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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 11/24/2025 has been entered.
Response to Amendment
Applicant has cancelled claims 3 and 8; claims 1-2, 4-7, and 9-12 remain pending.
Claim Objections
Claims 1, 6, and 10 are objected to because of the following informalities:
Regarding claim 1, there is a typographical error wherein there is improper antecedent basis for the claim term “configured to target a plume of medication between the middle and inferior turbinates within a nasal cavity” which should likely instead recite “configured to target a plume of medication between middle and inferior turbinates within a nasal cavity”.
Regarding claim 1, there is a typographical error wherein the claim refers first to “doses of a sprayable material”, later refers to “target a plume of medication”, and later refers to “activation in a plume of material”, and while the specification makes clear that these are meant to be the same plume and material, consistent wording and antecedent basis is required.
Similarly regarding claim 10, there is a typographical error wherein the claim appears to have improper antecedent basis where it refers to “a medication or treatment material” while claim 1 (which claim 10 depends on) now refers to medication. Changes made to claim 1 must be applied consistently in claim 10 (and claim 12 which depends on claim 10).
Regarding claim 6, there is a typographical error wherein there is improper antecedent basis for the claim term “the surface of said spray tip” which should instead “a surface of said spray tip”.
Appropriate correction is required.
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.
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.
Claim(s) 1,2, 4, 5, 7, and 10-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bonney et al. (US 20080272144, henceforth Bonney) in view of Gold et al. (US 20220032022, henceforth Gold) and Xu (US 20130334339, henceforth Xu) and as evidenced by Eldredge (US 20100057048, henceforth Eldredge, previously made of record on 04/01/2025).
Regarding claim 1, Bonney discloses a device (fluid dispenser 1, fig. 2A) comprising: a spray application device (fluid dispenser 1, fig. 2A) further comprising an activator (actuation mechanism 100, fig. 1); where said spray application device dispenses one or more doses of a sprayable material (liquid 2, fig. 2A) when activated by said activator ([0042] and [0059]); where the device is adapted for a user to self-administer said sprayable material (see [0062], the device is meant to be used by one person); where the device comprises an angled nozzle (inner tubular section 23, fig. 2A, which is angled as it is provided at an angle in parallel with the longitudinal extension direction of the dispenser 1 as shown) having a nozzle center (this is called out as line X in fig. 2A) said angled nozzle having a nozzle shroud (nozzle 19, fig. 2A) with an angled shape (nozzle 19 has an angled shape which is its slightly tapered conical shape provided at an angle in parallel with the longitudinal extension direction of the dispenser 1 as shown in fig. 2A) conforming to the geometry of said angled nozzle (nozzle 19 conforms to the geometry of inner tubular section 23 where it extends along it and is colinear with it, see fig. 2A), and the nozzle geometry configured to target a plume of medication (atomized spray S, fig. 2F) into a nasal cavity (see [0076]; note that the limitation of “configured to target” is understood to mean “configured to direct”); where a distal portion of said angled nozzle (the interior distalmost portion of section 23 proximal to upper opening 27, fig. 2A) is directly connected to, and capped by, a spray tip (upper opening 27, which is immediately adjacent to tubular section 23 and is connected thereto as they have integrally formed openings, and since the opening 27 forms the distal end of tubular section 23, it is considered to cap it as claimed); where said angled nozzle is wholly disposed within said angled nozzle shroud (see fig. 2A, inner tubular section 23 exists entirely within nozzle 19 as claimed); where said angled nozzle shroud extends along the entirety of the angled nozzle (see fig. 2A, nozzle 19 extends entirely along inner tubular section 23 as claimed) and encloses said spray tip (see fig. 2A, nozzle 19 radially surrounds, and thus encloses, upper opening 27 as shown).
Bonney does not disclose that the angled nozzle has a mid-nozzle bend angle of 15 to 30 degrees from the nozzle center to create an angled bend creating an optimized nozzle geometry, that the nozzle shroud is compliant, that the targeted plume of medication material is meant to be directed between the middle and inferior turbinates within the nasal cavity, that said compliant angled nozzle shroud is configured to deform to fit within a user’s nasal passage dimensions, or where said sprayable material is dispensed by said activation in a plume of material conforming to the bend angle of said angled nozzle to target the sphenopalatine ganglion (SPG) within said cavity as an aerosol. Gold teaches a nasally inserted element (drug delivery component 20) which has a bend angle (single bend 82, fig. 11B causes a bend angle) in the middle of the element (see fig. 11B) to create an optimized geometry (see at least [0105]-[0107]) with the angle readily determinable for the target anatomy ([0114]) such that a targeted delivery of medication as a plume of spray (see [0109], the drug is delivered as a spray plume) is directed between the middle and inferior turbinates within the nasal cavity (see at least figs. 12D and 13). Eldredge evidences that the sphenopalatine ganglion is anatomically located between the middle and inferior turbinates in the nasal cavity (see fig. 1, ganglion 120 is anatomically provided with nerves extending between inferior turbinate 112 and middle turbinate 114). Additionally, Gold teaches its nasally inserted element to be compliant (see [0104], the listed materials are compliant as elastomers are flexible hence their soft durometer) such that it is configured to deform to fit within a user’s nasal passage dimensions (see [0104], the element must deform to reach its target location; see also [0080] and [0117]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have changed the shape of the nozzle and nozzle shroud of Bonney from its original shape to the shape of Gold as Gold teaches the shape of its nasally insertable element to be beneficial for being able to deliver medicament directly to a target site by traversing patient anatomy (see at least Gold [0104]-[0110]) and further because Gold teaches this direct delivery to increase the effectiveness of drug delivery to target anatomy deep in the nasal cavity (see Gold [0007]-[0009] and [0013]). Such a modification would have entailed elongating the nozzle and nozzle shroud of Bonney to have the shape of the nasally inserted element of Gold. As modified, the changed nozzle and nozzle shroud shape thus target the SPG in the nasal cavity as an aerosol as Gold teaches the location between the inferior and middle turbinates to be effective for treatment and Eldredge evidences that this anatomic location is where the SPG is located, and thus the configuration to target the aerosolized spray between the inferior and middle turbinates is a targeting of the SPG.
