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 .
Priority
Acknowledgment is made of applicant's claim for foreign priority based on an application filed in Japan on 02/15/2022. It is noted, however, that applicant has not filed a certified copy of the 2022-021484 application as required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 08/07/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The extensive number of drawings have not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the drawings.
The drawings are objected to because in many of the drawings, parts of the drawings have been labeled with multiple reference numbers, listed as A (B), with A being one reference number and B being another. It is confusing to the examiner because it appears as though there are different reference numbers for the same part, but then the specification identifies the reference numbers as different parts. The examiner suggests providing only one reference number for each labeled part. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
The disclosure is objected to because of the following informalities:
Paragraph [0014] states “The sleeve body 22 includes a body main structure 30 has a cylindrical shape…”. The examiner suggests modifying the specification to state “The sleeve body 22 includes a body main structure 30 that has a cylindrical shape…” to correct the grammar error. Appropriate correction is required.
Regarding the paragraph numbers throughout the entire specification, per 37 CFR § 1.52(b)(6), “The numbers and enclosing brackets should appear to the right of the left margin as the first item in each paragraph, before the first word of the paragraph, and should be highlighted in bold.”. The examiner suggests correcting the specification to properly format the paragraph numbers before the first word of a paragraph, instead of above the first word. Appropriate correction is required.
Claim Objections
Claims 8 and 9 are objected to because of the following informalities: Both the claims state “the projection protrudes toward both sides of the extending portion in a width direction perpendicular to a direction of extension of the extending portion”. The examiner is unclear by what the applicant is intending to claim using this verbiage. The specification and FIG. 13 give some context to what is meant by “width direction”, but the manner in which the claim is written is not clear and concise, which could lead to indefiniteness. For the purposes of examination, the examiner will interpret this specific line from each claim to mean the projection of the second connection expands outward as opposed to the direction of extension of the extending portion. Appropriate correction is required.
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 4 and 5 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 4 and 5, the claims state “the second connection comprises a projection protruding in a direction perpendicular to the axial direction of the casing”. Based on the provided drawings and specification, it is confusing to the examiner how the projection of the second connection is perpendicular to the axial direction. Using FIG. 8 and FIG. 13 as guidance, as well as the specification, it appears that the projection of the second connection (123b) is parallel to the axial direction (direction of arrows A to B). If the projection was perpendicular, there were be a point at which a right angle is formed. This contradiction renders the claim indefinite as it is unclear what the applicant is trying to claim in the limitation. For the purposes of examination, the examiner will interpret the claim as depicted by the drawings, and therefore a parallel arrangement may be acceptable.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-5 are rejected under 35 U.S.C. 103 as being unpatentable over Iwasa et al. (WO 2019/156201 A1; herein, Iwasa), and further in view of André et al. (United States Patent Application Publication No. US 2020/0129696 A1; herein, André).
