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
The Amendment filed 4/14/2026 has been entered. Claims 1 and 3-14 remain pending in the application. Applicant’s amendments to the Claims have overcome each and every 112(b) rejections previously set forth in the Non-Final Office Action mailed 1/28/2026.
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 1 and 3-14 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 1 and 10 recites the limitation “a plurality of deformation unit portions, each comprising a plurality of flat surfaces” but figure 7 of the original disclosure shows deformable unit 38 comprising a single flat surface 40. Therefore, the original disclosure does not provide a single deformable unit comprising a plurality of flat surfaces as required by claims 1 and 10. For examination purposes, examiner construes plurality of flat surfaces as an inner and outer surface.
Claims 3-9 and 11-14 being dependent on either claim 1 or claim 10 are also rejected.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1 and 3-14 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claims 1 and 10, the recitation of “a plurality of deformation unit portions, each comprising a plurality of flat surfaces” renders the claim indefinite because the claim is unclear regarding how a single deformation unit portion comprise a plurality of flat surfaces when the original disclosure discloses a single flat surface 40 in figure 7. For examination purposes, examiner construes plurality of flat surfaces as an inner and outer surface.
Claims 3-9 and 11-14 being dependent on either claim 1 or claim 10 are also rejected.
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.
Claims 1, 3, 5-7, 9 and 10-14 are rejected under 35 U.S.C. 103 as being unpatentable over Swan et al. (US 9,387,289 B2) in view of Dolveck (US 3,721,371).
Regarding claim 1, Swan discloses a liquid medicine administration device (figure 4) for administering a liquid medicine into a living body, the liquid medicine administration device comprising:
a cylindrical body 2 defining a space (hollow space inside element 2);
a container 46 housed in the space of the cylindrical body 2 and filled with the liquid medicine 6; and
a plunger mechanism (mechanism formed by elements 12, 14, 16, 20, 18, 22, 28, 21, 24 shown in figure 1, figure 4 is variation of the embodiment shown in figure 1 with plunger mechanism same as the one shown in figure 1) provided movably in an axial direction with respect to the cylindrical body 2, the plunger mechanism comprising a pressing member 12 configured to press a proximal end (end of element 46 in contact with element 12) of the container toward a distal end side (side where element 8 is present) to push out the liquid medicine, wherein the container is having a discharge hole (opening in element 48 that allows medicine to exit out of element 46) at a distal end (end comprising element 8) for discharging the liquid medicine and is compressed along a central axis (longitudinal axis of element 46) of container 46 with movement of the pressing member 12.
Swan discloses the container being an IV bag with flexible walls or may be a concertina-like structure (column 2, lines 38-42) but is silent regarding the container being a tube wherein: the tube is formed in a tubular shape having a discharge hole at a distal end for discharging the liquid medicine, and is formed to be deformable toward a central axis, the tube comprises a plurality of deformation unit portions, each comprising a plurality of flat surfaces and a plurality of ridge portions formed by ridgelines formed by two adjacent flat surfaces and constituting an outer edge, the deformation unit portions comprising: a plurality of first deformation unit portions provided on a first side of a boundary plane extending orthogonal to the central axis and a plurality of second deformation unit portions provided on an opposing second side of the boundary plane; and a portion of the tube at the boundary plane rotates as the tube is compressed along the central axis with movement of the pressing member.
