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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the "inner annular surface" (claim 1) and "needle body" (claim 7) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
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.
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 1-10 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
In claim 1, it is unclear whether or not the cartridge module comprises the injection module in addition to the plunger. It is unclear whether or not the injection module comprises the starter in addition to the actuator. For examination purposes, examiner interprets the cartridge module as comprising only of the plunger, the injection module as comprising the actuator and the starter, and the medical system as comprising the cartridge and injection modules.
In claim 1, the term “and” should only be used before the last limitation of the claim. Thus, the usage of “and” before “one or more rotational protrusions…” is incorrect.
All remaining claims are rejected as they depend from rejected independent claim 1.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1 and 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Holmqvist (EP 3548116 B1) in view of Atterbury et al. (US Pub No. 2018/0200442 A1, herein Atterbury).
Regarding claim 1, Holmqvist discloses a medical injection system (100) (Fig. 1) comprising:
a cartridge module (plunger rod 13, "The plunger rod 13, which has radial recesses…" - Para [0067]) comprising:
a plunger (plunger rod 13, Fig. 2) comprising a plunger recess ("The plunger rod 13, which has radial recesses…" - Para [0067]) and configured to move in an axial direction of the medical injection system ("The plunger rod 13, configured to move axially inside the housing…" - Para [0026]); and
an injection module (tubular extension member 15, movable sleeve 17, delivery member cover 5, Fig. 2) comprising:
an actuator (tubular extension member 15) configured to accommodate the plunger ("a tubular extension member 15 configured to receive the plunger rod 13 in an axial opening…" - Para [0040], Fig. 2) and comprising one or more upper elastic pieces (radially flexible arms, Para [0067]) corresponding to the plunger recess, wherein the one or more upper elastic pieces are compressed inward against the plunger recess, and the actuator limits movement of the plunger in the axial direction ("… the tubular extension member 15 may be provided with radially flexible arms…", "The plunger rod 13, which has radial recesses configured to receive a respective one of the radially flexible arms, is thereby maintained in an initial axial position." - Para [0067]);
a starter (movable sleeve 17) comprising one or more rotational ramps (radially extending portion 17a, Fig. 3) and forming a penetrable structure for accommodating the actuator ("The movable sleeve 17 is configured to receive the tubular extension member 15…" - Para [0067]), wherein the penetrable structure of the starter further comprises:
an inner annular surface ("… the inner surface of the movable sleeve." - Para [0067], Fig. 4) configured to compress the one or more upper elastic pieces inward (" the radially flexible arms are configured to be pressed radially inwards by the inner surface of the movable sleeve." - Para [0067]);
one or more accommodating space located on the inner annular surface ("The movable sleeve 17 may furthermore have an inner surface provided with recesses." - Para [0067]); and
wherein the one or more upper elastic pieces are no longer compressed inward by the inner annular surface when the one or more accommodating space are rotated to align with the one or more upper elastic pieces ("When the movable sleeve 17 is being rotated, the radially flexible arms, which initially are pressed radially inwards by the inner surface of the movable sleeve, will be able to flex radially outwards, into the recesses of the movable sleeve 17" - Para [0067]): and
a needle cover (delivery member cover 5) which forms a penetrable structure for accommodating the cartridge module (Figs. 2 and 8a) and comprises one or more motion steering protrusions (legs 5a, 5b) which contact the one or more rotational ramps ("The movable sleeve 17 may have two such radially extending portions 17a, each configured to cooperate with a respective distal end surface 5c of a leg 5a, 5b." - Para [0043]).
Holmqvist does not expressly disclose an actuator comprising one or more rotating chutes and one or more rotational protrusions located on the inner annular surface for rotating the starter by moving along the one or more rotating chutes
Atterbury teaches an actuator (screw 104, Fig. 7) comprising one or more rotating chutes (threads 120) and
one or more rotational protrusions (projections 114) located on the inner annular surface for rotating the starter (nut 106, Fig. 6) by moving along the one or more rotating chutes (“The nut generally has a cylindrical shape a pair of projections 114 that ride in the threads of the screw.”; “The threads cause the nut to rotate…” – Para [0064])
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the medical injection system of Holmqvist to include an actuator comprising one or more rotating chutes and one or more rotational protrusions located on the inner annular surface for rotating the starter by moving along the one or more rotating chutes as taught by Atterbury in order to cause “so that the needle advances in a controlled manner.” (Atterbury, Para [0064]).
