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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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.
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.
Claim(s) 1-7, 10, 11, and 16-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lev (US 20120323210) in view of Poynter (US 20080083691).
Regarding claim 1, Lev discloses a pre-filled medical delivery assembly (fig. 1) comprising:
(i) a first module (vial 20B in fig. 1) having a first reservoir (bottle 21 in fig. 1) having a first fluid agent therein (liquid medicament 27 in fig. 1) and a first neck (see below) with a first seal at an end thereof (vial stopper 22 in fig. 1), the first neck being in fluid communication with the first reservoir (fig. 7 shows the neck forms a portion of the bottle 21);
(ii) a second module (vial 20A in fig. 1) having a second reservoir (bottle 21 in fig. 1) having a second fluid agent therein (liquid medicament 26 in fig. 1) and a second neck (see below) with a second seal at an end thereof (stopper 22 in fig. 1), the second neck being in fluid communication with the second reservoir fig. 7 shows the neck forms a portion of bottle 21);
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(iii) a first connector (adaptor 130 in fig. 4, 5, and 7) having a first recess (recess formed by skirt 132 and flexing members 133 in fig. 4 and 5; area within dotted line see below) constructed to receive at least part of the first neck of the first module (fig. 7 shows the neck of vial 20B received in the recess formed by 132/133) and an outlet port in fluid communication with the first recess (male connector 137 in fig. 4), the first recess having a first piercing element therein (cannula 134 in fig. 4); and
(iv) a second connector (adaptor 110 in fig. 2, 3, and 7) having a second recess (skirt 112 and flexing members 113 in figs. 2 and 3 form a recess; area within dotted line see below) constructed to receive at least part of the second neck of the second module (fig. 7 shows the neck of module 20A received in the recess formed by 112/133) and an inlet/outlet (I/0) port in fluid communication with the second recess (female connector 117 in fig. 3), the second recess having a second piercing element therein (cannula 114 in fig. 3),
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wherein the first and second connectors are constructed to be coupled together via the outlet port and the 1/O port, so as to provide a fluid path between the first and second reservoirs (fig. 7).
However, Lev does not teach or disclose the modules being (blow-fill-seal) BFS modules.
Poynter teaches a similar module (fig. 3) comprising a reservoir (body portion 200 in fig. 3) and a neck (see below) which comprises a seal (stopper 100 in fig. 5) which is configured to be pierced by a piercing element (fig. 11). Poynter further teaches that the module is a BFS module (paragraph 41). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the first and second modules of Lev to be BFS modules, as taught by Poynter, since Poynter teaches that this method ensures the product is sterile (paragraph 5).
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Regarding claim 2, in the modified assembly of Lev, Lev discloses an end of the second connector having the I/O port has threads for coupling to the first connector (external screw thread 117a in fig. 2).
Regarding claim 3, in the modified assembly of Lev, Lev discloses the first connector is disposed between the first BFS module and the second connector with respect to a longitudinal direction of the first BFS module (fig. 7 shows adaptor 130 positioned between vial 20B and adaptor 110); the second connector is disposed between the second BFS module and the first connector with respect to a longitudinal direction of the second BFS module (fig. 7 shows adaptor 110 positioned between vial 20A and adaptor 130); the first and second connectors are disposed between the first and second BFS modules with respect to a longitudinal direction of either the first or second BFS module (fig. 7 shows both adaptors 110 and 130 between vials 20A and 20B); or any combination of the foregoing.
Regarding claim 4, in the modified assembly of Lev, Lev discloses a first longitudinal direction of the first BFS module extends from the first reservoir toward the first seal (fig. 7), a second longitudinal direction of the second BFS module extends from the second reservoir toward the second seal (fig. 7), and the first and second longitudinal directions are co-axial (fig. 7 shows the entire assembly longitudinally aligned).
Regarding claim 5, in the modified assembly of Lev, Lev discloses a central axis of the outlet port, a central axis of the I/O port, or both are co-axial with the first and second longitudinal directions (fig. 7).
Regarding claim 6, in the modified assembly of Lev, Lev discloses (c) the first piercing element breaches or extends through the first seal (fig. 7 shows the cannula extending through the seal of vial 20B), (d) the second piercing element breaches or extends through the second seal (fig. 7 shows the cannula extending through the seal of vial 20A), or both (c) and (d).
Regarding claim 7, in the modified assembly of Lev, Lev discloses (e) a tip of the first piercing element is spaced from the first seal (fig. 1 shows that in a state prior to assembly, the cannula is spaced apart from the seal 22 of vial 20B), (f) a tip of the second piercing element is spaced from the second seal (fig. 1 shows that in a state prior to assembly, the cannula is spaced apart from seal 22 of vial 20A), or both (e) and (f).
Regarding claim 10, in the modified assembly of Lev, Lev discloses (j) the first recess has a first mating feature (see gray dotted line below), and the first neck has a laterally-protruding portion that is received in the first mating feature (see below); (k) the second recess has a second mating feature, and the second neck has a laterally-protruding portion that is received in the second mating feature (the examiner notes that the second recess designated above has a similar mating feature which receives a similar laterally protruding portion as shown in fig. 7); or both (j) and (k).