However, Dolveck teaches a design of a dispensing container (figure 3) wherein the container is a tube 2 wherein: the tube 2 is formed in a tubular shape (see figures 2 and 3, embodiment 2 and 3 differs with the fact that element 2 in figure 3 is used to store the contents, column 2, lines 62-65, “tubular side wall”) having a discharge hole (opening in element 2) at a distal end (end from where contents are released) for discharging the liquid medicine, and is formed to be deformable toward a central axis (see figures 2 and 3 where side of element 2 is moving inwards when compressed), the tube 2 comprises a plurality of deformation unit portions (see “DP” in figure 2 below), each comprising a plurality of flat surfaces (surfaces of element “DP” in figure 2 below) and a plurality of ridge portions (portions formed by elements 8 and 10, examiner construes element 8 as being referring to the fold lines that are at an angle with respect to the axial direction and element 10 as being referring to the fold lines that are orthogonal to the axial direction) formed by ridgelines 8, 10 formed by two adjacent flat surfaces (surfaces of element “DP” in figure 2 below) and constituting an outer edge (edges of “DP” in figure 2 below), the deformation unit portion (see “DP” in figure 2 below) comprising: a plurality of first deformation unit portions (see “FDP” in figure 2 below) provided on a first side (side where “FDP” is present) of a boundary plane (plane between “FDP” and “SDP” in figure 2 below and passing orthogonal to longitudinal axis of device shown in figure 2 as shown by element “BP” in figure 2 below) extending orthogonal to the central axis and a plurality of second deformation unit portion (see “SDP” in figure 2 below) provided on an opposing second side of the boundary plane; and a portion of the tube 2 at the boundary plane rotates (due to presence of ridge, portion of element 2 will rotate in order to collapse and claim does not recite the rotation along any referenced direction) as the tube is compressed along the central axis (see figure 1) for the purpose of designing the container/tube that can be compressed in concertina fashion (column 1, lines 25-28) and deliver the fluid in fluid tight manner (column 1, lines 23-25).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art to modify the container of Swan to incorporate the container being a tube wherein: the tube is formed in a tubular shape having a discharge hole at a distal end for discharging the liquid medicine, and is formed to be deformable toward a central axis, the tube comprises a plurality of deformation unit portions, each comprising a plurality of flat surfaces and a plurality of ridge portions formed by ridgelines formed by two adjacent flat surfaces and constituting an outer edge, the deformation unit portions comprising: a plurality of first deformation unit portions provided on a first side of a boundary plane extending orthogonal to the central axis and a plurality of second deformation unit portions provided on an opposing second side of the boundary plane; and a portion of the tube at the boundary plane rotates as the tube is compressed along the central axis as taught by Dolveck for the purpose of designing the container/tube that can be compressed in concertina fashion (column 1, lines 25-28) and deliver the fluid in fluid tight manner (column 1, lines 23-25).
One of ordinary skill in the art will be motivated to combine Swan and Dolveck because Swan discloses the use of a container with flexible walls or concertina-like structure without disclosing the detailed structure of the bag/container. Dolveck discloses the detailed structure of a container that can be expanded and contracted in concertina-like manner. Additionally, Swan modified in view of Dolveck will result in a modified device having a portion of the tube at the boundary plane rotates as the tube is compressed along the central axis with movement of the pressing member.
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Regarding claim 3, Swan is silent regarding wherein: the tube comprises a first region including only the first deformation unit portions and a second region including only the second deformation unit portions in the axial direction of the central axis.
However, Dolveck teaches, and the tube 2 comprises a first region (region including element “FDP” only in figure 2 above) including only the first deformation unit portions (see “FDP” in figure 2 above) and a second region (region including element “SDP” only in figure 2 above) including only the second deformation unit portions (see “SDP” in figure 2 above) in the axial direction of the central axis for the purpose of designing the container/tube that can be compressed in concertina fashion (column 1, lines 25-28) and deliver the fluid in fluid tight manner (column 1, lines 23-25).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art to modify the container of Swan to incorporate wherein: the tube comprises a first region including only the first deformation unit portions and a second region including only the second deformation unit portions in the axial direction of the central axis as taught by Dolveck for the purpose of designing the container/tube that can be compressed in concertina fashion (column 1, lines 25-28) and deliver the fluid in fluid tight manner (column 1, lines 23-25).
Regarding claim 5, Swan is silent regarding wherein: each deformation unit portion include a set of first ridge portions, a set of second ridge portions and a deformation concave portion.