Regarding claim 2, Holmqvist in view of Atterbury discloses the medical injection system (Holmqvist, 100, Fig. 1) as recited above,
wherein the needle cover (Holmqvist, delivery member cover 5) is moved in another axial direction of the medical injection system (Holmqvist, "wherein the delivery member cover is configured to be moved in an axial direction…" - Para [0009]), the one or more steering protrusions (Holmqvist, legs 5a, 5b) push the one or more rotational ramps (Holmqvist, "… the distal end surface 5c cooperates with the radially extending portion 17a of the movable sleeve 17." - Para [0045]) to cause the starter (Holmqvist, movable sleeve 17) to rotate around an axis aligned with the axial direction (Holmqvist, "In particular, the linear movement of the delivery member cover 5 causes rotation of the movable sleeve 17." - Para [0045]).
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Holmqvist (EP 3548116 B1) in view of Atterbury et al. (US Pub No. 2018/0200442 A1, herein Atterbury) and in further view of Yin (US Pub No. 20220215779, A1).
Regarding claim 3, Holmqvist in view of Atterbury discloses the medical injection system (Holmqvist, 100, Fig. 1) as recited above,
further comprising a housing (Holmqvist, housing 3) for accommodating the cartridge module and the injection module (Holmqvist, "… the medicament delivery device 1 further comprises a medicament container holder 9 configured to hold a medicament container 11, a plunger rod 13, a tubular extension member 15 configured to receive the plunger rod 13 in an axial opening, a movable sleeve 17....", "... a delivery member cover 5 is further received by the housing 3..." - Para [0040], Para [0039], Figs. 1 and 2) and when the cartridge module is pressed down against skin of the subject (Holmqvist, "The present disclosure relates to an activation assembly for a medicament delivery device. The medicament delivery device may for example an auto-injector or an eye-dispenser." - Para [0032]), the needle cover (Holmqvist, delivery member cover 5) is moved in another axial direction of the medical injection system (Holmqvist, “wherein the delivery member cover is configured to be moved in an axial direction…” – Para [0009]) and the one or more steering protrusions (Holmqvist, legs 5a, 5b) push the one or more rotational ramps (Holmqvist, "… the distal end surface 5c cooperates with the radially extending portion 17a of the movable sleeve 17." - Para [0045]) to cause the starter to rotate around an axis aligned with the axial directions (Holmqvist, "In particular, the linear movement of the delivery member cover 5 causes rotation of the movable sleeve 17." - Para [0045]).
Holmqvist does not expressly disclose the actuator is fixed to the housing
Yin teaches that the actuator (holding structure 21) is fixed to the housing (“The holding structure 21 is configured to be fixedly arranged in the housing 3.” – Para [0060])
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the medical injection system of Holmqvist to include that the actuator is fixed to the housing as taught by Yin in order to further cause “…the plunger rod to move towards the proximal container end…” (Yin, Para [0008]).
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Holmqvist (EP 3548116 B1) in view of Atterbury et al. (US Pub No. 2018/0200442 A1, herein Atterbury) and in further view of Chang et al. (US Pub No. 2021/0023309 A1, herein Chang) and Hou et al. (CN 113209421 A, herein Hou).
Regarding claim 4, Holmqvist in view of Atterbury discloses the medical injection system (Holmqvist, 100, Fig. 1) as recited above.
Holmqvist in view of Atterbury does not expressly disclose an injection completion feedback module, wherein the injection completion feedback module comprises:
a click ring which forms a penetrable structure for accommodating the actuator; and
a compression collar which forms a penetrable structure for accommodating the plunger, the compression collar comprising an impact surface formed in the penetrable structure of the compression collar corresponding to the click ring, wherein when the click ring contacts the impact surface of the compression collar, an injection completion feedback prompt is generated.
Chang teaches an injection completion feedback module (10, Fig. 3), wherein the injection completion feedback module comprises:
a click ring (dose plate 163) which forms a penetrable structure for accommodating the actuator (driver sleeve 143) (“The dose plate 163 is a ring-shaped structure comprising a central opening as a passage for the driver sleeve 143…” – Para [0066]); and
a compression collar (dose knob 146) which forms a penetrable structure for accommodating the plunger (Fig. 6), the compression collar comprising an impact surface (See annotated Fig. 22) formed in the penetrable structure of the compression collar corresponding to the click ring (“The fourth teeth 1632 is engaged with the second teeth 1462 of the dose knob 146…”; “The dose plate… comprises… a fourth teeth 1632.” – Para [0098], Fig. 22),
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Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the medical injection system of Holmqvist to include an injection completion feedback module, wherein the injection completion feedback module comprises: a click ring which forms a penetrable structure for accommodating the actuator; and a compression collar which forms a penetrable structure for accommodating the plunger, the compression collar comprising an impact surface formed in the penetrable structure of the compression collar corresponding to the click ring as taught by Chang in order to “generate nonvisual responses…” (Chang, Para [0098]).
