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 .
Response to Amendment
The Amendments filed 02/25/2026 have been entered.
Claims 1, 2 and 16 have thereby been amended.
Claims 1-21 are being examined in this office action.
Claim Interpretation
The limitations “substantially stiffer than” and “substantially more elastic than” recited in claim 8, in light of the specification, are interpreted under the broadest reasonable interpretation as having a lower elastic modulus and a higher elastic modulus, respectively. Although they are used as suggestive guidelines, the ranges for elastic moduli and yield strains recited in the claims and specification are not written as required limitations or definitions for “substantially stiffer than” and “substantially more elastic than”.
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 1-2, 5-6, 13, 15 and 21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Osypka (US 20090221965).
Regarding claim 1, Osypka discloses a vascular access system comprising: a first sheath (Fig. 1: 7; para. [0043], last sentence) having a first sheath lumen extending between a proximal end and a distal end of the first sheath (Figs. 1 and 8: first sheath lumen shown extending from the proximal end labeled on Fig. 1, to the distal end shown on Fig. 8) the first sheath configured to allow for passage of a first portion of a medical device (Figs. 7-8: balloon catheter 2), wherein the medical device is configured to be inserted into a blood vessel (para. [0040], sentence 1), the first portion of the medical device having a first radial cross section, and a second portion of the medical device having a second radial cross section that is larger than the first radial cross section (Fig. 7: the first portion of the medical device 2 with deflated balloon 5, having a cross section equivalent to catheter 2; Fig. 8: the second portion being inflated balloon 5 over 2, having a larger, expanded cross section; see annotated Figs. 7-8 below); a slitted sleeve (Fig. 1: 1), wherein the slitted sleeve comprises a tubular sleeve body having a longitudinal slit along its length (Fig. 1: slit 9 along the length of tubular sleeve 1), wherein the slitted sleeve is adapted to receive the first portion of the medical device therein (Fig. 7: 1 receives device 2 within it), the tubular sleeve body having a first opening at a proximal end thereof and a second opening at a distal end thereof and a continuous lumen from the first opening to the second opening (proximal opening of sleeve 1 at funnel 3; distal opening of sleeve 1 at 8; lumen which catheter 2 goes through shown in cross-section of Fig. 2), and wherein the longitudinal slit closes, but does not seal, after the first portion of the medical device is inserted therein (Figs. 3 and 7: slit 9 is closed upon medical device 2 inserted but not yet expanded; para. [0044], the slit 9 does not self-seal); and a sealing portion of the slitted sleeve configured to fill a gap and form a seal between an inner surface of the first sheath (portion of the sleeve 1 just proximal to distal projection 10 + projection 10, see annotated figure below; para. [0044], last sentence; para. [0048], this portion of the sleeve 1 forms fluid-tight seal with outer casing 7, seen for example in Fig. 8) and a portion of the first portion of the medical device disposed in the first sheath when the first sheath is inserted in the blood vessel and the slitted sleeve is inserted into the first sheath lumen over the portion of the first portion of the medical device disposed in the first sheath (Fig. 7: medical device first portion disposed in slitted sheath 1, disposed in sleeve 7), such that blood from the blood vessel is prevented from migrating past the seal (para. [0043], sentence 1; para. [0044], last sentence). Examiner interprets Osypka to disclose that the medical instrument is loaded into the slitted sleeve through the longitudinal slit in the slitted sleeve, because it functions in the same manner as the claimed invention, and has all the same required structures to be capable of accommodating the medical device being inserted through the longitudinal slit prior to placement into the outer sheath, as claimed.
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Annotated Figure, Osypka
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Annotated Figs. 7-8, Osypka
Regarding claim 2, Osypka discloses the vascular access system of claim 1, as described above, wherein the sealing portion of the slitted sleeve is a slitted sleeve tip at the distal end of the tubular sleeve body (sleeve tip of sleeve 1 being just proximal to distal projection 10 + projection 10, see annotated figure above), the slitted sleeve tip having an inner surface defining a slitted sleeve tip lumen that is in fluid communication with the tubular sleeve body (Figs. 3-4: the lumen of the sleeve tip is continuous with the lumen of the remaining proximal length of the sleeve 1).
Regarding claim 5, Osypka discloses the vascular access system of claim 2, as described above, wherein a diameter of the inner surface at the proximal end of the slitted sleeve tip is equal to a diameter of the inner surface at the distal end of the slitted sleeve tip (Figs. 3-4: the inner diameters are equal, not tapered).
