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 1 and 5-20 are currently pending. Claims 1 and 5-7 are currently rejected. Claims 8-20 are currently withdrawn. Claims 2-4 are newly cancelled. Claims 1, 6, and 7 are currently amended.
Response to Arguments
Applicant’s arguments, see Remarks, filed 01/28/2026, with respect to the rejection(s) of claim(s) 1 under 35 U.S.C. 102 have been fully considered and are persuasive, since previously unconsidered limitations have been added to the independent claim. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of further interpretation of Wisniewski and Willemsen.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
In this case, Applicant argues that since Miller teaches a sealed, leak-free pump body, then Wisniewski modified by Miller would not meet the claimed limitations. However, Miller is only being relied on to teach a foot pump having an integral flexible hinge between two plates instead of the pin hinge disclosed by Wisniewski. Miller is not depended on to show a “non-sealed cavity open to ambient air”.
In response to applicant's argument that since Wisniewski shows an open/non-sealed liquid displacement arrangement and Miller discloses a sealed/leak free arrangement, combining the two references would render the combination unsatisfactory is not persuasive. The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
Examiner acknowledges that the cancellation of claim 2 and the amendments to claims 6 and 7 obviate the previous 112b rejections, which are therefore withdrawn.
Claim Objections
Claim 1 is objected to because of the following informalities:
Claim 1 line 9 recites “wherein the base plate and the squeezing plate comprises”. This should read “wherein the base plate and the squeezing plate comprise[[s]]”
Appropriate correction is required.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1 and 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wisniewski (US 20040087891 A1; hereafter Wisniewski) in view of Miller et al (US 20050025646 A1; hereafter Miller).
Regarding claim 1, Wisniewski discloses an intravenous (IV) blood set foot pump (fig. 1 and 2) comprising:
a base plate (base member 42, fig. 2, [0038]);
a squeezing plate (foot pedal 44, fig. 2, [0038]) movably coupled to the base plate (42) by a pivot member ([0038] The operating mechanism 14 includes a base member 42 which has a foot pedal 44 pivotally mounted thereon; see fig. 2 which shows pivot member at left end of squeezing plate/foot pedal 44); and
a biasing member (spring 46, fig. 2, [0038]) coupled to the base plate (42) and the squeezing plate (44), the biasing member configured to exert a biasing force against the squeezing plate when the biasing member is in a compressed state ([0038] spring 46 acts between the base member 42 and the foot pedal 44 for urging the pedal into its fully retracted position as shown; [0039] first stop formation 48 defines the fully retracted position; see fig. 2),
wherein the base plate (42) and the squeezing plate (44) comprises a non-sealed cavity open to ambient air (see fig. 2, note that foot pedal 44 pivots towards base member 42 as described in [0038]-[0039]; operating mechanism as shown does not have walls so forms a non-sealed cavity open to ambient air between the base plate 42 and squeezing plate 44) configured (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) to receive an IV pump bulb (liquid displacement means 12 and connector formation 32, fig. 2, [0036]) ([0040] As is shown in detail in FIG. 2 of the drawings, the end of the piston rod 28 of the liquid displacement means 12 has a locating formation 54 that cooperates with a complementary locating formation 56 that is pivotally located with respect to the base member 42), and
wherein the base plate (42), the squeezing plate (44) and the biasing member (46) form an integral (since base plate 42, squeezing plate 44, and biasing member 46 are all connected as shown in fig. 2 and essential to the function of the pedal these elements are interpreted to together form an “integral” clamshell configuration) clamshell configuration (see clamshell configuration in fig. 2).
Examiner notes that the cavity formed in the base plate which receives displacement means 12 and connector formation 32 could receive an IV pump bulb, and thus the cavity satisfies the functional limitation.
Wisniewski is silent to the pivot member comprising a flexible hinge integrally formed with the base plate and the squeezing plate.
Miller, directed to a foot pedal medical irrigation system, teaches the pivot member comprising a flexible hinge (point where top and bottom portion of pump housing 10a of pump body 10 meet, see annotated Miller fig. 2 below, see [0019]) integrally formed with the base plate (bottom portion of pump housing 10a shown in annotated fig. 2a below) and the squeezing plate (bottom portion of pump housing 10a shown in annotated fig. 2a below) (see annotated Miller fig. 2 below which shows that the flexible hinge is integrally formed; [0015] pump body material should be sufficiently flexible to deform and recover its former shape in time for the next application of the user’s foot).
