Prosecution Insights
Last updated: October 25, 2026
Application No. 18/383,354

RESPIRATORY DROPLET DELIVERY DEVICE WITH FACE SEAL AND METHODS OF USE

Final Rejection §102§103§112
Filed
Oct 24, 2023
Priority
Apr 24, 2021 — provisional 63/179,212 +2 more
Examiner
RAUBENSTRAW, TYLER ALLEN
Art Unit
3785
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
Pneuma Respiratory Inc.
OA Round
2 (Final)
71%
Grant Probability
Favorable
3-4
OA Rounds
3m
Est. Remaining
99%
With Interview

Examiner Intelligence

Grants 71% — above average
71%
Career Allowance Rate
99 granted / 139 resolved
+1.2% vs TC avg
Strong +31% interview lift
Without
With
+30.6%
Interview Lift
resolved cases with interview
Typical timeline
3y 3m
Avg Prosecution
29 currently pending
Career history
174
Total Applications
across all art units

Statute-Specific Performance

§101
2.3%
-37.7% vs TC avg
§103
55.9%
+15.9% vs TC avg
§102
20.7%
-19.3% vs TC avg
§112
17.4%
-22.6% vs TC avg
Black line = Tech Center average estimate • Based on career data from 139 resolved cases

Office Action

§102 §103 §112
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 . Response to Amendment The amendment filed on 06/30/2026 has been entered. Claims 1-2, and 7-13 have been amended. No claims have been newly added nor cancelled. Claims 1-16 remain pending in the instant application. Response to Arguments Applicant’s arguments with respect to claims 1 and 13 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 a different embodiment of the “Hebrank” reference is now relied upon as the primary reference. 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 and 13 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. Regarding claims 1 and 13, Applicant recites “the face seal contacts and seals the aperture plate”. The metes and bounds of the claimed limitation are unclear because Applicant refers to the aperture plate as both elements 72 and 75 in their specification (Paragraph 0021 refers to the aperture plate as element 72; Paragraph 0032 discloses the aperture plate is element 75). For the sake of interpretation, examiner is interpreting the limitation “the face seal contacts and seals the aperture plate” to mean the face seal (indirectly) contacts and seals the aperture plate. Claims 2-12 and 14-16 depend from claims 1 and 13 and thus inherit this 112(b) rejection. Claim Rejections - 35 USC § 102 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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action: A person shall be entitled to a patent unless – (a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention. Claims 1-3, 8-10, 13, and 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO2019094628A1 to Hebrank et al. (hereinafter “Hebrank”). Regarding claim 1, Hebrank discloses a droplet delivery device comprising (See Figs. 4A-B generally) a mouthpiece (Fig. 4B mouthpiece 408); a fluid cartridge (Fig. 6 reservoir 435; Paragraph 00133 discloses the reservoir holds fluid); an aperture plate in fluid communication with the fluid cartridge (Fig. 22D aperture plate 2104); a cover configured to removably couple to the mouthpiece (Fig. 4A mouthpiece cover 402); and a face seal coupled to the cover, wherein, when the cover is coupled to the mouthpiece, the face seal contacts and seals the aperture plate (See Annotated Fig. 22D for designation of the face seal). PNG media_image1.png 343 776 media_image1.png Greyscale Regarding claim 2, Hebrank discloses the device of claim 1, and Hebrank further discloses wherein the face seal is coupled within the cover (Examiner notes the designated face seal is coupled within cover 408), and wherein the mouthpiece comprises an air flow opening in fluid communication with the aperture plate (Figs. 4B & 22D shows the mouthpiece 408 has an airflow opening in fluid communication with aperture plate 2104). Regarding claim 3, Hebrank discloses the device of claim 2, and Hebrank further discloses wherein the face seal couples to an O-ring (Fig. 10C O-ring 903; Examiner notes the face seal would be indirectly coupled to the O-ring through the device’s structure). Regarding claim 8, Hebrank discloses the device of claim 1, and Hebrank further discloses wherein the face seal is configured to block a plurality of air flow paths within the droplet delivery device when the cover is coupled to the mouthpiece (Paragraph 00128 discloses there may be airflow entrances on opposite sides of the device and/or same side of the device which are connected to the airflow pathway in mouthpiece 408; Examiner notes that when the designated face seal is pressed against the aperture plate, the multiple air pathways would be blocked upstream by the seal). Regarding claim 9, Hebrank discloses