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 .
Claims 1-20 are examined.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-5, 7, 9, 10-11, 15-16, and 20 is/are rejected under 35 U.S.C. 102(1) as being anticipated by Ferreri et al. (US 2013/0345669 A1).
Regarding claim 1, Ferreri discloses a system (delivery device 10, deformable container 20, Fig. 4) comprising an accessory (clip element 30, Fig. 4) for a medical dispensing device (delivery device 10, Fig. 4), comprising:
an assistive dispensing cover (delivery device 10, Fig. 4), comprising an interior passage (See annotated Fig. 4) sized to fit at least partially around a blow- fill-seal (BFS) vial (deformable container 20, Fig. 4) comprising a collapsible fluid reservoir (chamber 23, Fig. 1) containing a liquid ("… a chamber 23 for retaining fluid …" - Para [0040]), an adjustable closure (clip element 30, Fig. 1), and at least one compression structure (longitudinal surfaces 70, Fig. 4) disposed within the interior passage (See annotated Fig. 4);
wherein the assistive dispensing cover is configured to, in response to receiving a compression force exerted thereon, move the adjustable closure from an open position into a closed position ("The embodiments of FIGS. 1-5 are activated by pressing the moveable distal and proximal ends of the clip element together to activate the device …" - Para [0054], Fig. 4) to secure the assistive dispensing cover at least partially around the BFS vial ("The locking element enables the clip element to be secured in place …" - Para [0050]), and
wherein further compressive forces applied to the assistive dispensing cover further advances the adjustable closure until at least one compression structure engages and applies a compressive force to the fluid reservoir ("The embodiments of FIGS. 1-5 are activated by pressing the moveable distal and proximal ends of the clip element together to activate the device and deliver the contents …" - Para [0054]).
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Regarding claim 2, Ferreri discloses the system (delivery device 10, deformable container 20, Fig. 4) comprising an accessory (clip element 30, Fig. 4) for a medical dispensing device (delivery device 10, Fig. 4) as recited above, further comprising
an injection assembly ("… the vascular access device is a syringe …" - Para [0043]) designed to be secured ("The male luer tip 26 may be removably connectable to a female luer connection of a vascular access device." - Para [0040]) to a distal end of the BFS vial ("The deformable container 20 further comprises … an open distal end 25 including a male luer tip 26 …" - Para [0040], Fig. 1).
Regarding claim 3, Ferreri discloses the system (delivery device 10, deformable container 20, Fig. 4) comprising an accessory (clip element 30, Fig. 4) for a medical dispensing device (delivery device 10, Fig. 4) as recited above, wherein
the adjustable closure ("… V-shaped clip element …", Fig. 4) includes a first latch portion ("… one longitudinal end of the clip element …" - Para [0054], See annotated Fig. 4) and a second latch portion ("… the opposite end of the clip element …" - Para [0054], See annotated Fig. 4) that are configured to engage each other ("… the locking element includes a plurality of teeth 92 on one longitudinal end of the clip element which engages a corresponding catch 94 located on the opposite end of the clip element." - Para [0054], Fig. 4), and wherein at least one of the first latch portion and the second latch portion are movable upon an application of the compression force ("The embodiment of FIGS. 1-5 are activated by pressing the moveable distal and proximal ends of the clip element together …" - Para [0054]).
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Regarding claim 4, Ferreri discloses the system (delivery device 10, deformable container 20, Fig. 4) comprising an accessory (clip element 30, Fig. 4) for a medical dispensing device (delivery device 10, Fig. 4) as recited above, wherein
the first latch portion and the second latch portion are configured for advancement toward each other (See the arrows in Fig. 4 above) in order to move the assistive dispensing cover into the closed position ("The embodiments of FIGS. 1-5 are activated by pressing the moveable distal and proximal ends of the clip element together to activate the device …" - Para [0054]), but are not configured for movement in the opposite direction in order to deter opening of the assistive dispensing cover once in the closed position ("The locking element enables the clip element to be secured in place …" - Para [0050]).
Examiner interprets the activation of the device to be the closed position of the device.
