Prosecution Insights
Last updated: May 04, 2026
Application No. 18/383,354

RESPIRATORY DROPLET DELIVERY DEVICE WITH FACE SEAL AND METHODS OF USE

Non-Final OA §103
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
1 (Non-Final)
72%
Grant Probability
Favorable
1-2
OA Rounds
9m
Est. Remaining
99%
With Interview

Examiner Intelligence

Grants 72% — above average
72%
Career Allowance Rate
94 granted / 131 resolved
+1.8% vs TC avg
Strong +32% interview lift
Without
With
+32.1%
Interview Lift
resolved cases with interview
Typical timeline
3y 3m
Avg Prosecution
21 currently pending
Career history
152
Total Applications
across all art units

Statute-Specific Performance

§101
3.2%
-36.8% vs TC avg
§103
53.0%
+13.0% vs TC avg
§102
19.9%
-20.1% vs TC avg
§112
17.9%
-22.1% vs TC avg
Black line = Tech Center average estimate • Based on career data from 131 resolved cases

Office Action

§103
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 filed on 07/11/2025 has been received and fully considered. Drawings The drawings are objected to because Figs. 1-6 are photographs of insufficient quality. Furthermore, Figs. 1-7 are objected to for lacking clarity regarding the lead lines. The lead lines in Figs. 1-7 appear to be hand drawn and there are erasure marks of lead lines next to other lead lines in the Figures. This leads to confusion regarding which element is being referred to when looking at the figures and reading the specification. The lead lines should be redrawn to be singular clear lines. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance. Examiner notes the following section of MPEP 608.02(V), 37 CFR 1.84: (b) Photographs.— (1) Black and white. Photographs, including photocopies of photographs, are not ordinarily permitted in utility and design patent applications. The Office will accept photographs in utility and design patent applications, however, if photographs are the only practicable medium for illustrating the claimed invention. For example, photographs or photomicrographs of: electrophoresis gels, blots (e.g., immunological, western, Southern, and northern), auto- radiographs, cell cultures (stained and unstained), histological tissue cross sections (stained and unstained), animals, plants, in vivo imaging, thin layer chromatography plates, crystalline structures, and, in a design patent application, ornamental effects, are acceptable. If the subject matter of the application admits of illustration by a drawing, the examiner may require a drawing in place of the photograph. The photographs must be of sufficient quality so that all details in the photographs are reproducible in the printed patent. Claim Interpretation The following is a quotation of 35 U.S.C. 112(f): (f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof. The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph: An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof. The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked. As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph: (A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function; (B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and (C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function. Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function. Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function. Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “ ejector mechanism” in claim s 1 and 13 . Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. 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. 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 1-16 are rejected under 35 U.S.C. 103 as being unpatentable over WO2019094628A1 to Hebrank et al. (hereinafter “ Hebrank ”) in view of US5740794A to Smith et al. (hereinafter “Smith”) . Regarding claim 1, Hebrank discloses a droplet delivery device (Fig. 2 droplet delivery device 200) comprising an ejector mechanism that couples to a fluid cartridge (Fig. 2 drug delivery ampoule 106; Paragraph 00117 discloses the drug delivery ampoule comprises both an ejector mechanism and a reservoir; Paragraph 00126 discloses the reservoir is used for fluid storage). Hebrank does not disclose a removable face seal that moves with a cover for a mouthpiece of the device . However, Smith teaches an inhalation apparatus for medicaments which has a removable face seal that moves with a cover for a mouthpiece of the device (Fig. 14 cover 344, seal 346; Examiner notes the seal is capable of being removed). 