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 .
Claims 1, 19 and 21-31 are examined in this office action.
Claims 27 and 31 are currently amended.
Claims 2-16 are cancelled.
Claims 17-18 and 20 are withdrawn.
Election/Restrictions
Claims 17, 18, and 20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 8/13/2026.
Claim Rejections - 35 USC § 112
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.
Claim 21 is 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 21 recites the limitation "the second component" in line 2. There is insufficient antecedent basis for this limitation in the claim.
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, 19, 22-25, 27-28, and 30 is/are rejected under 35 U.S.C. 102(1) as being anticipated by Goumeniouk et al. (US Pub No. 2018/0344950 A1).
Regarding claim 1, Goumeniouk discloses a high-dose drug delivery device (embodiment 100 and 200, Figs. 2-4) comprising:
a first body part (See annotated Fig. 4);
a second body part (top housing element 201, Fig. 4);
an internal chamber within the first body part (medication storage depot 113, Fig. 2);
an actuator mechanism (threads 202 and gas cylinder 103, Fig. 40) configured to rotate at least one of the first body part or the second body part with respect to one another ("The proximal end of the gas cylinder 103 abuts the interior underside of the housing element 201 such that … an approximately quarter turn of said housing element 201 in relation to threads 202 …" - Para [0056]) about a central axis of the high-dose drug delivery device (See annotated Fig. 4);
a first attachment part (conduit 120, Fig. 2) in communication with the internal chamber (as shown in Fig. 2); and
an injector mechanism (gas 106, gas cylinder 103, spring 104, and spike 105 Fig. 2) configured to apply pressure on the internal chamber during or after rotation of the first body part or the second body part with respect to one another ("… the pressurized gas 106 discharged from the gas cylinder 103 drives pneumatic actuator 109 … to drive hydraulic piston 110 … to advance piston 110 thereby dispensing a precise amount of medication 112 stored in a substantially cylindrical medication storage depot 113." - Para [0038]).
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Regarding claim 19, Goumeniouk discloses the high-dose drug delivery device (embodiment 100 and 200, Figs. 2-4), wherein
the injector mechanism (gas 106, gas cylinder 103, spring 104, and spike 105 Fig. 2) comprises a breakable seal (gas cylinder 103, Fig. 2) ("… a compressed gas cylinder 103 is forced against a spring 104 onto a lance or rupture pin 105." - Para [0038]).
Regarding claim 22, Goumeniouk discloses the high-dose drug delivery device (embodiment 100 and 200, Figs. 2-4), wherein
the injector mechanism (gas 106, gas cylinder 103, spring 104, and spike 105, Fig. 2) comprises a spike (rupture pin 105, Fig. 2) configured to pierce a container (gas cylinder 103, Fig. 2) ("… a compressed gas cylinder 103 is forced against a spring 104 onto a lance or rupture pin 105." - Para [0038]).
Regarding claim 23, Goumeniouk discloses the high-dose drug delivery device (embodiment 100 and 200, Figs. 2-4), wherein
the injector mechanism (gas 106, gas cylinder 103, spring 104, and spike 105 Fig. 2) comprises a compression spring (spring 104, Fig. 2).
Regarding claim 24, Goumeniouk discloses the high-dose drug delivery device (embodiment 100 and 200, Figs. 2-4), wherein
the internal chamber (compressed gas cylinder 103, Fig. 2) is under pressure prior to the rotation (pressurized gas 106, Fig. 2).
Regarding claim 25, Goumeniouk discloses the high-dose drug delivery device (embodiment 100 and 200, Figs. 2-4), wherein
the first attachment part (conduit 120, Fig. 2) comprises a channel fluidly connecting the internal chamber (connecting tube 121, Fig. 2) ("… it [conduit 120] accommodates a passageway/connecting tube 121 for the medication 112 to travel through to the interior of the nostril cavity …" - Para [0040]) and an outer surface of the first attachment part (orifice 140, Fig. 2).
Regarding claim 27, Goumeniouk discloses the high-dose drug delivery device (embodiment 100 and 200, Figs. 2-4), wherein
the internal chamber (compressed gas cylinder 103, Fig. 2) has a volume of at least 1 mL ("The delivery device is designed to deliver between (and including) about .5ml to about 1.5 ml of medication …" - Para [0046]).
Regarding claim 28, Goumeniouk discloses the high-dose drug delivery device (embodiment 100 and 200, Figs. 2-4), wherein
the internal chamber (compressed gas cylinder 103, Fig. 2) is configured to releasably retain an active drug substance ("Such medications include, but are not limited to, anticonvulsants, drugs to treat anaphylactic shock, antidotes for poisoning, and medications which are required urgently …" - Abstract).
