Prosecution Insights
Last updated: October 04, 2026
Application No. 18/832,326

INHALATION THERAPY APPARATUS

Non-Final OA §112
Filed
Jul 23, 2024
Priority
Jan 28, 2022 — EU 22153887.9 +1 more
Examiner
JANG, JAEICK
Art Unit
Tech Center
Assignee
Pari Pharma GmbH
OA Round
1 (Non-Final)
67%
Grant Probability
Favorable
1-2
OA Rounds
1y 3m
Est. Remaining
99%
With Interview

Examiner Intelligence

Grants 67% — above average
67%
Career Allowance Rate
66 granted / 99 resolved
+6.7% vs TC avg
Strong +53% interview lift
Without
With
+52.6%
Interview Lift
resolved cases with interview
Typical timeline
3y 5m
Avg Prosecution
29 currently pending
Career history
115
Total Applications
across all art units

Statute-Specific Performance

§101
4.3%
-35.7% vs TC avg
§103
43.2%
+3.2% vs TC avg
§102
18.6%
-21.4% vs TC avg
§112
27.6%
-12.4% vs TC avg
Black line = Tech Center average estimate • Based on career data from 99 resolved cases

Office Action

§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 . Status of Claims The present office action is in response to the Remarks and Amendment filed 07/23/2024. As directed by the amendment, claims 3-4, 6-10, and 12-13 have been amended. Thus, claims 1-13 are presented pending in this application. Specification The abstract of the disclosure is objected to because of the following informalities: Abstract recites, “at least one connecting element (88, 9)” which Examiner suggest amending to read --at least one connecting element (8, 9)-- A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b). The disclosure is objected to because of the following informalities: Amended specification recites, “which claims priority to European Application No. 22153887.9, filed January 28, 2022, each of which is herein incorporated by reference in its entirety” under section, “CROSS-REFERENCE TO RELATED APPLICATION”. Examiner suggests replacing with -- which claims priority to European Application No. 22153887.9, filed January 28, 2022-- Examiner notes that the filing date of the PCT is the filing date for the national stage application. Therefore, any amendment that comes in with or after the filing of the national stage application in the US is not part of the original disclosure. Per MPEP 608.01(p)(I)(B) states that to be effective an incorporation by reference statement must be filing at time of filing and cannot be added after an application’s filing date. Since a 371 application’s filing date is the date the PCT was filed, an amendment in the 371 application to add an incorporation by reference is not effective and improper as new matter. Appropriate correction is required. Claim Objections Claims 1-13 are objected to because of the following informalities: Claim 1 recites, “on the other side” in ln 6 which Examiner suggest amending to read --on an opposite side-- Claim 2-13 are objected by virtue of dependency to claim 1. Claim 3-4 recite, “to one of claim” in ln 1 which Examiner suggest amending to read --to claim-- for clarity. Claim 6 recites “to any of claim” in ln 1 which Examiner suggest amending to read --to claim-- for clarity. Claims 7-10 and 12-13 recites, “to one of claim” in ln 1 which Examiner suggest amending to read --to claim-- for clarity. Appropriate correction is required. Claim Interpretation Claim 1 recites the limitation, “configured to clamp an output signal caused by the respiration of a patient”. Examiner interprets the “clamp” in light of the specification as requiring adjustment of the level of the respiration-dependent output signal (¶0027-0032; Fig 5). Thus, it allows to hold or clamp the output value at specific amplitude value that resulted from the breathing-induced pressure fluctuations such as the shift (¶0032) from the amplitude value B0 as described from ¶0028 and as a function of the signal processing filtering techniques disclosed in the specification of the instant application. 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. 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: at least one connecting element (8, 9) in claim 1. 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 § 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 6-7, and 10 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 6 recites, “preferably below 0.06 Hz” which renders claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Claim 7 recites, “preferably between 0.1 Hz and at least 40 Hz” which renders claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Claim 10 recites, “in particular a piezoelectric element” which renders claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Allowable Subject Matter Claims 1-5, 8-9, and 11-13 would be allowable if amended to overcome the claim objections, set forth in this Office action. Claims 6-7, and 10 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims. Reasons for Indication of Allowable Subject Matter The following is a statement of reasons for the indication of allowable subject matter: the closest identified prior art documents of record are Feiner et al. (US 20050034719 A1; cited in IDS filed 10/02/2024), Wilkerson et al. (US 20140151457 A1), and Koerner et al. (machine translation of EP 2221079 A1) Feiner et al. discloses the main components of the claim 1 and wherein the oscillation generating device (6, 7) provides an output signal caused by the respiration of a patient (claim 1) in order to sense the respiration of the patient without a separate respiration sensor (¶0003) , but the prior art does not suggest or teach a processing unit configured to “clamp an output signal caused by the respiration”. The instant application identifies the stability problem (¶0009) of Feiner et al. and provides solution by clamping the output signal. Wilkerson et al. discloses, a drive signal generator configured to generate a drive signal for driving the piezoelectric actuator (abstract) and teaches different techniques applied to a range of suitable drive signal types, including, but not limited to, sinusoidal, square, ramp, chirp, amplitude modulated and frequency modulated drive signals and waveforms (¶0068), but the prior art fails to suggest or teach the drive signal caused by the respiration and the technique comprising of the clamping/holding the output signal. Koerner et al. discloses the output voltage of the piezoelectric sensor is amplified by an amplifier when the breathing of the patient has been identified via a deflection (¶0027-0028) while low-pass filter the output signal, but the prior art fails to suggest or teach clamping/holding the output signal. It is thus found that one of ordinary skills in the art at the time of the invention would only have arrived at the instantly claimed inventions by way of improper hindsight reasoning. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAEICK JANG whose telephone number is (703)756-4569. The examiner can normally be reached M-F 8:30 - 4:30. 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, Kendra D Carter can be reached at (571) 272-9034. 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. /J.J./Examiner, Art Unit 3785 /JOSEPH D. BOECKER/Primary Examiner, Art Unit 3785
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Prosecution Timeline

Jul 23, 2024
Application Filed
Sep 24, 2026
Non-Final Rejection mailed — §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

1-2
Expected OA Rounds
67%
Grant Probability
99%
With Interview (+52.6%)
3y 5m (~1y 3m remaining)
Median Time to Grant
Low
PTA Risk
Based on 99 resolved cases by this examiner. Grant probability derived from career allowance rate.

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