Regarding claim 5, Ferreri discloses the system (delivery device 10, deformable container 20, Fig. 4) comprising an accessory (clip element 30, Fig. 4) for a medical dispensing device (delivery device 10, Fig. 4) as recited above, wherein
the first latch portion and the second latch portion are configured for advancement toward each other (See the arrows in Fig. 4 above) until the at least one compression structure (longitudinal surfaces 70, Fig. 4) provides a sufficient force on the fluid reservoir to deliver the liquid from the fluid reservoir ("The clip element 30 comprises a distal end 31, a proximal end 32, and a pivot 33 … for collapsing the deformable container 20 to drive the fluid out of the chamber 23 …" - Para [0040]).
Regarding claim 7, Ferreri discloses the system (delivery device 10, deformable container 20, Fig. 4) comprising an accessory (clip element 30, Fig. 4) for a medical dispensing device (delivery device 10, Fig. 4) as recited above, wherein
the first latch portion (longitudinal surface 70, Fig. 4) comprises a first mating arm (See annotated Fig. 4) having a plurality of indexed protrusion (teeth 92, Fig. 4), and the second latch portion (longitudinal surface 70, Fig. 4) comprises a second mating arm (See annotated Fig. 4) having a plurality of indexed protrusions (catch 94, Fig. 4) ("… the locking element 40 includes at least one protrusion and at least one corresponding cavity." - Para [0045]), and wherein the plurality of indexed protrusions are configured to mate at different stages of engagement between the first mating arm and the second mating arm ("… a plurality of teeth 92 on one longitudinal end of the clip element which engages a corresponding catch 94 …" - Para [0054]) upon continued application of compression forces ("The locking element 40 is arranged to be manually activated by a user …" - Para [0045], See annotated Fig. 4).
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Examiner interprets the different stages of engagement to correspond with the engagement of the catch with different teeth, caused by the compressive force as shown in Fig. 4.
Regarding claim 9, Ferreri discloses the system (delivery device 10, deformable container 20, Fig. 4) comprising an accessory (clip element 30, Fig. 4) for a medical dispensing device (delivery device 10, Fig. 4) as recited above, wherein
the plurality of indexed protrusions are configured to produce an indication ("The locking element 40 provides feedback to the user to confirm delivery of a desired volume of fluid from the chamber 23." - Para [0050]) upon achievement of each of the different stages of engagement between the first mating arm and the second mating arm (See annotated Fig. 4).
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Examiner interprets the delivery of desired volume of fluid from the chamber to be a stage of engagement. The position of the arms in Fig. 4 is another stage of engagement.
Regarding claim 10, Ferreri discloses the system (delivery device 10, deformable container 20, Fig. 4) comprising an accessory (clip element 30, Fig. 4) for a medical dispensing device (delivery device 10, Fig. 4) as recited above, wherein
the indication is audible ("The feedback may be tactile, visual or audible." - Para [0050]).
Regarding claim 11, , Ferreri discloses the system (delivery device 10, deformable container 20, Fig. 4) comprising an accessory (clip element 30, Fig. 4) for a medical dispensing device (delivery device 10, Fig. 4) as recited above, wherein
the first mating arm and the second mating arm are configured for advancement toward each other until the at least one compression structure provides a sufficient force on the fluid reservoir to deliver the liquid from the fluid reservoir ("The embodiments of FIGS. 1-5 are activated by pressing the moveable distal and proximal ends of the clip element together to activate the device and deliver the contents …" - Para [0054], Fig. 4).
