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: there appears to be a typo regarding “the bias member 1925” in paragraph [0188] as opposed to “the bias member 1295”. Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
“an energy storage member configured to produce a pressurized gas” in claim 2, line 3, which has been interpreted to be “any suitable member or device that stores potential energy and, when actuated, releases the energy to produce a force. For example, the energy storage member can be any of a gas container, a chemical energy storage member, a spring, or an electrical energy storage member” in accordance with paragraph [0096] of the specification.
“first energy storage member configured to produce a first force” in claim 10, lines 12-13, which has been interpreted to be a bias member, “a spring or the like” in accordance with paragraphs [0124] and [0187-0188]
“second energy storage member being configured to produce a second force” in claim 10, lines 18-19, which has been interpreted to be “any suitable member or device that stores potential energy and, when actuated, releases the energy to produce a force. For example, the energy storage member can be any of a gas container, a chemical energy storage member, a spring, or an electrical energy storage member” in accordance with paragraph [0096] of the specification.
“a bias member configured to apply a proximal retraction force” in claim 4, line 2. This limitation has been interpreted to be “a spring or the like” in accordance with paragraph [0124] of the specification.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 10-14 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 10, the limitation “the second elastomeric member, the first elastomeric member, and a portion of the medicament container collectively defining a second volume containing a second substance” in lines 8-10 is a recitation of new matter. The disclosure as originally filed on 04/30/24 does not provide support for the second volume being defined by the second elastomeric member, the first elastomeric member and a portion of the medicament container. Paragraph [0140] states “The dry medicament volume 1227 is a volume disposed within medicament container 1210 defined between the second elastomeric member 1220 and the seal member 1217 disposed at the distal end portion 1213 of the medicament container 1210”. This is depicted in at least Figure 36. The disclosed “dry medicament volume 1226” is equivalent to the claimed “second volume”. This second volume is disclosed to be defined by the second elastomeric member and a portion of the medicament container, not by the first elastomeric member. It is noted that the claimed “first volume” is disclosed to be defined between the first and second elastomeric members. It is suggested to amend claim 10, lines 8-10 to “the second elastomeric member
Claims 11-14 are rejected for being dependent upon claim 10.
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 1-5, 15-16 and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Edwards (US 2007/0088268), hereinafter Edwards 2007.
Regarding claim 2, Edwards 2007 discloses an apparatus (system 1000), comprising:
a housing (housing 1100) defining a gas chamber (gas chamber 3200);
an energy storage member (gas container 2400) configured to produce a pressurized gas within the gas chamber when the energy storage member is actuated (“system actuator 2000 can comprise a compressed gas container 2400, which initially can contain a compressed gas 2500, an actuating portion of which can be released from container 2400 by penetration of a gas port 2600 via a point of a puncturer 2700.” [0076]);
a medicament container assembly (system actuator 2000 having pre-compressed spring 2300 and compressed gas container 2400) disposed within the housing (Figure 4), the medicament container assembly including a container body (vials 5100) and an elastomeric member (medicament actuator 4000 including pusher 4100, plunger 4300, and piston 4400; “Pistons 4400 can be constructed of a resilient, durable, and/or sealing material, such as a rubber.” [0078]) disposed within the container body (Figure 4), a surface of the elastomeric member (pusher 4100) defining a first portion of a boundary of the gas chamber (Figure 4), the medicament container assembly including a delivery member (needle 6100) coupled to a distal end portion of the container body (Figure 4); and
a sealing assembly (seals 4200 and o-ring 8400) coupled to the medicament container assembly and disposed within the housing (Figure 4), a proximal surface of the sealing assembly defining a second portion of the boundary of the gas chamber (Figures 4-8, wherein seal 4200 seals the gas chamber 3200), the sealing assembly configured to move within the housing from a first sealing assembly position (Figure 4) to a second sealing assembly position (Figure 7) in response to a first force exerted by the pressurized gas on the proximal surface of the sealing assembly (“Referring to FIG. 7, as gas chamber 3200 continues to expand, medicament carrier 9000 can be driven until medicament carrier stop 9400 contacts actuator bar stop 1300 thereby resisting further travel of medicament carrier 9000.” [0085]), the delivery member being outside of the housing when the sealing assembly is in the second sealing assembly position (Figure 7), the elastomeric member (pistons 4440 of medicament actuator 4000) configured to move within the container body to deliver a dose of a medicament from the container body via the delivery member in response to a second force exerted by the pressurized gas on the surface of the elastomeric member (“additional expansion of gas chamber 3200 can cause medicament actuator 4000, pusher bar 4100, plungers 4300, and/or pistons 4400 to initiate travel with respect to medicament storage assembly 5000, thereby generating an expulsion pressure in vials 5100…and allowing medicament 5200 to enter medicament carrier 9000, and begin flowing through medicament channels 9200, medicament conduit 9300, needle 6100, and/or out needle tip 6200 and into a patient.” [0085]);
the sealing assembly including a first seal member (seals 4200) and a second seal member (o-ring 8400), the first seal member disposed within a first groove (between pusher 4100 and walls 1520; Figure 4) between the sealing assembly and an inner surface of the housing (Figures 4-9), the second seal member disposed within a second groove (seat 8500) between the container body and the sealing assembly (Figure 4).
