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 § 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(s) 1, 8-9, 11, and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vaassen (DE 100 06 026; see IDS filed 8/4/2023; citations are taken from the English translation of the description available at worldwide.espacenet.com) in view of Trenner (US 4,781,684).
Regarding claim 1, Vaassen discloses (Figure 1-3) a disposable nasal liquid dispenser device for dispensing a controlled quantity of a liquid solution into the nasal cavities and / or paranasal sinuses of a user (¶ [0012]), comprising: a liquid solution holding cylinder (housing 2) having a distal (comprising nozzles 3, 4) and a proximal end (opposite the distal end), said cylinder containing a quantity of liquid solution to be dispensed (¶ [0012] discloses dispensing liquid media into the nasal mucosa) and comprising two cannulas (8, 9) arranged at its distal end (Figure 1, they extend to the nozzles and connect thereto) for dispensing the liquid solution into both nasal cavities simultaneously (see ¶ [0013] which discloses the simultaneous dispensing); two resilient nostril plugs (3,4; see ¶ [0023] which discloses that the nozzles fit the shape of the nostrils) having a distal and proximal end, said nostril plugs being designed to seal the nostrils upon application therein (¶ [0023] discloses the conical shape is formed to fit the shape of the nostrils which is considered to “seal” the device during use at least to some extent), and comprising: a discharge orifice (5, 6) at their distal end (Figure 1); and coupling means (push pump as per ¶ [0018]; this section is understood to be disclosing an embodiment using a standard syringe type pressure pump for each cannula; see e.g., ¶ [0020] which discloses two pump gripping surfaces as abutments for facilitating the manual generation of pressure at each cannula; a standard syringe barrel pump would utilize an elastic member abutting the barrel to seal the fluid to generate the pressure) configured to be mounted on said cannulas (2); a piston (7) comprising elastic piston seals to offer sealing on the liquid solution holding cylinder (2), wherein the piston is mounted in the cylinder (the housing would comprise first and second syringes for applying force to each conduit) and designed to slide in an axial direction relative to said cylinder (for ejecting the fluid); and an actuator (gripping abutment surfaces as per ¶ [0020]) mounted with the piston (syringe piston) and configured to move the piston along the inside of the cylinder (2) upon manual actuation of a user. Even if apparently disclosed, Vaassen fails to explicitly disclose the structure of the elastic piston seal, the piston, and the actuator.
Trenner teaches (Figures 1-3) a syringe type pump comprising an actuator (18, 22), a piston (26) comprising elastic seals (64, 66; Col. 4, line 64-Col. 5, line 4), wherein the piston is mounted in a cylinder (barrel 4) and designed to slide in an axial direction relative to the cylinder (to drive the fluid through the cannula) and an actuator (piston rod 18 and thumb press 22) mounted with the piston (Figure 1) and configured to move the piston along the inside of the cylinder upon manual actuation of a user (via depression).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the manual pressure generating means of Vaassen to comprise the syringe, piston type force application means of Trenner so as to allow a user to generate the necessary force for expelling the liquid through a well-known manual pressure generating means as taught by Trenner. Vaassen teaches the application of manual force to drive the fluid delivery, and Trenner teaches a known means for generating such pressure. The single barrel embodiment could be applied to both conduits simultaneously and would eject the fluid via actuation of the plunger rod driving the piston through the reservoir to force the liquid from the nozzles.
Regarding claim 8, Vaassen/Trenner further teach wherein the liquid solution holding cylinder (e.g., syringe barrel housing of the combined device) has two radially extending shoulders arranged at its proximal end (see e.g., Figure 2 of Trenner which depicts finger flanges (40, 42 for grabbing by a user; Col. 4, lines 31-35; see also Vaassen which discloses finger gripping surfaces for the manual pump embodiment as per ¶ [0020]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the body of the device of Vaassen to comprise the finger grips of Trenner to provide the means of generating pressure (via applying pressure to the finger grips while depressing the plunger) via depression of the actuator during use as taught by Vaassen and Trenner.
Regarding claim 9, Vaassen fails to explicitly disclose the actuator detaching from the piston when moved in an opposite direction with regard to the liquid solution holding cylinder, preventing the user from returning the piston to its original position.
Trenner teaches (Figures 1-3) wherein the actuator (18, 22) detaches from the piston (26) when moved in an opposite direction with regard to the liquid solution holding cylinder (barrel), preventing the user from returning the piston to its original position (cooperation of washer 24 with groove 32; Col. 6, lines 6-41).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the device of Vaassen to comprise the single-use locking system of Trenner to provide a means of preventing reuse of the device after a single administration if desired, as taught by Trenner.
Regarding claim 11, Trenner further teaches wherein the actuator (18, 22) has an actuation surface configured to move the piston along the inside of the cylinder upon manual actuation of a user on the same (circular member 48 on piston rod and spear head 20 engage the piston 26 during delivery).
Regarding claim 13, Vaassen further teaches the dispensing of a medical solution (see ¶¶ [0012]-[0013]).
Claim(s) 2-7, 12, and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vaassen in view of Trenner, and further in view of Kim et al. (US 2022/0395677).
Regarding claims 2-3, Vaassen/Trenner teach the claimed invention substantially as set forth above for claim 1, but fail to explicitly disclose the angle between the nostril plugs.
