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 .
Election/Restrictions
Applicant’s election without traverse of group I (claims 1-15) in the reply filed on 05 January 2026 is acknowledged.
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 1-3 and 13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kubo et al (US 2013/0096493).
Regarding claim 1, Kubo discloses:
A drug delivery system (Fig. 1), comprising: a dispensing head (5) including a proximal tip configured to be positioned in a nose of a patient (¶0002 – nasal administration), the tip (5) having an opening (51; Fig. 2) therein, a drug holder (1) containing a drug therein (¶0040); a plunger (3) configured to move distally in response to a manual user force applied thereto (¶0040); and a mechanical stop (32); wherein the plunger (3) is configured to move a first predetermined distance distally relative to the dispensing head (5) in a first stage of operation in which the drug is delivered from the drug holder (1) and out of the opening (51) before the mechanical stop (32) prevents further distal movement of the plunger(3) (¶0045); and wherein the plunger (3) is configured to move a second predetermined distance distally relative to the dispensing head in a second stage of operation in which the drug is delivered from the drug holder and out of the opening (51) (¶0052).
Regarding claim 2, Kubo discloses:
The system of claim 1, further comprising a body (12) in which the drug holder (1) is disposed; wherein: the plunger (3) is configured to move the first predetermined distance and the second predetermined distance relative to the body (12); the body (12) includes a flange (6) with a hole (61; Fig. 6) therein through which the plunger (3) is configured to move distally (¶0043); and the mechanical stop (32) comprises a feature (rib of 32) on the plunger (3) that is configured to abut the flange (6).
Regarding claim 3, Kubo discloses:
The system of claim 2, wherein the plunger (3) is configured to be rotated relative to the body (12) after the plunger (3) moves the first predetermined distance and before the plunger (3) moves the second predetermined distance (¶0052).
Regarding claim 13, Kubo discloses:
The system of claim 1, further comprising a viewing window (Fig. 8 – gap that allows device to be slipped into body 6) configured to allow a user to visualize whether or not each of the first and second stages of operation have occurred (¶0048).
Claims 1, 2, 4-6, 8, and 10-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Grabenkort et al (US 2005/0004530).
Regarding claim 1, Grabenkort discloses:
A drug delivery system (Fig. 2A), comprising: a dispensing head (64; Fig. 2A) including a proximal tip (fully capable of being positioned in a nose of a patient), the tip having an opening therein, a drug holder (10) containing a drug therein (¶0051); a plunger (20) configured to move distally in response to a manual user force applied thereto (¶0052); and a mechanical stop (30); wherein the plunger (20) is configured to move a first predetermined distance distally relative to the dispensing head in a first stage of operation (Fig. 2B) in which the drug is delivered from the drug holder (10) and out of the opening before the mechanical stop (30) prevents further distal movement of the plunger (20); and wherein the plunger (20) is configured to move a second predetermined distance distally relative to the dispensing head in a second stage of operation (Fig. 2E) in which the drug is delivered from the drug holder (10) and out of the opening (¶0053).
Regarding claim 2, Grabenkort discloses:
The system of claim 1, further comprising a body (18) in which the drug holder (10) is disposed; wherein: the plunger (20) is configured to move the first predetermined distance and the second predetermined distance relative to the body (18); the body (18) includes a flange with a hole therein through which the plunger (20) is configured to move distally (¶0053); and the mechanical stop (32) comprises a feature on the plunger (10) that is configured to abut the flange (¶0053).
Regarding claim 4, Grabenkort discloses:
The system of claim 2, wherein the mechanical stop (262; Fig. 12B – the embodiment of Figs. 12 is an alternative to that of Figs. 2) is configured to be manually removed (Fig. 12B) from the plunger (20) after the plunger (20) moves the first predetermined distance and before the plunger (20) moves the second predetermined distance (¶0068).
Regarding claim 5, Grabenkort discloses:
The system of claim 2, wherein the mechanical stop (32) is configured to be manually pushed radially inward (Fig. 2D) relative to the body (18) after the plunger (20) moves the first predetermined distance and before the plunger (20) moves the second predetermined distance (¶0053).
Regarding claim 6, Grabenkort discloses:
The system of claim 1, further comprising a body (226; Fig. 8A – the embodiment of Figs. 8 is an alternative to that of Figs. 2) in which the drug holder (10) is disposed; wherein the mechanical stop (220; Fig. 8B) comprises a tab (222) frangibly attached to the body (¶0064).
Regarding claim 8, Grabenkort discloses:
The system of claim 1, wherein the mechanical stop (220; Fig. 8B – the embodiment of Figs. 8 is an alternative to that of Figs. 2) comprises a tab (222) frangibly attached to the plunger (20).
Regarding claim 10, Grabenkort discloses:
The system of claim 1, further comprising a housing (Fig. 9A – the embodiment of Figs. 9 is an alternative to that of Figs. 2) in which the drug holder (10) and the plunger (20) are disposed; wherein the mechanical stop (230) comprises a stop member (234) that is internal to the housing and that is configured to abut a flange (232) of the plunger (20).