Chang does not teach that when the click ring contacts the impact surface of the compression collar, an injection completion feedback prompt is generated.
Hou teaches that when the click ring (sounding body 5) contacts the impact surface of the compression collar (the limiting part of fixing sleeve 4), an injection completion feedback prompt is generated (“… the sounding body 5… moving upwards… until the limiting part of the fixing sleeve 4 is impacted, sending the sound representing injection completion.” – Para [0056])
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the medical injection system of Holmqvist to include that when the click ring contacts the impact surface of the compression collar, an injection completion feedback prompt is generated as taught by Hou in order to inform the user that “the product has begin injection, has been substantially completely injected and the user can pull out the device from the injection part.” (Hou, Para [0003]).
Claim(s) 5 and 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Holmqvist (EP 3548116 B1) in view of Atterbury et al. (US Pub No. 2018/0200442 A1, herein Atterbury) and Chang et al. (US Pub No. 2021/0023309 A1, herein Chang) and Hou et al. (CN 113209421 A, herein Hou), and in further view of Smith et al. (US Pub No. 2019/0374721 A1, herein Smith).
Regarding claim 5, Holmqvist in view of Atterbury and Chang discloses the medical injection system (Holmqvist, 100, Fig. 1) as recited above.
Holmqvist does not expressly disclose that the actuator further comprises one or more lower elastic pieces, and when the one or more lower elastic pieces are pushed outward by the plunger, the one or more lower elastic pieces compress against the click ring to prevent the click ring from contacting the impact surface of the compression collar.
Smith teaches that the actuator (the drive sleeve 2) further comprises one or more lower elastic pieces (“The drive sleeve 2 further comprises a deflectable feature 39.”; “The deflectable feature 39 may be elastic.” – Para [0174], [0176]), and when the one or more lower elastic pieces are pushed outward by the plunger (“… the piston rod 4 abuts or almost abuts the inner surface of the deflectable feature 39. Thus, the piston rod 4 prevents an inward deflection of the deflectable feature 39 in the primed state.” – Para [0177]) the one or more lower elastic pieces compress against the click ring (dose setting sleeve 5b) (“… the deflectable feature 39 returns elastically to into its outward position. The projection 40 arranged on the deflectable feature 39 now abuts the second stop face 44 of the dose setting sleeve 5b.” – Para [0229]) to prevent the click ring from rotating (“Thereby a rotation of the dose setting sleeve 5…is prevented.” – Para [0213])
Smith does not teach that the one or more lower elastic pieces compress against the click ring to prevent the click ring from contacting the impact surface of the compression collar.
Examiner interprets the prevention of the rotation of the dose setting sleeve to be the equivalent of the claimed prevention of the click ring from contacting the impact surface of the compression collar because they both achieve the same function of preventing the feedback mechanism from delivering a feedback output to the user (“During the first step of the dose setting operation, the dose setting sleeve 5 is rotated. Thereby, the deflectable detent 6 is subsequently disengaged from and engaged with the grooves 3d of the body 3. Each time the deflectable detent 6 is engaged with or disengaged from a groove 3d, an audible and/or tactile feedback is provided to a user.” – Para [0201]).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the medical injection system of Holmqvist to include that the actuator further comprises one or more lower elastic pieces, and when the one or more lower elastic pieces are pushed outward by the plunger, the one or more lower elastic pieces compress against the click ring to prevent the click ring from contacting the impact surface of the compression collar as taught by Smith in order to “…creates an audible and tactile feedback…” (Smith, Para [0153]).
Regarding claim 6, Holmqvist in view of Atterbury and Chang discloses the medical injection system (Holmqvist, 100, Fig. 1) as recited above.
Holmqvist does not expressly disclose that after the plunger moves in the axial direction of the medical injection system, the plunger no longer pushes the one or more lower elastic pieces of the actuator outward.
Smith teaches that after the plunger (piston rod 4) moves in the axial direction of the medical injection system, the plunger no longer pushes the one or more pieces (deflectable feature 39) of the actuator outward ("The piston rod 4 is designed to transfer an axial movement through the medication delivery device 1...", "...the third axial section 4c of the piston rod 4 having the maximum radial extension has been moved relative to the deflectable feature 39 during the dose setting operation. Thus, the section 4c having the maximum radial extension no longer prevents a deflection of the deflectable feature 39." - Para [0136], Para [0228])
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the medical injection system of Holmqvist to include that after the plunger moves in the axial direction of the medical injection system, the plunger no longer pushes the one or more lower elastic pieces of the actuator outward as taught by Smith in order to create “an audible and tactile feedback…” (Smith, Para [0153]).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Holmqvist (EP 3548116 B1) in view of Atterbury et al. (US Pub No. 2018/0200442 A1, herein Atterbury) and in further view of Dasbach et al. (WO 2022029097 A1, herein Dasbach).
