Prosecution Insights
Last updated: July 17, 2026
Application No. 18/550,513

ARRANGEMENT IN THE MANNER OF A SPEECH VALVE FOR PLACING AND FITTING ON A TRACHEOSTOMY CANNULA

Final Rejection §112
Filed
Sep 14, 2023
Priority
Mar 24, 2021 — EU 21164568.4 +1 more
Examiner
BOECKER, JOSEPH D
Art Unit
3785
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
Albert-Ludwigs-Universit¿T Freiburg
OA Round
2 (Final)
84%
Grant Probability
Favorable
3-4
OA Rounds
0m
Est. Remaining
99%
With Interview

Examiner Intelligence

Grants 84% — above average
84%
Career Allowance Rate
749 granted / 897 resolved
+13.5% vs TC avg
Strong +23% interview lift
Without
With
+22.8%
Interview Lift
resolved cases with interview
Typical timeline
2y 10m
Avg Prosecution
46 currently pending
Career history
929
Total Applications
across all art units

Statute-Specific Performance

§101
1.0%
-39.0% vs TC avg
§103
60.4%
+20.4% vs TC avg
§102
10.9%
-29.1% vs TC avg
§112
25.0%
-15.0% vs TC avg
Black line = Tech Center average estimate • Based on career data from 897 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 . Response to Amendment The Amendment filed 05 Jun 2026 has been entered. Claims 37-54 are pending in the application with claims 19-36 canceled. Claims 37-54 are newly filed. Applicant has not successfully addressed the prior Specification objection previously set forth in the Non-Final Office Action mailed 22 Apr 2026. The newly filed claims do not resolve many of the Claim objections and 35 U.S.C. 112 rejections set forth in the Non-Final Office Action mailed 22 Apr 2026. Response to Arguments Applicant's arguments filed 05 Jun 2026 have been fully considered but they are not fully persuasive. Regarding the objection to the specification applicant asserts that incorporation by reference on the same date as entry into national phase does not constitute new matter (Pg. 8). It is respectfully submitted that applicant has not cited to any rule or policy to substantiate this allegation. The previously cited MPEP sections of 1893 and 608 do not include any provision for an incorporation by reference being submitted after the filing date of the instant application, that being the filing date of the associated PCT. Applicant is welcome to cite the foreign patent application as a priority document but the particular phrasing “incorporation by reference” will result in a new matter objection. Applicant’s arguments, see Pg. 8-9, filed 05 Jun 2026, with respect to the 35 U.S.C. 103 rejection have been fully considered and are persuasive. The prior 35 U.S.C. 103 rejection of the claims has been withdrawn. Examiner concurs with applicant’s assertion that newly filed claim 37 patentably distinguishes over the prior art of record. Specification The amendment filed 14 Sep 2023 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows: the incorporation by reference of the international patent application PCT/EP2022/057574 and of the foreign patent application EP 21164568.4 is ineffective as it was added on the date of entry into the national phase, which is after the filing date of the instant application. The filing date of this national stage application is the filing date of associated PCT, in this case 23 May 2022, see MPEP 1893.03(b). Therefore the specification amendment of 14 Sep 2023 to include the incorporation by reference is new matter, per MPEP 608.01(p). Applicant is required to cancel the new matter in the reply to this Office Action. Claim Objections Claim(s) 37-54 is/are objected to because of the following informalities: Claim 37, Ln. 12 recites “the valve flap” which should read “the at least one elastically deformable valve flap” for consistency with the prior limitation (and how the limitation is recited in the dependent claims) Claim 37, Ln. 13 recites “the flap” which should read “the at least one elastically deformable valve flap” for consistency with the prior limitation (and how the limitation is recited in the dependent claims) Claim 38, Ln. 3 recites “one way” which should read “one-way” for consistency Claim 45, Ln. 2-3 recites “a throughflow body” which should read “the throughflow body” following after claim 37 Claim 46, Ln. 2-3 recites “the elastically deformable valve flap” which should read “the at least one elastically deformable valve flap” for consistency with claim 37 Claim 46, Ln. 3 recites “the second state” which should read “the second pressure state” for consistency with claim 37 Claim 46, Ln. 3-4 recites “the first state” which should read “the first pressure state” for consistency with claim 37 Claim 47 twice recites “the elastically deformable valve flap” which should read “the at least one elastically deformable valve flap” for consistency with claim 37 Claim 50, Ln. 2-3 recites “the first state” which should read “the first pressure state” for consistency with claim 37 Claim 50, Ln. 4 recites “the valve flap” which should read “the at least one elastically deformable valve flap” for consistency with claim 37 Claim 52, Ln. 2 recites “the first state” which should read “the first pressure state” for consistency with claim 37 Claim 52, Ln. 3 recites “a throughflow body α longitudinal axis” where the middle alpha character should be removed Appropriate correction is