the surrounding hepatic vein tissue for piercing (see Fig. 6), and
wherein the balloon (1751 and 1753) is configured to selectively anchor the rail line (1701) to the targeted area by the balloon being inflated, and unanchor the rail line (1701) to the targeted area by the balloon (1751 and 1753) being deflated (PP [0083]: “First balloon 1751 and a second balloon 1753 provide beneficial stabilizing functionality to aid in effective creation of an intrahepatic shunt”, by stabilizing 1701 in place the balloon can anchor or unanchor it).
However, DeCicco et al. fails to disclose:
providing a sheath with a singular lumen;
advancing the sheath over the stiff rail line;
advancing the TIPS needle within the singular lumen of the sheath;
wherein the stiffness of the rail line is configured to allow the advancement and retraction of the outer sheath over the rail line,
wherein the stiffness of the rail line is configured to allow the TIPS needle to advance through a sheath bareback without kinking or piercing the sheath, and further is configured to allow a distal end of the TIPS needle to extend beyond a distal end of the sheath,
wherein the balloon is configured to be inflated outside of the sheath.
In the same field of transjugular intrahepatic portosystemic shunt procedures (abstract), Naumann et al. teaches an assembly (see Figs. 23a-b) including a needle guide sheath (2100, also referred to as an NGS by the disclosure) comprising an anchoring balloon (810) and a needle (2107). Naumann et al. further teaches wherein the assembly includes an outer sheath (PP [0110]: “the NGS may include may include an introducer with a guidewire lumen that allows the NGS to be advanced over the guidewire into the appropriate position (not shown)”), wherein the balloon (810) is configured to be inflated outside of the sheath (see Fig. 23A, 810 is inflated outside of the sheath as it is not shown).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified the DeCicco et al. method to further incorporate the outer introducer sheath of Naumann et al. such that the sheath is advanced over the rail line (the sheath is advanced during insertion), the TIPS needle advances within the sheath (the needle of DeCicco et al. would advance within the rail line which would be within the introducer of Naumann et al. in the combination as proposed), wherein the stiffness of the rail line is configured to allow the advancement and retraction of the outer sheath over the rail line (see MPEP 2112.01, the stiff rail line of DeCicco et al. is configured to allow the advancement and retraction of the outer sheath of Naumann et al.), wherein the stiffness of the rail line is configured to allow the TIPS needle to advance through a sheath bareback without kinking or piercing the sheath, and further is configured to allow a distal end of the TIPS needle to extend beyond a distal end of the sheath (see MPEP 2112.01, in the combination as proposed, the needle of DeCicco et al. can advance through both the rail line and the sheath of Naumann et al.). One of ordinary skill in the art would have been motivated to perform this modification because it involves applying a known technique (the use of an outer introducer sheath in transjugular intrahepatic portosystemic shunt procedures) to a similar method (the TIPS procedure as taught by DeCicco et al.) ready for improvement to yield predictable results.
Regarding claim 2, DeCicco et al. as modified by Naumann et al. further discloses wherein the stiff rail line (1701 in Figs. 17-18) includes a lumen (1901 in Fig. 19 of DeCicco et al.) sufficiently sized and configured to only allow the passage of a gaseous or liquid substance therethrough (see MPEP 2112.01, 1901 is sufficiently sized and configured to let gaseous/liquid substances therethrough before the needle 1725 is inserted, note that the claim does not positively recite a method including passing gaseous or liquid substance therethrough).
Regarding claim 3, DeCicco et al. as modified by Naumann et al. further discloses wherein a wedge venogram is possible when the balloon (1751 and 1753 in Figs. 17-20 of DeCicco et al.) is inflated within the targeted area surrounding the hepatic vein tissue (see MPEP 2112.01, a wedge venogram is possible through 1901 or via another device when the balloon is inflated, note that the claim does not positively recite a method step including performing a wedge venogram).
Regarding claim 4, DeCicco et al. as modified by Naumann et al. further discloses wherein portal venography is possible when the balloon (1751 and 1753 in Figs. 17-20 of DeCicco et al.) is inflated within the targeted area surrounding the hepatic vein tissue (see MPEP 2112.01, portal venography is possible through 1901 or via another device when the balloon is inflated, note that the claim does not positively recite a method step including performing portal venography, PP [0084]: “Imaging sensor 1707 can view portal vein, aiding a practitioner in creating a shunt. In certain embodiments, sensor 1707 includes one or more IVUS transducers for taking intravascular images via ultrasound”).
