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 .
Status of the Claims
Claims 30, 34-35, 37-38, 40, and 42 are cancelled. Claims 50-55 are newly added. Claims 29, 31-33, 36, 39, 41, and 43-55 are currently pending. Claims 29, 31-33, 36, 39, 41, and 43-55 are currently rejected.
Response to Arguments
Applicant’s arguments, see Remarks filed 04/24/2026, with respect to the rejection(s) of claim(s) 29 under 35 U.S.C. 103 have been fully considered and are persuasive due to the amendments to claim 29 changing the scope of the claim. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Wojke, Chen, Jess, and Rielly.
Examiner notes that although the previously noted drawing objections are rectified in regards to the drawings in the associated PGPUB, no drawings have been officially filed with the instant application.
Examiner notes that the amendment to claim 47 does not fix the previous objection, which is repeated below. Additionally, multiple 112b issues were not addressed or newly arose due to the amendments to the claims. Please see 112b rejections below.
The previous objections to the specification are obviated by the amendments to the claims and the specification. Likewise, the previous 112f issue is obviated by the cancellation of claim 34, and the previous 112a issue is obviated by the amendment to claim 43.
Drawings
The subject matter of this application admits of illustration by a drawing to facilitate understanding of the invention. Applicant is required to furnish a drawing under 37 CFR 1.81(c). No new matter may be introduced in the required drawing. 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).
Claim Objections
Claim 47 is objected to because of the following informalities:
Claim 47 line 1 recites “a gas trap apparatus of claim 29”. This should read “the gas trap apparatus of claim 29”.
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 29-55 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 29 recites the limitation “a lateral dimensional component” on line 19. It is unclear whether this “lateral dimensional component” is meant to refer back to the “lateral dimensional component” introduced in line 14-15 of claim 29, or introduce a different lateral dimensional component of the flow/chamber, or introduce a lateral dimensional component of a different structure/flow. For the purposes of examination, any of the situations described has been interpreted to meet the claim limitation.
Claim 33 recites the limitation “a diverter” in line 2. Claim 29, on which claim 33 depends, already introduced “a flow diverter”. It is unclear whether the instance of this limitation in the dependent claim is meant to introduce a new structure (in which case the naming convention should be altered to distinguish the structures) or refer back to the same structure earlier introduced (in which case the article should be changed to “the”). For the purposes of examination, any of the situations described has been interpreted to meet the claim limitation.
Claim 36 recites the limitation “an inlet port” on line 2. Claim 29, on which claim 36 depends, already introduced “an inlet port”. It is unclear whether the instance of this limitation in the dependent claim is meant to introduce a new structure (in which case the naming convention should be altered to distinguish the structures) or refer back to structure earlier introduced (in which case the limitation should be changed to “the inlet port”). For the purposes of examination, any of the situations described has been interpreted to meet the claim limitation.
Claim 36 recites the limitation “a port” on line 3. Claim 29, on which claim 36 depends, already introduced “an inlet port”, “an outlet port”, and “a venting port”. It is unclear whether the instance of this limitation in the dependent claim is meant to introduce a new structure (in which case the naming convention should be altered to distinguish the structures) or refer back to one of the plurality of structures earlier introduced (in which case the limitation should be changed to match the wording of the earlier introduced structure and “the” should be used as the article). For the purposes of examination, any of the situations described has been interpreted to meet the claim limitation.
Claim 36 recites the limitation "the purpose" in line 3. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, the phrase “for the purpose of transferring” has been interpreted to read “for transferring”.
Claim 47 recites the limitation “infusion lines linked with the inlet port” on line 2. It is unclear whether that should say “an infusion line linked with the inlet port”, since the claim has been amended to recite a single inlet port instead of multiple inlet ports, or whether there are meant to be multiple infusion lines somehow linked to a single inlet port. For the purposes of examination, any of the situations described has been interpreted to meet the claim limitation.
Claim 47 recites the limitation “an infusion line linked with the outlet” on lines 2-3. It is unclear whether this infusion line is meant to be the same as the one or more infusion lines linked to the inlet port already recited in claim 47, or introduce a different, separate infusion line linked only to the outlet port. For the purposes of examination, any of the situations described has been interpreted to meet the claim limitation.
