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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the electric compressor and pump controller must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 1-10 is objected to because of the following informalities: Claim 1 states “A infusion system for intravenous delivery" this should read "An infusion system for intravenous delivery".
All remaining claims are objected to by virtue of their dependency on claim 1.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding Claim 1, the limitation “A infusion system for intravenous delivery of a fluid from a fluid container, comprising: a malleable fluid container configured to store a fluid and deliver the fluid” is unclear because it is not known if the delivery of a fluid from a fluid container is the same container and fluid as from a malleable fluid container. Examiner interprets the fluid container to be the same as the malleable fluid container.
Regarding Claim 11, the limitation “A method for intravenous delivery of a fluid from a fluid container, comprising: encompassing a malleable fluid container” is unclear because it is not known if the fluid container is the same as a malleable fluid container. Examiner interprets the fluid container to be the same as the malleable fluid container.
Regarding Claim 14, the limitation “A method for intravenous delivery of a fluid from a fluid container, comprising: providing a malleable fluid container” is unclear because it is not known if the fluid container is the same as a malleable fluid container. Examiner interprets the fluid container to be the same as the malleable fluid container.
Regarding Claims 2, 12, and 15 state the limitation, “an internal coiled gas chamber in a shape of a coil such that a helical axis of the coil traverses an axis of the malleable fluid container” it is unclear which axis the helical axis of the coil is traversing in relation to the malleable fluid container, thus can be an indeterminate number of axes. Examiner interprets the coil to traverse a longitudinal axis of the malleable fluid container.
All remaining claims are rejected by virtue of their dependency.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 5-7, 9, 11, 14, and 17-19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Pavlo et al. (US 5824000, herein Pavlo).
Regarding Claim 1, Pavlo discloses an infusion system for intravenous delivery of a fluid from a fluid container (Abstract), comprising: a malleable fluid container (24) configured to store a fluid and deliver the fluid via a connected infusion tubing (Col. 4 Lines 21-26); a fluid container pressure sleeve (12 with an air chamber 46 between inner and outer sheets 26 and 30 respectively) configured to wrap around, connect and form to the malleable fluid container (Figs. 9-10) such that, when the fluid container pressure sleeve is inflated with a gas (Col. 6 Lines 59-60, examiner interprets that the cuff is inflated with air), the fluid container pressure sleeve applies an inward directional pressure to the malleable fluid container from an exterior of the malleable fluid container (Col. 4 Lines 44-48); a pump (16, Fig. 1) configured to provide the gas to the fluid container pressure sleeve (Col. 2 Lines 55-59); and a pressure measuring device (14) configured to measure a pressure associated with the malleable fluid container by the fluid container pressure sleeve (Col. 5 Lines 39-51).
Regarding Claim 5, Pavlo discloses the infusion system of Claim 1, wherein the pressure measuring device is configured to measure a fluid pressure of the fluid within the malleable fluid container (Col. 5 Lines 3-10).
Regarding Claim 6, Pavlo discloses the infusion system of Claim 1, wherein the pressure measured by the pressure measuring device is indicative of a compression force applied to the malleable fluid container by the fluid container pressure sleeve (Cuff 12 applies a compressive pressure to bag 24, Col. 4 Lines 28-30, gauge 14 is able to determine and display pressure within the cuff, Col. 5 Lines 3-10, thus pressure being applied to the bag 24).
Regarding Claim 7, Pavlo discloses the infusion system of Claim 1, wherein the pump is a hand pump (16, Fig. 1, Col. 5 Lines 54-55).
Regarding Claim 9, Pavlo discloses the infusion system of Claim 1, wherein the pressure measuring device comprises a pressure gauge (Col. 5 Lines 3-10).
