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 .
Specification
The abstract of the disclosure is objected to because:
In line 4, “the medication” should be changed to “a medication”
A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Claims 1-12 are objected to because of the following informalities:
In regards to claim 1, line 29, “each guide rib” should be changed to “each guide rib of the at least three guide ribs”.
In regards to claim 1, line 30, “a respective one of the guide grooves” should be changed to “a respective one of the at least three guide grooves”.
In regards to claim 1, line 31, “each guide rib” should be changed to “each guide rib of the at least three guide ribs”.
In regards to claim 1, line 31, “each guide groove” should be changed to “each guide groove of the at least three guide grooves”.
In regards to claim 1, line 32, “the guide rib” should be changed to “the guide rib of the at least three guide ribs”.
In regards to claim 1, line 34, “the guide rib” should be changed to “the guide rib of the at least three guide ribs”.
In regards to claim 2, line 3, “each of the guide ribs” should be changed to “each of the at least three guide ribs”.
In regards to claim 2, line 4, “the guide rib” should be changed to “the guide rib of the at least three guide ribs”.
In regards to claim 2, lines 4-5, “the respective guide groove” should be changed to “the respective one of the at least three guide grooves”.
In regards to claim 2, line 6, “each guide rib” should be changed to “each guide rib of the at least three guide ribs”.
In regards to claim 2, line 8, “the guide rib” should be changed to “the guide rib of the at least three guide ribs”.
In regards to claim 3, line 4, “the respective guide rib” should be changed to “a respective guide rib of the at least three guide ribs”.
In regards to claim 4, line 3, “the guide ribs” should be changed to “the at least three guide ribs”.
In regards to claim 5, line 26, “each guide rib” should be changed to “each guide rib of the at least three guide ribs”.
In regards to claim 5, line 27, “a respective one of the guide grooves” should be changed to “a respective one of the at least three guide grooves”.
In regards to claim 5, line 28, “each guide rib” should be changed to “each guide rib of the at least three guide ribs”.
In regards to claim 5, line 28, “each guide groove” should be changed to “each guide groove of the at least three guide grooves”.
In regards to claim 5, line 29, “the guide rib” should be changed to “the guide rib of the at least three guide ribs”.
In regards to claim 5, line 31, “the guide rib” should be changed to “the guide rib of the at least three guide ribs”.
In regards to claim 6, line 3, “each of the guide ribs” should be changed to “each of the at least three guide ribs”.
In regards to claim 6, line 4, “the guide rib” should be changed to “the guide rib of the at least three guide ribs”.
In regards to claim 6, lines 4-5, “the respective guide groove” should be changed to “the respective one of the at least three guide grooves”.
In regards to claim 6, line 6, “each guide rib” should be changed to “each guide rib of the at least three guide ribs”.
In regards to claim 6, line 8, “the guide rib” should be changed to “the guide rib of the at least three guide ribs”.
In regards to claim 7, line 4, “the respective guide rib” should be changed to “a respective guide rib of the at least three guide ribs”.
In regards to claim 8, line 3, “the guide ribs” should be changed to “the at least three guide ribs”.
In regards to claim 9, line 22, “an the inner peripheral surface” should be changed to “an inner peripheral surface”.
In regards to claim 9, line 26, “each guide rib” should be changed to “each guide rib of the at least three guide ribs”.
In regards to claim 9, line 27, “a respective one of the guide grooves” should be changed to “a respective one of the at least three guide grooves”.
In regards to claim 9, line 28, “each guide rib” should be changed to “each guide rib of the at least three guide ribs”.
In regards to claim 9, line 28, “each guide groove” should be changed to “each guide groove of the at least three guide grooves”.
In regards to claim 9, line 29, “the guide rib” should be changed to “the guide rib of the at least three guide ribs”.
In regards to claim 9, line 31, “the guide rib” should be changed to “the guide rib of the at least three guide ribs”.
In regards to claim 10, line 3, “each of the guide ribs” should be changed to “each of the at least three guide ribs”.
In regards to claim 10, line 4, “the guide rib” should be changed to “the guide rib of the at least three guide ribs”.
In regards to claim 10, lines 4-5, “the respective guide groove” should be changed to “the respective one of the at least three guide grooves”.
In regards to claim 10, line 6, “each guide rib” should be changed to “each guide rib of the at least three guide ribs”.
In regards to claim 10, line 8, “the guide rib” should be changed to “the guide rib of the at least three guide ribs”.
In regards to claim 11, line 4, “the respective guide rib” should be changed to “a respective guide rib of the at least three guide ribs”.
