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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 04/13/2026 has been entered.
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 1-2, 4-5, 7, 11-16, and 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Walborn et al. (US 20080262441 A1) in view of Summers (US 3625199 A) in further view of Whitaker et al. (US 20160213862 A1).
Regarding claim 1, Walborn discloses a medical pressure indicator (indicator component 24, Fig 2) for an infusion procedure, wherein the medical pressure indicator (24) is secured over adjacent spaced ends of the infusion line (Fig 1-2, shows the indicator secured over adjacent spaced ends of infusion line 40), and configured to expand and contract (Fig 3A-C) in at least one dimension (movement in an axial direction, Fig 3A-C) in response to an internal pressure in the discrete flexible tube (24) to provide a direct visible indication (visual cue; [0030]) of a state of the internal pressure in the discrete flexible tube (24) to a person administering the infusion procedure ([0030]).
Walborn is silent regarding the medical pressure indicator is formed as a discrete flexible tube; the medical pressure indicator which is combinable with a filter element via an infusion line.
Summers discloses a medical pressure indicator (pressure indicator 25, Fig 5), wherein the medical pressure indicator (25) is formed as a discrete flexible tube (25) that is secured over adjacent spaced ends of the line (the tubular conduits 27 and 28 are connected by indicator 25, Fig 5), and configured to expand (Fig 6) and contract (Fig 5) in at least one dimension (longitudinal dimension, Fig 5-6) in response to an external pressure in the discrete flexible tube (25).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Walborn with similar discrete flexible tube indicator as taught by Summers for the purpose of providing indicator of pressure by expansion and contraction in the longitudinal direction (abstract).
Walborn/Summers are silent regarding the medical pressure indicator which is combinable with a filter element via an infusion line.
Whitaker teaches a medical pressure indicator (precision flow controller 701, Fig 7, provides a relative pressure indication; [0084]) which is combinable with a filter element (air stop membrane 305, Fig 7) via an infusion line (coupling tubing 303b).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Walborn/Summers with similar filter as taught by Whitaker for the purpose of preventing air from entering the tubing (abstract).
Regarding claim 2, Walborn/Summers/Whitaker discloses the medical pressure indicator according to claim 1. Walborn is silent wherein the discrete flexible tube is configured to be arranged downstream of the filter element.
Whitaker teaches a medical pressure indicator (precision flow controller 701, Fig 7, provides a relative pressure indication; [0084]) which is combinable with a filter (air stop membrane 305, Fig 7) via an infusion line (coupling tubing 303b). Whitaker further teaches wherein the pressure indicator (701) is configured to be arranged downstream of the filter element (305, Fig 7).
Note: Walborn/Summers/Whitaker as modified discloses wherein the discrete flexible tube (indicator 24 of Walborn now in the form of a flexible tube as modified with teaching of Summers as seen in claim 1) configured to be arranged downstream of the filter element (305, Fig 7 of Whitaker).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Walborn/Summers/Whitaker with similar filter at the proximal end of the pressure indicator as taught by Whitaker for the purpose of preventing air from entering the tubing (abstract).
Regarding claim 4, Walborn/Summers/Whitaker discloses the medical pressure indicator according to claim 1. Walborn discloses wherein the pressure indicator (24) expands when the pressure is greater than or equal to 30 mm Hg (7psi =362mm Hg; Fig 3C), and contracts when the pressure is less than or equal to 20 mm Hg (0psi = 0mm Hg; Fig 3A) ([0014]).
Walborn is silent regarding wherein the pressure indicator comprises a discrete flexible tube.
Summers discloses a medical pressure indicator (pressure indicator 25, Fig 5), wherein the medical pressure indicator (25) is formed as a discrete flexible tube (25) that is secured over adjacent spaced ends of the line (the tubular conduits 27 and 28 are connected by indicator 25, Fig 5), and configured to expand (Fig 6) and contract (Fig 5) in at least one dimension (longitudinal dimension, Fig 5-6) in response to an external pressure in the discrete flexible tube (25).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Walborn/Summers/Whitaker with similar discrete flexible tube indicator as taught by Summers for the purpose of providing indicator of pressure by expansion and contraction in the longitudinal direction (abstract).
Regarding claim 5, Walborn/Summers/Whitaker discloses the medical pressure indicator according to claim 1. Walborn is silent wherein the discrete flexible tube is formed as a line section with folds, wherein the discrete flexible tube is expandable along a longitudinal direction when the pressure is increased and is contractable along the longitudinal direction when the pressure is decreased.