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 mouthpiece cover of Hebrank to further include a removable face seal that moves with the mouthpiece cover, as taught by Smith, in order to provide a means of sealing the medicament chamber until ready for inhalation (Col. 19 lines 39-56). Hebrank as modified by Smith further discloses the removable face seal is configured to couple to an ejector mechanism that couples to a fluid cartridge (Examiner notes that Smith’s seal would be coupled to the ejector mechanism and fluid cartridge when the mouthpiece cover is closed). Regarding claim 2, Hebrank in view of Smith discloses the device of claim 1 , and Hebrank as modified by Smith further discloses wherein the face seal is coupled within the cover configured to removably couple to a mouthpiece with an air flow opening in fluid communication with the ejector mechanism (Examiner notes that modified Hebrank would have the face seal covering the main air flow opening which is in fluid communication with the ampoule 106). Regarding claim 3, Hebrank in view of Smith discloses the device of claim 2 , and Hebrank as modified by Smith further discloses wherein the face seal couples to an O-ring (Fig. 10B O-ring 903; Examiner notes the face seal would be indirectly coupled to the O-ring through the device’s structure). Regarding claim 4, Hebrank in view of Smith discloses the device of claim 3 , and Hebrank as modified by Smith further discloses wherein the face seal is operably coupled to a spring mechanism of the cover configured to actuate the face seal (Fig. 2 spring 214; Paragraph 00121 discloses the spring pushes open the mouthpiece; Examiner notes the face seal is within the mouthpiece and thus is operably connected to the spring mechanism as the mouthpiece opens via the spring). Regarding claim 5, Hebrank in view of Smith discloses the device of claim 2 , Hebrank as modified by Smith further discloses wherein the face seal is operably coupled to a spring mechanism of the cover configured to actuate the face seal (Fig. 2 spring 214; Paragraph 00121 discloses the spring pushes open the mouthpiece; Examiner notes the face seal is within the mouthpiece and thus is operably connected to the spring mechanism as the mouthpiece opens via the spring). Regarding claim 6, Hebrank in view of Smith discloses the device of claim 1 , and Hebrank as modified by Smith further discloses wherein the face seal is operably coupled to a spring mechanism of the cover configured to actuate the face seal (Fig. 2 spring 214; Paragraph 00121 discloses the spring pushes open the mouthpiece; Examiner notes the face seal is within the mouthpiece and thus is operably connected to the spring mechanism as the mouthpiece opens via the spring). Regarding claim 7, Hebrank in view of Smith discloses the device of claim 6 , and Hebrank in view of Smith further discloses wherein the face seal is configured to block a plurality of air flow paths within the droplet delivery device when coupled to the ejector mechanism (Examiner notes the face seal of Smith within Hebrank’s mouthpiece would block intake element 1006 which has an array of holes (air flow paths) 1006a (See Fig. 11B); Examiner further notes the seal of Smith is coupled to the ampoule 106 (comprising the ejector mechanism) ). Regarding claim 8, Hebrank in view of Smith discloses the device of claim 1 , and Hebrank as modified by Smith further discloses wherein the face seal is configured to block a plurality of air flow paths within the droplet delivery device when coupled to the ejector mechanism (Examiner notes the face seal of Smith within Hebrank’s mouthpiece would block intake element 1006 which has an array of holes (air flow paths) 1006a (See Fig. 11B); Examiner further notes the seal of Smith is coupled to the ampoule 106 (comprising the ejector mechanism)). Regarding claim 9, Hebrank in view of Smith discloses the device of claim 2 , and Hebrank as modified by Smith further discloses wherein the face seal is configured to block a plurality of air flow paths within the droplet delivery device when coupled to the ejector mechanism (Examiner notes the face seal of Smith within Hebrank’s mouthpiece would block intake element 1006 which has an array of holes (air flow paths) 1006a (See Fig. 11B); Examiner further notes the seal of Smith is coupled to the ampoule 106 (comprising the ejector mechanism)). Regarding claim 10, Hebrank in view of Smith discloses the device of claim 3 , and Hebrank as modified by Smith further discloses wherein the face seal is configured to block a plurality of air flow paths within the droplet delivery device when coupled to the ejector mechanism (Examiner notes the face seal of Smith within Hebrank’s mouthpiece within the droplet delivery device 100 would block intake element 1006 which has an array of holes (air flow paths) 1006a (See Fig. 11B); Examiner further notes the seal of Smith is coupled to the ampoule 106 (comprising the ejector mechanism)). Regarding claim 11, Hebrank in view of Smith discloses the device of claim 4 , and Hebrank as modified by Smith further discloses wherein the face seal is configured to block a plurality of air flow paths within the droplet delivery device when coupled to the ejector mechanism (Examiner notes the face seal of Smith within Hebrank’s mouthpiece within the droplet delivery device 100 would block intake element 1006 which has an array of holes (air flow paths) 1006a (See Fig. 11B); Examiner further notes the seal of Smith is coupled to the ampoule 106 (comprising the ejector mechanism)). Regarding claim 12, Hebrank in view of Smith discloses the