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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Amendment
This office action is responsive to the amendment filed on December 15, 2025. As directed by the amendment: claims 40 and 52 have been amended and claim 62 has been cancelled. Thus, claims 40, 42-45, 47-52, and 54-61 are presently pending in this application.
As a result of amendments made to claim 40, the claim no longer invokes 35 U.S.C. 112f/6th paragraph as set forth in the previous office action.
Applicant’s amendments to the Specification, Drawings, and Claims have overcome each and every 112(b) rejections previously set forth in the Non-Final Office Action mailed October 1, 2025.
Response to Arguments
Applicant’s arguments, filed December 15, 2025, with respect to the rejection(s) of claim(s) 40 under 35 U.S.C 103 have been fully considered and are persuasive, specifically in regards to Goumeniouk not teaching or disclosing a viscous dampener. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Applicant’s amendments.
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.
Claim(s) 40, 42-44, 47-52, and 54-57 is/are rejected under 35 U.S.C. 103 as being unpatentable over Atkinson (US 20130174849) in view of Dragisic (US 6536437) in view of Levin (US 20160361507) in view of Oechsel (US 6401987) and in further view of Anderson (US 20140148784.
Regarding claim 40, Atkinson discloses a fluid delivery device for delivering fluid to a nasal cavity of a subject, the device comprising a dispensing tip for dispensing a fluid (see below), the dispensing tip comprises a flexible nib configured to conform with a nasal cavity of the subject through an internal nasal geometry of the subject to a location proximate to an olfactory region in the subject's nasal cavity (flexible catheter/cannula 30 in fig. 4A).
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Atkinson further teaches the device is configured to deliver a liquid therefrom (“aerosol, liquid, or gel” 10 in fig. 4A; paragraph 28). However, Atkinson does not explicitly teach or disclose a damping mechanism comprising a viscous damper for creating a controlled velocity profile of the fluid comprising laminar flow upon exiting the dispensing tip. Additionally, Atkinson does not explicitly teach or disclose the nib is compliant and soft and is configured to be self-guided through an internal nasal geometry.
Dragisic teaches a similar device comprising a nib (wand 116 in fig. 8) which is compliant and soft (5:31-37 discloses the wand is made from silicone and is soft) and is configured to be self-guided through an internal nasal geometry (5:31-37 discloses the wand can follow the contours of the nasal passageway). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the nib of Atkinson to be compliant and soft and be configured to be self-guided through an internal nasal geometry, as taught by Dragisic. This modification would facilitate insertion into the nose and would reduce damage and trauma to the nasal passage (5:31-37).
Levin teaches a fluid delivery device for delivering fluid to a nasal cavity (fig. 1; paragraph 10) and teaches that the fluid can comprise a laminar flow upon exiting a dispensing tip (paragraphs 34-35). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the device of modified Atkinson so that the fluid comprises a laminar flow upon exiting the dispensing tip, as taught by Levin, as Levin teaches that this type of flow is useful in delivering fluid to a nasal structure and since it appears the device of modified Atkinson would operate equally well with the modification.
Oechsel teaches a fluid delivery device for delivering fluid to a nasal cavity (fig. 1) which comprises a dispensing tip (see below) attached to a dispensing mechanism (see below). It would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have substituted the generic squeeze bottle of Atkinson (see annotated figure above) with the dispensing mechanism below of Oechsel in order to deliver a precise dose of fluid to the nasal cavity (2:50-54).
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Anderson further teaches a damping mechanism embodied as a viscous damper for creating a controlled velocity profile of fluid (paragraph 169). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the device of modified Atkinson to incorporate a viscous damper which dampens the spring (30 in fig. 1) of Oechsel. This modification to provide a more controlled release of fluid delivery (paragraph 219)
Regarding claim 42, in the modified device of Atkinson, Atkinson discloses the dispensing tip is coupled to a chamber for containing the fluid to be dispensed (in modified Atkinson, cannula 30 of Atkinson would be coupled to reservoir 20 of Oechsel).