Regarding claim 11, Grabenkort discloses:
The system of claim 1, further comprising a body (Fig. 9A – the embodiment of Figs. 9 is an alternative to that of Figs. 2) in which the drug holder (10) is disposed; wherein the mechanical stop (230) includes a stop member (234) that is internal to the body and that is configured to releasably seat a flange (232) of the plunger (20) therein.
Claims 1, 9, and 12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Borchard (US 4962868).
Regarding claim 1, Borchard discloses:
A drug delivery system (Fig. 1), comprising: a dispensing head (1) including a proximal tip configured to be positioned in a nose of a patient (Col. 1:27-30), the tip (1) having an opening therein, a drug holder (2) containing a drug therein; a plunger (2a) configured to move distally in response to a manual user force applied thereto (Col. 2:65-68); and a mechanical stop (7; Fig. 3b); wherein the plunger (2a) is configured to move a first predetermined distance distally relative to the dispensing head (1) in a first stage of operation (b; Fig. 3c) in which the drug is delivered from the drug holder (2) and out of the opening before the mechanical stop (7) prevents further distal movement of the plunger (2); and wherein the plunger (2) is configured to move a second predetermined distance distally relative to the dispensing head (1) in a second stage of operation (d) in which the drug is delivered from the drug holder (2) and out of the opening.
Regarding claim 9, Borchard discloses:
The system of claim 1, further comprising a body (3b) in which the drug holder (2) is disposed; wherein: the body (3b) has a proximal hole (closed end of groove 16) formed therein, a distal hole (11) formed therein, and an intermediate hole (12) formed therein that is located between the proximal and distal holes; and the mechanical stop (7) comprises a depressible pin that extends radially outward from the plunger (2) and that is configured to be successively seated in the proximal hole, the intermediate hole (12), and the distal hole (11) (Col. 4:24-40).
Regarding claim 12, Borchard discloses:
The system of claim 1, wherein the mechanical stop (7) comprises a protrusion (7) extending from the plunger (2); the drug delivery system further comprises a body (3b) having a track (16) formed therein; the protrusion (7) is configured to slide longitudinally within the track (16) during the first stage of operation (b); the plunger (2) is configured to be rotated (c) relative to the body (3b) between the first and second stages of operation (b, d); the protrusion (7) is configured to slide axially within the track (16) in response to the rotation of the plunger (2); and the protrusion (7) is configured to slide longitudinally within the track (16) during the second stage of operation (d).
Claims 1 and 7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Pollard Jr. et al (US 2010/0286513).
Regarding claim 1, Pollard Jr. discloses:
A drug delivery system (Fig. 2), comprising: a dispensing head (58) including a proximal tip (fully capable of being positioned in a nose of a patient), the tip having an opening therein, a drug holder (50) containing a drug therein (¶0028); a plunger (14) configured to move distally in response to a manual user force applied thereto (¶0030); and a mechanical stop (flange surrounding opening 30 in Fig. 1); wherein the plunger (14) is configured to move a first predetermined distance distally relative to the dispensing head (58) in a first stage of operation (Fig. 3) in which the drug is delivered from the drug holder (50) and out of the opening before the mechanical stop prevents further distal movement of the plunger (14); and wherein the plunger (14) is configured to move a second predetermined distance distally relative to the dispensing head (58) in a second stage of operation (Fig. 2) in which the drug is delivered from the drug holder (50) and out of the opening.
Regarding claim 7, Pollard Jr. discloses:
The system of claim 1, wherein the plunger (14) includes a first plunger (16) and a second plunger (18); the first plunger (16) is configured to move the first predetermined distance distally relative to the dispensing head (58) and the second plunger (18); the mechanical stop comprises a proximal flange of the second plunger (18); and the second plunger (18) is configured to move the second predetermined distance distally relative to the dispensing head (58).
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Kubo in view of Vedrine et al (US 2002/0010428).
Regarding claim 14, Kubo disclose the system of claim 1 but is silent regarding “the drug is one of ketamine, esketamine, naloxone, and sumatriptan.” However, Vedrine teaches a nasal syringe device (Fig. 1), thus being in the same field of endeavor, that delivers a variety of drugs such as ketamine (¶0065). It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the claimed invention to have used the drug product of Vedrine in the device of Kubo in order to deliver ketamine to a patient. As such, Kubo in view of Vedrine also makes obvious claim 15, namely a drug product disposed in the system of claim 1, wherein the drug product is one of ketamine, esketamine, naloxone, and sumatriptan.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TASNIM M AHMED whose telephone number is (571)272-9536. The examiner can normally be reached M-F 9am-5pm Pacific time.
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/TASNIM MEHJABIN AHMED/Primary Examiner, Art Unit 3783