Claim 55 recites the limitation “a lateral dimensional component” on line 9. It is unclear whether this “lateral dimensional component” is meant to refer back to the “lateral dimensional component” introduced in line 6-7 of claim 55, or introduce a different lateral dimensional component of the flow/chamber, or introduce a lateral dimensional component of a different structure/flow. For the purposes of examination, any of the situations described has been interpreted to meet the claim limitation.
Claims 30-54 are rejected for being dependent upon a claim rejected under 112b, since dependent claims inherit the deficiencies of the claims on which they depend.
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.
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.
Claim(s) 29, 41, and 47-54 are rejected under 35 U.S.C. 103 as being unpatentable over Wojke (US 5849065 A; hereafter Wojke) in view of Chen et al (US 20190083906 A1; hereafter Chen), Reilly et al (US 20100298699 A1; hereafter Reilly), and Jess (US 4013072 A; hereafter Jess).
Regarding claim 29, Wojke discloses a gas trap apparatus for medical fluids (Abstract “A device for separating gas bubbles out of medical fluids”), the apparatus comprising:
a bubble entrapment chamber (chamber 1, fig. 1, col. 4 ln. 23-29),
an inlet (see Modified Fig. 1) to the bubble entrapment chamber (1, fig. 1) comprising an inlet port (inlet connection 6, fig. 1, col. 4 ln. 30-43 “inlet connection 6 for attaching a supply intake line”),
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a venting port (circular orifice 8 and hydrophobic membrane 9, fig. 1, col. 4 ln. 23-29) comprising a vent opening (circular orifice 8, fig. 1, col. 4 ln. 23-29 “Circular orifice 8 … is sealed in a fluid-tight manner by a circular, hydrophobic membrane 9”), and
an outlet (see Modified Fig. 1) with at least one outlet port (outlet connection 7, fig. 1, col. 4 ln. 30-43 “outlet connection 7 for attaching an outlet line”), wherein:
the chamber (chamber 1, fig. 1) comprises a diffuser (flow guide member 10, fig. 2, col. 4 ln. 44-col. 5 ln. 7) comprising apertures (two orifices 17 and 18 of flow-guide tubes 15 and 16, fig. 2, col. 4 ln. 44-col. 5 ln. 7) around an inflow tube (short connecting piece 11, fig. 1, col. 4 ln. 44-54) of the inlet (see Modified Fig. 1) for causing an inflow of fluids into the chamber to have a lateral dimensional component (col. 5 ln. 8-16, “the vertical flow is diverted into a horizontal circulation flow”),
the venting port (8/9, fig. 1) is disposed upstream of the diffuser (see Modified Fig. 1 which shows that the venting port 8/9 is upstream of diffuser 10, since fluid flows from inlet port 6 to outlet port 7; see also col. 5 ln. 14-27), and
Wojke is silent to the apparatus comprising a flow diverter.
Chen, directed to a tank for removing bubbles from a fluid flow (see [0056-0057]), teaches wherein the apparatus comprises a flow diverter (shield 324C and second surface 322C, fig. 13, [0056] The shield 324C is mounted on the second surface 322C of the branch portion 32C, and said second surface 322C is the surface that faces the outlet component 20) in the chamber (container 10, fig. 1-3, [0028], note similar structure in reserve tank pictured in fig. 13) arranged to divert flow from the inlet to have a lateral directional component ([0039] the branch tunnels 342 are arranged radially and the main tunnel 341 is connected to a radial center of the branch tunnels 342; [0056] The reserve tank of the fourth embodiment is similar to any of the reserve tanks of the first, the second, and the third embodiments) with respect to a longitudinal flow direction from the inlet (inlet channel 34, fig. 2, [0039]), and away from the outlet port ([0057] the bubbles moving out of the inlet channel 34C may be blocked by the shield 324C, so that the bubbles may not be drawn in the outlet channel 24 no matter at what angle the reserve tank is disposed.) and towards an internal surface of the chamber (see fig. 13, note that fluid is prevented from moving toward the center of the chamber, instead being forced out to and then to remain at the periphery; [0056] shield 324C is annular in shape and around the open end 222 of the extending portion 22 of the outlet component 20.).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the diffuser of Wojke to include the diverter portion (shield 324C and second surface 322C, fig. 13) as taught by Chen since both references include the diffuser with multiple fluid ports, and the concept of pushing fluid away from the outlet toward the edge of a bubble entrapment chamber. One would have been motivated to make the modification because, as noted by Chen, having the diverter ensures that “[0057] the bubbles moving out of the inlet channel 34C may be blocked by the shield 324C, so that the bubbles may not be drawn in the outlet channel 24 no matter at what angle the reserve tank is disposed.”. Thus, the addition of the diverter to the diffuser would better ensure no bubbles enter the infusion fluid, and thus this modification serves to better protect the patient from an embolism.
