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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 04/28/2026 has been entered.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-10, 12, 16, 18-19, 21-22, and 25-28 are rejected under 35 U.S.C. 103 as being unpatentable over Helmer et al. (US 20130041325 A1) in view of Boyd et al. (US 20100137792 A1) in further view of Berenshteyn et al. (US 10245386 B1).
Regarding claim 1, Helmer discloses a controlled multidosing delivery device (drug delivery device 1, Fig 1-2) for coupling to and use with a syringe (cartridge 3 + piston 6+ outlet 25, Fig 1) including a barrel (cartridge 3, Fig 1), plunger stopper (piston 6, Fig 1), and a delivery conduit (outlet 25, Fig 1), the barrel (3) including a proximal end (proximal end 1009, Annotated Fig 7) and a distal end (distal end 1010, Annotated fig 7), the controlled multidosing delivery device (1) comprising:
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a housing (housing 2, Fig 1; note: element 21 even though is defined with another term is also interpreted as the housing in [0040]) defining an axis (1100, Annotated Fig 1) and including a proximal end (1001, Annotated Fig 1), a distal end (1003, Annotated Fig 1), an axially extending chamber (chamber of housing 2, Fig 2) including a first opening (1000, Annotated Fig 1) to the proximal end (1001,Annotated Fig 1) of the housing (2) and a second opening (1002, Annotated Fig 1) to the distal end (1003, Annotated Fig 1) of the housing (2), the distal end (1003, Annotated Fig 1)of the housing (2) being adapted for attachment to the proximal end (1009, Annotated Fig 7 above) of the syringe barrel (3) along said axis (1100, Annotated Fig 1) (housing 2 is connected to cap 9 to secure cartridge holder 24 at both proximal and distal end of cartridge 3; [0035]; note: functional limitation adapted for attachment includes both direct and indirect attachment);
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a plunger rod (drive member 5, Fig 3) including an elongated shaft (1004, Annotated Fig 2) having a proximal end (1005, Annotated Fig 2) and a distal end (1006, Annotated Fig 2), a contact button (button 8, Fig 1) disposed at the proximal end (1005) of the elongated shaft (1004), and a pusher feature (displacement member 17, Fig 3) disposed at the distal end (1006, Annotated Fig 2) of the elongated shaft (1004), a portion of the elongated shaft (1004) being disposed within the axially extending chamber of the housing (2), the proximal end (1005) of the elongated shaft (1004) extending at least partially from the proximal end (1001) of the housing (2), the contact button (8) being disposed external to the housing (2) (Fig 1-2); a retaining structure (stop member 15, Fig 2) adapted to inhibit removal of the plunger rod (5) and permit the plunger rod (5) to translate axially a predetermined distance (stop member 15 limit movement of drive member 5 in the proximal direction 12 preventing its removal and permits axial translation a predetermined distance; [0044];[0046]); a drive element (piston rod 13, Fig 3-5) disposed within the axially extending chamber of the housing (2), the drive element (13) including a head (1008, Annotated Fig 2) disposed for translation along the axis (1100, Annotated Fig 1) (head 1008 translates along the axis 1100; See Fig 3-5), the drive element (13) further including a plurality of engagement surfaces (1012, Annotated Fig 2), the pushing feature (17) of the plunger rod (5) being biased toward at least one of the engagement surfaces (1012) ([0042]), the pushing feature (17) being disposed to engage the at least one of the engagement surfaces (1012) to translate the drive element (13) in a distal direction (11, Fig 1), a retention feature (1010 + 1011, Annotated Fig 2) including at least one retention finger (1010_1, Annotated Fig 2) and a plurality of retention surfaces (1011, Annotated Fig 2), the retention feature (1010 + 1011) being adapted to inhibit proximal movement of the drive element (13) within the axially extending chamber when retention finger (1010_1, Annotated Fig 2) is engaged with at least one of the plurality of retention surfaces (1011, Annotated Fig 2; [0040]), at least one of the at least one retention finger (1010_1, Annotated Fig 2) and the plurality of retention surfaces (1011, Annotated Fig 2) being associated with the drive element (13), the other (23) of the retention finger (1010, Annotated Fig 2) and the plurality of retention surfaces (1011, annotated Fig 2) being associated with the housing (2) whereby, depression of the contact button (8) axially translates the elongated shaft (1004) and pusher feature (17) in engagement with the at least one of the engagement surfaces (1012, Annotated Fig 2) in the distal direction (11, Fig 1) along the axis (1100, Annotated Fig 1) to translate the drive element (13) in the distal direction (11) based upon said predetermined distance ([0019]) to cause corresponding movement of the plunger stopper (6) within the barrel (3) for a dose delivery (abstract), whereby the at least one retention finger (1010, Annotated Fig 2) engages with at least one of the plurality of retention surfaces (1011, Annotated Fig 2) to maintain an axial position of the drive element (13) (See position of drive element 13, Fig 4) in the housing (2) following movement of the drive element (13) in the distal direction (11).