Regarding Claim 11, Pavlo discloses a method for intravenous delivery of a fluid from a fluid container (Abstract), comprising: encompassing a malleable fluid container (24) within a fluid container pressure sleeve (12 with an air chamber 46 between inner and outer sheets 26 and 30 respectively) configured to wrap around, connect and form to the malleable fluid container (Figs. 9-10) such that, when the fluid container pressure sleeve is inflated with a gas (Col. 6 Lines 59-60, examiner interprets that the cuff is inflated with air), the fluid container pressure sleeve applies an inward directional pressure to the malleable fluid container from an exterior of the malleable fluid container to compress the malleable fluid container (Col. 4 Lines 44-48); and activating a pump (16) connected to the fluid container pressure sleeve (Col. 4 Lines 19-20) to provide the gas to the fluid container pressure sleeve to compress the malleable fluid container (Col. 4 Lines 28-30) and direct a fluid within the malleable fluid container toward and through a connected infusion tubing (Col. 4 Lines 24-26).
Regarding Claim 14, Pavlo discloses a method for intravenous delivery of a fluid from a fluid container (Abstract), comprising: providing a malleable fluid container (24) configured to store a fluid and deliver the fluid via a connected infusion tubing (Col. 4 Lines 22-26); providing a fluid container pressure sleeve (12 with an air chamber 46 between inner and outer sheets 26 and 30 respectively) configured to wrap around, connect and form to the malleable fluid container (Figs. 9-10) such that, when the fluid container pressure sleeve is inflated with a gas (Col. 6 Lines 59-60, examiner interprets that the cuff is inflated with air), the fluid container pressure sleeve applies an inward directional pressure to the malleable fluid container from an exterior of the malleable fluid container (Col. 4 Lines 44-48); providing a pump (16) configured to provide the gas to the fluid container pressure sleeve (Col. 4 Lines 28-30); and providing a pressure measuring device (14) configured to measure a pressure associated with the malleable fluid container by the fluid container pressure sleeve (Col. 5 Lines 39-51).
Regarding Claim 17, Pavlo discloses the method of Claim 14, further comprising: providing a pressure measuring device (14) operably connected to the fluid container pressure sleeve (Fig. 1) and configured to measure a pressure indicative of a compression force applied to the malleable fluid container by the fluid container pressure sleeve (Cuff 12 applies a compressive pressure to bag 24, Col. 4 Lines 28-30, gauge 14 is able to determine and display pressure within the cuff, Col. 5 Lines 3-10, thus pressure being applied to the bag 24).
Regarding Claim 18, Pavlo discloses the method of Claim 14, further comprising: providing a pressure measuring device (14) operably connected to the malleable fluid container (Fig. 1) and configured to measure a fluid pressure of the fluid within the malleable fluid container (Col. 5 Lines 3-10).
Regarding Claim 19, Pavlo discloses the method of Claim 14, wherein the pump is a hand pump (16).
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.
Claim(s) 2-4, 12,13, 15 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pavlo in view of Gan et al. (CN 109550108 A, herein Gan).
Regarding Claim 2, Pavlo discloses the infusion system of Claim 1,
Pavlo does not expressly disclose wherein the fluid container pressure sleeve comprises: an internal coiled gas chamber in a shape of a coil such that a helical axis of the coil traverses an axis of the malleable fluid container when the fluid container pressure sleeve is wrapped around the malleable fluid container.
Gan teaches a malleable fluid container pressure airbag comprising: an airbag (2) in the shape of a coil (Fig. 1) such that the airbag surrounds the malleable fluid container (6) to extrude a liquid from the malleable fluid container (Page 4 Paragraph 2).
Gan further teaches that the airbag is made from an inflatable, flexible material (Page 4 Paragraph 2).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to modify the infusion system as disclosed by Pavlo so that the fluid container pressure sleeve comprises: an internal coiled gas chamber in a shape of a coil such that a helical axis of the coil traverses an axis of the malleable fluid container when the fluid container pressure sleeve is wrapped around the malleable fluid container since one of ordinary skill in the art would modify the airbag as evidenced by Gan to be in a helically coiled shape so that expansion of the fluid container pressure sleeve can occur from one end to another (Gao, Page 4 Paragraph 2).
Regarding Claim 3, modified Pavlo in view of Gan discloses the infusion system of Claim 2, wherein a first end of the internal coiled gas chamber is configured to, when the fluid container pressure sleeve is wrapped around the malleable fluid container, terminate at a first end of the malleable fluid container opposite a second end of the malleable fluid container to which the infusion tubing is connected, and extend along the axis of the malleable fluid container toward the second end of the malleable fluid container (See annotated Pavlo Fig. 10 Below, pressure sleeve extends along a longitudinal axis of bag 24).
