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 .
Specification
The disclosure is objected to because of the following informalities: in paragraph [0032] “actuator 210” should be corrected to “actuator ring 210” and in paragraph [0040] “catheter tube 230” should be corrected to “catheter tube 30” or “catheter tube 232”.
Appropriate correction is required.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: numeral 232 is not provided in the written description. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 102
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 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.
Claim(s) 1-3, 5-8, 14, and 16-17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Harding (US 20170035992 A1).
Regarding claim 1, Harding discloses a catheter assembly (abstract) comprising: a catheter (catheter 18, abstract and [0072] & Fig. 1A); a catheter hub connected to the catheter (catheter hub 14, [0103] & Fig. 13), the catheter hub including: a septum valve that is configured to permit or block a flow of fluid through the catheter (valve 38, [0075] Fig. 1B, 2B, and 13); a valve actuator movable between a first position and a second position, the valve actuator opening the septum valve in the second position to permit the flow of fluid therethrough (actuator 98, [0103]-[0105] & Fig. 13); an actuator ring fixed to the catheter hub (fixed support 102, [0104] & Fig. 13); and an elastomeric bellow member attached to the actuator ring and the valve actuator (one or more elastic members 100 attached to support 102 and actuator 98, [0104]-[0105] & Fig. 13; member 100 may be “a circular or radially extending silicone member, a plurality of elastic bands, rubber, silicone rubber, a thermal plastic, or a thermal plastic elastomer.”, [0104]; member 100 is a flexible and expansible structure configured to contain actuator 98, or a bellow; “the biasing members depicted in FIGS. 13-16 may be, but are not limited to, a spring washer, an elastomeric washer, a plurality of elastic bands, a compression spring, an extension spring, a disc spring, rubber, silicone rubber, a thermal plastic, a thermal plastic elastomer or other suitable biasing member.”, [0110]), wherein: the elastomeric bellow member is configured to expand when the valve actuator moves from the first position where the septum valve is closed to the second position where the septum valve is open; and the elastomeric bellow member is configured to retract to cause the valve actuator to retract from the second position to the first position ([0103]-[0105] & Fig. 13; also see [0005]).
Regarding claim 2, Harding discloses all the limitations of claim 1. Harding discloses the assembly wherein the actuator ring is fixed to an inner diameter of the catheter hub (“The biasing member 100 is connected to a fixed support 102 attached to the inner surface of the catheter hub 14.”, [0104] & Fig. 13).
The limitation of “…via an interference fit” is considered to be a product-by-process limitation. A product-by-process limitation adds no patentable distinction to the claim, and is unpatentable if the claimed product is the same as a product of the prior art. In the instant case, the fixed support 102 is the same as the claimed actuator ring since support 102 is fixedly attached to catheter hub 14. Fixed support 102 would be fixed to an inner diameter of the catheter hub 14 via an interference fit, glue, molding, etc.
Regarding claim 3, Harding discloses all the limitations of claim 1. Harding discloses the assembly wherein the elastomeric bellow member comprises an elastic membrane ([0103]; a radially extending silicone member may be interpreted as an elastic membrane).
Regarding claim 5, Harding discloses all the limitations of claim 1. Harding discloses the assembly wherein: the elastomeric bellow member includes a proximal end and a distal end; the proximal end of the elastomeric bellow member is attached to the actuator ring; and the distal end of the elastomeric bellow member is attached to the valve actuator (the proximal end of member 100 is being interpreted as the end attached to fixed support 102 and the distal end of member 100 is being interpreted as the end attached to actuator 98, see [0104]-[0105] & Fig. 13).
Regarding claim 6, Harding discloses all the limitations of claim 1. Harding discloses the assembly wherein the elastomeric bellow member is attached to the actuator ring and the valve actuator ([0104]-[0105] & Fig. 13; member 100 may be attached to actuator 98 by adhesive or molded bond, see [0108]).