the device of claim 2, and Hebrank further discloses wherein the face seal is configured to block a plurality of air flow paths within the droplet delivery device when the cover is coupled to the mouthpiece (Paragraph 00128 discloses there may be airflow entrances on opposite sides of the device and/or same side of the device which are connected to the airflow pathway in mouthpiece 408; Examiner notes that when the designated face seal is pressed against the aperture plate, the multiple air pathways would be blocked upstream by the seal). Regarding claim 10, Hebrank discloses the device of claim 3, and Hebrank further discloses wherein the face seal is configured to block a plurality of air flow paths within the droplet delivery device when the cover is coupled to the mouthpiece (Paragraph 00128 discloses there may be airflow entrances on opposite sides of the device and/or same side of the device which are connected to the airflow pathway in mouthpiece 408; Examiner notes that when the designated face seal is pressed against the aperture plate, the multiple air pathways would be blocked upstream by the seal). Regarding claim 13, Hebrank discloses a droplet delivery device (See Figs. 4A-B generally) comprising: a body housing (Fig. 4A base unit 404); a fluid cartridge coupled to the body housing (Fig. 6 reservoir 435; Paragraph 00133 discloses the reservoir holds fluid; Examiner notes the fluid cartridge is coupled to the base unit); an aperture plate in fluid communication with the fluid cartridge (Fig. 22D aperture plate 2104); a mouthpiece with an air flow opening in fluid communication with the aperture plate (Fig. 4B mouthpiece 408), wherein the mouthpiece is coupled to the body housing (Fig. 4B shows the mouthpiece is coupled to the base unit); a cover configured to removably couple to the mouthpiece (Fig. 4A mouthpiece cover 402); and a face seal coupled to the cover, wherein, when the cover is coupled to the mouthpiece, the face seal contacts and seals the aperture plate (See Annotated Fig. 22D for designation of the face seal). PNG media_image1.png 343 776 media_image1.png Greyscale Regarding claim 16, Hebrank discloses the device of claim 13, and Hebrank further discloses wherein the face seal is configured to block a plurality of air flow paths within the droplet delivery device when the cover is coupled to the mouthpiece (Paragraph 00128 discloses there may be airflow entrances on opposite sides of the device and/or same side of the device which are connected to the airflow pathway in mouthpiece 408; Examiner notes that when the designated face seal is pressed against the aperture plate, the multiple air pathways would be blocked upstream by the seal). Claim Rejections - 35 USC § 103 The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action. Claims 4-7, 11-12, and 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Hebrank in view of US20230061288A1 to Lee et al. (hereinafter “Lee”). Regarding claim 4, Hebrank discloses the device of claim 3, but does not disclose wherein the face seal is operably coupled to a spring mechanism of the cover configured to actuate the face seal. However, Lee teaches an aerosol-generating device which has a spring connected to a seal (Paragraph 0161 discloses a spring 344 may be connected to mouthpiece 34 which allows actuation from a closed (engaged) position of the sealing cap 35 to an open (disengaged) position). 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 cap of Hebrank to have a spring mechanism, as taught by Lee, in order to provide an alternative means of engaging the seal against the aperture plate. Regarding claim 5, Hebrank discloses the device of claim 2, but does not disclose wherein the face seal is operably coupled to a spring mechanism of the cover configured to actuate the face seal. However, Lee teaches an aerosol-generating device which has a spring connected to a seal (Paragraph 0161 discloses a spring 344 may be connected to mouthpiece 34 which allows actuation from a closed (engaged) position of the sealing cap 35 to an open (disengaged) position). 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 cap of Hebrank to have a spring mechanism, as taught by Lee, in order to provide an alternative means of engaging the seal against the aperture plate. Regarding claim 6, Hebrank discloses the device of claim 1, but does not disclose wherein the face seal is operably coupled to a spring mechanism of the cover configured to actuate the face seal. However, Lee teaches an aerosol-generating device which has a spring connected to a seal (Paragraph 0161 discloses a spring 344 may be connected to mouthpiece 34 which allows actuation from a closed (engaged) position of the sealing cap 35 to an open (disengaged) position). 