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 .
Response to Amendment
Claims 1 and 25 have been amended, and claim 26 has been added; claims 1, 2, 4, 10, 12-23, and 25-26 remain pending.
Claim Objections
Claim 25 is objected to because of the following informalities: there is a typographical error wherein the claim recites “wherein the fourth tube portion an external wall portion comprising a flat compartment” and should instead recite “wherein the fourth tube portion comprises an external wall portion comprising a flat compartment”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 25 and 26 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 25 and 26 contain new matter where they each require the flat compartment of the fourth tube portion to have a cutaway portion for receiving the outlet. This does not appear to be disclosed by the application as originally filed; fig. 4b as originally provided (reproduced below for clarity) shows a section view in which the outlet 33 and the flat compartment of the tube portion 37a are shown as being integrally formed; this is shown especially where there are no lines to delineate a difference between outlet 33 and compartment 37a structurally. Thus, compartment 37 does not have a cutaway portion which is functionally capable of receiving the outlet as claimed, as the outlet is already integrally formed with the compartment.
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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 1, 2, 10, 12, 14-16, 21-22, and 25-26 are rejected under 35 U.S.C. 103 as being unpatentable over Deckert et al. (US Pat. No. 6203528, henceforth Deckert et al.) in view of Williams (US Pat. No. 4856339, henceforth Williams), Platt et al. (US 20030004458, henceforth Platt et al.), Ben-Shalom et al. (US 20080095649, henceforth Ben-Shalom et al.), and Eberhard (US 20150032054, henceforth Eberhard).
Regarding claim 1, Deckert et al. discloses a peristaltic infusion pump tube segment (Unitary molded elastomer conduit 1000, fig. 16) having an upstream inlet (Inlet is tubing 52, fig. 17) and a downstream outlet (Outlet is tubing 54, fig. 17) and adapted to be temporally squeezed at at least one squeezed point (Region 1012 contains a plurality of squeezing points, see col. 17 lines 33-51 and fig. 2a) to be generated by an engagement structure (Rotary pump wheel 49, fig. 3a) and to be moved towards the outlet (Fluid flows from upstream to downstream and from tubing 52 to 54, col. 8 lines 1-3) for passing a medical fluid from the inlet to the outlet (Liquid medicant, col. 1 lines 21-23, flows from inlet 52 to outlet 43, col. 8 lines 1-3), comprising: a first tube portion next to the inlet (Region 1020, see fig. 17) and having a surrounding wall (Tubing has a wall as seen in fig. 18) which is adapted for an upstream occlusion detection (See col. 17 lines 33-51; the tubing cooperates with the occlusion sensor 270 because it is adapted for it), a second tube portion downstream of the first tube portion (Regions 1016 and 1012 are downstream of region 1020, fig. 17) and adapted to be temporally engaged by the engagement structure (See col. 17 lines 33-51), wherein the second tube portion comprises a surrounding wall (Tubing has a wall as seen in fig. 18) being at least partly thicker than the wall of the first tube portion (See fig. 20; region 1016 has coarse interior surface 1026 which makes it thicker than region 1020 which does not have a coarse surface) and preferably made of an elastic material (Elastomer such as silicone, see col. 17 lines 52-67) which allows the second tube portion to be at least partially reformed at those portions which are currently not subject to the engagement by the engagement structure (See col. 18 lines 1-31), a third tube portion (Region 1014, see fig. 17) having a surrounding wall (Tubing has a wall as seen in fig. 18) which is adapted for an air in line detection (Air-in-line sensor 300 works at region 1014, see col. 16 lines 51-67; the tubing cooperates with the occlusion sensor 272 because it is adapted for it), and a fourth tube portion next to the outlet (Region 1018, fig. 17) and adapted for a downstream pressure detection (See col. 17 lines 33-51; the tubing cooperates with the occlusion sensor 272 because it is adapted for it), with the first tube portion (Region 1020, see fig. 17 and col. 17 lines 33-51); and wherein the wall of the second tube portion is at least partially unpolished (See fig. 20; region 1016 has coarse interior surface 1026; this is considered by Examiner to be an unpolished wall).
