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 .
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.
Claims 26-37 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. Particularly, claim 26 recites “the manual user action includes one of insertion of an unlocking tool”; this limitation is not understood by the Examiner.
Claims 38-44 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. Particularly, claim 38 recites “the manual user action includes one of insertion of an unlocking tool”; this limitation is not understood by the Examiner.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-2,7-10,22,24-25 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Fuchs et al. (US 5,944,222).
Claim 1, Fuchs discloses a drug delivery system, comprising: a drug delivery device (fig.1; from the tip of 38 to lowest portion of 38) comprising a dispensing head (34) including a tip configured to be positioned in a nose of a patient, the tip having an opening (36) therein, a drug holder (27) containing a drug (29) therein, and an actuator (31) configured to be actuated by a user to cause the drug to be delivered out of the opening; an accessory (38) comprising a locking mechanism configured to releasably couple to the drug delivery device; wherein, with the locking mechanism (38) and the drug delivery device releasably coupled together (fig.1), the drug delivery device and the accessory are a mated unit (fig.1) and the drug cannot exit through the opening (36) into the nose of the patient; and wherein, with the locking mechanism (38) released from the drug delivery device, the accessory is a separate, independent member from the drug delivery device and the actuator (31) is configured to be actuated to cause the drug to be delivered out of the opening into the nose of the patient.
Claim 2, Fuchs discloses wherein, with the locking mechanism (38) and the drug delivery device (fig.1) releasably coupled together, the accessory (38) covers the opening (36).
Claim 7, Fuchs discloses wherein the accessory (38) is a box that contains a partial portion of the drug delivery device therein when releasably coupled to the drug delivery device (fig.1).
Claim 8, Fuchs discloses wherein the accessory (38) is a box that fully contains the drug delivery device therein when releasably coupled to the drug delivery device (fig.5).
Claim 9, Fuchs discloses wherein the accessory (38) includes a cavity formed therein; and with the locking mechanism (38) and the drug delivery device (fig.1) releasably coupled together, the
drug delivery device is seated in the cavity and extends proximally from the accessory (38).
Claim 10, Fuchs discloses wherein the actuator (31) is configured to be seated in the cavity (fig.1).
Claim 22, Fuchs discloses wherein the releasable coupling is mechanical (fig.1; using the broadest reasonable interpretation, 38 is decoupled from the device when mechanical force is applied).
Claim 24, Fuchs discloses wherein the drug is one of ketamine, esketamine, naloxone, and sumatriptan. Claim 24 fails to further structurally limit the apparatus claim and only further limit the material handled by the apparatus and therefore does not determine patentability (see at least MPEP 2114,2115).
Claim 25, Fuchs discloses a drug product disposed in the drug delivery device of claim 1, wherein the drug product is one of ketamine, esketamine, naloxone, and sumatriptan. Claim 25 fails to further structurally limit the apparatus claim and only further limit the material handled by the apparatus and therefore does not determine patentability (see at least MPEP 2114,2115).
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.
Claim 12 rejected under 35 U.S.C. 103 as being unpatentable over Fuchs et al. (US 5,944,222) in view of Sutherland et al. (US 2021/0204870).
Claim 12, Fuchs does not disclose wherein the accessory (38) includes a measurement mechanism configured to facilitate a determination of an amount of drug contained in the drug holder.
Sutherland discloses a measurement mechanism configured to facilitate a determination of an amount of drug contained in the drug holder (para.0112). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to provide the device of Fuchs with wherein the accessory includes a measurement mechanism configured to facilitate a determination of an amount of drug contained in the drug holder simply to have medication quantity sensing functionality.
Claims 22-23 rejected under 35 U.S.C. 103 as being unpatentable over Fuchs et al. (US 5,944,222).
Claim 22, Although Fuchs does not disclose wherein the releasable coupling is mechanical, it would have been obvious to one having ordinary skill in the art before the effective filing date to implement an electrical releasable coupling since it has been held that broadly providing a mechanical or automatic means to replace manual activity which has accomplished the same result involves only routine skill in the art. In re Venner, 120 USPQ 192.
Claim 23, Although Fuchs does not disclose wherein the releasable coupling is electrical, it would have been obvious to one having ordinary skill in the art before the effective filing date to implement an electrical releasable coupling since it has been held that broadly providing a mechanical or automatic means to replace manual activity which has accomplished the same result involves only routine skill in the art. In re Venner, 120 USPQ 192.
Allowable Subject Matter
Claims 3-6,11,13-21 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 AYODEJI T OJOFEITIMI whose telephone number is (571)272-6557. The examiner can normally be reached 8:30 AM - 5:00 PM.
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/AYODEJI T OJOFEITIMI/Examiner, Art Unit 3651
/GENE O CRAWFORD/Supervisory Patent Examiner, Art Unit 3651