Wojke modified by Chen is silent to wherein the inlet port comprises a valve for fully or partly restricting fluid flow through the inlet.
Reilly, in the art of mixing and delivery multiple fluids, teaches wherein the inlet port (mixing stopcock valve 300, fig. 10a-e, [0054]) comprises a valve (stopcock body 302, fig. 10a-e, [0052]) for fully (see fig. 10A, “an "off" or no-flow position of stopcock valve 300 is illustrated”) or partly (see fig. 10E, “stopcock actuator 304 is positioned such that first conduit portion 316 is in fluid communication but not aligned directly with saline port 310 resulting in restricted flow of saline”) restricting fluid flow through the inlet (inlet port 310, fig. 10A-E, [0054]).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the inlet of Wojke modified by Chen to include a valve for fully or partly restricting fluid flow through the inlet, since Reilly also deals with fluid transport, and specifically delivery of medical fluids similar to Wojke. One would have been motivated to make the modification because having the valve allows a user to control the amount of fluid delivered to the patient easily, and, as noted by Reilly [0057], the flow rate depends on how restricted flow through the inlet is.
Wojke as modified is silent to and wherein the venting port comprises a cap and the vent opening of the venting port is selectively sealable by the cap.
Jess, directed to a drip chamber for air elimination during intravenous administration (col. 4 ln. 37-41, fig. 5), teaches wherein the apparatus (drip chamber 44, fig. 5, col. 4 ln. 38-64) comprises a venting port (opening 62, hydrophobic filter element 60, and closure 66, fig. 5 and 6, col. 4 ln. 65-col. 5 ln. 4, hydrophobic filter element can be mounted over the opening 62) comprising a vent opening (opening 62, fig. 5) and a cap (closure 66, fig. 6), and wherein the vent opening of the venting port is selectively sealable by the cap (col. 5 ln. 5-26, “hydrophobic filter element 60 is provided with a closure 66 … adapted to engage in a sealing relationship with the nipple 68 in which the hydrophobic filter is mounted by means of an annular flange 70”).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the air elimination device of Wojke as modified to include a venting port with a cap as taught by Jess since Jess also deals with air elimination from medical fluid. One would have been motivated to make the modification because, as noted in Jess col. 5 ln. 5-26, such an arrangement of a cap can be used to operate the venting port as either air blocking, if desired, or air eliminating, to vent air during infusion. Thus, the modification makes the device more versatile. Additionally, having a cap over the air filter may allow for better protecting against bacteria or other contaminants which may contact the hydrophobic filter if the filter is left uncovered when not in use. Additionally, the cap can be used to protect against perforation of the hydrophobic filter during storage or transport.
Regarding claim 41, Wojke as modified discloses the apparatus as claimed in claim 29, as described above, including wherein the cap (Jess: closure 66, fig. 6) and the vent opening (Jess: opening 62, fig. 5) have inter-engaging features (Jess: col. 5 ln. 5-10, “closure 66 … adapted to engage in a sealing relationship with the nipple 68 in which the hydrophobic filter is mounted by means of an annular flange 70”) which are engageable by pushing the cap into the opening (see Jess fig. 5), and wherein the cap (Jess: 66) comprising a ridge (Jess: annular flange 70 of closure 66, see fig. 6) and the vent opening (Jess: 62) comprises a groove (Jess: annular groove 64, fig. 5, col. 4 ln. 65-col. 5 ln. 4 “hydrophobic filter element can be mounted over the opening 62 in any desired manner such as by positioning it in an annular groove designated 64 as shown in FIG. 5 annular groove designated 64 as shown in FIG. 5”).
Regarding claim 47, Wojke as modified discloses an infusion apparatus comprising a gas trap apparatus of claim 29, as described above, including infusion lines (see 112b interpretation) (supply intake line noted in col. 4 ln. 30-43) linked with the inlet port (inlet connection 6, fig. 1, col. 4 ln. 30-43 “inlet connection 6 for attaching a supply intake line”) and an infusion line (see 112b interpretation) (outlet line noted in col. 4 ln. 30-43) linked with the outlet (outlet connection 7, fig. 1, col. 4 ln. 30-43 “outlet connection 7 for attaching an outlet line”).