Summers teaches wherein the discrete flexible tube (25) is formed as a line section with folds (Fig 5), wherein the discrete flexible tube (25) is expandable along a longitudinal direction (Fig 6) when the pressure is increased and is contractable along the longitudinal direction (Fig 5) when the pressure is decreased (Col 2, line 71- Col 3, line 3).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Walborn/Summers/Whitaker with similar discrete flexible tube indicator as taught by Summers for the purpose of providing indicator of pressure by expansion and contraction in the longitudinal direction (abstract).
Regarding claim 7, Walborn/Summers/Whitaker discloses the medical pressure indicator according to claim 1. Walborn is silent wherein the filter element is a capillary membrane.
Whitaker teaches a medical pressure indicator (precision flow controller 701, Fig 7, provides a relative pressure indication; [0084]) which is combinable with a filter (air stop membrane 305, Fig 7) via an infusion line (coupling tubing 303b); the filter element (305) is a capillary membrane (air stop membrane 305 functions as a capillary membrane formed of a hydrophilic porous material, filtering air and allowing fluid to flow; [0047]).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Walborn/Whitaker with similar filter as taught by Whitaker for the purpose of preventing air from entering the tubing (abstract).
Regarding claim 11, Walborn discloses a pressure indicator (Indicator component 24, Fig 2) that is sterile, packaged (indicator component 24 needs to be sterile for infusion and would need to be packaged for transport prior installation), wherein the pressure indicator (24) is adapted to be coupled as a discrete portion of a line section (indicator 24 is coupled to tubing 40, Fig 2) for an infusion solution (medical fluid infusion; [0010]), wherein the pressure indicator (24) is secured over adjacent spaced ends of the line section (Fig 1-2, shows the indicator secured over adjacent spaced ends of infusion line 40), and is expandable and contractable in at least one dimension (movement in an axial direction, Fig 3A-C) in response to an internal pressure in the pressure indicator (internal pressure of line section along pressure indicator 24) to provide a direct visible indication (visual cue; [0030]) of a state of the internal pressure in the pressure indicator to a person administering an infusion procedure ([0030]).
Walborn is silent regarding wherein the pressure indicator comprises a discrete flexible tube; pressure indicator configured for connection to an outlet of a medical infusion filter or to a connection of the medical infusion filter, for an infusion solution in connection to the outlet of the medical infusion filter or in connection to the connection of the medical infusion filter.
Summers teaches a pressure indicator (pressure indicator 25, Fig 5) that is sterile, packaged (indicator component 25 needs to be sterile for infusion and would need to be packaged for transport prior installation), wherein the pressure indicator (25) is adapted to be coupled as a discrete portion of a line section (the tubular conduits 27 and 28 are coupled to indicator 25, Fig 5 for infusion), wherein the pressure indicator comprises a discrete flexible tube (pressure indicator 25, Fig 5) that is secured over adjacent spaced ends of the line section (the tubular conduits 27 and 28 are connected by indicator 25, Fig 5), and the discrete flexible tube (25) is expandable and contractable in at least one dimension (longitudinal) in response to an internal pressure in the discrete flexible tube (25)
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Walborn with similar discrete flexible tube indicator as taught by Summers for the purpose of providing indicator of pressure by expansion and contraction in the longitudinal direction (abstract)
Walborn/Summers are silent wherein the pressure indicator configured for connection to an outlet of a medical infusion filter or to a connection of the medical infusion filter, for an infusion solution in connection to the outlet of the medical infusion filter or in connection to the connection of the medical infusion filter.
Whitaker teaches a medical pressure indicator (precision flow controller 701, Fig 7, provides a relative pressure indication; [0084]) which is combinable with a filter element (air stop membrane 305, Fig 7) via an infusion line (coupling tubing 303b) wherein pressure indicator (701) is configured for connection to an outlet (outlet of filter 305 housing 320) of a medical infusion filter (305) or to a connection of the medical infusion filter, for an infusion solution (fluid solution; Fig 7) in connection to the outlet of the medical infusion filter (outlet of filter 305 housing 320, Fig 7) or in connection to the connection of the medical infusion filter.
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Walborn/Summers with similar filter coupled to the pressure indicator as taught by Whitaker for the purpose of preventing air from entering the tubing (abstract).