However, Dolveck teaches wherein: each deformation unit portion (see “DP” in figure 2 above) include a set of first ridge portions 10, a set of second ridge portions 8 and a deformation concave portion (see “CP” in figure 2 above) for the purpose of designing the container/tube that can be compressed in concertina fashion (column 1, lines 25-28) and deliver the fluid in fluid tight manner (column 1, lines 23-25).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the container of Swan to incorporate wherein: each deformation unit portion include a set of first ridge portions, a set of second ridge portions and a deformation concave portion as taught by Dolveck for the purpose of designing the container/tube that can be compressed in concertina fashion (column 1, lines 25-28) and deliver the fluid in fluid tight manner (column 1, lines 23-25).
Regarding claim 6, Swan is silent regarding wherein: in a side view of the tube, the first ridge portions of each deformation unit portion are parallel.
However, Dolveck teaches wherein: in a side view of the tube 2, the first ridge portions 10 of each deformation unit portion are parallel (see figure 2) for the purpose of designing the container/tube that can be compressed in concertina fashion (column 1, lines 25-28) and deliver the fluid in fluid tight manner (column 1, lines 23-25).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the container of Swan to incorporate wherein: in a side view of the tube, the first ridge portions of each deformation unit portion are parallel as taught by Dolveck for the purpose of designing the container/tube that can be compressed in concertina fashion (column 1, lines 25-28) and deliver the fluid in fluid tight manner (column 1, lines 23-25).
Regarding claim 7, Swan is silent regarding wherein: a set of the plurality of the deformation unit portions are connected to each other over an entire region in a circumferential direction of the tube, and each adjacent two deformation unit portions in the circumferential direction are connected to each other by sharing one of the second ridge portions.
However, Dolveck teaches wherein: a set of the plurality of the deformation unit portions (see “DP” in figure 2 above) are connected to each other over an entire region in a circumferential direction (direction along the circumference of element 2) of the tube 2, and each adjacent two deformation unit portions in the circumferential direction are connected to each other by sharing one of the second ridge portions 8 for the purpose of designing the container/tube that can be compressed in concertina fashion (column 1, lines 25-28) and deliver the fluid in fluid tight manner (column 1, lines 23-25).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing of the claimed invention to modify the container of Swan to incorporate wherein: a set of the plurality of the deformation unit portions are connected to each other over an entire region in a circumferential direction of the tube, and each adjacent two deformation unit portions in the circumferential direction are connected to each other by sharing one of the second ridge portions as taught by Dolveck for the purpose of designing the container/tube that can be compressed in concertina fashion (column 1, lines 25-28) and deliver the fluid in fluid tight manner (column 1, lines 23-25).
Regarding claim 9, Swan is silent regarding wherein: the deformation concave portion comprises a valley portion formed by a ridgeline protruding inward in a radial direction of the tube.
However, Dolveck teaches wherein: the deformation concave portion (see “CP” in figure 2 above) comprises a valley portion (portion where element “RL” in figure 2 above is present) formed by a ridgeline (see “R” in figure 2 above) protruding inward in a radial direction of the tube 2 for the purpose of designing the container/tube that can be compressed in concertina fashion (column 1, lines 25-28) and deliver the fluid in fluid tight manner (column 1, lines 23-25).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the container of Swan to incorporate wherein: the deformation concave portion comprises a valley portion formed by a ridgeline protruding inward in a radial direction of the tube as taught by Dolveck for the purpose of designing the container/tube that can be compressed in concertina fashion (column 1, lines 25-28) and deliver the fluid in fluid tight manner (column 1, lines 23-25).