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However, Helmer is silent regarding the drive element being a drive shell and a biasing structure disposed to bias the contact button away from the housing; and whereby the biasing structure translates the plunger rod in a proximal direction following translation of the drive shell; the proximal end of the barrel including an outwardly extending flange; at least one clip adapted to couple the proximal end of the barrel to the distal end of the housing.
Boyd teaches a controlled multidosing delivery device (medication delivery device 1, Fig 1A) comprises a housing (housing 4, Fig 1A); a barrel (cartridge 3, Fig 1A) having a delivery conduit (outlet 3’, Fig 1A); a plunger stopper (moveable piston 5, Fig 1A); a drive shell (10, Fig 1A) includes an elongated drive arm (10_2, Annotated Fig 4) and an elongated retention arm (10_1, See annotated Fig 4), at least one of the retention fingers (2000, Annotated Fig 4) and the plurality of retention surfaces (2001, Ann Annotated Fig 4) being associated with the retention arm (10_1), and the plurality of engagement surfaces (2002, Annotated Fig 4) being associated with the drive arm (10_2). Boyd further teaches a biasing structure (resilient member 21 [0066]: “for instance a circular spring, a leaf spring or a coil spring.”, Fig 1) disposed to bias the contact button (drive member 17; [0076]) away from the housing (4); and whereby the biasing structure (21) translates the plunger rod (18) in the proximal direction following translation of the drive shell (10).
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Therefore, it would have been obvious for one of ordinary skill in the art before the effective
filing date of the claim invention to modify the drive element of Helmer with a similar drive shell and a spring as taught by Boyd to increase the contact area to push the piston. The incorporation of the spring will remove pressure on the piston and reduction of unintentional weeping ([0076]).
Helmer/Boyd are silent wherein the proximal end of the barrel including an outwardly extending flange; at least one clip adapted to couple the proximal end of the barrel to the distal end of the housing.
Berenshteyn teaches wherein the proximal end of the barrel (proximal end of syringe barrel 30, Fig 6) including an outwardly extending flange (flanges 33, Fig 6); at least one clip (cover 26, Fig 6) adapted to couple the proximal end of the barrel (30) to the distal end of the housing (housing 14, Fig 6).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Helmer/Boyd with a removable syringe at the proximal end coupled to the housing via a clip as taught by Berenshteyn for the purpose of re-use the system and refill the syringe when needed (Col 3, lines 46-50).
Regarding claim 2, Helmer/Boyd/Berenshteyn discloses the controlled multidosing delivery device of claim 1. Helmer teaches wherein the plurality of retention surfaces (1011, Annotated Fig 2) forms a sawtooth configuration with a plurality of ramped surfaces (1014, Annotated Fig 3).
Regarding claim 3, Helmer/Boyd/Berenshteyn discloses the controlled multidosing delivery device of claim 1. Helmer discloses wherein the drive element (13) includes an elongated drive arm (13), and the plurality of engagement surfaces (1012, Annotated Fig 2) being associated with the drive arm (13).
Helmer is silent wherein the drive shell includes an elongated retention arm, at least one of the retention fingers and the plurality of retention surfaces being associated with the retention arm.
Boyd teaches a controlled multidosing delivery device (medication delivery device 1, Fig 1A) comprises a housing (housing 4, Fig 1A); a barrel (cartridge 3, Fig 1A) having a delivery conduit (outlet 3’, Fig 1A); a plunger stopper (moveable piston 5, Fig 1A); a drive shell (10, Fig 1A) includes an elongated drive arm (10_2, Annotated Fig 4) and an elongated retention arm (10_1, See annotated Fig 4), at least one of the retention fingers (2000, Annotated Fig 4) and the plurality of retention surfaces (2001, Ann Annotated Fig 4) being associated with the retention arm (10_1), and the plurality of engagement surfaces (2002, Annotated Fig 4) being associated with the drive arm (10_2). Boyd further teaches a biasing structure (resilient member 21 [0066]: “for instance a circular spring, a leaf spring or a coil spring.”, Fig 1) disposed to bias the contact button (drive member 17; [0076]) away from the housing (4); and whereby the biasing structure (21) translates the plunger rod (18) in the proximal direction following translation of the drive shell (10).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claim invention to modify the drive shell of Helmer/Boyd/Berenshteyn to include a retention arm similar to the one taught by Boyd to provide increased structural support by having two elongated arms structurally capable of retention when moving the plunger stopper ([0061], Fig 1A).
