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 before the mailing date of the instant action are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Objections
Claim 68 is objected to because of the following informalities:
On line 16 of claim 68, “pressurize” should read “pressurized” to correct a minor typographical error.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
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.
Claim(s) 49-55, 62-65, and 68 are rejected under pre-AIA 35 U.S.C. 102(a)(1) as being anticipated by Anderson et al. (US 2015/0151047; hereafter Anderson).
In regard to claim 49, Anderson discloses an auto-injector (see Figs. 17A-17B), comprising: a housing (600); a container (12) configured to store a medicament (see par. [0109]); a fluid source (21) configured to store a pressurized fluid (see par. [0109]); and a valve assembly (612, 614, 616, 20) fluidly coupled to the fluid source and the container and configured to direct the pressurized fluid from the fluid source towards the container to expel the medicament from the housing (see par. [0186]-[0189]), the valve assembly including a first cavity (space proximal of diaphragm 612), a second cavity (space distal of diaphragm 612), and a diaphragm (612) positioned between the first cavity and the second cavity (see Figs. 17A-17B), wherein, in response to the fluid source releasing the pressurized fluid, a pressure differential is generated within the valve assembly such that the diaphragm is urged away from the first cavity and toward the second cavity to direct the pressurized fluid towards the container through the first cavity (the propellant is released in the first cavity to cause pressure differential to move diaphragm in distal direction), and wherein, in response to the fluid source ceasing release of the pressurized fluid, the pressure differential within the valve assembly reduces, such that the diaphragm is urged away from the second cavity and toward the first cavity to redirect the pressurized fluid into the housing through the second cavity (see par. [0186]- “In contrast, when the a bi-stable diaphragm 612 is in the second configuration, the plug element 616 is no longer disposed in the bore 618 such that vapor pressure in the second chamber 20 may act on the stopper 16 in order to move the stopper axially forwardly and expel medicament.”- the pressurized fluid is used to move the piston 16 after the diaphragm- the location of the pressurized fluid is within the second cavity as defined and the housing- see Fig. 17B).
In regard to claims 50-51, Anderson discloses wherein the diaphragm (612) includes: (i) a body (entirety of diaphragm); (ii) an outer rim (flexible arms of diaphragm) extending outwardly about a periphery of the body; and (iii) a central portion (614) extending outwardly from a center of the body, and wherein the body of the diaphragm is flexible such that the central portion is configured to move relative to the outer rim when the diaphragm is urged toward the first cavity or toward the second cavity (see Figs. 17A-17B).
In regard to claims 52-53, Anderson discloses, wherein the first cavity is configured to receive the pressurized fluid from the fluid source at a first pressure and the second cavity is configured to receive the pressurized fluid from the fluid source at a second pressure that is less than the first pressure (see par. [0186]-[0189]-the propellant is not a continuous source and will expire throughout the injection), and the valve assembly is further configured to generate the pressure differential between the first cavity and the second cavity in response to the first pressure of the pressurized fluid received within the first cavity being greater than the second pressure of the pressurized fluid received within the second cavity (see par. [0186]-[0189]-the propellant is not a continuous source and will expire throughout the injection).
In regard to claims 54-55, Anderson discloses further comprising a needle (15) disposed within the housing, wherein the needle is configured to extend out of the housing and to expel the medicament from the auto-injector after the pressure differential is generated within the valve assembly, and wherein the needle is configured to retract into the housing after expelling the medicament from the auto-injector (see embodiments in Figures 19-21 which show needle exposure and retraction).
In regard to claims 62-64, Anderson discloses a needle (15) configured to move between a retracted position and an extended position; and a resilient member (632) configured to move between an expanded state and a compressed state, wherein: the needle is disposed inside the housing in the retracted position when the resilient member is in the expanded state, the needle is extended out of the housing in the extended position when the resilient member is in the compressed state, the resilient member is moved toward the compressed state from the expanded state as the pressurized fluid is released from the fluid source and the needle is moved toward the extended position, and the resilient member is moved toward the expanded state from the compressed state in response to the pressurized fluid from the fluid source urging the needle back into the housing toward the retracted position (see embodiments in Figures 19-21 which show needle exposure and retraction).