Regarding claim 6, DeCicco et al. as modified by Naumann et al. further discloses wherein a dilator is advanceable over the rail line (1701 in Figs. 17-18 of DeCicco et al., see MPEP 2112.01, a dilator is advanceable over the rail line 1705, please note that the claim does not positively recite a method step comprising advancing a dilator over the rail line).
Regarding claim 7, DeCicco et al. as modified by Naumann et al. further discloses wherein the stiff rail line includes a lumen (DeCicco et al. PP [0085]: “FIG. 19 gives a cross-section view of device 1701 showing a first inflation lumen 1907 for inflating first balloon 1751, second inflation lumen 1913 for inflating second balloon 1753, and needle lumen 1901, which lumens extend through the catheter of device 1701”) and at least one aperture (1723) and that intersects with the lumen (1901 in Figs. 19-20).
Regarding claim 8, DeCicco et al. as modified by Naumann et al. further discloses wherein the aperture (1723 in Figs. 17-18 of DeCicco et al.) is sufficiently sized to allow passage of the TIPS needle therethrough (see 1725 extend through 1723 in Fig. 17).
Regarding claim 9, DeCicco et al. as modified by Naumann et al. fails to disclose wherein the aperture is approximately 4cm from the terminal distal end of the rail line.
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified the combination as proposed such that the aperture is approximately 4cm from the terminal distal end of the rail line
since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” (Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984)). In the instant case, the device of DeCicco et al. would not operate differently with the claimed distance between the aperture and the terminal distal end of the rail line since the aperture (1723 in Fig. 17) is already distanced from the terminal distal end of the rail line. Furthermore, the present disclosure does not present any statements of criticality regarding this distance, stating only that “Such an aperture may be approximately 4cm from the distal end of the catheter/sheath” (PP [0064, emphasis added).
Regarding claim 10, DeCicco et al. as modified by Naumann et al. further discloses wherein the aperture (1723 in Figs. 17-18 of DeCicco et al.) is provided superior to the balloon (1751 and 1753, 1723 is distal to a proximal end of the balloon therefore it is superior to the balloon) on the rail line (1701).
With respect to claim 11, DeCicco et al. discloses a method of performing a transjugular intrahepatic portosystemic shunt procedure (abstract), comprising the steps of:
providing a medical device (see Figs. 17-18), comprising:
a stiff rail line (1701) including inflatable balloon (1751 and 1753) positioned proximal to a terminal distal end of the rail line (1701, see Fig. 18);
providing at least one TIPS needle (1725);
advancing and positioning the rail line (1701) within a targeted area surrounding hepatic vein tissue (see Fig. 6 showing placement of comparable embodiment);
inflating the balloon (1751 and 1753) at the targeted area (see Figs. 19-20 showing balloons inflated within hepatic artery 149);
advancing the TIPS needle (1725) alongside the rail (1701, 1725 is advanced alongside the inner lumen 1901 of rail 1701) toward the hepatic vein tissue (PP [0083]: “Needle 1725 preferably provides a lateral reach (LR) of at least 1 cm. This allows needle 1725 to reach portal vein 145”); and
puncturing the hepatic vein tissue and entering a targeted area within a portal vein (PP [0084]: “Needle 1725 is extended from apparatus 1701 and used to cross the tissue between portal vein 145 and hepatic vein 149, thus creating a shunt. The needle 1725 is extended from catheter device 1701 and used to puncture the liver from a central portion of the hepatic vein 149 while first balloon 1751 and a second balloon 1753 brace the device 1701 therein”);
wherein the stiffness of the rail line (1701) is configured to allow the TIPS needle (1725) to advance,
wherein the stiffness of the rail line (1701) is configured to allow a distal end of the TIPS needle (1725) to extend to expose the distal end portion of the TIPS needle (1725) to the surrounding hepatic vein tissue for piercing (PP [0084]: “Needle 1725 is extended from apparatus 1701 and used to cross the tissue between portal vein 145 and hepatic vein 149, thus creating a shunt. The needle 1725 is extended from catheter device 1701 and used to puncture the liver from a central portion of the hepatic vein 149 while first balloon 1751 and a second balloon 1753 brace the device 1701 therein”), and
wherein the balloon (1751 and 1753) is configured to selectively anchor the rail line (1701) to the surrounding hepatic vein tissue by the balloon (1751 and 1753) being inflated, and unanchor the rail line (1701) to the surrounding hepatic vein tissue by the balloon (1751 and 1753) being deflated (see Figs. 19-20 with balloons inflated anchoring the device in hepatic artery 149 surrounding the hepatic vein tissue).