Regarding claim 4, Helmer/Boyd/Berenshteyn discloses the controlled multidosing delivery device of claim 3. Helmer discloses the housing (2) includes the plurality of retention surfaces (1011 Annotated Fig 2).
Helmer is silent wherein the retention arm includes at least one retention finger.
Boyd teaches a controlled multidosing delivery device (medication delivery device 1, Fig 1A) comprises a housing (housing 4, Fig 1A); a barrel (cartridge 3, Fig 1A) having a delivery conduit (outlet 3’, Fig 1A); a plunger stopper (moveable piston 5, Fig 1A); a drive shell (10, Fig 1A) includes an elongated drive arm (10_2, Annotated Fig 4) and an elongated retention arm (10_1, See annotated Fig 4), at least one of the retention fingers (2000, Annotated Fig 4) and the plurality of retention surfaces (2001, Ann Annotated Fig 4) being associated with the retention arm (10_1).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claim invention to modify the drive shell of Helmer/Boyd/Berenshteyn to include a retention arm including at least a retention finger similar to the one taught by Boyd to provide increased structural support by having two elongated arms structurally capable of retention when moving the plunger stopper ([0061], Fig 1A).
Regarding claim 5, Helmer/Boyd/Berenshteyn discloses the controlled multidosing delivery device of claim 3. Helmer discloses wherein the housing (2) includes the at least one retention finger (23). Helmer is silent wherein a retention arm includes the plurality of retention surfaces.
Boyd teaches a controlled multidosing delivery device (medication delivery device 1, Fig 1A) comprises a housing (housing 4, Fig 1A); a barrel (cartridge 3, Fig 1A) having a delivery conduit (outlet 3’, Fig 1A); a plunger stopper (moveable piston 5, Fig 1A); a drive shell (10, Fig 1A) includes an elongated drive arm (10_2, Annotated Fig 4) and an elongated retention arm (10_1, See annotated Fig 4), at least one of the retention fingers (2000, Annotated Fig 4) and the plurality of retention surfaces (2001, Ann Annotated Fig 4) being associated with the retention arm (10_1).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claim invention to modify the drive shell of Helmer/Boyd/Berenshteyn to include a retention arm including the plurality of retention surfaces similar to the one taught by Boyd to provide increased structural support by having two elongated arms structurally capable of retention when moving the plunger stopper ([0061], Fig 1A).
Regarding claim 6, Helmer/Boyd discloses the controlled multidosing delivery device of claim 5. Helmer is silent regarding the device including a gear rotatably coupled to the housing, the gear including the at least one retention finger.
Boyd teaches a gear (15) rotatably coupled to the housing (4), the gear (15) including the at least one retention finger (Fig 3, gear 15 having retention finger interacting with racks 9 and 20 coupled to the housing 4).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Helmer/Boyd/Berenshteyn with similar a gear as taught by Boyd for the purpose of having an additional retention means ([0072]).
Regarding claim 7, Helmer/Boyd/Berenshteyn teaches the controlled multidosing delivery device of claim 1. Helmer discloses wherein the plurality of engagement surfaces (1012) forms a sawtooth configuration with a plurality of ramps (1015, Annotated Fig 3).
Regarding claim 8, Helmer/Boyd/Berenshteyn discloses the controlled multidosing delivery device of claim 7. Helmer discloses wherein the pushing feature (17) is adapted to ride along at least one of the plurality of ramps (1015) following the dose delivery (Fig 2-5).
Regarding claim 9, Helmer/Boyd/Berenshteyn discloses the controlled multidosing delivery device of claim 1. Helmer discloses wherein the plunger rod (5) is disposed at least partially within the drive shell (13, see claim 1).
Regarding claim 10, Helmer/Boyd/Berenshteyn discloses the controlled multidosing delivery device of claim 9. Helmer disclosed the at least one engagement surface (1012_1, Fig 4). Helmer is silent wherein the at least one engagement surface is disposed along an internal surface of the drive shell.
