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 § 112(b)
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 19–21 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.
Claim 19 recites:
19. The fluid delivery system of claim 1, wherein:
the outlet is a liquid outlet,
the gas removal device further comprises a gas outlet,
the inlet and the gas outlet are one side of the gas removal device, and
the liquid outlet is on the other side of the gas removal device.
Claim 19 is indefinite because “the other side” lacks antecedent basis, as the gas removal device could have more than two sides. To overcome this rejection, claim 19 could be amended to read:
19. The fluid delivery system of claim 1, wherein:
the outlet is a liquid outlet,
the gas removal device further comprises a gas outlet,
the inlet and the gas outlet are one side of the gas removal device, and
the liquid outlet is on another side of the gas removal device.
Claims 20 and 21 are indefinite because they depend from claim 19.
Claim Rejections - 35 USC § 102
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.
Claims 1, 13, 19 and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ford, US 5,779,674.
Regarding claim 1, Ford teaches a system for delivering fluid to a patient, which reads on the claimed “fluid delivery system.” See Ford Fig. 1, col. 3, ll. 22–24.
The system comprises a media bag 12 (the “fluid source”) comprising fluid having a liquid and a gas, as claimed. See Ford Fig. 1, col. 3, ll. 54–63.
The system also comprises a “fluid destination,” which is the location at the end of outlet line 16 for receiving fluid from the bag 12. See Ford Fig. 1, col. 3, ll. 54–63.
The system further comprises a fluid gas removal drip chamber 10 located between the bag 12 and the “fluid destination,” which reads on the “gas removal device that is configured to separate gas from the fluid between the fluid source and the fluid destination.”
The system also comprises an inlet line 14 (the “inlet supply line”) that is configured to convey the fluid from the bag 12 to the drip chamber 10 at a flow rate. See Ford Fig. 1, col. 3, ll. 54–63. The inlet line 14 has an inner diameter, as seen in Fig. 2.
The system further comprises an outlet line 16 (the “outlet supply line”) that is configured to convey the fluid from the drip chamber 10 to the “fluid destination” at a flow rate. See Ford Fig. 1, col. 3, ll. 54–63. The outlet line 16 has an inner diameter, as seen in Fig. 2.
The drip chamber 10 has a throughbore 46 (the “inlet”) fluidly connected to the inlet line 14. See Ford Fig. 2, col. 4, ll. 35–37. The drip chamber 10 also comprises an outlet nipple 38 (the “outlet”) fluidly connected to the outlet line 16. Id. at Fig. 2, col. 4, ll. 17–21.
The throughbore 46 has an inner diameter that is greater than the inner diameter of the inlet line 14, as claimed, as seen in Fig. 2.
The outlet nipple 38 has an inner diameter that is greater than the inner diameter of the outlet line 16, as seen in Fig. 2
Also, “an entirety of a flow path defined by” the drip chamber 10 is unobstructed between the throughbore 46 and the outlet nipple 38 so as to not restrict the flow rate of the fluid through the inlet line 14 and the outlet line 16, as claimed, because there are no obstructions in the interior chamber 26 of the drip chamber 10 between the throughbore 46 and the outlet nipple 38 in the area of the interior chamber 26 on the left-hand side of the filter assembly 28, as seen in the annotated version of Fig. 2 below.
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Regarding claim 13, Ford teaches that the outlet nipple 38 (the “outlet”) is a liquid outlet, as claimed. See Ford col. 3, ll. 54–63,
Also, the drip chamber 10 (the “gas removal device”) comprises a filter assembly 28 (the “filter”). See Ford Fig. 2, col. 4, ll. 7–25.
The drip chamber 10 comprises a “body” (the structure of the drip chamber 10) defining an “interior” (the inner spaces of the drip chamber 10). See Ford Fig. 2, col. 4, ll. 7–25. The filter assembly 28 is within the interior chamber 26. Id. The filter assembly 28 segments the “interior” into a “first chamber” (the space upstream of the filter assembly 28, including interior chamber 26) and a “second chamber” (the space downstream of the filter assembly 28, including the interior of the filter assembly 28 and the space holding check valve 30).
The space holding the check valve 30 reads on the “gas outlet that is configured to communicate the gas out of the second chamber,” because the check valve 30 allows gas to be vented from the drip chamber 10. See Ford Fig. 2, col. 5, ll. 60–65.
