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 .
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over Claim 1 of copending Application No. 18/824,143 in view of Chiba (US PGPUB 2015/0122353 – “Chiba”). Claim 1 of co-pending patent application 18/824,143 disclosed all features of Claim 1, except for the feature of a curved guide on a valve stem, wherein the inlet, the outlet and the curved flow guide are configured to provide a curved sideways flow path for the fluid through the suction valve in the valve open state.
Chiba teaches a stem (Chiba FIG. 2, guide shaft 32) with a curved flow guide (Chiba FIG. 2, deflection surface 40 on valve disc 30), wherein the inlet, the outlet and the curved flow guide are configured to provide a curved sideways flow path for the fluid through the suction valve in the valve open state (Chiba FIG. 2, curved sideways flow path depicted an inflow direction D1 and passing direction D2).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine Chiba’s curved deflection surface with the stem disclosed by Leong in the endoscope disclosed by Leong. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of a suction valve having smooth suction flow (see Chiba paragraph [0063]).
See the following table for a comparison of Claim 1 to Claim 1 of co-pending U.S. patent application 18/824,143, showing non-overlapping elements in bold.
This is a provisional nonstatutory double patenting rejection.
Current patent application 18/824,157
Co-pending patent application 18/824,143
Claim 1
Claim 1
An endoscope comprising:
An endoscope comprising:
a handle or interface including a suction valve configured to control a suction;
a handle including a housing and a suction valve, the housing comprising a first half-shell and a second half-shell, the first half-shell including an outer fixing portion and an inner fixing portion, the second half-shell including an outer fixing portion and an inner fixing portion having a different geometry than the inner fixing portion of the first half-shell, the suction valve being mounted between the first half-shell and the second half-shell and comprising a valve body, a stem, a first portion and an second portion,
an insertion cord extending distally from the handle or interface and configured to be inserted into a patient; and
an insertion cord extending from the handle and configured to be inserted into a patient; and
a working channel extending through the insertion cord and configured to let fluids suctioned from the patient flow therethrough,
a working channel extending through the insertion cord and being connected to the inlet of the suction valve and configured to suction fluids from the patient;
wherein the outer fixing portion and the inner fixing portion of the first half-shell receive, respectively, the first portion and the second portion of the suction valve, wherein the outer fixing portion and the inner fixing portion of the second half-shell receive, respectively, the first portion and the second portion of the suction valve, and wherein the inner fixing portion of the first half-shell is configured to suppress at least one degree of freedom of the suction valve and the inner fixing portion of the second half-shell is configured to suppress a remaining degree or remaining degrees of freedom of the suction valve, the inner fixing portion of the first half-shell and the inner fixing portion of the second half-shell fixing a position and an orientation of the suction valve in the housing.
the suction valve being configured to control the suction through the working channel and comprising:
a working channel extending through the insertion cord and being connected to the inlet of the suction valve and configured to suction fluids from the patient;
a valve body including a valve cylinder;
, the suction valve being mounted between the first half-shell and the second half-shell and comprising a valve body
an inlet connected to the working channel, the inlet also connected to and extending away from the valve cylinder;
the valve body having an inlet and an outlet, and the stem being movable axially in the valve body to open and close the suction valve to control a suction through the suction valve;
an outlet adapted to be connected to a suction device, the outlet also connected to and extending away from the valve cylinder;
the valve body having an inlet and an outlet, and the stem being movable axially in the valve body to open and close the suction valve to control a suction through the suction valve;
a stem comprising a curved flow guide and being movable axially in the valve cylinder between at least a first position, in which the suction valve is in a valve closed state, and a second position, in which the suction valve is in a valve open state, the stem being configured to guide the fluid from the inlet to the outlet in the valve open state,
the stem being movable axially in the valve body to open and close the suction valve to control a suction through the suction valve
wherein the inlet, the outlet and the curved flow guide are configured to provide a curved sideways flow path for the fluid through the suction valve in the valve open state.
Claims 2-13 and 16-22 are rejected based on their dependence on rejected independent Claim 1.