Regarding claim 15, Ferreri discloses a system (delivery device 10, deformable container 20, Fig. 4) comprising an accessory (clip element 30, Fig. 4) for a medical dispensing device (delivery device 10, Fig. 4), comprising:
a lockable (lockable element 40, Fig. 1) assistive dispensing cover (delivery device 10, Fig. 4) comprising an interior passage (See annotated Fig. 4 above) sized to fit at least partially around a blow-fill-seal (BFS) vial (deformable container 20, Fig. 4) comprising a collapsible fluid reservoir (chamber 23, Fig. 1) containing a liquid ("… a chamber 23 for retaining fluid …" - Para [0040]), an adjustable closure (clip element 30, Fig. 1), and at least one compression structure disposed within the interior passage (longitudinal surfaces 70, Fig. 4) designed to apply pressure to the fluid reservoir upon engagement with the fluid reservoir ("The clip element 30 comprises a distal end 31, a proximal end 32, and a pivot 33 … for collapsing the deformable container 20 …" - Para [0040]);
wherein the assistive dispensing cover is configured to, in response to receiving a first compression force, move the adjustable closure from an open position into a closed position ("The embodiments of FIGS. 1-5 are activated by pressing the moveable distal and proximal ends of the clip element together to activate the device …" - Para [0054], Fig. 4) to secure the assistive dispensing cover at least partially around the BFS vial ("The locking element enables the clip element to be secured in place …" - Para [0050]), and
wherein additional compression forces applied to the assistive dispensing cover further advances the adjustable closure until at least one compression structure engages the fluid reservoir with a force sufficient to dispense the liquid out of the fluid reservoir ("The embodiments of FIGS. 1-5 are activated by pressing the moveable distal and proximal ends of the clip element together to activate the device and deliver the contents …" - Para [0054]).
Examiner interprets the activation of the device as the closed position.
Regarding claim 16, Ferreri discloses the system (delivery device 10, deformable container 20, Fig. 4) comprising an accessory (clip element 30, Fig. 4) for a medical dispensing device (delivery device 10, Fig. 4) as recited above, further comprising
an injection assembly ("… the vascular access device is a syringe …" - Para [0043]) designed to be secured ("The male luer tip 26 may be removably connectable to a female luer connection of a vascular access device." - Para [0040]) to a distal end of the BFS vial ("The deformable container 20 further comprises … an open distal end 25 including a male luer tip 26 …" - Para [0040], Fig. 1).
Regarding claim 20, , Ferreri discloses the system (delivery device 10, deformable container 20, Fig. 4) comprising an accessory (clip element 30, Fig. 4) for a medical dispensing device (delivery device 10, Fig. 4) as recited above, wherein
the adjustable closure is configured to produce an indication ("The locking element 40 provides feedback to the user to confirm delivery of a desired volume of fluid from the chamber 23." - Para [0050]) upon achievement of each of the different stages of engagement between the first mating arm and the second mating arm (See annotated Fig. 4 above).
Examiner interprets the delivery of desired volume of fluid from the chamber to be a stage of engagement. The position of the arms in Fig. 4 is another stage of engagement.
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) 6, 12-13, 17-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ferreri et al. (US 2013/0345669 A1) in view of Ko et al. (US Pub No. 2023/0095848 A1).
Regarding claim 6, Ferreri discloses the system (delivery device 10, deformable container 20, Fig. 4) comprising an accessory (clip element 30, Fig. 4) for a medical dispensing device (delivery device 10, Fig. 4) as recited above, wherein
the first latch portion and the second latch portion are locked in a mated position after delivery of the liquid ("The locking element 40 enables the clip element 30 to be secured in place after the solution has been expelled." - Para [0050])
Ferreri does not expressly disclose so that the dispensing cover may not be removed from the vial without partial destruction of the cover
Ko teaches so that the dispensing cover (locking guide unit 5, Fig. 5) may not be removed from the vial without partial destruction of the cover ("The locking guide unit 5 according to the present embodiment has a through-hole 500 formed therein to allow the internal needle to pass through, wherein the through-hole 500 is deformed in withdrawal of the penetrating internal needle 110 …" - Para [0071]).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the system of Ferreri to include so that the dispensing cover may not be removed from the vial without partial destruction of the cover as taught by Ko to structurally prevent the re use of thereof (Ko, Para [0004]).
Regarding claim 12, Ferreri discloses the system (delivery device 10, deformable container 20, Fig. 4) comprising an accessory (clip element 30, Fig. 4) for a medical dispensing device (delivery device 10, Fig. 4) as recited above, wherein
the first mating arm and the second mating arm are locked in a mated position after delivery of the liquid ("The locking element 40 enables the clip element 30 to be secured in place after the solution has been expelled." - Para [0050])
Ferreri does not expressly disclose so that the dispensing cover may not be removed from the vial without partial destruction of the dispensing cover.