Regarding claim 10, Swan discloses a method administering a liquid medicine, the method comprising:
providing a liquid medicine administration device (figure 4) comprising:
a cylindrical body 2 defining a space (hollow space inside element 2);
a container 46 housed in the space of the cylindrical body 2 and filled with the liquid medicine 6 and is compressed along a central axis with movement of the pressing member 12; and
a plunger mechanism (mechanism formed by elements 12, 14, 16 shown in figure 1, figure 4 is variation of the embodiment shown in figure 1 with plunger mechanism same as the one shown in figure 1) provided movably in an axial direction with respect to the cylindrical body 2, the plunger mechanism comprising a pressing member 12 configured to press a proximal end (end of element 46 in contact with element 12) of the container toward a distal end side (side where element 8 is present) to push out the liquid medicine;
providing a drive unit (unit formed by elements 20, 18, 22, 28, 21, 24 in figure 1) comprising: a motor 24 comprising a drive shaft 22, and a feed screw shaft 20 coupled to the drive shaft 22 of the motor 24;
attaching an administration line (column 5, lines 34-36, “primed patient connection tube”) to a distal end portion (portion of element 2 comprising element 8) of the cylindrical body;
driving (column 4, line 64-columnn 5, lines 3, 38-42) the motor 24 so as to rotate the drive shaft 22, and thereby rotate the feed screw shaft 20, which advances the pressing member 12 and compresses the container 46, thereby pushing the liquid medicine out from the discharge hole, wherein the container 46 is having a discharge hole (opening in element 48 that allows medicine to exit out of element 8) at a distal end (end comprising element 8) for discharging the liquid medicine, and is compressed along an axial direction with movement of the pressing member 12.
Swan discloses the container being an IV bag with flexible walls or may be a concertina-like structure (column 2, lines 38-42) but is silent the container being a tube wherein: the tube is formed in a tubular shape having a discharge hole at a distal end for discharging the liquid medicine, and is formed to be deformable, the tube comprises a plurality of deformation unit portions, each comprising a plurality of flat surfaces and a plurality of ridge portions formed by ridgelines formed by two adjacent flat surfaces and constituting an outer edge, the deformation unit portions comprising: a plurality of first deformation unit portions provided on a first side of a boundary plane extending orthogonal to the central axis and a plurality of second deformation unit portions provided on an opposing second side of the boundary plane; and a portion of the tube at the boundary plane rotates as the tube is compressed along the central axis with movement of the pressing member.
However, Dolveck teaches a design of a dispensing container (figure 3) wherein the container is a tube 2 wherein: the tube 2 is formed in a tubular shape (see figures 2 and 3, embodiment 2 and 3 differs with the fact that element 2 in figure 3 is used to store the contents, column 2, lines 62-65, “tubular side wall”) having a discharge hole (opening in element 2) at a distal end (end from where contents are released) for discharging the liquid medicine, and is formed to be deformable toward a central axis (see figures 2 and 3 where side of element 2 is moving inwards when compressed), the tube 2 comprises a plurality of deformation unit portions (see “DP” in figure 2 below), each comprising a plurality of flat surfaces (surfaces of element “DP” in figure 2 below) and a plurality of ridge portions (portions formed by elements 8 and 10, examiner construes element 8 as being referring to the fold lines that are at an angle with respect to the axial direction and element 10 as being referring to the fold lines that are orthogonal to the axial direction) formed by ridgelines 8, 10 formed by two adjacent flat surfaces (surfaces of element “DP” in figure 2 below) and constituting an outer edge (edges of “DP” in figure 2 below), the deformation unit portion (see “DP” in figure 2 below) comprising: a plurality of first deformation unit portions (see “FDP” in figure 2 below) provided on a first side (side where “FDP” is present) of a boundary plane (plane between “FDP” and “SDP” in figure 2 below and passing orthogonal to longitudinal axis of device shown in figure 2) extending orthogonal to the central axis and a plurality of second deformation unit portion (see “SDP” in figure 2 below) provided on an opposing second side of the boundary plane; and a portion of the tube 2 at the boundary plane rotates (due to presence of ridge, portion of element 2 will rotate in order to collapse and claim does not recite the rotation along any referenced direction) as the tube is compressed along the central axis (see figure 1) for the purpose of designing the container/tube that can be compressed in concertina fashion (column 1, lines 25-28) and deliver the fluid in fluid tight manner (column 1, lines 23-25).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art to modify the container of Swan to incorporate the container being a tube wherein: the tube is formed in a tubular shape having a discharge hole at a distal end for discharging the liquid medicine, and is formed to be deformable toward a central axis, the tube comprises a plurality of deformation unit portions, each comprising a plurality of flat surfaces and a plurality of ridge portions formed by ridgelines formed by two adjacent flat surfaces and constituting an outer edge, the deformation unit portions comprising: a plurality of first deformation unit portions provided on a first side of a boundary plane extending orthogonal to the central axis and a plurality of second deformation unit portions provided on an opposing second side of the boundary plane; and a portion of the tube at the boundary plane rotates as the tube is compressed along the central axis as taught by Dolveck for the purpose of designing the container/tube that can be compressed in concertina fashion (column 1, lines 25-28) and deliver the fluid in fluid tight manner (column 1, lines 23-25).