Regarding claim 1, Iwasa discloses a medicinal solution administration device (drug solution injection device 120) comprising:
a casing (device main body 14) having a hollow cylindrical shape ("the apparatus main body 14 that has a substantially cylindrical shape as a whole");
a syringe (prefilled syringe 124) comprising a cylinder that is housed in the casing (syringe barrel 126) and filled with a medicinal solution ("The medical solution can be stored in the prefilled syringe 124"), and a puncture needle (hollow needle 122) that communicates with the cylinder (FIG. 23, "needle hub 130 to which the hollow needle 122 is fixed is integrally formed at the distal end portion of the syringe barrel 126") and is configured to administer the medicinal solution to a living body ("The medicinal solution contained in 124 is injected into the blood vessel of the patient.");
a needle cover (needle tip cover 16) having a hollow cylindrical shape (FIG. 23, "The needle tip cover 16 has a substantially cylindrical shape as a whole"), wherein the needle cover is disposed inside the casing (FIG. 23, "The outer diameter of the peripheral wall 58 is substantially equal to or slightly smaller than the inner diameter of the outer peripheral wall portion 32 of the apparatus main body 14." The OD of 58 being smaller than the ID of 32 allows the device main body 14 to house the needle tip cover 16.) and covering a distal side of the syringe (FIG. 23, "The tip 22 is protected by a needle tip cover 16 that protrudes from the apparatus main body 14 toward the distal end side."), and is configured to be displaced in a proximal direction relative to the casing when pressed against a puncture target (FIG. 23 to FIG. 24, "the distal end side of the chemical solution injector 10 in such a state is pressed against the patient's skin. Accordingly,...the needle tip cover 16 is pushed into the inside of the apparatus main body 14");
a cap (cap 114) that is detachably disposed on a distal end of the needle cover and configured to be detached before the puncture target is punctured with the puncture needle ("Then, by removing the cap 114 from such a state, the medicinal solution injection device 10 is brought into the state before the puncture");
a drive unit (pusher member 132 and parts along the path the pusher member 132 travels from FIG. 23 to FIG. 25), wherein the drive unit comprises:
a locking mechanism (lock fixing mechanism 112) that blocks the plunger from moving in a distal direction in an initial state (FIG. 23, " the push fixing member [132] cannot be pushed into the device main body 14 by the lock fixing mechanism 112") and allows the plunger to move in the distal direction along with the movement of the needle cover in the proximal direction ("the lock by the lock fixing mechanism 112 is released by rotating the pusher member [132] by 45 degrees in the circumferential direction with respect to the apparatus main body 14");
a movement restricting mechanism (cap locking portion 42) that restricts the movement of the needle cover in the proximal direction relative to the casing when the cap is attached to the casing ("In such a state [when the cap 114 is secured on the cap locking portion 42], the needle tip cover 16 is not in contact with the cap 114 or is zero-touched so that an external force from the cap 114 is not exerted on the needle tip cover 16. That is, the needle tip cover 16 is prevented from unintentionally moving to the proximal end side with respect to the apparatus main body 14", the needle tip cover 16 is restricted from moving because pressure cannot be applied when covered by cap 114) and allows the movement of the needle cover in the proximal direction when the cap is detached from the casing ("Then, by removing the cap 114 from such a state, the medicinal solution injection device 10 is brought into the state before the puncture", when the cap 114 is not connected to the cap locking portion 42, the needle tip cover has freedom to move into puncture position); and
a coupling mechanism that couples a proximal end of the needle cover and the drive unit to each other in an axial direction of the casing (FIG. 25, "the restricting protrusion 70 and the inclined portion 94 come into contact with each other. Thus, the movement of the needle tip cover 16 toward the base end side with respect to the apparatus main body 14 is restricted or prevented.").
Iwasa does not disclose a drive unit that is housed on a proximal side of the casing, wherein the drive unit is configured to bias a gasket of the syringe toward a distal end of the casing by a plunger along with movement of the needle cover in the proximal direction.
However, André teaches a drive unit (transport assembly 1) that is housed on a proximal side of the casing (Fig. 8), wherein the drive unit is configured to bias a gasket of the syringe toward a distal end of the casing by a plunger along with movement of the needle cover in the proximal direction (Fig. 10c, [0068], "The plunger rod 9 has in particular been moved"). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the drive unit of the device disclosed by Iwasa with the automated drive unit taught by André in order to reduce the risk of accidental firing off of a biased component ([0043]).
Regarding claim 2, in the modified device of Iwasa, Iwasa discloses the coupling mechanism comprises: a first connection disposed in the drive unit (FIG. 24, inclined portion 94 of the arm portion 92), and a second connection disposed on the proximal end of the needle cover (FIG. 24, restricting protrusion 70) and coupled to the first connection (FIG. 25, "the restricting protrusion 70 and the inclined portion 94 come into contact with each other.”).