Ko teaches so that the dispensing cover (locking guide unit 5, Fig. 5) may not be removed from the vial without partial destruction of the dispensing cover ("The locking guide unit 5 according to the present embodiment has a through-hole 500 formed therein to allow the internal needle to pass through, wherein the through-hole 500 is deformed in withdrawal of the penetrating internal needle 110 …" - Para [0071]).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the system of Ferreri to include so that the dispensing cover may not be removed from the vial without partial destruction of the cover as taught by Ko to structurally prevent the re use of thereof (Ko, Para [0004]).
Regarding claim 13, Ferreri discloses the system (delivery device 10, deformable container 20, Fig. 4) comprising an accessory (clip element 30, Fig. 4) for a medical dispensing device (delivery device 10, Fig. 4) as recited above, further comprising
Ferreri does not expressly disclose at least one gripping portion disposed on an outer surface of the assistive dispensing cover.
Ko teaches at least one gripping portion (holder 305, Fig. 3) ("… the shape of the holder 305 has a structure capable of being projected or forming friction …" - Para [0053]) disposed on an outer surface of the assistive dispensing cover (slide casing 30, Figs. 3&4).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the system of Ferreri to include at least one gripping portion disposed on an outer surface of the assistive dispensing cover as taught by Ko to enable an operator to push up the slide casing (Ko, Para [0053]).
Examiner interprets a structure capable of forming friction to be inclusive of a gripping portion.
Regarding claim 17, Ferreri discloses the system (delivery device 10, deformable container 20, Fig. 4) comprising an accessory (clip element 30, Fig. 4) for a medical dispensing device (delivery device 10, Fig. 4) as recited above, wherein
the adjustable closure ("… V-shaped clip element …", Fig. 4) includes a first mating arm ("… one longitudinal end of the clip element …" - Para [0054], See annotated Fig. 4) and a second mating arm ("… the opposite end of the clip element …" - Para [0054], See annotated Fig. 4) that are movable between different stages of engagement (Fig. 4), with a final stage of engagement being locked in a mated position after dispensing the liquid ("The locking element 40 enables the clip element 30 to be secured in place after the solution has been expelled." - Para [0050])
Ferreri does not expressly disclose so that the dispensing cover may not be removed from the vial without partial destruction of the dispensing cover.
Ko teaches so that the dispensing cover (locking guide unit 5, Fig. 5) may not be removed from the vial without partial destruction of the dispensing cover ("The locking guide unit 5 according to the present embodiment has a through-hole 500 formed therein to allow the internal needle to pass through, wherein the through-hole 500 is deformed in withdrawal of the penetrating internal needle 110 …" - Para [0071]).
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Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the system of Ferreri to include so that the dispensing cover may not be removed from the vial without partial destruction of the cover as taught by Ko to structurally prevent the re use of thereof (Ko, Para [0004]).
Regarding claim 18, Ferreri discloses the system (delivery device 10, deformable container 20, Fig. 4) comprising an accessory (clip element 30, Fig. 4) for a medical dispensing device (delivery device 10, Fig. 4) as recited above, further comprising
Ferreri does not expressly disclose at least one gripping portion disposed on an outer surface of the assistive dispensing cover.
Ko teaches at least one gripping portion (holder 305, Fig. 3) ("… the shape of the holder 305 has a structure capable of being projected or forming friction …" - Para [0053]) disposed on an outer surface of the assistive dispensing cover (slide casing 30, Figs. 3&4).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the system of Ferreri to include at least one gripping portion disposed on an outer surface of the assistive dispensing cover as taught by Ko to enable an operator to push up the slide casing (Ko, Para [0053]).
Claim(s) 8 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ferreri et al. (US 2013/0345669 A1) in view of Beran et al. (US Patent No. 11,020,566 B2).