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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 base plate and squeezing plate of Wisniewski to have an integrally formed flexible hinge as taught by Miller instead of a hinge pin since both references deal with a squeezing plate and base plate used to deliver a medical fluid at pressure. This modification is a simple substitution of one known, equivalent element (a hinge pin) for another (an integrally formed flexible hinge) to obtain predictable results (pivotable connection between a squeezing plate and a base plate). Since Miller teaches use of the flexible hinge for a foot pedal similarly actuated to the device of Wisniewski, the results of the modification would have been predictable. One would have been motivated to make the modification because using a flexible hinge that is integrally form reduces the number of parts, simplifying the device manufacture and assembly process and potentially decreasing production time, cost, and opportunities for erroneous assembly.
Regarding claim 5, Wisniewski modified by Miller discloses the IV blood set foot pump of claim 1, as described above. Wisniewski further discloses wherein the biasing member (46, fig. 2) is a compression spring (see fig. 2 and note [0038] spring 46 acts between the base member and the foot pedal for urging the pedal into its fully retracted position as shown).
Claim(s) 1 and 5 is/are alternatively rejected under 35 U.S.C. 103 as being unpatentable over Wisniewski in view of Willemsen al (US 20080314192 A1; hereafter Willemsen).
Alternatively, regarding claim 1, Wisniewski discloses an intravenous (IV) blood set foot pump (fig. 1 and 2) comprising:
a base plate (base member 42, fig. 2, [0038]);
a squeezing plate (foot pedal 44, fig. 2, [0038]) movably coupled to the base plate (42) by a pivot member ([0038] The operating mechanism 14 includes a base member 42 which has a foot pedal 44 pivotally mounted thereon; see fig. 2 which shows pivot member at left end of squeezing plate/foot pedal 44); and
a biasing member (spring 46, fig. 2, [0038]) coupled to the base plate (42) and the squeezing plate (44), the biasing member configured to exert a biasing force against the squeezing plate when the biasing member is in a compressed state ([0038] spring 46 acts between the base member 42 and the foot pedal 44 for urging the pedal into its fully retracted position as shown; [0039] first stop formation 48 defines the fully retracted position; see fig. 2),
wherein the base plate (42) and the squeezing plate (44) comprises a non-sealed cavity open to ambient air (see fig. 2, note that foot pedal 44 pivots towards base member 42 as described in [0038]-[0039]; operating mechanism as shown does not have walls so forms a non-sealed cavity open to ambient air between the base plate 42 and squeezing plate 44) configured (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) to receive an IV pump bulb (liquid displacement means 12 and connector formation 32, fig. 2, [0036]) ([0040] As is shown in detail in FIG. 2 of the drawings, the end of the piston rod 28 of the liquid displacement means 12 has a locating formation 54 that cooperates with a complementary locating formation 56 that is pivotally located with respect to the base member 42), and
wherein the base plate (42), the squeezing plate (44) and the biasing member (46) form an integral (since base plate 42, squeezing plate 44, and biasing member 46 are all connected as shown in fig. 2 and essential to the function of the pedal these elements are interpreted to together form an “integral” clamshell configuration) clamshell configuration (see clamshell configuration in fig. 2).
Examiner notes that the cavity formed in the base plate which receives displacement means 12 and connector formation 32 could receive an IV pump bulb, and thus the cavity satisfies the functional limitation.
Wisniewski is silent to the pivot member comprising a flexible hinge integrally formed with the base plate and the squeezing plate.
Willemsen, directed to a foot pedal, teaches the pivot member comprising a flexible hinge (hinge noted in [0023]) integrally formed with the base plate (base member 12, fig. 1, [0023]) and the squeezing plate (pedal arm 34, fig. 1, [0023]) ([0023] “the hinge may be an integrally formed living hinge interconnecting the pedal arm and base member”).
