DETAILED ACTION
This Office Action is in response to the filing of an amendment to the claims on 1/28/2026. As per the preliminary amendment, claims 7, 13, and 17 have been amended, and no claims have been added or cancelled. Thus, claims 1-24 are pending in the application.
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 § 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.
Claims 1-3, 7-12, and 22-23 are rejected under 35 U.S.C. 103 as being unpatentable over Shahaf et al. (US Pub. 2018/0344951) in view of Haider et al. (US Pat. 6,840,921).
Regarding claim 1, Shahaf discloses a drug delivery system (see the system of Figs. 20A-20C), comprising: a first nasal drug delivery device (see Figs. 20A-20C a first delivery device D10A) comprising: a first tip configured to be positioned in a nose of a patient (see Figs. 20A-20C the distal tip of delivery device D10A; see [0543] where the tip is a nose piece, thus positioned to be in the nose for drug delivery; see also [0326]), the first tip having a first opening therein (see Figs. 20A-20C where the tip of delivery device D10A has an opening (analogous to aerosol exit D7A in Fig. 22C)), a first drug holder containing a first drug therein (see [0543] where delivery device D10A contains a dose of the drug), and a first actuator configured to be actuated and thereby cause the first drug to be delivered out of the first opening (see Figs. 20A-20C where delivery device D10A has an actuator button on the bottom is expel the drug from the reservoir and out the nozzle, as seen in [0546] which is a substantially similar embodiment (said button analogous to button 10 in Fig. 11B)); a second nasal drug delivery device (see Figs. 20A-20C a second delivery device D10B) comprising: a second tip configured to be positioned in the nose of the patient (see Figs. 20A-20C the distal tip of delivery device D10B; see [0543] where the tip is a nose piece, thus positioned to be in the nose for drug delivery; see also [0326]), the second tip having a second opening therein (see Figs. 20A-20C where the tip of delivery device D10B has an opening (analogous to aerosol exit D7B in Fig. 22C)), a second drug holder containing a second drug therein (see [0543] where delivery device D10B contains a dose of the drug), and a second actuator configured to be actuated and thereby cause the second drug to be delivered out of the second opening (see Figs. 20A-20C where delivery device D10B has an actuator button on the bottom is expel the drug from the reservoir and out the nozzle, as seen in [0546] which is a substantially similar embodiment (said button analogous to button 10 in Fig. 11B)).
Shahaf lacks a detailed description of a coupling mechanism comprising a body that defines first and second openings, the first opening being configured to releasably seat the first tip therein, and the second opening being configured to releasably seat the second tip therein. It is noted that Shahaf does disclose embodiments where the first and second nozzles are coupled together (see Figs. 20C and 22A-22E where the nozzles are formed together as a piece).
However, Haider teaches a dual drug delivery device, with a coupling mechanism comprising a body that defines first and second openings (see Figs. 1-3 where a first portion 24 of housing 12 is a coupling mechanism that couples two barrels 16 together, with two recesses 26 for fitting the barrel 16), the first opening being configured to releasably seat the first tip therein (see Figs. 1-3 where a first recess 26 holds the first barrel 16 with needle 20), and the second opening being configured to releasably seat the second tip therein (see Figs. 1-3 where a first recess 26 holds the first barrel 16 with needle 20).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the dual drug delivery system of Shahaf to have a coupling mechanism for the two tips as taught by Haider, as it would maintain the two drug delivery tips in a spaced apart fixed distance from one another to make it easier to deliver simultaneous drug deliveries from both tips (Haider; see Col. 4 lines 50-55).
Regarding claim 2, the modified Shahaf device has wherein the first and second openings are located at respective proximal ends of the first and second drug delivery devices (Haider; see Figs. 1-3 where the recesses 26 are on the proximal end of barrel 16); and the coupling mechanism is configured such that the first tip seated in the first opening faces proximally and the second tip seated in the second opening faces proximally (Haider; see Figs. 1-3 where both tips of needles 20 face the same direction, on the proximal end; further see Shahaf Figs. 20A-20C where the tips of the delivery devices are aligned with one another facing a proximal end of the device).
Regarding claim 3, the modified Shahaf device has wherein the first and second actuators are configured to be selectively actuated so as to be actuated simultaneously to deliver the first and second drugs simultaneously into the nose (Haider; see Col. 4 lines 50-55) or to be actuated sequentially to deliver the first and second drugs sequentially into the nose (Shahaf; see [0546] where the actuations can be one at a time).