Regarding claim 7, Holmqvist in view of Atterbury discloses the medical injection system (Holmqvist, 100, Fig. 1) as recited above
Holmqvist does not expressly disclose a cap structure, wherein the cap structure comprises:
a cap cover which forms a structure accommodating at least a portion of the cartridge module;
and a shield remover, which is arranged to be coupled to the cap cover and comprises a needle guard remover, wherein when the shield remover is removed from the medical injection system, the needle guard remover removes a needle guard to expose a needle body.
Dasbach teaches a cap structure (cap 101, grabber 103, needle shield 125), wherein the cap structure comprises:
a cap cover (cap 101) which forms a structure accommodating at least a portion of the cartridge module;
and a shield remover (grabber 103) which is arranged to be coupled to the cap cover (“The cap 101 may include grabber 103…” – Para [0074]) and comprises a needle guard remover (needle shield 125), wherein when the shield remover is removed from the medical injection system, the needle guard remover removes a needle guard to expose a needle body ("The cap 101 may include a grabber 103 which can act as a removal mechanism for the needle shield 125.", "the protective needle shield may be removably coupled to the needle and/or the syringe. The needle shield may be interlocked with the cap, e.g., via the grabber, and removed together with the cap to prepare the device for operation." - Para [0074]).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the medical injection system of Holmqvist to include a cap structure, wherein the cap structure comprises: a cap cover which forms a structure accommodating at least a portion of the cartridge module; and a shield remover, which is arranged to be coupled to the cap cover and comprises a needle guard remover, wherein when the shield remover is removed from the medical injection system, the needle guard remover removes a needle guard to expose a needle body as taught by Dasbach for “dispensing medicament to injection site of patient.” (Dasbach, Para [2])
Claim(s) 8-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Holmqvist (EP 3548116 B1) in view of Atterbury et al. (US Pub No. 2018/0200442 A1, herein Atterbury) and in further view of Smith et al. (US Pub No. 2019/0374721 A1, herein Smith) and Fiard et al. (US Pub No. 2022/0370720 A1, herein Fiard).
Regarding claim 8, Holmqvist in view of Atterbury discloses the medical injection system (Holmqvist, 100, Fig. 1) as recited above.
Holmqvist does not expressly disclose a backstop module, wherein the backstop module comprises: a front housing which forms a structure accommodating at least a portion of the cartridge module and the injection module and comprises one or more fixing holes; and a syringe holder which is accommodated in the front housing and includes one or more fixing protrusions corresponding to the one or more fixing holes of the front housing to fix the syringe holder to the front housing, the syringe holder further comprising one or more elastic pieces coupled to the needle cover to limit movement of the needle cover in the axial direction of the medical injection system, wherein the syringe holder further comprises one or more fixing pieces corresponding to the one or more elastic pieces, and when the needle cover moves in another axial direction of the medical injection system, the one or more elastic pieces are compressed to be accommodated in the one or more fixing pieces, and the movement of the needle cover is no longer limited.
Smith teaches a backstop module (1, Fig. 1), wherein the backstop module comprises:
a front housing (body 3) which forms a structure comprising at least a portion of the cartridge module and the injection module (Fig. 2) and comprises one or more fixing holes (“the body 3 comprises an opening 3c…” – Para [0129]); and a syringe holder (non-return ratchet 15) which is accommodated in the front housing (Fig. 2) and includes on or more fixing protrusions (“a lug 15a of a non-return ratchet 15…” – Para [0129]) corresponding to the one or more fixing holes of the front housing (“The lug 15a is configured to be received in the opening 3c of the body 3.” – Para [0167]) to fix the syringe holder to the front housing (“The engagement of the non-return ratchet 15 with the body 3 by the lug 15a being received in the opening 3c fixes the non-return ratchet 15 with respect to the body 3.” – Para [0167]).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the medical injection system of Holmqvist to include a backstop module, wherein the backstop module comprises: a front housing which forms a structure accommodating at least a portion of the cartridge module and the injection module and comprises one or more fixing holes; and a syringe holder which is accommodated in the front housing and includes one or more fixing protrusions corresponding to the one or more fixing holes of the front housing to fix the syringe holder to the front housing as taught by Smith in order to increase the security of the device (Smith, Para [0007]).
