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 .
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.
Claim(s) 1-14, 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2003/0116731 (“Hartley”) in view of U.S. Patent No. 2,434,835 (“Colley”).
Regarding Claim 1, Hartley discloses a hemostasis valve (Fig. 1), comprising:
a main housing (6) having a proximal end (see generally at 11) and a distal end (see generally at 7);
a rolling housing (12) rotatable relative to the main housing between a first position (see Fig. 4) and a second position (see Fig. 3);
a gasket (8) disposed in the rolling housing (see Figs. 1-4), the gasket comprising a proximal end (11) secured to the proximal end of the main housing, a distal end (10) secured to the distal end of the main housing, and a tubular body defining a lumen between the proximal end and the distal of the gasket (see Figs. 1-2), the tubular body being collapsible (see Fig. 2 and 4) and elastic (Par. 16) allowing the lumen to be closed (see Fig. 2 and 4) and open (see Fig. 1 and 3); and
a flexible member (14) extending between the rolling housing and the tubular body of the gasket and arranged to constrict the tubular body of the gasket when the rolling housing is in the first position (see Fig. 2, 4) thereby collapsing the tubular body of the gasket to close or narrow the lumen and unconstrict the tubular body of the gasket when the rolling housing is in the second position (see Fig. 1, 3), thereby allowing the lumen of the tubular body to open.
Hartley discloses the invention substantially as claimed except that that the flexible member comprises a plurality of such members, each of the plurality comprising a first end coupled to the main housing, a second end coupled to the rolling housing. However, Colley discloses a related adjustable valve construction (see Figs. 1-4) which like that of Hartley uses flexible member(s) (25) and a rolling housing (18, 16) to cause the flexible member(s) to cinch an elastic, tubular gasket (10) between open (see Fig. 2) and closed (see Fig. 4) configurations. Colley discloses the arrangement to comprise a plurality of such flexible members each having a first end (26 at 17) coupled to a main housing (17) and a second end (26 at 16) coupled the rolling housing and extending between the rolling housing and the tubular body of the gasket such that the flexible members may constrict the tubular body in a first position (see Fig. 4) and release/open the tubular body in the second position (see Fig. 2). It would have been obvious for one having ordinary skill in the art at the time the invention was made to configure the arrangement of Hartley to comprise a plurality of flexible members with opposed first and second ends fixed, respectively to the main ho-using and rolling housing, as disclosed by Colley, in order to duplicate the restricting flexible members of the invention and distribute their applied forces over a greater area thereby increasing the constriction and reliability of the valve. It has been held that duplication of the working parts of an invention is obvious and requires only routine and customary skill when only expected and predictable results are to be obtained, see In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960) and it has been held that rearranging the working parts of an invention is likewise obvious and routine where it affects only expected and predictable results, see In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950).
Regarding Claim 2, Hartley discloses the rolling housing is rotatable relative to the main housing at an angle ranging from 30 degrees to 330 degrees ( e.g. 45 degrees or 90 degrees with expected variability thereto – see Par. 34). Likewise, when the concepts are embodied by Colley rotation of approximately 120 degrees is depicted (see Fig. 4 – compare the location of the handle 18 in the starting position in phantom with the final position when closed).
Regarding Claim 3, Hartley, as modified by Colley, provides for each of the first ends of the plurality of the flexible members is coupled to the main housing in a first plane, and each of the second ends of the plurality of the flexible members is coupled to the rolling housing in a second plane proximal of the first plane (see Fig. 3 of Colley where the ends 26 are proximally/distally offset from one another at the attachment points with the rolling housing (16) and the main housing (17).
Regarding Claim 4, Hartley, as modified by Colley, provides for each of the plurality of the flexible members partially circumferentially surrounds the tubular body of the gasket in extending between the rolling housing and the tubular body of the gasket (see Fig. 2 and 4 - Colley).
Regarding Claim 5, Hartley, as modified by Colley, provides for the first ends of the plurality of the flexible members are coupled to the main housing at locations generally evenly spaced apart around a circle (see Fig. 2 – Colley).
Regarding Claim 6, Hartley, as modified by Colley, provides for the second ends of the plurality of the flexible members are coupled to the rolling housing at locations generally evenly spaced apart around a circle (see Fig. 2 – Colley).