Regarding claim 48, Wojke as modified discloses an infusion apparatus comprising a gas trap apparatus of claim 29, as described above. Wojke further discloses comprising steps of directing a flow of a fluid via the inlet port (col. 5 ln. 8-16, “the vertical flow is diverted into a horizontal circulation flow”), and entrapment of gases from the fluid in the chamber (col. 5 ln. 16-22, “air bubbles being forced in the direction of the longitudinal axis and, because of their low density, rising upwards”).
Regarding claim 49, Wojke as modified discloses an infusion apparatus comprising a gas trap apparatus of claim 29, as described above. Wojke further discloses the step of aspirating the gases via the venting port (col. 5 ln. 16-22, “air bubbles being forced in the direction of the longitudinal axis and, because of their low density, rising upwards, and escaping from chamber 1 through hydrophobic membrane 9.”).
Regarding claim 50, Wojke as modified discloses an infusion apparatus comprising a gas trap apparatus of claim 29, as described above, including wherein the diverter (Chen: shield 324C and second surface 322C, fig. 13) is integral (see 103 modification of Wojke and Chen above as applied to claim 29) with the diffuser (Wojke: flow guide member 10, fig. 2).
Regarding claim 51, Wojke as modified discloses an infusion apparatus comprising a gas trap apparatus of claim 29, as described above, including wherein the diverter (Chen: shield 324C and second surface 322C, fig. 13) comprises a base portion (Chen: second surface 322C, fig. 13) and a rim (Chen: shield 324C, fig. 13).
Regarding claim 52, Wojke as modified discloses an infusion apparatus comprising a gas trap apparatus of claim 29, as described above, including wherein the outlet (Chen: outlet component 20, fig. 13, [0030]) comprises an exit tube (Chen: outlet channel 24, fig. 13, [0035]) with an intake end (Chen: exhaust opening 241, fig. 13, [0035]) and an export end (Chen: outlet opening 242, fig. 3 shows similar position as in fig. 13, [0035] outlet opening 242 is formed on an outer end surface of the outlet connecting portion 23), wherein the intake end is located within the chamber (Chen: see fig. 13).
Regarding claim 53, Wojke as modified discloses an infusion apparatus comprising a gas trap apparatus of claim 29, as described above, including wherein: the diverter (Chen: shield 324C and second surface 322C, fig. 13) comprises a base portion (Chen: second surface 322C, fig. 13) and a rim (Chen: shield 324C, fig. 13), the outlet (Chen: outlet component 20, fig. 13, [0030]) comprises an exit tube (Chen: outlet channel 24, fig. 13, [0035]) with an intake end (Chen: exhaust opening 241, fig. 13, [0035]) located within the chamber (Chen: see fig. 13), and the rim of the diverter surrounds the intake end of the exit tube (see Chen fig. 13 which shows that rim/shield 324C surrounds the intake end 241 of exit tube 24).
Regarding claim 54, Wojke as modified discloses an infusion apparatus comprising a gas trap apparatus of claim 29, as described above, including wherein the cap (Jess: closure 66, fig. 6) and the vent opening (Jess: opening 62, fig. 5) have inter-engaging features (Jess: col. 5 ln. 5-10, “closure 66 … adapted to engage in a sealing relationship with the nipple 68 in which the hydrophobic filter is mounted by means of an annular flange 70”) which are engageable by pushing the cap into the opening (see Jess fig. 5), and wherein the cap (Jess: 66) comprising a groove (Jess opening formed within annular flange 70, fig. 6, see fig. 6) and the vent opening (Jess: 62) comprises a ridge (Jess: nipple 68, fig. 6).
Claim(s) 31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wojke as modified and applied to claim 29 above, and further in view of Sun et al (CN 107115579 A; hereafter Sun). Text reference is made to the pdf of Sun included in the previous Office Action.
Regarding claim 31, Wojke as modified discloses the apparatus as claimed in claim 29, as described above.
Wojke as modified is silent to wherein the inlet includes a turbulence-inducing flow barrier.