In regards to claim 12, line 3, “the guide ribs” should be changed to “the at least three guide ribs”.
Appropriate correction is required.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-12 are rejected under 35 U.S.C. 103 as being unpatentable over Wieselblad (US 2016/0287801), and further in view of Liscio (WO 2019/086443) and Hjertman et al (US 5,679,111).
In regards to claim 1, Wieselblad teaches a medication administration device (Figures 1-11) comprising:
a casing (10/50/60/80) having a hollow cylindrical shape (Figure 5)
a syringe comprising:
a barrel (85) housed in the casing (Figure 8) and filled with a medication (paragraph [0002]: medicament is arranged in a container)
a puncture needle in fluid communication with the barrel (paragraph [0036]: the medicament container may have an injection needle) and configured to administer the medication to a living body (paragraph [0002]: a needle… capable of delivering medicament to a patient)
a plunger (20) disposed inside the casing and configured to eject the medication through the puncture needle upon movement of a distal end of the plunger inside the barrel (Figures 3-4)
a cap detachably disposed, and configured to be detached before the puncture needle punctures the puncture target (paragraph [0037]: cap (not shown) may be provided for releasably covering the proximal end of the device, and thereby the proximal end of the medicament container holder 80, when not in use)
wherein: one of an inner peripheral surface of the casing and an outer peripheral surface of the plunger facing the inner peripheral surface includes guide ribs (66) that extend axially and protrude toward the other of the inner peripheral surface of the casing and the outer peripheral surface of the plunger (Figure 7)
the other of the inner peripheral surface of the casing and the outer peripheral surface of the plunger includes guide grooves (25) that extend in a moving direction of the plunger (Figure 7), wherein at least a part of each guide rib is inserted into a respective one of the guide grooves (paragraph [0047]: protrusions 66 fit into the elongated grooves 25)
between each guide rib and each guide groove, a first clearance is formed in a protruding direction of the guide rib and a second clearance is formed in a direction perpendicular to the protruding direction of the guide rib (paragraph [0047] states “protrusions 66 fit into the elongated grooves 25 on the outer surface of the piston plunger 20. This structure provides a rotational lock of the piston plunger 20 but allows a movement of the piston plunger 20 in the longitudinal direction” from which it is understood that there are first and second clearances between each guide rib and each guide groove, otherwise the plunger would not be able to move axially with respect to the casing in the longitudinal direction)
Wieselblad does not teach a needle cover having a hollow cylindrical shape, disposed inside the casing, covering a distal end of the syringe, and configured to be displaced toward a proximal end relative to the casing when the needle cover is pressed against a puncture target, and Wieselblad does not teach the cap detachably disposed at a distal end of the needle cover. Liscio teaches a medication administration device (Figures 2-5B) comprising a needle cover (19/38) having a hollow cylindrical shape, disposed inside a casing (10), covering a distal end of a syringe (18/17), and configured to be displaced toward a proximal end relative to the casing when the needle cover is pressed against a puncture target (Figure 3B), and a cap (12) detachably disposed at a distal end of the needle cover (Figure 3A). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the device, of Wieselblad, to comprise a needle cover with the cap detachably disposed at a distal end of the needle cover, as taught by Liscio, as such a needle cover will lock the needle therewithin to cover the needle after an injection (page 7, lines 1-6) in order to prevent an accidental needlestick to a user of the device with a used needle.
Further, Wieselblad does not teach that the guide ribs are at least three guide ribs, and Wieselblad does not teach that the guide grooves are at least three guide grooves, as Wieselblad instead teaches that the guide ribs are two guide ribs (66), and Wieselblad teaches that the guide grooves are two guide grooves (25). Hjertman et al teaches a medication administration device (Figures 1-5) wherein: one of a casing (7) and an outer peripheral surface of a plunger (12) includes at least three guide ribs (14) that extend axially and protrude toward the other of the casing and the outer peripheral surface of the plunger, and the other of the casing and the outer peripheral surface of the plunger includes at least three guide grooves (13) that extend in a moving direction of the plunger, wherein at least a part of each guide rib is inserted into a respective one of the guide grooves (Figure 4). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the guide ribs and the guide grooves, of the modified device of Wieselblad and Liscio, to be at least three guide ribs and at least three guide grooves, as taught by Hjertman et al, as an obvious matter of design choice, as either two guide ribs and two guide grooves, as taught by Wieselblad, or three guide ribs and three guide grooves, as taught by Hjertman et al, will arrive at the same end result of allowing for guiding of the plunger with respect to the casing in the longitudinal direction.
