DETAILED ACTION
This is the first office action on the merits with reference to the above identified patent application filed on 21 October 2025. Claims 1 – 20 are pending and currently being examined.
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 .
Election/Restrictions
Applicant’s election of Species E in the reply filed on 12 May 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). Claims 1 – 20 read on the elected species, and will be examined on the merits. There are no withdrawn claims.
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.
Claim 14 is 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.
In Re Claim 14, the phrase “the top case or the bottom case integrally forms” in Lines 3 – 4 is unclear. The meaning of “integrally” in this context is unclear. For the purpose of prior art analysis, the phrase --the top case and the bottom case together form-- will be assumed instead.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Neftel (US Patent 5,741,125 A).
In Re Claim 15, Neftel discloses a peristaltic pump (Figure 5 embodiment) comprising: a flexible tube (22); and a roller module (68, 48, 38) rotatable relative to the flexible tube, the roller module comprising: a holder structure (68) movable relative to the flexible tube (22), the holder structure comprising a first holder and a second holder (there are three holder structures, two of them are being designated as claimed); a roller mechanism (38, 48) rotatably mounted on the holder structure (68) (Column 4, Lines 11 – 12 states that each wheel 48 has its own rotation axis), the roller mechanism comprising at least one first roller (48a) rotatably mounted on the first holder (68) and at least one second roller (48b) rotatably mounted on the second holder (68); and an actuating rod (38) movable relative to the flexible tube (22) in a longitudinal direction, a protruding structure (74, 76) protruding laterally from the first holder; wherein before the actuating rod (38) is moved longitudinally toward the flexible tube (22), the at least one first roller (48a) is facing the flexible tube (22), and the at least one second roller (48b) is not facing the flexible tube (this limitation is met when 48b is rotated counterclockwise in Figure 1); after the actuating rod (38) is moved longitudinally toward the flexible tube (22) by a longitudinal force, the protruding structure (74, 76) drives the first holder (68) to move laterally, for making the at least one first roller (48a) compress the flexible tube (22); upon rotating the roller module (68, 48, 38) by a rotational force from the actuating rod (38) (i.e. when the motor 30 rotates), the at least one first roller (48a) and the at least one second roller (48b) compress the flexible tube (22) for fluid transfer in the flexible tube (22) (Column 3, Lines 36 – 55; Column 4, Lines 10 – 16 and 48 – 67; Column 5, Lines 1 – 23; Figures 1 – 5).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1 – 7, 13, 15 – 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Repka (WIPO document WO 2016180951 A1) in view of Inoue (Japanese Patent JP 2012189045 A, Machine Translation provided).
In Re Claim 1, the Figure 8 embodiment of Repka discloses an infusion device (paragraphs [0001],[0002]) comprising: a fluid path module comprising: a first housing (24); and a peristaltic pump disposed within the first housing and comprising: a flexible tube (“T”); and a roller module (32, 34, 84) rotatable relative to the flexible tube (“T”), the roller module (32, 34, 84) comprising: a holder structure having at least one holder (34) movable in a lateral direction relative to the flexible tube (“T”); a roller mechanism comprising at least one roller (32; note that the two-rollers embodiment in paragraph [0030] is being relied upon) rotatably mounted on the at least one holder (34); and an actuating rod (84) driving the roller module; and a drive module (22) comprising: a second housing (housing of 22); a spinning head (rotor of motor 22) disposed within the second housing at a position corresponding to the actuating rod (84); and a power source (this is disclosed by any conventional battery driven motor) disposed within the second housing (housing of 22) and connected to the spinning head (rotor of motor 22), for driving the spinning head (rotor of motor 22) to rotate; wherein when the actuating rod is at an initial position, the flexible tube is uncompressed by any rollers (actuating rod 84 does not contact the holders in Figure 8, so in this position, the tube is uncompressed by any of the rollers), and when the actuating rod (84) is engaged with the holders (34), the flexible tube (“T”) is compressed by the at least one roller (32) for fluid transfer in the flexible tube (paragraphs [0030], [0041] – [0043]; Figures 8, 9).
Although Repka discloses that the second housing (22) is assembled with the first housing (24), it does not disclose that the spinning head (rotor of motor 22) becomes detachably engaged with the actuating rod.