Claim Objections
Claim 16 is objected to because of the following informalities: line 11 includes the feature of “stop of the step”, which appears to contain a typographical error and should read “stop of the stem”. Appropriate correction by Applicant is required.
Claim 17 is objected to because of the following informalities: line 3 includes the features of “the input and the output”, which have not antecedent basis, and which are interpreted as being a typographical error that should read “the inlet and the outlet”. Appropriate correction by Applicant is required.
Claim 18 is objected to because of the following informalities: line 3 includes the features of “the input and the output”, which have not antecedent basis, and which are interpreted as being a typographical error that should read “the inlet and the outlet”. Appropriate correction by Applicant is required.
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.
The present rejection(s) reference specific passages from cited prior art. However, Applicant is advised that the rejections are based on the entirety of each cited prior art. That is, each cited prior art reference “must be considered in its entirety”. Therefore, Applicant is advised to review all portions of the cited prior art if traversing a rejection based on the cited prior art.
Claims 1-7, 10, 13, 18, and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Leong et al. (US PGPUB 2019/0350440 – “Leong”) in view of Chiba (US PGPUB 2015/0122353 – “Chiba”).
Regarding Claim 1, Leong discloses:
An endoscope (Leong FIG. 1, endoscope 102) comprising:
a handle (Leong FIG. 1, handle 108) or interface including a suction valve (Leong FIG. 1, suction valve assembly 114) configured to control a suction (Leong paragraph [0052]);
an insertion cord (Leong FIG. 1, shaft 110) extending distally from the handle or interface and configured to be inserted into a patient (Leong paragraph [0029]); and
a working channel (Leong FIGs.3A-3C, working channel 206) extending through the insertion cord and configured to let fluids suctioned from the patient flow therethrough (Leong FIG. 2B, showing suction valve assembly 114 connected to working channel 206 by internal suction connector 224),
the suction valve being configured to control the suction through the working channel (Leong paragraphs [0049] – [0050]) and comprising:
a valve body (Leong FIG. 6A, cylindrical housing 600) including a valve cylinder (Leong FIG. 6A, cylindrical interior of housing 600);
an inlet (Leong FIB. 6A, inlet 626 in suction valve assembly 114) connected to the working channel, the inlet also connected to and extending away from the valve cylinder (Leong paragraph [0054], “Inlet 626 is configured project outwardly from housing 600 adjacent lower chamber 616 and sized to receive a proximal end of suction connector 224”);
an outlet (Leong FIG. 6A, outlet 624) adapted to be connected to a suction device, the outlet also connected to and extending away from the valve cylinder (Leong paragraph [0054], “Outlet 624 is configured to project outwardly from housing 600 adjacent upper chamber 614 to receive a source of negative pressure (suction)”);
a stem (Leong FIG. 6A, plunger 604) comprising a curved flow guide and being movable axially in the valve cylinder between at least a first position, in which the suction valve is in a valve closed state, and a second position, in which the suction valve is in a valve open state, the stem being configured to guide the fluid from the inlet to the outlet in the valve open state (Leong paragraph [0057]),
Leong does not explicitly disclose a stem with a curved flow guide, wherein the inlet, the outlet and the curved flow guide are configured to provide a curved sideways flow path for the fluid through the suction valve in the valve open state.
Chiba teaches a stem (Chiba FIG. 2, guide shaft 32) with a curved flow guide (Chiba FIG. 2, deflection surface 40 on valve disc 30), wherein the inlet, the outlet and the curved flow guide are configured to provide a curved sideways flow path for the fluid through the suction valve in the valve open state (Chiba FIG. 2, curved sideways flow path depicted an inflow direction D1 and passing direction D2).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine Chiba’s curved deflection surface with the stem disclosed by Leong in the endoscope disclosed by Leong. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of a suction valve having smooth suction flow (see Chiba paragraph [0063]).
Regarding Claim 2, Leong in view of Chiba teaches the features of Claim 1, as described above.
Leong in view of Chiba further teaches:
wherein the curved sideways flow path is provided by the curved flow guide of the stem in combination with an enclosed angle, between a first orientation or center axis of the inlet and a second orientation or center axis of the outlet, being larger than 90° and smaller than 180° seen in a side view of the handle or interface in an assembled state (Leong FIG. 6B, showing the center axis of the inlet 626 and the center axis of the outlet 624 being larger than 90° and smaller than 180°).