However, DeCicco et al. fails to disclose:
providing a sheath with a singular lumen;
advancing the sheath over the stiff rail line;
advancing the TIPS needle within the singular lumen of the sheath;
wherein the stiffness of the rail line is configured to allow the advancement and retraction of the outer sheath over the rail line,
wherein the stiffness of the rail line is configured to allow the TIPS needle to advance through a sheath bareback without kinking or piercing the sheath, and further is configured to allow a distal end of the TIPS needle to extend beyond a distal end of the sheath,
wherein the balloon is configured to be inflated outside of the sheath.
In the same field of transjugular intrahepatic portosystemic shunt procedures (abstract), Naumann et al. teaches an assembly (see Figs. 23a-b) including a needle guide sheath (2100, also referred to as an NGS by the disclosure) comprising an anchoring balloon (810) and a needle (2107). Naumann et al. further teaches wherein the assembly includes an outer sheath (PP [0110]: “the NGS may include may include an introducer with a guidewire lumen that allows the NGS to be advanced over the guidewire into the appropriate position (not shown)”), wherein the balloon (810) is configured to be inflated outside of the sheath (see Fig. 23A, 810 is inflated outside of the sheath as it is not shown).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified the DeCicco et al. method to further incorporate the outer introducer sheath of Naumann et al. such that the sheath is advanced over the rail line (the sheath is advanced during insertion), the TIPS needle advances within the sheath (the needle of DeCicco et al. would advance within the rail line which would be within the introducer of Naumann et al. in the combination as proposed), wherein the stiffness of the rail line is configured to allow the advancement and retraction of the outer sheath over the rail line (see MPEP 2112.01, the stiff rail line of DeCicco et al. is configured to allow the advancement and retraction of the outer sheath of Naumann et al.), wherein the stiffness of the rail line is configured to allow the TIPS needle to advance through a sheath bareback without kinking or piercing the sheath, and further is configured to allow a distal end of the TIPS needle to extend beyond a distal end of the sheath (see MPEP 2112.01, in the combination as proposed, the needle of DeCicco et al. can advance through both the rail line and the sheath of Naumann et al.). One of ordinary skill in the art would have been motivated to perform this modification because it involves applying a known technique (the use of an outer introducer sheath in transjugular intrahepatic portosystemic shunt procedures) to a similar method (the TIPS procedure as taught by DeCicco et al.) ready for improvement to yield predictable results.
Regarding claim 12, DeCicco et al. as modified by Naumann et al. further discloses wherein a wedge venogram is possible when the balloon (1751 and 1753 in Figs. 17-20 of DeCicco et al.) is inflated within the targeted area surrounding the hepatic vein tissue (see MPEP 2112.01, a wedge venogram is possible through 1901 or via another device when the balloon is inflated, note that the claim does not positively recite a method step including performing a wedge venogram).
Regarding claim 13, DeCicco et al. as modified by Naumann et al. further discloses wherein a dilator is advanceable over the rail line (1701 in Figs. 17-18 of DeCicco et al., see MPEP 2112.01, a dilator is advanceable over the rail line 1705, please note that the claim does not positively recite a method step comprising advancing a dilator over the rail line).
Regarding claim 15, DeCicco et al. as modified by Naumann et al. further discloses wherein the stiff rail line (1701 in Figs. 17-18) includes a lumen (1901 in Fig. 19 of DeCicco et al.) sufficiently sized and configured to only allow the passage of a gaseous or liquid substance therethrough (see MPEP 2112.01, 1901 is sufficiently sized and configured to let gaseous/liquid substances therethrough before the needle 1725 is inserted, note that the claim does not positively recite a method including passing gaseous or liquid substance therethrough).
Regarding claim 16, DeCicco et al. as modified by Naumann et al. further discloses wherein portal venography is possible when the balloon (1751 and 1753 in Figs. 17-20 of DeCicco et al.) is inflated within the targeted area surrounding the hepatic vein tissue (see MPEP 2112.01, portal venography is possible through 1901 or via another device when the balloon is inflated, note that the claim does not positively recite a method step including performing portal venography, PP [0084]: “Imaging sensor 1707 can view portal vein, aiding a practitioner in creating a shunt. In certain embodiments, sensor 1707 includes one or more IVUS transducers for taking intravascular images via ultrasound”).