Regarding claim 12, Walborn/Summers/Whitaker discloses the pressure indicator according to claim 1. Walborn discloses wherein the indicator (24) expands when the pressure is more than 30 mm Hg (7psi =362mm Hg; Fig 3C) and contracts when the pressure is less than 20mm Hg (0psi = 0mm Hg; Fig 3A) ([0014]).
Walborn is silent regarding wherein the pressure indicator comprises a discrete flexible tube.
Summers discloses a medical pressure indicator (pressure indicator 25, Fig 5), wherein the medical pressure indicator (25) is formed as a discrete flexible tube (25) that is secured over adjacent spaced ends of the line (the tubular conduits 27 and 28 are connected by indicator 25, Fig 5), and configured to expand (Fig 6) and contract (Fig 5) in at least one dimension (longitudinal dimension, Fig 5-6) in response to an external pressure in the discrete flexible tube (25).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Walborn/Summers/Whitaker with similar discrete flexible tube indicator as taught by Summers for the purpose of providing indicator of pressure by expansion and contraction in the longitudinal direction (abstract).
Regarding claim 13, Walborn/Summers/Whitaker discloses the medical pressure indicator according to claim 1. Walborn is silent wherein the medical pressure indicator is combined with the filter element.
Whitaker teaches a medical pressure indicator (precision flow controller 701, Fig 7, provides a relative pressure indication; [0084]); a filter element (air stop membrane 305, Fig 7) wherein the medical pressure indicator (701) is combined with the filter element (305) (medical pressure indicator and filter are combined by fluid coupling allowing the infusion of a filtered flow; Fig 7)
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Walborn/Summers/Whitaker with similar filter coupled to the pressure indicator as taught by Whitaker for the purpose of preventing air from entering the tubing (abstract).
Regarding claim 14, Walborn/Summers/Whitaker discloses a method of measuring a pressure ([0014]) comprising a medical pressure indicator (24) according to claim 1. Walborn is silent regarding comprising a step of connecting the medical pressure indicator according to claim 1 to an outlet of a medical infusion filter.
Whitaker teaches a method comprising a medical pressure indicator (precision flow controller 701, Fig 7, provides a relative pressure indication; [0084]) a step of connecting the medical pressure indicator (701) to an outlet of a medical infusion filter (outlet of filter 305 housing 320, Fig 7).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the method of Walborn/Summers/Whitaker with similar filter having an outlet in connection with the pressure indicator as taught by Whitaker for the purpose of preventing air from entering the tubing (abstract).
Regarding claim 15, Walborn discloses an infusion line (tubing 40 + Indicator component 24, Fig 2, from Walborn) comprising a pressure indicator according to claim 11. Walborn discloses a pressure indicator (pressure indicator 24, Fig 1) but is silent wherein the pressure indicator comprises a discrete flexible tube; pressure indicator configured for connection to an outlet of a medical infusion filter or to a connection of the medical infusion filter, for an infusion solution in connection to the outlet of the medical infusion filter or in connection to the connection of the medical infusion filter.
Summers teaches a pressure indicator (pressure indicator 25, Fig 5) that is sterile, packaged (indicator component 25 needs to be sterile for infusion and would need to be packaged for transport prior installation), wherein the pressure indicator (25) is adapted to be coupled as a discrete portion of a line section (the tubular conduits 27 and 28 are coupled to indicator 25, Fig 5 for infusion), wherein the pressure indicator comprises a discrete flexible tube (pressure indicator 25, Fig 5) that is secured over adjacent spaced ends of the line section (the tubular conduits 27 and 28 are connected by indicator 25, Fig 5), and the discrete flexible tube (25) is expandable and contractable in at least one dimension (longitudinal) in response to an internal pressure in the discrete flexible tube (25)
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Walborn with similar discrete flexible tube indicator as taught by Summers for the purpose of providing indicator of pressure by expansion and contraction in the longitudinal direction (abstract)
Walborn/Summers are silent wherein the pressure indicator configured for connection to an outlet of a medical infusion filter or to a connection of the medical infusion filter, for an infusion solution in connection to the outlet of the medical infusion filter or in connection to the connection of the medical infusion filter.
