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 .
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 63/519100, fails to provide adequate support in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. Claims 6-10, and 12-20, therefore the effective filing date of claims 6-10, and 12-20 is the filing date of the instant application which is Aug. 12, 2024, because the prior application fails to teach a specific helical coil, biasing member (as claimed), the cup seal having an annular channel, the specific limitations drawn to the compliance chamber (as well as multiple compliance chambers), the specific limitations to the flexible material (e.g. pleats), a clamp, a pressure measuring device or any indicia as claimed. Claims 1-5, and 11 have an effective filing date of August 11, 2023.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 2,5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chalekian et al. US Patent Pub. 2020/0368514.
With regards to claim 1, Chalekian et al. teaches an introducer system (fig. 1, 26A-26D, 29E), comprising an introducer sheath (2906/2902a); a valve assembly (2904a/2908, Fig. 29E) connected to the introducer sheath; a medical device passage (passage defined by the valve - 2908) defined by the introducer sheath and the valve assembly; a flexible material (2908) within the valve assembly having an inner surface exposed along a portion of the medical device passage and an outer surface at least partially defining a valve membrane chamber (see Fig 29E); and, a compliance chamber (2920) within the valve assembly and in communication with the valve membrane chamber; the compliance chamber further comprising a piston assembly (2920) within the compliance chamber and movable between a plurality of positions to accommodate inflation media (Fig. 29E, para. 107).
With regards to claim 2, 5, Chalekian et al. teaches, wherein the piston assembly comprises a piston member connected to a piston seal (2922) and a biasing member (spring – see para. 0107), where the biasing member biases the piston member to reduce a working volume of the compliance chamber (para. 107). Re. clm. 3, wherein the compliance chamber is positioned annularly around at least a portion of the valve membrane chamber (see fig. 29E).
Claims 1-6, 8, 9 and 19-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wang et al. WO 2021/136460 A1 (Citations are drawn to US 2022/0339419 as the English translation acting as the machine translation – US corresponding case).
With regards to claim 1, Wang et al. teaches an introducer system (fig. 23a-26d), comprising an introducer sheath (fig, 23a – sheath); a valve assembly (1 – fig. 26a-26d) connected to the introducer sheath; a medical device passage (11 - passage) defined by the introducer sheath and the valve assembly; a flexible material (2) within the valve assembly having an inner surface exposed along a portion of the medical device passage and an outer surface at least partially defining a valve membrane chamber (12 - see Fig 26a-26d); and, compliance chambers (31/33) within the valve assembly and in communication with the valve membrane chamber; the compliance chamber further comprising a piston assembly (34/341) within the compliance chamber and movable between a plurality of positions to accommodate inflation media (fig. 26a-26d, para. 0297-320).
With regards to claim 2, Wang et al. teaches, wherein the piston assembly comprises a piston member connected to a piston seal (34 – see fig. 23b) and a biasing member (341, spring, see fig. 23b), where the biasing member biases the piston member to reduce a working volume of the compliance chamber (para. 297-320). Re. clm. 3, wherein the compliance chamber is positioned annularly around at least a portion of the valve membrane chamber (see fig. 26b). Re. clm. 4, wherein the piston member is a ring (the piston seal has a proximal annular ring/flange that seals the piston member and the compliance chamber (31). Re. clm. 5-6, wherein the biasing member is a spring, and the spring is a helical coil spring (341, see fig. 26a-26d). Re. clm. 8, wherein the piston seal is a cup seal having an annular channel (the distal proximal annular ring/flange that seals the piston member and the compliance chamber and engages the ridge [outer surface] of the compliance chamber, 31). Re. clm. 9, wherein the compliance chamber further comprises an annular ridge positioned to mate with the annular channel of the cup seal (the structure in the chamber that engages the piston in fig. 26a, 26c). Re. clm. 19-20, wherein the compliance chamber further comprises a plurality of compliance chambers that are arranged annularly around the medical device passage (see fig. 26a-26d).
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 10-13 are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. WO 2021/136460 A1 as applied to the claims above, and further in view of Arcaro US Patent 9,314,605.
Re. clm. 10-13, Wang et al. fails to disclose the particulars of the flexible material, such as the shape (generally tubular shape, radially enlarged end portions, plurality of longitudinal pleats extending radially outward and comprises a slit valve covering a lumen of the generally tubular shape element).