Regarding claim 3, Edwards 2007 discloses the apparatus of claim 2, wherein:
the first seal member (seals 4200) is in sliding contact with the inner surface of the housing (“Seals 4200, such as o-rings, can resist gas leakage, such as past pusher 4100 and/or out of housing 1100. Thus, pusher 4100 can function as a piston traveling within a cylinder,” [0077]; Figures 4-9); and
the second seal member (o-ring 8400) is in contact with a proximal end portion of the container body and the sealing assembly (Figure 4), the second seal member being maintained in a fixed position relative to the first seal member (seal 4200) during movement of the sealing assembly from the first sealing assembly position to the second sealing assembly position (Figures 4-8).
Regarding claim 4, Edwards 2007 discloses the apparatus of claim 2, further comprising: a bias member (compressed springs 1600) configured to apply a proximal retraction force on the medicament container assembly to retract the delivery member into the housing after delivery of the dose of the medicament from the container body (“as sufficient gas is vented from gas chamber 3200, the pressure applied by the gas in gas chamber 3200 can decrease until the force applied by the gas on medicament actuator 4000 is less than the force of compressed spring 1600. Thus, spring(s) 1600 can begin to expand, thereby moving medicament carrier 9000, vial assembly 5000, and medicament actuator 4000 away from actuator bar 1300 and helping to exhaust gas from gas chamber 3200…As medicament carrier 9000 moves away from actuator bar 1300, needle 6100 can retract into sheath 6300 which un-buckles and/or un-deforms towards its original shape. Eventually, needle 6100 can retract completely within the boundaries of housing 1100” [0088-0089]).
Regarding claim 5, Edwards 2007 discloses the apparatus of claim 4, further comprising: a vent assembly (gas venting mechanism 8000) including a vent opening (“a gas escape port located on housing 1100” [0087]) defined by the housing, the vent opening being configured to vent a portion of the pressurized gas to reduce the first force exerted by the pressurized gas to a magnitude that is less than a retraction force exerted by the bias member (“as sufficient gas is vented from gas chamber 3200, the pressure applied by the gas in gas chamber 3200 can decrease until the force applied by the gas on medicament actuator 4000 is less than the force of compressed spring 1600. Thus, spring(s) 1600 can begin to expand, thereby moving medicament carrier 9000, vial assembly 5000, and medicament actuator 4000 away from actuator bar 1300 and helping to exhaust gas from gas chamber 3200” [0088]).
