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
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.
Claims 1-3 and 5-14 are rejected under 35 U.S.C. 103 as being unpatentable over Layser et al. (WO 2016/100083 A1) in view of Houle et al. (US 6,709,417 B1).
Regarding claim 1, Layser discloses a surgical cassette (Fig. 4, feat. 314; ¶0036), comprising: a housing (410, 420; ¶0036), and a valve assembly (306, 324; ¶0036) coupled to the housing and configured to control fluid communication of a channel within the housing (350; ¶0037), the valve assembly comprising: a valve body having a first end (Annotated Fig. 5/11, feat. A), a second end (Annotated Fig/11. 5, feat. B), and a cylindrical surface (Annotated Fig. 5/11, feat. C) connecting the first end and the second end (Figs. 5A-E, feat. 324; ¶0039-0042).
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[AltContent: textbox (Annotated Figs. 5/11 adapted from Fig. 5 of Layser and Fig. 11 of Houle.)]Layser does not disclose a retaining ring coupled to the housing, that the valve assembly is coupled to the housing by the retaining ring, or a valve elastomer comprising: a first side configured to couple the valve elastomer to the second end of the valve body; and a second side having a recessed surface, wherein the recessed surface is configured to: engage with the housing to form a seal with a base of the housing, and reduce mechanical stress across the valve elastomer during rotation of the valve assembly.
Houle teaches a cassette for controlling the flow of IV fluid to a patient (Figs. 1-3; Col. 3, lines 17-51) comprising a housing (Figs. 1-3 and 11, feats. 5, 16, 17, 18; Col. 3, line 63 – Col. 4, line 8) and stopcock-type control valve (Figs. 1-3 and 11-14, feats. 2, 20; Col. 3, lines 52-62). The control valve (Figs. 11-14, feats. 2, 20; Col. 5, line 4-39) comprises a valve body (20) having a first end (Annotated Fig. 5/11, feat. D), a second end (Annotated Fig. 5/11, feat. E), and a cylindrical surface connecting the first end and the second end (Annotated Fig. 5/11, feat. F). The control valve further comprises a resilient seal (Figs. 11-13, feats. 25, 26, 27, 28; Col. 5, line 4 – Col. 6, line 16), corresponding to the claimed valve elastomer, having a first side coupling it to the second end of the valve body (Annotated Fig. 5/11, feat. G, 27), a second side having a recessed surface (Annotated Fig. 5/11, feat. H) configured to engage with the housing to form a seal with a base of the housing (Fig. 11, feats. 18, 26; Col. 5, line 54 – Col. 6, line 16). The valve further comprises a rigid valve seat member (Figs. 11-13, feat. 22; Col. 5, line 4 – Col. 6, line 16) which retains the valve body (20) and resilient seal (25, 26, 27, 28) in the housing (16, 17, 18). Houle teaches that the interface between the ort of the housing (Fig. 11, feat. 16, 17, 18) and resilient seal (Fig. 11, feats. 25, 26, 27) advantageously minimizes the resistance and actuating torque between the resilient seal and housing while ensuring sealing and preventing leakage (Col. 5, lines 4-53). Because the resistance and actuating torque are minimized, the mechanical stress on the resilient seal is also reduced. Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the cassette disclosed by Layser so that it includes a retaining ring coupled to the housing, so that the valve assembly is coupled to the housing by the retaining ring, and so that it includes a valve elastomer comprising: a first side configured to couple the valve elastomer to the second end of the valve body; and a second side having a recessed surface, wherein the recessed surface is configured to: engage with the housing to form a seal with a base of the housing, and reduce mechanical stress across the valve elastomer during rotation of the valve assembly in order to minimize the resistance and actuating torque while ensuring sealing and preventing leakage as taught by Houle.