Regarding claim 43, in the modified device of Atkinson, Oechsel discloses the chamber is a shot chamber (absent any other limitations over the “shot” chamber, barrel reservoir 20 is equated to the claimed shot chamber).
Regarding claim 44, in the modified device of Atkinson, Oechsel discloses the device further comprises an actuator operatively coupled to the chamber such that upon actuation of the actuator the fluid flows from the chamber and out of the dispensing tip (intermediate member 60 in fig. 1; 5:23-33).
Regarding claim 47, in the modified device of Atkinson, Oechsel discloses the actuator is loaded by a spring (spring 30 in fig. 1).
Regarding claim 48, in the modified device of Atkinson, Oechsel discloses the spring is in alignment with a plunger (spring 30 is concentric with piston 25 in fig. 1).
Regarding claim 49, in the modified device of Atkinson, Oechsel discloses upon actuation of the device the plunger exerts pressure on the chamber and forces the fluid flow out of the chamber (5:33-37).
Regarding claim 50, in the modified device of Atkinson, Oechsel discloses the fluid delivery device is: hand held, useable with a single hand, designed for ambidextrous use, promotes proper positioning in the nasal cavity, requires only a single user action to deliver a primed dose, prevents dispensing partial doses, or combinations thereof (the device is capable of being held in a single hand which can activate triggering member 50 in fig. 1).
Regarding claim 51, in the modified device of Atkinson, Oechsel discloses the device is configured to deliver multiple doses (2:50-54).
Regarding claim 52, in the modified device of Atkinson, Atkinson discloses the fluid therefrom as a liquid jet comprises a discrete liquid slug (paragraph 28 discloses the fluid being a liquid and would exit out as a “jet” since the fluid is pressurized in modified Atkinson; in modified Atkinson, the fluid would be a discrete liquid slug since the device is capable of delivering a single, continuous stream of liquid, which is equated to the claimed language absent any further limitations on the term “slug”).
Regarding claim 54, in the modified device of Atkinson, Oechsel discloses a housing (outer element 55 in fig. 1), wherein the housing defines an outer body of the device (fig. 1).
Regarding claim 55, in the modified device of Atkinson, Anderson discloses the housing comprises a dispensing opening (see below, the opening below would receive the dispensing tip of Atkinson).
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Regarding claim 56, in the modified device of Atkinson, Dragisic discloses the dispensing tip is biased to follow the subject's septum (5:31-37 discloses the tip is made from silicone and can follow the contours of the nasal passageway, which would include the septum).
Regarding claim 57, in the modified device of Atkinson, Atkinson discloses the dispensing tip conforms to the anterior aspect of the intranasal passage (paragraph 44).
Claim(s) 45 is/are rejected under 35 U.S.C. 103 as being unpatentable over Atkinson in view of Dragisic in view of Levin in view of Oechsel and in view of Anderson, as applied to claim 40 above, and further in view of Levin (US 20180256867), hereinafter “Levin ‘867”.
Regarding claim 45, modified Atkinson teaches all of the claimed limitations set forth in claim 40, as discussed above, but does not teach or disclose the dispensing tip further comprises a nostril stop that is configured to: (I) limit depth of insertion of the dispensing tip into the nasal cavity of the subject; and (II) provide feedback to the subject when the dispensing tip reaches a location proximate to the olfactory region in the nasal cavity of the subject.
Levin ‘867 teaches a similar device with a tip (fig. 1A) comprising a nostril stop (fitting 120 in fig. 1A) which is configured to (I) limit depth of insertion of the dispensing tip into the nasal cavity of the subject (paragraph 57 discloses the fitting engaging the nostril which would limit depth); and (II) provide feedback to the subject when the dispensing tip reaches a target region in the nasal cavity of the subject (a user would feel the fitting engage the nostrils). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the tip to further comprise a nostril stop that is configured to: (I) limit depth of insertion of the dispensing tip into the nasal cavity of the subject; and (II) provide feedback to the subject when the dispensing tip reaches a location proximate to the olfactory region in the nasal cavity of the subject, as taught by Levin ‘867, for the purpose of ensure proper positioning of the tip (paragraph 57).