Arcaro et al. discloses a valve assembly that includes an inner tubular element that is made of flexible material that has a generally tubular shape (200, see fig. 3), that allows for medical devices to pass through (abstract). The flexible material (200) within the valve assembly (fig. 3) has a flexible middle portion that includes a plurality of longitudinal pleats extending radially outward (see the middle portion of 200 in fig. 3), and radially enlarged end portions (see 202, hour glass shaped as illustrated in fig. 3) and further comprises a slit valve covering a lumen of the generally tubular shape (see fig. 4, which illustrated the tubular shape closed [collapsed] thus creating a slit valve based on the BRI and the construction of the tubular shape element which would inherently have a lumen in order to allow the medical devices to pass through).
At the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to modify the flexible material (2) of Wang et al. with the tubular shape element of figure 3 of Arcaro et al. because the inner tubular shape element and constructions allows for a wide range of surgical implement diameters, shapes, and multiple implements without imposing the high frictional forces of known valves (see Arcaro et al., abstract). Therefore, it would have been obvious to modify the sealing element of Wang et al. with the teachings of Arcaro in figure 3 to include a generally tubular shape element (based on the shape of the lumen of Wang et al. and to accommodate the medical devices) and have a flexible middle portion (so that valve adjusts and seals around the medical device) and radially enlarged end portions (in order to engage the first and second end cap in order to maintain the position and hold the valve in place). Re. clm. 12, it would have been obvious to modify the flexible material to have a plurality of longitudinal pleats extending radially outward (since this provides additional strength and material in order to expand the flexible middle portion. The longitudinal pleat structure is illustrated in fig. 3 of Arcaro, thus making the modification and obvious modification based on the teachings and level of skill in the art. Re. claim 13, it would have been obvious to include a slit valve covering a lumen of the generally tubular shape since Arcaro teaches the valve structure acting as a slit valve and having similar structure (see fig. 2, 2A and 4) because the valve structure has an structure that opens and closes (acts as a slit) based in movement and pressure of the medical device. Furthermore, one of ordinary skill in the art would have found it obvious to include a slit valve as slit valves are commonly used in the trocar and introducer art, thus making it an obvious modification to include slit valve structure to the combined device of Wang et al. and Arcaro.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. as applied to claims 1 and 2 above, and further in view of Haase, US Patent Pub. 20120053562.
Wang et al. teaches in figure 26a, a biasing member being a spring (341) and a second pressure regulating hole 331 for injecting gas (para. 0524), however Wang et al. fails to explicitly state the use of a pneumatic piston mechanism or a hydraulic piston mechanism.
Haase teaches a fluid delivery system that incorporates a reservoir unit (152) and a propellant (biasing element) that creates pressure within the fluid delivery system. Haase teaches different biasing means that can be used, such as a spring, hydraulic piston or similar biasing means (see para. 0071).
At the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to modify replace the spring biasing member of Wang et al. with a hydraulic piston mechanism as taught by Haase because Haase teaches the level of skill in the art and that replacing one type of biasing member (spring) with a different type (hydraulic piston) is well-known and an obvious modification because the modification would be simple substitution of one known element for another to obtain predictable results which is based on the teachings of Haase. MPEP further supports this obvious modification, see MPEP 2143.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. as applied to claim 1 above, and further in view of Arnett et al., US Patent Pub. 20210113198.
Wang et al. discloses an introducer system according to claim 1 but fails to include a clamping element connected to the valve assembly (hub) and is configured to control the movement of a dilator (medical device), such that the clam has a closed clamp position configured to clamp a proximal portion of a dilator and an open clamp position configured to release the proximal portion of the dilator and allow longitudinal movement of the dilator relative to the introducer sheath.
Arnett et al. discloses a clamp system that includes a spacer (150/1050) and a lock (108/1008) such that the spacer engages the hub of the introducer system (valve assembly) and the lock (clamp) has multiple positions (configurations) to control the movement of the medial device (dilator), see figs 10-16 and para. 0077-0081.