One of ordinary skill in the art will be motivated to combine Swan and Dolveck because Swan discloses the use of a container with flexible walls or concertina-like structure without disclosing the detailed structure of the bag/container. Dolveck discloses the detailed structure of a container that can be expanded and contracted in concertina-like manner. Additionally, Swan modified in view of Dolveck will result in a modified device having a portion of the tube at the boundary plane rotates as the tube is compressed along the central axis with movement of the pressing member.
Regarding claim 11, Swan is silent regarding wherein each of the second deformation unit portions has mirror symmetry with each respective one of the first deformation unit portions about the boundary plane.
However, Dolveck teaches wherein each of the second deformation unit portions (see “SDP” in figure 2 above) has mirror symmetry (as seen in figure 2 above, “FDP” and “SDP” are mirror symmetry) with each respective one of the first deformation unit portions (see “FDP” in figure 2 above) about the boundary plane for the purpose of designing the container/tube that can be compressed in concertina fashion (column 1, lines 25-28) and deliver the fluid in fluid tight manner (column 1, lines 23-25).
Therefore, it would have been prima facie obvious to modify the container of Swan to incorporate wherein each of the second deformation unit portions has mirror symmetry with each respective one of the first deformation unit portions about the boundary plane as taught by Dolveck for the purpose of designing the container/tube that can be compressed in concertina fashion (column 1, lines 25-28) and deliver the fluid in fluid tight manner (column 1, lines 23-25).
Regarding claim 12, Swan is silent regarding wherein: all of the first deformation unit portions are provided on the first side of the boundary plane such that none of the first deformation unit portions are provided on the second side of the boundary plane; and all of the second deformation unit portions are provided on the second side of the boundary plane such that none of the second deformation unit portions are provided on the first side of the boundary plane.
However, Dolveck teaches wherein: all of the first deformation unit portions (see “FDP” in figure 2 above) are provided on the first side (side where “FDP” is present in figure 2 above) of the boundary plane (see “BP” in figure 2 above) such that none of the first deformation unit portions (only “SDP” are shown on side where “SDP” are shown in figure 2 above without showing any “FDP”) are provided on the second side (side where “SDP” in figure 2 above are shown) of the boundary plane (see “BP” in figure 2 above); and all of the second deformation unit portions (see “SDP” in figure 2 above) are provided on the second side (side where “SDP” in figure 2 above are present) of the boundary plane (see “BP” in figure 2 above) such that none of the second deformation unit portions (none of the “SDP” are present on the side where “FDP” are present in figure 2 above) are provided on the first side (side where “FDP” is present) of the boundary plane (see “BP” in figure 2 above) for the purpose of designing the container/tube that can be compressed in concertina fashion (column 1, lines 25-28) and deliver the fluid in fluid tight manner (column 1, lines 23-25).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the container of Swan to incorporate wherein: all of the first deformation unit portions are provided on the first side of the boundary plane such that none of the first deformation unit portions are provided on the second side of the boundary plane; and all of the second deformation unit portions are provided on the second side of the boundary plane such that none of the second deformation unit portions are provided on the first side of the boundary plane as taught by Dolveck for the purpose of designing the container/tube that can be compressed in concertina fashion (column 1, lines 25-28) and deliver the fluid in fluid tight manner (column 1, lines 23-25).
Regarding claim 13, Swan is silent regarding wherein each of the second deformation unit portions has mirror symmetry with each respective one of the first deformation unit portions about the boundary plane.
