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 .
Response to Amendment
This office action is responsive to the preliminary amendment filed on 5/10/2022. As directed by the amendment: no claims have been amended, claims 1-13 have been cancelled, and claims 14-33 have been added. Thus, claims 14-33 are presently pending in this application.
Claim Objections
Claim 14 recites the limitation “the proximal end of the biased plunger rod” in lines 12 and 14. There is insufficient antecedent basis for this limitation in the claim.
Claim 17 recites the limitation "the first, the second and the third retaining member” in lines 3-4. There is insufficient antecedent basis for this limitation in the claim.
Claim 19 recites the limitation “the first retaining member” in line 4. There is insufficient antecedent basis for this limitation in the claim.
Claim 20 recites the limitation “the second retaining member” in line 4. There is insufficient antecedent basis for this limitation in the claim.
Claim 21 recites the limitation “the third retaining member” in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 23 recites the limitation "the second retaining member” in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 24 recites the limitation “the first and the second retaining member” in line 2 and in line 4. There is insufficient antecedent basis for this limitation in the claim.
Claim 29 is objected to because of the following informalities: “wherein the” is repeated in the sentence twice back to back.
Appropriate correction is required.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 14-33 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Karlsson (US 20140228769 A1).
In regards to claim 14, Karlsson discloses a medicament delivery device (medicament delivery device 1, Fig.1, [0061]), comprising:
a housing (housing 10, Fig.1) having a proximal end (proximal end 2, Fig.1) and a distal end (distal end 3, Fig.1) ;
a medicament container (medicament container 30, Fig.3, [0084]) arranged within the housing (within housing as seen in Fig.3) and comprising a stopper (internal stopper 31, Fig.3, [0074]) and a delivery member (needle 94, Fig.2); a biased delivery member cover (shield sleeve 70 and shield driver 120, Fig.1, [0061]) associated with the housing ("shield sleeve 70 projects from the proximal end of the housing 10" [0064], Fig.1) and movable in relation to the housing (shield sleeve 70 is locked from being rotated relative to the housing [0065], Fig.1);
a biased plunger rod (plunger rod 40, Fig.2, [0068]) associated with the medicament container (plunger rod stops 43 slidably correspond to "corresponding grooves at the inner surface of the medicament container holder 20" [0069] and thus the plunger rod is associated to medicament container 30 [0074] in which container 30 is inside of container holder 20, Fig.2) and movable in relation to the housing (plunger rod moves to the "proximal end of the medicament delivery device" [0092], Fig.6);
a tubular rotator (plunger locking means 60 and medicament container holder 20, Fig.2) associated with both the delivery member cover (plunger locking means 60 is besides medicament holder 20 which is within shield sleeve 70 [0065], Fig.2) and the biased plunger rod (distal abutment surface 67 on plunger locking means 60 forms an initial abutment surface for the plunger rod 40 [0089], Fig. 7);
and a cap assembly (cap assembly 90, Fig.3) associated with the housing (associated with housing by retainer member 92 being connected to shield sleeve 70, [0078], Fig.3);
wherein a gap (space between the internal stopper 31 and the plunger rod 40 [0019], Fig.6) is defined between the proximal end of the biased plunger rod and the stopper of the medicament container (as can be seen in Fig.6, [0019]) when the medicament delivery device is in an assembled state (Fig.6 is when the device is in its assembled state [0084]);
and wherein the proximal end of the biased plunger rod is in contact with the stopper of the medicament container when the medicament delivery device is in a calibrated state (plunger rod is contactable with the stopper when in the loaded state [0019], Fig.6).
In regards to claim 15, Karlsson discloses wherein the tubular rotator (plunger locking means 60, Fig.2,7) comprises a tubular body ( cylindrical configuration, Fig.7, [0066, 0073]) having at least one retaining member (abutment surfaces 67 and 68 [0089], Fig.7) on its inner surface (abutment surfaces 67 and 68 are on inside of the plunger locking means 60, Fig.7).
In regards to claim 16, Karlsson discloses wherein the tubular rotator comprises a first (abutment surfaces 67, Fig.7), a second (abutment surfaces 68, Fig.7) and a third retaining member (inner groove 23) on its inner surface (on the inside of plunger locking means 60 and of medicament container holder 20, Fig.7).
