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 Objections
Claim 22 is objected to because of the following informalities: Claim 22 recites “the second sidewall has a plurality of fins extending from the second sidewall into the chamber and configured to support the diaphragm” but this is repetitive since claim 21 has been amended to recite this exact language. Accordingly, this language should be removed from claim 22 and the term “having” on line 3 of claim 22 should be replaced with the term “has” in order to be grammatically correct. Appropriate correction is required.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-8 and 20-22 are rejected under 35 U.S.C. 103 as being unpatentable over Manske (US Pat 4,141,379) in view of Ruschke (US Pat 4,966,199).
Re claim 1, Manske discloses an inline flow control device (Fig 1; it is noted that all reference characters cited below refer to Fig 1 unless otherwise noted) for a passive irrigation tubing 20 to be used with an electrophysiology device1 22 (as seen in Fig 1; Col 2, Lines 53-65), comprising: a proximal lumen 42 coupled to a portion of the irrigation tubing (the portion extending proximally from valve CV and directly connected to drip chamber 18 in Fig 1; oriented toward the top of Fig 2,3) that is coupled to an irrigation fluid source (container of solution A, as seen in Fig 1); a distal lumen 44 coupled to a portion of the irrigation tubing (the portion extending distally from valve CV and having adapter 26 thereon in Fig 1; oriented toward the bottom of Fig 2,3) that is coupled to the electrophysiology device (as seen in Fig 1); a diaphragm 54 (Fig 2) having a first surface (facing upward in Fig 2,3) and a second surface (facing downward in Fig 2,3), the diaphragm housed in a chamber (the space within portion 46, as seen in Fig 2,3) having first and second opposing sidewalls (seen in Fig 2,3 but not labeled; labeled in annotated Fig A below), the first sidewall having a first opening (seen in Fig 2, but not labeled; labeled in Fig A below) in communication with the proximal lumen (as seen in Fig 2,3) and the second sidewall having a second opening (seen in Fig 2, but not labeled; labeled in Fig A below) in communication with the distal lumen (as seen in Fig 2,3), the second sidewall having a plurality of fins 58 (Fig 2-4) extending from the second sidewall into the chamber and configured to support the diaphragm (as seen in Fig 2), each fin of the plurality of fins having a generally uniform thickness along its length (as seen in Fig 4), wherein the diaphragm is elastically flexible (Col 3, Line 43 – “resilient disc 54”; Col 3, Line 54 – “synthetic rubber”) and at least unfixed at its peripheral edge (Col 3, Lines 43-44 – “a thin resilient disc 54 which […] rests loosely on screen 52”) within the chamber so as to assume configurations including: a neutral2 configuration (as seen in Fig 2) in which there is a space gap construction between the diaphragm and the chamber that allows a first predetermined fluid flow through the device (Col 3, Line 67 – Col 4, Line 2), the space gap construction comprising a first space gap between the first surface of the diaphragm and an interior surface of the first sidewall (as seen in Fig 2) and a second space gap between the peripheral edge of the diaphragm and the first sidewall (as seen in Fig 2) and a second flexed configuration (as seen in Fig 3) in which the space gap between the first surface of the diaphragm and the interior surface of the first sidewall is reduced to zero to thereby block backflow through the device from the distal lumen (Col 4, Lines 2-8), and the diaphragm configured to move from the neutral configuration to the second flexed configuration when fluid enters the chamber from the distal lumen and surpasses the predetermined threshold flow rate or when a positive pressure is generated in the distal lumen that surpasses the pressure imparted by the predetermined threshold flow rate, and the diaphragm configured to return to the neutral configuration to again allow the first predetermined fluid flow when the fluid entering the distal lumen decreases to below the predetermined threshold flow rate or when the positive pressure in the distal lumen reduces below the pressure imparted by the predetermined threshold flow rate (Col 3, Line 67 – Col 4, Line 8).
