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 08 Jan 2026 has been entered. Claims 1 and 7-17 are pending in the application with claims 2-6 and 18-19 canceled. Claims 1, 7, 9-11 and 13-14 are currently amended. Applicant’s amendment to the Specification and Claims have overcome some, but not every, objection and 35 U.S.C. 112 rejection previously set forth in the Non-Final Office Action mailed 08 Oct 2025.
It is noted that applicant failed to address most of the prior claim objections. The remaining claim objections are restated below.
The prior 35 U.S.C. 102(a)(2) rejection is withdrawn as requested (Pg. 10) based on the amendment to the claims.
Response to Arguments
Applicant's arguments filed 08 Jan 2026 have been fully considered and are persuasive in part. Regarding the 35 U.S.C. 112(b) rejections related to the limitation “or other patient airway device” applicant has responded by amending the specification to include a special definition of “airway device” (Pg. 8-9). Applicant wishes the terminology “airway device” to be understood to mean “a device passed into the trachea” (see amendment to the specification).
However, it is noted that the original claim language reads “a mask or other patient airway device”. The specific language “or other” implies that applicant considers a mask to be a form of patient airway device. Since one or ordinary skill in the art would not expect a mask to be “passed into the trachea” applicant’s newly proposed definition is inconsistent with the language in the originally filed application. The amendment to the specification thus constitutes new matter and should be removed.
But in consideration of applicant’s arguments it is acknowledged that one of ordinary skill in the art would have recognized that only a small collection of devices could suitably be used as a patient airway device during resuscitation ventilation. The prior 35 U.S.C. 112(b) rejections are thus withdrawn in light of how one of ordinary skill in the art of resuscitation ventilation would have been suitably apprised of the types of options available to serve as a patient airway device which are not a mask.
Specification
The amendment filed 08 Jan 2026 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 specification has been amended to add a special definition of “airway device”. Applicant wishes the terminology “airway device” to be understood to mean “a device passed into the trachea” (see amendment to the specification). However, the original specification and claim language reads “a mask or other patient airway device”. The specific language “or other” implies that applicant considers a mask to be a form of patient airway device. Since one or ordinary skill in the art would not expect a mask to be “passed into the trachea” applicant’s newly proposed definition is inconsistent with the language in the originally filed application. The amendment to the specification thus constitutes new matter and should be removed.
Applicant is required to cancel the new matter in the reply to this Office Action.
Claim Objections
Claim(s) 8-11 and 13-17 is/are objected to because of the following informalities:
Claim 8, Ln. 2 recites “a filter housing” which should read “the filter housing” following after claim 1
Claim 9, Ln. 4 recites “the housing, said housing” which should read “the filter housing, said filter housing” for consistency
Claim 10, Ln. 2-3 recites “the housing” which should read “the filter housing” for consistency
Claim 11, Ln. 2 recites “the housing” which should read “the filter housing” for consistency
Claim 11, Ln. 3 recites “the inflow side” which should read “an inflow side” as it is a first introduction
Claim 11, Ln. 4 recites “the outflow side” which should read “an outflow side” as it is a first introduction
Claim 13, Ln. 22 recites “is flows” which should read “flows”
Claim 14, Ln. 4 recites “the amount of PEEP” which should read “an amount of PEEP” as it is a first introduction
Claim 17, Ln. 3 recites “delivery of inspiratory gas” which should read “delivery of the inspiratory gas”
Appropriate correction is required.
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.
Claim(s) 13-17 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 13 recites the limitation “the T piece assembly” in Ln. 17. There is insufficient antecedent basis for this limitation in the claim. The limitation appears to refer to the same structure previously recited as the distal tubular assembly. For the purposes of examination the limitation will be interpreted as reading “the distal tubular assembly.”
Claim Interpretation - 35 USC § 112(f)
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: “patient airway device” in claims 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.
The specification fails to define any specific structure(s) for the “patient airway device” but one of ordinary skill in the art of resuscitation ventilation would ready be able to recognize the limited number of devices suitable for use as a patient airway device during resuscitation ventilation.
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.
Allowable Subject Matter
Claims 1 and 7-12 are allowed over the prior art.
Claims 13-17 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.
The following is a statement of reasons for the indication of allowable subject matter: claim 1 is allowed for having been amended to include the limitations of former claim 6, which was indicate as allowable subject matter in the preceding Office action. Claim 13 is allowed for having been amended into independent form while including all limitations of former claim 13, which was indicate as allowable subject matter in the preceding Office action.
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.
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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.
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/JOSEPH D. BOECKER/Primary Examiner, Art Unit 3785