DETAILED ACTION
Receipt is acknowledged of applicant’s Supplemental Amendment/Remarks filed 3/24/2026.
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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 3/16/2026 has been entered.
Status of the Claims
Claims 1-3, 22 and 23 have been amended. Claims 6-20 and 25-34 are cancelled or Claims 35-44 are newly added. Accordingly, claims 1-5, 21-24 and 35-44 remain pending in the application and are currently under examination.
Information Disclosure Statements
The IDS’s dated 3/26/2026 and 3/30/2026 have been considered. Signed copies are enclosed herewith.
Withdrawn Rejections
Applicant’s amendment renders the rejection of claims 1-5, 21, 22, 25 and 27-29 under 35 USC 103 over Djupesland, Kapadia and Monti-Bloch moot. Specifically, Kapadia was previously relied upon to teach the limitation, “a distance of the distal orifice being about 35 mm to 45 mm from a nostril”. Said limitation has been deleted from the claims. Thus, Kapadia is no longer relevant to the claims as they are currently written. Additionally, applicant’s arguments were persuasive. Thus, said rejection has been withdrawn. After further consideration, a new grounds of rejection is made under 35 USC 103 over Djupesland, Allan and Monti-Bloch.
Applicant’s amendment renders the rejection of claim 23 under 35 USC 103 over Djupesland, Kapadia, Monti-Bloch and Smyth moot. Specifically, Kapadia was previously relied upon to teach the limitation, “a distance of the distal orifice being about 35 mm to 45 mm from a nostril”. Said limitation has been deleted from the claims. Thus, Kapadia is no longer relevant to the claims as they are currently written. Additionally, applicant’s arguments were persuasive. Thus, said rejection has been withdrawn. After further consideration, a new grounds of rejection is made under 35 USC 103 over Djupesland, Allan, Monti-Bloch and Smyth.
Applicant’s amendment renders the rejection of claim 24 under 35 USC 103 over Djupesland, Kapadia, Monti-Bloch and Berliner moot. Specifically, Kapadia was previously relied upon to teach the limitation, “a distance of the distal orifice being about 35 mm to 45 mm from a nostril”. Said limitation has been deleted from the claims. Thus, Kapadia is no longer relevant to the claims as they are currently written. Additionally, applicant’s arguments were persuasive. Thus, said rejection has been withdrawn. After further consideration, a new grounds of rejection is made under 35 USC 103 over Djupesland, Allan, Monti-Bloch and Berliner.
Applicant’s amendment renders the rejection of claim 26 under 35 USC 103 over Djupesland, Kapadia, Monti-Bloch and Hubert moot. Specifically, claim 26 has been cancelled. Thus, said rejection is withdrawn.
Applicant’s amendment renders the rejection of claims 30-34 under 35 USC 103 over Djupesland, Kapadia, Monti-Bloch and Scrimgeour moot. Specifically, claims 30-34 has been cancelled. Thus, said rejection is withdrawn.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. See, e.g., paragraphs [0089], [0113], and [0144] of the instant specification. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
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 1-5 and 21-24 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.
Claim 1 recites the administration of “a therapeutically effective amount” of a “first metered dose of the drug” and “a therapeutically effective amount” of “a second metered dose of the same drug”. This limitation is indefinite because it is not clear what the amount being administered is effective for. The preamble of the claim is not linked to the body of the claim in such a way as to clearly convey what condition is being treated by administration of the “therapeutically effective amount”. The phrase “therapeutically effective amount” has been held to be indefinite when the claim fails to state the function which is to be achieved and more than one effect can be implied from the specification or the relevant art. In re Fredericksen 213 F.2d 547, 102 USPQ 35 (CCPA 1954).
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 1, 4, 22, 35 and 37 are rejected under 35 U.S.C. 103 as being unpatentable over Djupesland (USPN 10,864,334 B2, Dec. 15, 2020, hereafter as “Djupesland”) in view of Allan et al. (WO 2022/219406 A1, Oct. 20, 2022, hereafter as “Allan”) and Monti-Bloch (WO 97/27887 A1, Aug. 7, 1997, hereafter as “Monti-Bloch”) as evidenced by Stoyanov et al. (“Chapter 20 - The vomeronasal organ: History, development, morphology, and functional neuroanatomy”, Handbook of Clinical Neurology, Volume 182, 2021, Pages 283-291; hereafter as “Stoyanov”).