Sun, in the art of infusion devices, teaches wherein the inlet (infusion tethering 5, fig. 1, pg. 3 para. 3, “the top of the hopper 6 is connected with a infusion tethering 5”) includes a turbulence-inducing flow barrier (disturbing flow columns 9, fig. 1 and fig. 4, pg. 4 last paragraph “A plurality of disturbing flow columns 9 in the body 7 of the transfusion tube are dispersed and mixed to form a plurality of disturbing flows, which not only sufficiently mix the three kinds of liquid, but also prevent the medicine in the liquid to be precipitated or deposited on the inner wall of the body 7”).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to include the flow disturbing columns 9 taught by Sun in the inlet of Wojke as modified since Sun also deals with delivery of medical fluid. One would have been motivated to make the modification because including the flow disturbing columns 9 taught by Sun in the inlet of Wojke as modified to encourages fluid mixing and prevents medicine in the primary and secondary fluids from precipitating on the inner walls of the inlet portions.
Claim(s) 32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wojke as modified and applied to claim 31 above, and further in view of Hlavinka et al (US 20030205454 A1; hereafter Hlavinka).
Regarding claim 32, Wojke as modified discloses the apparatus as claimed in claim 31, as described above.
Wojke as modified is silent to wherein the turbulence-inducing flow barrier is a helical flow barrier.
Hlavinka, in the art of mixing biological fluids, teaches wherein a turbulence-inducing flow barrier (blade elements 18, fig. 1, [0023]) is a helical flow barrier ([0023] static mixer device 16 comprises an axially extending series of angularly offset helical "screw" or paddle or blade elements 18 defining pairs of flow paths which are divided equally and mixed at the junctions 19 between successive elements 18 thereby providing a degree of mixing which increases with the number of elements used).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify Wojke as modified by Sun to have the turbulence-inducing flow barrier specifically, as taught by Hlavinka, since Hlavinka also deals with flow barrier used with medical fluids. One would have been motivated to make the modification because, as noted by Wojke col. 5 ln. 17-20 notes “a helical flow, the circular components building up a pressure difference which leads to the air bubbles being forced in the direction of the longitudinal axis”. Thus, the helical disruption of flow is known to aid in bubble separation, so augmenting the helical flow and further disrupting the fluid flow better ensures removal of all bubbles from the flow.
Claim(s) 33 and 36 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wojke as modified and applied to claim 29 above, and further in view of Kay (GB 2059776 A; hereafter Kay). Text reference is made to the copy of Kay included in the previous Office Action.
Regarding claim 33, Wojke as modified discloses the apparatus as claimed in claim 29, as described above.
Wojke as modified is silent to a hydrophilic membrane.
Kay, in the art of air bubble removal, teaches wherein the chamber includes a hydrophilic membrane (final sterilizing filter 74, fig. 2) mounted at a distal end of a diverter (support 60, fig. 2, pg. 7/8 ln. 5-12; see 112b interpretation above) (central support 60, fig. 2 shows that final sterilizing filter 74 extends to the distal end of diverter/support 60) (pg. 7/8 ln. 5-12 “Central support 60 is of the construction shown in the referenced patent and carries on its outer surface a final sterilizing filter 74 of a hydrophilic, a microporous membrane which will pass liquid but, when wet, will prevent passage of air.”).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the diverter of Wojke as modified to include a filter mounted at a distal end of a diverter since Kay also deal with air bubble removal and delivery of medical fluids. One would have been motivated to make the modification because, as noted by Kay, the filter prevents any air from leaving the chamber in the direction of the patient, thus better protecting against an embolism.
Regarding claim 36, Wojke as modified discloses the apparatus of claim 29, as described above.
Wojke as modified is silent to a membrane.
