Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 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) configured to accommodate the cartridge module and 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]), and
a needle cover (delivery member cover 5), which forms a penetrable structure for accommodating the cartridge module (Figs. 2 and 8a), comprising 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]),
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 spaces 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 spaces 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]).
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
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]), comprising 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, comprising one or more fixing holes; and a syringe holder which is accommodated in the front housing comprising: 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, 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, and 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), comprising 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) comprising 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, comprising one or more fixing holes; and a syringe holder which is accommodated in the front housing comprising: 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 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, and 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 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]) and 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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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 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, and 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 as taught by Fiard in order to “prevent a further movement from the initial position to the retracted position…” (Fiard, Para[ 0004]).
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, such 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), such 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 , such 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]).
Response to Arguments
Applicant's arguments filed 4/09/2026 have been fully considered but they are not persuasive.
Applicant argues that although both Holmqvist and Atterbury involve medical injection devices, Holmqvist and Atterbury address different technical problems with different structural approaches and thus that one of ordinary skill in the art would not have been motivated to combine the teachings of Holmqvist and Atterbury. The cam geometry of Holmqvist already provides complete and precise control over the rotation angle of the movable sleeve. There is no deficiency or unresolved problem in the rotational control mechanism of Holmqvist that would motivate a person of ordinary skill in the art to look to the screw-thread mechanism of Atterbury for a solution.
Applicant argues that in addition, even assuming that the motivation to combine the teachings of Holmqvist and Atterbury is proper, to which Applicant does not concede, applying the thread-protrusion structure of Atterbury to modify Holmqvist would fail to achieve the technical features and effects of the claimed invention. A person of ordinary skill in the art would understand that the threads 120 and the projections 114 of Atterbury are part of an integrated torsion spring delivery system designed for continuous force modulation. Extracting the threads 120 and the projections 114 from the integrated torsion spring system of Atterbury and repurposing the threads 120 and the projections 114 in a fundamentally different device architecture, namely, one that relies on external force-driven rotation (skin pressure against a needle cover) for one-time lock release, rather than spring-driven continuous rotation for force curve control, would require a conceptual leap that is not supported by either Holmqvist or Atterbury.
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, regardless of the fact that Holmqvist and Atterbury disclose complete inventions that do not require additional features to complete their intended functions, Holmqvist and Atterbury both disclose autoinjector devices that each have features that read upon the application and can be combined to read upon the entire claimed invention. As recited above, the modification of Holmqvist with the features of Atterbury further ensures that the needle advances in a controlled manner.
In response to applicant's argument that "the function of the rotating chutes and the rotational protrusions in the present application differs fundamentally from the function of the threads 120 and the projections 114 in Atterbury. As recited in claim 1, the “one or more rotational protrusions located on the inner annular surface” are for “rotating the starter by moving along the one or more rotating chutes” and thus rotation causes “the one or more upper elastic pieces [to be] 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.” , a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Examiner interprets the projections 114 to read exactly upon the claim language of rotational protrusions located on an inner annular surface that function to rotate the nut 106 along the rotating chutes.
In response to applicant's argument that a structural gap exists for the click ring, compression collar, lower elastic pieces, syringe holder, fixing pieces, and annular protrusions, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. The structural pieces of the click ring, compression collar, lower elastic pieces, syringe holder, fixing pieces, and annular protrusions found in the prior art are all capable of performing the intended use as disclosed in the claimed invention.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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
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