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Regarding Claim 4, modified Pavlo in view of Gan discloses the infusion system of Claim 3, wherein the internal coiled gas chamber incrementally increases in diameter toward the first end of the internal coiled gas chamber from a second end of the internal coiled gas chamber opposite the first end of the internal coiled gas chamber (Gan, “Preferably, when the air bag 2 is inflated, the expansion speed gradually reduces to the other end from one end far away from the infusion bag of the liquid outlet.” - Page 4 Paragraph 2, examiner interprets that the gradual expansion speed can be dependent on the diameter of each coil of the helically coiled air bag 6), such that when the internal coiled gas chamber is inflated the internal coiled gas chamber applies a greater pressure to the first end of the malleable fluid container than the second end of the malleable fluid container to which the infusion tubing is connected, so as to direct a flow of the fluid within the malleable fluid container toward and through the connected infusion tubing (Gan, “Thus in the infusion bag earlier is pressed away from the outlet portion so as to extrude the liquid infusion, more thoroughly [through] the liquid output.” – Page 4 Paragraph 2).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to modify the infusion system as disclosed by Pavlo wherein the internal coiled gas chamber incrementally increases in diameter toward the first end of the internal coiled gas chamber from a second end of the internal coiled gas chamber opposite the first end of the internal coiled gas chamber, such that when the internal coiled gas chamber is inflated the internal coiled gas chamber applies a greater pressure to the first end of the malleable fluid container than the second end of the malleable fluid container to which the infusion tubing is connected, so as to direct a flow of the fluid within the malleable fluid container toward and through the connected infusion tubing as taught by Gan so that expansion can occur from one end to another (Gao, Page 4 Paragraph 2).
Regarding Claim 12, Pavlo discloses the method of Claim 11, wherein the fluid container pressure sleeve comprises: a first end of the gas chamber is configured to, when the fluid container pressure sleeve is wrapped around the malleable fluid container, terminate at a first end of the malleable fluid container opposite a second end of the malleable fluid container to which the infusion tubing is connected, and extend along the axis of the malleable fluid container toward the second end of the malleable fluid container (See annotated Pavlo Fig. 10, pressure sleeve extends a longitudinal axis of bag 24), wherein activating the pump (16) comprises causing the internal chamber (46) to fill with the gas and inflate (when activating pump 16, air chamber 46 inflates with air).
Pavlo does not expressly disclose an internal coiled gas chamber in a shape of a coil such that a helical axis of the coil traverses an axis of the malleable fluid container when the fluid container pressure sleeve is wrapped around the malleable fluid container, wherein a first end of the internal coiled gas chamber is configured to, when the fluid container pressure sleeve is wrapped around the malleable fluid container, terminate at a first end of the malleable fluid container opposite a second end of the malleable fluid container to which the infusion tubing is connected, and extend along the axis of the malleable fluid container toward the second end of the malleable fluid container, wherein activating the pump comprises causing the internal coiled gas chamber to fill with the gas and inflate.
Gan teaches a malleable fluid container pressure airbag comprising: an airbag (2) in the shape of a coil (Fig. 1) such that the airbag surrounds the malleable fluid container (6) to extrude a liquid from the malleable fluid container (Page 4 Paragraph 2).
Gan further teaches that the airbag is made from an inflatable, flexible material (Page 4 Paragraph 2).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to modify the method as disclosed by Pavlo wherein the fluid container pressure sleeve comprises: an internal coiled gas chamber in a shape of a coil such that a helical axis of the coil traverses an axis of the malleable fluid container when the fluid container pressure sleeve is wrapped around the malleable fluid container, wherein a first end of the internal coiled gas chamber is configured to, when the fluid container pressure sleeve is wrapped around the malleable fluid container, terminate at a first end of the malleable fluid container opposite a second end of the malleable fluid container to which the infusion tubing is connected, and extend along the axis of the malleable fluid container toward the second end of the malleable fluid container, wherein activating the pump comprises causing the internal coiled gas chamber to fill with the gas and inflate since one of ordinary skill in the art would modify the airbag as evidenced by Gan to be in the shape of a coil in order to wrap the pressure sleeve around a malleable fluid container so that expansion can occur from one end to another (Gao, Page 4 Paragraph 2).