Regarding claim 17, DeCicco et al. as modified by Naumann et al. further discloses wherein repeated portal venography’s are possible when the balloon (1751 and 1753 in Figs. 17-20 of DeCicco et al.) is inflated within the targeted area surrounding the hepatic vein tissue (see MPEP 2112.01, repeated portal venography is possible through 1901 or via another device when the balloon is inflated, note that the claim does not positively recite a method step including performing repeated portal venography, PP [0084]: “Imaging sensor 1707 can view portal vein, aiding a practitioner in creating a shunt. In certain embodiments, sensor 1707 includes one or more IVUS transducers for taking intravascular images via ultrasound”).
With respect to claim 18, DeCicco et al. discloses a method of performing a transjugular intrahepatic portosystemic shunt procedure (abstract), comprising the steps of:
providing a medical device (see Figs. 17-18), comprising:
a stiff rail line (1701) including inflatable balloon (1751 and 1753) positioned proximal to a terminal distal end of the rail line (1701);
providing at least one TIPS needle (1725);
advancing and positioning the rail line (1701) within a targeted area surrounding hepatic vein tissue (see Fig. 6 showing placement of comparable embodiment);
inflating the balloon (1751 and 1753) at the targeted area (see Figs. 19-20 showing balloons inflated within hepatic artery 149);
advancing the TIPS needle (1725) alongside the rail (1701, 1725 advanced alongside the inner lumen of the rail) toward the hepatic vein tissue (PP [0083]: “Needle 1725 preferably provides a lateral reach (LR) of at least 1 cm. This allows needle 1725 to reach portal vein 145”); and
puncturing the hepatic vein tissue and entering a targeted area within a portal vein (PP [0084]: “Needle 1725 is extended from apparatus 1701 and used to cross the tissue between portal vein 145 and hepatic vein 149, thus creating a shunt. The needle 1725 is extended from catheter device 1701 and used to puncture the liver from a central portion of the hepatic vein 149 while first balloon 1751 and a second balloon 1753 brace the device 1701 therein”);
wherein the stiffness of the rail line (1701) is configured to allow the TIPS needle (1725) to advance,
wherein the stiffness of the rail line (1701) is configured to allow a distal end of the TIPS needle (1725) to extend to expose the distal end portion of the TIPS needle (1725) to the surrounding hepatic vein tissue for piercing (PP [0084]: “Needle 1725 is extended from apparatus 1701 and used to cross the tissue between portal vein 145 and hepatic vein 149, thus creating a shunt. The needle 1725 is extended from catheter device 1701 and used to puncture the liver from a central portion of the hepatic vein 149 while first balloon 1751 and a second balloon 1753 brace the device 1701 therein”), and
wherein the balloon (1751 and 1753) is configured to selectively anchor the rail line (1701) to the surrounding hepatic vein tissue by the balloon (1751 and 1753) being inflated, and unanchor the rail line (1701) to the surrounding hepatic vein tissue by the balloon (1751 and 1753) being deflated (see Figs. 19-20 with balloons inflated anchoring the device in hepatic artery 149 surrounding the hepatic vein tissue).
wherein portal venography is possible when the balloon (1751 and 1753 in Figs. 17-20) is inflated within the targeted area surrounding the hepatic vein tissue (see MPEP 2112.01, portal venography is possible through 1901 or via another device when the balloon is inflated, note that the claim does not positively recite a method step including performing portal venography, PP [0084]: “Imaging sensor 1707 can view portal vein, aiding a practitioner in creating a shunt. In certain embodiments, sensor 1707 includes one or more IVUS transducers for taking intravascular images via ultrasound”), and
wherein a wedge venogram is possible when the balloon (1751 and 1753 in Figs. 17-20) is inflated within the targeted area surrounding the hepatic vein tissue (see MPEP 2112.01, a wedge venogram is possible through 1901 or via another device when the balloon is inflated, note that the claim does not positively recite a method step including performing a wedge venogram).
However, DeCicco et al. fails to disclose:
providing a sheath with a singular lumen;
advancing the sheath over the stiff rail line;
advancing the TIPS needle within the singular lumen of the sheath;
wherein the stiffness of the rail line is configured to allow the advancement and retraction of the outer sheath over the rail line,
wherein the stiffness of the rail line is configured to allow the TIPS needle to advance through a sheath bareback without kinking or piercing the sheath, and further is configured to allow a distal end of the TIPS needle to extend beyond a distal end of the sheath,
wherein the balloon is configured to be inflated outside of the sheath.