In regards to claim 17, Karlsson discloses wherein the biased plunger rod (plunger rod 40) comprises a counter retaining element (plunger rod stop rib 43, Fig.2, [0089]) configured to interact with the at least one retaining member (plunger rod stop rib 43 abuts axially against the initial abutment surface 67, Fig. 2, [0089]) or selectively (connects with one of the 3 based on stage of the device) with each of the first (abutment surfaces 67, Fig.7), the second (abutment surfaces 68, Fig.7) and the third retaining members (inner groove 23, Fig.8).
In regards to claim 18, Karlsson discloses wherein the biased delivery member cover (shield sleeve 70 and shield driver 120, Fig.1,15 [0061]) comprises a guide element (shield driver 120 contains inner guide protrusion 124 [0037]); and the tubular rotator (plunger locking means 60, Fig.2) comprises a tubular body (as can be seen in Fig.2, [0066, 0073]) arranged with a guide track on its outer surface (the outer surface that outer groove structure 61 and a shield link lock structure 62 is on, Fig.2);
wherein the guide element (inner guide protrusion 124, Fig.2) is configured to interact with the guide track (locks into the guide the grooves of the plunger locking means 60, "inner guide protrusion 124 is finally locked by means of a shield link lock structure 62" [0108], Fig.15) such that an axial movement of the biased delivery member cover causes the tubular rotator to rotate ("movement of the shield sleeve to its second position may result in rotation of the plunger locking means" [0025]).
In regards to claim 19, Karlsson discloses wherein the medicament delivery device is in the assembled state (initial state [0092]) when the tubular rotator is in a first rotation position (when plunger locking means 60 hasn't been rotated yet, as can be seen in Fig.8) which is defined when the biased plunger rod (plunger rod 40) is in an initial position (in the first pic of Fig.8) in which the counter retaining element is engaged with the first retaining member (plunger rod stop rib 43 abuts against the initial abutment surface 67, first figure in Fig.8, [0092]); when the biased delivery member cover (shield sleeve 70 and shield driver 120, Fig. 9) is in a first retracted position (initial state [0095], Fig.9) in which the guide element is positioned on a first distal end point of the guide track ("shield driver 120 engages with an inner guide protrusion 124 into the outer groove structure 61 of the plunger locking means 60" [0095], Fig.9); and when the biased delivery member cover is held in said position by the cap assembly (in the initial state the shield sleeve 70 and shield driver 120 aren't moving and the cap assembly holds it in place as can be seen in Fig.9 [0095]) which is releasably connected to the housing (cap assembly 90 can be taken off when ready for injection [0083]).
In regards to claim 20, Karlsson discloses wherein the medicament delivery device is in the calibrated state (medicament delivery device 1 in the priming state, Fig.11) when the tubular rotator (plunger locking means 60, Fig.2) is in a second rotation position ("rotational movement of the plunger locking means 60 from its initial state to the priming state" [0099], Fig.11) which is defined when the biased plunger rod (plunger rod 40, Fig.2, [0068]) is in a calibrated position in (priming position as plunger rod stop rib 43 moves position [0099]) which the counter retaining element (plunger rod stop rib 43, Fig.2, [0089]) is engaged with the second retaining member (rib stop 43 now engages with abutment surfaces 68 [0099]), and when the biased delivery member cover (shield sleeve 70 and shield driver 120) is in a first extended position (moved in a proximal direction [0099]) in which the guide element (inner guide protrusion 124 [0099]) is positioned on a first proximal end point of the guide track ("inner guide protrusion 124 thereby moved in the outer groove structure 61 of the plunger locking means 60 in proximal direction" [0099]) after the cap assembly is removed from the housing (outer cap 91 has already been removed from the housing, Fig.11, [0099]).
In regards to claim 21, Karlsson discloses wherein the biased plunger rod (plunger rod 40, [0094], Fig.8) is configured to move from the calibrated position to a final position ("displaced further axially towards the proximal end of the medicament delivery device 1" [0094]) in which the counter retaining element (plunger rod stop rib 43, Fig.8, [0094]) is engaged with the third retaining member (plunger rod stop rib 43 abuts against the abutment surface formed by the inner dose groove 23, Fig.8, [0094, 0102]) when the biased delivery member cover is moved from the first extended position to a second retracted position in which the guide element (inner guide protrusion 124) is positioned on a second distal end point of the guide track ("inner guide protrusion 124 has moved (along with the shield driver 120) along an inclined groove in distal direction relative to the plunger locking means 60" [01730], Fig.14) such that the medicament contained in the medicament container is thereby delivered to a user of the medicament delivery device (medicament delivery device 1 upon injection activation as demonstrated by Fig.14, so the medicament will be delivered to the patient [0107]).