However, Inoue discloses an infusion device comprising: a fluid path module (8) comprising: a first housing (81, 82); and a peristaltic pump (1) disposed within the first housing and comprising: a flexible tube (4); and a roller module/holder (5) rotatable relative to the flexible tube (4), and an actuating rod (61) driving the roller module (5) to rotate; and a drive module (7) comprising: a second housing (housing of the motor 7); a spinning head (71) disposed within the second housing at a position corresponding to the actuating rod (as seen in Figure 6); and a power source disposed within the second housing (this is disclosed by any conventional battery driven motor) and connected to the spinning head (71), for driving the spinning head to rotate; wherein when the actuating rod (61) is at an initial position (best seen in Figure 5b), the flexible tube is uncompressed; wherein when the second housing (housing of motor 7) is assembled with the first housing (Figure 6 represents the disassembled position, 61 can be moved sufficiently such that the tube is completely un-occluded close to the position in Figure 5b; Figure 5a is being designated the assembled position), the spinning head (71) becomes detachably engaged (via 71a) with the actuating rod (61) and the flexible tube (4) is compressed for fluid transfer in the flexible tube (paragraphs [0021]-[0024] of Translation; Figures 4 – 6).
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Annotated Figure 8 of Repka (on the left) and Figure 5 of Inoue (on the right)
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed the invention to substitute the drives (84, 22, 80, 48) of Repka with the drives (61, 71, 7; pictorial view seen in Figure 6) of Inoue (modification indicated by the arrow in the annotated figures above) because it is only a matter of substituting one type of tube occluding mechanism with another type of tube occluding mechanism, therefore the results of the substitution are predictable (MPEP 2141, Section III, Rationale B).
In Re Claim 2, the combined references above disclose all the limitations of Claim 1, and Repka discloses that the actuating rod (84) is movable in a longitudinal direction relative to the flexible tube (“T”), causing the actuating rod (84) to move the at least one holder (34) in the lateral direction by exerting a longitudinal force for making the at least one roller (32) compress the flexible tube (“T”), and Inoue discloses that the spinning head (71) exerts a rotational force to rotate the roller module (5).
In Re Claim 3, the combined references above disclose all the limitations of Claim 2, and Repka discloses that the protruding structure (labeled “second protruding portion” in above annotated figure) protrudes from the at least one holder (34) and has an inclined surface formed thereon; when the actuating rod (84) moves in the longitudinal direction, the actuating rod (84) slides against the inclined surface of the at least one holder (34) for making the at least one roller (32) compress the flexible tube (“T”) by the lateral movement of the at least one holder (34).
In Re Claim 4, the combined references above disclose all the limitations of Claim 2, and Repka discloses that the protruding structure (84 has the protruding structure similar to the one labeled “first protruding portion” in Inoue) protrudes from the actuating rod (84) and has an inclined surface formed thereon; when the actuating rod (48) moves in the longitudinal direction, the inclined surface of the actuating rod (84) slides against the at least one holder (34) for making the at least one roller (32) compress the flexible tube (“T”) by the lateral movement of the at least one holder (34).
In Re Claim 5, the combined references above disclose all the limitations of Claim 2, and Repka discloses that the protruding structure comprises a first protruding portion (84 has the protruding structure similar to the one labeled “first protruding portion” in Inoue) protruding from the actuating rod (84) and a second protruding portion (see annotated figures above) protruding from the at least one holder (34), the first protruding portion has a first inclined surface formed thereon, and the second protruding portion has a second inclined surface formed thereon corresponding to the first inclined surface as depicted; when the actuating rod (84) moves in the longitudinal direction, the first inclined surface slides along the second inclined surface for making the at least one roller (32) compress the flexible tube (“T”) by the lateral movement of the at least one holder (34).
In Re Claim 6, the combined references above disclose all the limitations of Claim 2, and Inoue discloses that the actuating rod (61) has a first patterned interface (61a) at an end of the actuating rod (61), the spinning head (71) has a second patterned interface (71a) corresponding to the actuating rod (61), and the first pattern interface (71a) is detachably engaged with the second patterned interface (61a) to make the actuating rod (61) receive both the longitudinal force (from 62) for moving the at least one holder (5) in the lateral direction and the rotational force (via motor 7) for rotating the roller module (5).