Independent claim 1 and its dependents are drawn to a method of delivering drugs to multiple regions of olfactory chemosensory epithelium of a subject's nasal cavity having an olfactory cleft and the vomeronasal pit (VP), the method comprising: inserting a distal end of an actuator of a delivery device through a first nostril and into a first nasal cavity of a person until: a distal orifice formed at an outermost tip of the distal end; and a first lateral orifice formed in a first portion of a sidewall of the actuator; and simultaneously delivering a therapeutically effective amount of a first metered dose of the drug to the chemosensory epithelium associated with the VP via the first lateral orifice and a therapeutically effective amount of a second metered dose of the same drug to the chemosensory epithelium associated with the olfactory cleft via the distal orifice.
Independent claim 35 and its dependents are drawn to a method of delivering drugs to multiple regions of a subject's nasal cavity having an olfactory epithelial lining and a vomeronasal pit (VP), using a delivery device having at least one actuator and a flange, the method comprising: inserting a first distal end of a first actuator of a delivery device through a first nostril and into a first nasal cavity; wherein the first actuator includes a first distal orifice and a first lateral orifice that is spaced from the first distal orifice, the first lateral orifice also being formed in a first sidewall of the first actuator; placing a lower edge of the flange on the face of the subject proximate the first nostril; wherein the lower edge of the flange helps to orient the first lateral orifice towards the VP; and using the delivery device to dispense drugs towards the olfactory cleft and towards the VP; and using the delivery device to: dispense a first quantity of a drug towards the olfactory epithelial lining via spray plume emitted from the first distal orifice, and dispense a second quantity of the drug towards the VP via a soft mist emitted from the first lateral orifice.
Regarding instant claim 1, Djupesland teaches a delivery device for and method of delivering a dose of a substance (medicaments) to a nasal cavity of a subject, wherein the delivery device includes a nosepiece unit for insertion into a nasal cavity of a subject and an outlet unity which includes at least one nozzle for delivery said substance substantially only to surfaces in one or both of the anterior region and an anterior section of the posterior region of the nasal cavity of the subject (abstract; col. 1, lines 13-17). In a particular embodiment, Djupesland teaches a device having an actuator comprising two lateral nozzles 335a, 335b and a distal nozzle 336 (Fig. 27). Djupesland teaches that the distal nozzle is directed to delivering a substance to the posterior region of the nasal cavity and that the posterior region encompasses the olfactory region and olfactory cleft (col. 2, lines 15-21; paragraph bridging cols 12-13). Djupesland further teaches olfactory epithelium is found in the posterior region as well as on both the lateral and medial sides of the nasal airway (i.e., chemosensory epithelium; col. 1, lines 54-64). Djupesland also teaches delivering metered doses from each orifice (col. 7, lines 12-15; col. 13, lines 50-57). Djupesland teaches an embodiment that a substance (i.e., same drug) is delivered from the lateral nozzles as well as the posterior nozzle (paragraph bridging cols 15-16; Fig. 31). Djupesland specifically teaches delivering a substance for central nervous system (CNS) application (paragraph bridging columns 12-13; col. 14, lines 4-12).
While Djupesland teaches generically delivering a substance to multiple regions of the nasal cavity including delivering a substance for CNS application as well as the posterior region of the nasal cavity, Djupesland is silent to the explicit recitation of delivering a drug to the olfactory cleft.
Allan teaches intranasal delivery to the olfactory region, specifically to the olfactory cleft (Examples 2-3). Allan teaches that a drug can be delivered through the olfactory region by diffusion into the olfactory mucosa and transport through the cribriform plate along the olfactory neuron pathways to the central nervous system ([0144]).
Djupesland and Allan are both drawn to delivering substances to the nasal cavity using a nasal delivery device comprising a distal orifice for delivery to the CNS, thus, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to include a distal orifice particularly targeting the olfactory cleft in the invention of Djupesland, as suggested by Allan, with a reasonable expectation of success. A skilled artisan would have been motivated to do so because Allan teaches targeting the olfactory region/cleft is effective when delivering a drug to the CNS.
