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 Claims
This office action is responsive to the amendment filed on 09/03/2026. As directed by the amendment: claims 1, 15 and 20 have been amended, no claims have been cancelled and no new claims have been added. Thus, claims 1-20 are presently pending in this application, and currently examined in the Office Action.
Terminal Disclaimer
The terminal disclaimer filed on 09/03/2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of US Patent Nos. 11,229,538 and 11,974,933 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Examiner’s Notes
As stated in the previous Office Action, claims 1-11 and 15-19 do not actively claim the “furcated stent”; therefore, the furcated stent/any structure associated with the furcated stent does not hold patentable weight and will only be considered to the extent that it further defines the structure of the claimed invention/device.
It is to be noted that in device/apparatus claims only the claimed structure of the final device bears patentable weight, and intended use/functional language is considered to the extent that it further defines the claimed structure of the final device (see MPEP 2114).
Examiner cites particular columns and line numbers in the references as applied to the claims below for the convenience of the applicant(s). Although the specified citations are representative of the teachings in the art and are applied to the specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested that, in preparing responses, the applicant(s) fully consider the references in entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the examiner.
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 1-12 and 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Blaeser et al. (US Patent No. 6,514,281), as previously disclosed, hereinafter Blaeser, in view of Duffy et al. (US PG Pub. 2009/0132019), as disclosed in the IDS dated 04/03/2024, hereinafter Duffy.
Regarding claims 1-4, 8, 10-12 and 19, Blaeser discloses a delivery system/kit (20), illustrated in Figures 2A-2D and 2F, comprising a furcated stent (210a), which is self-expanding or non-self-expanding, having a stem (216a) and two arms (214a & 212a), illustrated in Figure 2F (Column 10, Lines 7-17); a delivery catheter (22) comprising an elongated first tube (24), having proximal and distal ends, and a tubular furcated part (26 & 28) at the distal end configured to accommodate the two arms (214a & 212a); wherein tubular furcated part (26 & 28) includes two limbs (26 & 28), each of the two limbs is provided with a slit (30 & 32); the slit in each of the two limbs together form multiple slits (30 & 32) which form a passageway for passage therethrough of the furcated stent (210a), wherein the tubular furcated part (26 & 28) is configured to constrain radially the two arms (214a & 212a) when the passageway in the narrowed state and resist expansion of the furcated stent (210a) when the passageway in the narrowed state; the passageway has a narrowed state and a widened state, is biased in the narrowed state, and is configured for repeatable transition between the narrowed state and the widened state which is actuated by application of mechanical force between the passageway and the furcated stent, illustrated in Figures 2A-2D (Column 3, Lines 8-56 & Column 4, Lines 15-44); and further comprising an access catheter/guide catheter (156) configured for an over-the-wire, example illustrated in Figure 10A, including an elongated second tube having proximal and distal end regions provided with a second lumen adapted to slidably accommodate the first tube (24/142), and configured to control a gradual opening or folding of the tubular furcated part of the first tube responsive to slidable relative displacement of the first and second tubes, example illustrated in Figure 10A (Column 4, Lines 14-15; Column 8, Lines 60-63; Column 8, Line 64 – Column 9, Line 1 & Column 9, Lines 22-24 and 30-35); but does not teach the tubular furcated part is formed from a compliant elastically deformable material.
However, Duffy teaches a delivery system, in the same field of endeavor, comprising a delivery catheter (102) having an elongated first tube (104) and a tubular furcated part with two limbs (112&118), wherein each of the two limbs has a slit and forms a coiled configuration having a narrowed state and a widened state, illustrated in Figure 6, wherein the tubular furcated part/two limbs (112&118) is formed from a compliant elastically deformable material biased to the narrowed state, and configured to provide repeatable transition between the narrowed state and the widened state ([0046] & [0055], Lines 7-13).
In view of the teachings of Duffy, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention for the tubular furcated part, of the delivery system of Blaeser, to comprise/be formed from a compliant elastically deformable material which is biased to bias the passageway to the narrowed state and configured to provide the repeatable transition between the narrowed state and the widened state, in order to simplify the delivery system/process by forming the tubular furcated part from a compliant elastically deformable material, and thereby eliminating the need for the containment rings and elongate release member to transition between the narrowed and widened states, and allowing for, repeatable, elastic transitioning between the narrowed state and the widened state, as taught by Duffy, while still achieving the intended purpose of delivering the furcated stent; and it has been held to be within the general skill of one having ordinary skill in the art to select a known material on the basis of its suitability for the intended use (see MPEP 2144.07).
Regarding claims 5 and 6, Blaeser in view of Duffy disclose the delivery system according to claim 1, wherein Blaeser further teaches each slit (30 & 32) extends from each limb (26 & 28) in a proximal direction from a distal terminal end of the limb, and connects at its proximal end to at least one other slit to form the passageway, and the slit (30 & 32) has edges that are always detached from each other, illustrated in Figures 2A and 2D.