In Re Claim 7, the combined references above disclose all the limitations of Claim 6, and Inoue discloses that the first patterned interface (61a) is a non-keyed torque transmitting coupling concave structure, the second patterned interface (71a) is a non-keyed torque transmitting coupling convex structure, and the non-keyed torque transmitting coupling convex structure (71a) is received within the non-keyed torque transmitting coupling concave structure (61a) to achieve engagement of the first patterned interface (61a) and the second patterned interface (71a).
In Re Claim 13, the combined references above disclose all the limitations of Claim 1, and Inoue discloses that the first housing (81, 82) has an inlet (41; paragraph [0013]) and an outlet (42; paragraph [0013]) (Figure 4), the inlet (41) is communicated with one end of the flexible tube (at 81a) for receiving a fluid, and the outlet (42) is communicated with another end of the flexible tube (at 81a) for outputting the fluid.
In Re Claim 15, Inoue discloses a peristaltic pump (paragraph [0002]; Figure 8 embodiment) comprising: a flexible tube (“T”); and a roller module (32, 34, 84) rotatable relative to the flexible tube (“T”), the roller module (32, 34, 84) comprising: a holder structure (34) movable relative to the flexible tube (“T”), the holder structure (34) comprising a first holder (there are two labels “34” one of which is being designated the first holder) and a second holder (there are two labels “34” the other one of which is being designated the second holder); a roller mechanism (32) rotatably mounted on the holder structure (34), the roller mechanism (34) comprising at least one first roller (there are two labels “32” one of which is being designated the first roller) rotatably mounted on the first holder (34) and at least one second roller (there are two labels “32” the other one of which is being designated the second roller) rotatably mounted on the second holder (34); and an actuating rod (84) movable relative to the flexible tube (“T”) in a longitudinal direction, a protruding structure (see label “second protruding portion” in the annotated figures above) protruding laterally from the first holder (34); wherein before the actuating rod (84) is moved longitudinally toward the flexible tube (“T”), the at least one first roller (32) is facing the flexible tube, and the at least one second roller (32) is not facing the flexible tube (“T”) (this position of the rollers is disclosed when the two rollers/roller module in Figure 9 are rotated by 90 degrees); after the actuating rod (84) is moved longitudinally toward the flexible tube (“T”) by a longitudinal force, the protruding structure (see label “second protruding portion” in the annotated figures above) drives the first holder (34) to move laterally, for making the at least one first roller (32) compress the flexible tube (“T”) (paragraphs [0030], [0041] – [0043]; Figures 8, 9),
Although Repka discloses that the at least one first roller (32) and the at least one second roller (32) compress the flexible tube (“T”) for fluid transfer in the flexible tube (“T”), it does not disclose that this happens upon rotating the roller module by a rotational force from the actuating rod.
However, Inoue discloses a peristaltic pump (embodiment of Figures 4 – 6) comprising: a flexible tube (4); and a roller module rotatable relative to the flexible tube (4), the roller module comprising: a holder structure (5) movable relative to the flexible tube, and an actuating rod (61) movable relative to the flexible tube (4) in a longitudinal direction, a protruding structure (the tapered portion of the frustoconical shape) protruding laterally from the actuating rod (central cylindrical portion of the frustoconical shape); after the actuating rod (61) is moved longitudinally (from its position in Figure 5b to its position in Figure 5a) toward the flexible tube (4) by a longitudinal force, the protruding structure (the tapered portion of the frustoconical shape) drives the first holder (5) to move laterally, for making the holder structure (5) compress the flexible tube (4); upon rotating the roller module (61, 71, 5) by a rotational force (supplied by motor 7) from the actuating rod (61), the holder structure (5) compress the flexible tube (4) for fluid transfer in the flexible tube (4) (paragraphs [0021]-[0024] of Translation; Figures 4 – 6).
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Annotated Figure 8 of Repka (on the left) and Figure 5 of Inoue (on the right)
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed the invention to substitute the drives (84, 22, 80, 48) of Repka with the drives (61, 71, 7; pictorial view seen in Figure 6) of Inoue (modification indicated by the arrow in the annotated figures above) because it is only a matter of substituting one type of tube occluding mechanism with another type of tube occluding mechanism, therefore the results of the substitution are predictable (MPEP 2141, Section III, Rationale B).