The filter assembly 28 is impermeable to the liquid and is configured to isolate the “second chamber” from the liquid when the liquid is in the “first chamber,” as claimed, because it is hydrophobic. See Ford Fig. 2, col. 4, ll. 7–25.
The filter assembly 28 is permeable to the gas and is configured to permit communication of the gas from the “first chamber” to the “second chamber,” to separate the gas from the liquid, as claimed, because air passes through hydrophobic membrane 52 of the filter assembly 28 to remove gas from the “first chamber” into the “second chamber” so the gas can be vented to the atmosphere. See Ford Fig. 2, col. 7, ll. 56–67.
Regarding claim 19, Ford teaches that the outlet nipple 38 (the “outlet”) is a liquid outlet. See Ford Fig. 2, col. 3, ll. 54–63. Also, the drip chamber 30 (the “gas removal device”) comprises a “gas outlet” (the vent where the check valve 30 is located). Id. at Fig. 2, col. 7, ll. 29–35.
The throughbore 46 and the “gas outlet” 30 are arranged on a top side (“one side”) of the drip chamber 10 (as seen in Fig. 2) and the outlet nipple 38 is located on the bottom side of the drip chamber 10 (“the other side”), as seen in Fig. 2.
Regarding claim 20, Ford teaches that the throughbore 46 (the “inlet”) and the “gas outlet” 30 are laterally offset from one another, as seen in Fig. 2.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 3, 4, 6 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Ford, US 5,779,674 in view of Schroeder, US 2023/0140392 A1.
Regarding claim 3, Ford teaches the limitations of claim 1, as explained above.
Ford differs from claim 3 because it is silent as to the throughbore 46 (the “inlet”) having dimensions described in the claim.
But the throughbore 46 is a connector of the drip chamber 10 used to attach the inlet line 14 to the drip chamber 10.
With this in mind, Schroeder teaches a connector portion 310 for a system for pharmaceutical fluids, where the connector portion 310 has an opening for receiving a tube 4, and with the opening having an abutment surface 310A provided internally in which the tube 4 is abutted against when the tube 4 is inserted into the opening. See Schroeder Fig. 3B, [0037]. The abutment surface 310A is beneficial because it enables alignment of the tube 4 with the opening of the connector portion 310 that the tube 4 is inserted into. Id.
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It would have been obvious to modify the throughbore 46 of Ford to have the abutment surface of Schroeder to enable the inlet line 14 to be aligned with the throughbore 46 when the inlet line 14 is inserted into the throughbore 46.
With this modification, the inner diameter of the throughbore 46 at the abutment surface reads on the “inner diameter of the inlet is a first diameter.” The inner diameter of the throughbore 46 where the inlet line 14 is inserted reads on “the inlet has a second inner diameter.” The outer diameter of the inlet line 14 reads on the “inlet supply line has an outer diameter.” The “second inner diameter” is greater than or equal to the outer diameter of the inlet line 14, as claimed, because the inlet line 14 is inserted into the throughbore 46 at the “second diameter.” The “second inner diameter” is also greater than the “first inner diameter,” as claimed, as seen in Fig. 3B of Schroeder where the area where the tube 4 is inserted (the “second inner diameter”) is greater than the abutment surface 310A (the “first inner diameter”).
Regarding claim 4, Ford teaches that the drip chamber 10 (the “gas removal device”) comprises a “body” (the structure of the drip chamber 10) defining an interior chamber 26 (the “interior”). See Ford Fig. 2, col. 4, ll. 7–24.
The abutment surface (the “first inner diameter”) of the throughbore 46 (the “inlet”) is between the interior chamber 26 and the “second inner diameter” (the area of the throughbore 46 where the inlet line 14 is inserted), as seen in Fig. 2 of Ford where the bottom of the inlet line 14 is between the interior chamber 26 and the top of the throughbore 46 where the inlet line 14 is inserted.
Regarding claim 6, Ford teaches the limitations of claim 1, as explained above.
For differs from claim 6 because it is silent as to the outlet nipple 38 (the “outlet”) having dimensions described in the claim.
But the outlet nipple 38 is a connector of the drip chamber 10 used to attach the outlet line 16 to the drip chamber 10.
