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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on April 27th, 2026 has been entered.
Claims 2-9 and 12 remain pending in the application. Claims 1, 10-11, and 13 are cancelled.
Response to Arguments
Applicant's arguments filed, April 27th, 2026, with respect to the rejections under 35 U.S.C. 112(a) are have been considered. The rejections under 35 U.S.C. 112(a) are withdrawn. However, additional rejections are added in view of the amendments.
Applicant's arguments filed, April 27th, 2026, with respect to the rejections under 35 U.S.C. 112(b) are have been considered. The rejections under 35 U.S.C. 112(b) are withdrawn. However, additional rejections are added in view of the amendments.
Applicant's arguments filed, April 27th, 2026, with respect to the rejections under 35 U.S.C. 101 have been fully considered but they are not persuasive.
At page 3-4, Applicant argues that the clinical decision support system provides a technological solution of increased accuracy in determining increases or decreases in ventilation without having to rely on arterial puncture and therefore provides an improvement that is not achieved by conventional means. Examiner respectfully disagrees. The improvement cannot be found in the abstract idea itself. “[I]t is important to keep in mind that an improvement in the abstract idea itself ... is not an improvement in technology.” MPEP 2106.05(a) Il. The claims recite steps for an analysis of data. The claims do not integrate the analysis into a practical application. Rather, the alleged improvement lies solely within the processing steps performed by the processor. “Merely adding generic computer components to perform the method is not sufficient. Thus, the claim must include more than mere instructions to perform the method on a generic component or machinery to qualify as an improvement to an existing technology." Id. Furthermore, the addition of the “pulse oximeter” and “device” does not add a meaningful limitation to the method as it merely adds data-gathering to perform the abstract idea. With or without the claimed abstract idea, the pulse oximeter and device gather data the same. Therefore, it is unclear how there can be an improvement to the technology. Under step 2B, the claim utilizes the pulse oximeter, device, and one or more processors cooperating with a non-transitory computer readable medium, which are generic components and well-known in the industry – as evidenced by the cited non-patent literature herewith. See REES. "The Intelligent Ventilator (INVENT) project: The role of mathematical models in translating physiological knowledge into clinical practice", Computer Methods and Programs in Biomedicine, Vol. 104A, pages S1-S29, 2011; Tehrani et al., Intelligent decision support systems for mechanical ventilation, Artificial Intelligence in Medicine, Volume 44, Issue 3, V 2008. Pages 171-182, ISSN 0933-3657, https://doi.org/10.1016/j.artmed.2008.07.006.
Claim Objections
Claims 7-8 and 12 are objected to because of the following informalities:
“the transient increase or decrease” in claim 7 line 5 should recite “the transient increase or decrease in ventilation”.
“the model” in claim 8 line 19 should recite “the ventilation disturbance model”.
“the transient” in claim 12 line 5 should recite “the transient increase or decrease in ventilation”.
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: “a device configured to acquire a venous blood sample” in claim 8.
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 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.
Claims 8 (2-7, 9, and 12 by virtue of dependency) 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 8 recites the limitation “a device configured to acquire a venous blood sample”. The specification as originally filed at the time of the effective filing date does not explicitly disclose “a device configured to acquire a venous blood sample”. The specification as originally filed discloses, on pages 1-2 & 7, that a venous blood sample of the subject is obtained. However, the specification as originally filed does not disclose the structure/device that performs the obtaining of the venous blood sample. Therefore, the limitation “a device configured to acquire a venous blood sample” fails to comply with the written description requirement.
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.
The claim limitation “a device configured to acquire a venous blood sample” in claim 8 (claims 2-7, 9, and 12 by virtue of dependency) 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. The publication specification discloses, on pages 1-2 & 7, that a venous blood sample of the subject is obtained but does not disclose the structure/device that performs the obtaining of the venous blood sample. 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.
Claims 2-9 and 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 8 (Claims 2-7, 9, and 12 by virtue of dependency) recites “a blood sample” in line 8 and “a venous blood sample” in line 9. It is unclear if the blood sample recited in line 8 and the venous blood sample recited in line 9 are in addition to or referring to the same venous blood sample obtained/recited in line 5. The limitations are suggested to recite “the venous blood sample”.