Regarding Claim 3, Leong in view of Chiba teaches the features of Claim 1, as described above.
Leong in view of Chiba further teaches:
wherein the curved sideways flow path is provided by the curved flow guide of the stem in combination with an enclosed angle, between a first orientation or center axis of the inlet and a second orientation or center axis of the outlet, being larger than 90° and smaller than 180° seen in a side view of the handle or interface in an assembled state (Leong FIG. 6B, showing the center axis of the inlet 626 and the center axis of the outlet 624 being larger than 90° and smaller than 180°).
Chiba further teaches wherein the stem (Chiba FIG. 1, guide shaft 32) comprises a sealing edge (Chiba FIG. 1, rim of valve disc 30), and wherein the valve body (Chiba FIG. 1, body 10) comprises a valve seat (Chiba FIG. 1, valve seat 20) configured to make circumferential contact with the sealing edge of the stem in the valve closed state (see Chiba paragraph [0080]).
Regarding Claim 4, Leong in view of Chiba teaches the features of Claim 1, as described above.
Chiba further teaches:
wherein the stem (Chiba FIG. 1, guide shaft 32) comprises a sealing edge (Chiba FIG. 1, rim of valve disc 30), and
wherein the valve body (Chiba FIG. 1, body 10) comprises a valve seat (Chiba FIG. 1, valve seat 20) configured to make circumferential contact with the sealing edge of the stem in the valve closed state (see Chiba paragraph [0080]).
Regarding Claim 5, Leong in view of Chiba teaches the features of Claim 4, as described above.
Chiba further teaches wherein the valve seat (Chiba FIG. 8B, valve seat 20) and the sealing edge (Chiba FIG. 8B, deflection surface 40 of disc 30) are tapered at an acute angle (see Chiba FIGs. 8A-8B), the valve seat forming a substantially conical sealing seat (Chiba FIG. 6, showing conical shape of valve seat/disc 30).
Regarding Claim 6, Leong in view of Chiba teaches the features of Claim 4, as described above.
Chiba further teaches wherein the valve seat and the sealing edge are tapered at an acute angle forming a substantially conical seal in the valve closed state (Chiba FIG. 8A, showing valve seat 20 and surface 40 of disc 30 in a valve closed state).
Regarding Claim 7, Leong in view of Chiba teaches the features of Claim 4, as described above.
Chiba further teaches wherein the stem comprises, at an end portion thereof, a sealing plate surrounded by the sealing edge (Chiba FIG. 8B, resin sheet 44; Chiba paragraph [0096], “resin sheet 44 is a water-tight, sheet-like sealing component held between the valve seat 20 and the valve disc 30”).
Regarding Claim 10, Leong in view of Chiba teaches the features of Claim 1, as described above.
Leong in view of Chiba further teaches:
wherein the curved sideways flow path is provided by the curved flow guide of the stem in combination with an enclosed angle, between a first orientation or center axis of the inlet and a second orientation or center axis of the outlet, being larger than 90° and smaller than 180° seen in a side view of the handle or interface in an assembled state (Leong FIG. 6B, showing the center axis of the inlet 626 and the center axis of the outlet 624 being larger than 90° and smaller than 180°).
Chiba further teaches:
wherein the stem comprises a sealing plate surrounded by a sealing edge (Chiba FIG. 8B, resin sheet 44; Chiba paragraph [0096], “resin sheet 44 is a water-tight, sheet-like sealing component held between the valve seat 20 and the valve disc 30”), wherein the valve body (Chiba FIG. 1, body 10) comprises a valve seat (Chiba FIG. 1, valve seat 20), and
wherein the valve seat (Chiba FIG. 8B, valve seat 20) and the sealing edge (Chiba FIG. 8B, deflection surface 40 of disc 30) are tapered at an acute angle (see Chiba FIGs. 8A-8B), the valve seat forming a substantially conical sealing seat (Chiba FIG. 6, showing conical shape of valve seat/disc 30).