Regarding claim 15, Edwards 2007 discloses a method of delivering a dose of a medicament (method 10000 “for operating a medicament delivery apparatus” [0091]; Figure 10) from a medical injector (system 1000) including a housing (housing 1100), a medicament container (medicament storage assembly 5000) within the housing (Figure 4), a needle (needle 6100) configured to couple ot the medicament container (Figure 4, via common conduit 9300), and an energy storage member (system actuator 2000 having pre-compressed spring 2300 and compressed gas container 2400) within the housing (Figure 4), the method comprising:
actuating the energy storage member (“system actuator 2000 can comprise a compressed gas container 2400, which initially can contain a compressed gas 2500, an actuating portion of which can be released from container 2400 by penetration of a gas port 2600 via a point of a puncturer 2700.” [0076]) to release a pressurized gas within an internal volume (gas chamber 3200) of the housing (“as at least a portion of contents 2500 of gas container 2400 escapes, it can flow through channel 3100. The gas, which can still be relatively pressurized, can begin to accumulate behind pusher 4100 to form an expanding gas chamber 3200” [0084]; see also [0076-0077, 0093]),
moving, in response to a first force produced by the pressurized gas upon the medicament container, the medicament container distally within the housing from a first container position (Figure 4) to a second container position (Figure 7; “as at least a portion of contents 2500 of gas container 2400 escapes, it can flow through channel 3100. The gas, which can still be relatively pressurized, can begin to accumulate behind pusher 4100 to form an expanding gas chamber 3200 and to cause medicament actuator 4000, medicament storage assembly 5000, and medicament carrier 9000 to slide together within sleeve 1500.” [0084]), the needle (needle 6100) extended from the housing when the medicament container is in the second container position (Figure 7), the moving the medicament container compressing a retraction spring (compressed springs 1600)) of the medical injector (“As medicament actuator 4000, medicament storage assembly 5000, and medicament carrier 9000 slide closer to actuator bar 1300, spring 1600 becomes increasingly compressed between bar stop 1320 and medicament carrier stop 9400.” [0084]);
moving, in response to a second force produced by the pressurized gas acting directly upon a surface (pusher bar 4100) of an elastomeric member (medicament actuator 4000 including pusher 4100, plunger 4300, and piston 4400; “Pistons 4400 can be constructed of a resilient, durable, and/or sealing material, such as a rubber.” [0078]), the elastomeric member distally within the medicament container to deliver the dose of the medicament from the medicament container via the needle (“additional expansion of gas chamber 3200 can cause medicament actuator 4000, pusher bar 4100, plungers 4300, and/or pistons 4400 to initiate travel with respect to medicament storage assembly 5000, thereby generating an expulsion pressure in vials 5100, and/or thereby rupturing frangibles 5300 and allowing medicament 5200 to enter medicament carrier 9000, and begin flowing through medicament channels 9200, medicament conduit 9300, needle 6100, and/or out needle tip 6200 and into a patient.” [0085]);
placing the internal volume (gas chamber 3200) in fluid communication with an external volume via a vent opening (“gas escape port located on housing 1100” [0087]) defined by the housing (“As gas chamber 3200 reaches its maximum size, medicament actuator 4000, pusher bar 4100, plungers 4300, and/or pistons 4400 can continue moving until they complete their travel with respect to medicament carrier 9000, thereby causing gas release actuator 9700 to engage with gas release valve 8200. Engagement of gas release actuator 9700 with gas release valve 8200 can cause within gas chamber 3200 to exit gas chamber 3200, discharge away from pistons 4400, and/or exhaust from system 1000 and/or housing 1100, such as via status indicator 1400 and/or a gas escape port located on housing 1100).” [0087]), the vent opening being sized to maintain the first force produced by the pressurized gas on the medicament container at a magnitude that is greater than a retraction force applied by the retraction spring onto the medicament container during a delivery time during which the dose of the medicament is being delivered, the vent opening being sized to such that a portion of the pressurized gas flows therethrough from the internal volume to the external volume to cause the first force to decrease to a magnitude that is less than the retraction force applied by the retraction spring after the delivery time (“As gas chamber 3200 reaches its maximum size, medicament actuator 4000, pusher bar 4100, plungers 4300, and/or pistons 4400 can continue moving until they complete their travel with respect to medicament carrier 9000, thereby causing gas release actuator 9700 to engage with gas release valve 8200. Engagement of gas release actuator 9700 with gas release valve 8200 can cause within gas chamber 3200 to exit gas chamber 3200, discharge away from pistons 4400, and/or exhaust from system 1000 and/or housing 1100…as sufficient gas is vented from gas chamber 3200, the pressure applied by the gas in gas chamber 3200 can decrease until the force applied by the gas on medicament actuator 4000 is less than the force of compressed spring 1600.” [0087-0088]); and
moving, in response to the decrease in the first force, the medicament container proximally within the housing from the second container position towards the first container position to retract the needle into the housing (“Referring to FIG. 8 and FIG. 9, as sufficient gas is vented from gas chamber 3200, the pressure applied by the gas in gas chamber 3200 can decrease until the force applied by the gas on medicament actuator 4000 is less than the force of compressed spring 1600. Thus, spring(s) 1600 can begin to expand, thereby moving medicament carrier 9000, vial assembly 5000, and medicament actuator 4000 away from actuator bar 1300 and helping to exhaust gas from gas chamber 3200…As medicament carrier 9000 moves away from actuator bar 1300, needle 6100 can retract into sheath 6300 which un-buckles and/or un-deforms towards its original shape. Eventually, needle 6100 can retract completely within the boundaries of housing 1100” [0088-0089]).
