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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 02/03/2026 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, 8, 11-13 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Saito et al. (US 5891097 A) in view of Lu et al. (US 20030168479 A1) in further view of Gan et al. (CN 109550108 A).
Regarding claim 1, Saito discloses a drug delivery device (fluid delivery device; Fig 1A) comprising: a drug product container (transformable fluid reservoir 113, Fig 1A-B) having at least one flexible wall (walls of fluid reservoir are flexible; see Fig 1B) and defining a cavity (cavity that reserves fluid 114) configured to contain a drug product; (fluid 114 is a liquid medicine; Col 5, lines 37-41; Col 11, lines 22-26); a pressurized vessel (compartment 106, Fig 1A-B) containing a gas (oxygen) under pressure (Col 4, lines 52-54: “the pressure of oxygen in the second compartment 106 increases so long as the current conduction is continued, because the second compartment 106 is kept air-tight.”); an urging member (partition member 103, Fig 1A-B) in working connection with the pressurized vessel (106) such that, upon at least partial release of the gas (oxygen) under pressure, the urging member (103) moves from a first end (portion seen in Fig 1A) of the drug product container (113) to a second end (portion seen in Fig 1B), of the drug product container (113) thereby applying pressure progressively to the drug product container (113) (pressure is applied progressively as the actuator compresses fluid reservoir 113) to eject at least a portion of the drug product (114) from the drug product container (113) (Col 4, lines 45-63).
Saito is silent wherein the urging member comprises an inflatable bag that envelops the drug product container as it moves from the first end to the second end.
Lu teaches a delivery device (Fig 7) comprising: a product container (20) having at least one flexible wall (22) and defining a cavity configured to contain a product ([0024]); a pressurized vessel (pressurized fluid source 70, Fig 7) containing a gas under pressure ([0033]); an urging member (inflatable balloon 80 (or other inflatable structure, Fig 7; [0046]) in working connection with the pressurized vessel (70) such that, upon at least partial release of the gas under pressure (air), the urging member (80) moves from a first portion of the product container to a second portion of the product container ([0050]: “single balloon having a gap in the center (similar to a doughnut) into which the container is disposed and that single balloon is inflated to constrict the surface of the container.”; The doughnut shaped balloon will contact the proximal end of container 20 when inflation begins, receiving air from pressurized fluid source 70; the balloon will begin to expand and increase the pressure on the container 20; when fully inflated, the balloon 80 will contact the distal surface of container 20), wherein the urging member (80) comprises an inflatable bag (doughnut shaped balloon, not shown; [0050]) that envelops the product container, thereby applying pressure progressively to the product container (20) to eject thereby ejecting at least a portion of the product (fluid) from the product container (20).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Saito with similar doughnut shaped balloon enveloping the container as it inflates as taught by Lu for the purpose of surround the container and that single balloon is inflated to constrict the surface of the container to dispense the fluid product ([0050]).
Saito/Lu are silent wherein the inflatable bag moves from the first end to the second end.
Gan teaches a drug delivery device (infusion device; Fig 1) comprising: a drug product container (infusion bag 6, Fig) having at least one flexible wall (walls of infusion bag 6 are compressed, therefore are flexible; [0032]) and defining a cavity (cavity inside bag 6, not shwon) configured to contain a drug product (medicine; [0031]); a pressurized vessel (electric pressurizing device 3, Fig 1) containing a gas (air) under pressure ([0032]); an urging member (air bladder 2, Fig 1) in working connection with the pressurized vessel (3) such that, upon at least partial release of the gas (air) under pressure, the urging member (2) moves from a first end (proximal end) of the drug product container (6) to a second end (distal end, near the outlet), of the drug product container (6), wherein the urging member (2) comprises an inflatable bag (air bladder 2, Fig 1).
Gan further teaches the inflatable bag (2) moves from the first end to the second end of the drug product container (6) thereby applying pressure progressively to the drug product container (6) ([0033]: “the part of the infusion bag furthest from the outlet is squeezed earlier, thus squeezing the liquid out of the infusion bag from the inside out, and outputting the liquid more thoroughly”) to eject at least a portion of the drug product (medicine) from the drug product container (6) ([0033]).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the inflatable bag of device of Saito/Lu with similar bag as taught by Gan for the purpose of squeezing the liquid out more thoroughly ([0033]).
Regarding claim 8, Saito/Lu/Gan discloses the drug delivery device as in claim 1. Saito discloses wherein the at least one flexible wall (walls of fluid reservoir 113, Fig 1A) comprises a first wall (1000, Annotated Fig 1) and a second wall (1001, Annotated Fig 1) cooperating to define the cavity (cavity containing fluid 114, Fig 1) configured to contain the drug product (114); and the drug product container (113) further comprises an outlet (opening connecting the reservoir 113 with fluid delivery pipe 115, Fig 1) in fluid communication with the cavity (cavity containing fluid 114, Fig 1) to selectively permit the drug product to exit the cavity (fluid 114 exit cavity of reservoir 133 and fluid is delivered through injection needle 116; Col 4, lines 60-63); wherein at least a portion of at least the first wall (1000, Annotated Fig 1) or the second wall (1001, Annotated Fig 1) includes and/or is coupled with an anti-sealing component (remaining volume of fluid 114; Fig 1B) that resists sealing between the first wall (1000, Annotated Fig 1) and the second wall (1001, Annotated Fig 1) while the drug product (114) exits the cavity (cavity containing fluid 114, Fig 1) (Col 5, lines 2-4 ; fluid 114 is coupled to a portion of the first 1000 and second 1001 wall and resist sealing between the walls; See Fig 1B which illustrates the termination of use state).