Regarding Claim 7, Hartley, as modified by Colley, discloses the invention substantially as claimed except that the first ends of the plurality of the flexible members are coupled to the main housing at locations unevenly spaced apart, and/or the second ends of the plurality of the flexible members are coupled to the rolling housing at locations unevenly spaced apart. However, in the instant case the spacing of the ends of the is held to be an obvious design choice wherein the particular arrangement is not stated to solve any particular problem or convey any specific benefit and the spacing of the ends would be expected to work equally well irrespective of whether it is even of uneven, whereby it would have been obvious for one having ordinary skill in the art at the time the invention was made to alter the spacing of the ends of modified Hartley to be uneven since it has been held that such rearrangements of the working parts of an invention wherein such modifications do not alter the operation of the device, convey any unexpected or unpredictable results, or solve any specific problem are obvious design choices, see In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950).
Regarding Claim 8, Hartley, as modified by Colley, provides for the plurality of flexible members comprises 3-12 flexible members (see Fig. 2 – Colley).
Regarding Claim 9, Hartley, as modified by Colley, provides for the at the second position of the rolling housing (see Fig. 2), a segment of each of the plurality of the flexible members is distanced from the central longitudinal axis of the lumen of the gasket at a minimal distance, the segments of the plurality of the flexible members collectively define a passage to allow a portion of the tubular body of the gasket to pass through without constriction (see Fig. 2 – Colley).
Regarding Claim 10, Hartley, as modified by Colley, provides for at the first position of the rolling housing, the plurality of the flexible members forms an intersection that compress or constricts the portion of the tubular body of the gasket (see Fig. 4 – Colley).
Regarding Claim 11, Hartley discloses the gasket comprises an annular band (11) outwardly extending from the tubular body of the gasket, the annular band being located proximal of the intersection (see Fig. 2).
Regarding Claim 12, Hartley discloses the gasket comprises an annular band (11) extending outwardly from the tubular body of the gasket.
Regarding Claim 13, Hartley discloses the annular band is integral of the tubular body of the gasket (see Fig. 1 – note the consistent cross-hatching).
Regarding Claim 14, Hartley discloses the invention substantially as claimed except that at the second position of the rolling housing the lumen of the gasket has a diameter ranging from 4 mm to 15 mm. However, it must be understood that the size of the diameter in the second position is a product of the size of the lumen necessary to permit receipt of various medical instruments whereby the size of the valve and the opening will be expected to be changed depending upon the specific function and purpose of the valve. It would have been obvious for one having ordinary skill in the art at the time the invention was made to alter the size of the device such that the open diameter of the gasket lies within a range from 4mm to 15mm, in order to scale the device to an appropriate size for any particular instrument, whereby such mere changes in size and proportion of an invention are obvious when they affect only predictable and expected results, see In re Rose, 220 F.2d 459, 105 USPQ 237 (CCPA 1955), In re Rinehart, 531 F.2d 1048, 189 USPQ 143 (CCPA 1976), and Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984).
Regarding Claim 21, Hartley discloses a connector (4) configured to be coupled to the distal end of the main housing, the connector comprising a tubular body defining a passageway in communication with the lumen of the gasket and a side port for connecting with a vacuum source or flushing source (see Fig. 1).
Claim(s) 15-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2003/0116731 (“Hartley”) in view of U.S. Patent No. 2,434,835 (“Colley”) as applied above, and further in view of U.S. Patent No. 4,412,669 (“Hanyu”).