Deckert et al. does not disclose the third tube portion (region 1014, fig. 17) as being downstream of the second tube portion (regions 1016 and 1012, fig. 17), but rather had the third tube portion upstream of the second tube portion.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have rearranged the second and third tube portions such that the third portion is downstream of the second portion, since it has been held that rearranging parts of a prior art structure involves only routine skill in the art. In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950).
Deckert et al. as modified discloses a third tube portion (Region 1014, see fig. 17) configured for air in line detection (Region 1014 is configured for air in line detection as it cooperates with air in line sensor 300, see col. 16 lines 51-67), by at least one ultrasound sensor (Air in line sensor 300 is ultrasonic, see col. 16 lines 51-67).
Deckert et al. as modified does not disclose the wall of the third tube portion comprises at least one flat wall portion, or that the third tube portion has a rectangular or square section at least at its external side. Williams teaches the walls of tubing comprising at least one flat portion, and teaches this as beneficial (flat walls create more repeatable orientation of the tube relative to transducers, see fig. 9 and col. 7 lines 16-36).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the walls of the third tube portion of Deckert et al. to have a flat portion as in Williams for the benefit of a more repeatable orientation of the tube segment relative to the sensors measuring the tube segment (Williams col. 7 lines 16-36). This modification would cause flat wall portions inside the tube and outside the tube since sensor 300 is external to the tube and thus should also see the same repeatable orientation at the exterior of the third tube portion.
Deckert et al. as modified discloses the tube segment wherein the outer surface of the at least one flat wall portion is polished (smoothing or narrowing of interior and exterior surfaces, col. 3 lines 6-15).
Deckert et al. as modified discloses that the third tube portion includes a plurality of external wall portions configured for the air in line detection by at least one ultrasound sensor (the modified third tube portion of Deckert et al. as modified by Williams could be considered to be 3 portions which are contiguous with one another as viewed along the longitudinal extension of the tube segment; since the 3 portions are the same in this interpretation, each one would be configured for the air in line detection since each has the flat wall from the modification with Williams), wherein one external wall portion of the plurality of external wall portions is a rectangular section (the middle of the three segments can be considered to be rectangular where it has a rectangular flat top), and wherein the plurality of external wall portions includes a first side portion (this could be considered to be third of the third tube portion having the flat wall which is closest to region 1024 as shown in fig. 18) and a second side portion (this could be considered to be third of the third tube portion having the flat wall which is closest to region 1022 as shown in fig. 18), wherein the first side portion and the second side portion are connected to the rectangular section (the called out portions are connected directly to the middle rectangular portion in this interpretation as the three portions combine to make the third tube portion as claimed) and extend about a part of a width of the third tube portion (the claimed first and second side portions extend about a part of a width of the third tube portion as claimed where they extend over the whole width of the third tube portion since they make up a third of the tube portion; see also the annotated fig. 16 provided in the Response to Arguments further explaining the portions).
Deckert et al. as modified discloses the fourth tube portion (Region 1018, fig. 17) configured for downstream pressure detection (See col. 17 lines 33-51).
Deckert et al. as modified does not disclose the tube segment wherein the fourth tube portion comprises a flat compartment. Williams teaches a flat compartment and teaches it as beneficial for configuring with transducers (flat walls create more repeatable orientation of the tube relative to transducers, see fig. 9 and col. 7 lines 16-36).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the fourth tube portion of Deckert et al. to have the shape of a flat compartment as in Williams for creating more repeatable orientation of the tube relative to transducers. Such a flat compartment could be made through intervention of an external wall as in Williams, or through shaping, especially since Deckert already comprises shaped flat tube portions such as positioning features 1002, 1004, and 1010.