Boyd teaches a controlled multidosing delivery device (medication delivery device 1, Fig 1A) comprises a housing (housing 4, Fig 1A); a barrel (cartridge 3, Fig 1A) having a delivery conduit (outlet 3’, Fig 1A); a plunger stopper (moveable piston 5, Fig 1A); a drive shell (10, Fig 1A) includes an elongated drive arm (10_2, Annotated Fig 4) and an elongated retention arm (10_1, See annotated Fig 4), at least one of the retention fingers (2000, Annotated Fig 4) and the plurality of retention surfaces (2001, Ann Annotated Fig 4) being associated with the retention arm (10_1, Annotated Fig 4), and the plurality of engagement surfaces (2002, Annotated Fig 4) being associated with the drive arm (10_2, Annotated Fig 4) wherein at least one engagement surface (2002, Annotated Fig 4) is disposed along an internal surface (internal surface of shell where engagement surfaces are disposed, Annotated Fig 4) of the drive shell (10).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claim invention to modify the drive shell of Helmer/Boyd/Berenshteyn to include a least one engagement surface disposed along an internal surface of the drive shell as taught by Boyd to engage with the pusher feature 17 of Helmer and drive the shell and move the plunger stopper to release the medication ([0061], Fig 1A).
Regarding claim 12, Helmer/Boyd/Berenshteyn discloses the controlled multidosing delivery device of claim 1. Helmer is silent wherein the biasing structure includes a spring.
Boyd teaches a controlled multidosing delivery device (medication delivery device 1, Fig 1A) comprises a housing (housing 4, Fig 1A); a barrel (cartridge 3, Fig 1A) having a delivery conduit (outlet 3’, Fig 1A); a plunger stopper (moveable piston 5, Fig 1A); a drive shell (10, Fig 1A) includes an elongated drive arm (10_2, Annotated Fig 4) and an elongated retention arm (10_1, See annotated Fig 4), at least one of the retention fingers (2000, Annotated Fig 4) and the plurality of retention surfaces (2001, Ann Annotated Fig 4) being associated with the retention arm (10_1), and the plurality of engagement surfaces (2002, Annotated Fig 4) being associated with the drive arm (10_2). Boyd further teaches wherein the biasing structure includes a spring(resilient member 21 [0066]: “for instance a circular spring, a leaf spring or a coil spring.”, Fig 1).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claim invention to modify the drive element of Helmer/Boyd/Berenshteyn with a similar drive shell and a spring as taught by Boyd to increase the contact area to push the piston. The incorporation of the spring will remove pressure on the piston and reduce unintentional weeping ([0076]).
Regarding claim 16, Helmer/Boyd/Berenshteyn discloses the controlled multidosing delivery device of claim 1. Helmer discloses wherein at least a portion of the elongated shaft (1004) includes a cross-section (cross-section of 1004) and the first opening (1000) of the housing have corresponding cross-sections (cross-section of 1000) such that the elongated shaft (1004) may translate through the first opening (1000) but will not rotate within the first opening (1000) ([0045]).
Regarding claim 18, Helmer/Boyd/Berenshteyn discloses the controlled multidosing delivery device of claim 1. Helmer is silent discloses the at least one clip being is adapted to couple the outwardly extending flange of the barrel of the syringe to the distal end of the housing.
Berenshteyn teaches the at least one clip (26) is adapted to couple the outwardly extending flange (33) of the barrel (30) of the syringe to the distal end of the housing (14).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Helmer/Boyd/Berenshteyn with a removable syringe at the proximal end coupled to the housing via a clip as taught by Berenshteyn for the purpose of re-use the system and refill the syringe when needed (Col 3, lines 46-50).
Regarding claim 19, Helmer/Boyd/Berenshteyn discloses the controlled multidosing delivery device of claim 1. Helmer discloses wherein the housing (2) includes a channel opening (1022, Annotated Fig 3) to the distal end (1003, Annotated Fig 1) of the housing (2), the second opening (1002, Annotated Fig 1) of the housing (2) opening into the channel (1022, Annotated Fig 3), the channel (1022 Annotated Fig 3) being adapted to receive the syringe proximal end (1018, Annotated Fig 2) (Fig 1).
Regarding claim 21, Helmer/Boyd/Berenshteyn discloses the controlled multidosing delivery device of claim 1. Helmer discloses wherein an initial engagement of the at least one retention finger (1010, Annotated Fig 2) with at least one of the plurality of retention surfaces (1011, Annotated Fig 2) provides at least one of a tactile feedback and audible click (snap; [0045]).
Regarding claim 22, Helmer/Boyd/Berenshteyn discloses the controlled multidosing delivery device of claim 1. Helmer discloses the device is adapted to deliver a controlled dose ([0049]) with each depression of the contact button (8) (each depression of button 8 dispense a controlled dose; [0010]-[0011]), the drive shell (13, modified with teaching of Boyd, see claim 1) including at least two engagement surfaces (1012, Annotated Fig 3), and the retention feature (1010 + 1011, Annotated Fig 2) including at least two retention surfaces (1011, Annotated Fig 2) such that the controlled multidosing delivery device (1) is adapted to deliver at least two sequential doses ([0035]: “The drug delivery device according to FIG. 1 is configured to deliver a plurality of fixed doses of a drug”.)