Regarding claim 16, Edwards 2007 discloses the method of claim 15, wherein the placing the internal volume in fluid communication with the external volume includes: actuating a gas release valve (gas release valve 8200) of a vent assembly (gas venting mechanism 8000), the gas release valve being configured to selectively release the pressurized gas from the internal volume via the vent opening (“As gas chamber 3200 reaches its maximum size, medicament actuator 4000, pusher bar 4100, plungers 4300, and/or pistons 4400 can continue moving until they complete their travel with respect to medicament carrier 9000, thereby causing gas release actuator 9700 to engage with gas release valve 8200. Engagement of gas release actuator 9700 with gas release valve 8200 can cause within gas chamber 3200 to exit gas chamber 3200, discharge away from pistons 4400, and/or exhaust from system 1000 and/or housing 1100, such as via status indicator 1400 and/or a gas escape port located on housing 1100).” [0087]).
Regarding claim 18, Edwards 2007 discloses the method of claim 15, wherein the placing the internal volume in fluid communication with the external volume includes: exposing the vent opening (“gas escape port located on housing 1100” [0087]) in response to a movement of the elastomeric member within the medicament container (“As gas chamber 3200 reaches its maximum size, medicament actuator 4000, pusher bar 4100, plungers 4300, and/or pistons 4400 can continue moving until they complete their travel with respect to medicament carrier 9000, thereby causing gas release actuator 9700 to engage with gas release valve 8200. Engagement of gas release actuator 9700 with gas release valve 8200 can cause within gas chamber 3200 to exit gas chamber 3200, discharge away from pistons 4400, and/or exhaust from system 1000 and/or housing 1100, such as via status indicator 1400 and/or a gas escape port located on housing 1100).” [0087]).
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.
Claims 6-9 are rejected under 35 U.S.C. 103 as being unpatentable over Edwards (US 2007/0088268) in view of Edwards et al. (US 2013/0317477), hereinafter Edwards 2013.
Regarding claims 6-9, Edwards 2007 discloses the apparatus of claim 2, wherein:
the elastomeric member is a first elastomeric member (pistons 4400) disposed within a proximal end portion of the container body (Figure 1);
Edwards fails to explicitly disclose the medicament container assembly includes a second elastomeric member disposed distally from the first elastomeric member within the container body, the second elastomeric member, the first elastomeric member, and a portion of the container body collectively defining a first volume containing a first substance, the second elastomeric member and a distal end portion of the container body defining a second volume containing a second substance; and the container body includes a bypass configured to selectively place the first volume in fluid contact with the second volume, as required by claim 6; wherein the first substance is a liquid diluent and the second substance is a dry medicament, as required by claim 7; wherein the dry medicament includes atropine, as required by claim 8; and wherein the dry medicament includes pralidoxime chloride and atropine, as required by claim 9.