At the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to add the clamping/locking mechanism of Arnett et al. to the device of Wang et al. because adding a clamp (lock and spacer of Arnett et al.) to the system of Wang et al. allows for better control of the medical devices by preventing movement and securing the devices in the proper location (see Arnett et al., para. 0003-0014). Therefore, it would have been obvious to modify the device of Wang et al. to include a clamp connected to the valve assembly and is configured to control the movement of a dilator, such that the clam has a closed clamp position configured to clamp a proximal portion of a dilator and an open clamp position configured to release the proximal portion of the dilator and allow longitudinal movement of the dilator relative to the introducer sheath (as suggested by Arnett et al.)
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. as applied to claims 1 and 2 above, and further in view of Perszyk et al., US Patent Pub. 20240325690, Bouchier-Hayes et al., US Patent Pub 2021/0260355 and Hershey et al., US Patent Pub. 2011/0152762.
Wang et al. discloses the device of claim 2 that further includes a fluid delivery port (32 – for inflation media), but fails to teach, wherein the valve assembly further comprises a valve housing where at least part of the valve housing is transparent and further comprising indicia indicating a pressure value of inflation media within the valve assembly.
Perszyk et al. discloses a valve body that is clear or transparent in order to allow direct visualization and improve visibility (para. 0075-0079).
Bouchier-Hayes et al. a valved introducer system that includes an overflow bulb that expands and acts as an indicia to indicate the pressure value of the inflation media within the value assembly (flexible material), (see fig. 4, para. 0073).
Hershey et al. discloses that its well-known in the medical art when using balloon(s) (flexible material) to measure and display the fluid pressure in the balloon (para. 0006). Hershey et al. further teaches different types of markings or scales that indicate a pressure value of inflation medica within balloon system (see abstract, para. 0005-007, 0013-0022).
At the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to modify the material of the valve assembly of Wang et al. to include at least part of a valve housing being made from transparent material because Perszyk et al. teaches the benefit of making a valve housing being clear or transparent since it allows for direct visualization so that the user can see if the device is working properly. Additionally, it would have been obvious to further include indicia indicating a pressure value of inflation media within the valve assembly because Hershey et al. teaches that its well known in the art to include indicia that indicate the pressure value when dealing with balloon structures and inflation fluid in order to determine if the device is working properly (properly inflated) and Bouchier-Hayes teaches the use of an indicator in a valve assembly to indicate the pressure value of inflation medica within the valve assembly by including a chamber that expands and deflates based on the inflation media and pressure within the valve. Therefore, it would have been obvious to one of ordinary skill in the art to further include an indicia indicating a pressure value of inflation media within the valve assembly of Wang et al. based on the teachings of Bouchier-Hayes and Hershey et al. so that the fluid pressure that is being delivered to port 32 of Wang can be monitored.
Claims 15 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. as applied to claim 1 above, and further in view of Al-Ali, US Patent 10,939,831.
Wang et al. discloses the device of claim 1 but fails to teach a pressure measurement device that is an electronic pressure transducer and an electronic display electrically connected to the pressure transducer.
Al-Ali discloses a catheter system that includes pressure measurement device that includes electronic pressure transducers (216) and the pressure transducer communicates with an external device such as a microcomputer or signal processing electronics, see fig. 2 and 7, col. 8, ll. 9-37. Al-Ali further teaches connecting systems to other external electronics.
At the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to modify the device of Wang et al. to further comprising a pressure measurement device that is an electronic pressure transducer and an electronic display electrically connected to the pressure transducer based on the teachings of Al-Ali because Al-Ali teaches using pressure transducers and displaying the pressure in real time as a benefit (col. 2, ll. 1-8). One of ordinary skill in the art would understand and only use routine skill to modify Wang et al. to include pressure transducers in the introducer system and display the data from the pressure transducer in order to ensure the catheter system is performing properly and within the required parameters (within the proper pressure levels). Furthermore, it would have been obvious to use an electronic display to display the data from an electronic pressure transducer because Al-Ali suggestions connecting to other external devices which a display would encompass and having a computer with a display is an obvious modification if the computer does not already include a display, thus making the use of an electronic display an obvious modification based on the teachings of Al-Ali.
Allowable Subject Matter
Claim 17 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
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Matthew DeSanto
/MATTHEW F DESANTO/Primary Examiner, Art Unit 3700
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