Regarding claim 2, Layser in view of Houle suggests the cassette of claim 1. Houle further teaches that the resilient seal, corresponding to the claimed valve elastomer, comprises an inner O-ring with inner and outer semi-circular profiles (Figs. 11 and 13, feat. 25), an outer O-ring with a semi-circular profile (Figs. 11 and 13, feat. 26), and inner and outer straight walls connecting the O-rings (Figs. 11 and 13, feat. 28; Col. 5, line 54 – Col. 6, line 16), which defines the recessed surface (Annotated Fig. 5/11, feat. H). Therefore, Layser in view of Houle further suggests that the recessed surface of the second side of the valve elastomer comprises a first semi-circular inner edge, two straight sides from the first semi-circular inner edge to an area of largest width of the recessed surface, and a second semi-circular outer edge.
Regarding claim 3, Layser in view of Houle suggests the cassette of claim 1. Houle further teaches that the first side of the resilient seal, corresponding to the claimed valve elastomer, includes a protruding O-ring (Fig. 11, feat. 27; Col. 5, lines 41-53) engaged to the second end of the valve body (Annotated Fig. 5/11, feat. E) inside a recess in the second end (Annotated Fig. 5/11, feat. I).
Regarding claim 5, Layser discloses a surgical cassette (Figs. 4 and 6A, feat. 314; ¶0036-0037), comprising: a housing (410, 420; ¶0036) for receiving a valve assembly (306, 324; ¶0036), the housing comprising: a base having a first side configured to contact the valve assembly (410; ¶0036), the base comprising: a port through the base configured to facilitate fluid communication of a channel within the housing (Fig. 6A, feats. 610, 612; ¶0043); and a recessed surface formed in the first side (Fig. 6A, feat. 430).
Layser does not disclose that the recessed surface is configured to: engages with the valve assembly to form a seal with a valve elastomer of the valve assembly, and reduce mechanical stress across the valve elastomer during rotation of the valve assembly.
As discussed above, Houle teaches a cassette for controlling the flow of IV fluid to a patient (Figs. 1-3; Col. 3, lines 17-51) comprising a housing (Figs. 1-3 and 11, feats. 5, 16, 17, 18; Col. 3, line 63 – Col. 4, line 8) and stopcock-type control valve (Figs. 1-3 and 11-14, feats. 2, 20; Col. 3, lines 52-62). The control valve (Figs. 11-14, feats. 2, 20; Col. 5, line 4-39) comprises a valve body (20) having a first end (Annotated Fig. 5/11, feat. D), a second end (Annotated Fig. 5/11, feat. E), and a cylindrical surface connecting the first end and the second end (Annotated Fig. 5/11, feat. F). The control valve further comprises a resilient seal (Figs. 11-13, feats. 25, 26, 27, 28; Col. 5, line 4 – Col. 6, line 16), corresponding to the claimed valve elastomer, having a first side coupling it to the second end of the valve body (Annotated Fig. 5/11, feat. G, 27), a second side having a recess surface (Annotated Fig. 5/11, feat. H) configured to engage with the housing to form a seal with a base of the housing (Fig. 11, feats. 18, 26; Col. 5, line 54 – Col. 6, line 16). The O-rings of the resilient seal (Fig. 11, feats. 25 and 26) engage against the recessed surface in the housing (18) to form a seal enabling leakage free flow from an inlet recess (Figs. 6-7 and 11, feat. 77) to an outlet port (23; Col. 5, line 4 – Col. 6, line 16). Houle teaches that the interface between the port of the housing (Fig. 11, feat. 16, 17, 18) and resilient seal (Fig. 11, feats. 25, 26, 27) advantageously minimizes the resistance and actuating torque between the resilient seal and housing while ensuring sealing and preventing leakage (Col. 5, lines 4-53). Because the resistance and actuating torque are minimized, the mechanical stress on the resilient seal is also reduced. Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the cassette disclosed by Layser so that the recessed surface is configured to: engages with the valve assembly to form a seal with a valve elastomer of the valve assembly, and reduce mechanical stress across the valve elastomer during rotation of the valve assembly in order to minimize the resistance and actuating torque while ensuring sealing and preventing leakage as taught by Houle.