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Regarding claim 11, Saito/Lu/Gan discloses the drug delivery device as in claim 8. Saito discloses wherein the first wall (1000, Annotated Fig 1) and the second wall (1001, Annotated Fig 1) are a single, integrally formed component (reservoir 133 is integrally formed by blow molding; Col 10, lines 1-10).
Regarding Claim 12, Saito/Lu/Gan discloses the drug delivery device as in claim 8. Embodiment of Fig 1A-2A of Saito is silent wherein the first wall and the second wall are separate components that are coupled with each other.
Saito embodiment of Fig 4, hereinafter Saito-4, teaches a drug delivery device (Fig 4) comprising an urging member (transformable portion 421+ plate 422, Fig 4); a drug product container (fluid reservoir 413, Fig 4) wherein a first wall (left sheet, Fig 4) and the second wall (right sheet, Fig 4) are separate components that are coupled with each other (Col 10, lines 3-5: “a laminated bladder produced by bonding two sheets at their outer peripheral portions through heat seal or the like”).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the inflatable bag of device of Saito/Lu/Gan with a laminated bladder coupled by bonding as taught by Saito-4 to increase the effective use of pressure, reduce the residual fluid and have a final compact plate shape after compression by the urging member (Col 10, lines 1-10).
Regarding claim 13, Saito/Lu/Gan discloses the drug delivery device as in claim 8. Saito discloses wherein the container (113) is a sterile, flexible, non-pressurized IV bag (Col 4, lines 21-23: transformable fluid reservoir 113 is sterile because it delivers a medicine fluid; if reservoir is not sterile will place the patient in risk of receiving a contaminated infusion; fluid reservoir 113 as shown in Fig 1A is in a non-pressurized state and comprise all necessary structure of an IV bag).
Regarding claim 21, Saito/Lu/Gan discloses the drug delivery device as in claim 1. Saito discloses comprising an enclosure (vessel body 101+ vessel cover 102, Fig 1) containing the drug product container (113) and the urging member (103).
Claims 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Saito et al. (US 5891097 A) in view of Lu et al. (US 20030168479 A1) in further view of Gan et al. (CN 109550108 A) in view of Cogley et al. (US 3838794 A).
Regarding claim 9, Saito/Lu/Gan discloses the drug delivery device as in claim 8. Saito is silent wherein the anti-sealing component includes a plurality of ridges or grooves.
Cogley teaches a drug delivery device (package 10, Fig 1) comprising an anti-sealing component (pattern of interconnected grooves 38, Fig 6) further including a plurality of ridges or grooves (36) (Col 3, lines: 51-57 “These grooves extend toward the side edges and also between the ends of the container, so that there will always be fluid access from the various regions of the container to its upper and lower parts”).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Saito/Lu/Gan with similar grooves as taught from Cogley for the purpose of having fluid access from the various regions of the container to its upper and lower parts fluid can always reach the port and reduce the volume of fluid remaining in the bag (Col 3, lines: 50-60).
Regarding Claim 10, Saito/Lu/Gan discloses the drug delivery device as in claim 8. Saito is silent wherein only one of the first wall and the second wall includes the anti-sealing component.
Cogley teaches a drug delivery device (package 10, Fig 1) comprising an anti-sealing component (pattern of interconnected grooves 38, Fig 6) further including a plurality of ridges or grooves (36) (Col 3, lines: 51-57) wherein only one of the first wall and the second wall includes the anti-sealing component (Col 3, lines 48-51: “the inside surface of at least one of the container sidewall members is modified by a pattern of interconnected grooves 38.”).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify one of the walls of the device of Saito/Lu/Gan with similar grooves as taught from Cogley for the purpose of having fluid access from the various regions of the container to its upper and lower parts fluid can always reach the port and reduce the volume of fluid remaining in the bag (Col 3, lines: 50-60).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Saito et al. (US 5891097 A) in view of Lu et al. (US 20030168479 A1) in further view of Gan et al. (CN 109550108 A) in view of Nordquist et al. (US 20160067148 A1).
Regarding Claim 20, Saito/Lu/Gan discloses the drug delivery device as in claim 8, Saito discloses the drug (fluid 114 is a liquid medicine which has an inherent surface tension; Col 5, lines 37-41) . Saito is silent wherein both first and second walls are treated with hydrophobic coatings or physical features to minimize any drug adhesion.
Nordquist teaches a drug delivery device (enteral feeding system 100, Fig 1) comprising a product container (reservoir 112, Fig 1) wherein both first and second walls (side walls of reservoir 112) are treated with hydrophobic coatings or physical features to minimize any drug adhesion. ([0074]: “In some embodiments a hydrophobic material can be used so that liquid in the reservoir does not stick to walls or corners. Special bag material, or a bag material inner layer (in a multi-layer bag film material construction), or a coated material lining on the inside of the reservoir bag can be implemented to reduce surface tension”).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the product container inner walls of device of Saito/Lu/Gan with a similar hydrophobic coating as taught by Nordquist to avoid adhesion of the liquid to the walls or corners ([0074]).
Response to Arguments
Applicant’s arguments with respect to claims 1, 8-13, and 20-21 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