Regarding Claim 13, modified Pavlo in view of Gan discloses the method of Claim 12, wherein the internal coiled gas chamber incrementally increases in diameter toward the first end of the internal coiled gas chamber from a second end of the internal coiled gas chamber opposite the first end of the coiled gas chamber (Gan, “Preferably, when the air bag 2 is inflated, the expansion speed gradually reduces to the other end from one end far away from the infusion bag of the liquid outlet.” - Page 4 Paragraph 2, examiner interprets that the gradual expansion speed can be dependent on the diameter of each coil of the helically coiled air bag 6), wherein activating the pump (Gan, 32) comprises causing the internal coiled gas chamber to apply a greater pressure to the first end of the malleable fluid container than the second end of the malleable fluid container to which the infusion tubing is connected, and direct a flow of the fluid within the malleable fluid container toward and through the connected infusion tubing (Gan, “Thus in the infusion bag earlier is pressed away from the outlet portion so as to extrude the liquid infusion, more thoroughly [through] the liquid output.” – Page 4 Paragraph 2).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to modify the method disclosed by Pavlo wherein the internal coiled gas chamber incrementally increases in diameter toward the first end of the internal coiled gas chamber from a second end of the internal coiled gas chamber opposite the first end of the coiled gas chamber, wherein activating the pump comprises causing the internal coiled gas chamber to apply a greater pressure to the first end of the malleable fluid container than the second end of the malleable fluid container to which the infusion tubing is connected, and direct a flow of the fluid within the malleable fluid container toward and through the connected infusion tubing since one of ordinary skill in the art would modify the airbag as evidenced by Gan to be in the shape of a coil in order to wrap the pressure sleeve around a malleable fluid container so that expansion can occur from one end to another (Gao, Page 4 Paragraph 2).
Regarding Claim 15, Pavlo discloses the method of Claim 14, wherein the fluid container pressure sleeve comprises: a first end of the internal gas chamber is configured to, when the fluid container pressure sleeve is wrapped around the malleable fluid container, terminate at a first end of the malleable fluid container opposite a second end of the malleable fluid container to which the infusion tubing is connected, and extend along the axis of the malleable fluid container toward the second end of the malleable fluid container (See annotated Pavlo Fig. 10, pressure sleeve extends a longitudinal axis of bag 24).
Pavlo does not expressly disclose wherein the fluid container pressure sleeve comprises: an internal coiled gas chamber in a shape of a coil such that a helical axis of the coil traverses an axis of the malleable fluid container when the fluid container pressure sleeve is wrapped around the malleable fluid container, wherein a first end of the internal coiled gas chamber is configured to, when the fluid container pressure sleeve is wrapped around the malleable fluid container, terminate at a first end of the malleable fluid container opposite a second end of the malleable fluid container to which the infusion tubing is connected, and extend along the axis of the malleable fluid container toward the second end of the malleable fluid container.
Gan teaches a malleable fluid container pressure airbag comprising: an airbag (2) in the shape of a coil (Fig. 1) such that the airbag surrounds the malleable fluid container (6) to extrude a liquid from the malleable fluid container (Page 4 Paragraph 2).
Gan further teaches that the airbag is made from an inflatable, flexible material (Page 4 Paragraph 2).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to modify the method as disclosed by Pavlo wherein the fluid container pressure sleeve comprises: an internal coiled gas chamber in a shape of a coil such that a helical axis of the coil traverses an axis of the malleable fluid container when the fluid container pressure sleeve is wrapped around the malleable fluid container, wherein a first end of the internal coiled gas chamber is configured to, when the fluid container pressure sleeve is wrapped around the malleable fluid container, terminate at a first end of the malleable fluid container opposite a second end of the malleable fluid container to which the infusion tubing is connected, and extend along the axis of the malleable fluid container toward the second end of the malleable fluid container since one of ordinary skill in the art would modify the airbag as evidenced by Gan to be in the shape of a coil in order to wrap the pressure sleeve around a malleable fluid container so that expansion can occur from one end to another (Gao, Page 4 Paragraph 2).