In Re Claim 16, the combined references above disclose all the limitations of Claim 15, and Repka discloses that the protruding structure (labeled “second protruding portion” in the annotated figure above) protrudes laterally from the first holder (34) and has an inclined surface formed thereon; when the actuating rod (84) moves in the longitudinal direction, the actuating rod (84) slides against the protruding structure along the inclined surface for making the first roller (32) compress the flexible tube by the lateral movement of the first holder (34).
In Re Claim 17, the combined references above disclose all the limitations of Claim 15, and Inoue discloses that the protruding structure (see annotated figures above) protrudes laterally from the actuating rod (61) and has an inclined surface formed thereon; when the actuating rod (61) moves in the longitudinal direction (from its position in Figure 5b to its position in Figure 5a), the inclined surface of the actuating rod slides against the first holder (34 of Repka in the modified apparatus) for making the first roller (34 of Repka in the modified apparatus) compress the flexible tube by the lateral movement of the at least one first holder (of Repka).
In Re Claim 18, the combined references above disclose all the limitations of Claim 15, and the combined references further disclose that the protruding structure comprises a first protruding portion (see black triangle on 61 of Inoue in the annotated figure above, a similar portion exists on 84 of Repka) protruding from the actuating rod and a second protruding portion (see black polygon on 34 of Repka in the annotated figure above) protruding from the first holder, the first protruding portion has a first inclined surface formed thereon, and the second protruding portion has a second inclined surface formed thereon corresponding to the first inclined surface (inclined surfaces of 84 and 34 of Repka); when the actuating rod (84 of Repka or 61 of Inoue) moves in the longitudinal direction toward the flexible tube, Repka discloses that the first inclined surface (of 84) slides along the second inclined surface (of 34) for making the at least one first roller compress the flexible tube by the lateral movement of the first holder (34).
In Re Claim 19, the combined references above disclose all the limitations of Claim 15, and Inoue discloses that the actuating rod (61) has a patterned interface (61a, 71a; Figure 6) at an end of the actuating rod (61) that receives both the longitudinal force (from 62) for moving the first holder (5) laterally (Figure 5a and Figure 5b show two positions of the first holder 5), and the rotational force (from motor 1 via 71a), and in the modified apparatus - the roller module of Repka would be rotated.
In Re Claim 20, the combined references above disclose all the limitations of Claim 19, and Inoue discloses that the patterned interface (61a; Figure 6) is a non-keyed torque transmitting coupling concave structure.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Repka (WIPO document WO 2016180951 A1) in view of Inoue (Japanese Patent JP 2012189045 A, Machine Translation provided) and further in view of Moss (US Patent 5,336,190 A).
In Re Claim 8, Repka and Inoue disclose all the limitations of Claim 1, but they do not disclose an aperture for a tool.
However, Moss discloses a first housing (20) of a linear peristaltic pump (Column 1, Lines 25 – 27: “a first tube section positioned within the pump assembly on which the pumps presses against the cassette pump plate to draw or pump the medicine out of the bag”), the first housing (20) has at least one through hole (40) to allow a tool (50) to physically access a fluid container (22) connected to the fluid path module (16, 24) (Column 1, Lines 15 – 60; Figures 1 – 3).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed the invention to modify the first housing of Repka / Inoue to incorporate a fluid container and through hole as taught by Moss for the purpose of allowing a tool to access and remove the fluid container when it is spent.
Claim(s) 9, 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Repka (WIPO document WO 2016180951 A1) in view of Inoue (Japanese Patent JP 2012189045 A, Machine Translation provided) and further in view of Kullas (US Patent 6,077,246 A).
In Re Claims 9 and 10, Inoue discloses that the second housing (7) is assembled with the first housing (81, 82) to make the spinning head (71) engaged with the actuating rod (61), Repka discloses causing at least one roller (32) to move laterally for compressing the flexible tube (“T”), but Repka and Inoue do not disclose that the second housing is detachably assembled (with the first housing).
However, Figure 5 of Kullas discloses a second housing (3) that is detachably assembled to the first housing (5, 41), the first housing (5, 41) is rotatably connected (via hinge 54) to the second housing (3) (Column 5, Lines 38 – 42, 63 – 65; Column 6, Lines 8 – 13; Figure 5).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed the invention to incorporate the hinge as taught by Kullas to rotatably connect the first and second housing of Repka / Inoue for the purpose of enabling ease of assembly and disassembly (Column 3, Lines 33 – 35 of Kullas).