Regarding Claim 13, Leong in view of Chiba teaches the features of Claim 1, as described above.
Leong in view of Chiba further teaches:
wherein the suction valve (Chiba FIG. 1, valve 100) comprises a valve spring (Chiba FIG. 1, spring 50) positioned between the valve body and the stem and configured to close the suction valve (Chiba FIG. 1, showing valve 100 in a closed position), and
wherein the valve spring comprises a bypass hole (Leong FIG. 2B, opening in access port assembly 116 connected to suction valve assembly 114 by internal connector 224) configured to allow ambient air to be drawn through the suction valve in the valve closed state (Examiner interprets the opening in Leong’s access port assembly 116 as allowing ambient air to be drawn to the suction valve assembly 114).
Regarding Claim 18, Leong in view of Chiba teaches the features of Claim 1, as described above.
Chiba further teaches wherein the stem (Chiba FIG. 2, guide shaft 32) comprises a recess (Chiba FIG. 2, recess formed at the end of valve disc 30) comprising the curved flow guide (Chiba FIG. 2, deflection surface 40 on valve disc 30), the recess extending, at least in sections, perpendicular to an axial direction of the stem (Chiba FIG. 2, showing the portion of the end of valve disc 30 that is adjacent to outflow cylinder 16 being perpendicular to the axial direction of guide shaft 32), and
wherein the recess in the valve open state connects the input and the output to each other (Chiba FIG. 2, inlet opening 23 outlet opening 25).
Regarding Claim 22, Leong in view of Chiba teaches the features of the endoscope (Leong FIG. 1, endoscope 102) of Claim 1, as described above.
Leong further discloses:
a video processing apparatus (Leong FIG. 9, processing unit 920 and output device 950; see also Leong paragraphs [0086] – [0087]).
Claims 8-9 and 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Leong et al. (US PGPUB 2019/0350440 – “Leong”) in view of Chiba (US PGPUB 2015/0122353 – “Chiba”) and Duex (US PGPUB 2006/0137747 – “Duex”).
Regarding Claim 8, Leong in view of Chiba teaches the features of Claim 4, as described above.
Leong in view of Chiba does not explicitly teach:
wherein the stem comprises a retention hook sized and configured to be pushed in a first direction through the valve seat and into the valve body during assembly, and
wherein the retention hook is sized and configured to hook onto the valve seat when the stem is pulled in a direction opposite the first direction to prevent removal of the stem from the valve body.
Duex teaches:
wherein the stem (Examiner-annotated Duex FIG. 1 shown below, valve stem 34) comprises a retention hook (Duex FIG. 1, retention hook) sized and configured to be pushed in a first direction through the valve seat (Duex FIG. 1, valve seat 30) and into the valve body (Duex FIG. 1, inner sleeve 46) during assembly, and
wherein the retention hook is sized and configured to hook onto the valve seat when the stem is pulled in a direction opposite the first direction to prevent removal of the stem from the valve body (Duex paragraph [0039], “poppet valve stem 34 is made of a resilient material and the cylindrical interior 72 of the inner sleeve 46 is of a diameter just slightly greater than the diameter of the major base 58 of the partial frustoconical structure 54…Consequently, the stem 34 may be inserted into the post 36…until the same enters the cylindrical section 72, at which time, its resilience will restore it to the shape illustrated in FIG. 2, 3, and 6”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine Duex’s retention hook with the suction valve taught by Leong in the endoscope taught by Leong in view of Chiba. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of a suction valve having a permanent snap-fit connection between the valve stem and the interior body of the valve assembly (see Duex paragraph [0039]).
Regarding Claim 9, Leong in view of Chiba and Deux teaches the features of Claim 8, as described above.
Duex further teaches wherein the valve seat is elastic and configured to allow the stem to be assembled into the valve body in a push-through manner (Duex paragraph [0039], “poppet valve stem 34 is made of a resilient material and the cylindrical interior 72 of the inner sleeve 46 is of a diameter just slightly greater than the diameter of the major base 58 of the partial frustoconical structure 54…Consequently, the stem 34 may be inserted into the post 36…until the same enters the cylindrical section 72, at which time, its resilience will restore it to the shape illustrated in FIG. 2, 3, and 6”).