Regarding claim 7, the modified Shahaf device has wherein the coupling mechanism includes a release configured to move between a closed state (Haider; see Figs. 1-3 where a locking device 32 and 32’ act together on the coupling mechanism to act as a release mechanism, where in a closed state the two halves 24 and 24’ are closed together), in which the body defines an enclosed perimeter that defines an enclosed perimeter of each of the first and second openings (Haider; see Fig. 1 where a closed state is shown, with a perimeter of portions 24 and 24’ surrounding the barrels), and an open state, in which the body has a discontinuous perimeter and neither of the first and second openings have an enclosed perimeter (Haider; see Figs. 2-3 where the portions 24 and 24’ prime are disconnected through mechanism 32/ 32’, such that there is open space and the barrels are not enclosed (similar to what is shown in Fig. 13)).
Regarding claim 8, the modified Shahaf device has wherein the first and second openings each have C- shapes that are back-to-back with one another (Haider; see Figs. 1-3 where bridge 30 is a back surface of each recess 26, such that the two recesses 26 are located back-to-back across the bridge 30).
Regarding claim 9, the modified Shahaf device has wherein the first and second drug are each one of ketamine (Shahaf; see [0578]), naloxone (Shahaf; see [0365]), and sumatriptan (Shahaf; see [0577]).
Regarding claim 10, the modified Shahaf device has a drug delivery method, comprising: actuating each of the first and second actuators of claim 1 (see above rejection of claim 1 and [0546] of Shahaf where the button actuators are actuated) and thereby causing the first drug to be delivered out of the first opening and causing the second drug to be delivered out of the second opening (Shahaf; see Figs. 20A-20C where delivery devices D10A and D10B have an actuator button on the bottom to expel the drug from the reservoir and out the nozzle, as seen in [0546], such that drugs are expelled from the openings at the tips of each delivery device upon actuation).
Regarding claim 11, the modified Shahaf device has wherein the first and second drugs are each one of ketamine (Shahaf; see [0578]), naloxone (Shahaf; see [0365]), and sumatriptan (Shahaf; see [0577]).
Regarding claim 12, the modified Shahaf device has wherein the drug product includes first and second drug products that each include one of ketamine (Shahaf; see [0578]), naloxone (Shahaf; see [0365]), and sumatriptan (Shahaf; see [0577]).
Regarding claim 22, the modified Shahaf device has a drug delivery method, comprising: causing each of the first and second drugs of claim 1 to be delivered out of the first and second openings, respectively (Shahaf; see Figs. 20A-20C where delivery devices D10A and D10B have an actuator button on the bottom to expel the drug from the reservoir and out the nozzle, as seen in [0546], such that drugs are expelled from the openings at the tips of each delivery device upon actuation).
Regarding claim 23, the modified Shahaf device has wherein the first and second drugs are each one of ketamine (Shahaf; see [0578]), naloxone (Shahaf; see [0365]), and sumatriptan (Shahaf; see [0577]).
Claims 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over Shahaf in view of Haider as applied to claim 1 above, and further in view of Sullivan et al. (US Pub. 2008/0177246).
Regarding claim 4, the modified Shahaf device has wherein the first and second openings are located at respective proximal ends of the first and second drug delivery devices (Haider; see Figs. 1-3 where the recesses 26 are on the proximal end of barrel 16).
The modified Shahaf device lacks a detailed description of the coupling mechanism is configured such that the first tip seated in the first opening faces proximally and the second tip seated in the second opening faces distally
However, Sullivan teaches a nasal spray system, where there are two nozzles that are disposed such that one faces proximally and the other faces distally (see Fig. 60 where chambers 462 and 460 both have nozzles 463; see also [0151]).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the orientation of the first and second nozzles of the modified Shahaf device to be pointed 180 degrees away from each other as taught by Sullivan, as it would provide an additional failsafe against a user accidentally placing a spent cartridge up the nose after the first actuation (Sullivan; see [0150]).
Regarding claim 5, the modified Shahaf device has wherein the first and second actuators are configured to be actuated sequentially to deliver the first and second drugs sequentially into the nose (Shahaf; see [0546] where the actuations occurs one before the other).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Shahaf in view of Haider as applied to claim 1 above, and further in view of Hoekman et al. (US Pat. 9,550,036).
Regarding claim 6, the modified Shahaf device has wherein the first and second openings are located at respective proximal ends of the first and second drug delivery devices (Haider; see Figs. 1-3 where the recesses 26 are on the proximal end of barrel 16); with the coupling mechanism coupled to both of the first and second drug delivery devices (Haider; see Figs. 1-3 where recesses 26 contain both barrels 16, and thus both delivery devices of Shahaf) and each of the first and second tips positioned in the nose (Shahaf; see [0326] where the tips are positioned in the nose).
The modified Shahaf device lacks a detailed description of and a proximal surface of the coupling mechanism defines a depth guide configured to contact a bottom surface of the nose.