Regarding claim 7, Blaeser in view of Duffy disclose the delivery system according to claim 1, wherein Blaeser further teaches the two limbs (26 & 28) are joined at a joint and spread apart as the limbs extend in a distal direction, illustrated in Figures 2A and 2D.
Regarding claim 9, Blaeser in view of Duffy disclose the delivery system according to claim 1, wherein Blaeser further teaches the tubular furcated part (26 & 28) is formed of a compliant material (34) that provides the bias of the passageway in the narrowed state and the repeatable transition between the narrowed state and widened state, illustrated in Figures 2A-2D (Blaeser: Column 3, Lines 21-25, 52-56 & Column 4, Lines 20-27).
Regarding claims 17 and 18, Blaeser in view of Duffy disclose the delivery system according to claim 1, wherein Blaeser further teaches the delivery catheter (22) is for a bodily vessel (12/14/16), specifically an artery or vein, illustrated in Figures 1, 2A, 2C and 2D (Blaeser: Column 1, Lines 5-9).
Regarding claim 20, Blaeser discloses a delivery assembly, illustrated in Figures 2A-2D and 2F, comprising a furcated stent (210a) including a stem (216a) and first arms (214a & 212a), illustrated in Figure 2F (Column 10, Lines 7-17); a delivery catheter (22) comprising an elongated first tube (24), having proximal and distal ends, and a tubular furcated part (26 & 28) proximate the distal end of the first tube (24), wherein the tubular furcated part (26 & 28) includes second tubular arms (26 & 28), which are configured to receive the first arms (214a & 212a) of the furcated stent (210a); and each second tubular arm (26 & 28) includes a slit (30 & 32) extending substantially the length of the tubular second tubular arm, each slit (30 & 32) contacting at least one other slit thereby forming a passageway, wherein the tubular furcated part (26 & 28) is formed of a material (34) having a native state that both applies a bias to the furcated stent resisting expansion of the furcated stent and allows forward and reverse passage of the furcated stent through the passageway, wherein the passageway has a narrowed state during which the second tubular arms (26 & 28) extend circumferentially around a majority of the circumference of each of the first arms (214a & 212a), and wherein the second tubular arms are biased in the narrowed state, and a widened state formed by first arms forcing the passageway apart and the second arms extending circumferentially each of the first arms less than in the narrowed state, illustrated in Figures 2A-2D (Column 3, Lines 8-56 & Column 4, Lines 15-44); but does not teach the tubular furcated part is formed from a compliant elastically deformable material.
However, Duffy teaches a delivery system, in the same field of endeavor, comprising a delivery catheter (102) having an elongated first tube (104) and a tubular furcated part with two limbs (112&118), wherein each of the two limbs has a slit and forms a coiled configuration having a narrowed state and a widened state, illustrated in Figure 6, wherein the tubular furcated part/two limbs (112&118) is formed from a compliant elastically deformable material to form a native state which biased to the narrowed state ([0046] & [0055], Lines 7-13).
In view of the teachings of Duffy, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention for the tubular furcated part, of the delivery assembly of Blaeser, to comprise/be formed from a compliant elastically deformable material to form the native state and which biases the passageway towards the narrowed state, and is configured to provide repeatable transition between the narrowed state and the widened state, in order to simplify the delivery system/process by forming the tubular furcated part from a compliant elastically deformable material, and thereby eliminating the need for the containment rings and elongate release member to transition between the narrowed and widened states, and allowing for elastic transitioning between the narrowed state and the widened state, as taught by Duffy, while still achieving the intended purpose of delivering the furcated stent; and it has been held to be within the general skill of one having ordinary skill in the art to select a known material on the basis of its suitability for the intended use (see MPEP 2144.07).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Blaeser in view of Duffy as applied to claim 12 above, and further in view of Penn et al. (US Patent No. 5,755,771), as previously disclosed, hereinafter Penn.
Regarding claim 13, Blaeser in view of Duffy disclose the delivery system according to claim 12, but do not specifically teach the furcated stent is provided with an elutable active pharmaceutical ingredient.
However, Penn teaches a furcated stent, in the same field of endeavor, which is provided with an elutable active pharmaceutical ingredient, in order to reduce thrombogenicity and/or provide anticoagulation (Column 4, Lines 61-67).
In view of the teachings of Penn, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention for the furcated stent, of the delivery system of Blaeser in view of Duffy, to be provided with an elutable active pharmaceutical ingredient, in order to reduce thrombogenicity and/or provide anticoagulation, as taught by Penn.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Blaeser in view of Duffy as applied to claim 12 above, and further in view of McHugo (US PG Pub. 2011/0313505), as previously disclosed.