Regarding claim 3, in the modified device of Iwasa, Iwasa does not disclose the drive unit comprises: a sliding member movable along the axial direction of the casing, and an elastic member that biases the sliding member toward the syringe; and the first connection is disposed on the sliding member. However, André teaches the drive unit (transport assembly 1) comprises: a sliding member movable along the axial direction of the casing (transport securing sleeve 3), and an elastic member (second resilient member 8) that biases the sliding member toward the syringe ([0050], "The transport securing sleeve 3 is thus biased in the proximal direction by the second resilient member 8."); and the first connection is disposed on the sliding member (recess or opening 3e). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the drive unit disclosed by modified Iwasa to include a sliding member and elastic member as taught by André in order that a medicinal solution be expelled in a controlled manner during a medicament administration mode ([0045]).
Regarding claim 4, in the modified device of Iwasa, Iwasa discloses the second connection comprises a projection protruding in a direction perpendicular to the axial direction of the casing (FIG. 23, restricting protrusion 70 projects perpendicular (vertical) to the axial direction (horizontal)), and the first connection comprises a flexible arm portion (inclined portion 94 is part of the arm portion 92) engaged with the projection (FIG. 25, "the restricting protrusion 70 and the inclined portion 94 come into contact with each other.”) and elastically deformable by contact with the projection ("the tip of the inclined portion 94 of the arm portion 92 elastically deformed", the inclined portion 94 has the ability to elastically deform if need be).
Regarding claim 5, in the modified device of Iwasa, Iwasa discloses the second connection comprises a projection protruding in a direction perpendicular to the axial direction of the casing (FIG. 23, restricting protrusion 70 projects perpendicular (vertical) to the axial direction (horizontal)), and the first connection comprises a flexible arm portion (inclined portion 94 is part of the arm portion 92) engaged with the projection (FIG. 25, "the restricting protrusion 70 and the inclined portion 94 come into contact with each other.”) and elastically deformable by contact with the projection ("the tip of the inclined portion 94 of the arm portion 92 elastically deformed", the inclined portion 94 has the ability to elastically deform if need be).
Claims 6 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Iwasa in view of André as applied to claims 2 and 3 above, and further in view of Kokane et al. (WO 2018/154452 A1; herein, Kokane).
Regarding claim 6, in the modified device of Iwasa, Iwasa discloses the first connection comprises a protrusion protruding toward the second connection (inclined portion 94 is part of the arm portion 92 protrudes outward from the outer wall and toward the location of the restricting protrusion 70). Iwasa does not disclose the second connection comprises a hole opened in a direction perpendicular to the axial direction of the casing, and the first connection engaged with the hole.
However, Kokane teaches the second connection comprises a hole opened in a direction perpendicular to the axial direction of the casing (FIGURE 6, groove 43 of cam profile 13), and the first connection engaged with the hole (FIGURE 5, “ In response to the proximal force, the cam follower 14 moves proximally in the cam profile 13.”). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the first and second connections disclosed by modified Iwasa so that the second connection comprises a hole and the first connection is engaged with the hole as taught by Kokane in order that the needle cover be supported as it travels in a linear or translational movement (Abstract).
Regarding claim 7, in the modified device of Iwasa, Iwasa discloses the first connection comprises a protrusion protruding toward the second connection (inclined portion 94 is part of the arm portion 92 protrudes outward from the outer wall and toward the location of the restricting protrusion 70). Iwasa does not disclose the second connection comprises a hole opened in a direction perpendicular to the axial direction of the casing, and the first connection engaged with the hole.
However, Kokane teaches the second connection comprises a hole opened in a direction perpendicular to the axial direction of the casing (FIGURE 6, groove 43 of cam profile 13), and the first connection engaged with the hole (FIGURE 5, “ In response to the proximal force, the cam follower 14 moves proximally in the cam profile 13.”). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the first and second connections disclosed by modified Iwasa so that the second connection comprises a hole and the first connection is engaged with the hole as taught by Kokane in order that the needle cover be supported as it travels in a linear or translational movement (Abstract).
Claims 8 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Iwasa in view of André as applied to claims 4 and 5 above, and further in view of Young et al. (United States Patent Application Publication No. US 2006/0030819 A1; herein, Young).