Regarding claim 6, Osypka discloses the vascular access system of claim 2, as described above, wherein the slitted sleeve tip extends beyond the first sheath when the tubular sleeve body of the slitted sleeve is inserted into the first sheath lumen (Figs. 3-4 and 8: projection 10 of the slitted sleeve tip extends distally past the end of casing 7).
Regarding claim 13, Osypka discloses the vascular access system of claim 1, as described above, wherein the slitted sleeve is configured to be inserted into the first sheath by moving the slitted sleeve and the first sheath axially relative to one another along a longitudinal axis of the slitted sleeve and the first sheath (para. [0051], first sentence, slitted sleeve 1 can slide axially within casing 7; para. [0040], last sentence, funnel 3 to aid in insertion of the instrument).
Regarding claim 15, Osypka discloses the vascular access system of claim 1, as described above, wherein an outer surface of the first sheath is coated with one of: a hydrophilic coating, a hydrophobic coating, or a coating to reduce friction (para. [0023], sleeve 1 is coated with hydrophobic silicone; para. [0051], the sleeve 1 can be coated in order to reduce friction to increase the slidability withing casing 7).
Regarding claim 21, Osypka discloses the vascular access system of claim 2, as described above, wherein the slitted sleeve tip comprises a tip slit, and wherein the tip slit substantially aligns with the longitudinal slit in the slitted sleeve (Figs. 3-4: the slit 9 of the proximal body of sleeve 1 is continuous through the sleeve tip and projection 10 portion of 1).
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 3-4 are rejected under 35 U.S.C. 103 as being unpatentable over Osypka (US 20090221965) in view of Worthley (US 20210308418).
Regarding claim 3, Osypka discloses the vascular access system of claim 2, as described above, but fails to disclose the outer diameter of the slitted sleeve tip being tapered.
Worthley teaches an analogous vascular access system with a slitted sleeve (Fig. 2: 220), wherein an outer diameter of the proximal end of the slitted sleeve tip is larger than an outer diameter of the distal end of the slitted sleeve tip such that the slitted sleeve tip is tapered along its proximal-to-distal length (Fig. 2: slitted sleeve tip 240 has a smaller diameter at the distal end, compared to diameter at the circumferential line depicting the proximal end of the tapered tip; Fig. 4(a): the outer diameter at cut through section B-B is larger than the outer diameter at cut through section C-C). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the sleeve tip of the Osypka slitted sleeve by incorporating the tapered structure of the tip taught by Worthley, in order to ease insertion of the sleeve with a smaller initial diameter and to allow for a greater degree of expansion after insertion (Worthley: para. [0020]).
Regarding claim 4, Osypka discloses the vascular access system of claim 2, as described above, but fails to disclose the inner diameter of the slitted sleeve tip being tapered.
Worthley teaches an analogous vascular access system with a slitted sleeve (Fig. 2: 220), wherein a diameter of the inner surface at the proximal end of the slitted sleeve tip is larger than a diameter of the inner surface of the slitted sleeve tip at the distal end (the inner diameter at cut through section B-B in Fig. 4(c) is larger than the inner diameter at cut through section C-C in Fig. 4(d)). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the sleeve tip of the Osypka slitted sleeve by incorporating the tapered structure of the tip taught by Worthley, in order to ease insertion of the sleeve with a smaller initial diameter and to allow for a greater degree of expansion after insertion, and create a tighter seal between the sleeve and the inserted medical device (Worthley: para. [0020]).
Claims 7-10 are rejected under 35 U.S.C. 103 as being unpatentable over Osypka (US 20090221965) in view of Nguyen (US 20140379067).
Regarding claim 7, Osypka discloses the vascular access system of claim 2, as described above, but fails to disclose that the slitted sleeve tip is made from a different material than the body of the sleeve.
Nguyen teaches an analogous vascular access system with a tubular sleeve (Fig. 35: 100), wherein the tubular sleeve body comprises a first material (paras. [0127]-[0128], the sleeve body made of layers 108 and 110 which may be made from high density polyethylene and Tecoflex) and the slitted sleeve tip (Figs. 35-36: 102) comprises a second material (para. [0130], sentence 1, the sleeve tip 102 is made from a softer material which may be made from low density polyethylene). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the materials of the sleeve body and sleeve tip such that the tip is a different, softer material than the body, as taught by Nguyen, in order to minimize trauma caused to the vessel upon insertion of the sleeve while maintaining the structural integrity of the sleeve body (Nguyen: para. [0130], sentence 1).