However, Dolveck teaches wherein each of the second deformation unit portions (see “SDP” in figure 2 above) has mirror symmetry (as seen in figure 2 above, “FDP” and “SDP” are mirror symmetry) with each respective one of the first deformation unit portions (see “FDP” in figure 2 above) about the boundary plane for the purpose of designing the container/tube that can be compressed in concertina fashion (column 1, lines 25-28) and deliver the fluid in fluid tight manner (column 1, lines 23-25).
Therefore, it would have been prima facie obvious to modify the container of Swan to incorporate wherein each of the second deformation unit portions has mirror symmetry with each respective one of the first deformation unit portions about the boundary plane as taught by Dolveck for the purpose of designing the container/tube that can be compressed in concertina fashion (column 1, lines 25-28) and deliver the fluid in fluid tight manner (column 1, lines 23-25).
Regarding claim 14, Swan is silent regarding wherein: all of the first deformation unit portions are provided on the first side of the boundary plane such that none of the first deformation unit portions are provided on the second side of the boundary plane; and all of the second deformation unit portions are provided on the second side of the boundary plane such that none of the second deformation unit portions are provided on the first side of the boundary plane.
However, Dolveck teaches wherein: all of the first deformation unit portions (see “FDP” in figure 2 above) are provided on the first side (side where “FDP” is present in figure 2 above) of the boundary plane (see “BP” in figure 2 above) such that none of the first deformation unit portions (only “SDP” are shown on side where “SDP” are shown in figure 2 above without showing any “FDP”) are provided on the second side (side where “SDP” in figure 2 above are shown) of the boundary plane (see “BP” in figure 2 above); and all of the second deformation unit portions (see “SDP” in figure 2 above) are provided on the second side (side where “SDP” in figure 2 above are present) of the boundary plane (see “BP” in figure 2 above) such that none of the second deformation unit portions (none of the “SDP” are present on the side where “FDP” are present in figure 2 above) are provided on the first side (side where “FDP” is present) of the boundary plane (see “BP” in figure 2 above) for the purpose of designing the container/tube that can be compressed in concertina fashion (column 1, lines 25-28) and deliver the fluid in fluid tight manner (column 1, lines 23-25).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the container of Swan to incorporate wherein: all of the first deformation unit portions are provided on the first side of the boundary plane such that none of the first deformation unit portions are provided on the second side of the boundary plane; and all of the second deformation unit portions are provided on the second side of the boundary plane such that none of the second deformation unit portions are provided on the first side of the boundary plane as taught by Dolveck for the purpose of designing the container/tube that can be compressed in concertina fashion (column 1, lines 25-28) and deliver the fluid in fluid tight manner (column 1, lines 23-25).
Claims 1, 4, 5 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Swan et al. (US 9,387,289 B2) in view of Kanfer et al. (US 2014.0166650 A1).
Regarding claim 1, Swan discloses a liquid medicine administration device (figure 4) for administering a liquid medicine into a living body, the liquid medicine administration device comprising:
a cylindrical body 2 defining a space (hollow space inside element 2);
a container 46 housed in the space of the cylindrical body 2 and filled with the liquid medicine 6; and
a plunger mechanism (mechanism formed by elements 12, 14, 16, 20, 18, 22, 28, 21, 24 shown in figure 1, figure 4 is variation of the embodiment shown in figure 1 with plunger mechanism same as the one shown in figure 1) provided movably in an axial direction with respect to the cylindrical body 2, the plunger mechanism comprising a pressing member 12 configured to press a proximal end (end of element 46 in contact with element 12) of the container toward a distal end side (side where element 8 is present) to push out the liquid medicine, wherein the container is having a discharge hole (opening in element 48 that allows medicine to exit out of element 46) at a distal end (end comprising element 8) for discharging the liquid medicine and is compressed along a central axis of the tube with movement of the pressing member 12.