Regarding Claim 11, Leong in view of Chiba teaches the features of Claim 10, as described above.
Leong in view of Chiba does not explicitly teach:
wherein the stem comprises a retention hook sized and configured to be pushed in a first direction through the valve seat and into the valve body during assembly, and
wherein the retention hook is sized and configured to hook onto the valve seat when the stem is pulled in a direction opposite the first direction to prevent removal of the stem from the valve body.
Duex teaches:
wherein the stem (Examiner-annotated Duex FIG. 1 shown below, valve stem 34) comprises a retention hook (Duex FIG. 1, retention hook) sized and configured to be pushed in a first direction through the valve seat (Duex FIG. 1, valve seat 30) and into the valve body (Duex FIG. 1, inner sleeve 46) during assembly, and
wherein the retention hook is sized and configured to hook onto the valve seat when the stem is pulled in a direction opposite the first direction to prevent removal of the stem from the valve body (Duex paragraph [0039], “poppet valve stem 34 is made of a resilient material and the cylindrical interior 72 of the inner sleeve 46 is of a diameter just slightly greater than the diameter of the major base 58 of the partial frustoconical structure 54…Consequently, the stem 34 may be inserted into the post 36…until the same enters the cylindrical section 72, at which time, its resilience will restore it to the shape illustrated in FIG. 2, 3, and 6”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine Duex’s retention hook with the suction valve taught by Leong in the endoscope taught by Leong in view of Chiba. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of a suction valve having a permanent snap-fit connection between the valve stem and the interior body of the valve assembly (see Duex paragraph [0039]).
Regarding Claim 12, Leong in view of Chiba and Deux teaches the features of Claim 11, as described above.
Deux further teaches wherein the valve seat is elastic and configured to allow the stem to be assembled into the valve body in a push-through manner (Duex paragraph [0039], “poppet valve stem 34 is made of a resilient material and the cylindrical interior 72 of the inner sleeve 46 is of a diameter just slightly greater than the diameter of the major base 58 of the partial frustoconical structure 54…Consequently, the stem 34 may be inserted into the post 36…until the same enters the cylindrical section 72, at which time, its resilience will restore it to the shape illustrated in FIG. 2, 3, and 6”).
Claims 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Leong et al. (US PGPUB 2019/0350440 – “Leong”) in view of Chiba (US PGPUB 2015/0122353 – “Chiba”) and Puster et al. (US Patent 3,116,905 – “Puster”).
Regarding Claim 16, Leong in view of Chiba teaches the features of Claim 1, as described above.
Leong in view of Chiba further teaches:
wherein the curved sideways flow path is provided by the curved flow guide of the stem in combination with an enclosed angle, between a first orientation or center axis of the inlet and a second orientation or center axis of the outlet, being larger than 90° and smaller than 180° seen in a side view of the handle or interface in an assembled state (Leong FIG. 6B, showing the center axis of the inlet 626 and the center axis of the outlet 624 being larger than 90° and smaller than 180°).
Chiba further teaches:
wherein the stem comprises a sealing plate surrounded by a sealing edge (Chiba FIG. 8B, resin sheet 44; Chiba paragraph [0096], “resin sheet 44 is a water-tight, sheet-like sealing component held between the valve seat 20 and the valve disc 30”), wherein the valve body (Chiba FIG. 1, body 10) comprises a valve seat (Chiba FIG. 1, valve seat 20),
wherein the valve seat and the sealing edge are tapered at an acute angle forming a substantially conical seal in the valve closed state,
wherein the valve seat (Chiba FIG. 8B, valve seat 20) and the sealing edge (Chiba FIG. 8B, deflection surface 40 of disc 30) are tapered at an acute angle (see Chiba FIGs. 8A-8B) forming a substantially conical seal in the valve closed state (Chiba FIG. 6, showing conical shape of valve seat/disc 30; Chiba FIG. 1A, showing valve in closed state).
wherein the suction valve (Chiba FIG. 1, valve 100) comprises a valve spring (Chiba FIG. 1, spring 50) positioned between the valve body and the stem and configured to close the suction valve (Chiba FIG. 1, showing valve 100 in a closed position),
wherein the valve spring comprises a bypass hole (Leong FIG. 2B, opening in access port assembly 116 connected to suction valve assembly 114 by internal connector 224) configured to allow ambient air to be drawn through the suction valve in the valve closed state (Examiner interprets the opening in Leong’s access port assembly 116 as allowing ambient air to be drawn to the suction valve assembly 114).
