DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-4, 6-7, 11-19 are rejected under 35 U.S.C. 103 as being unpatentable over Walborn et al. (US 20080262441 A1) in 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 formed as a discrete portion of a tube section (indicator 24 is disposed as a section of tubing 40, Fig 2) that is 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 tube section (24) to provide a direct visible indication (visual cue; [0030]) of a state of the internal pressure in the tube section (24) to a person administering the infusion procedure ([0030]).
Walborn is 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 with similar filter as taught by Whitaker for the purpose of preventing air from entering the tubing (abstract).
Regarding claim 2, Walborn/Whitaker discloses the medical pressure indicator according to claim 1, wherein the tube section is a line section (indicator 24 is disposed as a section of tubing 40, which is a line section of entire fluid line, Fig 2).
Walborn is silent wherein a line section 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 a line section (line section for 701) is configured to be arranged downstream of the filter element (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/Whitaker with similar filter at the proximal end of tubing as taught by Whitaker for the purpose of preventing air from entering the tubing (abstract).
Regarding claim 3, Walborn/Whitaker discloses the medical pressure indicator according to claim 1. Walborn discloses wherein the tube section (24) or at least parts of the tube section (24 comprises membrane 36, Fig 3A-3C) of the medical pressure indicator (24) is or are at least partially formed of elastic or non-elastic material (elastic material of flexible membrane 36, Fig 3A-3C) which is shaped to expand and contract ([0030]-[0031]; Fig 3A-3C).
Regarding claim 4, Walborn/Whitaker discloses the medical pressure indicator according to claim 1. Walborn discloses wherein the tube section (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]).
Regarding claim 6, Walborn/Whitaker discloses the medical pressure indicator according to claim 1. Walborn discloses wherein: the tube section (24) comprises an elastic membrane (36), the elastic membrane (36) is expandable in a first direction (outward radial direction, Fig 3A) when the pressure is increased, and the elastic membrane (36) is expandable in a second direction (inward radial direction, Fig 3C) opposite to the first direction (outward radial direction, Fig 3A) when the pressure is decreased (Fig 3A and Fig 3C; ([0030]-[0031]).
Regarding claim 7, Walborn/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 disposed as a line section of tubing 40, Fig 2) for an infusion solution (medical fluid infusion; [0010]), wherein the pressure indicator (24) is at least partially made of an elastic material (flexible membrane 36, Fig 3A-C is made of an elastic material) that is expandable and contractable (Fig 3A-3C), and wherein the pressure indicator (24) 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 line section (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 line section to a person administering an infusion procedure ([0030]).
Walborn is silent wherein 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 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/Whitaker discloses the pressure indicator according to claim 1. Walborn discloses wherein the elastic material (36) 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]).
Regarding claim 13, Walborn/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/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/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/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/Whitaker discloses an infusion line (tubing 40 + Indicator component 24, Fig 2, from Walborn) comprising a pressure indicator (24, from Walborn) according to claim 11.
Regarding claim 16, Walborn/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/Whitaker with similar filter as taught by Whitaker for the purpose of preventing air from entering the tubing (abstract).
Regarding claim 17, Walborn/Whitaker discloses the medical pressure indicator according to claim 2. Walborn discloses wherein the line section is a section of an infusion tube or an infusion system (indicator 24 is disposed as a section of tubing 40, Fig 2 which defines a line section of the entire fluid line path; and represents a portion of the infusion system as seen in Fig 1)
Regarding claim 18, Walborn/Whitaker discloses the medical pressure indicator according to claim 4. Walborn discloses wherein the tube section (indicator 24 is disposed as a section of tubing 40, 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]).
Regarding claim 19, Walborn/Whitaker discloses the pressure indicator according to claim 12. Walborn discloses wherein the elastic material (36) 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]).
Claims 5 is rejected under 35 U.S.C. 103 as being unpatentable over Walborn et al. (US 20080262441 A1) in view of Whitaker et al. (US 20160213862 A1) in further view of Stephens (US 4178939 A).
Regarding claim 5, Walborn/Whitaker discloses the medical pressure indicator according to claim 1. Walborn/Whitaker are silent wherein the tube section is formed as a line section with folds, wherein the tube section is expandable along a longitudinal direction when the pressure is increased and is contractable along the longitudinal direction when the pressure is decreased.
Stephens teaches a tube section (indicator 113, Fig 6-7) is formed as a line section (hollow tubular passageway 115, Fig 6-7) with folds (ridges 118, Fig 6-7), wherein the tube section (113) is expandable along a longitudinal direction when the pressure is increased and is contractable along the longitudinal direction when the pressure is decreased (See Fig 6-7; Col 4, lines 1-10: “When pressurized air is inserted through indicator 113, the ridges 118 and valleys 119 inflate into a balloon-like shape visually indicative of the inflation of cuff 111 within the body passageway. A negative pressure generated by source 114 collapses tubular passageway 115 into its initial bellows-like shape without occluding the fluid-flow passageway through indicator 113.)
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, modify the device of Walborn/Whitaker with similar indicator as taught by Stephens for apparent visualization of pressure changes (Claim 3).
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 Whitaker et al. (US 20160213862 A1) in further view of Liffman et al. (WO 2009097650 A1).
Regarding claim 8, Walborn/Whitaker discloses the medical pressure indicator according to claim 1. Walborn/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 material of tube of device of Walborn/Whitaker with similar 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]).
Regarding claim 10, Walborn/Whitaker discloses the medical pressure indicator according to claim 1. Walborn/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/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 Whitaker et al. (US 20160213862 A1) in further view of Dundaroz (WO 2019216858 A2).
Regarding claim 9, Walborn/Whitaker discloses the medical pressure indicator according to claim 1. Walborn/Whitaker are silent wherein: a color marking is applied to the tube section which changes in response to expansion or contraction of the tube section, or a color feature on the tube section produces a different color impression depending on a state of elongation.
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 tube section, or a color feature on the tube section produces a different color impression depending on a state of elongation (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/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 1-19 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
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 date of this final action.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Sirmons can be reached on (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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/GUILLERMO G PAZ ESTEVEZ/ Examiner, Art Unit 3783
/Lauren P Farrar/ Primary Examiner, Art Unit 3783
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