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 .
Amendment Entered
In response to the amendment filed on November 6th, 2025, amended claims 1-2 and 6 and new claim 14 are entered. Claims 8-10 remain withdrawn. Claims 1-7 and 11-14 are currently being considered for examination.
Response to Arguments
Applicant's remarks and amendments with respect to the rejections under 35 U.S.C. 101 have been fully considered. The rejections are withdrawn in view of the amendment.
Applicant's remarks and amendments with respect to the rejections under 35 U.S.C. 103 have been fully considered. The rejections are withdrawn in view of the amendment.
Claim Objection
Claim 13 is objected to because of the following informality:
Claim 13 recites “the variation of time intervals” in line 1, but should read “the variation of the two or more systolic time intervals”
Appropriate correction is required.
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:
“volume status determination system” in claim 1
“communication device” in claim 3
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 1-7 and 11-14 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 1 recites “by allowing air flow during inhalation or exhalation, or both, by the patient after the patient's inhalation or exhalation, or both, provides a pressure that exceeds a pressure threshold” in lines 5-7. It is unclear as to what this limitation exactly entails as there seems to be a missing word or a grammatical error present. Currently, it is unclear as to how the air flow can be allowed during inhalation or exhalation, or both by the patient after the patient's inhalation or exhalation, or both, provides a pressure that exceeds a pressure threshold. Assuming that “the patient's inhalation or exhalation, or both” recited in line 6 is referring to the same “inhalation or exhalation, or both, by the patient” recited earlier in line 6, it seems contradictory that the device can allow air flow during a breath based on a condition that occurs afterwards. Clarification is requested.
Furthermore, it is unclear as to what “both” exactly means in the context of these limitations. If the term “both” is meant to include both inhalation and exhalation, the claim would be understood as “by allowing air flow during both inhalation and exhalation, by the patient after both the patient's inhalation and exhalation provides a pressure that exceeds a pressure threshold”. It is unclear as to how these conditions could be met simultaneously to allow air flow during both inhalation and exhalation, as inhalation and exhalation can only happen at separate times. Furthermore, if the conditions are not meant to be met simultaneously, it is unclear as to whether there is a chronological order that must be met instead. Clarification is requested.
Claim 1 recites the limitation “the airway resistance devices” in lines 8-9. There is insufficient antecedent basis for this limitation in the claim. Examiner notes that this limitation is in a plural form. Therefore, it is unclear as to whether this limitation is supposed to be referring to the singular “airway resistance device” previously introduced in line 4, or supposed to be referring to a separate element of a plural group of “airway resistance devices”.
Claim 1 recites the limitation “repeatable intrathoracic pressure perturbations” in line 10. Examiner notes that this limitation is in a plural form. Therefore, it is unclear as to whether this limitation is supposed to be referring to the singular “repeatable intrathoracic pressure perturbation” previously introduced in line 5, or supposed to be referring to a separate element of a plural group of “repeatable intrathoracic pressure perturbations”.
Claim 2 recites “a variation of the two or more systolic time intervals measured during the presence of air flow” in line 3. It is unclear as to whether this limitation is referring to the previously introduced “a variation of the two or more systolic time intervals” from Claim 1, or a separate element. Examiner notes that since the “two or more systolic time intervals” of Claim 1 were obtained during the repeatable intrathoracic pressure perturbations, there would also be a presence of air flow then.
Claim 6 recites “the pulse contours” in line 3. It is unclear as to whether this limitation is referring to the previously introduced “pulse contours” from line 2 of Claim 1, “one or more pulse contours obtained from the patient during repeatable intrathoracic pressure perturbations” in lines 9-10 of Claim 1, or a separate element.
Claim 14 recites “at least one flow-independent pressure valve” in lines 1-2. It is unclear as to whether this limitation is referring to the previously introduced “at least one flow-independent pressure valve” from line 4 of Claim 1, or a separate element.
Claim 14 recites “a repeatable intrathoracic pressure perturbation” in lines 2-3. It is unclear as to whether this limitation is referring to the previously introduced “repeatable intrathoracic pressure perturbation” from line 5 of Claim 1, or a separate element.
Claim 14 recites “exhalation by the patient” in line 3. It is unclear as to whether this limitation is referring to the previously introduced “exhalation…by the patient” from line 6 of Claim 1, or a separate element.
Claim 14 recites “a pressure” in line 4. It is unclear as to whether this limitation is referring to the previously introduced “pressure” from line 7 of Claim 1, or a separate element.
Claim 14 recites “a pressure threshold” in line 4. It is unclear as to whether this limitation is referring to the previously introduced “pressure threshold” from line 7 of Claim 1, or a separate element.
Furthermore, Claim 14 recites “wherein the airway resistance device comprises at least one flow-independent pressure valve configured to generate in the patient a repeatable intrathoracic pressure perturbation by allowing air flow during exhalation by the patient after exhalation by the patient provides a pressure that exceeds a pressure threshold” in lines 1-4. It is unclear as to what this limitation exactly entails as there seems to be a missing word or a grammatical error present. Currently, it is unclear as to how the air flow can be allowed during exhalation after exhalation by the patient provides a pressure that exceeds a pressure threshold. Assuming that the second recitation of the “exhalation by the patient” recited in line 3 of Claim 14 is referring to the same “exhalation by the patient” recited earlier in line 3, it seems contradictory that the device can allow air flow during a breath based on a condition that occurs afterwards. Clarification is requested.
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 CHANEL J YOON whose telephone number is (571) 272-2695. The examiner can normally be reached on Monday-Friday 9:00AM-5:00PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alexander Valvis can be reached on 571-272-4233. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHANEL J YOON/Examiner, Art Unit 3791
/ALEX M VALVIS/Supervisory Patent Examiner, Art Unit 3791