Regarding Claim 16, modified Pavlo in view of Gan discloses the method of Claim 15, wherein the internal coiled gas chamber incrementally increases in diameter toward the first end of the internal coiled gas chamber from a second end of the internal coiled gas chamber opposite the first end of the internal coiled gas chamber (Gan, “Preferably, when the air bag 2 is inflated, the expansion speed gradually reduces to the other end from one end far away from the infusion bag of the liquid outlet.” - Page 4 Paragraph 2, examiner interprets that the gradual expansion speed can be dependent on the diameter of each coil of the helically coiled air bag 6), such that when the internal coiled gas chamber is inflated the internal coiled gas chamber applies a greater pressure to the first end of the malleable fluid container than the second end of the malleable fluid container to which the infusion tubing is connected, so as to direct a flow of the fluid within the malleable fluid container toward and through the connected infusion tubing (Gan, “Thus in the infusion bag earlier is pressed away from the outlet portion so as to extrude the liquid infusion, more thoroughly [through] the liquid output.” – Page 4 Paragraph 2).
Claim(s) 8, 10, and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pavlo in view of Lampropoulos et al. (Pub. No. US 20030208158, herein Lampropoulos).
Regarding Claim 8, Pavlo discloses the infusion system of Claim 1.
Pavlo does not expressly disclose wherein the pump is a foot controlled pump.
Lampropoulos teaches wherein the pump is a foot controlled pump (“manual pump 60 can comprise a billows pump, foot pump, or other non-motorized pump.” - Paragraph [0039]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to modify the infusion system as disclosed by Pavlo wherein the pump is a foot controlled pump as taught by Lampropoulos so that a user can inflate the bag without the need for using a motorized pump (Lampropoulos, Paragraph [0039]).
Regarding Claim 10, Pavlo discloses the infusion system of Claim 1.
Pavlo does not expressly disclose further comprising: a pump controller, wherein the pump comprises an electrical compressor configured to provide a metered amount of the gas to the fluid container pressure sleeve based on a signal from the pump controller.
Lampropoulos teaches a pump controller (70), wherein the pump (72) comprises an electrical compressor (“Motor driver 72 can comprise any of a variety of mechanical, electromechanical, electrical, chemical or other drivers known in the art.” – Paragraph [0050]) configured to provide a metered amount of the gas to the fluid container pressure sleeve based on a signal from the pump controller (Paragraph [0051]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to modify the infusion system as disclosed by Pavlo further comprising: a pump controller, wherein the pump comprises an electrical compressor configured to provide a metered amount of the gas to the fluid container pressure sleeve based on a signal from the pump controller as taught by Lampropoulos so that a precise amount of air may be delivered to a pressure sleeve controlling infusion rates (Lampropoulos, Paragraph [0051]).
Regarding Claim 20, Pavlo discloses the method of Claim 14.
Pavlo does not expressly disclose further comprising: providing a pump controller comprising an electrical compressor configured to provide a metered amount of the gas to the fluid container pressure sleeve based on a signal from the pump controller.
Lampropoulos teaches further comprising: a pump controller (70), wherein the pump (72) comprises an electrical compressor (“Motor driver 72 can comprise any of a variety of mechanical, electromechanical, electrical, chemical or other drivers known in the art.” – Paragraph [0050]) configured to provide a metered amount of the gas to the fluid container pressure sleeve based on a signal from the pump controller (Paragraph [0051]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to modify the method disclosed by Pavlo further comprising: providing a pump controller comprising an electrical compressor configured to provide a metered amount of the gas to the fluid container pressure sleeve based on a signal from the pump controller as taught by Lampropoulos so that a precise amount of air may be delivered to a pressure sleeve controlling infusion rates (Lampropoulos, Paragraph [0051]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Mark Golovan whose telephone number is (571)272-2119. The examiner can normally be reached Monday - Friday 7:30am-4:30pm Alt Fri. off
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/MARK GOLOVAN/Patent Examiner, Art Unit 3783 /CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783