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 .
Election/Restrictions
Applicant’s election without traverse of Group I, Species A-1, in the reply filed on 6 October 2025 is acknowledged.
The reply did not address the election of Species B-1 or B-2; as noted in the attached interview summary, species B-1 was elected by Daniel Brean on 22 October 2025.
Claims 5-9 and 13-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 6 and 22 October 2025.
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:
Electronic controller, first recited in claim 1 (electronic processor or a microprocessor, paragraph [0023] as filed)
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 1-4 and 10-12 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 calls for finding “a pressure value of a chest” – it is unclear if the intent is to find a pressure of some area within a chest, or a pressure of the chest itself? It does not appear possible to find a pressure of a chest itself, such that the claim should more clearly identify what pressure value is being determined and how it relates to a chest. Clarification is required.
Claim 10 calls for further receiving data “during mechanical ventilation therapy”; claim 1 defines receiving data “while the patient undergoes mechanical ventilation therapy”. It is unclear if the therapy provided in claim 10 is the same as that of claim 1 or if this refers to some other therapy being provided; if the same, claim 10 should refer to “the mechanical ventilation therapy”, and if different the claim should clearly distinguish it as such. Clarification is required.
Claim 11 calls for the device to further include “a mechanical ventilator configured to delivery mechanical ventilation therapy to the patient” – claim 1 defines the ventilation therapy as being provided by “an associated mechanical ventilator”. It is entirely unclear if this is the same ventilator or some other ventilator, particularly as claim 11 also refers to “mechanical ventilation therapy” without identifying that it is the same or different therapy as the therapy provided per claim 1. Clarification is required.
Claim limitation “mechanical ventilator device” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. At best, paragraph [0023] as filed describes “a mechanical ventilator 2” but only describes it as comprising “an outlet 4” and “and electronic controller 13”. Further, claim 11 indicates that “a mechanical ventilator” is a separate component from “a mechanical ventilator device” as claim 11 recites that the device comprises a ventilator, such that the device itself cannot be the ventilator. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-4 and 10-12 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Please see the following Subject Matter Eligibility (“SME”) analysis:
For analysis under SME Step 1, the claims herein are directed to a system, which would be classified under one of the listed statutory classifications (SME Step 1=Yes).
For analysis under revised SME Step 2A, Prong 1, independent claim 1 recites a ventilation device comprising an electronic controller configured to receive imaging data of a ventilated patient, calculate a pressure value from the data, and if the calculated value does not meet a criterion, output an alert or output a recommendation.
The dependent claims (claims 17-30) appear to be encompassed by the abstract idea of the independent claims since they merely indicate processing the data (claims 2, 12), obtaining additional data and generating additional information based on the additional data (claim 3, 4 , 10, 11)
The underlined portions of the claims are an indication of elements additional to the abstract idea (to be considered below).
The claim elements may be summarized as the idea of obtaining and storing model data to report biometric information; however, the Examiner notes that although this summary of the claims is provided, the analysis regarding subject matter eligibility considers the entirety of the claim elements, both individually and as a whole (or ordered combination). This idea is within the following grouping(s) of subject matter:
Mental processes (e.g., concepts performed in the human mind such as observation, evaluation, judgment, and/or opinion) as based on the observation and evaluation of imaging data to generate a pressure for evaluation – including a judgment or opinion regarding pressure values.
Therefore, the claims are found to be directed to an abstract idea.
For analysis under revised SME Step 2A, Prong 2, the above judicial exception is not integrated into a practical application because the additional elements do not impose a meaningful limit on the judicial exception when evaluated individually and as a combination. The additional elements are that claim 1 recites an electronic controller as apparently performing the activities, where the activities also include output of an alert or recommendation. These additional elements do not reflect an improvement in the functioning of a computer or an improvement to other technology or technical field, effect a particular treatment or prophylaxis for a disease or medical condition (the “recommended adjustment” is not actively implemented a nor is the generation of the “recommended adjustment” recited with any specificity), implement the judicial exception with, or by using in conjunction with, a particular machine or manufacture that is integral to the claim, effect a transformation or reduction of a particular article to a different state or thing (there is no transformation/reduction of a physical article), and/or apply or use the judicial exception in some other meaningful way beyond generically linking use of the judicial exception to a particular technological environment.
The claims appear to merely apply the judicial exception, include instructions to implement an abstract idea on a computer, or merely use a computer as a tool to perform the abstract idea. The additional elements appear to merely add insignificant extra-solution activity to the judicial exception and/or generally link the use of the judicial exception to a particular technological environment or field of use.
For analysis under SME Step 2B, the claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements, as indicated above, are merely “[a]dding the words ‘apply it’ (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, e.g., a limitation indicating that a particular function such as creating and maintaining electronic records is performed by a computer, as discussed in Alice Corp.” that MPEP § 2106.05(I)(A) indicates to be insignificant activity.
There is no indication the Examiner can find in the record regarding any specialized computer hardware or other “inventive” components, but rather, the claims merely indicate computer components which appear to be generic components and therefore do not satisfy an inventive concept that would constitute “significantly more” with respect to eligibility. Paragraph [0023] as filed indicates “an electronic controller 13 (e.g., an electronic processor or a microprocessor)” – i.e., a generic or general-purpose computer.