Regarding claim 8, in the modified device of Iwasa, Iwasa does not disclose the proximal end of the needle cover comprises an extending portion protruding proximally; the projection of the second connection is disposed on a proximal end of the extending portion; and the projection protrudes toward both sides of the extending portion in a width direction perpendicular to a direction of extension of the extending portion.
However, Young teaches the proximal end of the needle cover comprises an extending portion protruding proximally (Annotated on FIG. 9 below, needle cover 150 extends from distal end to a proximal position); the projection of the second connection is disposed on a proximal end of the extending portion (Annotated of FIG. 10 below); and the projection protrudes toward both sides of the extending portion in a width direction perpendicular to a direction of extension of the extending portion (FIG. 54, going from distal to proximal needle cover 150 tapers at opening 154 before extending outward again at proximal end). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the needle cover disclosed by modified Iwasa to include an extending portion with the projection of the second connector at the proximal end of the extending portion as taught by Young in order to prevent the needle cover from being reinserted into outer body ([0113]), keeping the used puncture needle concealed (FIG. 9).
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Regarding claim 9, in the modified device of Iwasa, Iwasa does not disclose the proximal end of the needle cover comprises an extending portion protruding proximally; the projection of the second connection is disposed on a proximal end of the extending portion; and the projection protrudes toward both sides of the extending portion in a width direction perpendicular to a direction of extension of the extending portion.
However, Young teaches the proximal end of the needle cover comprises an extending portion protruding proximally (Annotated on FIG. 9 above, needle cover 150 extends from distal end to a proximal position); the projection of the second connection is disposed on a proximal end of the extending portion (Annotated of FIG. 10 above); and the projection protrudes toward both sides of the extending portion in a width direction perpendicular to a direction of extension of the extending portion (FIG. 54, going from distal to proximal needle cover 150 tapers at opening 154 before extending outward again at proximal end). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the needle cover disclosed by modified Iwasa to include an extending portion with the projection of the second connector at the proximal end of the extending portion as taught by Young in order to prevent the needle cover from being reinserted into outer body ([0113]), keeping the used puncture needle concealed (FIG. 9).
Claims 10 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Iwasa in view of André as applied to claim 3 above, and further in view of Appy et al. (WO 2019/224784 A1; herein, Appy).
Regarding claim 10, in the modified device of Iwasa, Iwasa does not disclose the sliding member has a proximal end comprises a cylindrical portion whose distal end comprises the first connection; and the second connection comprises first and second flexible arm portions separated from each other along a circumferential direction of the cylindrical portion, the first and second flexible arm portions having a cantilever structure in which distal ends of the first and second flexible arm portions are connected to the distal end of the cylindrical portion, the first and second flexible arm portions being inclined from the distal ends toward proximal ends of the flexible arm portions, and the first flexible arm portion and the second flexible arm portion approaching each other toward the proximal ends.
However, André teaches the sliding member has a proximal end comprises a cylindrical portion whose distal end comprises the first connection (Fig. 3, cylindrical transport securing sleeve 3). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the drive unit disclosed by modified Iwasa to include a cylindrical sliding member comprising the first connection as taught by André in order that the sliding member fit within tubular housing and be engageable with tubular elements ([0009]).
Iwasa in view of André still does not disclose the second connection comprises first and second flexible arm portions separated from each other along a circumferential direction of the cylindrical portion, the first and second flexible arm portions having a cantilever structure in which distal ends of the first and second flexible arm portions are connected to the distal end of the cylindrical portion, the first and second flexible arm portions being inclined from the distal ends toward proximal ends of the flexible arm portions, and the first flexible arm portion and the second flexible arm portion approaching each other toward the proximal ends. However, teaches the second connection comprises first and second flexible arm portions separated from each other along a circumferential direction of the cylindrical portion (Fig. 14, longitudinal arms 152, 154 maintain cylindrical shape), the first and second flexible arm portions having a cantilever structure in which distal ends of the first and second flexible arm portions are connected to the distal end of the cylindrical portion (Fig. 14, longitudinal arms 152, 154 have both projection 174 and through hole 176 for connecting with other components), the first and second flexible arm portions being inclined from the distal ends toward proximal ends of the flexible arm portions (“a second transition 170 between the first longitudinal arm portion 168 and a second longitudinal arm portion 172 forms a second inclined shoulder”). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the second connection disclosed by modified Iwasa to include flexible inclined arms that connect to the first connection as taught by Appy in order to permanently cover the puncture needle during the retraction process (pg. 62 lines 24-30).
