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 .
Specification
The disclosure is objected to because of the following informalities:
The reference characters “144” in paragraph 0023, line 8 and “145” in paragraph 0023, line 1 are both used to refer to “proximal end”.
The reference character “143” has been used to refer to “plunger rod follower” in paragraph 0024, line 5 and “drive member” in paragraph 0024, line 6.
Appropriate correction is required.
Claim Objections
Claim 14 is objected to because of the following informalities:
Claim 14 recites the limitation “the container holder” in line 4. There is insufficient antecedent basis for this limitation in the claim.
Claim 14 recites the limitation “the ring” in line 4. There is insufficient antecedent basis for this limitation in the claim.
Claim 14 recites the limitation “the ball bearing” in lines 4-5. There is insufficient antecedent basis for this limitation in the claim.
Claim 14 recites the limitation “the compression spring” in line 5. There is insufficient antecedent basis for this limitation in the claim.
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)(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.
Claims 1-7 and 13-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Saussaye (US 10,207,052 B2).
Regarding claim 1, Saussaye teaches a subassembly (components located inside element 1b in figure 1a) for a drug delivery device (figure 1a), comprising:
a housing 1b having a proximal end (end of element 1b comprising element 9), a distal end (end of element 1b facing/touching element 1a), and a sidewall (wall of element 1b) defining an interior (interior of element 1b), the sidewall (wall of element 1b) including at least one opening (opening inside element 1b that enables positioning element 70 and “S”) therethrough;
a plunger rod 5 received at least partially in the housing interior (interior of element 1b), the plunger rod 5 having a proximal end (end of element 5 facing/touching element 80) and a distal end (end of element 5 touching “P”);
a drive member 8 received at least partially in the housing interior (interior of element 1b) and configured to displace the plunger rod 5 distally;
a plunger rod follower 82 received at least partially in the housing interior (interior of element 1b) and having a proximal end (end of element 82 towards element 81) and a distal end (end of element 82 away from element 81), the distal end (end of element 82 away from element 81) of the plunger rod follower 82 configured to couple with the proximal end (end of element 5 facing/touching element 80) of the plunger rod 5 (see figure 5a); and
an indicator 70 received at least partially in the housing interior (interior of element 1b), comprising a proximal end (end of element 70 comprising element 71), a distal end (end of element 70 opposite to element 71), and a sidewall (wall of element 70) therebetween defining an indicator interior (interior of element 70), the indicator 70 comprising one or more resiliently-biased arms (arm or structure connecting element 71 to element 70) having a protrusion 71 thereon, wherein the protrusion 71 is configured to be received at least partially within the opening 9 in the housing sidewall (wall of element 1b) following activation of the drug delivery device (column 7, lines 27-38).
Regarding claim 2, Suassaye teaches further comprising one or more ball bearings 7, the ball bearings 7 being biased radially outward (column 7, lines 14-17) and configured to maintain the drive member 8 in a biased configuration (column 7, lines 14-20).
Regarding claim 3, Suassaye teaches further comprising a ring 23, the ring 23 being slidable relative to the housing 1b between a distal position (position in which element 23 blocks element 7), in which the ring 23 maintains the ball bearings in a biased position (position in which element 7 are tending to move outward), and a proximal position (position where element 23 is no longer contact with element 7), in which the ball bearings are displaced radially outward (column 7, lines 14-17).
Regarding claim 4, Suassaye teaches further comprising a container holder 10, the container holder 10 configured to displace the ring 23 from the distal position to the proximal position (column 7, lines 6-12).
Regarding claim 5, Suassaye teaches wherein the drive member 8 is a compression spring 8, and wherein, in a biased configuration, the compression spring 8 is compressed (column 6, lines 24-28).
Regarding claim 6, Suassaye teaches wherein the one or more resiliently-biased arms (arm or structure connecting element 71 to element 70) are biased radially outwardly (see figures 4a and 5a).
Regarding claim 7, Suassaye teaches wherein the indicator 70 is slidable relative to the housing 1b from a distal position (position shown in figure 4a) in which the protrusion 71 is held within the housing interior (interior of element 1b) and approximal position (position shown in figure 5a) in which the protrusion 71 is received at least partially within the opening 9 in the housing 1b.