Kay, in the art of air bubble removal, teaches further comprising a membrane (penetrable seal 52, fig. 2) which is selectively sealable (pg. 6/8 ln. 124-130 resilient penetrable seal 52 may optionally be breached by a secondary tube) at an inlet port (see 112b interpretation above) (inlet 50, fig. 2) or the outlet port, to maintain a closed system integrity when an external device (secondary tube noted in pg. 6/8 ln. 124-130) is connected to a port (see 112b interpretation above; inlet 50) for the purpose (see 112b interpretation above) of transferring liquids or gases into or out of the chamber (40, fig. 2) (pg. 6/8 ln. 124-130 “Fig. 2 herein illustrates a vertical, generally diametric section of the modification wherein the top is modified to provide a primary liquid chamber 42 having an inlet 44 for connection to primary tubing 46 and a secondary liquid chamber 48 having an inlet 50 for insertion of a secondary tube (not shown) through resilient, penetrable seal 52.”).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to include a selectively sealable membrane at an inlet port, as taught by Kay, since Kay also deals with bubble removal in a fluid delivery context, like Wojke does. One would have been motivated to make the modification because, as described by Kay, the membrane prevents flow prior to the membrane being penetrated, and penetration allows for the connection of an additional fluid source. This modification thus increases the versatility of the device while ensuring that the chamber remains uncontaminated through the inlet port prior to connection of the secondary tube.
Claim(s) 39 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wojke as modified and applied to claim 29 above, and further in view of Woodard (US 6013060 A; hereafter Woodard).
Regarding claim 39, Wojke as modified discloses the apparatus as claimed in claim 29, as described above.
Wojke as modified is silent to wherein the apparatus comprises a bracket for attachment to a support as part of an infusion set.
Woodard, in the field of intravenous liquid flow systems with a bubble separator (see col. 5 ln. 26-47), teaches wherein the apparatus comprises a bracket (clamp bracket 74, figs. 10 and 11, col. 5 ln. 26-47) for attachment to a support (I.V. stand 12, figs. 10 and 11, col. 5 ln. 26-47) as part of an infusion set (see fig. 1 which shows bubble separator 32 as part of an IV set) (col. 5 ln. 26-47 “bubble separator 32 includes a housing or container 70 consisting of a container, having a cover 72 that includes a clamp bracket 74 connected or formed therein, which is snapped onto the I.V. stand 12 … to insure [sic] that the bubble separator 32 is retained in an upright position”).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the apparatus of Wojke as modified to include the bracket for attachment to a support as part of an infusion set as taught by Woodard since Woodard also deals with an infusion system including an air elimination system. One would have been motivated to make the modification because, as noted by Woodard col. 5 ln. 26-47, the bracket ensures that the bubble separator is retained in an upright position. Maintaining the air elimination system of Wojke as modified in an upright position would aid in ensuring that bubbles vent correctly through the vent opening.
Claim(s) 43 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wojke as modified and applied to claim 29 above, and further in view Hoang et al (US 20120016318 A1; hereafter Hoang).
Regarding claim 43, Wojke as modified discloses the apparatus as claimed in claim 29, as described above, including wherein the cap (Jess: closure 66, fig. 6) has a curved exposed surface (Jess: see curved edge of cap 66 in figs. 5 and 6), and wherein the cap is linked with the vent opening by a ribbon comprising a ring engaged around the vent opening to allow rotation about an axis of the vent opening.
Wojke as modified is silent to wherein the cap is linked with the vent opening by a ribbon comprising a ring engaged around the vent opening to allow rotation about an axis of the vent opening, although Jess figs. 5 and 6 do appear to show a flexible linkage between the cap and the vent opening.
Hoang, in the field of portable aspirators with vents for medical use, teaches wherein a cap (cap 10, fig. 6, [0038]) is linked with an opening (adaptor 50, fig. 6, [0038]) by a ribbon (tether 70, fig. 6, [0038]) comprising a ring (loop 72, fig. 6, [0038]) engaged around the vent opening (50) to allow rotation about an axis (axis through center of adaptor 50 in fig. 6, from left to right) of the vent opening (50) ([0038] tether 70 with loops 72 and 74 permitting free rotation of access cap 10 when threadedly coupling access cap 10 proximal end 52 of adapter 50).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to further modify the vent opening and cap of Wojke as modified to include the ribbon and ring tether taught by Hoang, since Hoang also deals with medical fluid delivery and air elimination. One would have been motivated to make the modification because the ribbon ensures that the cap is not lost (see Hoang [0031]), and the ring, allowing the cap to rotate, ensures that the ribbon is not easily damaged from rotating during use of the cap, thus better ensuring the cap is not lost longer by preventing the ribbon from fracturing.
Claim(s) 44 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wojke as modified and applied to claim 29 above, and further in view of Ferrer (WO 2015173457 A1; hereafter Ferrer). Text reference is made to the include pdf Espacenet translation of Ferrer.
Regarding claim 44, Wojke as modified discloses the apparatus as claimed in claim 29, as described above.