Regarding claim 8, Osypka in view of Nguyen teaches the vascular access system of claim 7, as described above, wherein the first material is substantially stiffer than the second material, and the second material is substantially more elastic than the first material (Nguyen: high density polyethylene is stiffer than low density polyethylene; paras. [0128] and [0130], sentence 1). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the materials of the sleeve body and sleeve tip such that the tip is a different, softer material than the body, as taught by Nguyen, in order to minimize trauma caused to the vessel upon insertion of the sleeve while maintaining the structural integrity of the sleeve body (Nguyen: para. [0130], sentence 1).
Regarding claim 9, Osypka in view of Nguyen teaches the vascular access system of claim 7, as described above, wherein the first material comprises at least one of: high-density polyethylene (HDPE) material, a medium-density polyethylene (MDPE) material, a low-density polyethylene (LDPE) material, a polyether block amide (PEBA), a material with an elastic modulus of about 81-307 MPa, or a material with a yield strain of 20-30% (Nguyen: para. [0128], sentence 2; the first material comprises high density polyethylene). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the materials of the sleeve body and sleeve tip such that the tip is a different, softer material than the body, as taught by Nguyen, in order to minimize trauma caused to the vessel upon insertion of the sleeve while maintaining the structural integrity of the sleeve body (Nguyen: para. [0130], sentence 1).
Regarding claim 10, Osypka in view of Nguyen teaches the vascular access system of claim 7, as described above, wherein the second material comprises at least one of: ethylene-vinyl acetate (EVA), styrene- butadiene copolymer (SBC), synthetic rubber, an elastomer, an elastic material, a material with an elastic modulus of about 1.6 ksi, or a material with a yield strain in excess of 200% (Nguyen: para. [0130], sentence 1, low density polyethylene being an elastic material). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the materials of the sleeve body and sleeve tip such that the tip is a different, softer material than the body, as taught by Nguyen, in order to minimize trauma caused to the vessel upon insertion of the sleeve while maintaining the structural integrity of the sleeve body (Nguyen: para. [0130], sentence 1).
Claims 11-12, 14, 16-17 and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Osypka (US 20090221965) in view of Bishop (US 20110152763).
Regarding claim 11, Osypka discloses the vascular access system of claim 1, as described above, wherein the first portion of the medical device is a catheter (2; para. [0040], sentence 1), but fails to disclose that the catheter is coupled to a percutaneous heart pump.
Bishop teaches an analogous vascular access system in which the inserted medical device is a catheter coupled to a percutaneous heart pump (para. [0006], third-to-last sentence, the introduced medical device being a catheter associated with a percutaneous device; para. [0034], sentences 1-2, the percutaneous device being a percutaneous pump). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the Osypka assembly by incorporating the percutaneous heart pump taught by Bishop in place of the Osypka balloon of the balloon catheter, in order to be able to be used for treating patients undergoing cardiac arrest or other condition in which they require blood to be mechanically pumped in an emergency.
Regarding claim 12, Osypka in view of Bishop teaches the vascular access system of claim 11, as described above, wherein the slitted sleeve is configured to slide distally along the catheter and be advanced into the blood vessel while assembled to the catheter (Bishop: para. [0059], last sentence). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the Osypka assembly by incorporating the sliding of the sleeve relative to the medical device in order to allow for adjustment of the medical device within the blood vessel to be able to be used for treating patients undergoing cardiac arrest.
Regarding claim 14, Osypka discloses the vascular access system of claim 1, as described above, but fails to disclose an antithrombogenic coating on the outer surface of the slitted sleeve.
Bishop teaches an analogous vascular access system with a sheath analogous to the slitted sleeve (first sheath 220; para. [0033], sentence 1), wherein an outer surface of the slitted sleeve is coated with at least one of: an antithrombogenic coating, or a coating configured to reduce a likelihood of blood clot formation between the first sheath and the first portion of the medical device when they are inserted into the blood vessel (para. [0012], sentence 4). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the coating on the Osypka slitted sleeve by incorporating the antithrombogenic coating on the inner, first sheath taught by Bishop, in order to prevent clotting of blood that may migrate between the slitted sleeve and the outer sheath (Bishop: para. [0012], sentence 4).
Regarding claim 16, Osypka discloses the vascular access system of claim 1, as described above, but fails to disclose an antimicrobial coating on the outer surface of the slitted sleeve.
Bishop teaches an analogous vascular access system with a sheath analogous to the slitted sleeve (first sheath 220; para. [0033], sentence 1), wherein an outer surface of the first sheath is coated with one of: an antimicrobial coating, or a coating configured to reduce a likelihood of infection occurring in the blood vessel when the first sheath is inserted into the blood vessel (para. [0012], sentence 6). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the coating on the Osypka slitted sleeve by incorporating the antimicrobial coating on the inner, first sheath taught by Bishop, in order to prevent microbes between the slitted sleeve and the outer sheath to prevent infection to the patient (Bishop: para. [0012], sentence 6).