Iwasa in view of André and the primary embodiment of Appy still does not disclose the first flexible arm portion and the second flexible arm portion approaching each other toward the proximal ends. However, in another embodiment of Appy, Appy teaches the first flexible arm portion and the second flexible arm portion approaching each other toward the proximal ends (Fig. 38, flexible longitudinal arms 446 are slightly inclined radially inwards). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the second connection disclosed by modified Iwasa to include flexible inclined arms that approach each other at an end as taught by Appy in order to increase flexibility and improve retention.
Regarding claim 11, in the modified device of Iwasa, Iwasa does not disclose the needle cover comprises a rib protruding in a direction opposite to the casing and locked by a distal end of the sliding member. However, Appy teaches the needle cover comprises a rib protruding in a direction opposite to the casing and locked by a distal end of the sliding member (Fig. 14 and Fig. 15, inner guiding profile 178 is ribbed and made to connect with projections 372 of projection plates 368, 370). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the needle cover disclosed by modified Iwasa to include a rib for locking into the sliding member as taught by Appy in order to facilitate the assembling process of moving the device from one state to the next (pg. 18 lines 27-32).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Iwasa, and further in view of André and Young.
Regarding claim 12, Iwasa discloses a medicinal solution administration device (drug solution injection device 120) comprising:
a casing (device main body 14) having a hollow cylindrical shape ("the apparatus main body 14 that has a substantially cylindrical shape as a whole");
a syringe (prefilled syringe 124) comprising a cylinder that is housed in the casing (syringe barrel 126) and filled with a medicinal solution ("The medical solution can be stored in the prefilled syringe 124"), and a puncture needle (hollow needle 122) that communicates with the cylinder (FIG. 23, "needle hub 130 to which the hollow needle 122 is fixed is integrally formed at the distal end portion of the syringe barrel 126") and is configured to administer the medicinal solution to a living body ("The medicinal solution contained in 124 is injected into the blood vessel of the patient.");
a needle cover (needle tip cover 16) having a hollow cylindrical shape (FIG. 23, "The needle tip cover 16 has a substantially cylindrical shape as a whole"), wherein the needle cover is disposed inside the casing (FIG. 23, "The outer diameter of the peripheral wall 58 is substantially equal to or slightly smaller than the inner diameter of the outer peripheral wall portion 32 of the apparatus main body 14." The OD of 58 being smaller than the ID of 32 allows the device main body 14 to house the needle tip cover 16.) and covering a distal side of the syringe (FIG. 23, "The tip 22 is protected by a needle tip cover 16 that protrudes from the apparatus main body 14 toward the distal end side."), and is configured to be displaced in a proximal direction relative to the casing when pressed against a puncture target (FIG. 23 to FIG. 24, "the distal end side of the chemical solution injector 10 in such a state is pressed against the patient's skin. Accordingly,...the needle tip cover 16 is pushed into the inside of the apparatus main body 14");
a cap (cap 114) that is detachably disposed on a distal end of the needle cover and configured to be detached before the puncture target is punctured with the puncture needle ("Then, by removing the cap 114 from such a state, the medicinal solution injection device 10 is brought into the state before the puncture");
a drive unit (pusher member 132 and parts along the path the pusher member 132 travels from FIG. 23 to FIG. 25), wherein the drive unit comprises:
a locking pin (lock fixing mechanism 112) that blocks the plunger from moving in a distal direction in an initial state (FIG. 23, " the push fixing member [132] cannot be pushed into the device main body 14 by the lock fixing mechanism 112") and allows the plunger to move in the distal direction along with the movement of the needle cover in the proximal direction ("the lock by the lock fixing mechanism 112 is released by rotating the pusher member [132] by 45 degrees in the circumferential direction with respect to the apparatus main body 14");