While Djupesland teaches generically delivering a substance to multiple regions of the nasal a cavity including delivering a substance for CNS application as well as the anterior region of a nostril which encompasses the vomeronasal organ/pit, Djupesland is silent to the explicit recitation of a vomeronasal pit.
Monti-Bloch teaches a method for targeted delivery of vaporized matter such as vomeropherins to the vomeronasal organ of the vertebrate nasal cavity using a device that is inserted into the nasal cavity and delivers said vomeropherins (abstract). Said device has a delivery orifice that is positioned to be aligned with the vomeronasal organ when it is inserted into the nasal cavity (abstract). Said orifice is a lateral orifice formed on the sidewall of an actuator (Fig. 1). It is noted that the vomeronasal organ is 1.5-2.5 cm (15-25 mm) from the nostrils as evidenced by Stoyanov (see abstract). Monti-Bloch teaches that the vomeronasal organ is a bilateral pouch lined with an epithelium containing chemoreceptor cells (page 2, lines 13-15). Monti-Bloch teaches that the vomeronasal organ is comprised of a central lumen and a pit (paragraph bridging pages 5-6 ; Fig. 1).
Djupesland and Monti-Bloch are both drawn to delivering substances to the nasal cavity using a nasal delivery device comprising a lateral orifice, thus, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to include a lateral orifice 15-25 mm from a nostril particularly targeting for the vomeronasal organ in the invention of Djupesland as suggested by Monti-Bloch with a reasonable expectation of success. A skilled artisan would have been motivated to do so because Monti-Bloch teaches targeting the vomeronasal organ which is 15-25 mm from a nostril is effective when administering particular medications such as vomeropherins.
Regarding instant claim 4, Djupesland, Allan and Monti-Bloch teach the elements discussed above. Djupesland also exemplifies orienting an actuator so that a lateral orifice is facing toward a septum of a nasal cavity (Fig. 27).
Regarding instant claim 22, Djupesland, Allan and Monti-Bloch teach the elements discussed above. Additionally, Monti-Bloch teaches administering a medicated vapor (soft mist; abstract) and Allan teaches delivering the medication as a liquid jet (jet spray plume) or a liquid stream ([0015]).
Regarding instant claim 35, Djupesland, Allan and Monti-Bloch teach the elements discussed above. Djupesland further exemplifies a flange (nosepiece member 23) attached to a lowermost portion of the actuator that abuts a nostril (Fig. 7), Monti-Bloch teaches administering a medicated vapor (soft mist; abstract), and Allan teaches delivering the medication as a liquid jet (jet spray plume) or a liquid stream ([0015]).
Regarding instant claim 37, Djupesland, Allan and Monti-Bloch teach the elements discussed above. The combined teachings of Djupesland having an orifice at the tip of the nozzle and Djupesland and Monti-Bloch having lateral orifices on the side of the nozzle at a different angle than that of the distal orifice of Djupesland meets the limitations of the claim.
Thus, the combined teachings of Djupesland, Allan and Monti-Bloch render the instant claims prima facie obvious.
Claims 2 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Djupesland (USPN 10,864,334 B2, Dec. 15, 2020, hereafter as “Djupesland”) in view of Allan et al. (WO 2022/219406 A1, Oct. 20, 2022, hereafter as “Allan”) and Monti-Bloch (WO 97/27887 A1, Aug. 7, 1997, hereafter as “Monti-Bloch”) as evidenced by Stoyanov et al. (“Chapter 20 - The vomeronasal organ: History, development, morphology, and functional neuroanatomy”, Handbook of Clinical Neurology, Volume 182, 2021, Pages 283-291; hereafter as “Stoyanov”), as applied to claim 1 above, and further in view of Kamishita et al. (EP 4039296 A1, Aug. 10, 2022, hereafter as “Kamishita”).
The instant invention is described above.
Djupesland, Allan and Monti-Bloch teach the elements discussed above. Djupesland exemplifies a flange (nosepiece member 23) attached to a lowermost portion of the actuator that abuts a nostril (Fig. 7).
Regarding instant claim 2, Djupesland, Allan and Monti-Bloch are silent to a flange that includes an arch shape with a curved upper edge joined to a linear lower edge, the arch shape ensuring the actuator is guided into the first nasal cavity so that the first lateral orifice is oriented to effectively target the VP and insertion of the actuator into the first nasal cavity occurs when the upper edge is oriented away from the subject's face and the lower edge is oriented toward or is in contact with the subject's face.
