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 amendment filed March 20th 2026 has been entered. Claims 1-6 and 13-14 are pending in the application. Applicant’s amendments to the Specification and Claims have overcome each and every objection and the double patenting rejection previously set forth in the Non-Final Office Action mailed January 12th 2026.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-2, 5-6, and 13-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Van Erp (WO 9934849 A1), in view of Agrawal (US 20180126143 A1), and further in view of Berry (US 5125915 A).
Regarding claim 1, Van Erp discloses a delivery device (abstract & Fig. 1) comprising: a handle (connector 18, which may be held, page 4 last paragraph & Fig. 1-2); a catheter sheath extending distally from the handle (tubular basic body 14 extending from connector 18, page 4 last paragraph & Fig. 1-2); a hemostasis valve assembly coupled to a proximal end of the handle (housing 12 comprising housing body 32 and intermediate collar 40, pages 4-5 & Fig. 1-4), a hemostasis valve positioned within the hemostasis valve assembly (gasket 58, configured to act as a hemostats valve, positioned within body 32 and collar 40, page 2 first paragraph and page 5 & Fig. 1-4), the hemostasis valve being located proximal to the catheter sheath and distal to a proximal end of the hemostasis valve assembly (gasket 58 located proximal to tubular body 14 and distal to the proximal end of intermediate colla 40, see Fig. 1-4);
a hemostasis bypass assembly coupled to the hemostasis valve assembly (end cap 46 coupled to intermediate collar 40, 5 first paragraph & Fig. 1-4), the hemostasis bypass assembly including a bypass tube coupled to an actuator (end cap 46 including a cylindrical plunger 54 coupled to finger knurls 48 defining an end flange, page 5 first paragraph & Fig. 1-4), the actuator being a rotatable knob and being configured to be transitioned between a first condition in which a distal end of the bypass tube is positioned proximal to the hemostasis valve and the hemostasis valve is closed, and
a second condition in which the distal end of the bypass tube traverses the hemostasis valve and the hemostasis valve is opened (“And the end cap 46 has finger knurls 48 for facilitating turning the end cap 46 in engagement with the threads 44… and a cylindrical plunger 54 for manually actuating the seal of the housing 12… Figure 3 shows an introducer according to one embodiment of the present invention with the gasket seal 58 in a closed state, while Figure 4 shows the same introducer with the plunger actuated to force the gasket seal 58 into an open state.”, page 5 & Fig. 1-4; end cap 46, which is rotatable around threads 44, transitions between a first condition (Fig. 3), in which a distal end of plunger 54 is positioned proximal to seal 58 and seal 58 is closed, and a second condition (Fig. 4), in which the distal end of plunger 54 traverses seal 58 and seal 58 is opened), and
wherein the hemostasis valve assembly includes a main body extending proximal of the hemostasis valve and a hub extending distally of the hemostasis valve (intermediate collar 40 extending proximal of gasket 58 and housing body 32 extending distal of gasket 58, see Figs. 1-4), and wherein rotation of the rotatable knob translates the bypass tube toward or away from the hemostasis valve (rotation of end cap 46 around threads 44 translates plunger 54 toward and away from gasket 58, pages 4-5 & Fig. 3-4).
However, Van Erp fails to explicitly disclose a wiper seal positioned within the hemostasis valve assembly proximal to the hemostasis valve and wherein the main body includes one or more pins extending radially outwardly from the main body, and the rotatable knob includes one or more enclosed slots, the one or more pins received within a corresponding one or more of the enclosed slots, wherein each of the one or more enclosed slots includes a central portion extending at an oblique angle relative to a central longitudinal axis of the rotatable knob, wherein each of the one or more enclosed slots includes a proximal end portion and a distal end portion, the central portion extending between the proximal end portion and the distal end portion, wherein the proximal end portion of each of the one or more enclosed slots extends in a circumferential direction around the rotatable knob with a pocket extending distally in an axial direction, the pocket configured to secure a corresponding one of the one or more pins therein.
However, Agrawal teaches a delivery device (hemostasis valve assembly 10, Fig. 1-2) comprising a valve assembly 44 ([0062] & Fig. 2-3) similar to the gasket 58 of Van Erp. Valve assembly 44 of Agrawal is a two-part assembly comprised of a first and second valve member 60 and 62 ([0065] & Fig. 3). First valve member 60 may be interpreted as a wiper seal, and second valve member 62 may be interpreted as a hemostasis valve ([0065]-[0066], [0069], and [0077] & Fig. 3-4 of Agrawal).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the hemostasis valve of Van Erp with Agrawal to include the two-part valve assembly since such a modification would prevent fluid from leaking from the device and improve performance of the seal without negatively affecting the insertion force of the plunger and is taught to be an art effective configuration for a seal in medical device configured to be traversed by a tube that would yield the same predictable result of sealing against escaping fluids (see [0063]-[0064] of Agrawal). As modified, gasket 58 of Van Erp would be substituted with the two-part valve assembly 44 of Agrawal, with first valve member 60 being a wiper seal disposed proximal to second valve member 62. Alternatively, first valve member 60 of Agrawal could be included with gasket 58 of Van Erp, proximal to gasket 58, similarly to how first valve member 60 is positioned proximally to second valve member 62 of Agrawal.