Regarding claim 25, Helmer/Boyd/Berenshteyn discloses a method of using the controlled multidosing delivery device (1) of claim 1. Helmer discloses priming the syringe ([0002]; doses are pre-set, meaning that priming of the device occurred); coupling the distal end of the housing (housing 2, Fig 1) to the proximal end of the syringe barrel (cartridge 3, Fig 1) ([0035]; distal end of housing 2 is coupled at least functionally to the proximal end of the syringe barrel, please note that direct contact is not required and includes both direct and indirect through intermediate components); depressing the contact button (button 8, Fig 1) to advance the elongated shaft (1004, Annotated Fig 2) and pusher feature (displacement member 17, Fig 3) in the distal direction (11, Fig 1) within the housing (2), whereby the pusher feature (17) exerts a force (force exerted by pressing of button) on at least a first of the engagement surfaces (1012) of the drive shell (13) ([0038]), whereby the drive shell (13) translates in the distal direction (11) in the housing (2) to cause the plunger stopper (piston 6, Fig 1) to translate in the distal direction (11) within the barrel (3) ([0045]) such that a first controlled dose (first dose) is delivered to the delivery conduit (outlet 25, Fig 1) [0049], and whereby the at least one retention finger (1010) engages at least a first of the plurality of retention surfaces (first of retention surfaces 1011, Annotated Fig 2) to inhibit proximal movement of the drive shell (13) ([0040]); whereby the biasing structure (spring 1200; from combination of claim 1) translates the plunger rod (5) in a proximal direction (12, Fig 1) relative to the drive shell (13) and the housing (2) until the retaining structure (15) prevents further movement of the plunger rod (5) in the proximal direction (12), such that the pusher feature (17) moves to a second of the engagement surfaces (1012) of the drive shell (13); and depressing the contact button (8) to advance the elongated shaft (5) and pusher feature (17) in the distal direction (11) within the housing (2), whereby the pusher feature (17) exerts a force (force exerted by pressing of button) on at least a second of the engagement surfaces (1012)of the drive shell (13), whereby the drive shell (13) translates in the distal direction (11) in the housing (2) to cause the plunger stopper (6) to translate in the distal direction (11) within the barrel (3) such that a second controlled dose (second dose; [0002]) is delivered to the delivery conduit (25), and whereby the at least one retention finger (1010) engages at least a second of the plurality of retention surfaces (1011, Annotated Fig 2) to inhibit proximal movement of the drive shell (13). However, Helmer is silent regarding releasing the contact button when a distal surface of the contact button contacts the proximal end of the housing.
Boyd teaches a controlled multidosing delivery device (medication delivery device 1, Fig 1A) comprises a housing (housing 4, Fig 1A); a barrel (cartridge 3, Fig 1A) having a delivery conduit (outlet 3’, Fig 1A); a plunger stopper (moveable piston 5, Fig 1A); a drive shell (10, Fig 1A) includes an elongated drive arm (10_2, Annotated Fig 4) and an elongated retention arm (10_1, See annotated Fig 4), at least one of the retention fingers (2000_1, Ann Annotated Fig 4) and the plurality of retention surfaces (2001_1, Ann Annotated Fig 4) being associated with the retention arm (10_1), and the plurality of engagement surfaces (2001_1, Ann Annotated Fig 4) being associated with the drive arm (10_2); a biasing structure (resilient member 21 [0066]: “for instance a circular spring, a leaf spring or a coil spring.”, Fig 1) disposed to bias the contact button (drive member 17; [0076]) away from the housing (4); and whereby the biasing structure (21) translates the plunger rod (18) in the proximal direction following translation of the drive shell (10). Boyd further teaches a contact button (drive member 17) and releasing the contact button when a distal surface of the contact button contacts the proximal end of the housing. (Fig 3 shows the final dose dispensed and the contact button (17) contacts the proximal end of the housing 4)
Therefore, it would have been obvious for one of ordinary skill in the art before the effective
filing date of the claim invention to modify the contact button, and grip surface and dose member of the method of Helmer/Boyd/Berenshteyn to be a unitary structure of similar geometry as taught by Boyd to improve user experience since less components are required, and all functions of the individual parts will be performed by a single piece. Button as modified with the teaching of Boyd is released upon contact with the housing ([0076]; Fig 3).