Manske does not disclose that the neutral configuration includes a third space gap between a peripheral outer edge of at least one of the plurality of fins and a radial wall between the first and second sidewalls or that the diaphragm can assume a first flexed configuration that is generally opposite the second flexed configuration and in which the space gap between the first surface of the diaphragm and the interior surface of the first sidewall is widened such that it allows a second fluid flow through the device that is greater than the first predetermined fluid flow through the device, wherein the diaphragm is configured to move from the neutral configuration to the first flexed configuration when fluid entering the proximal lumen surpasses a predetermined threshold flow rate or when negative pressure in the distal lumen surpasses a pressure imparted by the predetermined threshold flow rate to thereby draw the diaphragm towards the plurality of fins, and the diaphragm is configured to return to the neutral configuration to again allow the first predetermined fluid flow when the fluid entering the proximal lumen decreases to below the predetermined threshold flow rate or when the negative pressure in the distal lumen reduces below the pressure imparted by the predetermined threshold flow rate.
Ruschke, however, teaches a valve 2 (Fig 1; it is noted that all reference characters cited below refer to Fig 3-6 unless otherwise noted) substantially similar to Manske’s valve CV, wherein the valve comprises a proximal lumen (the tubular structure forming passage 4), a distal lumen (the tubular structure forming passage 6), a diaphragm 10 having a first surface (facing to the left in Fig 3-5) and a second surface (facing to the right in Fig 3-5), and a chamber 8 having a first sidewall (seen in Fig 3-5 but not labeled; labeled in annotated Fig B below) with a first opening (seen in Fig 3-5, but not labeled; labeled in annotated Fig B below) in communication with the proximal lumen (as seen in Fig 3-5) and an opposed second sidewall (seen in Fig 3,5, but not labeled; labeled in annotated Fig B below) with a second opening (seen in Fig 3-5, but not labeled; labeled in annotated Fig B below) in communication with the distal lumen (as seen in Fig 3-5), the second sidewall having a plurality of fins 38 extending from the second sidewall into the chamber and configured to support the diaphragm (as seen in Fig 3), each fin of the plurality of fins having a generally uniform thickness along its length (as seen in Fig 6,7), wherein the diaphragm is elastically flexible (Col 3, Lines 23-27 – “flexible diaphragm 10”, “made of a medical grade silicone rubber material”) and at least unfixed at its peripheral edge within the chamber (as seen in Fig 3-5; Col 4, Lines 65-66) so as to assume configurations including a neutral configuration (seen in Fig 3) in which there is a space gap construction between the diaphragm and the chamber that allows a first predetermined fluid flow through the device (Col 4, Lines 7-9 – “the above-mentioned line contact when the diaphragm is in an at rest position is desirable but not necessary”), the space gap construction comprising a first space gap between the first surface of the diaphragm and an interior surface of the first sidewall (as set forth in Col 4, Lines 7-9 – “the above mentioned line contact when the diaphragm is in an at rest position is desirable but not necessary”; additionally, Fig 3 shows such a gap existing between the upper surface of the diaphragm and the portion of the first side wall that is radially outward from the concave sealing surface 34), a second space gap between the peripheral edge of the diaphragm and the first sidewall (as seen in Fig 3, such a gap exists between the peripheral edge of the diaphragm and the portion of the first sidewall that is radially outward from the concave sealing surface 34), and a third space gap between a peripheral outer edge of at least one of the plurality of fins and a radially wall between the first and second sidewalls (as seen in Fig 6, the peripheral outer edge of at least one fin 38 is spaced from wall 44), a first flexed configuration (seen in Fig 4) in which the space gap between the first surface of the diaphragm and the interior surface of the first sidewall is widened such that it allows a second fluid flow through the device that is greater than the first predetermined fluid flow through the device (Col 4, Lines 49-64), and a second flexed configuration (seen in Fig 5) that is generally opposite the first flexed configuration in which the space gap between the first surface of the diaphragm and the interior surface of the first sidewall is reduced to zero to thereby block backflow through the device from the distal lumen (Col 5, Lines 43-50; Col 6, Lines 8-13), the diaphragm configured to move from the neutral configuration to the first flexed configuration when fluid entering the proximal lumen surpasses a