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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 08/05/2026 has been entered.
Response to Amendment
Claim 1 has been amended and claim 14 has been cancelled. No new matter has been entered.
Claims 1-3, 7, 9-13, and 15-20 remain pending; claims 7 and 15-20 remain withdrawn.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-3 and 9-13 are rejected under 35 U.S.C. 103 as being unpatentable over Holmqvist (US 20140343503, henceforth Holmqvist) in view of Jennings et al. (US 20100016793, henceforth Jennings), Habeshaw et al. (WO 2005115508, henceforth Habeshaw), Voellmicke et al. (US 20110092952, henceforth Voellmicke), Laiosa et al. (US 20170259002, henceforth Laiosa), and Fournier et al. (US Pat. No. 10973984, henceforth Fournier).
Regarding claim 1, Holmqvist discloses a drug delivery device (medicament delivery device, [0002]) including a housing (see proximally directed end surface 56 of the housing of the medicament delivery device, figs. 4 and 5b), a syringe (syringes to be positioned within an injection device, [0002] and shown in fig. 5a) comprising a reservoir (interior of the syringe shown in fig. 5a) containing a drug (drug to be delivered, [0005]) and a needle (see fig. 5a) fluidly coupled to the reservoir (see [0004], [0012], and fig. 5a, it is understood that since the needle is described as an injection needle used to deliver a drug and since fluid coupling between the source of the fluid and the needle used to deliver said fluid would have to be required for such an injection, the structures are fluidly coupled), and a cap assembly kit (assembly of fig. 1) the cap assembly kit comprising: a first remover (a first instance of remover body 12 is the claimed first remover and can be used to remove flexible needle shields, fig. 1) having a sidewall (tubular wall of remover body 12, fig. 1) defining a central passage (hollow interior of remover body 12, fig. 1) and configured to receive a first type of needle shield (remover body 12 can be used to remove a flexible needle shield which is a first type of needle shield, see flexible needle shield 58, fig. 6a, and see [0059]-[0061]), the first remover including a first plurality of retention portions (second set of gripping members 24, fig. 1) comprising tabs (gripping members 26, fig. 1) which are angled to extend inwardly into the central passage of the first remover (see fig. 1), the tabs including distally oriented pointed ends (pointed sharp section 30, fig. 1, which is distally oriented where the point is in the direction of lid piece 40, and in the fully assembled device as shown in fig. 5a, the direction towards lid piece 40 is the distal direction) adapted to indent or pierce a portion of the first type of needle shield ([0060], “causes the pointed sections 30 of the second set of gripping members 24 to be pushed into the material of the flexible needle shield” means that there is an indentation or piercing between related bodies as claimed); a second remover (a second instance of remover body 12 is the claimed second remover and can be used to remove rigid needle shields, fig. 1) having a sidewall (tubular wall of remover 12, fig. 1) defining a central passage (hollow interior of remover body 12, fig. 1) and configured to receive a second type of needle shield (remover body 12 can be used to remove a rigid needle shield which is a second type of needle shield, see rigid needle shield 52, fig. 5a, and see [0056]-[0058]), the second remover including a second plurality of retention portions (first set of gripping members 18, fig. 1) comprising tabs (gripping members 20, fig. 1) which are angled to extend inwardly into the central passage of the second remover (see fig. 1), the tabs having a generally rectangular configuration (see fig. 1, gripping members 20 are considered to have a generally rectangular configuration where they have elongated sides which extend generally parallel to longitudinal axis 22, a proximal end which is shown as having a line to demonstrate bending, and a distal end which is rounded with the proximal and distal ends being parallel, especially at a tangent to the distalmost end of gripping member 20 which would extend perpendicularly to longitudinal axis 22), the tabs configured to exert a compression force on the second type of needle shield that is distributed across an axial length (see [0056] and [0058]; when a rigid needle shield is inserted into the assembly of fig. 1, gripping members 20 will exert a radially compressive force on said rigid needle shield as they are flexed radially outwards as disclosed, and this force is distributed across an axial length of the rigid needle shield where it would be applied at the interface between the rigid needle shield and gripping members 20; since the rigid