Deckert et al. as modified thus discloses a flat compartment in the fourth tube portion (Region 1018, fig. 17, which has a flat compartment as in the modification above).
Deckert et al. as modified does not disclose that the flat compartment of the fourth tube portion retains its flat shape without being externally compressed. Platt et al. teaches that flattening of rounded tubes to create flat walls of the tubes can cause disproportionate flattening and/or collapsing of the walls which does not provide for optimal contact with the sensors pressed against the flat walls ([0010]). Ben-Shalom et al. teaches that elastically walled tubes with cross-sectional shapes which are circular, square, or rectangular, and that these shapes are known as art effective equivalents (see [0027], since the shapes of tubular conduit 12 are taught as being circular, square, rectangular, and so on, it is taught that these shapes can be selected by one of ordinary skill in the art depending on the desired characteristics of the tubular conduit; note also that this teaching that the tubular conduit 12 can have various shapes is without external compression since the tubular conduit is formed in the taught shapes).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have shaped the tube segment of Deckert et al. in the fourth tube portion to have flat walls without external compression as in Ben-Shalom et al. as this provides the benefit of Williams discussed above where flat walls create more repeatable orientation of the tube relative to transducers (see Williams fig. 9 and col. 7 lines 16-36) while avoiding the problem taught in Platt et al. where a forced flattening of a rounded tube wall can cause crumpling of the walls and create issues between the contact of the transducer and the wall (see Platt et al. [0010]).
Deckert et al. as modified discloses a flat compartment (modified fourth tube segment, Deckert et al. region 1018, fig. 17).
Deckert et al. as modified does not disclose the tube segment wherein the flat compartment comprises a disc-like element having an at least part-circle or part-elliptical shape with a diameter or width being larger than the diameter or width of the first tube portion and/or the second tube portion and/or the third tube portion. Eberhard teaches a disc-like element having an at least part-elliptical shape (elliptical side of [0030] is beneficial as it prevents undesired creep behaviors from elastomers).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the flat compartment of Deckert et al. with the part-elliptical shaped disc-like element of Eberhard for preventing undesired creep behaviors of the elastomeric tubing ([0030]). Such a modification would include the modified compartment having a diameter or width being larger than the diameter or width of the first tube portion and/or the second tube portion and/or the third tube portion because a variation from the cross-sectional area of the flat compartment from the rest of the tubing would cause an undesired pressure difference between the various portions; the modification would account for this and accordingly increase the ellipse’s width to compensate.
Regarding claim 2, Deckert et al. as modified discloses the tube segment which is, at least partly, made of silicone (Elastomer such as silicone, see col. 17 lines 52-67) by a silicone molding process (Unitary molded elastomer conduit implies it is molded, see col. 17 lines 52-67; The applicant is advised that patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process MPEP 2113.).
The applicant is advised that patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process MPEP 2113.
Regarding claim 10, Deckert et al. as modified disclose the tube segment wherein the flat compartment comprises a long side (Flat part runs along the tube as would be obvious for the modification in light of Williams fig. 9, and thus would create an elongated long side) extending in the direction of the peristaltic infusion pump tube segment (flat part extends in same direction as tube segment, see Williams fig. 9).
Regarding claim 26, Deckert et al. as modified discloses the tube segment wherein the flat compartment (this is the modified fourth compartment, see modifications made above in claim 1) includes a rectangular cutaway portion (this is the end of the compartment which is closest to tubing 54 and is still a part of the flat compartment; the claimed cutaway portion is considered to be a cross section of the flattened disc-like element taken perpendicular to the longitudinal direction of the tubing, which would then have a rectangular cross section) for receiving the outlet (this cross section could be considered to be receiving the outlet where it is directly and integrally connected with the outlet as shown in figs. 17 and 18).