Whitaker teaches a medical pressure indicator (precision flow controller 701, Fig 7, provides a relative pressure indication; [0084]) which is combinable with a filter element (air stop membrane 305, Fig 7) via an infusion line (coupling tubing 303b) wherein pressure indicator (701) is configured for connection to an outlet (outlet of filter 305 housing 320) of a medical infusion filter (305) or to a connection of the medical infusion filter, for an infusion solution (fluid solution; Fig 7) in connection to the outlet of the medical infusion filter (outlet of filter 305 housing 320, Fig 7) or in connection to the connection of the medical infusion filter.
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Walborn/Summers with similar filter coupled to the pressure indicator as taught by Whitaker for the purpose of preventing air from entering the tubing (abstract).
Regarding claim 16, Walborn/Summers/Whitaker discloses the infusion line according to claim 15. Walborn is silent regarding further comprising the medical infusion filter.
Whitaker teaches an infusion line (coupling tubing 303a-b + precision flow controller 701+ air stop membrane 305, Fig 7) further comprising the medical infusion filter (air stop membrane 305, Fig 7).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Walborn/Summers/Whitaker with similar filter as taught by Whitaker for the purpose of preventing air from entering the tubing (abstract).
Regarding claim 18, Walborn/Summers/Whitaker discloses the medical pressure indicator according to claim 4. Walborn discloses wherein the pressure indicator (indicator 24, Fig 2) expands when the pressure is greater than or equal to 40 mm Hg (7psi =362mm Hg; Fig 3C), and contracts when the pressure is less than or equal to 10 mm Hg (0psi = 0mm Hg; Fig 3A) ([0014]).
Walborn is silent regarding wherein the pressure indicator comprises a discrete flexible tube.
Summers discloses a medical pressure indicator (pressure indicator 25, Fig 5), wherein the medical pressure indicator (25) is formed as a discrete flexible tube (25) that is secured over adjacent spaced ends of the line (the tubular conduits 27 and 28 are connected by indicator 25, Fig 5), and configured to expand (Fig 6) and contract (Fig 5) in at least one dimension (longitudinal dimension, Fig 5-6) in response to an external pressure in the discrete flexible tube (25).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Walborn/Summers/Whitaker with similar discrete flexible tube indicator as taught by Summers for the purpose of providing indicator of pressure by expansion and contraction in the longitudinal direction (abstract).
Regarding claim 19, Walborn/Summers/Whitaker discloses the pressure indicator according to claim 12. Walborn discloses wherein the pressure indicator (24) expands when the pressure is more than 40 mm Hg (7psi =362mm Hg; Fig 3C) and contracts when the pressure is less than 10 mm Hg (0psi = 0mm Hg; Fig 3A) ([0014]).
Walborn is silent regarding wherein the pressure indicator comprises a discrete flexible tube.
Summers discloses a medical pressure indicator (pressure indicator 25, Fig 5), wherein the medical pressure indicator (25) is formed as a discrete flexible tube (25) that is secured over adjacent spaced ends of the line (the tubular conduits 27 and 28 are connected by indicator 25, Fig 5), and configured to expand (Fig 6) and contract (Fig 5) in at least one dimension (longitudinal dimension, Fig 5-6) in response to an external pressure in the discrete flexible tube (25).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Walborn/Summers/Whitaker with similar discrete flexible tube indicator as taught by Summers for the purpose of providing indicator of pressure by expansion and contraction in the longitudinal direction (abstract).
Regarding claim 1, Walborn discloses a medical pressure indicator (indicator component 24, Fig 2) for an infusion procedure, wherein the medical pressure indicator (24) is secured over adjacent spaced ends of the infusion line (Fig 1-2, shows the indicator secured over adjacent spaced ends of infusion line 40), and configured to expand and contract (Fig 3A-C) in at least one dimension (movement in an axial direction, Fig 3A-C) in response to an internal pressure in the discrete flexible tube (24) to provide a direct visible indication (visual cue; [0030]) of a state of the internal pressure in the discrete flexible tube (24) to a person administering the infusion procedure ([0030]).
Walborn is silent regarding the medical pressure indicator is formed as a discrete flexible tube; the medical pressure indicator which is combinable with a filter element via an infusion line.
Summers embodiment of Fig 1, hereinafter Summers-1, discloses a medical pressure indicator (pressure indicator 10, Fig 1), wherein the medical pressure indicator (10) is formed as a discrete flexible tube (10) and configured to expand (Fig 2) and contract (Fig 1) in at least one dimension (radial direction, Fig 1-2) in response to an external pressure in the discrete flexible tube (10).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Walborn with similar discrete flexible tube indicator as taught by Summers-1 for the purpose of providing indicator of pressure by expansion and contraction of the indicator (abstract).