Further, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have formed the nozzle and nozzle shroud of Bonney as modified by Gold from the same materials as those used in Gold as Gold teaches these materials to be beneficial for providing increased patient comfort and traversing varying patient anatomy (see at least Gold [0104] and [0117]). Such a modification would then mean that the nozzle and nozzle shroud of Bonney as modified would be compliant and deformable as claimed.
Bonney as modified by Gold does not explicitly disclose that the bend angle is 15 to 30 degrees as claimed. However, Gold teaches that the particular angle to be used is determinable by one of ordinary skill in the art using measurements of a patient’s anatomy ([0114]), and that the angle could be between 10 and 720 degrees or more ([0106]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have shaped the bend angle to be 15 to 30 degrees as claimed since Gold teaches that the bend angle is a result effective variable which is determinable by one of ordinary skill in the art depending on the user’s particular anatomy (Gold [0106] and [0114] provides instructions for how to achieve this optimization) such as to achieve the desired entry characteristics to point the plume of material towards the intended target area (Gold [0105]).
Bonney as modified does not disclose that the spray tip comprises features designed to achieve target droplet size, dispersion and cavity and surface deposition characteristics. Xu teaches a spray tip (aperture plate of fig. 8B) which have features (apertures of fig. 8B) shaped to produce a desired spray pattern and droplet size (see at least [0002], [0004], and [0038]). Xu additionally teaches that its spray plate can be manipulated to obtain the desired spray characteristics for any given application (see [0036] and [0038]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have replaced the spray tip of Bonney with the silicon-plate spray tip of Xu to produce a set of spray pattern and droplet size characteristics as desired (Xu [0004]), and as the plate of Xu is more manufacturable and cost efficient (Xu [0004] and [0033]), and further since the replacement would yield the same, predictable result of an aerosolized mist of droplets being nebulized by the device of Bonney and sprayed through a tip into a user's nasal passage in the modified device. Such a spray pattern could be the narrow and targeted plume originally disclosed and depicted in Bonney as well (see Bonney figs. 2F and 3 and see Bonney [0106]) and would be achieved by attaching the spray plate where the opening of Bonney was previously located in the tubular portion 23. Thus, in the modified device, the spray tip comprises features (apertures) designed to achieve target droplet size (see Xu [0036] and [0040], aperture size and shaping controls the size of the droplets in Xu), dispersion (the curvature of the plate of Xu causes a dispersion as in [0093] and thus the apertures are considered to be designed to achieve the dispersion as claimed), and cavity and surface deposition characteristics (droplet dispersion, size, and evenness make up surface deposition characteristics since they affect the way that the spray moves and falls within the nasal cavity, see at least Xu [0036], [0040], [0093], and [0096]).
Regarding claim 2, Bonney as modified discloses the device of claim 1 where said compliant nozzle shroud is adapted to deform under pressure to fit into a user's nasal passage (see the added flexibility and deformability of Gold at least at Gold [0027] and [0028]).
Regarding claim 4, Bonney as modified discloses the device of claim 1 where the customized features comprise one or more apertures of 6.0 µm +/- 1.0 µm diameter (Xu [0036] teaches a diameter range overlapping with the claimed range of Applicant at 5 µm).
Regarding claim 5, Bonney as modified discloses the device of claim 5 where the one or more apertures comprise 40 apertures +/- 20 apertures (See Xu [0038], a number between 1-1000 per square mm is disclosed as are some typical sizes) organized as a central inner aperture surrounded by a circular array of outer apertures (A circular array is listed in a list of equivalent shapes in Xu [0038]; Xu fig. 3B shows an equivalent with a central inner aperture).