Regarding claim 12, Deckert et al. as modified discloses an infusion pump device (Ambulatory infusion pump 10, fig. 1) comprising a pump mechanism (Rotary pump wheel 49, fig. 2a) configured as a peristaltic mechanism (Rotary pump wheel 49, fig. 2a is a peristaltic pump mechanism because peristaltic pumps can include rotary motion) and including the peristaltic infusion pump tube segment according to claim 1 (Conduit 1000 is understood to be a part of configuration since it is in cassette 12, fig. 17, which is in the device, fig. 3a; see the rejection of claim 1 above), wherein the upstream inlet of the peristaltic infusion pump tube segment (Inlet is tubing 52, fig. 17) is adapted to be fluidly connected to an outlet of a medication reservoir (Widened end as in fig. 19 is for press fitting of tubing from source of medicament, including possibly a reservoir which would need to be connected in that manner).
Regarding claim 14, Deckert et al. as modified discloses the tube segment wherein the peristaltic infusion pump tube segment is replaceable and/or disposable (Conduit 1000 is part of cassette 12 as in fig. 17, and cassette 12 is replaceable as in col. 1 lines 13-15).
Regarding claim 15, Deckert et al. as modified discloses the infusion device comprising an upstream pressure sensor (Pressure sensor 270, see col. 7 lines 56-62) provided at the first tube portion (pressure sensor 270 is understood to be provided at 1020 since col. 7 lines 56-62 refers to it being upstream).
Regarding claim 16, Deckert et al. as modified discloses the infusion device wherein the pump mechanism comprises an engagement structure (Rollers 48, fig. 2a) adapted to generate at least one squeezed point in the second tube portion (See fig. 2a, one of rollers 48 is squeezing the tube structure, it is understood to be the second tube portion as per col. 17 lines 33-51) and to move it in the direction towards the outlet of the peristaltic infusion pump tube segment (in order to move fluid towards outlet, roller 48 and its squeeze point would have to rotate towards outlet too).
Regarding claim 21, Deckert et al. as modified discloses the infusion device comprising a first air in line sensor (Air in line sensor 300, see col. 16 lines 51-67, which is ultrasonic, see col. 16 lines 51-67), provided at the third tube portion (Air in line sensor 300 operates on third portion 1014, see col. 16 lines 51-67).
Regarding claim 22, Deckert et al. as modified discloses the infusion device comprising a downstream pressure sensor (Pressure sensor 272, see col. 7 lines 56-62) provided at the fourth tube portion (pressure sensor 272 is understood to be provided at 1018 since col. 7 lines 56-62 refers to it being downstream).
Regarding claim 25, Deckert et al. discloses a peristaltic infusion pump tube segment (Unitary molded elastomer conduit 1000, fig. 16) having an upstream inlet (Inlet is tubing 52, fig. 17) and a downstream outlet (Outlet is tubing 54, fig. 17) and adapted to be temporally squeezed at at least one squeezed point (Region 1012 contains a plurality of squeezing points, see col. 17 lines 33-51 and fig. 2a) to be generated by an engagement structure (Rotary pump wheel 49, fig. 3a) and to be moved towards the outlet (Fluid flows from upstream to downstream and from tubing 52 to 54, col. 8 lines 1-3) for passing a medical fluid from the inlet to the outlet (Liquid medicant, col. 1 lines 21-23, flows from inlet 52 to outlet 43, col. 8 lines 1-3), the peristaltic infusion pump tube segment comprising: a first tube portion (Region 1020, see fig. 17) next to the inlet (see fig. 17) and having a surrounding wall (Tubing has a wall as seen in fig. 18) which is adapted for an upstream occlusion detection (See col. 17 lines 33-51; the tubing cooperates with the occlusion sensor 270 because it is adapted for it), a second tube portion downstream of the first tube portion (Regions 1016 and 1012 are downstream of region 1020, fig. 17) and adapted to be temporally engaged by the engagement structure (See col. 17 lines 33-51), wherein the second tube portion comprises a surrounding wall (Tubing has a wall as seen in fig. 18) being at least partly thicker than the wall of the first tube portion (See fig. 20; region 1016 has coarse interior surface 1026 which makes it thicker than region 1020 which does not have a coarse surface) and preferably made of an elastic material (Elastomer such as silicone, see col. 17 lines 52-67) which allows the second tube portion to be reformed at those portions which are currently not subject to the engagement by the engagement structure (See col. 18 lines 1-31), a third tube portion (Region 1014, see fig. 17) having a surrounding wall (Tubing has a wall as seen in fig. 18) which is adapted for an air in line detection (Air-in-line sensor 300 works at region 1014, see col. 16 lines 51-67; the tubing cooperates with the occlusion sensor 272 because it is adapted for it), and a fourth tube portion next to the outlet (Region 1018, fig. 17) and adapted for a downstream pressure detection (See col. 17 lines 33-51; the tubing cooperates with the occlusion sensor 272 because it is adapted for it).