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Regarding claim 11, in the modified assembly of Lev, Lev discloses :(I) with the laterally-protruding portion of the first neck received in the first mating feature, the first piercing element breaches or extends through the first seal (fig. 7); (m) with the laterally-protruding portion of the second neck received in the second mating feature, the second piercing element breaches or extends through the second seal (fig. 7); or both (1) and (m).
Regarding claim 16, in the modified assembly of Lev, Lev discloses the first fluid agent, the second fluid agent, or both comprise a vaccine, a drug, a medicament, or a component of any of the foregoing (paragraph 39 discloses that both 26 and 27 in fig. 1 are “liquid medicaments”).
Regarding claim 17, in the modified assembly of Lev, Lev discloses the first seal, the second seal, or both the first and second seals comprise a foil, wax, paper, a section of the respective BFS module, or any combination of the foregoing (as defined in claim 1, the seals are a part of the BFS module so that the seals defined above are “a section of the respective BFS module”).
Regarding claim 18, in the modified assembly of Lev, Lev discloses an administration assembly (syringe 10 in fig. 1) comprising: a hub constructed to be coupled to the I/O port of the second connector so as to provide a fluid path from the second reservoir (see below; paragraph 9); and at least one administration conduit (a conduit exists from the inside of syringe barrel 11 to the outlet of luer 13 in fig. 1) having an outlet at an end thereof longitudinally spaced from the hub (see below; the end of the male luer is shown to extend below the hub designated below so that a portion of the “outlet” is longitudinally spaced from the hub) and being in fluid communication with the second reservoir so as to receive a combination of the first and second fluid agents therefrom (paragraph 10).
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Regarding claim 19, in the modified assembly of Lev, Lev discloses the at least one administration conduit comprises a needle or cannula (paragraph 11 discloses a needle is attached).
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lev in view of Poynter, as applied to claim 1 above, and further in view of Miller (EP 1426069).
Regarding claim 8, modified Lev teaches all of the claimed limitations set forth in claim 1, as discussed above, but does not teach or disclose (g) an exterior of the first connector has a knurled surface, (h) an exterior of the second connector has a knurled surface, or both (g) and (h).
Miller teaches a connector (adaptor 22 in fig. 2) which is configured to attach to a syringe (fig. 2). Miller further teaches that the adaptor comprises a knurled exterior surface (external knurled surface 23 in fig. 2; paragraph 46). Since the second connector of Lev is configured to attach to a syringe (paragraph 9),it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified an exterior of the second connector to have a knurled surface, as taught by Miller, as this modification would facilitate manipulation of the connector during assembly (paragraph 46).
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lev in view of Poynter, as applied to claim 1 above, and further in view of Zinger (US 20030109846).
Regarding claim 9, modified Lev teaches all of the claimed limitations set forth in claim 1, as discussed above. Lev further discloses that the first connector comprises an annular hub surrounding the outlet port (see below). However, modified Lev does not teach or disclose the second connector comprises an annular hub surrounding the I/O port.
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Zingler teaches a similar system (fig. 3) comprising a second connector (second adaptor 30 in fig. 3) comprising an annular hub (second connector 38a in fig. 3) which surrounds an I/O port (outlet 38a in fig. 3) which engages an outlet of a first connector (first connector 24 in fig. 3). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have reversed the structure of the outlet port and I/O port of the first and second connector, respectively, as taught by Zingler, since Zingler teaches that this modification would not impact operation of the device and since it has been held that a mere reversal of parts is an obvious modification. In re Gazda, 219 F.2d 449, 104 USPQ 400 (CCPA 1955)
Claim(s) 13-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lev in view of Poynter, as applied to claim 1 above, and further in view of Rauleder (US 20130183337).
Regarding claim 13, modified Lev teaches all of the claimed limitations set forth in claim 1, as discussed above, but does not teach or disclose (p) a volume of the second reservoir is greater than a volume of the first reservoir; (q) a volume of the second fluid agent is greater than a volume of the first fluid agent; or both (p) and (q).
Rauleder is directed towards a similar assembly (fig. 5) comprising a first reservoir (second container 9 in fig. 2) and a second container (first container 1 in fig. 1). Rauleder further teaches that a volume of the second reservoir is greater than a volume of the first reservoir (figs. 1, 2, and 5). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the volumes of the first and second containers of modified Lev so that a volume of the second reservoir is greater than a volume of the first reservoir, as taught by Rauleder, since Rauleder teaches that this modification ensures adequate mixing space (paragraph 33).
Regarding claim 14, in the modified assembly of Lev, Rauleder discloses the volume of the second reservoir is at least two times greater than the volume of the first reservoir (paragraph 57 discloses that the starting material 10 completely fills the volume of container 9 in fig. 2; paragraph 58 discloses that the volume of container 1 is greater than the combined volumes of materials 7 and 10 in figs. 1 and 2; paragraph 82 discloses that the ratio of volume of first starting material 7 to second starting material 10 is 3:1 so that the volume of container 1 would be more than 2x the volume of container 9).