Leong in view of Chiba does not explicitly teach the stem comprises a stop, the stop of the stem is configured to be brought into contact with the valve body to limit motion of the stem.
Puster teaches the stem (Puster FIG. 2, actuator stem 44) comprises a stop (Puster FIG. 2, snap ring 50), the stop of the stem is configured to be brought into contact with the valve body (Puster FIG. 2, casing 14) to limit motion of the stem (Puster col. 3, lines 63-76, “actuator stem 44 will continue to move upwardly until snap ring 50 engages the bottom wall of the transmitter casing 14, thereby preventing damage to the bellows due to overtravel.”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine Puster’s stem stop with the stem taught by Chiba in the endoscope taught by Leong in view of Chiba. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of a stem whose travel is limited, thus preventing damage to the valve (see Puster col. 1, lines 61-72).
Regarding Claim 17, Leong in view of Chiba and Puster teaches the features of Claim 16, as described above.
Chiba further teaches wherein the stem (Chiba FIG. 2, guide shaft 32) comprises a recess (Chiba FIG. 2, recess formed at the end of valve disc 30) comprising the curved flow guide (Chiba FIG. 2, deflection surface 40 on valve disc 30), the recess extending, at least in sections, perpendicular to an axial direction of the stem (Chiba FIG. 2, showing the portion of the end of valve disc 30 that is adjacent to outflow cylinder 16 being perpendicular to the axial direction of guide shaft 32), and
wherein the recess in the valve open state connects the input and the output to each other (Chiba FIG. 2, inlet opening 23 outlet opening 25).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Leong et al. (US PGPUB 2019/0350440 – “Leong”) in view of Chiba (US PGPUB 2015/0122353 – “Chiba”) and Closs et al. (WO 2022/152674 A1 – “Closs”).
Regarding Claim 19, Leong in view of Chiba teaches the features of Claim 1, as described above.
Leong in view of Chiba does not explicitly teach wherein the valve body and the stem are each comprised in one piece of a thermoplastic material comprising at least 70% polypropylene.
Closs teaches an analogous valve body and stem that are each comprised in one piece of a thermoplastic material (injection molded or 3D printed/additive manufactured, see page 4, lines 23-30, page 5, lines 1-12, preferably made from a polymer/plastic material including thermoplastic polyurethane, silicone, etc., page 10, lines 7-23), which are known for their cost-effectiveness, sufficient rigidity and flexibility, and preferred tensile strength and modulus of elasticity (page 10, lines 7-16).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to have manufactured each of the valve body and the stem of the suction valve of Leong to each comprised in one piece of a thermoplastic material as taught by Closs in order to have provided a cost effective and low priced endoscope having an improved suction valve that has cost effective valve body and stem which are cheap to manufacture while having the desired material properties of a thermoplastic polymer.