Deckert et al. does not disclose the third tube portion (region 1014, fig. 17) as being downstream of the second tube portion (regions 1016 and 1012, fig. 17), but rather had the third tube portion upstream of the second tube portion.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have rearranged the second and third tube portions such that the third portion is downstream of the second portion, since it has been held that rearranging parts of a prior art structure involves only routine skill in the art. In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950).
Deckert et al. as modified discloses the fourth tube portion (Region 1018, fig. 17) configured for downstream pressure detection (See col. 17 lines 33-51).
Deckert et al. as modified does not disclose the tube segment wherein the fourth tube portion comprises an external wall portion comprising a flat compartment. Williams teaches a flat compartment and teaches it as beneficial for configuring with transducers (flat walls create more repeatable orientation of the tube relative to transducers, see fig. 9 and col. 7 lines 16-36).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the wall of the fourth tube portion of Deckert et al. to be a flat compartment of Williams for creating more repeatable orientation of the tube relative to transducers. This would then mean that the modified wall is the external wall portion comprising a flat compartment as claimed.
Deckert et al. as modified thus discloses flat wall portions in the third tube portion (Region 1014, see fig. 17, which has flat wall portions as in the modification above) and a flat compartment in the fourth tube portion (Region 1018, fig. 17, which has a flat compartment as in the modification above).
Deckert et al. as modified does not disclose that the at least one flat wall portion configured for the air in line detection by at least one ultrasound sensor retains its flat shape without being externally compressed or that the flat compartment of the fourth tube portion retains its flat shape without being externally compressed. Platt et al. teaches that flattening of rounded tubes to create flat walls of the tubes can cause disproportionate flattening and/or collapsing of the walls which does not provide for optimal contact with the sensors pressed against the flat walls ([0010]). Ben-Shalom et al. teaches that elastically walled tubes with cross-sectional shapes which are circular, square, or rectangular, and that these shapes are known as art effective equivalents (see [0027], since the shapes of tubular conduit 12 are taught as being circular, square, rectangular, and so on, it is taught that these shapes can be selected by one of ordinary skill in the art depending on the desired characteristics of the tubular conduit; note also that this teaching that the tubular conduit 12 can have various shapes is without external compression since the tubular conduit is formed in the taught shapes).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have shaped the tube segment of Deckert et al. in the third and fourth tube portions to have flat walls without external compression as in Ben-Shalom et al. as this provides the benefit of Williams discussed above where flat walls create more repeatable orientation of the tube relative to transducers (see Williams fig. 9 and col. 7 lines 16-36) while avoiding the problem taught in Platt et al. where a forced flattening of a rounded tube wall can cause crumpling of the walls and create issues between the contact of the transducer and the wall (see Platt et al. [0010]).
Deckert et al. as modified discloses a flat compartment (modified fourth tube segment, Deckert et al. region 1018, fig. 17).