With this in mind, Schroeder teaches a connector portion 310 for a system for pharmaceutical fluids, where the connector portion 310 has an opening for receiving a tube 4, and with the opening having an abutment surface 310A provided internally in which the tube 4 is abutted against when the tube 4 is inserted into the opening. See Schroeder Fig. 3B, [0037]. The abutment surface 310A is beneficial because it enables alignment of the tube 4 with the opening of the connector portion 310 that the tube 4 is inserted into. Id.
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It would have been obvious to modify the outlet nipple 38 of Ford to have the abutment surface 310A of Schroeder to enable the outlet line 16 to be aligned with the outlet nipple 38 when the outlet line 16 is inserted into the outlet nipple 38.
With this modification, the inner diameter of the outlet nipple 38 at the abutment surface reads on the “inner diameter of the outlet is a first diameter.” The inner diameter of the outlet nipple 38 where the outlet line 16 is inserted reads on “the outlet has a second inner diameter.” The outer diameter of the outlet line 16 reads on the “outlet supply line has an outer diameter.” The “second inner diameter” is greater than or equal to the outer diameter of the outlet line 16, as claimed, because the outlet line 16 is inserted into the outlet nipple 38 at the “second diameter.” The “second inner diameter” is also greater than the “first inner diameter,” as claimed, as seen in Fig. 3B of Schroeder where the area where the tube 4 is inserted (the “second inner diameter”) is greater than the abutment surface 310A (the “first inner diameter”).
Regarding claim 7, Ford teaches that the drip chamber 10 (the “gas removal device”) comprises a “body” (the structure of the drip chamber 10) defining an interior chamber 26 (the “interior”). See Ford Fig. 2, col. 4, ll. 7–24.
The abutment surface (the “first inner diameter”) of the outlet nipple 38 (the “outlet”) is between the interior chamber 26 and the “second inner diameter” (the area of the outlet nipple 38 where the outlet line 16 is inserted), as seen in Fig. 2 of Ford where the bottom of the outlet line 16 is between the interior chamber 26 and the bottom of the outlet nipple 38 where the outlet line 16 is inserted.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Ford, US 5,779,674 in view of Schroeder, US 2023/0140392 A1 and in further view of Jess, US 4,031,891.
Regarding claim 8, Ford as modified teaches that the outlet line 16 (the “outlet supply line”) defines a cross-sectional flow area (the “second cross-sectional flow area through which the fluid is configured to flow”), as seen in Fig. 2.
The inner diameter of the outlet nipple 38 at the abutment surface (the “first inner diameter of the outlet”) defines a cross-sectional flow area (the “third cross-sectional flow area through which the fluid is configured to flow”).
The cross-sectional flow area at the abutment surface (the “third cross-sectional flow area”) is less than the cross-sectional flow area of the outlet line 16 (the “second cross-sectional flow area”), as seen in Fig. 3B of Schroeder where the cross-sectional area of the abutment surface 310A is less than the cross-sectional area of the tube 4.
Ford as modified differs from claim 8 because it is silent as to the cross-sectional flow area of the location receiving fluid from the outlet line 16 (the “fluid destination”). Therefore, the reference fails to provide enough information to teach the cross-sectional area of the abutment surface (the “third cross-sectional flow area”) is greater than the cross-sectional area of the “fluid destination” (the “first cross-sectional flow area”).
But the system of Ford is intended to supply fluid to a patient. See Ford col. 1, ll. 6–9. Also, Jess teaches a system for delivering fluid to a patient comprising a drip chamber 52, tubing 58 and a needle 60, with the tip of the needle 60 having a relatively small cross-sectional flow area of the system for insertion into a patient (as seen in Fig. 4). See Jess Fig. 4, col. 4, l. 65–col. 5, l. 16. The needle is beneficial because it provides a mechanism for connecting the system to a patient.
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It would have been obvious to use the needle 60 of Jess with the system of Ford to provide a mechanism for connecting the system to a patient to enable delivery of fluid. With this modification, the needle 60 reads on the “fluid destination” and the cross-sectional flow area at the tip of the needle 60 reads on the “first cross-sectional flow area.” The cross-sectional flow area of the tip of the needle 60 is interpreted as being less than the cross-sectional flow area of the abutment surface (the “third cross-sectional flow area”) because the tip of the needle is required to be relatively small to enable insertion into a patient.
Claims 9 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Ford, US 5,779,674 in view of Meng et al., US 2021/0116057 A1.
Regarding claim 9, Ford teaches the limitations of claim 1, as explained above.
