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 .
Status of the Claims
The amendment filed 10/27/2025 has been entered. At entry, claims 1-10, 12-20 and 22 are pending and under consideration.
Response to Arguments
In response to applicant’s argument, see pages 6-7, with respect 35 USC 103 rejections have been considered and are at least partially persuasive, but are moot in light of new rejection/interpretation.
Claim Objections
Claims 20 and 22 are objected to because of the following informalities:
Claim 20 line 15 recites “the outer surface” which should read “an outer surface”
Claim 20 line 17 recites “the cylindrical saddle region” which should read “a cylindrical saddle region”
Claim 22 line 2 recites “assymetrical” which should read “asymmetrical”
Appropriate correction is required.
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.
Claims 1-9, 12-19 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Binmoeller (US 20160135941 A1) in view of Gianotti (US 20040098077 A1).
Regarding Claim 1, Binmoeller teaches claim 1 and the claims dependent therefrom, Binmoeller substantially teaches applicant’s claimed invention, and specifically discloses a device with every structural limitation of applicant’s claimed invention (except for the limitations shown in italics and grayed-out) including:
a medical device (figure 3, stent 100), comprising:
an elongate tubular body (figure 3 and [0036], stent 100 comprises a body formed from woven filament braid) formed of one or more woven filaments having a constrained configuration ([0024] “The stents can be self-expanding such that the stent expands from a constrained tubular position to the expanded configurations”),
the elongate tubular body ([0024] the stent body 100 having expanded configuration, for example as shown figure 2b when the device being deployed) having an expanded configuration with a proximal portion of the elongate tubular body expanded into a proximal retention member (figure 3 and [0024] and [0027] proximal portion including flange 106 in the expanded configuration), a distal portion of the elongate tubular body expanded into a distal retention member (figure 3, [0024] and [0027] distal portion including upstream flange 108), and a cylindrical saddle region (figure 3, saddle region 110) extending between the proximal and distal retention members ;and
a plurality of bumps disposed in a pattern around a circumference of the elongate tubular body at a junction between the distal retention member and the cylindrical saddle region,
wherein the proximal retention member, distal retention member and the cylindrical saddle region define an open interior passage configured to permit flow therethrough (figure 2b and [0049] passage formed within the stent body allows fluid flow therethrough).
Binmoeller does not teach the medical device comprising a plurality of bumps disposed in a pattern around a circumference of the elongate tubular body at a junction between the distal retention member and the cylindrical saddle region,
In the same field of endeavor, namely a stents with proximal and distal end elevations, Gianotti teaches a flexible self-expanding braided tubular wall (figure 3, 1) comprising a plurality of bumps (figure 3 [0030] plurality of outwardly formed elevations 12 disposed around a circumference of the tubular wall in annular pattern ) disposed in a pattern around a circumference of the elongate tubular body at a junction between the distal retention member and the cylindrical saddle region (figure 3 [0033], the elevations 12 are distributed regularly all over the body including a region between middle and distal end portion of the body).
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Binmoeller to incorporate the teachings of Gianotti and provides the plurality of bumps as claimed for the purpose of effectively anchoring the stent with the body vessel as taught by Gianotti ([0011]-[0013]).
Examiner’s note: the limitation “disposed, …, at a junction between the distal retention member and the cylindrical saddle region” does not exclude the tubular body having bumps other than the junction, i.e., distal, proximal, or saddle regions of the elongate tubular body, therefore, having bumps disposed regularly all over the tubular body, including junction, as taught by Gianotti, falls under the limitation above.
Furthermore, Binmoeller teaches the medical device comprising an uncovered area disposed at a junction between the distal retention member and the cylindrical saddle region (figure 8b, 154’) for the purpose of allowing tissue ingrowth that prevent migration of the stent ([0063]).
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Binmoeller to incorporate the teachings of Gianotti and provide the bumps at the junction for the purpose of enhancing anti-migration feature as taught by Gianotti ([0011]-[0013])
Regarding Claim 2, Binmoeller, as modified by Gianotti, teaches the medical device of Claim 1.
Binmoeller further teaches wherein the proximal retention member includes a single or double-walled flange structure (Binmoeller; figure 3, downstream flange 106 [0027] “Referring to FIG. 3, biliary stent 100 is shown in its radially expanded configuration. A double-walled downstream flange 106 may be formed at the downstream end 102 as shown”), and the distal retention member includes a flared flange structure (Binmoeller; figure 3, upstream flange 108 [0030] "gentle curves of flared upstream flange 108").