However, Hoekman teaches a nasal drug delivery device, where surfaces around the nozzle include depth guides, which contact the bottom surface of the nose (see Fig. 5 and Col. 12 lines 20-45 where an upper-lip aiming guide 76 is understood to contact the area of the upper lip on the bottom of the nose, being used as a depth guide for the depth of the nozzle 66).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the coupling mechanism surface about the nozzle tips of the modified Shahaf device to include an upper lip aiming depth guide as taught by Hoekman, in order to better control the depth of the tips in the nostrils to help prevent injury and ensure proper positioning.
Claims 13-15, 19-21 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Shahaf in view of Haider, and further in view of Le Maner et al. (US. Pat. 9,555,950).
Regarding claim 13, the modified Shahaf device, as modified in claim 1, has everything as found in claim 1, of which claim 13 is similar.
The modified Shahaf device further has a viewing window configured to indicate whether the first drug has or has not been delivered out of the first opening and whether the second drug has or has not been delivered out of the second opening (Haider; see Figs. 1-3 where viewing apertures 22 and 22’ show the content of the syringes, and thus allow a person to visually see whether or not the drugs are still in the delivery device; see also Col. 5 lines 7-9).
The modified Shahaf device lacks a detailed description of at least one viewing window, and at least one device indicator configured to move within the at least one viewing window.
However, Le Maner teaches an actuatable fluid dispensing nozzle for medical use, where the fluid dispenser has a pair of viewing windows that have a moving device indicator within for showing whether or not the dosage has been delivered (see Figs. 6-10 where dispenser head 30 has a pair of viewing windows 35/36, and indicator 40 that moves within the device to visually show which dose(s) have been expelled; see also Col. 3 line 65 to Col. 4 line 12).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify each tip of the modified Shahaf device to have a pair of windows and an indicator within as taught by Le Maner, as it would provide an easy to see visual indication as to whether or not each dose has been expelled, as well as being modifiable for situations where each drug delivery device contains more than one dose (Le Maner; see Col. 3 line 65 to Col. 4 line 12 and Col. 4 lines 45-49).
Regarding claim 14, the modified Shahaf device has a first actuator configured to be actuated and thereby cause the first drug to be delivered out of the first opening (Shahaf; see Figs. 20A-20C where delivery device D10A has an actuator button on the bottom is expel the drug from the reservoir and out the nozzle, as seen in [0546] which is a substantially similar embodiment (said button analogous to button 10 in Fig. 11B)); and a second actuator configured to be actuated and thereby cause the second drug to be delivered out of the second opening (Shahaf; see Figs. 20A-20C where delivery device D10B has an actuator button on the bottom is expel the drug from the reservoir and out the nozzle, as seen in [0546] which is a substantially similar embodiment (said button analogous to button 10 in Fig. 11B)); wherein the actuation of the first actuator automatically causes the viewing window to indicate that the first drug has been delivered (Shahaf; see Figs. 20A-20C where delivery device D10A has an actuator button on the bottom which results in the axial movement of gates D12A/D12B (e.g. Fig. 21C); Le Maner see Col. 4 lines 13-38 where the actuation causes motion of the indicator relative the viewing window, the indicator being on the gates in the modified Shahaf device), and the actuation of the second actuator automatically causes the viewing window to indicate that the second drug has been delivered (Shahaf; see Figs. 20A-20C where delivery device D10A has an actuator button on the bottom which results in the axial movement of gates D12A/D12B (e.g. Fig. 21C); Le Maner see Col. 4 lines 13-38 where the actuation causes motion of the indicator relative the viewing window, the indicator being on the gates in the modified Shahaf device).
Regarding claim 15, the modified Shahaf device has a first spring configured to be released in response to the actuation of the first actuator (Shahaf; see [0807] where a spring is part of the actuation system, such that is released during the actuation), the release of the first spring providing a force that moves the first drug holder relative to the first tip and thereby causes delivery of the first drug (Shahaf; see [0807] where a spring is part of the actuation system, and its motion forces the drug out of the nozzle); and a second spring configured to be released in response to the actuation of the second actuator (Shahaf; see [0807] where a spring is part of the actuation system, such that is released during the actuation), the release of the second spring providing a force that moves the second drug holder relative to the second tip and thereby causes delivery of the second drug (Shahaf; see [0807] where a spring is part of the actuation system, and its motion forces the drug out of the nozzle).
Regarding claim 19, the modified Shahaf device has wherein a dispensing head of the drug delivery device has the first and second tips integrally formed therewith (Shahaf; see Figs. 20A-20C where the nozzle tip of the delivery device is formed onto the delivery devices D10A and D10B).