Claim 8 (Claims 2-7, 9, and 12 by virtue of dependency) recites “the subject” in line 11. There is insufficient antecedent basis for this limitation in the claim. The limitation is suggested to recite “a subject”.
Claim 8 (Claims 2-7, 9, and 12 by virtue of dependency) recites “the degree to which the arterial blood sample has been modified by the presence of a transient increase or decrease in the ventilation of the subject” in lines 27-29. There is insufficient antecedent basis for this limitation in the claim. The limitation is suggested to recite “a degree to which the arterial blood has been modified by a presence of a transient increase or decrease in ventilation of the subject”.
Claim 3 (Claims 4-5 by virtue of dependency) recites “a non-transitory computer readable medium” in lines 2-3. It is unclear if this is in addition to or the same non-transitory computer readable medium recited in claim 8. The limitation is suggested to recite “the non-transitory computer readable medium”.
Claim 6 recites “a non-transitory computer readable medium” in lines 2-3. It is unclear if this is in addition to or the same non-transitory computer readable medium recited in claim 8. The limitation is suggested to recite “the non-transitory computer readable medium”.
Claim 9 recites “the operations” in line 2. There is insufficient antecedent basis for this limitation in the claim. The limitation is suggested to recite “carry out operations of the clinical decision support system of claim 8 …”.
Claim Rejections - 35 USC § 101
Claims 2-9 and 12 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) as a whole, considering all claim elements both individually and in combination, do not amount to significantly more than an abstract idea. A streamlined analysis of claim 8 follows.
STEP 1
Regarding claim 8, the claim recites a series of structural elements, including a system. Thus, the claim is directed to a machine, which is one of the statutory categories of invention.
STEP 2A, PRONG ONE
The claim is then analyzed to determine whether it is directed to any judicial exception. The steps of:
a) determine venous blood values by performing at least one of measuring and estimating an acid-base status in a blood sample that has been obtained with the device configured to acquire a venous blood sample from the subject with the device configured to acquire a venous blood sample from the subject;
c) convert the venous blood values by applying a venous-to-arterial conversion model for deriving the acid-base status and the at least one of measured and estimated arterial oxygenation into first estimated arterial blood values (1_ABGC);
e) implement a ventilation disturbance model using at least one of a measure of a total carbon dioxide content (tCO2) in the arterial blood, the model having as input at least the first estimated arterial blood values (1_ABGC) and the second reference values of arterial blood (2_ABG) wherein the ventilation disturbance model calculates a measure indicative of a difference (ΔtCO2,V) in the total carbon dioxide content between the first estimated arterial blood values (1_ABGC) and the second reference values of arterial blood (2_ABG);
set forth a judicial exception. These steps describe a concept performed in the human mind (including an observation, evaluation, judgment, opinion) and or mathematical concepts (including mathematical relationships, mathematical formulas or equations, and mathematical calculations). Thus, the claim is drawn to a Mental Process and/or Mathematical Concepts, which is an Abstract Idea.
STEP 2A, PRONG TWO
Next, the claim as a whole is analyzed to determine whether the claim recites additional elements that integrate the judicial exception into a practical application. The claim fails to recite an additional element or a combination of additional elements to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limitation on the judicial exception. Claim 8 recites a pulse oximeter configured to acquire arterial oxygen saturation information, a device configured to acquire a venous blood sample, at least one of receive and provide a value of at least one of measured and estimated arterial oxygenation (SO2AM, SO2AE, SpO2) from the subject; at least one of receive and provide second reference acid-base status and oxygenation values of arterial blood (2_ABG) from the subject; and an output cooperative with the one or more processors and configured to inform a clinician of an output measure, which is merely adding insignificant pre-solution and insignificant extra-solution activity to the judicial exception (MPEP 2106.05(g)). The acquired oxygen saturation information/blood sample, received/provided values, and output measure does not provide an improvement to the technological field, the method does not effect a particular treatment or effect a particular change based on the acquired oxygen saturation information/blood sample, received/provided values, and output measure, nor does the method use a particular machine to perform the Abstract Idea.