Kamishita teaches a nasal spray/spout nozzle capable of further improving the performance of a medicament delivery with respect to a target site located in a nasal cavity (abstract). The nasal spray/spout nozzle comprises a tip portion having a nozzle exit port, and a nose rest capable of abutting on a nose region around an external naris (abstract). Kamishita defines nose rest to mean:
[0048] A member/part provided as a portion of the nasal spray/spout nozzle, the portion being capable of abutting on the nose region around the external naris. More specifically, the nose rest refers to a member including a nozzle portion capable of abutting onto the nose region located around the external naris upon insertion of the nozzle into the external naris with the tip portion thereof being firstly inserted thereinto. The nose rest according to the present invention can be a member/part that protrudes or extends outward such that at least a part thereof is capable of abutting on the nose region around the external naris. The nose rest may be referred to also as a "nose-insertion stopper" or the like. It is preferred that the nose rest is a nozzle portion or member capable of abutting onto the nose region located around the external naris such that the inserted nasal spray/spout nozzle cannot be further inserted deeper into the nasal cavity.
Kamishita also teaches that the nose rest may extend outward such that the nose rest has approximately a projecting shape or a flange shape ([0051]) and exemplifies a nose rest/flange that includes an arch shape with a curved upper edge joined to a linear lower edge (3A). Kamishita teaches that such configuration/form of the nasal spray/spout nozzle can facilitate a further increase in a contact area between the at least a part of the nose rest and the nose region located around the external naris at a point in time when the nozzle is used ([0052]). Thus, the nasal spray/spout nozzle can be more firmly positioned with respect to the external naris during the use of the nozzle, and thereby the inserted position of the nozzle exit port can be more suitably ensured ([0052]). Kamishita further teaches an orientation and/or angle of the nasal spray/spout nozzle can be facilitated to be suitably adjusted while a prevention of the further insertion of the nasal spray/spout nozzle into the nasal cavity is suitably kept ([0050].
The references are drawn to nasal devices for administering active agents to the nasal cavity, thus, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a nose rest/flange that includes an arch shape with a curved upper edge joined to a linear lower edge into the invention of Djupesland/Allan/Monti-Bloch, as suggested by Kamishita, with a reasonable expectation of success. A skilled artisan would have been motivated to do so because Kamishita teaches modifying the nose rest/flange effectively allows for positioning of the nozzle to a targeted location.
Regarding instant claim 21, the references teach the elements discussed above. Both Djupesland and Monti-Bloch demonstrate that the devices are inserted at an angle within the nasal cavity (see Figures). Additionally, the combined teachings of Djupesland and Kamishita having a nose rest/flange that abuts a nostril keeps the nozzle in the correct placement and Monti-Bloch having a nozzle design that particularly targets the vomeronasal organ meets the limitations of the claim.
Thus, the combined teachings of Djupesland, Allan, Monti-Bloch and Kamishita render the instant claim(s) prima facie obvious.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Djupesland (USPN 10,864,334 B2, Dec. 15, 2020, hereafter as “Djupesland”) in view of Allan et al. (WO 2022/219406 A1, Oct. 20, 2022, hereafter as “Allan”) and Monti-Bloch (WO 97/27887 A1, Aug. 7, 1997, hereafter as “Monti-Bloch”) as evidenced by Stoyanov et al. (“Chapter 20 - The vomeronasal organ: History, development, morphology, and functional neuroanatomy”, Handbook of Clinical Neurology, Volume 182, 2021, Pages 283-291; hereafter as “Stoyanov”), as applied to claim 1 above, and further in view of Lindal (“Lindal launches new nasal actuator, Cyrano”, Oct. 23, 2018, hereafter as “Lindal”).
The instant invention is described above.
Djupesland, Allan and Monti-Bloch teach the elements discussed above including lateral orifices.
Djupesland, Allan and Monti-Bloch are silent to wherein the actuator includes an inferior portion with a substantially triangular cross-sectional shape that is widest nearest to a base of the actuator, and narrows in width as it approaches the first lateral orifice.