the cap comprises a plurality of retaining arms (the cap locking portion 42 contacts the inner peripheral surface of the cylindrical wall portion 115b of the cap 114, cylindrical wall portion 115b act as retaining arms formed in a cylindrical manner) that restrict the movement of the needle cover in the proximal direction relative to the casing when the cap is attached to the casing ("In such a state [when the cap 114 is secured on the cap locking portion 42], the needle tip cover 16 is not in contact with the cap 114 or is zero-touched so that an external force from the cap 114 is not exerted on the needle tip cover 16. That is, the needle tip cover 16 is prevented from unintentionally moving to the proximal end side with respect to the apparatus main body 14", the needle tip cover 16 is restricted from moving because pressure cannot be applied when covered by cap 114) and allow the movement of the needle cover in the proximal direction when the cap is detached from the casing ("Then, by removing the cap 114 from such a state, the medicinal solution injection device 10 is brought into the state before the puncture", when the cap 114 is not connected to the cap locking portion 42, the needle tip cover has freedom to move into puncture position); and
the medicinal solution administration device further comprises a coupling mechanism that couples a proximal end of the needle cover and the drive unit to each other in an axial direction of the casing (FIG. 25, "the restricting protrusion 70 and the inclined portion 94 come into contact with each other. Thus, the movement of the needle tip cover 16 toward the base end side with respect to the apparatus main body 14 is restricted or prevented."), wherein the coupling mechanism comprises:
a first connection (FIG. 24, inclined portion 94 of the arm portion 92), and a second connection disposed on the proximal end of the needle cover (FIG. 24, restricting protrusion 70) and coupled to the first connection (FIG. 25, "the restricting protrusion 70 and the inclined portion 94 come into contact with each other.”), wherein:
the second connection comprises a projection protruding in a direction perpendicular to the axial direction of the casing (FIG. 23, restricting protrusion 70 projects perpendicular (vertical) to the axial direction (horizontal)), and the first connection comprises a flexible arm portion (inclined portion 94 is part of the arm portion 92) engaged with the projection (FIG. 25, "the restricting protrusion 70 and the inclined portion 94 come into contact with each other.”) and elastically deformable by contact with the projection ("the tip of the inclined portion 94 of the arm portion 92 elastically deformed", the inclined portion 94 has the ability to elastically deform if need be).
Iwasa does not disclose a drive unit that is housed on a proximal side of the casing, wherein the drive unit is configured to bias a gasket of the syringe toward a distal end of the casing by a plunger along with movement of the needle cover in the proximal direction, a sliding member movable along the axial direction of the casing, and an elastic member that biases the sliding member toward the syringe, the locking pin comprising a cylindrical pin main structure, the first connection disposed on the sliding member.
However, André teaches a drive unit (transport assembly 1) that is housed on a proximal side of the casing (Fig. 8), wherein the drive unit is configured to bias a gasket of the syringe toward a distal end of the casing by a plunger along with movement of the needle cover in the proximal direction (Fig. 10c, [0068], "The plunger rod 9 has in particular been moved"), a sliding member movable along the axial direction of the casing (transport securing sleeve 3), and an elastic member (second resilient member 8) that biases the sliding member toward the syringe ([0050], "The transport securing sleeve 3 is thus biased in the proximal direction by the second resilient member 8."), and the first connection is disposed on the sliding member (recess or opening 3e). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the drive unit of the device disclosed by Iwasa with the automated drive unit taught by André in order to reduce the risk of accidental firing off of a biased component ([0043]). Further, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the drive unit disclosed by Iwasa to include a sliding member and elastic member as taught by André in order that a medicinal solution be expelled in a controlled manner during a medicament administration mode ([0045]).