Wojke as modified is silent to wherein the cap is configured to require a tool for removal.
Ferrer, in the art of valve covers, teaches wherein a cap is configured to require a tool for removal ([0034] In this way, the screw cap that is the security nut (17) can only be operated with the aforementioned key of a matching profile, which is not accessible to the general public, and only the owner of the installation can unlock the security system by unscrewing the screw cap that is the security nut (17)).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the device of Wojke as modified to include the cap being configured to require a tool for removal, as taught by Ferrer, since Ferrer also deals with fluid delivery. One would have been motivated to make the modification because requiring a cap for removing/applying the cap ensures that the vent will not be tampered with by anyone other than a medical professional or a personal user of the device, ensuring that the vent to the bubble trap cannot be maliciously opened/unopened by providing better security measures.
Claim(s) 45 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wojke as modified and applied to claim 29 above, and further in view of Singer et al (US 20090227987 A1; hereafter Singer).
Regarding claim 45, Wojke as modified discloses the apparatus as claimed in claim 29, as described above, including wherein the cap (Jess: closure 66, fig. 6) and the vent opening (Jess, 62, fig. 6) have inter-engaging features (Jess: annular flange 70 and nipple 68, see fig. 6) which provide a snap-fit lock with engagement of the cap (66) and the vent opening (62) (Jess: col. 5 ln. 5-10, “closure 66 … adapted to engage in a sealing relationship with the nipple 68 in which the hydrophobic filter is mounted by means of an annular flange 70”).
Wojke as modified is silent to engagement of the cap and the vent opening being pushing of the cap into the vent opening.
Singer, in the art of valve closures, teaches wherein a cap (cap D2a, fig. 7, [0058]) and an opening (upper port D1, fig. 7, [0038]) have inter-engaging features ([0058] Cap D2a is removable to expose Luer Lok fitting LF for fluid suction) which provide a snap-fit lock with pushing of the cap (D2a) into the vent opening (D1) ([0058] cap has a descending stopper DS on its lower portion of said cap that fits inside opening of upper port D1).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the cooperation of the cap and vent opening of Wojke as modified to have the descending stopper DS included in the cap and engageable with an upper port D1 as taught by Singer, since Singer also deals with closing/opening medical valves. One would have been motivated to make the modification because this modification amounts to a rearrangement of parts or a simple substitution of one closure kind for another, and the extended engagement feature, the descending stopper DS shown in fig. 7 of Singer, provides additional frictional contact which may provide a better seal less likely to become accidentally disengaged due to the length of the engaged portions of the vent opening and the cap. Note that it has been held that rearranging parts of an invention involves only routine skill in the art. See MPEP 2144.04 (VI-C). The modified device could still perform the function of optional engagement between the cap and the vent opening just as well with the described arrangement.
Claim(s) 46 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wojke as modified and as applied to claim 29 above, and further in view of Kawano et al (US 20040087885 A1; hereafter Kawano).
Regarding claim 46, Wojke as modified discloses the apparatus as claimed in claim 29, as described above.
Wojke as modified is silent to wherein, the inlet port has a diameter in the range of 1.5 mm to 8.0 mm.
Kawano, in the art of medical tubing, teaches wherein the inlet ports have a diameter in the range of 1.5 mm to 8.0 mm ([0106] inner diameter of tubing is standard for blood infusion, for example between 3.2-4.7 mm).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to have the diameter of the inlet port be 3.2-4.7mm as taught by Kawano since Kawano is also in the field of fluid delivery and notes that this is a standard range. One would have been motivated to make the modification because Kawano notes that 3.2-4.7mm is a typical tubing size and thus is likely cheaper and more easily accessible than other tubing sizes.
Claim(s) 55 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wojke in view of Jess and Rielly.