required. Claim Rejections - 35 USC § 112 The following is a quotation of the first paragraph of 35 U.S.C. 112(a): (a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention. The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112: The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention. Claim(s) 37-54 is/are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 37 recites the limitation “the valve flap responds to the second pressure state in the throughflow channel to partially open the one-way valve by elastic deformation of the flap” in Ln. 12-13. The limitation thus requires the one-way valve to be partially opened by elastic deformation of the valve flap. The disclosed valve which corresponds to the one-way valve of claim 37 is one-way flap valve arrangement 23 as shown in Fig. 5 (¶0101 of the PGPub copy of the instant application). The disclosed flap which corresponds to the valve flap of the overpressure valve arrangement is valve flap 15 of overpressure valve arrangement 11, also shown in Fig. 5 (¶0053 of the PGPub copy of the instant application). Notably, one-way flap valve arrangement 23 is on a separate flow path from valve flap 15 (e.g. Fig. 5). There is lack of sufficient written description support in the application as originally filed for the present claiming of the one-way valve (23) being partially opened by elastic deformation of the valve flap (15). It is questioned whether the proper concept might be the valve opening being partially opened by elastic deformation of the valve flap 15? Claim 38 recites the limitation “the signal generator generates a signal in response to an overpressure causing opening of the one-way valve” in Ln. 2-4. There is not found to be disclosure in the originally filed application of a signal generator operating in response to overpressure causing opening of the one-way valve 23. See also the discussion above in regard to claim 37 about confusion in how the one-way valve appears to have been incorrectly recited. There is lack of sufficient written description support in the application as originally filed for the present claiming of a signal generator operating in response to overpressure causing opening of the one-way valve 23. It is questioned whether the proper concept might be the signal generator operating in response to overpressure causing opening the valve flap 15? Claim 40 recites the limitation “the signal generator generates the perceptible sound by vibrational excitation of air flow passing through the one-way valve” in Ln. 2-3. There is not found to be disclosure in the originally filed application of a signal generator operating based on vibrational excitation of air flow passing through the one-way valve 23. See also the discussion above in regard to claim 37 about confusion in how the one-way valve appears to have been incorrectly recited. There is lack of sufficient written description support in the application as originally filed for the present claiming of a signal generator operating based on vibrational excitation of air flow passing through the one-way valve 23. It is questioned whether the proper concept might be the signal generator operating based on vibrational excitation of air flow passing through the valve flap 15? Claim 41 recites the limitation “the signal generator is located downstream from the valve opening and is turned off by the one-way valve” in Ln. 2-3. There is not found to be disclosure in the originally filed application of a signal generator turned off by the one-way valve 23. See also the discussion above in regard to claim 37 about confusion in how the one-way valve appears to have been incorrectly recited. There is lack of sufficient written description support in the application as originally filed for the present claiming of a signal generator turned off by the one-way valve 23. It is questioned whether the proper concept might be the signal generator turned off by the valve flap 15? 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. Claim(s) 38-46, 48-49, 51 and 53-54 is/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 pre-AIA the applicant regards as the invention. Claim 38 recites the limitation “the overpressure responsive one-way valve” in Ln. 2. There is insufficient antecedent basis for this limitation in the claim. Claim 37 has not recited an overpressure one-way valve. It appears the limitation may refer to the overpressure valve arrangement of claim 37. Claim 46 recites the limitation “the one-way valve flap” in Ln. 2. There is insufficient antecedent basis for this limitation in the claim. Claim 37 has not recited the valve flap as being one-way. Claim 48 recites the limitation “the overpressure valve” in Ln. 3. There is insufficient antecedent basis for this limitation in the claim. Claim 37 has not recited an overpressure valve. It appears the limitation may refer to the overpressure valve arrangement of claim 37. Claim 49 recites the limitation “at least two elastically deformable valve flaps are stored prior to use …” in Ln. 2-5 which deems the claim indefinite. The claim is drawn to a speech valve and can only accurately positively recite elements which are actually part of the speech valve. The speech valve does not appear to use two different