device of claim 5 , and Hebrank as modified by Smith further discloses wherein the face seal is configured to block a plurality of air flow paths within the droplet delivery device when coupled to the ejector mechanism (Examiner notes the face seal of Smith within Hebrank’s mouthpiece within the droplet delivery device 100 would block intake element 1006 which has an array of holes (air flow paths) 1006a (See Fig. 11B); Examiner further notes the seal of Smith is coupled to the ampoule 106 (comprising the ejector mechanism)). Regarding claim 13, Hebrank discloses a droplet delivery device (Fig. 2 droplet delivery device 200) comprising: a body housing (Fig. 1 base unit 104); a fluid cartridge coupled to the body housing; an ejector mechanism coupled to the fluid cartridge (Fig. 2 drug delivery ampoule 106; Paragraph 00117 discloses the drug delivery ampoule comprises both an ejector mechanism and a reservoir; Paragraph 00126 discloses the reservoir is used for fluid storage); a mouthpiece with an air flow opening in fluid communication with the ejector mechanism, and wherein the mouthpiece is coupled to the body housing (Figs. 1A-B mouthpiece 108; Examiner notes Fig. 2 shows that mouthpiece 108 is fluidly connected to ampoule 106 and coupled to base unit 104). Hebrank does not disclose a removable face seal that moves with a cover for a mouthpiece of the device . However, Smith teaches an inhalation apparatus for medicaments which has a removable face seal that moves with a cover for a mouthpiece of the device (Fig. 14 cover 344, seal 346; Examiner notes the seal is capable of being removed). 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 mouthpiece cover of Hebrank to further include a removable face seal that moves with the mouthpiece cover, as taught by Smith, in order to provide a means of sealing the medicament chamber until ready for inhalation (Col. 19 lines 39-56). Regarding claim 14, Hebrank in view of Smith discloses the device of claim 13 , and Hebrank as modified by Smith further discloses wherein the face seal is operably coupled to a spring mechanism of the cover configured to actuate the face seal (Fig. 2 spring 214; Paragraph 00121 discloses the spring pushes open the mouthpiece; Examiner notes the face seal is within the mouthpiece and thus is operably connected to the spring mechanism as the mouthpiece opens via the spring). Regarding claim 15, Hebrank in view of Smith discloses the device of claim 14 , and Hebrank as modified by Smith further discloses wherein the face seal is configured to block a plurality of air flow paths within the droplet delivery device when coupled to the ejector mechanism (Examiner notes the face seal of Smith within Hebrank’s mouthpiece within the droplet delivery device 100 would block intake element 1006 which has an array of holes (air flow paths) 1006a (See Fig. 11B); Examiner further notes the seal of Smith is coupled to the ampoule 106 (comprising the ejector mechanism)). Regarding claim 16, Hebrank in view of Smith discloses the device of claim 13 , and Hebrank as modified by Smith further discloses wherein the face seal is configured to block a plurality of air flow paths within the droplet delivery device when coupled to the ejector mechanism (Examiner notes the face seal of Smith within Hebrank’s mouthpiece within the droplet delivery device 100 would block intake element 1006 which has an array of holes (air flow paths) 1006a (See Fig. 11B); Examiner further notes the seal of Smith is coupled to the ampoule 106 (comprising the ejector mechanism)). Conclusion The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: US-6629524-B1 to Goodall; US-5524613-A to Haber; US-20210177055-A1 to Lahoud ; US-20210093796-A1 to Finkelstein; US-20210093793-A1 to Finkelstein; US-20210023315-A1 to Goldenberg; US-20210022410-A1 to Huang; US-20200397059-A1 to Zongbo ; US-20200119489-A1 to Novak; US-20190366018-A1 to Conlon; US-20190275267-A1 to Calderon Oliveras ; US-20190125987-A1 to Germinario ; US-20190125986-A1 to Germinario ; US-20190125985-A1 to Germinario ; US-20170319796-A1 to Germinario ; US-20160089526-A1 to Hofland ; US-20150320948-A1 to Eicher; US-20140336618-A1 to Wilkerson; US-20130299607-A1 to Wilkerson; US-20130152956-A1 to von Borstel ; and US-20120217184-A1 to Edwards. Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT TYLER RAUBENSTRAW whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)272-0662 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT 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 571-270-3525. 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
Read full office action

Prosecution Timeline

Oct 24, 2023
Application Filed
Mar 26, 2026
Non-Final Rejection — §103 (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

1-2
Expected OA Rounds
72%
Grant Probability
99%
With Interview (+32.1%)
3y 3m (~9m remaining)
Median Time to Grant
Low
PTA Risk
Based on 131 resolved cases by this examiner. Grant probability derived from career allowance rate.

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