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 base plate and squeezing plate of Wisniewski to have an integrally formed flexible hinge as taught by Willemsen instead of a hinge pin since both references deal with a squeezing plate and base plate pivotably attached to form a foot pedal. This modification is a simple substitution of one known, equivalent element (a hinge pin) for another (an integrally formed flexible hinge) to obtain predictable results (pivotable connection between a squeezing plate and a base plate). Since Willemsen teaches use of the flexible hinge for a foot pedal similarly actuated to the device of Wisniewski, the results of the modification would have been predictable. One would have been motivated to make the modification because using a flexible hinge that is integrally form reduces the number of parts, simplifying the device manufacture and assembly process and potentially decreasing production time, cost, and opportunities for erroneous assembly.
Regarding claim 5, Wisniewski modified by Willemsen discloses the IV blood set foot pump of claim 1, as described above. Wisniewski further discloses wherein the biasing member (46, fig. 2) is a compression spring (see fig. 2 and note [0038] spring 46 acts between the base member and the foot pedal for urging the pedal into its fully retracted position as shown).
Claim(s) 6 and 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wisniewski modified by Miller or alternatively over Wisniewski modified by Willemsen as applied to claim 1 above, and further in view of Manzie et al (US 5505707 A; hereafter Manzie).
Regarding claim 6, Wisniewski discloses an IV blood set comprising:
the IV blood set foot pump of claim 1 (see 103 rejection of claim 1 over Wisniewski modified by Miller above, or 103 rejection of claim 1 over Wisniewski modified by Willemsen).
Wisniewski further discloses a first IV tube (inflow tube 34, fig. 2, [0036]) coupled to an inlet (see fig. 2 below) and a second IV tube (outflow tube 36, fig. 2, [0036]) coupled to an outlet (see fig. 2 below) ([0036] connector formation 32 having an inflow tube 34 and an outflow tube 36 connected in liquid communication therewith, as shown in fig. 2 as annotated below).
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Wisniewski is silent to an IV pump bulb coupled to IV tubes.
Manzie, in the art of manual pumps for controlling infusion fluid, teaches an IV pump bulb (pump 130 is a bulb pump, fig. 2, col. 5 ln. 20-32 “pump 130 is a bulb pump”);
a first IV tube (first section of tubing 114, fig. 2, col. 5 ln. 14-16 “In the embodiment of FIG. 2, there is an irrigation tubing set 110 having a first section of tubing 114 that defines a first fluid passage 116.”) coupled to an inlet (inlet 133, fig. 2) of the IV pump bulb (col. 5 ln. 20-32 “The bulb pump is composed of a resilient, hollow, flexible plastic bulb defining an internal chamber 132 and having an inlet 133 and an outlet 134”); and
a second IV tube (second section of tubing 140, fig. 2, col. 5 ln. 33-34 “connected to the outlet 134 of the pump 130 is a second section of tubing 140 defining a second fluid passage 142”) coupled to an outlet (outlet 134, fig. 2) of the IV pump bulb.
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to replace the liquid displacement means 12 and connector formation 32 (Wisniewski: fig. 2, [0036]) of Wisniewski with the IV pump bulb taught by Manzie since both deal with manual compression of reservoirs for delivery of infusion fluid. See Wisniewski [0041] which describes the fluid movement through the system. This modification would have been a simple substitution of one known, equivalent element (liquid displacement means 12 with connector formation 32 of Wisniewski) for another (pump bulb 130 of Manzie) to obtain predictable results. Note that both elements have inlets and outlets through which fluid may flow from a reservoir to a patient. Wisniewski [0045] discloses “liquid feed means 12 also can be manually used when separated from the operating mechanism 14, whenever this may be required”, which further supports the obviousness of using the hand operate pump bulb of Manzie with the foot pedal setup of Wisniewski, since Wisniewski discloses using the foot pedal with a potentially hand-operated pump system. One would have been motivated to make the modification because using the pump bulb of Manzie would be less likely to break or suffer damage due to potential lateral forces than the syringe of Wisniewski if the pedal where to be stepped on unevenly or the spring was to become off center. The modified invention would still be able to displace liquid in a controlled manner as disclosed by Wisniewski.