Regarding claim 6, Layser in view of Houle suggests the cassette of claim 5. Houle further teaches that the inlet recess (Figs. 6-7 and 11, feat. 77; Col. 5, line 4 – Col. 6, line 16) of the housing (16, 17, 18) comprises semi-circular edges joined by straight lines (Fig. 7, feat. 77). Therefore, Layser in view of Houle further suggests that the recessed surface of the first side comprises a first semi-circular inner edge, two straight sides from the first semi-circular inner edge to an area of largest width of the recessed surface, and a second semi-circular outer edge.
Regarding claim 7, Layser in view of Houle suggests the cassette of claim 5, and Layser further discloses that the recessed surface of the first side (Fig. 6A, feat. 430) is adjacent to the port of the base (Fig. 6A, feats. 610, 612).
Regarding claim 8, Layser in view of Houle suggests the cassette of claim 5. Houle further teaches that the port of the base (Fig. 11, feats. 16, 17, 18) comprises a protruding outer collar (21) which the valve seat member attaches to (22; Col. 5, lines 4-38). Therefore, Layser in view of Houle further suggests the port comprises a ring protruding from the first side around a perimeter of the port.
Regarding claim 9, Layser discloses a surgical cassette (Fig. 4, feat. 314; ¶0036), comprising: a housing (410, 420; ¶0036) for receiving a valve assembly (306, 324; ¶0036), the housing comprising: a base having a first side configured to contact the valve assembly (410; ¶0036), the base comprising: a port through the base configured to facilitate fluid communication of a channel within the housing (Fig. 6A, feats. 610, 612; ¶0043).
Layser does not disclose that the port comprises a ring protruding from the first side around a perimeter of the port configured to engage with the valve assembly to form a seal with the valve assembly, and prevent a liquid from leaking into the port during rotation of the valve assembly.
As discussed above, Houle teaches a cassette for controlling the flow of IV fluid to a patient (Figs. 1-3; Col. 3, lines 17-51) comprising a housing (Figs. 1-3 and 11, feats. 5, 16, 17, 18; Col. 3, line 63 – Col. 4, line 8) and stopcock-type control valve (Figs. 1-3 and 11-14, feats. 2, 20; Col. 3, lines 52-62). The control valve (Figs. 11-14, feats. 2, 20; Col. 5, line 4-39) comprises a valve body (20) having a first end (Annotated Fig. 5/11, feat. D), a second end (Annotated Fig. 5/11, feat. E), and a cylindrical surface connecting the first end and the second end (Annotated Fig. 5/11, feat. F). The control valve further comprises a resilient seal (Figs. 11-13, feats. 25, 26, 27, 28; Col. 5, line 4 – Col. 6, line 16) and a valve seat member (Figs. 11-13, feat. 22; Col. 5, line 4 – Col. 6, line 16), which engages against an outer collar (Fig. 11, feat. 21) of the housing to prevent leakage through the housing (Fig. 11, feat. 19; Col. 5, line 54 – Col. 6, line 16). Houle teaches that the interface between the ort of the housing (Fig. 11, feat. 16, 17, 18) and resilient seal (Fig. 11, feats. 25, 26, 27) advantageously minimizes the resistance and actuating torque between the resilient seal and housing while ensuring sealing and preventing leakage (Col. 5, lines 4-53). Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the cassette disclosed by Layser so that the port comprises a ring protruding from the first side around a perimeter of the port configured to engage with the valve assembly to form a seal with the valve assembly, and prevent a liquid from leaking into the port during rotation of the valve assembly in order to minimize the resistance and actuating torque while ensuring sealing and preventing leakage as taught by Houle.
Regarding claim 10, Layser in view of Houle suggests the cassette of claim 9. Houle further teaches that the protruding outer collar (Fig. 11, feat. 21) and valve-seat member (Fig. 11, feat. 22) bear against each other to seal the housing (Fig. 11, feat. 19; Col. 5, line 54 – Col. 6, line 16). Therefore, Layser in view of Houle further suggests that the protruding ring is configured to form the seal between the valve assembly and the housing.
