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 .
Claim Rejections - 35 USC § 102
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 17-18 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 17 recites there is insufficient antecedent basis for the limitation “the indicator” in line 1 and “the state” in line 2. For examination purposes “the indicator” has been interpreted as “an indicator” and “the state” has been interpreted as “a state.”
Claim 18 recites the limitation “the activation element” in line 1. There is insufficient antecedent basis for this limitation in the claim. For examination purposes “the activation element” has been interpreted as “an activation element.”
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.
Claim(s) 1-15 and 17-18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by KraMer et al. (Pub. No. 2009/0292240).
Regarding claim 1, KraMer et al. teaches a drug delivery device (10, Fig. 1) comprising: a storage assembly (24, Fig. 1) comprising a first compartment (22) and second compartment (23, see [0029]), wherein the storage assembly (24) transitions from an initial state (state of device prior to movement of 28/29, see [0041]) in which the first compartment (22) and the second compartment (23) are separated to a merged state (state of device when 28/29 are moved, see [0041] and [0043]) in which the first compartment (23) and the second compartment (23) are in fluid communication (see [0043]); a merging trigger (52/56/57/100, Fig. 1) configured for actuation responsive to manipulation ([00421]); a merging mechanism (60/62, Fig. 1) comprising a compression element (62, see [0034]); and wherein the transition between the initial state and the merged state occurs upon the actuation of the merging trigger (60) to cause movement of the merging mechanism (60/62) such that the compression element (62) compresses the first compartment (22, see [0042]-[0043]).
Regarding claim 2, KraMer et al. teaches further comprising an arming trigger (56) configured to actuate responsive to manipulation, wherein the drug delivery device (10) transitions to an armed state (state when 60 prior to firing of 10) when the arming trigger is actuated (see [0046]).
Regarding claim 3, KraMer et al. teaches wherein the merging trigger (52/56/57/100) comprises the arming trigger (56).
Regarding claim 4, KraMer et al. teaches wherein the arming trigger (56) is configured to resist actuation when the storage assembly (24) is in the initial state (see [0042]) and to actuate freely when the storage assembly is in the merged state (see [0046]-[0047] and [0050]; 56 freely actuates by movement of 66).
Regarding claim 5, KraMer et al. teaches wherein the merging trigger (52/56/57/100) comprises a first mechanical element (100) and the merging mechanism (60/62) comprises a second mechanical element (62), wherein actuation of the merging trigger (52/56/57/100) actuates the first mechanical element (100) against the second mechanical element (62) to move the merging mechanism (60/62, see [0042]).
Regarding claim 6, KraMer et al. teaches wherein the first mechanical element (100) comprises a first cam surface (101, Fig. 2) and the second mechanical element (62) comprises a second cam surface (distal end surface of 62). It is the examiner’s position that a “cam surface” is the surface of a rotating or sliding piece and 101 is the surface of 100 which is rotatable and the distal end surface of 62 is a surface of 62 which is slidable within 10).
Regarding claim 7, KraMer et al. teaches wherein the compression element (62) further comprises a compression panel (distal end surface of 62). Thefreedictionary.com defines “panel”as “any distinct section or component of something formed from a sheet of material” and it is the examiner’s position that the distal end surface of 62 is a distinct section of 62 as it the initial section of 62 that engages to apply a force on 60).
Regarding claim 8, KraMer et al. teaches wherein the storage assembly comprises a frangible seal (seal between 22 and 29, Fig. 1, it is the examiner’s position that the seal is frangible as a result of the seal being broken via movement of 29 distally)) disposed between the first compartment (22) and the second compartment (23) to separate the first compartment (22) and the second compartment (23) in the initial state (see Fig. 1 and [0029], [0031] and [0043]).
Regarding claim 9, KraMer et al. teaches wherein the frangible seal (seal between 22 and 29) is configured to separate and provide fluid communication between the first compartment (22) and the second compartment (23) responsive to compressing the first compartment (22, see [0043] it is the examiner’s position that movement of 28 compresses 22 as it reduces the volume of diluent within 22).
Regarding claim 10, KraMer et al. teaches further comprising a first substance (liquid diluent, see [0029]) stored in the first compartment (22) and a second substance (drug, see [0029]) stored in the second compartment (23) when the drug delivery device (10) is in the initial state (state of device prior to movement of 28/29, see [0029]), and wherein the first substance (liquid diluent) and the second substance (drug) mix to form a reconstituted substance when the storage assembly is in the merged state (see [0043]).
Regarding claim 11, KraMer et al. teaches wherein the first substance comprises a diluent (liquid diluent, see [0029]) and the second substance comprises a medical agent (drug, see [0029]).
Regarding claim 12, KraMer et al. teaches wherein a physical characteristic (dissolving of drug) of the medical agent (drug) is controlled (see[0043]; it is the examiner’s position that the dissolving of the drug into the diluent is controlled via the movement of 28 and 29) to promote rapid reconstitution in the diluent (it is the examiner’s position that this is a functional recitation and the and plungers are capable or promoting rapid reconstitution of the diluent).
Regarding claim 13, KraMer et al. teaches wherein the merging trigger (52/56/57/100) includes a mechanical actuator (all of elements 52/56/57/100 are mechanical components of 10; hence, they are mechanical actuators).
Regarding claim 14, KraMer et al. teaches wherein the mechanical actuator (100) includes any of a cap (see [0022]), knob, compression panel, lever, or button.
Regarding claim 15, KraMer et al. teaches wherein the merging trigger (52/56/57/100) includes at least a portion of a shell (13, Fig. 1) of the drug delivery device (10, see [0046, where 52 includes a portion of housing 13).
Regarding claim 17, KraMer et al. teaches wherein the indicator (14, Fig. 4]) includes an indication of the state (mixing state) of the storage assembly (10, see [0044]).
Regarding claim 18, KraMer et al. teaches wherein the activation element (66, Fig. 1; see 112b rejection above for interpretation) is manipulable responsive to actuation of the merging trigger (52/56/57/100, see [0042]-[0050]; 66 is manipulable after stage 1 in which 100 is actuated).
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.
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over KraMer et al. (Pub. No. 2009/0292240) in view of Schiff et al. (Pub. No. 2013/0082057).
Regarding claim 16, KraMer et al. teaches an activation element (80/110, Fig. 2 and see [0037] and [0042]) but does not teach an indicator, the indicator configured to activate responsive to manipulation of the activation element. However, Schiff et al. teaches a drug delivery device (10, Fig. 1) having and indicator (snapping noise, see [0007]) configured to activate response to manipulation of an activation element (cap, see [0007]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the device taught by KraMer et al. by forming the cap to have snapping feature as taught by Schiff et al. to prevent tampering of the device prior to use (see [0007]). Further, KraMer et al. teaches that modification may be made (see [0060]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TIFFANY LEGETTE-THOMPSON whose telephone number is (571)270-7078. The examiner can normally be reached 7:00 am - 4:00 pm.
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/TIFFANY LEGETTE/ Supervisory Patent Examiner, Art Unit 1723