Regarding claim 26, Helmer/Boyd/Berenshteyn discloses the method of claim 25. Helmer discloses further including repeatedly depressing and releasing the contact button (8) to administer subsequent controlled doses. ([0035]: “The drug delivery device according to FIG. 1 is configured to deliver a plurality of fixed doses of a drug”; depression and release of contact button is performed for each dose)
Regarding claim 27, Helmer/Boyd/Berenshteyn discloses the method of claim 25. Helmer discloses including priming the syringe after coupling the housing (2) to the syringe barrel (3) ([0007]: “the device is primed before the first usage”; in order for the device to be primed the barrel would need to be inserted and coupled to the housing).
Regarding claim 28, Helmer/Boyd/Berenshteyn discloses the method of claim 25. Helmer discloses further including filling the syringe (cartridge 3 has fluid which was filled at some point ([0002]; [0023)).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Helmer et al. (US 20130041325 A1) in view of Boyd et al. (US 20100137792 A1) in further view of Berenshteyn et al. (US 10245386 B1) in view of Schwab (US 20080287913 A1).
Regarding claim 11, Helmer/Boyd/Berenshteyn discloses the controlled multidosing delivery device of claim 1. Helmer is silent wherein the retaining structure includes a retaining pin secured with and extending from the elongated shaft, the retaining pin being disposed within the housing.
Schwab teaches a device (syringe, Fig 2A-2B) comprising retaining structure (pin 306, Fig 2A-B) includes a retaining pin (306) secured with and extending from the elongated shaft (210, Fig 2A-2B), the retaining pin (306) being disposed within the housing (plunger 206, Fig 2A-2B).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective
filing date of the claim invention to modify the device of Helmer/Boyd/Berenshteyn to include a pin secured to the elongated shaft and a corresponding slot in the housing as taught by Schwab to have additional securing means and limit the movement of the elongated shaft to a desired distance ([0021]).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Helmer et al. (US 20130041325 A1) in view of Boyd et al. (US 20100137792 A1) in further view of Berenshteyn et al. (US 10245386 B1) in view of Dasbach et al. (US 20130018327 A1).
Regarding claim 13, Helmer/Boyd/Berenshteyn discloses the controlled multidosing delivery device of claim 12. Helmer is silent wherein the spring is disposed about the elongated shaft between the contact button and the proximal end of the housing.
Dasbach teaches a controlled multidosing delivery device (100, Fig 5) comprising a housing (housing 10, Fig 5) an elongated shaft (drive element 20) and a biasing structure (bias support element 60, Fig 5) disposed to bias a contact button (dose button 24, Fig 5) away from the housing ([0116]); wherein the spring (60) is disposed about the elongated shaft (20) between the contact button (24) and the proximal end of the housing (10).
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Therefore, it would have been obvious for one of ordinary skill in the art before the effective
filing date of the claim invention to modify the location of the spring of Helmer/Boyd/Berenshteyn to be in contact with the button disposed about the elongated shaft between the contact button and the proximal end of the housing as taught by Dasbach to bias the button and elongated member in the proximal direction after a dose has been dispensed, eliminating the need to manually pull the button 8, which improves user experience and efficiency ([0116]).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Helmer et al. (US 20130041325 A1) in view of Boyd et al. (US 20100137792 A1) in further view of Berenshteyn et al. (US 10245386 B1) in view of Dasbach et al. (US 20130018327 A1) in further view of Jansen et al. (US 20020120239 A1).
Regarding claim 14, Helmer/Boyd/Berenshteyn/Dasbach discloses the controlled multidosing delivery device of claim 13. Helmer is silent regarding further including a sleeve disposed about the spring.
Jansen teaches a device (syringe, Fig 1) comprising a sleeve (end fitting 32, Fig 5) disposed about a spring (spring 30, Fig 5) ([0044]).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective
filing date of the claim invention to modify the device disclosed by Helmer/Boyd/Berenshteyn/Dasbach to include a similar sleeve as the one taught by Jansen to provide support and stability of the spring as well as maintaining its position ([0044]).
Claim 15, and 23-24 are rejected under 35 U.S.C. 103 as being unpatentable over Helmer et al. (US 20130041325 A1) in view of Boyd et al. (US 20100137792 A1) in further view of Berenshteyn et al. (US 10245386 B1) in view of Marsh et al. (US 20170128673 A1).
Regarding claim 15, Helmer/Boyd/Berenshteyn disclose the controlled multidosing delivery device of claim 1. However, Helmer is silent regarding further including a cover coupled to the housing over the axially extending chamber.