The limitation of “…by at least one of a glue application and an overmolding procedure” is considered to be a product-by-process limitation. A product-by-process limitation adds no patentable distinction to the claim, and is unpatentable if the claimed product is the same as a product of the prior art. In the instant case, member 100 is the same as the claimed elastomeric bellow member since member 100 is attached to support 102 and actuator 98. Member 100 would be attached to support 102 and actuator 98 by a glue application, an overmolding procedure, groove and flange connection, etc.
Regarding claim 7, Harding discloses all the limitations of claim 1. Harding discloses the assembly wherein the elastomeric bellow member is in a rest state to movably hold the valve actuator in the first position ([0105]).
Regarding claim 8, Harding discloses all the limitations of claim 1. Harding discloses the assembly wherein the assembly does not include metallic components (hub 14, and support 102, made of a polymer material, [0073], catheter 18 being flexible, [0072], septum 38 made of silicone rubber, [0077], actuator 98 made of a polymer, [0079], and member 100 made of silicone rubber, etc., [0104] and [0110]).
Regarding claim 14, Harding discloses a catheter assembly (abstract) comprising: a catheter (catheter 18, abstract and [0072] & Fig. 1A); a catheter hub connected to the catheter (catheter hub 14, [0103] & Fig. 13), the catheter hub including: a septum valve that is configured to permit or block a flow of fluid through the catheter (septum 128, [0112]-[0115] & Fig. 1B, 2B, and 17; also see [0075]); a valve actuator movable between a first position and a second position, the valve actuator opening the septum valve in the second position to permit the flow of fluid therethrough (actuator 122, [0112]-[0115] & Fig. 17; also see [0005]); and a disc spring contacting the septum valve to close the septum valve (biasing member 124, including a central hub 132, which is a cylindrical member, [0112]-[0113] & Fig. 17; biasing member 124 is connected to septum 128 and is configured to close slits 42 of septum 128, [0113]-[0115] & Fig. 17).
Regarding claim 16, Harding discloses all the limitations of claim 14. Harding further discloses the assembly wherein when a luer adapter of the catheter hub is disengaged, the valve actuator moves from the second position to the first position and the septum valve closes (“The outer surface 26 includes one or more projections 30 to secure a Luer connector 32 (FIG. 4) to the catheter hub 14. The projections 30 may form a threaded connection with the Luer connector 32 or they may connect to the Luer connector 32 through a snap fit or other twisting connection”, [0073]; when projections 30 of hub 14 are disengaged, actuator 122 moves from the second position, where it is passed through septum 128, to the first position, when it is in an initial position (proximal to septum 128), in which slits 42 are closed, see [0113]-[0115] & Fig. 17).
Regarding claim 17, Harding discloses all the limitations of claim 14. Harding further discloses the assembly wherein when a luer adapter of the catheter hub is engaged, the valve actuator moves to the second position to open the septum valve and elastically open a plurality of flaps of the disc spring (“The outer surface 26 includes one or more projections 30 to secure a Luer connector 32 (FIG. 4) to the catheter hub 14. The projections 30 may form a threaded connection with the Luer connector 32 or they may connect to the Luer connector 32 through a snap fit or other twisting connection”, [0073]; when projections 30 of hub 14 are engaged, actuator 122 moves to the second position in which slits 42 of septum 128 are opened and one or more arms 130, which are being interpreted as flaps, of biasing member 124 are stretched, or opened, see [0113]-[0115] & Fig. 17).
Claim(s) 14 and 16-17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Haindl (US 4917668 A).
Regarding claim 14, Haindl discloses a catheter assembly (valve housing 10 and plastic cannula 15, abstract and col 2 line 55-col 3 line 2 & Fig. 6-8) comprising: a catheter (plastic cannula 15, col 2 line 66-col 3 line 2); a catheter hub connected to the catheter (housing 10, col 2 lines 55-63 & Fig. 6-8), the catheter hub including: a septum valve that is configured to permit or block a flow of fluid through the catheter (valve body 14, col 4 lines 7-45 & Fig. 6-8); a valve actuator movable between a first position and a second position, the valve actuator opening the septum valve in the second position to permit the flow of fluid therethrough (annular collar 35 configured to be moved between a first position (Fig. 6) and a second position (Fig. 8) to open valve body 14 to permit flow of fluid, col 4 lines 7-55 & Fig. 6-8); and a disc spring contacting the septum valve to close the septum valve (plate spring 39 contacting valve body 14 to close body 14, col 4 lines 29-36 & Fig. 6-8).