needle shield slides into remover body 12 as shown through figs. 4 and 5a, the force would be distributed along the axial length of the rigid needle shield as the interface between gripping members 20 and the rigid needle shield would travel axially along the outer surface of the rigid needle shield as it is inserted); and a cap housing (cap 14 and lid piece 40, fig. 1) having an internal cavity (interior of cap 14, see fig. 1) and an arrangement to interchangeably receive one of the first remover or the second remover (see fig. 1, the interior of cap 14 is sized such as to be able to receive either a first instance of remover body 12 or a second instance of remover body 12 as shown; the first instance of remover body 12 is the claimed first remover and can be used to remove flexible needle shields and the second instance of remover body 12 is the claimed second remover and can be used to remove rigid needle shields; the two instances of remover bodies are identical structurally but can have different functionalities). Holmqvist additionally appears to show a cassette around the syringe (see fig. 4, there is a structure shown between the syringe and the housing which terminates in proximal end 56; this is considered to be a cassette although it is not called out or referred to further) and it is understood that Holmqvist’s medicament delivery device would require a mechanism to initiate injection as it is described as a medicament delivery device ([0002]) and in order for a medicament delivery device to achieve its functionality of delivering medicament, there must a mechanism which can allow for this functionality.
Holmqvist does not disclose the device wherein the first remover is not configured to remove the second type of needle shield and the second remover is not configured to remove the first type of shield. Jennings and Habeshaw each teach removers (see guiding element 191, fig. 5 of Jennings, and see grip washer 160, fig. 7 of Habeshaw) which are configured to remove needle shields (see rigid needle shield 118, fig. 3 of Jennings, and see rubber needle shield, or boot 120 which is a flexible needle shield, fig. 10 of Habeshaw) and fit into caps (see cap 190, fig. 3 of Jennings, and see cap 130, fig. 9 of Habeshaw) but are not configured to remove other kinds of needle shields (see Jennings [0037], guiding element 191 is configured to remove rigid needle shields such as needle shield 118, and see pg. 5, 7th paragraph of Habeshaw, the remover cuts into the soft plastic or rubber material of the flexible boot, it would not work with a rigid needle shield as it would not be able to cut into it). Additionally, Voellmicke teaches use of a device (shield apparatus 1, fig. 5) which is interchangeable with different syringe components depending on the scenarios of use and the syringe component characteristics (see [0004] and [0009]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the removers of Holmqvist such as to have separate removers which are only configured for removing one kind of needle shield as Jennings and Habeshaw teach this as an acceptable, art equivalent means of removing needle shields from drug delivery device assemblies (see Jennings [0037], the cap is configured to remove rigid needle shields; see pg. 5, 7th paragraph of Habeshaw, the cap and remover are configured to remove flexible needle shields) where such a modification would have yielded the same, predictable result of a drug device assembly which is capable of removing multiple kinds of needle shields with different kinds of removers, and also since Voellmicke teaches that it is beneficial to have components which are prepared for multiple scenarios of use and able to work with syringe components having different structural characteristics (see [0004] and [0009]; in Voellmicke, this is in relation to different needle characteristics, however the same teaching of the benefit of being capable of use a device with different syringe components would also reasonably extend to different needle shields and needle shields removers, and thus it would be beneficial to have multiple needle shield removers configured for removing rigid needle shields or flexible needle shields depending on the specifics of the usage scenario and the structural characteristics of the syringe being used) and finally since it has been held that constructing a formerly integral structure in various elements involves only routine skill in the art. Nerwin v. Erlichman, 168 USPQ 177, 179. Such a modification could entail removing the second plurality of tabs from the first instance of the remover of Holmqvist and removing the first plurality of tabs from the second instance of the remover of Holmqvist such as to yield two different removers configured for removing either flexible or rigid needle shields.