Ford differs from claim 1 because it is silent as to the system comprising a pump.
But the system can be used to supply fluid to a patient. See Ford col. 1, ll. 11–17. Also, Meng teaches that an infusion pump can facilitate the delivery of fluids to a patient. See Meng [0019]. Therefore, it would have been obvious for the system of Ford to include an infusion pump to facilitate the delivery of IV fluids to a patient.
Regarding claim 10, Ford as modified teaches that the drip chamber 10 (the “gas removal device”) would be upstream or downstream from the infusion pump, as claimed, because the infusion pump would be in the fluid pathway for delivery of fluid. See Kim [0058].
Claims 14, 15 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Ford, US 5,779,674 in view of Bedingfield et al., US 2004/0025693 A1.
Regarding claims 14 and 15, Ford teaches the limitations of claim 13, as explained above.
Ford differs from claims 14 and 15 because it is silent as to the hydrophobic filter assembly 28 (the “filter”) being substantially planar with only one surface of the filter assembly 28 being exposed to the “first chamber.”
But the filter assembly 28 is provided so that gas that collects within the interior chamber 26 of the drip chamber 10 can move through the filter 28 to be vented to the atmosphere, while liquid remains within the interior chamber 26.
With this in mind, Bedingfield teaches an apparatus for venting gas from a liquid delivery system comprising a chamber for degassing liquid and a venting tube 2 for venting gas from the chamber, where the venting tube 2 comprises a planar, hydrophobic membrane 16 with only one surface (the bottom surface) that is exposed to the interior of the chamber. See Bedingfield Figs. 2, [0064], [0066].
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It would have been obvious to use the venting tube 2 of Bedingfield as the filter assembly 28 of Ford because this would merely represent the simple substitution of one known element for another to yield predictable results. See MPEP 2143, subsection I, B. With this modification the planar hydrophobic membrane 16 reads on the “filter.”
Regarding claim 22, Ford teaches the limitations of claim 13, as explained above.
Ford differs from claim 13 because it is silent as to the filter assembly 28 comprising at least one of PTFE or acrylic copolymer matrix, as claimed.
But the filter assembly 28 comprises a hydrophobic membrane 52 that is configured to allow gas but not liquid to pass through it. See Ford Fig. 2, col. 4, ll. 53–67. Also, Bedingfield teaches a gas venting device comprising a hydrophobic membrane 16 that is configured to allow gas but not liquid to pass through it, where the membrane 16 is made of a material, such as PTFE. See Bedingfield Fig. 2, [0066].
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Ford, US 5,779,674 in view of Meng et al., US 2021/0116057 A1 and in further view of Hu et al., US 2022/0203004 A1.
Regarding claim 18, Ford as modified teaches the limitations of claim 10, as explained above.
Ford differs from claim 18 because it is silent as to the drip chamber 10 being a first gas removal device that is upstream of the pump and the system further comprising a second drip chamber 10 that is downstream of the pump, as claimed.
But Hu teaches a dialysis system comprising a pump 142 with an air separator 187 located upstream and downstream of the pump 142, with the multiple air separators 187 being beneficial for removing excess air from the liquid. See Hu Fig. 9, [0107], [0116], [0120]. It would have been obvious to provide a drip chamber 10 of Ford upstream and downstream of the infusion pump to ensure that excess air is removed from the liquid.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Ford, US 5,779,674.
Regarding claim 21, Ford teaches that the throughbore 46 extends along a “first axis” and the “gas outlet” 30 extends along a “second axis” that is parallel to the “first axis,” as seen in Fig. 2.
Ford differs from claim 19 because it is silent as to the throughbore 46 (the “inlet”) and the outlet nipple 38 (the “outlet”) extending along a first axis, as claimed. Instead, Fig. 2 shows the throughbore 46 and outlet nipple 38 being slightly offset from one another. But it would have been obvious for the throughbore 46 and outlet nipple 38 to be aligned with one another so that they extend along a common axis because this would merely represent obvious rearrangement of parts with no significant change in function. See MPEP 2144.04, subsection VI, C.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to T. BENNETT MCKENZIE whose telephone number is (571)270-5327. The examiner can normally be reached Mon-Thurs 7:30AM-6:00PM.
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T. BENNETT MCKENZIE
Primary Examiner
Art Unit 1776
/T. BENNETT MCKENZIE/Primary Examiner, Art Unit 1776