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 cap of Hebrank to have a spring mechanism, as taught by Lee, in order to provide an alternative means of engaging the seal against the aperture plate. Regarding claim 7, Hebrank in view of Lee discloses the device of claim 6, and Hebrank as modified by Lee further discloses wherein the face seal is configured to block a plurality of air flow paths within the droplet delivery device when the cover is coupled to the mouthpiece (Paragraph 00128 discloses there may be airflow entrances on opposite sides of the device and/or same side of the device which are connected to the airflow pathway in mouthpiece 408; Examiner notes that when the designated face seal is pressed against the aperture plate, the multiple air pathways would be blocked upstream by the seal). Regarding claim 11, Hebrank in view of Lee discloses the device of claim 4, and Hebrank as modified by Lee further discloses wherein the face seal is configured to block a plurality of air flow paths within the droplet delivery device when the cover is coupled to the mouthpiece (Paragraph 00128 discloses there may be airflow entrances on opposite sides of the device and/or same side of the device which are connected to the airflow pathway in mouthpiece 408; Examiner notes that when the designated face seal is pressed against the aperture plate, the multiple air pathways would be blocked upstream by the seal). Regarding claim 12, Hebrank in view of Lee discloses the device of claim 5, and Hebrank as modified by Lee further discloses wherein the face seal is configured to block a plurality of air flow paths within the droplet delivery device when the cover is coupled to the mouthpiece (Paragraph 00128 discloses there may be airflow entrances on opposite sides of the device and/or same side of the device which are connected to the airflow pathway in mouthpiece 408; Examiner notes that when the designated face seal is pressed against the aperture plate, the multiple air pathways would be blocked upstream by the seal). Regarding claim 14, Hebrank discloses the device of claim 13, but does not disclose wherein the face seal is operably coupled to a spring mechanism of the cover configured to actuate the face seal. However, Lee teaches an aerosol-generating device which has a spring connected to a seal (Paragraph 0161 discloses a spring 344 may be connected to mouthpiece 34 which allows actuation from a closed (engaged) position of the sealing cap 35 to an open (disengaged) position). 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 cap of Hebrank to have a spring mechanism, as taught by Lee, in order to provide an alternative means of engaging the seal against the aperture plate. Regarding claim 15, Hebrank in view of Lee discloses the device of claim 14, and Hebrank as modified by Lee further discloses wherein the face seal is configured to block a plurality of air flow paths within the droplet delivery device when the cover is coupled to the mouthpiece (Paragraph 00128 discloses there may be airflow entrances on opposite sides of the device and/or same side of the device which are connected to the airflow pathway in mouthpiece 408; Examiner notes that when the designated face seal is pressed against the aperture plate, the multiple air pathways would be blocked upstream by the seal). Conclusion The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: US-8733935-B2 to Ballou; US-20120143152-A1 to Hunter; and US-20080066741-A1 to LeMahieu. 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 TYLER RAUBENSTRAW whose telephone number is (571)272-0662. The examiner can normally be reached Monday-Friday 7:30-5:30. 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, BRANDY LEE can be reached at 571-270-7410. 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. /TYLER A RAUBENSTRAW/Examiner, Art Unit 3785 /BRADLEY H PHILIPS/Primary Examiner, Art Unit 3799
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Prosecution Timeline

Oct 24, 2023
Application Filed
Mar 30, 2026
Non-Final Rejection mailed — §102, §103, §112
Jun 30, 2026
Response Filed
Oct 01, 2026
Final Rejection mailed — §102, §103, §112 (current)

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Study what changed to get past this examiner. Based on 5 most recent grants.

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Prosecution Projections

3-4
Expected OA Rounds
71%
Grant Probability
99%
With Interview (+30.6%)
3y 3m (~3m remaining)
Median Time to Grant
Moderate
PTA Risk
Based on 139 resolved cases by this examiner. Grant probability derived from career allowance rate.

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