Moreover, it would have also obvious to one of ordinary skill in the art to have used 70% polypropylene as the thermoplastic polymer material that is known for its lightweight, durability, high chemical resistance, and high-heat tolerance which is ideal for endoscopes that are exposed to high-heat sterilization during the endoscope’s product lifecycle, also because it has been held that the selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945) also see In re Leshin, 277 F.2d 197, 125 USPQ 416 (CCPA 1960) (selection of a known plastic to make a container of a type made of plastics prior to the invention was held to be obvious). Furthermore, with regards to the 70% polypropylene, a skilled artisan would have recognized polypropylene as an interchangeable and known thermoplastic choice and would have tried known polypropylene blends to obtain acceptable mechanical and processing properties (such as being lightweight, durable, high chemical resistance, and high-heat tolerance which is ideal for endoscopes that are exposed to high-heat sterilization during the endoscope’s product lifecycle which is a predictable result). Selection of a specific polypropylene content is a predictable optimization—balancing mechanical and processing properties (see above)—such that choosing 70% polypropylene would have been an obvious design choice. Under Graham v. John Deere and KSR v. Teleflex, the limitation ‘70% polypropylene’ is an obvious variation of the prior art in view of the cited references and common general knowledge. The applicant does not show any evidence of criticality or unexpected properties arising from 70% polypropylene that would establish nonobviousness. See paragraph [0106] of Applicant’s written specification, which teaches that components may comprise more than 70% of polypropylene, but does not evidence any criticality of this percentage or any unpredictable result from the use thereof. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007) and In re Brana, 51 F.3d 1560 (Fed. Cir. 1995).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Leong et al. (US PGPUB 2019/0350440 – “Leong”) in view of Chiba (US PGPUB 2015/0122353 – “Chiba”), Christensen et al. (EP 3 903 661 A1 – “Christensen”), and Closs et al. (WO 2022/152674 A1 – “Closs”).
Regarding Claim 20, Leong in view of Chiba teaches the features of Claim 1, as described above.
Leong in view of Chiba does not explicitly teach wherein the handle, the valve body and the stem, are each comprised of at least 70% polypropylene material.
Christensen teaches wherein the handle is comprised of at least 70% polypropylene material.
Christensen teaches an analogous endoscope (Christensen FIG. 1, endoscope 1) having a handle (Christensen FIG. 1, handle 2) having an analogous handle housing (Christensen FIG. 1, handle housing 116). Christensen further teaches the handle is composed of polypropylene (Christensen paragraphs [0017] – [0018]) for the advantage of saving material costs, weight, and ease of manufacture (Christensen paragraph [0012]).
Therefore, it would have been obvious to one ordinary skill in the art at the time the invention was made to have manufactured the handle of Leong such that it is composed of 70% polypropylene in order to have provided a cost effective endoscope that has a lightweight handle that is cheap and easy to manufacture while providing the preferred rigidity, tensile strength, durability, and heat/chemical resistance (Christensen paragraph [0012]). Furthermore, with regards to the 70% polypropylene limitation, a skilled artisan would have recognized polypropylene as an interchangeable and known thermoplastic choice and would have tried known polypropylene blends to obtain acceptable mechanical and processing properties (such as being lightweight, durable, high chemical resistance, and high-heat tolerance which is ideal for endoscopes that are exposed to high-heat sterilization during the endoscope’s product lifecycle which is a predictable result). Selection of a specific polypropylene content is a predictable optimization—balancing mechanical and processing properties (see above)—such that choosing 70% polypropylene would have been an obvious design choice. Under Graham v. John Deere and KSR v. Teleflex, the limitation ‘70% polypropylene’ is an obvious variation of the prior art in view of the cited references and common general knowledge. The applicant does not show any evidence of criticality or unexpected properties arising from 70% polypropylene that would establish nonobviousness. That is, while applicant’s written specification teaches that the suction valve may comprise at least 70% polypropylene (paragraph [0038]) and valve components may comprise at least 70% polypropylene (paragraph [0106]), there is no evidence in the specification that these percentages are critical to the operation of the invention or that they would result in any unpredictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007) and In re Brana, 51 F.3d 1560 (Fed. Cir. 1995).
Leong in view of Chiba and Christensen does not explicitly teach wherein the valve body and the stem are each comprised of at least 70% polypropylene material.
Closs teaches an analogous valve body and stem that are each comprise in one piece of a thermoplastic material (injection molded or 3D printed/additive manufactured, see page 4, lines 23-30, page 5, lines 1-12, preferably made from a polymer/plastic material including thermoplastic polyurethane, silicone, etc., page 10, lines 7-23), which are known for their cost-effectiveness, sufficient rigidity and flexibility, and preferred tensile strength and modulus of elasticity (page 10, lines 7-16).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to have manufactured each of the valve body and the stem of the suction valve of Leong to each comprised in one piece of a thermoplastic material as taught by Closs in order to have provided a cost effective and low priced endoscope having an improved suction valve that has cost effective valve body and stem which are cheap to manufacture while having the desired material properties of a thermoplastic polymer.