Regarding claim 14, Blaeser in view of Duffy disclose the delivery system according to claim 12, but do not specifically teach the furcated stent is prepared by laser cutting or braiding.
However, McHugo teaches a furcated stent, in the same field of endeavor, which is prepared by laser cutting or braiding/weaving, illustrated in Figure 3 ([0028]).
In view of the teachings of McHugo, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention for the furcated stent, of the delivery system of Blaeser in view of Duffy, to be prepared by laser cutting or braiding/weaving, since these are well-known ways, in the art, of forming stents/furcated stents, as taught by Hugo.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Blaeser in view of Duffy as applied to claim 1 above, and further in view of Jordan et al. (US PG Pub. 2008/0262592), as previously disclosed, hereinafter Jordan.
Regarding claim 15, Blaeser in view of Duffy disclose the delivery system according to claim 1, but do not specifically teach a pusher having an elongated flexible rod and a capture element.
However, Jordan teaches a delivery system (100), in the same filed of endeavor, comprising a first tube (120); a pusher (160) including an elongated flexible rod (162) having proximal and distal end regions, and a capture element (140) at the distal end region of the elongated flexible rod (162) for releasable attachment to a proximal end of a stent (20), wherein the capture element (140) is radially self-expanding to adopt an open or folded configuration, such that the folded configuration is configured for passage within a first lumen of the first tube (120) and peripheral edges of the capture element (140) are closer together to grip a proximal end of the stent (20), and the open configuration is configured for release of the stent (20), illustrated in Figures 1-5, the pusher system aiding in moving, retrieving, adjusting and/or repositioning a stent in a vessel ([0030]; [0033]; [0034], Lines 1-6 & [0038], Lines 1-5).
In view of the teachings of Jordan, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention for the delivery system, of Blaeser in view of Duffy, to further comprising a pusher including an elongated flexible rod having proximal and distal end regions, and a capture element at the distal end region of the elongated flexible rod for releasable attachment to a proximal end of the furcated stent, wherein the capture element is radially self-expanding to adopt open and folded configurations, such that the folded configuration is configured for passage within a first lumen of the first tube and peripheral edges of the capture element are closer together to grip the proximal end of the furcated stent, and the open configuration is configured for release of the furcated stent; such a pusher system aids in moving, retrieving, adjusting and/or repositioning the furcated stent in a vessel, as taught by Jordan.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Blaeser in view of Duffy as applied to claim 1 above, and further in view of Hebert et al. (US PG Pub. 2016/0206419), as previously disclosed, hereinafter Hebert.
Regarding claim 16, Blaeser in view of Duffy disclose the delivery system according to claim 1, but do not specifically teach a loader for loading of the furcated stent into the delivery catheter.
However, Hebert teaches a delivery system, in the same filed of endeavor, comprising a stent/micrograft (10), a delivery catheter/microcatheter, and a loader (136), for loading the stent/micrograft (10) into the delivery catheter/microcatheter, the loader (136) comprising an elongated third tube (138) having a proximal end, a distal end, and a lumen, adapted to slidably accommodate the stent/micrograft (10) in a folded configuration, wherein the distal end of the third tube (138) is configured to couple with a proximal end of the delivery catheter/microcatheter such that a lumen of the delivery catheter and the lumen of the elongated third tube (138) are connected to form a continuous passage for advancement of the stent/micrograft (10) in the folded configuration from the loader (136) to the delivery catheter/microcatheter, illustrated in Figure 9 ([0197] & [0199], Last 5 Lines).
In view of the teachings of Hebert, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention for the delivery system, of Blaeser in view of Duffy, to further comprising a loader comprising an elongated third tube having a proximal end, a distal end and a third lumen adapted to slidably accommodate the furcated stent in a folded configuration, wherein the distal end of the third tube is configured to couple with a proximal end of the delivery catheter such that a first lumen of the delivery catheter and the third lumen are connected to form a continuous passage for advancement of the furcated stent in the folded configuration from the loader to the delivery catheter, in order to load the furcated stent into the delivery catheter, as taught by Hebert.
Response to Arguments
Applicant’s arguments with respect to independent claims 1 and 20 have been considered but are moot because the arguments do not apply to the current rejections presently used in the Office Action. Specifically, in response to Applicant’s amendment, Examiner now cites the prior art of Duffy, in addition to the prior art of Blaeser; rejecting independents claim 1 and 20 as being unpatentable over Blaeser in view of Duffy.
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 DINAH BARIA whose telephone number is (571)270-1973. The examiner can normally be reached Monday - Friday 10am - 5pm.
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/DINAH BARIA/Primary Examiner, Art Unit 3774 10/05/2026
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