Regarding claim 11, Layser in view of Houle suggests the cassette of claim 9. Houle further teaches a resilient seal (Figs. 11-13, feats. 25, 26, 27, 28; Col. 5, line 4 – Col. 6, line 16), corresponding to the claimed elastomeric sealing element, held between the valve-seat member (Fig. 11, feat. 22) and the protruding outer collar (Fig. 11, feat. 21) to form the seal. Therefore, Layser in view of Houle further suggests that the protruding ring is configured to engage with the valve assembly to compress an elastomeric sealing material against the first side of the base.
Regarding claim 12, Layser in view of Houle suggests the cassette of claim 9. Houle further teaches that the protruding outer collar (Fig. 11, feat. 21) comprises a straight internal side and straight external side extending between an opening with a flat surface for receiving the valve assembly and an opposing opening with a flat surface. Modifying the protruding outer collar to have semi-circular surfaces that the ends of the straight sides is a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular claimed configuration is significant. In the current case, the present specification indicates that the particular shape of the protruding ring, corresponding to the protruding outer collar of Houle, may take a variety of shapes and is therefore non-critical (Present Specification: ¶0127-0128). Please see MPEP §2144.04(IV)(B). Therefore, Layser in view of Houle further suggests that the protruding ring comprises a first-semi circular inner edge, two straight sides from the first semi-circular inner edge to an area of largest width of the ring, and a second semi-circular outer edge.
Regarding claim 13, Layser in view of Houle suggests the cassette of claim 9. Houle further teaches that the protruding outer collar (Fig. 11, feat. 21) and valve-seat member (Fig. 11, feat. 22) bear against each other to seal the housing (Fig. 11, feat. 19; Col. 5, line 54 – Col. 6, line 16). Therefore, Layser in view of Houle further suggests that the protruding ring is configured to provide localized sealing around the port.
Regarding claim 14, Layser in view of Houle suggests the cassette of claim 9. Houle further teaches that the protruding outer collar (Fig. 11, feat. 21) receives a recessed surface of the resilient seal (Annotated Fig. 5/11, feat. H). Therefore, Layser in view of Houle further suggests that the protruding ring is configured to align with a recessed portion of the valve assembly.
Regarding claim 15, Layser in view of Houle suggests the cassette of claim 9. Houle further teaches a resilient seal (Figs. 11-13, feats. 25, 26, 27, 28; Col. 5, line 4 – Col. 6, line 16), corresponding to the claimed elastomeric sealing element, held between the valve-seat member (Fig. 11, feat. 22) and the protruding outer collar (Fig. 11, feat. 21) to form and maintain the fluid seal, thereby squeegeeing the resilient seal as defined in the present specification (Present specification: ¶0129). Therefore, Layser in view of Houle further suggests that the protruding ring is configured to prevent the liquid from leaking into the port during the rotation of the valve assembly by squeegeeing a valve elastomer of the valve assembly.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Layser in view of Houle and in further view of Wolf (GB 1583821 A).
Regarding claim 4, Layser in view of Houle suggests the cassette of claim 1, but does not suggest that the valve elastomer is coated with a self-lubricating material.
Wolf teaches a rotary stopcock valve (Figs. 1-4, feat. 1; Page 1, line 72 – Page 2, line 39) comprising a bushing which is made of a self-lubricating material to ensure a good seal and long-term lubrication without needing to add lubricant (6; Page 2, lines 7-39). Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the cassette disclosed by Layser in view of Houle so that the valve elastomer is made of a self-lubricating material and therefore that the valve elastomer is coated with a self-lubricating material in order to ensure a good seal and long-term lubrication without needing to add lubricant as taught by Wolf.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Nitsche (US 2002/0084437 A1) discloses a valve assembly.
Ambrosina (US 2015/0137017 A1) discloses a fluid flow regulator.
Sonnier (US 11,598,439 B1) discloses a fluid valve.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARJUNA P CHATRATHI whose telephone number is (571)272-8063. The examiner can normally be reached M-F 8:30-5:00.
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/ARJUNA P CHATRATHI/Examiner, Art Unit 3781
/JESSICA ARBLE/Primary Examiner, Art Unit 3781
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