Deckert et al. as modified does not disclose the tube segment wherein the flat compartment comprises a disc-like element having an at least part-circle or part-elliptical shape with a diameter or width being larger than the diameter or width of the first tube portion and/or the second tube portion and/or the third tube portion. Eberhard teaches a disc-like element having an at least part-elliptical shape (elliptical side of [0030] is beneficial as it prevents undesired creep behaviors from elastomers).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the flat compartment of Deckert et al. with the part-elliptical shaped disc-like element of Eberhard for preventing undesired creep behaviors of the elastomeric tubing ([0030]). Such a modification would include the modified compartment having a diameter or width being larger than the diameter or width of the first tube portion and/or the second tube portion and/or the third tube portion because a variation from the cross-sectional area of the flat compartment from the rest of the tubing would cause an undesired pressure difference between the various portions; the modification would account for this and accordingly increase the ellipse’s width to compensate.
Deckert et al. as modified discloses the tube segment wherein the flat compartment (this is the modified fourth compartment, see modifications made above in claim 1) includes a rectangular cutaway portion (this is the end of the compartment which is closest to tubing 54 and is still a part of the flat compartment; the claimed cutaway portion is considered to be a cross section of the flattened disc-like element taken perpendicular to the longitudinal direction of the tubing, which would then have a rectangular cross section) for receiving the outlet (this cross section could be considered to be receiving the outlet where it is directly and integrally connected with the outlet as shown in figs. 17 and 18).
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Deckert et al. (US Pat. No. 6203528, henceforth Deckert et al.) in view of Williams (US Pat. No. 4856339, henceforth Williams), Platt et al. (US 20030004458, henceforth Platt et al.), Ben-Shalom et al. (US 20080095649, henceforth Ben-Shalom et al.), and Eberhard (US 20150032054, henceforth Eberhard) as applied to claim 1 above, and further in view of Tamari (WO 9428309, henceforth Tamari).
Regarding claim 4, Deckert et al. as modified discloses a second tube portion (Regions 1016 and 1012, fig. 17).
Deckert et al. as modified does not disclose the infusion device wherein the wall of the second tube portion is configured to allow a viscous fluid to be passed through by suction. Tamari teaches a second tube portion (curved tube portion of fig. 8(a)) wherein the wall of the second tube portion is configured to allow a viscous fluid to be passed through by suction (see pg. 17 lines 13-24, managing pressure differentials and choosing wall thicknesses depending on anticipated pressures).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have applied the teachings of Tamari to the second tube portion of Deckert et al. to choose an appropriate tubing wall thickness to keep the tubing from collapsing due to anticipated suction effects (Tamari pg. 3 lines 18-22).
Claims 13 and 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over Deckert et al. (US Pat. No. 6203528, henceforth Deckert et al.) in view of Williams (US Pat. No. 4856339, henceforth Williams), Platt et al. (US 20030004458, henceforth Platt et al.), Ben-Shalom et al. (US 20080095649, henceforth Ben-Shalom et al.), and Eberhard (US 20150032054, henceforth Eberhard) as applied to claim 12 above, and further in view of Tsoukalis (EP 0560720, henceforth Tsoukalis).
Regarding claim 13, Deckert et al. as modified discloses the infusion device (Ambulatory infusion pump 10, fig. 1) using a peristaltic pumping mechanism (Rotary pump wheel 49, fig. 2a is a peristaltic pump mechanism).
Deckert et al. as modified does not disclose the pump mechanism wherein the pump mechanism is configured as a linear peristaltic mechanism. Tsoukalis teaches a pump mechanism (Abstract) wherein the pump mechanism is configured as a linear peristaltic mechanism (Abstract).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have replaced the peristaltic pumping mechanism of Deckert et al. with a linear peristaltic pumping mechanism of Tsoukalis for the benefit of disposable parts of the mechanism being less expensive to replace (Tsoukalis col. 1 lines 21-28).