In regard to claim 65, Anderson discloses an auto-injector (see Figs. 17A-17B), comprising: a housing (600); a container (12) disposed within the housing and storing a medicament (see par. [0109]); a fluid source (21) disposed within the housing and storing a pressurized fluid (see par. [0109]); and a valve assembly (612, 614, 616, 20) disposed within the housing and in fluid communication with each of the fluid source and the container (see par. [0186]-[0189]), the valve assembly including a first body (space proximal of diaphragm 612), a second body (space distal of diaphragm 612) coupled to the first body, and a diaphragm (612) coupled between the first body and the second body (see Figs. 17A-17B), wherein, in response to the fluid source releasing the pressurized fluid into the valve assembly, the valve assembly is configured to form a pressure differential between the first body and the second body and the diaphragm is configured to move away from the first body and toward the second body (the propellant is released in the first cavity to cause pressure differential to move diaphragm in distal direction), wherein the first body is configured to direct the pressurized fluid toward the container for delivering the medicament out of the housing (see par. [0186]-[0189]), and wherein, in response to the fluid source ceasing release of the pressurized fluid into the valve assembly, the valve assembly is further configured to reduce the pressure differential between the first body and the second body and the diaphragm is further configured to move away from the second body and toward the first body, wherein the second body is configured to redirect the pressurized fluid into the housing (see par. [0186]- “In contrast, when the a bi-stable diaphragm 612 is in the second configuration, the plug element 616 is no longer disposed in the bore 618 such that vapor pressure in the second chamber 20 may act on the stopper 16 in order to move the stopper axially forwardly and expel medicament.”- the pressurized fluid is used to move the piston 16 after the diaphragm- the location of the pressurized fluid is within the second cavity as defined and the housing- see Fig. 17B).
In regard to claim 65, Anderson discloses an auto-injector (see Figs. 17A-17B), comprising: a housing (600); a container (12) storing a medicament (see par. [0109]); a fluid source (21) storing a pressurized fluid (see par. [0109]); and a valve assembly(612, 614, 616, 20) fluidly coupled to the fluid source and the container, the valve assembly including a diaphragm (612) that is moveable between a high pressure cavity (space proximal of diaphragm 612) and a low pressure cavity (space proximal of diaphragm 612), wherein the fluid source is configured to generate a pressure differential within the valve assembly to move the diaphragm away from the high pressure cavity and into the low pressure cavity in response to releasing the pressurized fluid into the valve assembly (see par. [0186]-[0189]), wherein a portion of the pressurized fluid is directed by the high pressure cavity toward the container for delivering the medicament out of the housing (see par. [0186]-[0189]); wherein the fluid source is configured to reduce the pressure differential within the valve assembly to move the diaphragm away from the low pressure cavity and toward the high pressure cavity in response to terminating further release of the pressurize fluid into the valve assembly, wherein the pressurized fluid released into the valve assembly is directed by the low pressure cavity into the housing for venting (see par. [0186]- “In contrast, when the a bi-stable diaphragm 612 is in the second configuration, the plug element 616 is no longer disposed in the bore 618 such that vapor pressure in the second chamber 20 may act on the stopper 16 in order to move the stopper axially forwardly and expel medicament.”- the pressurized fluid is used to move the piston 16 after the diaphragm- the location of the pressurized fluid is within the second cavity as defined and the housing- see Fig. 17B).
Allowable Subject Matter
Claims 56-61 and 66-67 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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THEODORE J STIGELL whose telephone number is (571)272-8759. The examiner can normally be reached M-F 9-5:30 EST.
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THEODORE J. STIGELL
Primary Examiner
Art Unit 3783
/THEODORE J STIGELL/ Primary Examiner, Art Unit 3783
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