Regarding claim 15, modified Lev teaches all of the claimed limitations set forth in claim 1, as discussed above, but does not teach or disclose a volume of the second fluid agent is at least 2 ml, and a volume of the first fluid agent is about 0.7 ml.
As discussed above, Rauleder teaches a first fluid agent (starting material 10 in fig. 2) and a second fluid agent (starting material 7) and that the first fluid agent can have a volume of about 0.7 ml (paragraph 90 discloses the container can contain a single dose and that 1 ml of the starting material corresponds to a single dose) and that the second fluid agent can be provided in a volume ratio of 3-1 relative to the first fluid agent so that the volume of the second fluid agent is greater than 2 ml (paragraph 82). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the a volume of the second fluid agent is at least 2 ml, and a volume of the first fluid agent is about 0.7 ml, as taught by Rauleder as it appears the device of Lev would operate as intended and Rauleder teaches that these volumes are effective are beneficial in creating a vaccinating agent (paragraph 2).
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lev in view of Poynter, as applied to claims 1, 18, and 19 above, and further in view of Richard (US 4252118).
Regarding claim 20, modified Lev teaches all of the claimed limitations set forth in claims 1, 18, and 19, as discussed above, but does not teach or disclose the needle has a length in a range of 0.5 mm to 4 mm, inclusive, or in a range of 4 mm to 15 mm, inclusive, or in a range of 15 mm to 30 mm, inclusive.
Richard is directed towards a similar administration assembly (fig. 1 shows a syringe) comprising a needle (needle 26 in fig. 1) having a length between 10-15 mm (8:48-52). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the length of the needle of modified Lev to have a length between 10-15 mm, as taught by Richard, since Richard teaches that this length offers a high degree of precision (8:45-48).
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lev in view of Poynter, as applied to claims 1 and 18 above, and further in view of Ennis (US 4923448).
Regarding claim 21, modified Lev teaches all of the claimed limitations set forth in claims 1 and 18, as discussed above, but does not teach or disclose the outlet of the at least one administration conduit is formed as a nozzle configured to facilitate dispersion of the combination of the first and second fluid agents into a spray, or the outlet of the at least one administration conduit is formed as a nozzle configured to facilitate dispersion of the combination of the first and second fluid agents into one or more droplets.
Ennis is directed towards a similar administration assembly (syringe 20 in fig. 1) comprising an outlet (nozzle tip 50 in fig. 1) which is formed as a nozzle configured to facilitate dispersion of a fluid agents into a spray (3:21-26). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the outlet to be configured as a nozzle configured to facilitate dispersion of the combination of the first and second fluid agents into a spray, as taught by Ennis, since Ennis teaches that this modification would allow convention syringes which are capable of receiving a needle to also be configured for administration into an ear, eye, nose, or throat (1:15-19).
Claim(s) 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lev in view of Poynter, as applied to claim 1 above, and further in view of Ariagno (US 20130334078).
Regarding claim 22, modified Lev teaches all of the claimed limitations set forth in claim 1, as discussed above. Poynter further teaches that the first and second BFS modules comprise an elastomeric material (paragraph 1 discloses that the stopper 100, which is part of the module, in fig. 5 is elastomeric). However, modified Lev does not explicitly teach or disclose the first connector, the second connector, or both the first and second connectors are formed of a material having a hardness greater than that of the first BFS module, the second BFS module, or both the first and second BFS modules.
Ariagno is directed towards a similar assembly (fig. 2) comprising first and second connectors (sleeves 20 and 30 in fig. 2) which receive first and second modules (containers 70 and 80 in fig. 2), respectively. Ariagno further teaches that the first and second connectors are made from a material having a hardness greater than the first and second modules (paragraph 38 discloses that the sleeves are made from a plastic such as ABS, PC, or acrylic and that the modules comprise an elastomeric stopper; the examiner notes that it is understood that the plastic material of the sleeves is harder than the elastomeric material). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the first and second connectors to be made from a plastic material such as ABS, PC, or acrylic, as taught by Ariagno, so that a material of the connectors is harder than a material of the modules. Ariagno teaches that this modification would render the connectors to be moldable and sterilizable (paragraph 38).
Allowable Subject Matter
Claim 12 is 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 following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 12, the closet prior art is Lev, as discussed above, which does not teach or disclose (n) the first mating feature comprises a scalloped portion of a sidewall of the first recess, and the laterally-protruding portion of the first neck has a toroidal shape in a side view; (o) the second mating feature comprises a scalloped portion of a sidewall of the second recess, and the laterally-protruding portion of the second neck has a toroidal shape in a side view; or both (n) and (o).
Conclusion
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/COURTNEY B FREDRICKSON/ Primary Examiner, Art Unit 3783