Regarding claim 17, Deckert et al. as modified discloses the infusion device wherein the engagement structure comprises a plurality of engagement units (Engagement units are cams, ball bearings, cam followers, see Tsoukalis Abstract) arranged side by side along the length of the second tube portion of the peristaltic infusion pump tube segment (see Tsoukalis fig. 3; it is understood that the pump of Tsoukalis would act on the second portion of Deckert et al. in the modified device in keeping with the design of Deckert et al.), wherein each engagement unit comprises a follower head (Tsoukalis end faces 11b, see fig. 3) which is movable at an angle relative to the second tube portion (Tsoukalis flexible tube 16 and end faces 11b are perpendicular to each other, see fig. 3, and are thus at an angle which is a right angle) and adapted to be brought into engagement with the second tube portion in order to squeeze it (Tsoukalis faces 11b are not in engagement with tube 16 until the tube is being squeezed in engagement, see fig. 3), wherein the engagement structure is further configured so that the follower heads are temporally brought into engagement with the second tube portion one after another (Tsoukalis travelling sequence, Abstract, is understood to be one after another and in temporal engagement as seen in fig. 3).
Regarding claim 18, Deckert et al. as modified discloses the infusion device wherein at least one engagement unit comprises a support (Tsoukalis stationary support 26, fig. 2), a follower body moveably mounted at the support (Tsoukalis cam followers 11, see fig. 3) and provided with the follower head (Tsoukalis end faces 11b is part of cam followers 11, fig. 3), a ball bearing rotatably mounted at the follower body (Tsoukalis ball bearings 10, fig. 3), a cam rotatably mounted at the support (Tsoukalis cams 30, fig. 3) and in sliding engagement with the ball bearing (see Tsoukalis col. 6 lines 31-40), and a spring (Tsoukalis col. 6 lines 41-44) biasing the moveable follower body with the follower head away from the second tube portion of the peristaltic infusion pump tube segment (Tsoukalis col. 6 lines 41-44).
Regarding claim 19, Deckert et al. as modified discloses the infusion device wherein the engagement structure comprises a drive unit (Tsoukalis motor 6, fig. 3), wherein the cam of each engagement unit is fixedly mounted to a common rotary shaft (Tsoukalis cam shaft 9, fig. 3; cam shaft has plurality of cams, understood to be fixedly mounted, col. 5 lines 28-33) which is rotated by the drive unit (Tsoukalis cam shaft 9 is driven by motor 6, col. 5 lines 28-33), and wherein the rotational angle offset of the cam relative to the rotary shaft increases from engagement unit to engagement unit (see Tsoukalis col. 3 lines 33-51) so that the follower heads are temporally brought into engagement with the second tube portion of the peristaltic infusion pump tube segment from engagement unit to engagement unit (see Tsoukalis col. 3 lines 33-51).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Deckert et al. (US Pat. No. 6203528, henceforth Deckert et al.) in view of Williams (US Pat. No. 4856339, henceforth Williams), Platt et al. (US 20030004458, henceforth Platt et al.), Ben-Shalom et al. (US 20080095649, henceforth Ben-Shalom et al.), Eberhard (US 20150032054, henceforth Eberhard), and Tsoukalis (EP 0560720, henceforth Tsoukalis) as applied to claim 18 above, and further in view of Bargh (EP 2075468, henceforth Bargh) in view of Ferme et al. (WO 2013175115, henceforth Ferme et al.).
Regarding claim 20, Deckert et al. as modified discloses the infusion device wherein the follower head (Tsoukalis end faces, fig. 3) is mounted upon a stem (Tsoukalis stem is shortened part of end face 11b as in fig. 3) fixed to the follower body (Tsoukalis shortened part of end face 11b is fixed to cam follower 11, fig. 3).