In regards to claim 22, Karlsson discloses wherein the biased delivery member cover (shield sleeve 70 and shield driver 120) is axially movable from the first retracted position initial state [0095], Fig.9) to the first extended position (moved in a proximal direction [0099]);
from the first extended position (moved in a proximal direction [0099]) to the second retracted position (shield sleeve 70 is no longer axially locked [0103]) ; and from the second retracted position to a second extended position in which the guide element (inner guide protrusion 124) is positioned on a second proximal end point of the guide track (inner guide protrusion 124 has moved along an inclined groove in distal direction relative to the plunger locking means 60 [0107], Fig.14);
such that the delivery member is extended (" the pointed distal end 96 of the needle 94 penetrates the sterile barrier 924" [0083]) from the delivery member cover (needle 94 extends past shield sleeve 70 and shield driver 120 as seen in Fig.6) when the delivery member cover is in the first and the second retracted positions (needle 94 penetrates through the seal when user starts to turn device when it's ready for the injection, as seen in Fig.6); and is covered by the delivery member cover when the delivery member cover is in the first and the second extended positions (when shield sleeve 70 and shield driver 120 are in their initial and dosing stage, the needle is still contained within the device, Fig.9).
In regards to claim 23, Karlsson discloses wherein the counter retaining element (plunger rod stop rib 43) is configured to disengage with the second retaining member (plunger rod stop rib 43 disengages with abutment surfaces 68 to abut against inner dose groove 23 [0094], Fig.8) when the biased delivery member cover (shield sleeve 70 and shield driver 120) is axially movable from the first extended position to the second retracted position (moved from a proximal direction [0099]) to the shield sleeve 70 is no longer axially locked, moved out of engagement [0103] ) such that the tubular rotator (plunger locking means 60) is moved from the second rotation position (in the priming state [0099], Fig.11) to a third rotation position (when "plunger locking means 60 are moved out of engagement with the distal end of the shield sleeve 70" [0103]).
In regards to claim 24, Karlsson discloses wherein the tubular rotator (plunger locking means 60, Fig.2) comprises a ramp surface arranged between the first and the second retaining member (between abutment surfaces 67 and abutment surface 68 there is a level difference between the two as seen in Fig.1,7); wherein the counter retaining element is configured to move along the ramp surface from the first retaining member to the second retaining member (plunger rod stop rib 43 moves from the initial abutment surface 67 to the priming abutment surface 68 [0099], Fig.7).
In regards to claim 25, Karlsson discloses wherein the axial movement of the biased delivery member cover (shield sleeve 70 and shield driver 120) from the first retracted position to the first extended position (when it goes from the initial state [0095] to moving in the proximal direction [0099]) causes (shield sleeve 70 is moved in a proximal direction to which then causes movement of the plunger locking means 60 [0099], Fig.11) the tubular rotator to rotate from the first rotation position to the second rotation position (when plunger locking means 60 rotates to where the plunger rod stop rib engages with abutment surface 67 and then abutment surface 68 [0099]).
In regards to claim 26, Karlsson discloses wherein the medicament delivery device comprises a resilient member (resilient member 80 [0208]) configured to proximally bias the biased delivery cover member ("the first resilient member 80 urges the shield sleeve 70 to again protrude proximally from the housing 10" [0108], Fig.15).