Regarding Claim 3, Binmoeller, as modified by Gianotti, teaches the medical device of Claim 1.
Binmoeller further teaches wherein a diameter of the proximal and distal retention members is larger than a diameter of the cylindrical saddle region (Binmoeller; [0027] "saddle region has a generally constant diameter that is smaller than a maximum diameter of both the downstream flange 106 and the upstream flange 108.").
Regarding Claim 4, Binmoeller, as modified by Gianotti, teaches the medical device of Claim 1.
Binmoeller further teaches wherein the cylindrical saddle region includes a constant outer diameter (Binmoeller; [0027] "saddle region has a generally constant diameter.")
Regarding Claim 5, Binmoeller, as modified by Gianotti, teaches the medical device of Claim 1.
Binmoeller does not teach wherein the cylindrical saddle region includes a varying outer diameter
However, In the same field of endeavor, namely a stent with elevations, Gianotti teaches (Gianotti; figure 3, at least middle portion of the tubular wall have varying outer diameter at elevation 7).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Binmoeller, as modified by Gianotti, to incorporate the teachings of Gianotti and the cylindrical saddle region includes a varying outer diameter, and one of skill in the art motivated to do so, for the purpose of securing the stent body to the vessel tissue without causing damage as taught by Gianotti ([0011]-[0013])
Regarding Claim 6, Binmoeller, as modified by Gianotti, teaches the medical device of Claim 1.
Binmoeller further teaches wherein a surface of the distal retention member is configured to contact a tissue wall of a second body lumen (Binmoeller; See figure 2b and [0027], surface of upstream flange contact a tissue wall of CBD).
Regarding Claim 7, Binmoeller, as modified by Gianotti, teaches the medical device of Claim 1.
Binmoeller further teaches wherein a surface of the proximal retention member is configured to contact a tissue wall of a first body lumen (Binmoeller; see figure 2b and [0027] , the downstream flange contact a wall of DO, surface of downstream flange contact a tissue wall of DO).
Regarding Claim 8, Binmoeller, as modified by Gianotti, teaches the medical device of Claim 1.
Binmoeller further teaches wherein the proximal retention member, distal retention member and saddle region are covered (Binmoeller; [0004] “The stent optionally includes a covering or membrane over the cylindrical saddle portion, which can extend over one or both of the upstream and downstream flanges”)
Regarding Claim 9, Binmoeller, as modified by Gianotti, teaches the medical device of Claim 1.
Binmoeller further teaches wherein the elongate tubular body is formed of a plurality of the one or more filaments (Binmoeller; [0036] “a body formed from a woven filament braid”), and a proximal end of the elongate tubular body includes adjacent filaments formed into looped ends. (Binmoeller; [0033] "In some embodiments the stents described herein can include a loop on either or both ends of the stent").
Regarding claim 12, Binmoeller teaches a medical device, comprising:
an elongate tubular body (figure 3 and [0036], stent comprises a body formed from woven filament braid) formed of one or more woven filaments having a constrained configuration,
the elongate tubular body having an expanded configuration ([0024] the stent body 100 having expanded configuration, for example as shown figure 2b when the device being deployed) with a proximal portion of the elongate tubular body expanded into a proximal retention member (figure 3, [0024] and [0027] the proximal portion including flange 16 in the expanded configuration), a distal portion of the elongate tubular body expanded into a distal retention member (figure 2, [0024] and [0027] distal portion including upstream flange 108 in the expanded configuration), and a cylindrical saddle region (figure 3, saddle region 110) extending between the proximal and distal retention members; and
a plurality of bumps disposed in a pattern around a circumference of the elongate tubular body at a junction between the distal retention member and the cylindrical saddle region,
wherein the proximal retention member, distal retention member and cylindrical saddle region define an open interior passage configured to permit flow therethrough (figure 2b and [0049] passage formed within the stent body allows fluid flow therethrough).
Binmoeller does not teach the medical device comprising a plurality of bumps disposed in a pattern around a circumference of the elongate tubular body at a junction between the distal retention member and the cylindrical saddle region,
In the same field of endeavor, namely a stents with proximal and distal end elevations, Gianotti teaches a flexible self-expanding braided tubular wall (figure 3, 1) a plurality of bumps (figure 3 [0030], plurality of outwardly formed elevations 12 disposed around a circumference of the tubular wall in annular pattern) disposed in a pattern around a circumference of the elongate tubular body at a junction between the distal retention member and the cylindrical saddle region (figure 3 [0033], the elevations 12 are distributed regularly all over the body).