Further, Berry teaches a delivery device (abstract and Col 5 lines 25-41; “This invention relates to devices for selectively attaching a fixture to the exterior of an elongated member of circular cross-section, such as a length of medical tubing.”, Col 1 lines 8-11 & Fig. 1) wherein the main body includes one or more pins extending radially outwardly from the main body (enlarged housing 40 includes upstanding retention pin 42, Col 6 lines 12-16 & Fig. 1-2 and 5-6), and the rotatable knob includes one or more enclosed slots, the one or more pins received within a corresponding one or more of the enclosed slots (locking hub 64, being rotatable, includes patterned recess 82 which receives pin 42, Col 8 lines 35-44 and Col 9 lines 32-50 & Fig. 1-6),
such that rotation of the rotatable knob translates the bypass tube toward or away from the hemostasis valve (rotation of locking hub 64 translates body portion 68 longitudinally, toward and away from member 100, Col 8 lines 35-56 and Col 9 lines 32-50 & Fig. 4-7), wherein each of the one or more enclosed slots includes a central portion extending at an oblique angle relative to a central longitudinal axis of the rotatable knob (pattern recess 82, which is being interpreted as an enclosed slot, includes retention slot 98, which is being interpreted as the central portion, seen extending at an oblique angle relative to longitudinal axis L of rotatable locking hub 64, see Figs. 1-4 and Col 7 lines 7-20 and Col 8 lines 42-43; alternatively, the retention slot 98 can be interpreted as the enclosed slot and the center portion of slot 98, extending from front ledge 84 to knob 94 can be interpreted as the central portion, which extends at an oblique angle relative to axis L of hub 64, see Fig. 1-4 and Col 7 lines 6-20 and annotated Fig. 4a below in which the central portion is denoted as “Central Portion”), wherein each of the one or more enclosed slots includes a proximal end portion and a distal end portion, the central portion extending between the proximal end portion and the distal end portion, wherein
the proximal end portion of each of the one or more enclosed slots extends in a circumferential direction around the rotatable knob with a pocket extending distally in an axial direction, the pocket configured to secure a corresponding one of the one or more pins therein (retention slot 98 includes a proximal end portion with a pocket, a distal end portion, and a central portion extending therebetween, see annotated Fig. 4a below in which the central portion is denoted as “Central Portion”, the distal end portion is denoted as “Distal End Portion”, and the proximal end portion is denoted as “Proximal End Portion” with the pocket extending distally in an axial direction denoted as “Pocket”; the “Proximal End Portion” seen extending in a circumferential direction around hub 64, see annotated Fig. 4a below; the space denoted as “Pocket”, between front ledge 84 and longitudinal ledge 88, seen securing retention pin 42, see Fig. 6 and Col 7 lines 6-20 and Col 9 lines 50-62).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the device of Van Erp, as modified, with Berry to include
one or more pins extending radially outwardly from the main body, and the rotatable knob includes one or more enclosed slots, the one or more pins received within a corresponding one or more of the enclosed slots, wherein each of the one or more enclosed slots includes a central portion extending at an oblique angle relative to a central longitudinal axis of the rotatable knob, wherein each of the one or more enclosed slots includes a proximal end portion and a distal end portion, the central portion extending between the proximal end portion and the distal end portion, wherein the proximal end portion of each of the one or more enclosed slots extends in a circumferential direction around the rotatable knob with a pocket extending distally in an axial direction, the pocket configured to secure a corresponding one of the one or more pins therein, since
such a modification would prevent accidental or creeping release of the seal typical in seals secured using threaded fittings (see Col 2 lines 38-42 of Berry). Berry teaches such a pin and angled slot coupling structure to be an art effective means for translating a cylindrical body part of a rotatable knob to actuate a valve that would provide a secure connection to set the rotatable knob in place and prevent accidental disengagement. The modification would yield predictable results pertaining to actuator displacement, valve actuation, and knob securement (see Col 9 line 32-end to Col 10 lines 1-2 and Col 8 lines 35-56 & Fig. 4-7 of Berry). As modified, the threaded connection 44 between end cap 46 and collar 40 of Van Erp would be substituted with retention pin 42 and pattern recess 82 of Berry.