In regards to claim 27, Karlsson discloses a medicament delivery device, comprising:
a housing (housing 10, Fig.1) having a proximal end (proximal end 2, Fig.1) and a distal end (distal end 3, Fig.1) ; a medicament container (medicament container 30, Fig.3, [0084]) arranged within the housing (within housing as seen in Fig.3) and comprising a stopper (internal stopper 31, Fig.3, [0074]) and a delivery member (92); a biased delivery member cover (shield sleeve 70 and shield driver 120, Fig.1, [0061]) associated with the housing ("shield sleeve 70 projects from the proximal end of the housing 10" [0064], Fig.1) and movable in relation to the housing (shield sleeve 70 is locked from being rotated relative to the housing [0065], Fig.1);
a spring biased plunger rod (plunger rod 40 is spring based since second resilient member 50, that can be a spring, "is at least with its proximal part received in a central bore of the plunger rod 40. Furthermore, the plunger rod guide rod 55 extends into the distal part of the second resilient member 50" [0068, Fig.2) movable in relation to the housing (plunger rod moves to the "proximal end of the medicament delivery device" [0092], Fig.6); from an assembled state (Fig.6 is when the device is in its assembled state [0084]) to a calibrated state (medicament delivery device 1 in the priming state, Fig.11) prior to activation of the medicament delivery device (still occurs before the medicament is delivered and dosage is chosen) where medicament in the medicament container (medicament container 30, Fig. 3, [0082]) is delivered through the delivery member (medicament is delivered via needle 94 [0082]); and a tubular rotator (plunger locking means 60 and medicament container holder 20, Fig.2) associated with both the delivery member cover (plunger locking means 60 is besides medicament holder 20 which is within shield sleeve 70 [0065], Fig.2)and the biased plunger rod (distal abutment surface 67 on plunger locking means 60 forms an initial abutment surface for the plunger rod 40 [0089], Fig. 7);
wherein when the plunger rod is in the assembled state (plunger rod 40 is in assembled state in Fig.6) there is a gap between a proximal end of the biased plunger rod and the stopper (space between the internal stopper 31 and the plunger rod 40 [0019], Fig.6) , wherein when the plunger rod is in the calibrated state the proximal end of the biased plunger rod is in contact with the stopper (plunger rod is contactable with the stopper when in the loaded state [0019], Fig.6), and wherein axial movement of delivery member cover (shield sleeve 70 and shield driver 120 moving to the second position [0025]) relative to the housing causes the plunger rod to transition (as the shield sleeve 70 is moved and locked into place [0101], the plunger rod moves [0102]) from the assembled state to the calibrated state (is when the plunger rod moves to set up dosing [0102]) .
In regards to claim 28, Karlsson discloses that the device further comprises a cap assembly (cap assembly 90, Fig.3) removably attached to the housing (cap assembly 90 can be taken off when ready for injection [0083]).
In regards to claim 29, Karlsson discloses herein the wherein the rotator (plunger locking means 60) comprises an inner surface (abutment surfaces 67 and 68 on inside of the plunger locking means 60, Fig.7) having a first retaining member (abutment surfaces 67 [0089], Fig.7) and a second retaining member (abutment surfaces 68 [0089], Fig.7).
In regards to claim 30, Karlsson discloses wherein the plunger rod comprises a counter retaining element plunger rod stop rib 43, Fig.2, [0089]) t that interacts with first retaining member (plunger rod stop rib 43 abuts axially against the initial abutment surface 67, Fig. 2, [0089]) and then subsequently with the second retaining member (the plunger rod stop rib 43 is rotationally and axially moved to the priming abutment surface 68" [0089]).
In regards to claim 31, Karlsson discloses wherein the axial movement of delivery member (when user turns to remove the outer cap 91 and thus the needle 94 is moved [0083]) rotates the rotator (rotates the plunger locking means 60 [0088,0091]) causing (so then can set the dose [0102]) the counter retaining element (plunger rod stop rib 43) to disengage from the first retaining member and to engage the second retaining member ("plunger rod stop rib 43 is now moved from the initial abutment surface 67 to the priming abutment surface 68" [0099]).
In regards to claim 32, Karlsson discloses wherein the rotator (plunger locking means 60, Fig.2) comprises a ramp surface arranged between the first and the second retaining member (between abutment surfaces 67 and abutment surface 68 there is a level difference between the two as seen in Fig.1,7) such that the counter retaining element moves along the ramp surface as the rotator is rotated (plunger rod stop rib 43 moves from the initial abutment surface 67 to the priming abutment surface 68 as plunger locking means 60 is rotated [0099], Fig.7).
In regards to claim 33, Karlsson discloses wherein the delivery member cover moves axially (shield sleeve 70 and shield driver 120) from a first retracted position to a first extended position (when it goes from the initial state [0095] to moving in the proximal direction [0099]), then from the first extended position to a second retracted position (shield sleeve 70 is no longer axially locked, moved out of engagement [0103]), and then from the second retracted position to a second extended position (when shield sleeve 70 and shield driver 120 are in their initial and dosing stage, Fig.9).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMINA JAMIL ISHRAT whose telephone number is (703)756-4563. The examiner can normally be reached Monday-Friday 7:30am-5pm ET.
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/AMINA ISHRAT/Examiner, Art Unit 3783
/BHISMA MEHTA/Supervisory Patent Examiner, Art Unit 3783
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