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Binmoeller to incorporate the teachings of Gianotti and provides the plurality of bumps as claimed for the purpose of effectively anchoring the stent with the body vessel as taught by Gianotti ([0011]-[0013]). Examiner’s note: the limitation “disposed, …, at a junction between the distal retention member and the cylindrical saddle region” does not exclude the tubular body having bumps other than the junction, i.e., distal or proximal portion of the elongate tubular body, therefore, having bumps disposed regularly over the tubular body falls under the limitation above.
Furthermore, Binmoeller teaches the medical device comprising an uncovered area disposed at a junction between the distal retention member and the cylindrical saddle region (figure 8b, 154’) for the purpose of allowing tissue ingrowth that prevent migration of the stent ([0063]).
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Binmoeller to incorporate the teachings of Gianotti and provide the bumps at the junction for the purpose of enhancing anti-migration feature as taught by Gianotti ([0011]-[0013])
Regarding Claim 13, Binmoeller, as modified by Gianotti, teaches the medical device of Claim 12.
Binmoeller further teaches wherein the proximal retention member includes a single or double-walled flange structure (Binmoeller; figure 3, downstream flange 106 [0027] “Referring to FIG. 3, biliary stent 100 is shown in its radially expanded configuration. A double-walled downstream flange 106 may be formed at the downstream end 102 as shown”), and the distal retention member includes a flared flange structure (Binmoeller; figure 3, upstream flange 108 [0030] "gentle curves of flared upstream flange 108").
Regarding Claim 14, Binmoeller, as modified by Gianotti, teaches the medical device of Claim 12.
Binmoeller further teaches wherein a diameter of the proximal and distal retention members is larger than a diameter of the cylindrical saddle region (Binmoeller; [0027] "saddle region has a generally constant diameter that is smaller than a maximum diameter of both the downstream flange 106 and the upstream flange 108.").
Regarding Claim 15, Binmoeller, as modified by Gianotti, teaches the medical device of Claim 12.
Binmoeller further teaches wherein the cylindrical saddle region includes a constant outer diameter (Binmoeller; [0027] "saddle region has a generally constant diameter.").
Regarding Claim 16, Binmoeller, as modified by Gianotti, teaches the medical device of Claim 12.
Binmoeller does not teach wherein the cylindrical saddle region includes a varying outer diameter
However, In the same field of endeavor, namely a stent with elevations, Gianotti teaches (Gianotti; figure 3, at least middle portion of the tubular wall have varying outer diameter at elevation 7).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Binmoeller, as modified by Gianotti, to incorporate the teachings of Gianotti and the cylindrical saddle region includes a varying outer diameter, and one of skill in the art motivated to do so, for the purpose of securing the stent body to the vessel tissue without causing damage as taught by Gianotti ([0011]-[0013])
Regarding Claim 17, Binmoeller, as modified by Gianotti, teaches the medical device of Claim 12.
Binmoeller further teaches wherein a surface of the distal retention member is configured to contact a tissue wall of a second body lumen (Binmoeller; See figure 2b and [0027] , surface of upstream flange contact a tissue wall of CBD).
Regarding Claim 18, Binmoeller, as modified by Gianotti, teaches the medical device of Claim 12.
Binmoeller further teaches wherein a surface of the proximal retention member is configured to contact a tissue wall of a first body lumen (Binmoeller; see figure 2b and [0027] , the downstream flange contact a wall of DO, surface of downstream flange contact a tissue wall of DO).
Regarding Claim 19, Binmoeller, as modified by Gianotti, teaches the medical device of Claim 12.
Binmoeller further teaches wherein the proximal retention member, distal retention member and saddle region are covered (Binmoeller; [0004] “The stent optionally includes a covering or membrane over the cylindrical saddle portion, which can extend over one or both of the upstream and downstream flanges”).
Regarding claim 22, Binmoeller, as modified by Gianotti, teaches the medical device of Claim 1.
The combination does not teach wherein the pattern is asymmetrical.
However, in an alternate embodiment of Gianotti (figure 2) teaches wherein the pattern is asymmetrical (figure 1, helical pattern 7, examiner’s note the helical pattern is asymmetrical along radial axis).