Edwards 2013 teaches an apparatus (medical injector 3000) comprising a housing (housing 3100); an energy storage member (spring 3420); a medicament container assembly (medicament container assembly 3200) including a container body (medicament container 3210) and a first elastomeric member (first elastomeric member 3221) disposed within a proximal end portion of the container body (Figure 10); and the medicament container assembly includes a second elastomeric member (second elastomeric member 3225) disposed distally from the first elastomeric member within the container body (Figure 10 and 12), the second elastomeric member, the first elastomeric member, and a portion of the container body collectively defining a first volume (diluent volume 3236; Figure 10 and 12) containing a first substance that is a liquid diluent (“the diluent volume 3236 can contain a medicament diluent, such as, for example, water” [0057]), the second elastomeric member and a distal end portion of the container body defining a second volume (dry medicament volume 3237; Figure 10 and 12) containing a second substance is a dry medicament (“the dry medicament volume 3237 can contain a lyophilized medicament” [0057]); and the container body includes a bypass (bypass 3220) configured to selectively place the first volume in fluid contact with the second volume (“the mixing piston 3370 moves in the direction of the arrow JJ to place the diluent volume 3236 in fluid communication with the dry medicament volume 3237 via the bypass 3220 such that the diluent within the diluent volume 3236 is transferred to the dry medicament volume 3237.” [0080]; Figure 16); wherein the dry medicament includes pralidoxime chloride and atropine (“Other suitable compositions that can be included in any of the medicament containers and/or devices described herein include pralidoxime chloride and atropine;” [0200]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the apparatus of Edwards 2007 to include a second elastomeric member disposed distally from the first elastomeric member within the container body, the second elastomeric member, the first elastomeric member, and a portion of the container body collectively defining a first volume containing a first substance that is a liquid diluent, the second elastomeric member and a distal end portion of the container body defining a second volume containing a second substance that is a dry medicament; and the container body includes a bypass configured to selectively place the first volume in fluid contact with the second volume, wherein the dry medicament includes pralidoxime chloride and atropine to increase the shelf life and stability of the medicament within the apparatus by storing the medicament in a lyophilized form, allowing for efficient emergency treatment when a user is exposed to a toxin (Edwards 2013 [0003-0008]).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Edwards (US 2007/0088268) in view of Gross (WO 93/23096).
Regarding claim 17, Edwards 2007 discloses the method of claim 15.
Edwards 2007 fails to explicitly disclose wherein the placing the internal volume in fluid communication with the external volume includes: continuously maintaining the vent opening in an unobstructed condition after the actuation of the energy storage member.
Gross teaches a method for delivering a dose of medicament (“The time and rate of delivery of the drug from reservoir 4 to the outlet 6 are controlled by the electrical control circuit 34 for energizing the electrolytic cell 14” [Page 7, lines 7-9]) from a medical injector (Figure 1) including an energy storage member (electrolytic cell 14), the method comprising actuating the energy storage member (electrolytic cell 14) to release a pressurized gas within an internal volume (pressure-control chamber 10b) of a housing (housing 2), the force causing an elastomeric member (diaphragm 12) to move distally to deliver a dose of the medicament (“the electrolytic cell 14 in compartment 16 is electrically controlled to generate a gas at a preselected time and at a preselected rate and to feed the gas to the pressure-control chamber 10b acting on diaphragm 12, to drive the diaphragm through its forward strokes for pumping liquid from the pumping chamber 10a to the outlet 6 via valve Vi.” [Page 5, lines 3-8]); and placing the internal volume in fluid communication with an external volume via a vent opening (slow-acting vent 20), which includes: continuously maintaining the vent opening in an unobstructed condition after the actuation of the energy storage member (“a slow-acting vent 20 for venting the gas from the pressure-control chamber 10b to the atmosphere continuously” [Page 5, line 9-11]; “The pressure-control chamber 10b is continuously vented to the atmosphere via the gas-permeable porous cap 20.” [Page 7, lines 26-27]; Figure 1).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the step of placing the internal volume in fluid communication with the external volume of the method of Edwards 2007 to include continuously maintaining the vent opening in an unobstructed condition after the actuation of the energy storage member based on the teachings of Gross to allow for venting that does not substantially influence the delivery of the medicament, but does allow the pressured gas to be slowly reduced to retract the medicament container assembly (Gross [Page 7, line 27 – Page 8, line 7]).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
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Claims 2-9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, and 5-7 of U.S. Patent No. 12005236 in view of Edwards et al. (US 2013/0317477), hereinafter Edwards 2013.