STEP 2B
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, is sufficient to ensure that the claim amounts to significantly more than the exception. Besides the Abstract Idea, the claim recites additional steps of:
a pulse oximeter configured to acquire arterial oxygen saturation information;
a device configured to acquire a venous blood sample;
one or more processors cooperating with a non-transitory computer readable medium;
at least one of receive and provide a value of at least one of measured and estimated arterial oxygenation (SO2AM, SO2AE, SpO2) from the subject;
at least one of receive and provide second reference acid-base status and oxygenation values of arterial blood (2_ABG) from the subject;
an output cooperative with the one or more processors and configured to inform a clinician of an output measure …
The acquiring, receiving, providing, and outputting steps are well-understood, routine and conventional activities for those in the field of medical diagnostics. Further, the acquiring, receiving, providing, and outputting steps are each recited at a high level of generality such that it amounts to insignificant pre-solution activity and insignificant extra-solution activity (e.g., mere data gathering and mere data outputting) steps necessary to perform the Abstract Idea. When recited at this high level of generality, there is no meaningful limitation, such as a particular or unconventional step that distinguishes it from well-understood, routine, and conventional data gathering and outputting activity engaged in by medical professionals prior to Applicant's invention. Furthermore, it is well established that the mere physical or tangible nature of additional elements such as the pulse oximeter, device, and processors cooperating with a non-transitory computer readable medium do not automatically confer eligibility on a claim directed to an abstract idea (see, e.g., Alice Corp. v. CLS Bank Int'l, 134 S.Ct. 2347, 2358-59 (2014)).
Consideration of the additional elements as a combination also adds no other meaningful limitations to the exception not already present when the elements are considered separately. Unlike the eligible claim in Diehr in which the elements limiting the exception are individually conventional, but taken together act in concert to improve a technical field, the claim here does not provide an improvement to the technical field. Even when viewed as a combination, the additional elements fail to transform the exception into a patent-eligible application of that exception. Thus, the claim as a whole does not amount to significantly more than the exception itself. The claim is therefore drawn to non-statutory subject matter.
Regarding claim 8, the system, pulse oximeter, device, processor, and non-transitory computer readable medium recited in the claim is a generic system comprising generic components configured to perform the abstract idea – as evidenced by the cited non-patent literature herewith. See REES. "The Intelligent Ventilator (INVENT) project: The role of mathematical models in translating physiological knowledge into clinical practice", Computer Methods and Programs in Biomedicine, Vol. 104A, pages S1-S29, 2011; Tehrani et al., Intelligent decision support systems for mechanical ventilation, Artificial Intelligence in Medicine, Volume 44, Issue 3, V 2008. Pages 171-182, ISSN 0933-3657. The recited pulse oximeter and device are generic sensors configured to perform pre-solutional data gathering activity, the output cooperative with the one or more processors is configured to perform insignificant extra-solution activity, and the one or more processors cooperating with a non-transitory computer readable medium is configured to perform the Abstract Idea. According to section 2106.05(f) of the MPEP, merely using a computer as a tool to perform an abstract idea does not integrate the Abstract Idea into a practical application.
The dependent claims also fail to add something more to the abstract independent claims. Claims 2-7, 9, and 12 are directed to more abstract ideas, which does not add anything significantly more. The steps recited in the independent claims maintain a high level of generality even when considered in combination with the dependent claims.
Claim 9 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because "computer program product” is not a process, machine, manufacture, or composition of matter. A “computer program product" is not tangible, as it is not tied to a structural element. To overcome this 35 U.S.C. 101 rejection, Examiner suggests amending "computer program product" to "a non-transitory computer readable medium comprising a computer program".
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Taro (US 20090182210 A1) directed to a method and apparatus for determining a deterioration of respiratory function.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW ELI HOFFPAUIR whose telephone number is (571)272-4522. The examiner can normally be reached Monday-Friday 8:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Marmor II can be reached at (571) 272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/A.E.H./Examiner, Art Unit 3791
/CARRIE R DORNA/Primary Examiner, Art Unit 3791
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