Further, Xu ([0038]-[0040]) discloses that the size, number, and arrangement of apertures, can be adjusted for the desired aerosol spraying characteristics in a given application. Thus, it would have been obvious for one of ordinary skill in the art to provide a number of apertures as claimed by Applicant as Xu teaches a wide range of apertures may be provided depending on the desired aerosol spray characteristics. Additionally, it would have been obvious for one of ordinary skill in the art to provide the claimed number of apertures in a circular arrangement with a central inner aperture as Xu teaches it is known to modify the number and arrangement of apertures to achieve a desired spray and since it has been held that where the general conditions of a claim are disclosed in the prior art (providing apertures to provide a spray), discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.}
Regarding claim 7, Bonney as modified discloses the device of claim 1 where the optimized nozzle geometry comprises a nozzle length of 4.0 cm +/- 0.5 cm (see Gold [0066], the length of the modified nozzle has been made the size and shape taught by Gold which is from 0.1-2 inches which encompasses the claimed range of lengths as this is a range of 0.254-5.08 cm).
{The range taught by Gold is sufficiently specific to anticipate the claimed range as the two ranges are both in the single digits of centimeters and Applicant's range is roughly in the middle of Gold's disclosed range. In addition, no unexpected results are shown as a result of the narrower range of Applicant compared to the disclosed range of Gold, and Applicant appears to have placed no criticality on the claimed range (see pg. 8 line 25 of Applicant's specification indicating the length "may" be within the claimed range).}
Regarding claim 10, Bonney as modified discloses the device of claim 1 where the sprayable material comprises a medication or treatment material (Bonney [0035]).
Regarding claim 12, Bonney as modified discloses the device of claim 10 where the spray application device is adapted to deliver multiple doses of the medication or treatment material through said nozzle (Bonney [0056]).
Regarding claim 11, Bonney as modified discloses the device of claim 1 where the optimized nozzle geometry is optimized for use in an anatomical orifice of a user to form an anatomically optimized nozzle geometry (Bonney [0019], the anatomical orifice is the nostril and nasal passage).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Bonney et al. (US 20080272144, henceforth Bonney) in view of Gold et al. (US 20220032022, henceforth Gold) and Xu (US 20130334339, henceforth Xu) and as evidenced by Eldredge (US 20100057048, henceforth Eldredge) as applied to claim 5 above, and further in view of Rennie (WO 9949923, henceforth Rennie).
Regarding claim 6, Bonney as modified discloses the device of claim 5 where the central inner aperture is oriented to point in a direction that is perpendicular to the surface of the spray tip (See Xu fig. 8B, the central inner aperture points straight downward and is perpendicular to the top surface of the curved plate at that point).
Bonney as modified does not disclose the device where each aperture comprising the circular array of outer apertures is oriented to point 15.0 degrees +/- 5.0 degrees away from the direction that the central inner aperture points. Rennie (pg. 8 lines 10-13) teaches a preferable spray cone angle of about 30-40 degrees, which is divided by 2 to get an angle for each side of about 15-20 degrees away from the central inner aperture.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have shaped the aperture plate of fig. 8A of Xu which is present in the modified device of Bonney as indicated above as a parabola where the maximum outward angle of the plate from its central most point is about 15-20 degrees as this is taught by Rennie as preferable (pg. 8 lines 10-13) for a set of desired spray characteristics (Rennie pg. 8 lines 10-15 teaches different factors influencing spray cone angle, and thus the desired spray characteristics includes said spray cone angle; Xu [0038]- [0040] additionally teaches characteristics that can be modified for a desired set of spray characteristics).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Bonney et al. (US 20080272144, henceforth Bonney) in view of Gold et al. (US 20220032022, henceforth Gold) and Xu (US 20130334339, henceforth Xu) and as evidenced by Eldredge (US 20100057048, henceforth Eldredge) as applied to claim 1 above, and further in view of Boehm et al. (US 20070181133, henceforth Boehm).
Regarding claim 9, Bonney as modified discloses the device of claim 1 comprising optimized nozzle geometry (see rejection of claim 1 above).
Bonney as modified does not disclose the optimized nozzle geometry comprising a cone angle of 30.0 degrees +/- 10.0 degrees. Boehm teaches a nozzle (End 10b of nosepiece 10, fig. 1) in an aerosol delivery device (Nebulizing device 1, fig. 1) for use in a nostril (See [0023]) with a cone angle of 30.0 degrees +/- 10.0 degrees (Angle a is in the range of 10 degrees to 40 degrees, see fig. 1 and [0023]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have tapered the nozzle shroud of Bonney, and correspondingly the nozzle, to a cone angle between 10 and 40 degrees as in Boehm for ensuring that the nozzle shroud can be placed simply and comfortably in the patient's nostril (Boehm [0023]).
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Examiner notes that while some of the same references are still applied (Bonney, Gold, and Xu for at least claim 1), the combination of references is different especially with regards to the modifications made to Bonney which render the amended claims obvious.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAMUEL J MARRISON whose telephone number is (703)756-1927. The examiner can normally be reached M-F 7:00a-3:30p ET.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Sirmons can be reached at (571) 272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SAMUEL J MARRISON/Examiner, Art Unit 3783 /EMILY L SCHMIDT/Primary Examiner, Art Unit 3783