The examiner notes that in the device of modified Atkinson, the nostril stop would provide feedback to the subject when the tip reaches a location proximate to the olfactory region since this is the target region.
Claim(s) 58-60 is/are rejected under 35 U.S.C. 103 as being unpatentable over Atkinson in view of Dragisic in view of Levin in view of Oechsel and in view of Anderson, as applied to claim 40 above, and further in view of Goumeniouk (US 20180344950).
Regarding claim 58, modified Atkinson teaches all of the claimed limitations set forth in claim 40, as discussed above. Oechsel further teaches a reservoir (reservoir 20 in fig. 1). However, modified Atkinson does not explicitly teach or disclose the reservoir to be removable.
Goumeniouk teaches a fluid delivery device (fig. 2) comprising a reservoir (canister 106 in fig. 2) which is removable (paragraph 69 discloses disassembling the device and installing a new canister). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the device of modified Atkinson to be able to be disassembled so that the reservoir can be removed, as taught by Goumeniouk. This modification would enable a new reservoir to be installed and the device reused (paragraph 69).
Regarding claim 59, in the modified device of Atkinson, Oechsel discloses the reservoir comprises a non-air interface mechanically pressurized fluid reservoir to enable dosing independent of orientation of the subject (fig. 1 shows reservoir 20 pressurized by piston 25).
Regarding claim 60, in the modified device of Atkinson, Oechsel discloses the reservoir comprises a disposable reservoir (the entire device, including the reservoir, is capable of being disposed).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 40, 42-45, 47-52, and 54-60 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 6-8, and 10 of U.S. Patent No. 11497862 in view of the teachings below (see table below).
Regarding claim 40, claim 1 of the issued patent claims all of the claimed limitations set forth in claim 40 of the instant application except that the device comprises a damping mechanism comprising a viscous damper for creating a controlled velocity profile of the fluid.
Anderson teaches this limitation as discussed above in claim 40. It would have been obvious to have modified the issued claim to have the claimed damping mechanism since Anderson teaches this modification provide for a more controlled release of energy (paragraph 219).
Instant Claim
Issued Claim
Teaching
40
1
See above
42
1
43
1
44
1
45
1
47
3
48
3
49
3
50
Oechsel teaches this limitation above. It would have been obvious to have modified the issued claim to have the claimed limitation since Goumeniouk teaches this enables ease of use.
51
Oechsel teaches this limitation above. It would have been obvious to have modified the issued claim to have the claimed limitation in order to reuse the device.
52
Djupesland (US 20090304802) teaches this limitation above. It would have been obvious to PHOSITA to modify the issued claim to have the claimed limitation since Djupesland teaches type of flow is useful in being delivered to the olfactory region (paragraph 68).
54
7
55
8
56
1
57
1
58
6
59
Oechsel teaches this limitation above. It would have been obvious to have modified the issued claim to have the claimed limitation since Oechsel teaches that this type of reservoir can be used in conjunction with a compressed gas cylinder to deliver a precise amount of medication.
60
6
Allowable Subject Matter
Claim 61 objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 61, the closest prior art is Oechsel modified with Goumeniouk, as discussed above, which does not teach or disclose the reservoir is a refillable reservoir. The examiner notes that while the reservoir of Goumeniouk is refillable (paragraph 56 discloses recharging the canister), the reservoir of Goumeniouk is structurally different from the reservoir of Oechsel so that it is the examiner’s opinion that PHOSITA would not understand how to modify the reservoir of Oechsel to be refillable.
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 COURTNEY FREDRICKSON whose telephone number is (571)270-7481. The examiner can normally be reached Monday-Friday (9 AM - 5 PM EST).
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/COURTNEY B FREDRICKSON/Primary Examiner, Art Unit 3783