In regards to claim 2, in the modified device of Wieselblad, Liscio, and Hjertman et al, Wieselblad teaches wherein:
each of the guide ribs has an end along the protruding direction of the guide rib (Figure 7), the end being inserted in the respective guide groove (paragraph [0047]: protrusions 66 fit into the elongated grooves 25)
the end of each guide rib comprises a protruding portion (66) that protrudes in a direction substantially perpendicular to the protruding direction of the guide rib (Figure 7)
In regards to claim 3, in the modified device of Wieselblad, Liscio, and Hjertman et al, Wieselblad does not teach wherein: each protruding portion is gradually tapered in a direction away from the respective guide rib. Hjertman et al teaches wherein: each protruding portion (14) is gradually tapered in a direction away from the respective guide rib (Figures 4-5). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify each protruding portion, of the modified device of Wieselblad, Liscio, and Hjertman et al, to be gradually tapered in a direction away from the respective guide rib, as taught by Hjertman et al, as such will by their wedge action, exert considerable pressure against the walls of the grooves to securely but releasably lock the plunger and prevent any longitudinal movement thereof (Abstract)(column 5, lines 1-7).
In regards to claim 4, in the modified device of Wieselblad, Liscio, and Hjertman et al, Wieselblad teaches wherein: the guide ribs are disposed at regular intervals in a circumferential direction of the plunger (Figure 7)(paragraph [0047]: protrusions 66 fit into the elongated grooves 25).
In regards to claim 5, Wieselblad teaches a medication administration device (Figures 1-11) comprising:
a casing (10/50/60/80) having a hollow cylindrical shape (Figure 5)
a syringe comprising:
a barrel (85) housed in the casing (Figure 8) and filled with a medication (paragraph [0002]: medicament is arranged in a container)
a puncture needle in fluid communication with the barrel (paragraph [0036]: the medicament container may have an injection needle) and configured to administer the medication to a living body (paragraph [0002]: a needle… capable of delivering medicament to a patient)
a plunger (20) disposed inside the casing and configured to eject the medication through the puncture needle upon movement of a distal end of the plunger inside the barrel (Figures 3-4)
a cap detachably disposed, and configured to be detached before the puncture needle punctures the puncture target (paragraph [0037]: cap (not shown) may be provided for releasably covering the proximal end of the device, and thereby the proximal end of the medicament container holder 80, when not in use)
wherein an inner peripheral surface of the casing includes guide ribs (66) that extend axially and protrude toward an outer peripheral surface of the plunger that faces the inner peripheral surface of the casing (Figure 7)
the outer peripheral surface of the plunger includes guide grooves (25) that extend in a moving direction of the plunger (Figure 7), wherein at least a part of each guide rib is inserted into a respective one of the guide grooves (paragraph [0047]: protrusions 66 fit into the elongated grooves 25)
between each guide rib and each guide groove, a first clearance is formed in a protruding direction of the guide rib and a second clearance is formed in a direction perpendicular to the protruding direction of the guide rib (paragraph [0047] states “protrusions 66 fit into the elongated grooves 25 on the outer surface of the piston plunger 20. This structure provides a rotational lock of the piston plunger 20 but allows a movement of the piston plunger 20 in the longitudinal direction” from which it is understood that there are first and second clearances between each guide rib and each guide groove, otherwise the plunger would not be able to move axially with respect to the casing in the longitudinal direction)
Wieselblad does not teach a needle cover having a hollow cylindrical shape, disposed inside the casing, covering a distal end of the syringe, and configured to be displaced toward a proximal end relative to the casing when the needle cover is pressed against a puncture target, and Wieselblad does not teach the cap detachably disposed at a distal end of the needle cover. Liscio teaches a medication administration device (Figures 2-5B) comprising a needle cover (19/38) having a hollow cylindrical shape, disposed inside a casing (10), covering a distal end of a syringe (18/17), and configured to be displaced toward a proximal end relative to the casing when the needle cover is pressed against a puncture target (Figure 3B), and a cap (12) detachably disposed at a distal end of the needle cover (Figure 3A). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the device, of Wieselblad, to comprise a needle cover with the cap detachably disposed at a distal end of the needle cover, as taught by Liscio, as such a needle cover will lock the needle therewithin to cover the needle after an injection (page 7, lines 1-6) in order to prevent an accidental needlestick to a user of the device with a used needle.