Regarding Claim 15, Hartley, as modified by Colley, discloses the invention substantially as claimed except that the main housing comprises a side wall defining a generally cylindrical structure to receive the rolling housing therein, the side wall being provided with one or more openings to allow access to the rolling housing to aid a user to rotate the rolling housing relative to the main housing. Colley discloses a similar arrangement but provide the rolling housing about the outer circumference of the main housing (see Fig. 3). However, similar arrangements are described by Hanyu where a rolling housing (5) having a plurality of flexible members (6) affixed thereto at a first end and a main housing (1) having the plurality of flexible members affixed thereto at the second end is provided. Hanyu discloses the main housing comprises a side wall defining a generally cylindrical structure to receive the rolling housing therein, the side wall being provided with one or more openings (see Fig. 1, i.e. the circumferential gap in the main housing through which the handle 51 protrudes) to allow access to the rolling housing to aid a user to rotate the rolling housing relative to the main housing (see Fig. 1-4). It would have been obvious for one having ordinary skill in the art at the time the invention was made to configure the rolling housing to be provided within the main housing in the modified invention of Hartley, as disclosed by Hanyu, whereby such a modification constitutes an obvious design choice based upon a mere reversal of parts to affect only a predictable and expected result, see In re Gazda, 219 F.2d 449, 104 USPQ 400 (CCPA 1955).
Regarding Claim 16, Hartley, as modified, provides the rolling housing comprises a side wall defining a generally cylindrical structure, the cylindrical structure of the rolling housing and the cylindrical structure of the main housing being substantially concentrically arranged (see Hanyu – Fig. 1-4).
Regarding Claim 17, Hartley, as modified, provides the rolling housing further comprises one or more tab members (51 – Hanyu) on the side wall of the rolling housing, the one or more tab members extending out of the one or more openings in the main housing respectively to aid the user to rotate the rolling housing relative to the main housing (see Fig. 1-4, Hanyu).
Regarding Claim 18, Hartley, as modified, provides the main housing further comprises a tab member to aid the user to operate the hemostasis valve by holding the tab member of the main housing and the one or more tab members of the rolling housing with a single hand (see e.g. the flange 7 of Hartley; the flange 81 or 91 of Hanyu; the flange 17 of Colley – whereby any of the provided flanges may be considered to comprise a greppable, holdable “tab member” upon which the fingers of a user may grip in order to provide a secure holding surface while using a thumb to operate the tab member).
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2003/0116731 (“Hartley”) in view of U.S. Patent No. 2,434,835 (“Colley”) as applied above, and further in view of U.S. Patent No. 12,453,564 (“Buck”).
Regarding Claim 19, Hartley, as modified, discloses the invention substantially as claimed except that the invention includes a tension spring having a first end coupled to the rolling housing and a second end coupled to the main housing, the tension spring being configured to maintain the rolling housing in the first position or provide a biasing force to return the rolling housing from the second position to the first position. However, Buck discloses a related valve comprising a constrictable gasket (254) a plurality of flexible members (262) to provide the constricting (see Fig. 14A, 14C), a main housing (not labeled), and a pivotable/rotatable actuator (276) which can be actuated by a user to selectively transition the valve from a first, closed position (Fig. 14A) and a second, open position (Fig. 14C), wherein the invention comprises a spring (282) provided between the actuatable portion and the main housing with a first end coupled to the actuator and a second end coupled to the main housing (see Fig. 14A), the spring being used to maintain the valve in a normally closed position. It would have been obvious for one having ordinary skill in the art at the time the invention was made to provide a spring between the main housing and rolling housing of modified Hartley, as disclosed by Buck, in order to ensure the valve is normally biased to a closed configuration thereby helping close the valve under force to improve the seal thereof
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2003/0116731 (“Hartley”) in view of U.S. Patent No. 2,434,835 (“Colley”) and U.S. Patent No. 12,453,564 (“Buck”) as applied above, and further in view of U.S. Patent No. 4,412,669 (“Hanyu”).
Regarding Claim 20, Hartley, as modified, discloses the invention substantially as claimed except that the device comprises a lock mechanism configured to lock the rolling housing in the second position. However, Hanyu discloses that a related valve may comprise a locking mechanism (pawl 52 and teeth 32) which can be used to selectively lock the position of the rolling housing in a second, open position when needed. It would have been obvious for one having ordinary skill in the art at the time the invention was made to provide the device of Hartley with an actuatable locking mechanism, as disclosed by Hanyu, in order to allow the position of the rolling housing to be secured in an open position, when needed, to prevent the valve from accidentally closing.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM R CARPENTER whose telephone number is (571)270-3637. The examiner can normally be reached Mon. to Thus. - 7:00AM to 5:00PM (EST/EDT).
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/WILLIAM R CARPENTER/Primary Examiner, Art Unit 3783 07/30/2026
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