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 .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 3 and 5-9 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 claim 3, line 3, the recitation “the deformation unit portion” renders the claim indefinite because the claim is unclear if “the deformation unit portion” refers to one or each one of “a plurality of deformation unit portions” recited in claim 2, lines 2-3. For examination purposes, examiner construes “the deformation unit portion” being referring to at least one of “a plurality of deformation unit portions”.
Claim 3 recites the limitation “the first deformation unit” in lines 9-10. There is insufficient antecedent basis for this limitation in the claim. Furthermore, the claim is unclear if “the first deformation unit” is part of “a plurality of deformation unit portions” recited in claim 2, lines 2-3 or additional. For examination purposes, examiner construes “the first deformation unit” is part of “a plurality of deformation unit portions”.
Claim 3 recites the limitation “the second deformation unit” in line 11. There is insufficient antecedent basis for this limitation in the claim. Furthermore, the claim is unclear if “the second deformation unit” is part of “a plurality of deformation unit portions” recited in claim 2, lines 2-3 or additional. For examination purposes, examiner construes “the second deformation unit” is part of “a plurality of deformation unit portions”.
Regarding claim 5, the recitation of “the ridge portions of each deformation unit portion include … a deformation concave portion” renders the claim indefinite because paragraph 0017 of the applicant’s disclosure recites “the deformation unit portion 38 includes a set of first ridge portions 44, a set of second ridge portions 46, and a deformation concave portion”. However, claim 5 requires the ridge portions of each deformation unit portion include a deformation concave portion. Therefore, the claim is unclear regarding whether the deformation unit portion or the ridge portion includes a deformation concave portion. For examination purposes, examiner construes that portion moving towards the center is construed as claimed deformation concave portion.
Claims 6-9 being dependent on claim 5 are also allowed.
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 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 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 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 side.
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 side (see figures 2 and 3 where side of element 2 is moving inwards when compressed) 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 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 side 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.
Regarding claim 2, Swan is silent regarding wherein: the tube comprises a plurality of deformation unit portions 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.
However, Dolveck discloses wherein: the tube 2 comprises a plurality of deformation unit portions (see “DP” in figure 2 below) 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) 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 tube comprises a plurality of deformation unit portions 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 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).
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Regarding claim 3, Swan is silent regarding wherein: the deformation unit portion comprises a first deformation unit portion provided on a first side in an axial direction with respect to a boundary surface orthogonal to the axial direction of the central axis and a second deformation unit portion provided on a second side in the axial direction with respect to the boundary surface, and the tube comprises a first region including only the first deformation unit portion, and a second region including only the second deformation unit portion in the axial direction of the central axis.
However, Dolveck teaches wherein: the deformation unit portion (see “DP” in figure 2 above) comprises a first deformation unit portion (see “FDP” in figure 2 above) provided on a first side (side where “FDP” is present) in an axial direction (direction along longitudinal axis passing through element 2) with respect to a boundary surface (surface extending orthogonal to longitudinal axis passing through element 2) orthogonal to the axial direction of the central axis and a second deformation unit portion (see “SDP” in figure 2 above) provided on a second side in the axial direction with respect to the boundary surface, and the tube 2 comprises a first region (region including element “FDP” only in figure 2 above) including only the first deformation unit portion (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 portion (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 deformation unit portion comprises a first deformation unit portion provided on a first side in an axial direction with respect to a boundary surface orthogonal to the axial direction of the central axis and a second deformation unit portion provided on a second side in the axial direction with respect to the boundary surface, and the tube comprises a first region including only the first deformation unit portion, and a second region including only the second deformation unit portion 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: the ridge portions of each deformation unit portion include a set of first ridge portions, a set of second ridge portions, a deformation concave portion.
However, Dolveck teaches wherein: the ridge portions (portions formed by elements 8 and 10) of 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, 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: the ridge portions of each deformation unit portion include a set of first ridge portions, a set of second ridge portions, 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
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 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 side.
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 that allows contents to exit out of element 2) at a distal end (end from where contents gets released) for discharging the liquid medicine, and is formed to be deformable toward a central axis side (see figures 2 and 3 where side of element 2 is moving inwards when compressed) 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 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 side 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.
Claims 1, 2, 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 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 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 side.
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 a central axis side (paragraph 0006, “folds inward”) 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 an axial direction 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 a central axis side 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 2, Swan is silent regarding wherein: the tube comprises a plurality of deformation unit portions 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.
However, Kanfer discloses wherein: the tube 400 comprises a plurality of deformation unit portions 450 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) 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: the tube comprises a plurality of deformation unit portions 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 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: the ridge portions of 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: the ridge portions (portions formed by elements 452, 454 and 456) of 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: the ridge portions of 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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Conclusion
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, CHELSEA STINSON can be reached at 571-270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NILAY J SHAH/Primary Examiner, Art Unit 3783