Regarding claim 8, Ferreri discloses the system (delivery device 10, deformable container 20, Fig. 4) comprising an accessory (clip element 30, Fig. 4) for a medical dispensing device (delivery device 10, Fig. 4) as recited above, wherein
the plurality of protrusions of the second mating arm (See annotated Fig. 4) comprises a plurality of teeth (teeth 92, Fig. 4), and wherein upon insertion of the second mating arm within the first mating arm the plurality of teeth mate with the plurality of catches ("… a plurality of teeth 92 on one longitudinal end of the clip element which engages a corresponding catch 94 …" - Para [0054]) ("… the locking element 40 includes at least one protrusion and at least one corresponding cavity." - Para [0045]) securing the assistive dispensing cover into the closed position ("The locking element enables the clip element to be secured in place …" - Para [0050]).
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Ferreri does not expressly disclose that the first mating arm includes a slot sized to receive at least a portion of the second mating arm, the plurality of indexed protrusions comprising a plurality of catches supported within the slot,
Beran teaches that the first mating arm (locking case 719, Fig. 37) includes a slot (opening 721, Fig. 37) sized to receive at least a portion of the second mating arm (gear rack 705, Fig. 37) ("The top opening 720 permits the gear rack 705 to slide into the locking case 719, and allows for engagement of gear rack notches 711 with the teeth of the ratchet 720." - Para [73]), the plurality of indexed protrusions comprising a plurality of catches supported within the slot (a ratchet with teeth 720, Fig. 37),
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the system of Ferreri to include that the first mating arm includes a slot sized to receive at least a portion of the second mating arm, the plurality of indexed protrusions comprising a plurality of catches supported within the slot as taught by Beran to lock the device closed (Beran, Para [66]).
Regarding claim 19, Ferreri discloses the system (delivery device 10, deformable container 20, Fig. 4) comprising an accessory (clip element 30, Fig. 4) for a medical dispensing device (delivery device 10, Fig. 4) as recited above, wherein
the second mating arm (See annotated Fig. 4 above) supporting a plurality of teeth (teeth 92, Fig. 4), and wherein upon insertion of the second mating arm within the first mating arm the plurality of teeth mate with the plurality of catches ("… a plurality of teeth 92 on one longitudinal end of the clip element which engages a corresponding catch 94 …" - Para [0054]) ("… the locking element 40 includes at least one protrusion and at least one corresponding cavity." - Para [0045]).
Ferreri does not expressly disclose that the first mating arm includes a slot sized to receive at least a portion of the second mating arm, the first mating arm supporting a plurality of catches within the slot,
Beran teaches that the first mating arm (locking case 719, Fig. 37) includes a slot (opening 721, Fig. 37) sized to receive at least a portion of the second mating arm (gear rack 705, Fig. 37) ("The top opening 720 permits the gear rack 705 to slide into the locking case 719, and allows for engagement of gear rack notches 711 with the teeth of the ratchet 720." - Para [73]), the first mating arm supporting a plurality of catches within the slot (a ratchet with teeth 720, Fig. 37),
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the system of Ferreri to include that the first mating arm includes a slot sized to receive at least a portion of the second mating arm, the first mating arm supporting a plurality of catches within the slot as taught by Beran to lock the device closed (Beran, Para [66]).
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ferreri et al. (US 2013/0345669 A1) in view of Consolaro et al. (US Patent No. 12,246,127 B2).
Regarding claim 14, Ferreri discloses the system (delivery device 10, deformable container 20, Fig. 4) comprising an accessory (clip element 30, Fig. 4) for a medical dispensing device (delivery device 10, Fig. 4) as recited above, wherein
Ferreri does not expressly disclose that the at least one compressive structure comprises a pair of curved compressive structures positioned at opposing sides of the interior passage.
Consolaro teaches that the at least one compressive structure comprises a pair of curved compressive structures (See annotated Fig. 6A below) positioned at opposing sides of the interior passage (activation compartment 2, Fig. 6A).
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Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the system of Ferrari to include that the at least one compressive structure comprises a pair of curved compressive structures positioned at opposing sides of the interior passage as taught by Consolaro to compress the activation compartment (Consolaro, Para [95]).
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