Regarding claim 7, Wisniewski (modified by Miller or by Willemsen in regards to the inclusion of the IV blood set foot pump of claim 1) discloses a method of operating an IV blood set foot pump, the method comprising:
coupling an IV set (inflow tube 34, outflow tube 36, connector formation 32, and syringe 12; fig. 2, [0036]) to a fluid source (liquid supply sachet 16, fig. 1, [0037) ([0037] The inflow tube 34, in use of the liquid displacement arrangement 10, is connected to the liquid supply sachet 16; see fig. 1);
inserting a pump (liquid displacement means 12, fig. 2, [0036]) of the IV set (34/36/32/12) into the IV blood set foot pump of claim 1 (see 103 rejection of claim 1 above over Wisniewski modified by Miller) ([0040] liquid displacement means 12 is easily replaceable; Examiner notes that since the liquid displacement means 12 is replaced, it must be inserted; see also [0043]);
pressing on the squeezing plate with a foot to compress the squeezing plate towards the base plate ([0041] displacement of the foot pedal 44 from its position as shown towards a depressed position providing for displacement of liquid from the cylinder 24 to the body 20 of the patient);
releasing pressure on the squeezing plate with the foot to allow the squeezing plate to move back to a default position based on the biasing force from the biasing member ([0041] reverse displacement of the foot pedal 44 will provide for displacement of further liquid from the sachet 16 into the cylinder 24); and
repeating the pressing and releasing steps ([0041] describes emptying and refilling the liquid displacement means 12 and implies repeated use since the end step is the same as the first) to pump the fluid from the fluid source through the IV set at a fluid flow rate that exceeds a maximum open flow fluid flow rate ([0042] a permanent flow of liquid through the flow line with the flow rate being determined by the level at which the sachet 16 is suspended. By permitting adjustability of this level, different continuous flow rates can be provided for and particularly by suspending the sachet 16 at a level beneath, the body 20 of a patient, continuous flow will cease.) of the IV set itself (Examiner notes that an open flow fluid rate of the IV set may vary based on bag height and may be zero, and in such a state the use of the foot pedal would necessarily provide a fluid flow rate exceeding the maximum open flow fluid flow rate).
Wisniewski is silent to the pump being a pump bulb and explicitly repeating the pressing and releasing steps.
Manzie, in the art of manual pumps for controlling infusion fluid, teaches an IV pump bulb (pump 130 is a bulb pump, fig. 2, col. 5 ln. 20-32 “pump 130 is a bulb pump”) and repeatedly pressing and releasing the bulb to move fluid through the IV set (col. 5 ln. 65 - col. 6 ln. 2, “tubing set 110 is preferably primed by actuating the pump 130 repeatedly to expel substantially all air from the tubing set”).
Manzie also teaches wherein the pressing and releasing steps pump the fluid from the fluid source through the IV set at a fluid flow rate that exceeds a maximum open flow fluid flow rate (see col. 6 ln. 3-18).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to replace the liquid displacement means 12 (Wisniewski: fig. 2, [0036]) of Wisniewski with the pump bulb taught by Manzie since both deal with manual compression of reservoirs for delivery of infusion fluid. See Wisniewski [0041] which describes the fluid movement through the system. This modification would have been a simple substitution of one known, equivalent element (liquid displacement means 12 with connector formation 32 of Wisniewski) for another (pump bulb 130 of Manzie) to obtain predictable results. Note that both elements have inlets and outlets through which fluid may flow from a reservoir to a patient. Wisniewski [0045] discloses “liquid feed means 12 also can be manually used when separated from the operating mechanism 14, whenever this may be required”, which further supports the obviousness of using the hand operate pump bulb of Manzie with the foot pedal setup of Wisniewski, since Wisniewski discloses using the foot pedal with a potentially hand-operated pump system. One would have been motivated to make the modification because using the pump bulb of Manzie would be less likely to break or suffer damage due to potential lateral forces than the syringe of Wisniewski if the pedal where to be stepped on unevenly or the spring was to become off center. The modified invention would still be able to displace liquid in a controlled manner as disclosed by Wisniewski.
Furthermore, one would have been motivated to modify the method of Wisniewski to include the repeated actuation of the pump bulb as taught by as this would prompt fluid to move faster through the system over a longer period of time if desired by the clinician, which may be necessary in certain cases.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ISABELLA NORTH whose telephone number is (703)756-5942. The examiner can normally be reached M-F 7:30-5:00.
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/I.S.N./Examiner, Art Unit 3783
/JASON E FLICK/Primary Examiner, Art Unit 3783 03/05/2026