Regarding claim 13, Suassaye teaches a drug delivery device (figure 1a), comprising:
a subassembly (components located inside element 1b in figure 1a) comprising:
a housing 1b having a proximal end (end of element 1b comprising element 9), a distal end (end of element 1b facing/touching element 1a), and a sidewall (wall of element 1b) defining an interior (interior of element 1b), the sidewall (wall of element 1b) including at least one opening (opening inside element 1b that enables positioning element 70 and “S”) therethrough;
a plunger rod 5 received at least partially in the housing interior (interior of element 1b), the plunger rod 5 having a proximal end (end of element 5 facing/touching element 80) and a distal end (end of element 5 touching “P”);
a drive member 8 received at least partially in the housing interior (interior of element 1b) and configured to displace the plunger rod 5 distally;
a plunger rod follower 82 received at least partially in the housing interior (interior of element 1b) and having a proximal end (end of element 82 towards element 81) and a distal end (end of element 82 away from element 81), the distal end (end of element 82 away from element 81) of the plunger rod follower 82 configured to couple with the proximal end (end of element 5 facing/touching element 80) of the plunger rod 5 (see figure 5a); and
an indicator 70 received at least partially in the housing interior (interior of element 1b), comprising a proximal end (end of element 70 comprising element 71), a distal end (end of element 70 opposite to element 71), and a sidewall (wall of element 70) therebetween defining an indicator interior (interior of element 70), the indicator 70 comprising one or more resiliently-biased arms (arm or structure connecting element 71 to element 70) having a protrusion 71 thereon, wherein the protrusion 71 is configured to be received at least partially within the opening 9 in the housing sidewall (wall of element 1b) following activation of the drug delivery device (column 7, lines 27-38);
a lower housing 1a;
a syringe “S” received at least partially within the lower housing 1a, the syringe “S” comprising a proximal end (end of element “S” towards element 5), a distal end (end of element “S” towards element “A”), a sidewall (wall of “S”) defining an interior (interior of “S”) configured to receive a medicament, a needle “A” arranged at the distal end of the syringe “S” and in fluid communication with the syringe interior (interior of “S”), and a stopper “P” arranged at the proximal end of the syringe “S” and slidable within the syringe interior (interior of “S”, see figures 4a, 5a), the stopper “P” configured to be contacted by the distal end (end of element 5 touching “P”) of the plunger rod 5; and
a displaceable needle cover 10 having a proximal end 19, a distal end 11 comprising an opening (opening in element 10 through which element “A” protrudes), and a sidewall (wall of element 10) therebetween, the needle cover 10 displaceable between a pre-use position (position shown in figure 2a) in which the needle cover 10 surrounds the needle “A”, a use position (position shown in figure 3a) in which the needle “A” protrudes through the opening in the distal end of the needle cover 10, and a post-use position (position shown in figure 6a), in which the needle cover 10 surrounds the needle “A”.
Regarding claim 14, Suassaye teaches wherein the needle cover 10 is configured such that: displacement of the needle cover 10 from the pre-use to the use position causes displacement of the container holder 4, displacement of the ring 23, and displacement of the ball bearings 7, thereby causing the compression spring 8 to expand from the biased configuration and displace the plunger rod distally (column 7, lines 6-25).
Regarding claim 15, Suassaye teaches wherein, distal displacement of the plunger rod by the compression spring 8 causes distal displacement of the plunger rod follower 82, causing the indicator 70 to be displaced proximally, such that the protrusion is received at least partially within the opening 9 in the housing 1b (column 7, lines 21-25).
Claim Rejections - 35 USC § 103
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) 8 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Saussaye (US 10,207,052 B2) in view of Fabien et al. (US 2018/0169341 A1).
Regarding claim 8, Suassaye discloses the claimed invention substantially as claimed, as set forth above in claims 1 and 7. Suassaye is silent regarding wherein the proximal end of the plunger rod follower is configured to be received within a washer received within the indicator interior, the washer comprising a proximal end and a distal end.
However, Fabien teaches a design of an autoinjector (figure 1b) comprising wherein the proximal end 21 of the plunger rod follower 20 is configured to be received within a washer 19 received within the indicator interior 16, the washer 19 comprising a proximal end (end of element 19 located near element 16) and a distal end (end of element 19 located near element 21) for the purpose of having a well-known alternative approach of using a component between the piston rod follower and the indicator to move the indicator to indicate end of use (paragraph 0086, lines 1-6, paragraph 0087).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the subassembly of Suassaye to incorporate wherein the proximal end of the plunger rod follower is configured to be received within a washer received within the indicator interior, the washer comprising a proximal end and a distal end as taught by Fabien for the purpose of having a well-known alternative approach of using a component between the piston rod follower and the indicator to move the indicator to indicate end of use (paragraph 0086, lines 1-6, paragraph 0087).
Regarding claim 9, Suassaye discloses the claimed invention substantially as claimed, as set forth above in claims 1 and 7. Suassaye is silent regarding wherein the washer comprises, at the proximal end thereof, a narrowed portion configured to releasably receive the proximal end of the plunger rod follower.
However, Fabien teaches wherein the washer 19 comprises, at the proximal end (end of element 19 located near element 16) thereof, a narrowed portion (portion of element 19 received inside element 16) configured to releasably receive the proximal end 21 of the plunger rod follower 20 (by removing elements 19 and 20 from the autoinjector, element 21 could be placed such that small portion of element 21 enters within the gaps formed at the proximal end of element 19 for the purpose of having a well-known alternative approach of using a component between the piston rod follower and the indicator to move the indicator to indicate end of use (paragraph 0086, lines 1-6, paragraph 0087).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the subassembly of Suassaye to incorporate wherein the washer comprises, at the proximal end thereof, a narrowed portion configured to releasably receive the proximal end of the plunger rod follower as taught by Fabien for the purpose of having a well-known alternative approach of using a component between the piston rod follower and the indicator to move the indicator to indicate end of use (paragraph 0086, lines 1-6, paragraph 0087).
Allowable Subject Matter
Claims 10-12 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The closest prior art of record, Saussaye (US 10,207,052 B2) in view of Fabien et al. (US 2018/0169341 A1), is silent regarding wherein the proximal end of the washer is biased radially inward, and wherein the proximal end of the plunger rod follower, when received within the narrowed portion, displaces the proximal end of the washer radially outward against inward bias in combination with other claimed limitations of claim 10.
The closest prior art of record, Saussaye (US 10,207,052 B2) in view of Fabien et al. (US 2018/0169341 A1), is silent regarding wherein, the proximal end of the washer is configured to be displaced radially inward when the plunger rod follower is released from the narrowed portion of the proximal end of the washer in combination with other claimed limitations of claim 11.
Claim 12 being dependent on claim 11 is also allowed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NILAY J SHAH whose telephone number is (571)272-9689. The examiner can normally be reached Monday-Thursday 8:00 AM-4:30 PM EST.
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/NILAY J SHAH/Primary Examiner, Art Unit 3783