Iwasa in view of André still does not disclose the locking pin comprising a cylindrical pin main structure. However, Young teaches the locking pin comprising a cylindrical pin main structure (release pin 120 includes a downwardly extending pin 125). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the locking pin disclosed by Iwasa to be of a cylindrical structure as taught by Young in order to prevent actuation of the auto-injector ([0082]) by securing all sides of the device.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Iwasa, and further in view of André, Young, and Kokane.
Regarding claim 13, Iwasa discloses a medicinal solution administration device (drug solution injection device 120) comprising:
a casing (device main body 14) having a hollow cylindrical shape ("the apparatus main body 14 that has a substantially cylindrical shape as a whole");
a syringe (prefilled syringe 124) comprising a cylinder that is housed in the casing (syringe barrel 126) and filled with a medicinal solution ("The medical solution can be stored in the prefilled syringe 124"), and a puncture needle (hollow needle 122) that communicates with the cylinder (FIG. 23, "needle hub 130 to which the hollow needle 122 is fixed is integrally formed at the distal end portion of the syringe barrel 126") and is configured to administer the medicinal solution to a living body ("The medicinal solution contained in 124 is injected into the blood vessel of the patient.");
a needle cover (needle tip cover 16) having a hollow cylindrical shape (FIG. 23, "The needle tip cover 16 has a substantially cylindrical shape as a whole"), wherein the needle cover is disposed inside the casing (FIG. 23, "The outer diameter of the peripheral wall 58 is substantially equal to or slightly smaller than the inner diameter of the outer peripheral wall portion 32 of the apparatus main body 14." The OD of 58 being smaller than the ID of 32 allows the device main body 14 to house the needle tip cover 16.) and covering a distal side of the syringe (FIG. 23, "The tip 22 is protected by a needle tip cover 16 that protrudes from the apparatus main body 14 toward the distal end side."), and is configured to be displaced in a proximal direction relative to the casing when pressed against a puncture target (FIG. 23 to FIG. 24, "the distal end side of the chemical solution injector 10 in such a state is pressed against the patient's skin. Accordingly,...the needle tip cover 16 is pushed into the inside of the apparatus main body 14");
a cap (cap 114) that is detachably disposed on a distal end of the needle cover and configured to be detached before the puncture target is punctured with the puncture needle ("Then, by removing the cap 114 from such a state, the medicinal solution injection device 10 is brought into the state before the puncture");
a drive unit (pusher member 132 and parts along the path the pusher member 132 travels from FIG. 23 to FIG. 25), wherein the drive unit comprises:
a locking pin (lock fixing mechanism 112) that blocks the plunger from moving in a distal direction in an initial state (FIG. 23, " the push fixing member [132] cannot be pushed into the device main body 14 by the lock fixing mechanism 112") and allows the plunger to move in the distal direction along with the movement of the needle cover in the proximal direction ("the lock by the lock fixing mechanism 112 is released by rotating the pusher member [132] by 45 degrees in the circumferential direction with respect to the apparatus main body 14");
the cap comprises a plurality of retaining arms (the cap locking portion 42 contacts the inner peripheral surface of the cylindrical wall portion 115b of the cap 114, cylindrical wall portion 115b act as retaining arms formed in a cylindrical manner) that restrict the movement of the needle cover in the proximal direction relative to the casing when the cap is attached to the casing ("In such a state [when the cap 114 is secured on the cap locking portion 42], the needle tip cover 16 is not in contact with the cap 114 or is zero-touched so that an external force from the cap 114 is not exerted on the needle tip cover 16. That is, the needle tip cover 16 is prevented from unintentionally moving to the proximal end side with respect to the apparatus main body 14", the needle tip cover 16 is restricted from moving because pressure cannot be applied when covered by cap 114) and allow the movement of the needle cover in the proximal direction when the cap is detached from the casing ("Then, by removing the cap 114 from such a state, the medicinal solution injection device 10 is brought into the state before the puncture", when the cap 114 is not connected to the cap locking portion 42, the needle tip cover has freedom to move into puncture position); and