Regarding claim 30, Goumeniouk discloses the high-dose drug delivery device (embodiment 100 and 200, Figs. 2-4), wherein
the active drug substance is a liquid and/or a suspension ("… the aqueous drug …" - Para [0013]).
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.
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Goumeniouk et al. (US Pub No. 2018/0344950 A1) in view of Shimizu et al. (US Pub No. 2021/0038872 A1).
Regarding claim 21, Goumeniouk in view of Shimizu discloses the high-dose drug delivery device (Goumeniouk, embodiment 100 and 200, Figs. 2-4), wherein
the first component (Goumeniouk, See annotated Fig. 4 above) is separated from the second component (Goumeniouk, top housing element 201, Fig. 4) via a plug (Goumeniouk, O-ring 108, Fig. 2).
Goumeniouk does not expressly disclose a pH releasable plug.
Shimizu teaches a pH releasable plug ("The elements 116 are configured to dissolve, degrade, and/or erode upon exposure to the environment of the small intestine (e.g., a water soluble material)." - Para [0501]-[0502]).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the high-dose drug delivery device of Goumeniouk to include a pH releasable plug as taught by Shimizu to cause the elements to dissolve and thereby lose their mechanical holding strength (Shimizu, Para [0502]).
Examiner interprets the small intestine to have a particular pH as known in the art. Exposure to the environment of the small intestine include exposure to its pH which may cause the elements to dissolve.
Claim(s) 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Goumeniouk et al. (US Pub No. 2018/0344950 A1)
Regarding claim 26, Goumeniouk discloses the high-dose drug delivery device (embodiment 100 and 200, Figs. 2-4), wherein
the internal chamber (compressed gas cylinder 103, Fig. 2) has a volume of at least 5 µL ("The delivery device is designed to deliver between (and including) about .5ml to about 1.5 ml of medication … those skilled in the art will appreciate that other volumes may be accommodated without departing from the invention as herein disclosed and claimed." - Para [0046]).
Goumeniouk does not expressly disclose a volume of at least 5 µL Goumeniouk discloses that the volume of medication in the delivery device needs to be optimized to deliver “other volumes” (Para [0046]) of medication. The volume of medication is a result effective variable in that changing the volume changes the amount of medication delivered. Further, one of ordinary skill in the art would have had a reasonable expectation of success in modifying the device of Goumeniouk to have a volume within the claimed range, as it only involves changing the amount of medication which is a parameter that is disclosed to require adjustment.
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the high-dose drug delivery device of Goumeniouk by including that the internal chamber has a volume of at least 5 µL as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discloser the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Claim(s) 29 and 31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Goumeniouk et al. (US Pub No. 2018/0344950 A1) in view of Lee et al. (US Pub No. 2011/0060309 A1).
Regarding claim 29, Goumeniouk in view of Lee discloses the high-dose drug delivery device (Goumeniouk, embodiment 100 and 200, Figs. 2-4), wherein
Goumeniouk does not expressly disclose that the active drug substance is a solid rod.
Lee teaches that the active drug substance is a solid rod ("… "solid" drug forms include drugs in … rod …" - Para [0037]).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the high-dose drug delivery device of Goumeniouk to include that the active drug substance is a solid rod as taught by Lee to deliver drug long after the implementation procedure has ended (Lee, Para [0032]).
Regarding claim 31, Goumeniouk in view of Lee discloses the high-dose drug delivery device (Goumeniouk, embodiment 100 and 200, Figs. 2-4), wherein
the internal chamber (Goumeniouk, compressed gas cylinder 103, Fig. 2) is configured to releasably retain the active drug substance (Goumeniouk, medication 112, Fig. 2).
Goumeniouk does not expressly disclose that the internal chamber is configured to releasably retain 1 µg – 500 mg of the active drug substance.
Lee teaches that the internal chamber is configured to releasably retain 1 µg – 500 mg (“… a total payload of about 60 mg.” – Para [0128]) of the active drug substance.
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the high-dose drug delivery device of Goumeniouk to include the internal chamber is configured to releasably retain the active drug substance as taught by Lee to deliver drug long after the implementation procedure has ended (Lee, Para [0032]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ESHA P KASHYAP whose telephone number is (571)272-9890. The examiner can normally be reached Monday - Friday 8:30am - 5:00pm.
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/ESHA PRAKASH KASHYAP/Examiner, Art Unit 3783 /CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783
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