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Binmoeller, as modified by Gianotti, to incorporate the teachings of the alternate embodiment of Gianotti and provide the pattern as claimed for the purpose of providing a greater stability of the braided tubular wall, i.e, parallel wires will be prevented from moving apart at the crossing points as taught by Gianotti ([0029]).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Binmoeller (US 20160135941 A1) in view of Gianotti (US 20040098077 A1), and in further view of Gill (US 20140277573 A1)
Regarding Claim 10, Binmoeller, as modified by Gianotti, teaches the medical device of Claim 1.
The combination further teaches wherein the elongate tubular body is formed of a plurality of the one or more filaments (Binmoeller; [0036] “a body formed from a woven filament braid”) and a proximal end of the elongate tubular body includes pointed free ends of the filaments (Binmoeller; at least figure 14 and [0073] illustrates cross section of stent and flange structure at proximal end including stent end 163 having open end)
The combination does not teach a proximal end of the elongate tubular body includes pointed free ends of the filaments.
However, In the same filed of endeavor, namely a stent, Gill teaches a stent comprising a proximal end (figure 5a, proximal end 102) includes pointed free ends of the filaments (figure 5a, free ends 513).
Gill provides the free ends at the proximal end of stent in order to weave the one or more strand in a given pattern in accordance with an appropriate braid design, i.e., structure comprising closed loop at one end and free end at the other end ([0028]). Such braid design allows fully automated braiding of the strand 112 ([0028]) while providing a closed loop at distal end 104, shown in figure 4, that distributes the expansive force of a stent acting on a body lumen when the stent is deployed ([0054]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Binmoeller, as modified by Gianotti, to incorporate the teachings of Gill and provides the proximal end includes pointed free end of the filaments, and one of skill in the art motivated to do so, for the purpose of weaving one or more filament in according with an appropriate braid design, i.e., one end having closed loop that distributes the expansive force of a stent acting on a body lumen when the stent is deployed, in fully automated braiding.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Sander (US 20090281557 A1) in view of Gianotti (US 20040098077 A1).
Regarding Claim 20, Sander teaches a method (figure 12a-f and[0056]-[0060]) comprising:
advancing a medical device into a first body lumen (figure 12e and [0060], advancing stent 150 into lumen of intestine), wherein the medical device includes an elongate tubular body having a first constrained configuration (constrain configuration as shown figure 12e) and a second expanded configuration (expanded configuration as shown figure 12f),
advancing the medical device into a second body lumen through an opening in the first body lumen (see figure 12e, advancing the stent 150 to lumen of gall bladder through intestine wall);
expanding a distal portion of the elongate tubular body to the second expanded configuration, such that a distal retention member of the elongate tubular body is deployed within the second body lumen (figure 12f, flange structure at distal portion of stent 150 anchored on GBW and [0060] " Preferably, the proximal and distal ends of the stent 150 will be expanded or flared to form relatively large flange regions 154"); and
expanding a proximal portion of the elongate tubular body to the second configuration, such that a proximal retention member of the elongate tubular body is deployed within the first body lumen (see figure 12f and [0060] flange region 154 anchored on GBW).
wherein an outer surface of the elongate tubular body includes a plurality of bumps disposed in a pattern around a circumference of the elongate tubular body at a junction between the distal retention member and a cylindrical saddle region.
Sander does not teach wherein the outer surface of the elongate tubular body includes a plurality of bumps disposed in a pattern around a circumference of the elongate tubular body at a junction between the distal retention member and the cylindrical saddle region.
In the same field of endeavor, namely a stents with proximal and distal end elevations, Gianotti teaches a flexible self-expanding braided tubular wall (figure 3, 1) a plurality of bumps (figure 3 [0030], plurality of outwardly formed elevations 12 disposed around a circumference of the tubular wall in annular pattern) disposed in a pattern around a circumference of the elongate tubular body at a junction between the distal retention member and the cylindrical saddle region (figure 3 [0033], the elevations 12 are distributed regularly all over the body.).
Examiner’s note: the limitation “disposed, …, at a junction between the distal retention member and the cylindrical saddle region” does not exclude the tubular body having bumps other than the junction, i.e., distal, proximal, or saddle regions of the elongate tubular body, therefore, having bumps disposed regularly all over the tubular body, including junction, as taught by Gianotti, falls under the limitation above.
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Sanders to incorporate the teachings of Gianotti and provides the plurality of bumps as claimed for the purpose of effectively anchoring the stent with the body vessel as taught by Gianotti ([0011]-[0013]).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SETH HAN whose telephone number is (571)272-2545. The examiner can normally be reached M-F 0900-1700.
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/S.H./Examiner, Art Unit 3781
/ANDREW J MENSH/Primary Examiner, Art Unit 3781
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