Deckert et al. as modified does not disclose the engagement unit further comprises a sealing membrane with an opening through which the stem extends in a sealing manner. Bargh teaches a sealing membrane (seals 237, fig. 20) with an opening through which a piston extends (see fig. 20, seals 237 surround piston 238) in a sealing manner (see [0044] regarding fluid containment).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added the sealing membrane of Bargh to the engagement unit of Deckert et al. for isolating the pump from the tube to protect the interior of the machine in case of leakage and improving sound insulation of the pump (see Ferme et al. machine translation [0022]).
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Deckert et al. (US Pat. No. 6203528, henceforth Deckert et al.) in view of Williams (US Pat. No. 4856339, henceforth Williams), Platt et al. (US 20030004458, henceforth Platt et al.), Ben-Shalom et al. (US 20080095649, henceforth Ben-Shalom et al.), and Eberhard (US 20150032054, henceforth Eberhard) as applied to claim 12 above, and further in view of Mohr et al. (CN 205073394, henceforth Mohr et al.).
Regarding claim 23, Deckert et al. as modified discloses the infusion device (ambulatory infusion pump 10, fig. 1) comprising the infusion tube segment (unitary molded elastomer conduit 1000, fig. 16) and a first air in line sensor (air in line sensor 300, col. 16 lines 51-67).
Deckert et al. as modified does not disclose the device comprising an air eliminating filter which is in fluid communication with the outlet of the peristaltic infusion pump tube segment, and a second air in line sensor adapted to detect air in a fluid path downstream of the air eliminating filter. Mohr et al. teaches an air eliminating filter (Air eliminating device 100 is a filtration device, see Abstract) which is in fluid communication with the outlet of an infusion pump (see fig. 1, infusion pump 145 and air elimination filter are connected by fluid line 130), and a second air in line sensor (second bubble sensor 182, fig. 1) adapted to detect air in a fluid path downstream of the air eliminating filter (sensor 182 is downstream of filter 100 in fig. 1 as fluid flows towards patient 160).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Deckert et al. by adding an air eliminating filter downstream of the outlet of the tube segment and adding a second air in line sensor downstream of the air eliminating filter for removing bubbles to be infused intravenously, as bubbles in the blood stream are not desirable (see the last paragraph of pg. 4 of Mohr et al.), and for controlling the infusion device to prevent infusion of undesired bubbles (see last paragraph of pg. 5 of Mohr et al.), respectively.
Response to Arguments
Applicant's arguments filed 12/03/2025 have been fully considered but they are not persuasive.
Applicant has argued that Deckert as modified does not disclose the newly claimed side portions of the third tube portion. Examiner respectfully disagrees. While Deckert as modified does not disclose that three of the sides are flat as appears to be shown in Applicant’s fig. 4A in the third tube portion, the claim does not specify that the side portions cannot be sub-portions of the third tube portion which extend longitudinally along the third tube portion. Thus, the extending shown in the annotated figure below and the side portions which extend along the third portion as parts of the flat face of the top of the third portion apply as the claimed side portions and Examiner respectfully finds Applicant’s arguments unpersuasive.
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Applicant also argued that Deckert et al. as modified did not disclose the newly introduced limitation there is a cutaway portion for receiving the outlet. While this appears to be new matter as indicated above, Examiner also notes that the cutaway portion could be considered to be a section view taken near the distal end of the fourth tube portion in the flat compartment which would be a rectangular cross section due to the flattened walls in the modified compartment and is configured for receiving the outlet where the outlet is integrally and monolithically formed with the compartment in Deckert as modified and thus the fluid from the outlet is received at the given rectangular cross section.
Thus, Examiner respectfully finds Applicant’s arguments unpersuasive and rejects the claims as indicated above.
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 SAMUEL J MARRISON whose telephone number is (703)756-1927. The examiner can normally be reached M-F 7:00a-3:30p ET.
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/SAMUEL J MARRISON/Examiner, Art Unit 3783 /EMILY L SCHMIDT/Primary Examiner, Art Unit 3783