Lindal teaches an actuator shape that is substantially triangular and states that the actuator shape forms a natural safeguard, preventing it from entering the nasal passage too fully, enabling a snug fit that facilitates a measured dispersion of its contents.
The references are drawn to nasal devices for administering active agents to the nasal cavity, thus, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include actuator includes an inferior portion with a substantially triangular cross-sectional shape that is widest nearest to a base of the actuator, and narrows in width as it approaches the first lateral orifice into the invention of Djupesland/Allan/Monti-Bloch, as suggested by Lindal, with a reasonable expectation of success. A skilled artisan would have been motivated to do so because Lindal teaches modifying the actuator to a substantially triangle shape forms a natural safeguard, preventing it from entering the nasal passage too fully, enabling a snug fit that facilitates a measured dispersion of its contents.
Thus, the combined teachings of Djupesland, Allan, Monti-Bloch and Lindal render the instant claim(s) prima facie obvious.
Claim 5, 38 and 39 are rejected under 35 U.S.C. 103 as being unpatentable over Djupesland (USPN 10,864,334 B2, Dec. 15, 2020, hereafter as “Djupesland”) in view of Allan et al. (WO 2022/219406 A1, Oct. 20, 2022, hereafter as “Allan”) and Monti-Bloch (WO 97/27887 A1, Aug. 7, 1997, hereafter as “Monti-Bloch”) as evidenced by Stoyanov et al. (“Chapter 20 - The vomeronasal organ: History, development, morphology, and functional neuroanatomy”, Handbook of Clinical Neurology, Volume 182, 2021, Pages 283-291; hereafter as “Stoyanov”), as applied to claim 1 above, and further in view of Morrison (US 2006/0219813 A1, Oct. 5, 2006, hereafter as “Morrison”) and Minotti (US 2009/0216183 A1, Aug. 27, 2009, hereafter as “Minotti”).
The instant invention is described above.
Djupesland, Allan and Monti-Bloch teach the elements discussed above. Monti-Bloch also teaches a body of an actuator comprised of an actuator sidewall that bounds an interior chamber, wherein the actuator sidewall includes an exterior surface and an opposite-facing interior surface separated by an actuator thickness (see Figs. 1-3).
Djupesland, Allan and Monti-Bloch are silent to wherein the first lateral orifice is recessed relative to a portion of a sidewall that surrounds the first lateral orifice (instant claim 5), the first lateral orifice is formed in a recessed portion of the actuator sidewall that is curved inward toward the interior chamber (instant claim 38), and wherein the first lateral orifice is formed in a nadir of the recessed portion (instant claim 39).
Morrison teaches a nasal spray device having an orifice formed in a nadir that is recessed relative to a portion of a sidewall that surrounds the orifice and is curved inward toward the interior chamber (Figs. 1 and 2A).
Minotti teaches a nasal spray device having an orifice formed in a nadir that is recessed relative to a portion of a sidewall that surrounds the orifice (Fig. 2).
The references are drawn to delivering substances to the nasal cavity, thus, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to include an orifice such as a lateral orifice that is formed in a nadir and recessed relative to a portion of a sidewall that surrounds the orifice and is curved inward toward the interior chamber into the invention of Djupesland/Allan/Monti-Bloch, as suggested by Morrison and Minotti, with a reasonable expectation of success. A skilled artisan would have been motivated to do so because Morrison/Minotti suggest that a recessed orifice and inward curvature is a conventional and suitable design choice routinely used in the nasal spray device art.
Thus, the combined teachings of Djupesland, Allan, Monti-Bloch, Morrison and Minotti render the instant claim(s) prima facie obvious.
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Djupesland (USPN 10,864,334 B2, Dec. 15, 2020, hereafter as “Djupesland”) in view of Allan et al. (WO 2022/219406 A1, Oct. 20, 2022, hereafter as “Allan”) and Monti-Bloch (WO 97/27887 A1, Aug. 7, 1997, hereafter as “Monti-Bloch”) as evidenced by Stoyanov et al. (“Chapter 20 - The vomeronasal organ: History, development, morphology, and functional neuroanatomy”, Handbook of Clinical Neurology, Volume 182, 2021, Pages 283-291; hereafter as “Stoyanov”), as applied to claims 1 and 22 above, and further in view of Liu et al. (“Assessment of the Influence Factors on Nasal Spray Droplet Velocity Using Phase-Doppler Anemometry (PDA)”, AAPS PharmSciTech. 2011 Feb 1; 12(1): pp. 337–343, hereafter as “Liu”).