Regarding claim 16, Haindl discloses all the limitations of claim 14. Haindl discloses the assembly wherein when a luer adapter of the catheter hub is disengaged, the valve actuator moves from the second position to the first position and the septum valve closes (“The housing part 10b is provided with connection elements 11 for a Luer-Lok-connector, the insertion opening 12 being provided as an inner core into which a pipe connection piece can be inserted.”, col 2 lines 59-63 & Fig. 1-2 and 6-8; “the opening of the valve body 14 is always effected by an axial displacement of the pipe stud 34. It is also possible to provide the pipe stud 34 with a swivel nut that engages with threaded parts of the housing 10, so that the opened position of the valve can be adjusted by turning the swivel nut. Turning the swivel nut in the opposite direction may shut the valve body 14.”, col 4 lines 43-50; when connection elements 11 of housing 10 are disengaged from the swivel nut of pipe stud 34, valve body 14 moves from the second position (Fig. 8) to the first, closed position (Fig. 6), col 4 lines 7-55).
Regarding claim 17, Haindl discloses all the limitations of claim 14. Haindl discloses the assembly wherein when a luer adapter of the catheter hub is engaged, the valve actuator moves to the second position to open the septum valve and elastically open a plurality of flaps of the disc spring (“The housing part 10b is provided with connection elements 11 for a Luer-Lok-connector, the insertion opening 12 being provided as an inner core into which a pipe connection piece can be inserted.”, col 2 lines 59-63 & Fig. 1-2 and 6-8; “the opening of the valve body 14 is always effected by an axial displacement of the pipe stud 34. It is also possible to provide the pipe stud 34 with a swivel nut that engages with threaded parts of the housing 10, so that the opened position of the valve can be adjusted by turning the swivel nut. Turning the swivel nut in the opposite direction may shut the valve body 14.”, col 4 lines 43-50; when connection elements 11 of housing 10 are engaged with the swivel nut of pipe stud 34, valve body 14 moves to the second position (Fig. 8) to open valve body 14 and elastically open resilient arms 41, which are being interpreted as flaps, of spring 39, col 4 lines 7-55).
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.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Harding (US 20170035992 A1) as applied to claim 1 above, and further in view of Tuysuz (EP 3677305 A1).
Regarding claim 4, Harding discloses all the limitations of claim 1. Harding further discloses the assembly wherein the elastomeric bellow member comprises a flexible material ([0104] and [0110]) but fails to explicitly disclose the elastomeric bellow member comprising polydimethyl siloxane. However, Tuysuz teaches an assembly wherein the elastomeric bellow member comprises polydimethyl siloxane (“The member (3) can be substantially formed from an organosilicon polymer. Polydimethyl siloxane (PDMS) can be considered highly suitable for being employed as a material to form the member (3) since it is highly compatible with bodily fluids.”, [0035]).
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 material of the elastomeric bellow member of Harding with Tuysuz to include polydimethyl siloxane since such a modification would increase the catheter assembly’s compatibility with bodily fluids ([0035] of Tuysuz).
Claim(s) 9 and 11-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Harding (US 20170035992 A1) as applied to claim 1 above, and further in view of Hamboly (US 20140107618 A1).
Regarding claims 9, 11, and 13, Harding discloses all the limitations of claim 1. However, Harding fails to explicitly disclose the assembly further comprising a disc spring that assists the elastomeric bellow member in moving the valve actuator from the second position to the first position, wherein the disc spring is disposed distal to the septum valve, wherein the disc spring includes a plurality of flaps that elastically move when the valve actuator opens the septum valve.