Regarding claim 20, the modified Shahaf device has wherein the first drug holder includes a first portion that is a first color, and includes a second portion that is a second color (Le Maner; see Col. 4 lines 22-38 where the indicator portion seen through the window has a first color (the “colorless” section), and a second color (the “colored” zone of the indicator)); the second drug holder includes a first portion that is the first color, and includes a second portion that is the second color (Le Maner; see Col. 4 lines 22-38 where the indicator portion seen through the window has a first color (the “colorless” section), and a second color (the “colored” zone of the indicator)); the first color being visible in the viewing window is indicative that drug delivery has not occurred (Le Maner; see Col. 4 lines 22-38 where the indicator portion seen through the window has a first color (the “colorless” section) which indicates the drug has not yet been dispensed); and the second color being visible in the viewing window is indicative that drug delivery has occurred (Le Maner; see Col. 4 lines 22-38 where the indicator portion seen through the window has a second color (the “colored” zone) which indicates the drug has been dispensed).
Regarding claim 21, the modified Shahaf device has wherein the first and second drugs are each one of ketamine (Shahaf; see [0578]), naloxone (Shahaf; see [0365]), and sumatriptan (Shahaf; see [0577]).
Regarding claim 24, the modified Shahaf device has wherein the drug product includes first and second drug products that each include one of ketamine (Shahaf; see [0578]), naloxone (Shahaf; see [0365]), and sumatriptan (Shahaf; see [0577]).
Claims 16-18 are rejected under 35 U.S.C. 103 as being unpatentable over Shahaf in view of Haider in view of Le Maner as applied to claim 13 above, and further in view of Sullivan.
Regarding claim 16, the modified Shahaf device has wherein the actuation of the actuator automatically causes the viewing window to indicate that the first and second drugs have been delivered (Le Maner; see Figs. 6-10 where dispenser head 30 has a pair of viewing windows 35/36, and indicator 40 that moves within the modified device to visually show which dose(s) have been expelled upon actuation; see also Col. 3 line 65 to Col. 4 line 12).
The modified Shahaf device lacks a detailed description of a single actuator configured to be actuated and thereby cause the first and second drugs to be delivered out of the first and second openings, respectively.
However, Sullivan teaches a nasal drug delivery device, where two nozzle members can be actuated by a single actuator button (see Figs. 61-62 and [0153] where button 540 actuated both chambers 510 and 512).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the actuator and nozzle system of the modified Shahaf device to be a single actuator as taught by Sullivan, as it would be a simple substitution of one actuation means for drug delivery for another, to yield the predictable result of still being able to deliver the drugs simultaneously or in sequence (Sullivan; see [0153]).
Regarding claim 17, the modified Shahaf device has a lock configured to automatically lock the actuator in position relative to the first and second tips in response to the actuation of the actuator (Haider; see locking mechanism 32 and 32’ in Figs. 1-3, which has already locked in place the portions 24 and 24’ before an actuation occurs).
Regarding claim 18, the modified Shahaf device has a spring configured to be released in response to the actuation of the actuator (Shahaf; see [0807] where a spring is part of the actuation system, such that is released during the actuation), the release of the spring providing a force that moves the first and second drug holders relative to the first and second tips and thereby causes delivery of the first and second drugs (Shahaf; see [0807] where a spring is part of the actuation system, and its motion forces the drug out of the nozzle).
Response to Arguments
Applicant's arguments filed 1/28/2026 have been fully considered but they are not persuasive. With regards to claim 13, the newly applied Le Maner reference is understood to teach the movement of a device indicator visible through a viewing window.
Applicant argues on pages 7-9 that the modification in light of Haider lacks 1) first and second openings that couple to the tips (instead allegedly coupling bodies), and 2) modifying Shahaf to deliver simultaneous drugs from both ends is against the principle of operation of Shahaf, which does one dispenser at a time. The argument are not well-taken. In response to 1), it is understood that Haider does have openings (see Figs. 1-3 two recesses 26 for fitting the barrels 16). Additionally, in Haider, the barrel 16 and needle 20 are together considered the “tip” with a base member at portions 24/24’. There is no language in the claim that the “tip” is only the most distal extension, and the applicant’s invention appears to also have the connecting elements proximal to the distal end of the “tip” as seen in Figs. 8-9. As such, in the modified Shahaf device, the coupling mechanism of Haider is applied to the cylindrical extensions of Shahaf which comprise the tip. In response to 2), it is understood that there is no mechanism stopping Shahaf from allowing both tips to be actuated at the same time. Rather, it is a choice of the user to activate both buttons at the same time, should they desire it. The teachings of Haider apply a framework that makes it easier for a person to deliver simultaneous dispensation, should they desire it, but does not lock the device into only functioning that way. Rather, the modification allows for simultaneous delivery as an additional functionality, and does not destroy or change Shahaf which is mechanically capable of already doing so.
For the reasons above, the rejections hold.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW D ZIEGLER whose telephone number is (571)272-3349. The examiner can normally be reached Mon-Fri 10:00-6:00.
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/MATTHEW D ZIEGLER/Examiner, Art Unit 3785
/TIMOTHY A STANIS/Supervisory Patent Examiner, Art Unit 3785