Moreover, it would have also obvious to one of ordinary skill in the art to have used 70% polypropylene as the thermoplastic polymer material that is known for its lightweight, durability, high chemical resistance, and high-heat tolerance which is ideal for endoscopes that are exposed to high-heat sterilization during the endoscope’s product lifecycle, also because it has been held that The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945) also see In re Leshin, 277 F.2d 197, 125 USPQ 416 (CCPA 1960) (selection of a known plastic to make a container of a type made of plastics prior to the invention was held to be obvious). Furthermore, with regards to the 70% polypropylene, a skilled artisan would have recognized polypropylene as an interchangeable and known thermoplastic choice and would have tried known polypropylene blends to obtain acceptable mechanical and processing properties (such as being lightweight, durable, high chemical resistance, and high-heat tolerance which is ideal for endoscopes that are exposed to high-heat sterilization during the endoscope’s product lifecycle which is a predictable result). Selection of a specific polypropylene content is a predictable optimization—balancing mechanical and processing properties (see above)—such that choosing 70% polypropylene would have been an obvious design choice. Under Graham v. John Deere and KSR v. Teleflex, the limitation ‘70% polypropylene’ is an obvious variation of the prior art in view of the cited references and common general knowledge. The applicant does not show any evidence of criticality or unexpected properties arising from 70% polypropylene that would establish nonobviousness. See paragraph [0106] of Applicant’s written specification, which teaches that components may comprise more than 70% of polypropylene, but does not evidence any criticality of this percentage or any unpredictable result from the use thereof. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007) and In re Brana, 51 F.3d 1560 (Fed. Cir. 1995).
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Leong et al. (US PGPUB 2019/0350440 – “Leong”) in view of Chiba (US PGPUB 2015/0122353 – “Chiba”), Christensen et al. (EP 3 903 661 A1 – “Christensen”), Closs et al. (WO 2022/152674 A1 – “Closs”), and Kulshrestha et al. (AU 2016201295 A1 – “Kulshrestha”).
Regarding Claim 21, Leong in view of Chiba, Christensen, and Closs teaches the features of Claim 21, as described above.
Leong in view of Chiba, Christensen, and Closs do not explicitly teach wherein at least 20% of the polypropylene material is bio-propylene.
Kulshrestha teaches that polypropylene polymers (i.e., those formed from virgin resin components such as fossil fuels) and bio-propylene (i.e., those formed from biological sources or renewable agricultural sources) are commonly used when fabricating medical articles (see Kulshrestha paragraphs [0035] – [0055]). The present patent application states in paragraph [0061] that a components of the endoscope can be made of polypropylene, and that natural fibers (not bio-based polypropylene) can be added to add additional strength to the components. The present specification does not describe why using at least 20% bio-polypropylene is critical or would show an unexpected result. As such, using at least 20% bio-polypropylene is merely a design choice, which is not described as critical in the specification.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to utilize polypropylene that includes at least 20% bio-polypropylene in the construction of an endoscope. A person having ordinary skill in the art would be motivated to use bio-polypropylene based on its availability, desire to protect Earth’s environment, etc.
Allowable Subject Matter
Claims 14-15 are 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.
The following is a statement of reasons for the indication of allowable subject matter: no combination of the identified prior art teaches or suggests a valve having a valve spring that forms a bellows shape configured to close the bypass hole as claimed in Claim 14.
The closest identified prior art is Lee et al. (US PGPUB 2020/0018414 – “Lee”), which teaches Lee FIG. 4C a valve spring 140 and a gas bypass hole 111. However, Lee’s valve spring does not close the bypass hole, and further does not form a bellow shape.
Claim 15 is deemed allowable based on depending on Claim 14.
Conclusion
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JIM BOICE
Examiner
Art Unit 3795
/JAMES EDWARD BOICE/Examiner, Art Unit 3795
/ANH TUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795
03/02/26