Kim et al. (henceforth Kim) teaches a dual-body nasal administration device (Figures 1A and 5A) comprising nostril plugs (40a, 40b) arranged at an angle relative to the body of the device (e.g., Figure 5A), but fails to explicitly disclose the angle between the plugs to be between 130 degrees and 140 degrees when mounted. However, Kim further teaches varying the angle of the nozzles to improve sealing properties for the nostrils (see ¶¶ [0088]-[0091]). Furthermore, it appears one of ordinary skill in the art at the time of filing would have had a reasonable expectation of success in modifying the device of Vaassen/Trenner to have the nozzles at the claimed angular offset as it involves only adjusting a dimension of a component disclosed to require adjustment. Therefore, it would have ben obvious to one of ordinary skill in the art at the time of filing to modify the device of Vaassen/Trenner to comprise forming the nozzles at an angle of between 130 degrees and 140 degrees (including 135 degrees as per claim 3) 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 discover the optimum or workable ranges by routine experimentation. See In re Aller, F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 4, Kim further teaches wherein the nostril plugs (40a, 40b) are designed to have an angle between them of between 15 and 20 degrees (Figure 5A, see ¶ [0083] which discloses the embodiment of Figure 4 to have an angle in the range of 5-45 degrees based upon the connection of the mounting bracket to the syringes; this would be applicable to the adjustable embodiment of Figure 5A which provides means for moving the two injector bodies through a range of angles depending on the needs of the user).
Regarding claim 5, Kim further teaches wherein the adapters (40a, 40b) are detachable attached to the injectors (¶ [0071]), but fails to explicitly disclose a snap-fit connection. There is no evidence of record that establishes that changing the insertion connection of Kim would result in a difference in function of the prior art device. Further, a person having ordinary skill in the art, being faced with modifying the connection of the nozzles of the prior art, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed snap-fit connection. Lastly, applicant has not disclosed that the claimed connection means solves any stated problem, indicating that the “nostril plugs 4 may be affixed to the cylinder 1 by means of a snap-fit system 9…”, and therefore there appears to be no criticality placed on the snap-fit connection means as claimed such that it produces an unexpected result. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the connection means of the nozzles of Vaassen/Trenner/Kim to be a snap-fit connection as an obvious matter of design choice within the skill of the art.
Regarding claim 6, Vaassen further discloses the use of polyethylene for the nozzles (¶ [0015]) and Kim further teaches wherein the adapters (40a, 40b) are formed of plastic, silicone, rubber, or elastic plastic to enhance sealing force by improving an adhesion property to the outer surface of the nostrils (¶ [0070]), but fails to explicitly disclose the material as low-density polyethylene (LDPE). There is no evidence of record that establishes that changing the adapter material of Kim would result in a difference in function of the prior art device. Further, a person having ordinary skill in the art, being faced with modifying the material of the nozzles of the prior art, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being formed from such low-density polyethylene. Lastly, applicant has not disclosed that the claimed connection means solves any stated problem, indicating only that the “in a preferred embodiment, the nostril plugs 4 are made from LDPE low density polyethylene…”, and therefore there appears to be no criticality placed on the material as claimed such that it produces an unexpected result. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the material forming the nozzles of Vaassen/Trenner/Kim to be of a low density polyethylene as an obvious matter of design choice within the skill of the art.
Regarding claim 7, Kim further discloses wherein the nostril plugs (40a, 40b) are bell-shaped to lock into the nose (¶ [0065], the adapters are considered substantially “bell-shaped” as they are depicted as truncated cones; such a shape is considered “bell-shaped” absent further definitions as to what said shape constitutes).
Regarding claim 12, Vaassen/Trenner further teach the use of therapeutic substances, but fail to explicitly disclose injecting saline solution.
Kim further teaches the injection of saline to cleanse the paranasal sinuses (¶ [0137]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the device of Vaassen/Trenner to comprise the use of saline within the device to provide a known means of cleansing the paranasal sinuses with the device as taught by Kim.
Regarding claim 14, Kim further teaches that the bell-shape and angle configuration of the nostril plugs (40a, 40b) generates an air-tight seal between the plugs and the nostrils causing the soft palate to elevate, sealing off of the nasal cavity, and allowing the liquid solution to reach the paranasal sinuses (see e.g., ¶ [0022] which discloses that the use of the device is designed to seal the nasal cavity, lifting the soft palate and allowing drug injection into the paranasal sinus as claimed).
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vaassen in view of Trenner, and further in view of Kojima et al. (US 2015/0045740).
Regarding claim 10, Vaassen/Trenner teach the claimed invention substantially as set forth above for claim 1, but fail to disclose the guiding features.
Kojima et al. (henceforth Kojima) teaches a syringe device comprising an actuator (plunger 120) and a cylinder (barrel 110 and annular member 131) which are provided with cooperating guiding features extending in the direction of actuation (plunger flanges 125A-125D engaged with rotation limiting features 133A-133D; ¶ [0087]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the injection device of Vaassen/Trenner to comprise cooperating guiding features between the plunger and housing as taught by Kojima so as to provide a means of limiting rotation of the plunger during liquid delivery to provide a more stable liquid delivery operation as taught by Kojima (¶ [0087]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JUSTIN L ZAMORY whose telephone number is (571)270-1238. The examiner can normally be reached M-F 8:30am-4:30pm ET.
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/JUSTIN L ZAMORY/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783