Further, Wieselblad does not teach that the guide ribs are at least three guide ribs, and Wieselblad does not teach that the guide grooves are at least three guide grooves, as Wieselblad instead teaches that the guide ribs are two guide ribs (66), and Wieselblad teaches that the guide grooves are two guide grooves (25). Hjertman et al teaches a medication administration device (Figures 1-5) wherein: a casing (7) includes at least three guide ribs (14) that extend axially and protrude toward an outer peripheral surface of a plunger (12) that faces the inner peripheral surface of the casing, and the outer peripheral surface of the plunger includes at least three guide grooves (13) that extend in a moving direction of the plunger, wherein at least a part of each guide rib is inserted into a respective one of the guide grooves (Figure 4). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the guide ribs and the guide grooves, of the modified device of Wieselblad and Liscio, to be at least three guide ribs and at least three guide grooves, as taught by Hjertman et al, as an obvious matter of design choice, as either two guide ribs and two guide grooves, as taught by Wieselblad, or three guide ribs and three guide grooves, as taught by Hjertman et al, will arrive at the same end result of allowing for guiding of the plunger with respect to the casing in the longitudinal direction.
In regards to claim 6, in the modified device of Wieselblad, Liscio, and Hjertman et al, Wieselblad teaches wherein:
each of the guide ribs has an end along the protruding direction of the guide rib (Figure 7), the end being inserted in the respective guide groove (paragraph [0047]: protrusions 66 fit into the elongated grooves 25)
the end of each guide rib comprises a protruding portion (66) that protrudes in a direction substantially perpendicular to the protruding direction of the guide rib (Figure 7)
In regards to claim 7, in the modified device of Wieselblad, Liscio, and Hjertman et al, Wieselblad does not teach wherein: each protruding portion is gradually tapered in a direction away from the respective guide rib. Hjertman et al teaches wherein: each protruding portion (14) is gradually tapered in a direction away from the respective guide rib (Figures 4-5). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify each protruding portion, of the modified device of Wieselblad, Liscio, and Hjertman et al, to be gradually tapered in a direction away from the respective guide rib, as taught by Hjertman et al, as such will by their wedge action, exert considerable pressure against the walls of the grooves to securely but releasably lock the plunger and prevent any longitudinal movement thereof (Abstract)(column 5, lines 1-7).
In regards to claim 8, in the modified device of Wieselblad, Liscio, and Hjertman et al, Wieselblad teaches wherein: the guide ribs are disposed at regular intervals in a circumferential direction of the plunger (Figure 7)(paragraph [0047]: protrusions 66 fit into the elongated grooves 25).
In regards to claim 9, Wieselblad teaches a medication administration device (Figures 1-11) comprising:
a casing (10/50/60/80) having a hollow cylindrical shape (Figure 5)
a syringe comprising:
a barrel (85) housed in the casing (Figure 8) and filled with a medication (paragraph [0002]: medicament is arranged in a container)
a puncture needle in fluid communication with the barrel (paragraph [0036]: the medicament container may have an injection needle) and configured to administer the medication to a living body (paragraph [0002]: a needle… capable of delivering medicament to a patient)
a plunger (20) disposed inside the casing and configured to eject the medication through the puncture needle upon movement of a distal end of the plunger inside the barrel (Figures 3-4)
a cap detachably disposed, and configured to be detached before the puncture needle punctures the puncture target (paragraph [0037]: cap (not shown) may be provided for releasably covering the proximal end of the device, and thereby the proximal end of the medicament container holder 80, when not in use)
between each guide rib (66) and each guide groove (25), a first clearance is formed in a protruding direction of the guide rib and a second clearance is formed in a direction perpendicular to the protruding direction of the guide rib (paragraph [0047] states “protrusions 66 fit into the elongated grooves 25 on the outer surface of the piston plunger 20. This structure provides a rotational lock of the piston plunger 20 but allows a movement of the piston plunger 20 in the longitudinal direction” from which it is understood that there are first and second clearances between each guide rib and each guide groove, otherwise the plunger would not be able to move axially with respect to the casing in the longitudinal direction)
Wieselblad does not teach a needle cover having a hollow cylindrical shape, disposed inside the casing, covering a distal end of the syringe, and configured to be displaced toward a proximal end relative to the casing when the needle cover is pressed against a puncture target, and Wieselblad does not teach the cap detachably disposed at a distal end of the needle cover. Liscio teaches a medication administration device (Figures 2-5B) comprising a needle cover (19/38) having a hollow cylindrical shape, disposed inside a casing (10), covering a distal end of a syringe (18/17), and configured to be displaced toward a proximal end relative to the casing when the needle cover is pressed against a puncture target (Figure 3B), and a cap (12) detachably disposed at a distal end of the needle cover (Figure 3A). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the device, of Wieselblad, to comprise a needle cover with the cap detachably disposed at a distal end of the needle cover, as taught by Liscio, as such a needle cover will lock the needle therewithin to cover the needle after an injection (page 7, lines 1-6) in order to prevent an accidental needlestick to a user of the device with a used needle.