However, Hamboly teaches a catheter assembly (abstract and [0018]) comprising a disc spring (septum unit 12, [0020]) that assists in moving the septum valve from the second position to the first position (septum 12 is capable of moving septum 11 from a second position (Fig. 1B) to a first position (Fig. 1A), [0023]-[0024] & Fig. 1A-1C; septa flaps 16, which are made of flexible material ([0021]), are biased to return to their original position (Fig. 1A); therefore, septum 12 imparts force proximally onto proximally positioned septum 11, urging septum 11 to return to its original position), wherein the disc spring includes a plurality of flaps that elastically move when the valve actuator opens the septum valve (septum 12 includes elastic flaps 16 that move when luer 33 opens septum 11, [0021]-[0023] & Fig. 1A-1C).
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 assembly of Harding with Hamboly to include a disc spring, wherein the disc spring is disposed distal to the septum valve, and wherein the disc spring includes a plurality of flaps that elastically move when the valve actuator opens the septum valve, since such a modification would strengthen the septum against fluid communication or flux through the slits of the septum valve (abstract and [0022] of Hamboly).
As modified, septum unit 12 of Hamboly would be included distal and adjacent to septum 38 of Harding, synonymously to how unit 12 is positioned in relation to unit 11 of Hamboly. As combined, considering septum unit 12 of Hamboly stores elastic energy as it is deflected distally by the actuator, unit 12 may be interpreted as configured to assist member 100 in moving actuator 98 from the second position to the first position. As unit 12 is deflected distally, it necessarily imparts proximally directed force onto actuator 98, through valve 38.
Regarding claim 12, Harding, as modified, discloses all the limitations of claim 9. As modified, Harding discloses the assembly wherein the disc spring contacts the septum valve to close the septum valve (as modified, septum unit 12 contacts valve 38 to close valve 38, [0021]-[0023] of Hamboly and [0075] of Harding).
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Harding (US 20170035992 A1), in view of Hamboly (US 20140107618 A1), and further in view of McKinnon (US 20130090607 A1).
Regarding claim 10, Harding, as modified, discloses all the limitations of claim 9. However, Harding fails to explicitly disclose the assembly wherein the disc spring comprises a polypropylene elastomer.
However, McKinnon teaches a catheter assembly (10, [0024] & Fig. 1) wherein the disc spring comprises a polypropylene elastomer (“valve 70 can be made of various flexible or semi-flexible materials including, for example, silicone, silicone rubber, polypropylene, or other suitable materials.”, [0039]).
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 disc spring of Harding, as modified, with McKinnon to include the disc spring comprising a polypropylene elastomer since McKinnon teaches such to be an art effective material for an elastic valve element in a catheter assembly and would yield the same predictable results of sealing and fluid control ([0039] of McKinnon).
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Harding (US 20170035992 A1) as applied to claim 14 above, and further in view of McKinnon (US 20130090607 A1).
Regarding claim 15, Harding discloses all the limitations of claim 14. Harding discloses that “The biasing member 124 is preferably made from an elastic material, for example a silicone rubber. The biasing member 124 can also be made from, but is not limited to, rubber, silicone rubber, a thermal plastic, or a thermal plastic elastomer.” ([0113]) but fails to explicitly disclose the assembly wherein the disc spring comprises a polypropylene elastomer.
However, McKinnon teaches a catheter assembly (10, [0024] & Fig. 1) wherein the disc spring comprises a polypropylene elastomer (“valve 70 can be made of various flexible or semi-flexible materials including, for example, silicone, silicone rubber, polypropylene, or other suitable materials.”, [0039]).
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 disc spring of Harding with McKinnon to include the disc spring comprising a polypropylene elastomer since McKinnon teaches such to be an art effective material for an elastic valve element in a catheter assembly and would yield the same predictable results of sealing and fluid control ([0039] of McKinnon).
Conclusion
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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/MARTIN A RADOMSKI/Examiner, Art Unit 3783 /EMILY L SCHMIDT/Primary Examiner, Art Unit 3783
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