Regarding claim 17, Osypka discloses the vascular access system of claim 1, as described above, further comprising a slitted sleeve hub (funnel 3), but fails to disclose a second hub being a first sheath hub (for casing 7).
Bishop teaches an analogous vascular access system with a first sheath hub of the first sheath (outer sheath 400 with hub 410), an inner sheath hub of an inner sheath (inner sheath 220 with hub 210), and a medical device inserted within (pump 120 + 130), wherein the slitted sleeve (220) is received into a lumen of a first sheath hub (Fig. 9: 220 is received into 420 and hub 410; para. [0057], sentences 1-3). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the Osypka assembly by incorporating the addition of the outer sheath hub taught by Bishop, in order to be able to fix the hubs together to securely fix the outer sheath to the slitted sheath so that it does not slip off (para. [0057], sentences 2-3; first sheath hub 410 is coupled to slitted sleeve hub 210).
Regarding claim 19, Osypka in view of Bishop teaches the vascular access system of claim 17, as described above, but fails to explicitly disclose wherein the slitted sleeve hub and the first sheath hub are configured to couple to each other via at least one of a threaded connection, a press fit connection, or a cliplock connection (Bishop: para. [0057], sentences 2-3; first sheath hub 410 is coupled to slitted sleeve hub 210 via threaded fit, press fit, or clip-lock connection). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the Osypka assembly by incorporating the sleeve-hub connection taught by Bishop, in order to be able to fix the hubs together to securely fix the outer sheath to the slitted sheath so that it does not slip off (para. [0057], sentences 2-3; first sheath hub 410 is coupled to slitted sleeve hub 210).
Regarding claim 20, Osypka in view of Bishop teaches the vascular access system of claim 17, as described above, wherein the slitted sleeve hub comprises a hub slit (Osypka: Fig. 1: slit 9 of hub 3), and wherein the hub slit substantially aligns with the longitudinal slit in the slitted sleeve (Osypka: Fig. 1: slit 9 is continuous and aligned along hub 3 and sleeve 1 to tip 10).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Osypka (US 20090221965) in view of Bishop (US 20110152763) in further view of Helgeson (US 20100094226).
Regarding claim 18, Osypka in view of Bishop teaches the vascular access system of claim 17, as described above, wherein the slitted sleeve comprises at least one of: a high-density polyethylene (HDPE) material, a medium-density polyethylene (MDPE) material, a low-density polyethylene (LDPE) material, polyether ether ketone (PEEK), or a polyether block amide (PEBA) (Bishop: para. [0036], second-to-last sentence, the sheath comprising a polyether block amide). However, Osypka in view of Bishop still fails to teach that the slitted sleeve hub, and not just the slitted sleeve body, is also made from the above listed materials including a polyether block amide.
Helgeson teaches an analogous vascular access system with a slitted sheath and a slitted sleeve hub (125), wherein the slitted sleeve comprises a polyether block amide (PEBA) (para. [0077], last sentence). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the Osypka-Bishop slitted sleeve hub by incorporating the polyether block amide material taught by Helgeson, such that the slitted sleeve and slitted sleeve hub comprise the same material, in order to allow the slitted sleeve and slitted sleeve hub to be made of the same material properties, lowering the costs for manufacturing.
Response to Arguments
Applicant's arguments filed 02/25/2026 regarding the prior art rejections have been fully considered but they are not persuasive.
Regarding claim 1, Applicant argues that Osypka does not read on the limitation “wherein the slitted sleeve is adapted to receive the first portion of the medical device therein, which is loaded into the slitted sleeve through the longitudinal slit in the slitted sleeve.” Examiner maintains that the limitation that the medical device “is loaded into the slitted sleeve through the longitudinal slit in the slitted sleeve” is functional language, and therefore, because Osypka has all the claimed physical structures as the invention including a longitudinal slit that extends across the entire sleeve and is expandable, it would be capable of being loaded in the same manner as the claimed invention. Applicant claims it would “not be physically possible for any component….to be inserted into the insertion sleeve 1 via slit 9 of Osypka,” however, claim 1 fails to recite any specific structures of the sleeve or its slit which Osypka does not possess, and which would indicate that Osypka is incapable of being loaded in the same manner as the claimed invention.
For these reasons, independent claim 1 and its depending claims 2-21 stand rejected as recited above.
Conclusion
THIS ACTION IS MADE FINAL. 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.
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/K.A.W./Examiner, Art Unit 3783
/NATHAN R PRICE/Primary Examiner, Art Unit 3783
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