Claims 1, 3, and 5-7 of USPN 12005236 disclose all of the limitations of the claims 2-9 of the present application (see Table below) except for: the medicament container assembly including a delivery member coupled to a distal end portion of the container body, the delivery member being outside of the housing when the sealing assembly is in the second sealing assembly position, the elastomeric member configured to move within the container body to deliver a dose of a medicament from the container body via the delivery member in response to a second force exerted by the pressurized gas on the surface of the elastomeric member, as required by claim 2; the first substance is a liquid diluent and the second substance is a dry medicament, as required by claim 7; the dry medicament includes atropine, as required by claim 8; and the dry medicament includes pralidoxime chloride and atropine, as required by claim 9
Edwards 2013 teaches an apparatus (3000) comprising a housing (3100); an energy storage member (3420); a medicament container assembly (3200) including a container body (3210) and a first elastomeric member (3221) disposed within a proximal end portion of the container body (Figure 10); the medicament container assembly including a delivery member (3216) coupled to a distal end portion of the container body (Figure 10), the delivery member being outside of the housing when the sealing assembly is in the second sealing assembly position (Figure 17), the elastomeric member configured to move within the container body to deliver a dose of a medicament from the container body via the delivery member in response to a second force exerted by the pressurized gas on the surface of the elastomeric member [0072]; the medicament container assembly includes a second elastomeric member (3225) disposed distally from the first elastomeric member within the container body (Figure 10 and 12), the second elastomeric member, the first elastomeric member, and a portion of the container body collectively defining a first volume (3236; Figure 10 and 12) containing a first substance that is a liquid diluent ([0057]), the second elastomeric member and a distal end portion of the container body defining a second volume (3237; Figure 10 and 12) containing a second substance is a dry medicament ([0057]); and the container body includes a bypass (3220) configured to selectively place the first volume in fluid contact with the second volume ([0080]; Figure 16); wherein the dry medicament includes pralidoxime chloride and atropine ([0200]). Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the apparatus of USPN 12005236 to include a delivery member coupled to a distal end portion of the container body, the first substance that is a liquid diluent, the second substance that is a dry medicament; wherein the dry medicament includes pralidoxime chloride and atropine to increase the shelf life and stability of the medicament within the apparatus by storing the medicament in a lyophilized form, allowing for efficient emergency treatment when a user is exposed to a toxin (Edwards 2013 [0003-0008]).
Claims 15-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 16-18 and 20 of U.S. Patent No. 12005236. Although the claims at issue are not identical, they are not patentably distinct from each other because claims 16-18 and 20 of USPN 12005236 disclose all of the limitations of claims 15-18 of the present application (see Table below), and therefore claims 15-18 are anticipated by claims 16-18 and 20 of USPN 12005236.
Nonstatutory Double Patenting
Present Claims
USPN 12005236
Secondary Art
2
1+3
Edwards et al. (US 2013/0317477)
3
1
4
6
5
7
6
5
7
Edwards et al. (US 2013/0317477)
8
Edwards et al. (US 2013/0317477)
9
Edwards et al. (US 2013/0317477)
10
No DP
11
No DP
12
No DP
13
No DP
14
No DP
15
16
16
17
17
18
18
20
Status of Claims
Claims 2-18 are pending
Claims 10-14 are rejected under 35 U.S.C. 112(a)
Claims 1-5, 15-16 and 18 are rejected under 35 U.S.C. 102(a)(1)
Claims 6-9 and 17 are rejected under 35 U.S.C. 103.
Claims 2-9 and 15-18 are rejected on the ground of nonstatutory double patenting.
There are no current rejections under 35 U.S.C. 102 or 103 or nonstatutory double patenting for claims 10-14
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Edwards et al. (WO 2007126851) discloses an apparatus (13002) comprising a housing (13110); a mixing protrusion (13282); a medicament container (13262) including first and second elastomeric members (Figures 106-107); a first energy storage member (13436) that causes the medicament container to be in a mixing position and a second energy storage member (Figure 104). The medicament container does not move in the proximal direction, and the elastomeric members move in the proximal direction to the mixing position.
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/LEAH J SWANSON/ Examiner, Art Unit 3783
/KEVIN C SIRMONS/ Supervisory Patent Examiner, Art Unit 3783
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