The instant invention is described above.
Djupesland, Allan and Monti-Bloch teach the elements discussed above. Allan further teaches a dispensing velocity of about 0.5 m/s to about 15 m/s or about 1.5 m/s to about 9 m/s and exemplifies a velocity of approximately 4-5 m/s ([0019] and [00333]).
Djupesland, Allan and Monti-Bloch are silent to
Liu teaches several factors (stroke length, actuation velocity, concentration of the gelling agent, and concentration of the surfactant) have significant influence on droplet velocity of a nasal spray (Abstract). Liu teaches that the relationships between the factors and the droplet velocity provides a better understanding as to how to optimize the device and formulation parameters to achieve the desired droplet velocity (Conclusion, 2nd paragraph).
The references are drawn to delivering substances to the nasal cavity, thus, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to optimize the droplet velocities of each orifice in the invention of Djupesland/Allan/Monti-Bloch by routine experimentation, as suggested by Liu, with a reasonable expectation of success. A skilled artisan would have been motivated to do so because Liu teaches that several factors directly affect droplet velocity and can be optimized to achieve the desired droplet velocity. It is further noted that the distance between the lateral orifice and the vomeronasal pit has less distance to travel as compared to the distal orifice and the olfactory cleft which would suggest to a skilled artisan that less force and thereby less velocity would be needed for the lateral orifice delivery than for the distal orifice delivery to the targeted locations.
Thus, the combined teachings of Djupesland, Allan, Monti-Bloch and Liu render the instant claim(s) prima facie obvious.
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Djupesland (USPN 10,864,334 B2, Dec. 15, 2020, hereafter as “Djupesland”) in view of Allan et al. (WO 2022/219406 A1, Oct. 20, 2022, hereafter as “Allan”) and Monti-Bloch (WO 97/27887 A1, Aug. 7, 1997, hereafter as “Monti-Bloch”) as evidenced by Stoyanov et al. (“Chapter 20 - The vomeronasal organ: History, development, morphology, and functional neuroanatomy”, Handbook of Clinical Neurology, Volume 182, 2021, Pages 283-291; hereafter as “Stoyanov”), as applied to claim 1 above, and further in view of Berliner et al. (USPN 6,331,534 B1, Dec. 18, 2001, hereafter as “Berliner”).
The instant invention is described above.
Djupesland, Allan and Monti-Bloch teach the elements discussed above including nasal administration of vomeropherins (abstract of Monti-Bloch).
Djupesland, Allan and Monti-Bloch are silent to a pherine compound selected from fasedienol, itruvone, PH80, PH15, and PH284.
Berliner teaches nasal administration of a vomeropherin including the specific vomeropherin, PH80 (abstract; Table III).
The references are drawn to delivering substances to the nasal cavity, thus, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to include the particular vomeropherin, PH80, into the invention of Djupesland/Allan/Monti-Bloch as suggested by Berliner with a reasonable expectation of success. A skilled artisan would have been motivated to do so because Berliner teaches that the particular vomeropherin, PH80, is suitable for nasal administration.
Thus, the combined teachings of Djupesland, Allan, Monti-Bloch and Berliner render the instant claims prima facie obvious.
Claim 36 is rejected under 35 U.S.C. 103 as being unpatentable over Djupesland (USPN 10,864,334 B2, Dec. 15, 2020, hereafter as “Djupesland”) in view of Allan et al. (WO 2022/219406 A1, Oct. 20, 2022, hereafter as “Allan”) and Monti-Bloch (WO 97/27887 A1, Aug. 7, 1997, hereafter as “Monti-Bloch”) as evidenced by Stoyanov et al. (“Chapter 20 - The vomeronasal organ: History, development, morphology, and functional neuroanatomy”, Handbook of Clinical Neurology, Volume 182, 2021, Pages 283-291; hereafter as “Stoyanov”), as applied to claim 35 above, and further in view of Hubert et al. (WO 2022/049136 A1, Mar. 10, 2022, hereafter as “Hubert”).