The output of an alert or a recommendation, as recited, is at best an insignificant post-solution output of a result (see MPEP 2106.05 - Presenting data, OIP Techs., 788 F.3d at 1362-63, 115 USPQ2d at 1092-93 - another type of activity that the courts have found to be well-understood, routine, conventional activity when they are claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity), where these outputs are not disclosed as being output to or with any particular component nor is there any indication of any response occurring as a result of these outputs.
The individual elements therefore do not appear to offer any significance beyond the application of the abstract idea itself, and there does not appear to be any additional benefit or significance indicated by the ordered combination, i.e., there does not appear to be any synergy or special import to the claim as a whole other than the application of the idea itself.
The dependent claims, as indicated above, appear encompassed by the abstract idea since they merely limit the idea itself or the computer components performing the abstract idea, or recite receiving additional data, where the additional data is not sensed by the claimed invention and as presented this is merely the transfer of information from an unnamed source; therefore the dependent claims do not add significantly more than the idea.
Therefore, SME Step 2B=No, any additional elements, whether taken individually or as an ordered whole in combination, do not amount to significantly more than the abstract idea, including analysis of the dependent claims.
Please see the Subject Matter Eligibility (SME) guidance and instruction materials at https://www.uspto.gov/patent/laws-and-regulations/examination-policy/subject-matter-eligibility, which includes the latest guidance, memoranda, and update(s) for further information.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-3 and 10-12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Euliano (US 2021/0016035).
Regarding claim 1, Euliano discloses a mechanical ventilation device (paragraph [0018]) comprising at least one electronic controller (paragraph [0078]) configured to:
receive imaging data related to a dimension of a diaphragm of a patient during inspiration and expiration while the patient undergoes mechanical ventilation therapy with an associated mechanical ventilator (paragraph [0105], any imaging data is “related” to a dimension);
calculate a pressure value (P;, DP,) of a chest of the patient based on at least the imaging data (paragraphs [0104], [0105]); and
when the calculated pressure value (P;, DP,) does not satisfy an acceptance criterion, at least one of:
output an alert indicative of the calculated pressure value (Pi, DP,) failing to satisfy the acceptance criterion (paragraph [0125], [0135]); and
output a recommended adjustment to one or more parameters of the mechanical ventilation therapy delivered to the patient (paragraph [0135]).
Regarding claim 2, Euliano further discloses that the at least one electronic controller is configured to calculate the pressure value by:
determining a diaphragmatic muscle pressure (Pmus) from the received imaging data; and calculating the pressure value based on at least the calculated diaphragmatic muscle pressure (paragraph [0105]).
Regarding claim 3, Euliano further discloses a wearable ultrasound transducer configured to acquire at least a portion of the imaging data as ultrasound imaging data of at least the diaphragm of the patient (paragraph [0105]).
Regarding claim 10, Euliano further discloses that the at least one electronic controller is further configured to:
receive, from the associated mechanical ventilator, at least one of an airflow during inhalation of the patient and an airflow pressure in an airway of the patient during mechanical ventilation therapy; and calculate the pressure value further based on the airflow and/or the airflow pressure (paragraph [0018]).
Regarding claim 11, Euliano further discloses a mechanical ventilator configured to deliver the mechanical ventilation therapy to the patient; wherein the mechanical ventilator is configured to measure the at least one of an airflow during inhalation of the patient and an airflow pressure in an airway of the patient during the mechanical ventilation therapy (paragraph [0018]).
Regarding claim 12, Euliano further discloses that the mechanical ventilator includes a display device (paragraph [0024]), and the at least one electronic controller is further configured to:
control the display device to display a pressure-volume curve of lungs of the patient during the mechanical ventilation therapy (paragraph [0109]; figure 15); and at least one of:
output the alert when the calculated pressure value is outside of a range of values defined by the displayed pressure-volume curve (paragraph [0076]); and
output a recommended adjustment to one or more parameters of the mechanical ventilation therapy delivered to the patient (figure 10).
Claim Rejections - 35 USC § 103
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.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Euliano in view of DiNino (DiNino E, Gartman EJ, Sethi JM, et al Diaphragm ultrasound as a predictor of successful extubation from mechanical ventilation Thorax 2014;69:431-435.).
Regarding claim 4, Euliano further discloses that the ultrasound imaging data includes at least a position of the diaphragm of the patient during inspiration and expiration while the patient undergoes mechanical ventilation therapy to determine the diaphragmatic muscle pressure (Pmus) (paragraph [0105]); Euliano does not disclose further determining a diaphragm thickness change (TFdi) of the diaphragm. DiNino teaches a device configured to receive ultrasound imaging data relating to a dimension of a diaphragm during mechanical ventilation therapy (p. 423, “Abstract: Methods”; p. 424, “Measurements”, “Protocol”), where the imaging data includes at least a position of the diaphragm during inhalation and exhalation for determining a thickness change of the diaphragm (p. 424, “Measurements”, particularly Δtdi%, the per cent change in diaphragm thickness between end-expiration and end-inspiration). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to have made the device of Euliano and configured it to further determine a diaphragm thickness change, as taught by DiNino, in order to allow additional assessment of possible diaphragm disfunction (DiNino, “Discussion” p. 425-426)
Conclusion
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/KAREN E TOTH/ Examiner, Art Unit 3791