the medicinal solution administration device further comprises a coupling mechanism that couples a proximal end of the needle cover and the drive unit to each other in an axial direction of the casing (FIG. 25, "the restricting protrusion 70 and the inclined portion 94 come into contact with each other. Thus, the movement of the needle tip cover 16 toward the base end side with respect to the apparatus main body 14 is restricted or prevented."), wherein the coupling mechanism comprises:
a first connection (FIG. 24, inclined portion 94 of the arm portion 92), and a second connection disposed on the proximal end of the needle cover (FIG. 24, restricting protrusion 70) and coupled to the first connection (FIG. 25, "the restricting protrusion 70 and the inclined portion 94 come into contact with each other.”), wherein:
the first connection comprises a protrusion protruding toward the second connection (inclined portion 94 is part of the arm portion 92 protrudes outward from the outer wall and toward the location of the restricting protrusion 70)
Iwasa does not disclose a drive unit that is housed on a proximal side of the casing, wherein the drive unit is configured to bias a gasket of the syringe toward a distal end of the casing by a plunger along with movement of the needle cover in the proximal direction, a sliding member movable along the axial direction of the casing, and an elastic member that biases the sliding member toward the syringe, the locking pin comprising a cylindrical pin main structure, the first connection disposed on the sliding member, the second connection comprises a hole opened in a direction perpendicular to the axial direction of the casing, and the first connection engaged with the hole.
However, André teaches a drive unit (transport assembly 1) that is housed on a proximal side of the casing (Fig. 8), wherein the drive unit is configured to bias a gasket of the syringe toward a distal end of the casing by a plunger along with movement of the needle cover in the proximal direction (Fig. 10c, [0068], "The plunger rod 9 has in particular been moved"), a sliding member movable along the axial direction of the casing (transport securing sleeve 3), and an elastic member (second resilient member 8) that biases the sliding member toward the syringe ([0050], "The transport securing sleeve 3 is thus biased in the proximal direction by the second resilient member 8."), and the first connection is disposed on the sliding member (recess or opening 3e). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the drive unit of the device disclosed by Iwasa with the automated drive unit taught by André in order to reduce the risk of accidental firing off of a biased component ([0043]). Further, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the drive unit disclosed by Iwasa to include a sliding member and elastic member as taught by André in order that a medicinal solution be expelled in a controlled manner during a medicament administration mode ([0045]).
Iwasa in view of André still does not disclose the locking pin comprising a cylindrical pin main structure. However, Young teaches the locking pin comprising a cylindrical pin main structure (release pin 120 includes a downwardly extending pin 125). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the locking pin disclosed by Iwasa to be of a cylindrical structure as taught by Young in order to prevent actuation of the auto-injector ([0082]) by securing all sides of the device.
Iwasa in view of André and Young still does not disclose the second connection comprises a hole opened in a direction perpendicular to the axial direction of the casing, and the first connection engaged with the hole. However, Kokane teaches the second connection comprises a hole opened in a direction perpendicular to the axial direction of the casing (FIGURE 6, groove 43 of cam profile 13), and the first connection engaged with the hole (FIGURE 5, “ In response to the proximal force, the cam follower 14 moves proximally in the cam profile 13.”). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the first and second connections disclosed by modified Iwasa so that the second connection comprises a hole and the first connection is engaged with the hole as taught by Kokane in order that the needle cover be supported as it travels in a linear or translational movement (Abstract).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Takemoto (United States Patent Application Publication No. US 2014/0025006 A1) is considered relevant prior art with regards to a liquid injection instrument having a cylindrical body and injector.
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/EVELYN A THOMAN/Patent Examiner, Art Unit 3783
/MICHAEL J TSAI/ Supervisory Patent Examiner, Art Unit 3783
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