Holmqvist as modified by Jennings, Habeshaw, and Voellmicke does not explicitly disclose that its drug delivery device includes an injection assembly, a cassette, or that the syringe is disposed within a cassette. Laiosa teaches a drug delivery device (drug delivery device 100, fig. 3) including a housing (generally tubular front body 12 and rear tubular rear body 13 make up a housing as shown in fig. 1), an injection assembly (power unit 20, see fig. 3 and see [0042]), a cassette (syringe carrier assembly 36, fig. 3 and [0031]), a syringe (syringe 16, fig. 1) disposed within the cassette ([0031]) and comprising a reservoir (interior of barrel is a reservoir, see [0047]) containing a drug (medicament of [0047]) and a needle (needle 16c, fig. 4) fluidly coupled to the reservoir (see [0051] and see fig. 4 where needle 16c is shown as being directly in contact with the interior of the barrel of syringe 16), and a cap assembly kit (cap assembly 50, [0031] and fig. 5); usable to remove a needle shield (see [0031] and see needle protection shield 50b, fig. 5).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used the device (particularly the structures of drug delivery device 100 shown in fig. 3, which do not include cap assembly 50 or needle protection shield 50b) of Laiosa as the medicament delivery device of Holmqvist (particularly the syringe, cassette, and drug delivery housing shown in fig. 4; needle shields 52 and 58 shown in figs. 5a and 6a are considered to be a part of the cap assembly) as the device of Laiosa has the benefit of ensuring a high degree of safety in handling and in prevention of fault or incomplete injections (Laiosa [0018]) and substituting the medicament delivery device of Holmqvist with the device of Laiosa would yield the same, predictable result of a drug being able to be administered via a drug delivery device where contamination and damage of the needle of the drug delivery device are prevented via a needle shield which is removable via a cap assembly. Such a modification would then be a combination of the medicament delivery device of Laiosa (see drug delivery device 100, fig. 3) with the cap assembly and needle shields of Holmqvist (see assembly of fig. 1 and needle shields of figs. 5a and 6a).
Holmqvist as modified by Jennings, Habeshaw, Voellmicke, and Laiosa additionally teaches that its cap housing has a circumferentially extending ledge or protrusion (protrusion 34, fig. 3) which is configured to cooperate with a circumferential groove (groove 36, fig. 3) for fixing the remover to the cap housing (see [0054]).
Holmqvist as modified does not disclose the cap housing comprising a plurality of arms, wherein at least a portion of each arm of the plurality of arms extends inwardly into the internal cavity of the cap housing and a retention surface configured to engage either the first remover or the second remover as the respective remover is inserted into the internal cavity of the cap housing past the retention surface to interchangeably receive one of the first remover or the second remover. Fournier teaches a cap housing assembly (outer cap 30, figs. 8-14) including a first embodiment which has a circumferentially extending ledge or protrusion (continuous peripheral flange 35, fig. 9) which is configured to cooperate with a circumferential groove (radial recess 22, fig. 9) for fixing the remover to the cap housing (see Col. 4 lines 4-9) and a second embodiment which comprises a plurality of arms (tabs 36, figs. 4 and 5), wherein at least a portion of each arm of the plurality of arms extends inwardly into an internal cavity of a cap housing (see figs. 4 and 5, the tabs 36 extend radially inwards into the hollow opening formed by cap 30) and a retention surface (the free end surface of tabs 36, figs. 4 and 5, which is shown in fig. 5 as being in direct surface contact with radial projection 25) configured to engage a needle shield remover (see fig. 5, the claimed needle shield remover is needle guard 20) as the respective remover is inserted into the internal cavity of the cap housing past the retention surface (see figs. 4 and 5, such an insertion is what causes the engagement shown in fig. 5).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have replaced the aligned grooves of Holmqvist with the arrangement using the plurality of arms as in Fournier as Fournier teaches both arrangements to be equivalent embodiments (see Col. 2 lines 36-56, the embodiments are all taught to be variants of each other achieving the same functionality) and because such a substitution would have yielded the same, predictable result of the cap housing being able to retain a needle shield remover once a needle shield remover was inserted into the cap housing as claimed.