Smith does not expressly disclose the syringe holder further comprising one or more elastic pieces coupled to the needle cover to limit movement of the needle cover in the axial direction of the medical injection system, wherein the syringe holder further comprises one or more fixing pieces corresponding to the one or more elastic pieces, and when the needle cover moves in another axial direction of the medical injection system, the one or more elastic pieces are compressed to be accommodated in the one or more fixing pieces, and the movement of the needle cover is no longer limited.
Fiard teaches the syringe holder (locking unit 30A) further comprising one or more elastic pieces (protrusion 303) (“The locking unit 30A also comprises a protrusion 303…” – Para [0115]) coupled to the needle cover (needle shield 20A, Fig. 7) to limit the movement of the needle cover in the axial direction of the medical injection system (“… the needle shield 20A can be locked in the safety position.” – Para [0119]) wherein the syringe holder further comprises one or more fixing pieces (first track portion 301) corresponding to the one or more elastic pieces (Fig. 7) and when the needle cover moves in the another axial direction of the medical injection system (See annotated Fig. 7) , the one or more elastic pieces are compressed to be accommodated in the one or more fixing pieces (“… the protrusion 303 can freely slide in the first track portion 301…” – and the movement of the needle is no longer limited (“This allows the needle shield 20A to move freely from the initial shielding position to the retracted position and vice versa…” – Para [0117]).
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Regarding claim 9, Holmqvist in view of Atterbury and Smith and Fiard discloses the medical injection system (Holmqvist, 100, Fig. 1) as recited above.
Holmqvist does not expressly disclose that the needle cover further comprises one or more buckles, and the front housing further comprises one or more annular protrusions, and when the one or more elastic pieces no longer limit the movement of the needle cover, the needle cover moves in the axial direction of the medical injection system so that the one or more annular protrusions contact the one or more buckles to limit the movement of the needle cover in the other axial direction of the medical injection system.
Fiard teaches that the needle cover (needle shield 20A) comprises one or more buckles (second track portion 302), and the front housing (locking actuator 40A) further comprises one or more annular protrusions (“a protrusion 303 provided on the locking actuator 40A.” – Para [0115]) and when the one or more elastic pieces no longer limit the movement of the needle cover, the needle cover moves in the axial direction of the medical injection system ("… the locking unit 30A is in an open mode: the protrusion 303 can freely slide in the first track portion 301… This allows the needle shield to move freely from the initial shielding position to the retracted position…" - Para [0117], Figs. 7 and 8) so that the one or more annular protrusions contact the one or more buckles to limit the movement of the needle cover in the other axial direction of the medical injection system ("… the protrusion 303 has completely moved to the second track portion 302…the needle shield 20A can be locked in the safety position." - Para [0119]).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the medical injection system of Holmqvist to include that the needle cover further comprises one or more buckles, and the front housing further comprises one or more annular protrusions, and when the one or more elastic pieces no longer limit the movement of the needle cover, the needle cover moves in the axial direction of the medical injection system so that the one or more annular protrusions contact the one or more buckles to limit the movement of the needle cover in the other axial direction of the medical injection system as taught by Fiard in order to “prevent a further movement from the initial position to the retracted position…” (Fiard, Para[ 0004]).
Regarding claim 10, Holmqvist in view of Atterbury and Smith discloses the medical injection system (Holmqvist, 100, Fig. 1) as recited above.
Holmqvist does not expressly disclose that when the one or more elastic pieces no longer limit the movement of the needle cover, the needle cover moves in the axial direction of the medical injection system, and the one or more fixing protrusions limit a movement range of the needle cover.
Fiard teaches that when the one or more elastic pieces (protrusion 303) no longer limit the movement of the needle cover (needle shield 20A, “the locking unit 30A is in an open mode: the protrusion 303 can freely slide in the first track position 301…” – Para [0117]), the needle cover moves in the axial direction of the medical injection system, and the one or more fixing protrusions limit a movement range of the needle cover (“This allows the needle shield 20A to move freely from the initial shielding position to the retracted position…" - Para [0117], Figs. 7 and 8).
Examiner interprets the movement range of the needle cover to be between the initial shielding position and the retracted position.
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the medical injection system of Holmqvist to include that when the one or more elastic pieces no longer limit the movement of the needle cover, the needle cover moves in the axial direction of the medical injection system, and the one or more fixing protrusions limit a movement range of the needle cover as taught by Fiard in order to “prevent a further movement from the initial position to the retracted position…” (Fiard, Para [0004]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ESHA P KASHYAP whose telephone number is (571)272-9890. The examiner can normally be reached Monday - Friday 8:30am - 5:00pm.
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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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/ESHA PRAKASH KASHYAP/Examiner, Art Unit 3783 /CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783