predetermined threshold flow rate or when negative pressure in the distal lumen surpasses a pressure imparted by the predetermined threshold flow rate to thereby draw the diaphragm towards the plurality of fins, and the diaphragm configured to return to the neutral configuration to again allow the first predetermined fluid flow when the fluid entering the proximal lumen decreases to below the pressure imparted by the predetermined threshold flow rate or when the negative pressure in the distal lumen reduces below the predetermined threshold flow rate (Col 4, Lines 49-64), and the diaphragm configured to move from the neutral configuration to the second flexed configuration when fluid enters the chamber from the distal lumen and surpasses the predetermined threshold flow rate or when a positive pressure is generated in the distal lumen that surpasses the pressure imparted by the predetermined threshold flow rate, and the diaphragm configured to return to the neutral configuration to again allow the first predetermined fluid flow when the fluid entering the distal lumen decreases to below the predetermined threshold flow rate or when the positive pressure in the distal lumen reduces below the pressure imparted by the predetermined threshold flow rate (Col 5, Lines 43-60; Col 6, Lines 8-13). Ruschke teaches that providing a diaphragm that can possess a neutral configuration having a space gap construction that allows a fluid flow through the device, a first flexed configuration that allows greater fluid flow through the device, and a second flexed configuration that blocks backflow through the device from the distal lumen allows for the valve to provide various rates of delivery (Col 4, Lines 54-57). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Manske to include the valve 2 of Ruschke – which possesses all three configurations – in place of valve CV – which only possesses two of the three configurations – for the purpose of providing various rates of delivery (Col 4, Lines 54-57). The Examiner reiterates that this modification would replace Manske’s entire valve CV with Ruschke’s valve 2.
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Re claim 2, Manske as modified by Ruschke in the rejection of claim 1 above discloses all the claimed features with Ruschke teaching that the device defines a fluid path that extends through the proximal lumen, over the first surface of the diaphragm, around a circumferential outer edge of the diaphragm, under the second surface of the diaphragm, and through the distal lumen. (as seen in Fig 4; Col 4, Lines 58-61).
Re claims 3 and 20, Manske as modified by Ruschke in the rejection of claim 1 discloses all the claimed features. Ruschke (whose valve 2 has replaced Manske’s valve CV in the rejection of claim 1) shows four substantially evenly-spaced fins and states that the number of fins “may be varied as desired” (Col 7, Lines 22-26), but does not explicitly disclose that the plurality of fins comprises eight fins (as required by claim 3) wherein each of the eight fins is spaced at about 45 degrees from an adjacent one of the plurality of fins about a longitudinal axis of the device (as required by claim 20). Manske, however, teaches eight fins 58 that are each spaced at about 45 degrees from each other (as seen in Fig 4) so as to provide a platform on which the diaphragm can rest (Col 3, Lines 62-67). Since this is the same purpose as Ruschke’s fins, a support formed of four substantially evenly-spaced fins and a support formed of eight substantially evenly-spaced fins were art-recognized equivalents at the time the invention was made. Therefore, it would have been obvious to one of ordinary skill in the art to modify Ruschke to include eight substantially evenly-spaced fins instead of four substantially evenly-spaced fins, as disclosed by Manske, since it has been held that substituting one arrangement with an equivalent arrangement involves only routine skill in the art. Additionally, it would have been obvious to one of ordinary skill in the art at the time the invention was made to include eight substantially evenly-spaced fins instead of four substantially evenly-spaced fins since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art.
Re claim 4, Manske as modified by Ruschke in the rejection of claim 1 discloses all the claimed features with Ruschke teaching that each fin of the plurality of fins has a tapered profile (as seen in Fig 6; Col 4, Lines 14-19).
Re claim 5, Manske as modified by Ruschke in the rejection of claim 1 discloses all the claimed features with Ruschke teaching that each fin of the plurality of fins has a taller inner edge and a shorter outer edge to provide the tapered profile (as seen in Fig 6; Col 4, Lines 14-24).
Re claim 6, Manske as modified by Ruschke in the rejection of claim 1 above discloses all the claimed features with Ruschke teaching that the diaphragm in the neutral configuration is generally planar (as seen in Fig 3).