Regarding claim 2, Holmqvist as modified by Jennings, Habeshaw, Voellmicke, Laiosa, and Fournier (henceforth Holmqvist as modified) discloses the device wherein the first type of needle shield has a non-rigid outer wall (flexible needle shield of [0031] is understood to have a non-rigid outer wall which is why it is a flexible needle shield) and the second type of needle shield has a rigid outer wall (rigid needle shield of [0006] is disclosed as having an outer cover made of rigid material).
{Examiner notes that in claim 1 which claim 2 depends on, the first and second needle shields are only functionally recited (“configured to receive a first type of needle shield” only functionally requires that the remover is capable of receiving a needle shield, but the needle shield is not required), and thus claim 2 only requires that the respective first and second removers are capable of working with the claimed needle shields. The respective needle shields are being called out here for clarity.}
Regarding claim 3, Holmqvist as modified discloses the device wherein the first remover and the second remover are each configured to be insertably mounted within the internal cavity of the cap housing (see [0047], [0054] and see figs. 5a-6b).
Regarding claim 9, Holmqvist as modified discloses the device wherein the first plurality of retention portions of the first remover and the second plurality of retention portions of the second remover differ from each other (see fig. 1).
Regarding claim 10, Holmqvist as modified discloses the device wherein the second plurality of retention portions comprise engagement edges that extend generally parallel to a longitudinal axis of the second remover (in the second instance of remover body 12, the exterior edges of gripping members 20, as shown in fig. 1, extend generally parallel to longitudinal axis 22, particularly where there is a bend shown which delineates gipping members 20).
Regarding claim 11, Holmqvist as modified discloses the device wherein the engagement edges have a blunted configuration (see fig. 1, the exterior edges of gripping members 20 is considered to be blunted as the corners are shown as rounded and thus are blunted since blunted means having an edge or point that is not sharp as per Merriam Webster and a corner which is rounded is not considered to be sharp).
Regarding claim 12, Holmqvist as modified discloses the device wherein the second plurality of retention portions are disposed in a proximal axial position of the second remover (see fig. 4, first set of gripping members 18, which are likened to Applicant’s claimed second plurality of retention portions as in claim 1, are placed near the proximal end surface of the tubular wall of the second instance of remover body 12 following the convention established in claim 1).
Regarding claim 13, Holmqvist as modified discloses the device wherein the sidewall of the second remover comprises a crenellation configuration (the tubular sidewall of remover body 12 is considered to have a crenellation configuration where the openings for first set of gripping members 18 exists; Examiner notes that Applicant has defined a crenellation configuration to be a repeating pattern of spaces extending between upstanding portions of the sidewall in [0060] of Applicant’s specification, and thus the axial location of first set of gripping members 18 is a crenellation configuration as there is a repeating pattern of spaces where the gripping members 20 are found and there are upstanding portions of the sidewall between these spaces) with the second plurality of retention portions extending radially inward from longitudinal edges of portions of the crenellation configuration (gripping members 20 extend radially inward from the bending attachment section which is a longitudinal edge of the space portions of the crenellation configuration).
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 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.
Examiner suggests further clarifying the crenellation configuration of claim 13 to add additional structural limitations.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAMUEL J MARRISON whose telephone number is (703)756-1927. The examiner can normally be reached M-F 7:00a-3:30p ET.
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/SAMUEL J MARRISON/Examiner, Art Unit 3783
/EMILY L SCHMIDT/Primary Examiner, Art Unit 3783
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