Swan discloses the container being an IV bag with flexible walls or may be a concertina-like structure (column 2, lines 38-42) but is silent regarding the container being a tube wherein: the tube is formed in a tubular shape having a discharge hole at a distal end for discharging the liquid medicine, and is formed to be deformable toward the central axis wherein: the tube comprising a plurality of deformation unit portions, each comprising a plurality of flat surfaces and a plurality of ridge portions formed by ridgelines formed by two adjacent flat surfaces and constituting an outer edge, the deformation unit portions comprising: a plurality of first deformation unit portions provided on a first side of a boundary plane extending orthogonal to the central axis, and a plurality of second deformation unit portions provided on an opposing second side of the boundary plane; and a portion of the tube at the boundary plane rotates as the tube is compressed along the central axis with movement of the pressing member.
However, Kanfer teaches a design of a dispensing container (figure 4B) wherein the container is a tube 400 wherein: the tube 400 is formed in a tubular shape (paragraph 0022, lines 2-7, tube is construed as “substantially rectangular shaped”) having a discharge hole (opening in element 400 that allows contents to exit out of element 400) at a distal end (end from where contents come out) for discharging the liquid medicine, and is formed to be deformable toward the central axis (paragraph 0006, “folds inward”), the tube 400 comprises a plurality of deformation unit portions 450, each comprising a plurality of flat surfaces (surfaces of element 450) and a plurality of ridge portions (portions formed by elements 452, 454, 456) formed by ridgelines 452, 454, 456 formed by two adjacent flat surfaces (surfaces of element 450) and constituting an outer edge (edges of element 450), the deformation unit portions 450 comprising: a plurality of first deformation unit portions 450a (any other two labeled as 450 in figure 4B adjacent to element 450a is construed as first deformation unit portions, hereinafter combined referred as 450a) provided on a first side (side where element 450a is present) of a boundary plane (plane comprising element 454) extending orthogonal to the central axis (longitudinal axis of device shown in figure 4B), and a plurality of second deformation unit portions 450b, 450c) provided on an opposing second side (side where elements 450b, 450c are present) of the boundary plane (plane comprising element 454); and a portion of the tube 400 at the boundary plane (plane comprising element 454) rotates as the tube (element 400 will rotate when compressed along certain axis due to presence of elements 454, 456, 452 since claim does not specify an axis along which the tube rotates) is compressed along the central axis when pressed for the purpose of designing the container/tube that can be compressed in proper manner thereby allowing the contents to be released without extra effort or load on the pump (paragraph 0003).
Swan modified in view of Kanfer will result in having the tube is compressed along an axial direction with movement of the pressing member because Swan already discloses compressing the container along a central axis with movement of the pressing member.
Therefore, it would have been prima facie obvious to one of ordinary skill in the art to modify the container of Swan to incorporate a tube wherein: the tube is formed in a tubular shape having a discharge hole at a distal end for discharging the liquid medicine, and is formed to be deformable toward the central axis wherein: the tube comprising a plurality of deformation unit portions, each comprising a plurality of flat surfaces and a plurality of ridge portions formed by ridgelines formed by two adjacent flat surfaces and constituting an outer edge, the deformation unit portions comprising: a plurality of first deformation unit portions provided on a first side of a boundary plane extending orthogonal to the central axis, and a plurality of second deformation unit portions provided on an opposing second side of the boundary plane; and a portion of the tube at the boundary plane rotates as the tube is compressed along the central axis with movement of the pressing member as taught by Kanfer for the purpose of designing the container/tube that can be compressed in proper manner thereby allowing the contents to be released without extra effort or load on the pump (paragraph 0003).
Regarding claim 4, Swan is silent regarding wherein each of the plurality of flat surfaces is triangular.
However, Kanfer discloses wherein each of the plurality of flat surfaces is triangular 450 (figure 4B) for the purpose of designing the container/tube that can be compressed in proper manner thereby allowing the contents to be released without extra effort or load on the pump (paragraph 0003).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the container of Swan to incorporate wherein each of the plurality of surfaces is triangular as taught by Kanfer for the purpose of designing the container/tube that can be compressed in proper manner thereby allowing the contents to be released without extra effort or load on the pump (paragraph 0003).
Regarding claim 5, Swan is silent regarding wherein: each deformation unit portion include a set of first ridge portions, a set of second ridge portions, a deformation concave portion.