Regarding claim 55, Wojke discloses a method of trapping gas in medical fluids using a gas trap apparatus (Abstract “A device for separating gas bubbles out of medical fluids”), the method comprising:
directing fluid flow through an inlet port (inlet connection 6, fig. 1, col. 4 ln. 30-43 “inlet connection 6 for attaching a supply intake line”) into a bubble entrapment chamber (chamber 1, fig. 1, col. 4 ln. 23-29);
causing an inflow of fluid into the chamber to have a lateral dimensional (col. 5 ln. 8-16, “the vertical flow is diverted into a horizontal circulation flow”) component via one or more apertures (see narrow gap 24, fig. 8, col. 5 ln. 60-col. 6 ln. 17) of a diffuser (rotation bodies 23 and 25, fig. 8, col. 5 ln. 60-col. 6 ln. 17) located in the bubble entrapment chamber (1, col. 5 ln. 60-col. 6 ln. 17 describes flow guide member disposed in chamber 1);
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diverting flow via a flow diverter (guide blades 27, fig. 9, col. 5 ln. 60-col. 6 ln. 17) to have a lateral directional component (see 112b interpretation above) with respect to a longitudinal flow direction from the inlet port, and away from an outlet port (outlet connection 7, fig. 1, col. 4 ln. 30-43 “outlet connection 7 for attaching an outlet line”) and towards an internal surface of the bubble entrapment chamber (col. 5 ln. 60-col. 6 ln. 17 describes the formation of a circular flow; col. 5 ln. 8-16, “the vertical flow is diverted into a horizontal circulation flow”); and
having a vent opening (circular orifice 8, fig. 1, col. 4 ln. 23-29 “Circular orifice 8 … is sealed in a fluid-tight manner by a circular, hydrophobic membrane 9”) disposed upstream of the diffuser (23/25; see fig. 1 which shows the vent opening disposed at the very top of the chamber 1, and thus upstream of the diffuser) to release gas entrapped in the bubble entrapment chamber (col. 5 ln. 16-22, “air bubbles being forced in the direction of the longitudinal axis and, because of their low density, rising upwards, and escaping from chamber 1 through hydrophobic membrane 9.”).
Wojke is silent to selectively unsealing the vent opening.
Jess, directed to a drip chamber for air elimination during intravenous administration (col. 4 ln. 37-41, fig. 5), teaches wherein the apparatus (drip chamber 44, fig. 5, col. 4 ln. 38-64) comprises a venting port (opening 62, hydrophobic filter element 60, and closure 66, fig. 5 and 6, col. 4 ln. 65-col. 5 ln. 4, hydrophobic filter element can be mounted over the opening 62) comprising a vent opening (opening 62, fig. 5) and a cap (closure 66, fig. 6), and wherein the vent opening of the venting port is selectively sealable by the cap (col. 5 ln. 5-26, “hydrophobic filter element 60 is provided with a closure 66 … adapted to engage in a sealing relationship with the nipple 68 in which the hydrophobic filter is mounted by means of an annular flange 70”).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the air elimination device of Wojke as modified to include a venting port with a cap as taught by Jess since Jess also deals with air elimination from medical fluid. One would have been motivated to make the modification because, as noted in Jess col. 5 ln. 5-26, such an arrangement of a cap can be used to operate the venting port as either air blocking, if desired, or air eliminating, to vent air during infusion. Thus, the modification makes the device more versatile. Additionally, having a cap over the air filter may allow for better protecting against bacteria or other contaminants which may contact the hydrophobic filter if the filter is left uncovered when not in use. Additionally, the cap can be used to protect against perforation of the hydrophobic filter during storage or transport.
Wojke modified by Jess is silent to using a valve at the inlet port to fully or partly restrict fluid flow through the inlet port.
Reilly, in the art of mixing and delivery multiple fluids, teaches using a valve (stopcock body 302, fig. 10a-e, [0052]) at the inlet port (mixing stopcock valve 300, fig. 10a-e, [0054]) to fully (see fig. 10A, “an "off" or no-flow position of stopcock valve 300 is illustrated”) or partly (see fig. 10E, “stopcock actuator 304 is positioned such that first conduit portion 316 is in fluid communication but not aligned directly with saline port 310 resulting in restricted flow of saline”) restricting fluid flow through the inlet (inlet port 310, fig. 10A-E, [0054]).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the inlet of Wojke modified by Jess to include a valve for fully or partly restricting fluid flow through the inlet, since Reilly also deals with fluid transport, and specifically delivery of medical fluids similar to Wojke. One would have been motivated to make the modification because having the valve allows a user to control the amount of fluid delivered to the patient easily, and, as noted by Reilly [0057], the flow rate depends on how restricted flow through the inlet is.
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 mailing date of this final action.
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/I.S.N./Examiner, Art Unit 3783
/JASON E FLICK/Primary Examiner, Art Unit 3783 07/23/2026
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