Re claim 7, Manske as modified by Ruschke in the rejection of claim 1 above discloses all the claimed features with Ruschke teaching that the diaphragm in the first flexed configuration is flexed toward the second sidewall (as seen in Fig 4).
Re claim 8, Manske as modified by Ruschke in the rejection of claim 1 above discloses all the claimed features with Ruschke teaching that the diaphragm in the second flexed configuration is flexed toward the first sidewall (as seen in Fig 5).
Re claim 21, Manske discloses irrigation system (Fig 1; it is noted that all reference characters cited below refer to Fig 1 unless otherwise noted) for irrigating an electrophysiology device3 22 (as seen in Fig 1; Col 2, Lines 53-65), the irrigation system comprising: a fluid source (container of solution A, as seen in Fig 1) connected to a first end of a proximal fluid conduit (the portion of 20 extending proximally from valve CV and directly connected to drip chamber 18 in Fig 1; oriented toward in the top in Fig 2,3); the electrophysiology device configured for connection to a first end of a distal fluid conduit (the portion of 20 extending distally from valve CV and having adapter 26 thereon in Fig 1; oriented toward in the bottom in Fig 2,3); an inline flow control device CV comprising: a proximal device lumen 42 in fluid communication with the proximal fluid conduit (as seen in Fig 2,3); a distal device lumen 44 in fluid communication with the distal fluid conduit (as seen in Fig 2,3); and a diaphragm 54 having a first surface (facing upward in Fig 2,3) and a second surface (facing downward in Fig 2,3), the diaphragm housed in a chamber (the space within portion 46, as seen in Fig 2,3) having first and second opposing sidewalls (seen in Fig 2,3 but not labeled; labeled in annotated Fig A above), the first sidewall having a first opening (seen in Fig 2,3 but not labeled; labeled in Fig A above) in communication with the proximal device lumen (as seen in Fig 2,3) and the second sidewall (seen in Fig 2,3 but not labeled; labeled in Fig A above) having a second opening (seen in Fig 2,3 but not labeled; labeled in Fig A above) in communication with the distal device lumen (as seen in Fig 2,3) and a plurality of fins 58 (Fig 2-4) extending from the second sidewall into the chamber and configured to support the diaphragm (as seen in Fig 2), wherein the diaphragm is elastically flexible (Col 3, Line 43 – “resilient disc 54”; Col 3, Line 54 – “synthetic rubber”) and at least unfixed at its peripheral edge (Col 3, Lines 43-44 – “a thin resilient disc 54 which […] rests loosely on screen 52”) within the chamber so as to assume configurations, including a neutral4 configuration (as seen in Fig 2) in which there is a space gap construction between the diaphragm and the chamber that allows a predetermined fluid flow through the device (Col 3, Line 67 – Col 4, Line 2), the space gap construction comprising a first space gap between the first surface of the diaphragm and an inner interior surface of the first sidewall (as seen in Fig 2) and a second space gap between the peripheral edge of the diaphragm and the first sidewall (as seen in Fig 2) and a second flexed configuration (as seen in Fig 3) that generally ceases fluid flow through the device (Col 4, Lines 2-8).
Manske does not disclose that the space gap construction also includes a third space gap between a peripheral outer edge of at least one of the plurality of fins and a radial wall between the first and second sidewalls and that the diaphragm can assume a first flexed configuration that allows an increased fluid flow through the device that is greater than the predetermined fluid flow through the device.