However, Kanfer teaches wherein: each deformation unit portion 450 include a set of first ridge portions 452, a set of second ridge portions 454, a deformation concave portion 450b for the purpose of designing the container/tube that can be compressed in proper manner thereby allowing the contents to be released without extra effort or load on the pump (paragraph 0003).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the container of Swan to incorporate wherein: each deformation unit portion include a set of first ridge portions, a set of second ridge portions, a deformation concave portion as taught by Kanfer for the purpose of designing the container/tube that can be compressed in proper manner thereby allowing the contents to be released without extra effort or load on the pump (paragraph 0003).
Regarding claim 8, Swan is silent regarding wherein: a set of the plurality of deformation unit portions is connected along a spiral direction, and each adjacent two deformation unit portions in the spiral direction are connected to each other by sharing one of the first ridge portions.
However, Kanfer teaches wherein: a set of the plurality of deformation unit portions 450 is connected along a spiral direction (see “SD” in figure 4B below), and each adjacent two deformation unit portions 450 in the spiral direction are connected to each other by sharing one of the first ridge portions 452 for the purpose of designing the container/tube that can be compressed in proper manner thereby allowing the contents to be released without extra effort or load on the pump (paragraph 0003).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the container of Kanfer o incorporate wherein: a set of the plurality of deformation unit portions is connected along a spiral direction, and each adjacent two deformation unit portions in the spiral direction are connected to each other by sharing one of the first ridge portions as taught by Kanfer for the purpose of designing the container/tube that can be compressed in proper manner thereby allowing the contents to be released without extra effort or load on the pump (paragraph 0003).
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Response to Arguments
Applicant's arguments filed 4/14/2026 have been fully considered but they are not persuasive.
The applicant argues on page 9, line 7-page 10, line 11 that the combination of Swan and Dolveck fails to disclose each and every limitations of the amended claims 1 and 10 because the combination of Swan and Dolveck fails to disclose “a plurality of first deformation unit portions provided on a first side of a boundary plane extending orthogonal to the central axis” and “a plurality of second deformation unit portions provided on an opposing second side of the boundary plane” where “a portion of the tube at the boundary plane rotates as the tube is compressed along the central axis with movement of the pressing member”. Examiner respectfully disagrees. As explained in the rejection of claims 1 and 10 above in the current Office Action, the combination of Swan and Dolveck discloses each and every limitation as claimed. Furthermore, the claim does not require a specific axis along which a portion of the tube rotates and since the combination of Swan and Dolveck does include the compression of the tube involving movement of one deformation unit portion with respect to the other deformation unit portion, the portion of the tube does rotate thereby meeting the claimed limitation. If claim is amended to indicate the rotation direction as shown by element “D” in figure 6 of the applicant’s original disclosure, then the claim could overcome the rejection over the prior art of record.
The applicant argues on page 10, line 20-page 11, last line that the combination of Swan and Kanfer does not teach a liquid medicine administration device that includes a tube including a plurality of deformation unit portions that include “a plurality of first deformation unit portions provided on a first side of a boundary plane extending orthogonal to the central axis” and “a plurality of second deformation unit portions provided on opposing second side of the boundary plane” where “a portion of the tube at the boundary plane rotates as the tube is compressed along the central axis with movement of the pressing member”. Examiner respectfully disagrees. As explained in the rejection of claim 1 above in the current Office Action, the combination of Swan and Kanfer discloses each and every limitation as claimed. Furthermore, the claim does not require a specific axis along which a portion of the tube rotates and since the combination of Swan and Kanfer does include the compression of the tube involving movement of one deformation unit portion with respect to the other deformation unit portion, the portion of the tube does rotate thereby meeting the claim limitation. If claim is amended to indicate the rotation direction as shown by element “D” in figure 6 of the applicant’s original disclosure, then the claim could overcome the rejection over the prior art of record.
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 NILAY J SHAH whose telephone number is (571)272-9689. The examiner can normally be reached Monday-Thursday 8:00 AM-4:30 PM EST.
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/NILAY J SHAH/Primary Examiner, Art Unit 3783
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