valve flaps at the same time. The claim thus appears to be attempting to claim a kit of parts, which includes at least two different elastically deformable valve flaps, rather than just the speech valve. The claim should either be amended to recite a kit including the speech valve of claim 37 or to merely recite that the at least one elastically deformable valve flap of claim 37 can be interchanged with an alternate elastically deformable valve flap of a different shape, size or elasticity. Claim 51 recites the limitation “the edge housing at a minimum has at least one point of contact” in Ln. 2 which deems the claim indefinite. It is unclear what the point of contact is to be understood as in relation to. One of ordinary skill in the art would be left to question “a point of contact with what?” Applicant is requested to clarify this limitation. Claim 53 recites the limitation “an opening completely penetrating the throughflow body wall” in Ln. 2-3 which deems the claim indefinite. It appears the presently claimed opening may refer to the same opening already recited in claim 37 as the valve opening which “penetrat[es] the throughflow body.” Applicant is requested to clarify is a different opening is being claimed or not. Claim 54 recites the limitation “the planar valve flap” in Ln. 2. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination the claim will instead be read as dependent on claim 52, which provides the proper antecedent basis. In that instance the limitation should be further amended to read “the at least one planar valve flap” for consistency with claim 52. 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 (claim 37) 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. The corresponding structure for the “connection means” is best understood from the specification as at least: connection structure 5 (e.g. Fig. 1). This application includes one or more claim limitations that use the word “means” or “step” but are nonetheless not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph because the claim limitation(s) recite(s) sufficient structure, materials, or acts to entirely perform the recited function. Such claim limitation(s) is/are: “means comprising at least one elastically deformable valve flap” in claim 37, Ln. 8. Because this/these claim limitation(s) is/are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are not being interpreted to cover only the corresponding structure, material, or acts described in the specification as performing the claimed function, and equivalents thereof. If applicant intends 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 remove the structure, materials, or acts that performs the claimed function; or (2) present a sufficient showing that the claim limitation(s) does/do not recite sufficient structure, materials, or acts to perform the claimed function. Allowable Subject Matter Claim(s) 37-54 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), 1st paragraph and 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. The following is a statement of reasons for the indication of allowable subject matter: Regarding claim 37, the prior art fails to teach or suggest a speech valve including all elements and functionality recited by the instant claim. Specifically, the claim initially defines “a one-way valve located at a second end of the throughflow body, which is opposite to the connection means” and then later specifies “the [at least one elastically deformable] valve flap responds to the second pressure state in the throughflow channel to partially open the one-way valve by elastic deformation of the [at least one elastically deformable valve] flap.” There is not found to be any teaching in the prior art of a one-way valve located in the claimed second end location which is acted upon by an elastically deformable valve flap of an overpressure valve arrangement as claimed. Note is made of the above new matter rejection of claim 37 under 35 U.S.C. 112(a). The claim has been interpreted as presented. Amending the claim to overcome the 35 U.S.C. 112(a) rejection will likely require further search and consideration. It is thus found that one having ordinary skill in the art at the time of the effective filing of the invention would only have arrived at the instantly claimed invention by way of improper hindsight reasoning. 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 JOSEPH D BOECKER whose telephone number is (571)270-0376. The examiner can normally be reached M-F 9:00 AM - 4:00 PM. 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 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. /JOSEPH D. BOECKER/Primary Examiner, Art Unit 3785
Read full office action

Prosecution Timeline

Sep 14, 2023
Application Filed
Apr 22, 2026
Non-Final Rejection mailed — §112
Jun 05, 2026
Response Filed
Jul 01, 2026
Final Rejection mailed — §112 (current)

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Prosecution Projections

3-4
Expected OA Rounds
84%
Grant Probability
99%
With Interview (+22.8%)
2y 10m (~0m remaining)
Median Time to Grant
Moderate
PTA Risk
Based on 897 resolved cases by this examiner. Grant probability derived from career allowance rate.

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