Walborn/Summers-1 are silent regarding the medical pressure indicator which is combinable with a filter element via an infusion line.
Whitaker teaches a medical pressure indicator (precision flow controller 701, Fig 7, provides a relative pressure indication; [0084]) which is combinable with a filter element (air stop membrane 305, Fig 7) via an infusion line (coupling tubing 303b).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Walborn/Summers-1 with similar filter as taught by Whitaker for the purpose of preventing air from entering the tubing (abstract).
Claims 8 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Walborn et al. (US 20080262441 A1) in view of Summers (US 3625199 A) in further view of Whitaker et al. (US 20160213862 A1) in further view of Liffman et al. (WO 2009097650 A1).
Regarding claim 8, Walborn/Summers-1/Whitaker discloses the medical pressure indicator according to claim 1. Walborn/Summers-1/Whitaker are silent wherein the tube section expands and contracts by at least 1 mm relative to an unexpanded state.
Liffman teaches the tube section (elongated tube 20; [46]) expands and contracts by at least 1 mm relative to an unexpanded state ([46]: “the elongated tube 20 is in the non-radially expanded state may be up to 1 mm or up to 2mm or greater than 2mm”; ([53]: the material can elastically deform and exhibit hardening if expanded about 100%); a 2mm tube as seen in [46] can be elastically deformed 50% to +/-1mm).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the of device of Walborn/Summers-1/Whitaker with similar length of elastic deformation as taught by Liffman for the purpose of having an increased range of extension and associate readings without breaking or leaking ([46];[53]).
Regarding claim 10, Walborn/Summers-1/Whitaker discloses the medical pressure indicator according to claim 1. Walborn/Summers-1/Whitaker are silent wherein the tube section has a diameter that is at least 2 mm in a normal state, is at least 3 mm in an expanded state, and is at least 1 mm in a contracted state.
Liffman teaches the tube section (20) expands and contracts by at least 1 mm relative to an unexpanded state ([46]: “the elongated tube 20 is in the non-radially expanded state may be up to 1 mm or up to 2mm or greater than 2mm”; ([53]: the material can elastically deform and exhibit hardening if expanded about 100%); a 2mm tube as seen in [46] can be elastically deformed 50% to +/-1mm).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the material of tube of device of Walborn/Summers-1/Whitaker with similar diameter and radial elastic deformation as taught by Liffman for the purpose of having a wider range of elastic deformation which increases the range of pressure that can withstand and associate obtained readings without breaking or leaking ([46];[53]).
Claims 9 is rejected under 35 U.S.C. 103 as being unpatentable over Walborn et al. (US 20080262441 A1) in view of Summers (US 3625199 A) in further view of Whitaker et al. (US 20160213862 A1) in further view of Dundaroz (WO 2019216858 A2).
Regarding claim 9, Walborn/Summers-1/Whitaker discloses the medical pressure indicator according to claim 1. Walborn/Summers-1/Whitaker are silent wherein: a color marking is applied to the tube section which changes in response to expansion or contraction of the discrete flexible tube, or a color feature on the discrete flexible tube produces a different color impression depending on a state of elongation of the discrete flexible tube.
Dundaroz discloses a medical pressure indicator (conduit 3, Fig 1) a color marking is applied to the tube section which changes in response to expansion or contraction of the discrete flexible tube, or a color feature on the discrete flexible tube produces a different color impression depending on a state of elongation of the discrete flexible tube (Claim 1: “contain the mechanochromic and piezochromic materials that have the ability of color production and color change simultaneously and reversibly according to the pressure”; Claim 2: “the said mechanochromic and piezochromic materials are adhered and/or coated and/or assembled after the production process”).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Walborn/Summers-1/Whitaker with similar mechanochromic and piezochromic materials of the line of as taught by Dundaroz for the purpose of indicating pressure changes based on changing the coloration of the tube according to the pressure (Claim 1-2).
Response to Arguments
Applicant’s arguments with respect to claims 1-2, 4-5, 7-16, and 18-19 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GUILLERMO G PAZ ESTEVEZ whose telephone number is (703)756-5951. The examiner can normally be reached Monday- Friday 8:00-5:00.
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/GUILLERMO G PAZ ESTEVEZ/ Examiner, Art Unit 3783
/Lauren P Farrar/Primary Examiner, Art Unit 3783
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