Further, Wieselblad does not teach wherein: an outer peripheral surface of the plunger includes at least three guide ribs that extend axially and protrude toward an the inner peripheral surface of the casing that faces the outer peripheral surface of the plunger; the inner peripheral surface of the casing includes at least three guide grooves that extend in a moving direction of the plunger, wherein at least a part of each guide rib is inserted into a respective one of the guide grooves, as Wieselblad instead teaches wherein: an inner peripheral surface of the casing includes two guide ribs (66) that extend axially and protrude toward an outer peripheral surface of the plunger that faces the inner peripheral surface of the casing (Figure 7), and the outer peripheral surface of the plunger includes two guide grooves (25) that extend in a moving direction of the plunger (Figure 7), wherein at least a part of each guide rib is inserted into a respective one of the guide grooves (paragraph [0047]: protrusions 66 fit into the elongated grooves 25). But before the effective filing date of the claimed invention, it would have been an obvious matter of design choice to a person having ordinary skill in the art to modify the outer peripheral surface of the plunger and the inner peripheral surface of the casing, of the modified device of Wieselblad and Liscio, to have guide ribs and guide grooves, respectively, as Applicant has not disclosed that such a configuration of the plunger and the casing provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected Applicant’s invention to perform equally well with the inner peripheral surface of the casing including two guide ribs and the outer peripheral surface of the plunger including two guide grooves, as taught by Wieselblad, as person having ordinary skill in the art would have realized that either configuration of the guide ribs and the guide grooves between the plunger and the casing would arrive at the same end result of allowing for guiding of the plunger with respect to the casing in the longitudinal direction.
However, Wieselblad does not teach that the guide ribs are at least three guide ribs, and Wieselblad does not teach that the guide grooves are at least three guide grooves, as Wieselblad instead teaches that the guide ribs are two guide ribs (66), and Wieselblad teaches that the guide grooves are two guide grooves (25). Hjertman et al teaches a medication administration device (Figures 1-5) comprising at least three guide ribs (14) and at least three guide grooves (13) (Figure 4). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the guide ribs and the guide grooves, of the modified device of Wieselblad and Liscio, to be at least three guide ribs and at least three guide grooves, as taught by Hjertman et al, as an obvious matter of design choice, as either two guide ribs and two guide grooves, as taught by Wieselblad, or three guide ribs and three guide grooves, as taught by Hjertman et al, will arrive at the same end result of allowing for guiding of the plunger with respect to the casing in the longitudinal direction.
In regards to claim 10, in the modified device of Wieselblad, Liscio, and Hjertman et al, Wieselblad teaches wherein:
each of the guide ribs has an end along the protruding direction of the guide rib (Figure 7), the end being inserted in the respective guide groove (paragraph [0047]: protrusions 66 fit into the elongated grooves 25)
the end of each guide rib comprises a protruding portion (66) that protrudes in a direction substantially perpendicular to the protruding direction of the guide rib (Figure 7)
In regards to claim 11, in the modified device of Wieselblad, Liscio, and Hjertman et al, Wieselblad does not teach wherein: each protruding portion is gradually tapered in a direction away from the respective guide rib. Hjertman et al teaches wherein: each protruding portion (14) is gradually tapered in a direction away from the respective guide rib (Figures 4-5). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify each protruding portion, of the modified device of Wieselblad, Liscio, and Hjertman et al, to be gradually tapered in a direction away from the respective guide rib, as taught by Hjertman et al, as such will by their wedge action, exert considerable pressure against the walls of the grooves to securely but releasably lock the plunger and prevent any longitudinal movement thereof (Abstract)(column 5, lines 1-7).
In regards to claim 12, in the modified device of Wieselblad, Liscio, and Hjertman et al, Wieselblad teaches wherein: the guide ribs are disposed at regular intervals in a circumferential direction of the plunger (Figure 7)(paragraph [0047]: protrusions 66 fit into the elongated grooves 25).
Conclusion
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/SHEFALI D PATEL/Primary Examiner, Art Unit 3783