Claim(s) 9, 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Repka (WIPO document WO 2016180951 A1) in view of Inoue (Japanese Patent JP 2012189045 A, Machine Translation provided) and further in view of Ishigaki (PG Pub US 20160061198 A1).
In Re Claims 9 and 11, Inoue discloses that the second housing (7) is assembled with the first housing (81, 82) to make the spinning head (71) engaged with the actuating rod (61), Repka discloses causing at least one roller (32) to move laterally for compressing the flexible tube (“T”), but Repka and Inoue do not disclose that the second housing is detachably assembled (with the first housing).
However, Figure 22 of Ishigaki discloses a second housing (63) that is detachably assembled to the first housing (body 52 of cassette 50), the second housing (63) has a bottom lid (60) with a socket (space inside 60) formed thereon, the bottom lid (60) openably covers the drive module (65, 651), and the socket (space inside 60) accepts the fluid path module (50) as a cassette; when the bottom lid (60) is closed, the cassette (50) is contained within the drive module (65, 651) (Figure 21 shows the closed position); when the bottom lid (60) is opened, the cassette (50) is removable from the socket (Figure 22 shows the removed position) (paragraphs [0160]-[0165]).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed the invention to modify the second housing of Repka / Inoue such that it has a bottom lid that accepts the fluid path module as a cassette as taught by Ishigaki for the purpose of enabling ease of assembly and disassembly.
Claim(s) 9, 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Repka (WIPO document WO 2016180951 A1) in view of Inoue (Japanese Patent JP 2012189045 A, Machine Translation provided) and further in view of Kirkpatrick (US Patent 8,465,454 B2).
In Re Claims 9 and 12, Inoue discloses that the second housing (7) is assembled with the first housing (81, 82) to make the spinning head (71) engaged with the actuating rod (61), Repka discloses causing at least one roller (32) to move laterally for compressing the flexible tube (“T”), but Repka and Inoue do not disclose that the second housing is detachably assembled (with the first housing).
However, Figure 1B of Kirkpatrick discloses a second housing (20) that is detachably assembled to the first housing (body of cassette 24 that form chambers 26), the second housing (20) has a socket (space that is covered by lid 22) and a bottom lid (22) openably covering the socket, and the socket accepts the fluid path module (24) as a cassette; when the bottom lid (22) is closed, the cassette (24) is contained within the drive module (portion of 20 that has 28); when the bottom lid (22) is opened, the cassette (24) is removable from the socket (Column 2, Line 42 – Column 3, Line 12; Figures 1, 2).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed the invention to modify the second housing of Repka / Inoue such that it has a bottom lid that covers the fluid path module as a cassette accepted in the socket of the second housing as taught by Kirkpatrick for the purpose of enabling ease of assembly and disassembly.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Repka (WIPO document WO 2016180951 A1) in view of Inoue (Japanese Patent JP 2012189045 A, Machine Translation provided) and further in view of Paukovits (PG Pub US 20040191086 A1).
In Re Claim 14, Repka and Inoue disclose all the limitations of Claim 1, but they do not disclose that the first housing has a top case and bottom case for receiving a fluid container.
However, Figure 4 of Paukovits discloses that the first housing comprising a top case (33) and a bottom case (27), and the roller module (29) and the flexible tube (30) are held together by the top case (33) and the bottom case (27); the top case (33) and the bottom case (27) together forms an adapter structure (“open ended receptacle”; paragraph [0023]) for receiving a fluid container (25) and forms a connector structure (20, 114) for connecting to an output component (fluid destination) (paragraphs [0022],[0023],[0026],[0031]; Figures 2 – 4).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed the invention to modify the first housing of Repka / Inoue to form a top case and bottom case for receiving a fluid container as taught by Paukovits for the purpose of making the device more compact by integrating the fluid source with the roller module.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DNYANESH G KASTURE whose telephone number is (571)270-3928. The examiner can normally be reached Mon-Thu, 7:30 AM to 6:00 PM.
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/D.G.K/Examiner, Art Unit 3746
/ESSAMA OMGBA/Supervisory Patent Examiner, Art Unit 3746
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