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Regarding claim 2, Van Erp, as modified, discloses all the limitations of claim 1. Van Erp further discloses the delivery device wherein the hemostasis bypass assembly includes an interior flange defining a central aperture that is coaxial with the bypass tube (annular anchor 60 defines a central aperture, in which gasket 58 is positioned, that is coaxial with plunger 54, page 5 lines 10-11 & Fig. 3-4).
Regarding claims 5-6, Van Erp, as modified, discloses all the limitations of claim 2. Van Erp, as modified, discloses the delivery device wherein the wiper seal includes a rim and a proximally contoured main body defining the seal opening (as modified, valve member 60 of Agrawal includes a flanged outer perimeter 78 and a tapered central region 76 on the proximal side 64 defining an opening, [0067] and [0077]-[0078] & Fig. 4 of Agrawal; “The slits 83, 85 may meet in the center of the thickness of the valve member 60… to define an opening extending entirely through the thickness of the first valve member 60”, [0078] & see Fig. 2, 4, and 7B).
However, Van Erp fails to explicitly disclose the delivery device wherein the wiper seal is coupled to a proximal face of the interior flange, the wiper seal defining a seal opening coaxial with the central aperture of the interior flange.
However, Agrawal further teaches the delivery device (hemostasis valve assembly 10, Fig. 1-2) comprising a valve assembly 44 ([0062] & Fig. 2-3) wherein the hemostasis bypass assembly includes an interior flange defining a central aperture that is coaxial with the bypass tube (one or more grooves or recesses 43, 45 in seal cartridge 42 define a central aperture that is coaxial with capillary 28, [0062] & Fig. 2), wherein
the wiper seal is coupled to a proximal face of the interior flange (groove 80 of first valve member 60, which is being interpreted as the wiper seal, is coupled to a surface proximal to the distal end of groove 43, or a proximal face of groove/recess 43, [0067] & Fig. 2 and 4), the wiper seal defining a seal opening coaxial with the central aperture of the interior flange (valve member 60 includes an opening that is coaxial with a central opening defined by groove 43; “The slits 83, 85 may meet in the center of the thickness of the valve member 60 (or at a point between the proximal side 64 and the distal side 66) at their intersection point 87 to define an opening extending entirely through the thickness of the first valve member 60”, [0078] & see Fig. 2, 4, and 7B).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify further the device of Van Erp, as modified, with Agrawal to include the wiper seal coupled to a proximal face of the interior flange, the wiper seal defining a seal opening coaxial with the central aperture of the interior flange, since such a modification would provide structure to securely receive the valve, allowing for an interlocking connection between the wiper seal and the main body ([0062] and [0067] of Agrawal). As modified, recess 43 would be included on a proximal face of annular anchor 60 of Van Erp to facilitate connection between valve member 60 and the hemostasis valve assembly.
Regarding claim 13, Van Erp, as modified, discloses all the limitations of claim 1. Van Erp, as modified, further discloses the delivery device wherein each of the one or more enclosed slots is formed only on an interior of the rotatable knob (as modified, patterned recess 82 may be interpreted as formed only on a surface of retention sleeve 74 of locking hub 64 between proximal end 76 and distal end 78 of sleeve 74, or on an interior of locking hub 64, as the surface on which recess 82 is formed is between, or inside of, the proximal and distal ends 76 and 78, Col 6 lines 52-64 & Fig. 1-2
Regarding claim 14, Van Erp, as modified, discloses all the limitations of claim 1. Van Erp, as modified, further discloses the delivery device wherein each of the one or more enclosed slots is formed through an entire thickness of a wall of the rotatable knob (as modified, patterned recess 82 seen formed through an entire thickness of retention sleeve 74 of locking hub 64, Col 6 lines 52-55 and Col 7 lines 6-20 & see Fig. 1-5 of Berry; “…patterned recess 82 formed through retention sleeve 74…”, Col 9 lines 32-35).
Response to Arguments
Applicant’s arguments with respect to the claim(s) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Dehdashtian (US 6024729 A) teaches a medical device with an interior mounting flange 104 and seal members 30 and 32 (see Figs. 1-4).
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 MARTIN ADAM RADOMSKI whose telephone number is (571)272-2703. The examiner can normally be reached Monday-Friday: 7:30-4:30 CT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Sirmons can be reached at (571) 272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARTIN A RADOMSKI/ Examiner, Art Unit 3783 /EMILY L SCHMIDT/Primary Examiner, Art Unit 3783
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