In the same field of transjugular intrahepatic portosystemic shunt procedures (abstract), Naumann et al. teaches an assembly (see Figs. 23a-b) including a needle guide sheath (2100, also referred to as an NGS by the disclosure) comprising an anchoring balloon (810) and a needle (2107). Naumann et al. further teaches wherein the assembly includes an outer sheath (PP [0110]: “the NGS may include may include an introducer with a guidewire lumen that allows the NGS to be advanced over the guidewire into the appropriate position (not shown)”), wherein the balloon (810) is configured to be inflated outside of the sheath (see Fig. 23A, 810 is inflated outside of the sheath as it is not shown).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified the DeCicco et al. method to further incorporate the outer introducer sheath of Naumann et al. such that the sheath is advanced over the rail line (the sheath is advanced during insertion), the TIPS needle advances within the sheath (the needle of DeCicco et al. would advance within the rail line which would be within the introducer of Naumann et al. in the combination as proposed), wherein the stiffness of the rail line is configured to allow the advancement and retraction of the outer sheath over the rail line (see MPEP 2112.01, the stiff rail line of DeCicco et al. is configured to allow the advancement and retraction of the outer sheath of Naumann et al.), wherein the stiffness of the rail line is configured to allow the TIPS needle to advance through a sheath bareback without kinking or piercing the sheath, and further is configured to allow a distal end of the TIPS needle to extend beyond a distal end of the sheath (see MPEP 2112.01, in the combination as proposed, the needle of DeCicco et al. can advance through both the rail line and the sheath of Naumann et al.). One of ordinary skill in the art would have been motivated to perform this modification because it involves applying a known technique (the use of an outer introducer sheath in transjugular intrahepatic portosystemic shunt procedures) to a similar method (the TIPS procedure as taught by DeCicco et al.) ready for improvement to yield predictable results.
Claims 5 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over DeCicco et al. (US PGPub 2016/0015422 A1) in view of Naumann et al. (US PGPub 2015/0141836 A1), as applied to claims 1 and 11 above, and further in view of Toth et al. (US PGPub 2015/0289929 A1).
Regarding claims 5 and 14, DeCicco et al. as modified by Naumann et al. fails to disclose wherein the rail line includes one or more hooks at a distal end of for alternatively anchoring the rail line to the targeted area surrounding the hepatic vein tissue.
In the relevant field of balloon catheters (abstract), relevant in that balloon catheters are also related to passing instruments to a target area, Toth et al. teaches a catheter comprising an anchoring balloon (PP [0157]: “the system may include one or more stabilizing members (e.g. a balloon, an anchor, a curved leg, etc.) coupled to the elongate member, configured to brace and/or position one or more regions of the elongate member near to or against the wall of a lumen during use”, PP [0159]: “In aspects, one or more stabilizing members may include a balloon, the balloon configured so as to take on a deployed shape”) and further comprising one or more hooks (PP [0160]: “In aspects, one or more of the stabilizing members may include a flexible member, coupled to the elongate member, optionally deployable therefrom during use (i.e. via use of a retractable sheath, by an actuation mechanism in accordance with the present disclosure, etc.). Some non-limiting examples of flexible members include coils, hooks, clips, leaf spring elements, mesh, netting, bistable forms, cantilever beams, and the like”) for anchoring the catheter to surrounding tissue.
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have further modified the combination of DeCicco et al. and Naumann et al. to incorporate the teachings of Toth et al. and include one or more hooks on the rail line for anchoring into the surrounding hepatic tissue. One of ordinary skill in the art would have been motivated to perform this modification because Toth et al. teaches the simultaneous use of anchoring balloons and anchoring hooks (see PP [0159-0160]) and one of ordinary skill in the art would have recognized that the balloon of DeCicco et al. could be further improved by the anchoring hooks of Toth et al. since Toth et al. teaches they can provide additional stability to the balloon during placement (see PP [0160] of Toth et al.).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Bridget E. Rabaglia whose telephone number is (571)272-2908. The examiner can normally be reached Monday - Thursday, 7am - 5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached at (571) 272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/BRIDGET E. RABAGLIA/Examiner, Art Unit 3771 /TAN-UYEN T HO/Supervisory Patent Examiner, Art Unit 3771