Ruschke, however, teaches a valve 2 (Fig 1; it is noted that all reference characters cited below refer to Fig 3-6 unless otherwise noted) substantially similar to Manske’s valve CV, wherein the valve comprises a proximal lumen (the tubular structure forming passage 4), a distal lumen (the tubular structure forming passage 6), a diaphragm 10 having a first surface (facing to the left in Fig 3-5) and a second surface (facing to the right in Fig 3-5), and a chamber 8 having a first sidewall (seen in Fig 3-5 but not labeled; labeled in annotated Fig B above) with a first opening (seen in Fig 3-5, but not labeled; labeled in annotated Fig B above) in communication with the proximal lumen (as seen in Fig 3-5) and an opposed second sidewall (seen in Fig 3,5, but not labeled; labeled in annotated Fig B above) with a second opening (seen in Fig 3-5, but not labeled; labeled in annotated Fig B above) in communication with the distal lumen (as seen in Fig 3-5) and a plurality of fins 38 (Fig 6) extending from the second sidewall into the chamber and configured to support the diaphragm (as seen in Fig 3), wherein the diaphragm is elastically flexible (Col 3, Lines 23-27 – “flexible diaphragm 10”, “made of a medical grade silicone rubber material”) and at least unfixed at its peripheral edge within the chamber (as seen in Fig 3-5; Col 4, Lines 65-66) so as to assume configurations including: a neutral configuration (seen in Fig 3) in which there is a space gap construction between the diaphragm and the chamber that allows a first predetermined fluid flow through the device (Col 4, Lines 7-9 – “the above-mentioned line contact when the diaphragm is in an at rest position is desirable but not necessary”), the space gap construction comprising a first space gap between the first surface of the diaphragm and an interior surface of the first sidewall (as set forth in Col 4, Lines 7-9 – “the above mentioned line contact when the diaphragm is in an at rest position is desirable but not necessary”; additionally, Fig 3 shows such a gap existing between the upper surface of the diaphragm and the portion of the first side wall that is radially outward from the concave sealing surface 34), a second space gap between the peripheral edge of the diaphragm and the first sidewall (as seen in Fig 3, such a gap exists between the peripheral edge of the diaphragm and the portion of the first sidewall that is radially outward from the concave sealing surface 34), and a third space gap between a peripheral outer edge of at least one of the plurality of fins and a radially wall between the first and second sidewalls (as seen in Fig 6, the peripheral outer edge of at least one fin 38 is spaced from wall 44), a first flexed configuration (seen in Fig 4) that allows an increase fluid flow through the device that is greater than the predetermined fluid flow through the device (Col 4, Lines 49-64), and a second flexed configuration (seen in Fig 5) that generally ceases fluid flow through the device (Col 5, Lines 43-50; Col 6, Lines 8-13). Ruschke teaches that providing a diaphragm that can possess a neutral configuration having a space gap construction that allows a fluid flow through the device, a first flexed configuration that allows greater fluid flow through the device, and a second flexed configuration that blocks backflow through the device from the distal lumen allows for the valve to provide various rates of delivery (Col 4, Lines 54-57). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Manske to include the valve 2 of Ruschke – which possesses all three configurations – in place of valve CV – which only possesses two of the three configurations – for the purpose of providing various rates of delivery (Col 4, Lines 54-57). The Examiner reiterates that this modification would replace Manske’s entire valve CV with Ruschke’s valve 2.
Re claim 22, Manske as modified by Ruschke in the rejection of claim 21 discloses all the claimed features with Ruschke teaching that the second sidewall has a plurality of fins 38 extending from the second sidewall into the chamber and configured to support the diaphragm (as seen in Fig 3), each fin of the plurality of fins having a generally uniform thickness along its length (as seen in Fig 6).
Response to Arguments
Applicant’s arguments filed 3/2/2026 have been fully considered but are not persuasive. Applicant asserts that the combination of Manske and Ruschke fails to teach the amended features of claims 1 and 21, but does not specifically point out how Manske and Ruschke fail to meet these limitations. As set forth above, Manske and Ruschke teach all of the claimed features including the amended features. Accordingly, Applicant’s assertion/argument is not persuasive.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAMI A BOSWORTH whose telephone number is (571)270-5414. The examiner can normally be reached Monday - Thursday 8 am - 4 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Sirmons can be reached at (571)272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783
1 Para 3, 24, 26 and 46 of Applicant’s specification set forth that an “electrophysiology device” can be a catheter or a sheath.
2 In light of the specification, the term “neutral” is interpreted as meaning “unflexed” (see Para 42,44).
3 Para 3, 24, 26 and 46 of Applicant’s specification set forth that an “electrophysiology device” can be a catheter or a sheath.
4 In light of the specification, the term “neutral” is interpreted as meaning “unflexed” (see Para 42,44).
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