Marsh teaches a device (Fig 1-3) comprising a housing (housing 10, Fig 1) and a chamber (chamber of housing 10, Fig 2); the device further includes a cover (translucent window covering opening 11b; [0136]: “FIGS. 17a and 17b. To reduce dust ingress and prevent the user from touching moving parts, these openings 11a, 11 b are covered by translucent windows. These windows may be separate components”) coupled to the housing (10) over the axially extending chamber (chamber of housing 10, Fig 2).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective
filing date of the claim invention to modify the device of Helmer/Boyd/Berenshteyn to create a housing opening and a translucent cover similar to the ones taught by Marsh to have a visual indication of the number of doses that has been injected based on the position of the elongated member ([0136]). Additionally, the transparent cover prevents intrusion of dirt into the device ([0056]).
Regarding claim 23, Helmer/Boyd/Berenshteyn discloses the controlled multidosing delivery device of claim 1. Helmer is silent regarding further including a visual indicator of at least one of a number of doses delivered or a number of doses remaining in the syringe.
Marsh teaches a device (Fig 1-3) comprising a housing (housing 10, Fig 1) and a chamber (chamber of housing 10, Fig 2); the device further includes a cover (translucent window covering opening 11a-b; [0136]: “FIGS. 17a and 17b. To reduce dust ingress and prevent the user from touching moving parts, these openings 11a, 11 b are covered by translucent windows. These windows may be separate components”) coupled to the housing (10) and a visual indicator (visual feedback; [0134]) of at least one of a number of doses delivered or a number of doses remaining in the syringe ([0134])
Therefore, it would have been obvious for one of ordinary skill in the art before the effective
filing date of the claim invention to modify the device of Helmer/Boyd/Berenshteyn to create a housing opening and include a translucent window similar to the ones taught by Marsh ([0136]) to have a visual indication of the number of doses that has been injected based on the position of the drive shell which creates a sliding scale similar to the one taught by Marsh ([0134])
Regarding claim 24, Helmer/Boyd/Berenshteyn/Marsh discloses the controlled multidosing delivery device of claim 23. Helmer disclose the visual indicator (See claim 23) includes at least window (house opening and translucent window, see claim 23). Helmer is are silent wherein the window disposed to view a position of a portion of the drive shell within the housing.
Boyd further teaches a window (window [0074]) disposed to view a position of a portion of a drive shell within the housing. ([0074]: “visual feedback regarding dose dispense may optionally be indicated by a graphical status indicator, provided on the drive member 17, which can be viewed through the optional window to the drive member 4' in the main housing 4.”)
Note: The device of Helmer/Boyd/Marsh will have the opening in the housing and the transparent window as modified in claim 23 now configure to see the position of drive shell. The drive shell and transparent window creates a drive scale as previously shown in claim 23 as taught by Marsh ([0134]).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claim invention to configure the window of Helmer/Boyd/Berenshteyn/Marsh to view a position of a portion of the drive shell within the housing implementing the teaching of Boyd ([0070]).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Helmer et al. (US 20130041325 A1) in view of Boyd et al. (US 20100137792 A1) in further view of Berenshteyn et al. (US 10245386 B1) in view of Klintenstedt et al. (US 20160166769 A1) in further view of Cowe (US 20170361022 A1).
Regarding claim 20, Helmer/Boyd/Berenshteyn discloses the controlled multidosing delivery device of claim 1. Helmer is silent regarding further including an elastomeric washer adapted to be disposed between the housing and the syringe proximal end.
Klintenstedt teaches a device (Fig 7) including at least one clip (retaining member 50, Fig 7) further including a washer (56) adapted to be disposed between the housing (housing of device 40, Fig 6) and the syringe proximal end (3002, Annotated Fig 6) (distal end of medicament delivery device 40, Fig 7) ([0057]; Fig 5 shows the engagement of the components).
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Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Helmer/Boyd/Berenshteyn with similar washer as taught by Klintenstedt for the purpose of securing the syringe components to the housing allowing large tolerances without affecting the accuracy of the dose delivery and protecting contact surfaces ([0053]).
Helmer/Boyd/Berenshteyn/Klintenstedt are silent wherein the washer is elastomeric.
Cowe teaches a device (autoinjector 1, Fig 1) comprising a housing (housing 19, Fig 1) and a syringe (syringe barrel 88+ sliding bung 91+ tip of the needle 89). Cowe further teaches an elastomeric washer (cushioning element 47; [0049]: “A cushioning element 47, in the form of an annular washer of elastomeric material is located at the bottom of the cup 43.”)