The instant invention is described above.
Djupesland, Allan and Monti-Bloch teach the elements discussed above.
Djupesland, Allan and Monti-Bloch are silent to the delivery device dispenses a first quantity of the drug out of the first distal orifice and a second quantity of the drug out of the first lateral orifice, wherein the first quantity of drug is greater than the second quantity of drug.
Hubert teaches a nasal drug delivery device having two separate drug compartments, wherein the drug compartments can contain the same or different drugs (abstract; [0011]). Hubert teaches that the delivery device can include different features depending upon various requirements, such as the type of drug, typical dosage(s) of the drug, safety requirements, etc. ([0051]).
The references are drawn to delivering substances to the nasal cavity, thus, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to administer a first quantity of the drug out of the first distal orifice and a second quantity of the drug out of the first lateral orifice, wherein the first quantity of drug is greater than the second quantity of drug in the invention of Djupesland/Allan/Monti-Bloch as suggested by Hubert with a reasonable expectation of success. A skilled artisan would have been motivated to do so because Hubert teaches a drug delivery device having two separate drug components having the same or different drugs which would allow a skilled artisan to formulate and utilize different concentrations of the same or different drugs depending on typical dosages of the drug(s) and the desired effect.
Thus, the combined teachings of Djupesland, Allan, Monti-Bloch and Hubert render the instant claims prima facie obvious.
Claims 40-44 are rejected under 35 U.S.C. 103 as being unpatentable over Djupesland (USPN 10,864,334 B2, Dec. 15, 2020, hereafter as “Djupesland”) in view of Allan et al. (WO 2022/219406 A1, Oct. 20, 2022, hereafter as “Allan”) and Monti-Bloch (WO 97/27887 A1, Aug. 7, 1997, hereafter as “Monti-Bloch”) as evidenced by Stoyanov et al. (“Chapter 20 - The vomeronasal organ: History, development, morphology, and functional neuroanatomy”, Handbook of Clinical Neurology, Volume 182, 2021, Pages 283-291; hereafter as “Stoyanov”), as applied to claim 35 above, and further in view of Scrimgeour et al. (WO 2022/049086 A1, Oct. 3, 2022, hereafter as “Scrimgeour”).
The instant invention is described above.
Djupesland, Allan and Monti-Bloch teach the elements discussed above.
Djupesland, Allan and Monti-Bloch are silent a second actuator including a second distal orifice and a second lateral orifice (instant claim 40), wherein the second actuator is inserted simultaneously with the first actuator (instant claim 41).
Scrimgeour teaches a nasal delivery device having a multi-dispensing head comprising two tips, wherein each tip is positioned in each nostril simultaneously (abstract). Scrimgeour teaches that the nasal delivery device has two actuators allowing for simultaneously or sequentially delivery of a first drug and a second drug ([0009]).
The references are drawn to delivering substances to the nasal cavity, thus, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to include a second actuator including a second distal orifice and a second lateral orifice into the invention of Djupesland/Allan/Monti-Bloch as suggested by Scrimgeour with a reasonable expectation of success. A skilled artisan would have been motivated to do so because Scrimgeour teaches that a nasal delivery device having two actuators allows for simultaneous or sequential delivery of a first drug and a second drug, depending on the desired effect.
Regarding instant claim 42-44, in view of the combined teachings of the references, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a lateral orifice on each nozzle targeting the vomeronasal organ/pit (facing in the medial direction) in each nostril with a reasonable expectation of success because Scrimgeour, as discussed above, teaches that a nasal delivery device having two actuators allows for simultaneous or sequential delivery of a first drug and a second drug and Monti-Bloch, as discussed above, teaches a lateral orifice on a nozzle is effective in targeting the vomeronasal organ when administering particular medications such as vomeropherins.
Thus, the combined teachings of Djupesland, Allan, Monti-Bloch and Scrimgeour render the instant claims prima facie obvious.
Response to Arguments
The arguments filed 3/24/2026 regarding the 103 rejections based on the combination of Djupesland, Kapadia and Monti-Bloch as well as additional references are moot in view of the withdrawn rejections discussed above.
Conclusion
All claims have been rejected; no claims are allowed.
Correspondence
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/CASEY S HAGOPIAN/Examiner, Art Unit 1617
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