Therefore, it would have been obvious for one of ordinary skill in the art before the effective
filing date of the claim invention to modify the material of washer of Helmer/Boyd/Berenshteyn/Klintenstedt to be an elastomeric material. The inherent properties of an elastomeric material will further assist to secure the syringe components to the housing allowing large tolerances without affecting the accuracy of the dose delivery and provide cushioning and protection of the internal components being coupled. ([0049])
Claims 29-31 are rejected under 35 U.S.C. 103 as being unpatentable over Helmer et al. (US 20130041325 A1) in view of Boyd et al. (US 20100137792 A1) in further view of Berenshteyn et al. (US 10245386 B1) in view of Cunningham (US 20130066266 A1).
Regarding claim 29, Helmer/Boyd/Berenshteyn discloses the method of claim 25. Helmer is silent regarding further including engaging the delivery conduit within a tumor before depressing the contact button, and moving the delivery conduit to another location with the tumor before again depressing the contact button.
Cunningham teaches a device (delivery system, Fig 5-7) comprising a stereotaxic device (Fig 5); a delivery canula (300; [0045]) having a delivery conduit (tip 330, Fig 7C) and engaging the delivery conduit (330) with a tumor (brain tumor; [0019]) before depressing the contact button, and moving the delivery conduit to another location within the tumor before again depressing the contact button. ([0045]: “Similar to the procedure described above, withdrawal of the delivery cannula can be interrupted at specified distances to allow multiple injections to be made along the delivery cannula's trajectory”)
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claim invention to modify the device of Helmer/Boyd/Berenshteyn to be coupled with a stereotaxic device and delivery canula similar to the ones taught by Cunningham to treat brain tumor by administration of injections at multiple sites, making interruptions along the trajectory of the cannula and depress the contact button to dispense each dose. ([0045]: “Similar to the procedure described above, withdrawal of the delivery cannula can be interrupted at specified distances to allow multiple injections to be made along the delivery cannula's trajectory”).
Regarding claim 30, Helmer/Boyd/Berenshteyn discloses the method of claim 25. Helmer is silent about including inserting at least one of a needle or cannula a desired depth into a tissue prior to depressing the contact button, and further inserting or partially retracting the needle or cannula before again depressing the contact button.
Cunningham teaches a device (delivery system, Fig 5-7) comprising a stereotaxic device (Fig 5); a delivery canula (300; [0045]) having a delivery conduit (tip 330, Fig 7C) and inserting at least one of a needle or cannula (300) a desired depth (insertion depth, [0045]) into a tissue (brain tissue where tumor is located [0019]; [0045]) prior to depressing the contact button, and further inserting or partially retracting the needle or cannula before again depressing the contact button ([0045]: “Similar to the procedure described above, withdrawal of the delivery cannula can be interrupted at specified distances to allow multiple injections to be made along the delivery cannula's trajectory”)
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claim invention to modify the device of Helmer/Boyd/Berenshteyn to be coupled with a stereotaxic device and delivery canula similar to the ones taught by Cunningham to treat brain tumor by administration of injections at multiple sites, making interruptions along the trajectory of the cannula and depress the contact button to dispense each dose. ([0045]: “Similar to the procedure described above, withdrawal of the delivery cannula can be interrupted at specified distances to allow multiple injections to be made along the delivery cannula's trajectory”).
Regarding claim 31, Helmer/Boyd/Berenshteyn discloses the method of claim 25. Helmer is silent about including inserting at least one of a needle or cannula a desired depth into a brain prior to depressing the contact button, and partially retracting the needle or cannula before again depressing the contact button.
Cunningham teaches a device (delivery system, Fig 5-7) comprising a stereotaxic device (Fig 5); a delivery canula (300; [0045]) having a delivery conduit (tip 330, Fig 7C) and inserting at least one of a needle or cannula (300) a desired depth (insertion depth, [0045]) into a brain (brain tissue where tumor is located [0019]; [0045]) prior to depressing the contact button, and further inserting or partially retracting the needle or cannula before again depressing the contact button ([0045]: “Similar to the procedure described above, withdrawal of the delivery cannula can be interrupted at specified distances to allow multiple injections to be made along the delivery cannula's trajectory”)
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claim invention to modify the device of Helmer/Boyd/Berenshteyn to be coupled with a stereotaxic device and delivery canula similar to the ones taught by Cunningham to treat brain tumor by administration of injections at multiple sites, making interruptions along the trajectory of the cannula and depress the contact button to dispense each dose. ([0045]: “Similar to the procedure described above, withdrawal of the delivery cannula can be interrupted at specified distances to allow multiple injections to be made along the delivery cannula's trajectory”).
Response to Arguments
Applicant’s arguments with respect to claims 1-16, and 18-33 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
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/GUILLERMO G PAZ ESTEVEZ/ Examiner, Art Unit 3783
/Lauren P Farrar/Primary Examiner, Art Unit 3783
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