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
This Office action is responsive to the Amendment filed on November 5th, 2025. The examiner acknowledges the amendments to claim 1. Claims 1-9 and 11-12 remain pending in the application. Claim 13 has been entered.
Response to Arguments
Applicant’s remarks and amendments, filed November 5th, 2025, with respect to the claim objections have been fully considered. The claim objections are withdrawn.
Applicant’s arguments, filed November 5th, 2025, with respect to the rejections under 35 U.S.C. 112(a) have been fully considered but are not persuasive. The rejections under 35 U.S.C. 112(a) are maintained. The Applicant has added limitations to the claims which were taught by references cited by the Applicant and incorporated by reference. The limitations directed to “g) performing an action …” are now deemed to be essential subject matter. "Essential material" is defined in 37 CFR 1.57(d) as that which is necessary to (1) provide a written description of the claimed 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 set forth the best mode contemplated by the inventor of carrying out the invention as required by 35 U.S.C. 112(a); (2) describe the claimed invention in terms that particularly point out and distinctly claim the invention as required by 35 U.S.C. 112(b); or (3) describe the structure, material, or acts that correspond to a claimed means or step for performing a specified function as required by 35 U.S.C. 112(f). In any application that is to issue as a U.S. patent, essential material may only be incorporated by reference to a U.S. patent or patent application publication. Since Applicant’s cited references are non-patent literature, and the limitation “g) performing an action …” is supported by the non-patent literature incorporated by reference, it is necessary that the Applicant provide the essential subject matter in the specification. Furthermore, additional rejections are added.
Applicant’s arguments, filed November 5th, 2025, with respect to the rejections under 35 U.S.C. 112(b) have been fully considered. The rejection of claims 1-7 and 12 under 35 U.S.C. 112(b) are withdrawn, however the rejection of claim 11 under 35 U.S.C. 112(b) is maintained.
Applicant’s arguments, filed November 5th, 2025, with respect to the rejections under 35 U.S.C. 101 have been fully considered but are not persuasive.
At page 7-9, Applicant argues that the claim now positively recites an action to treat a subject that may be experiencing a transient increase or decrease in ventilation such that the claim applies the judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition. Examiner respectfully disagrees. The step of performing an action of therapeutic character comprising administering supplemental oxygen or adjusting ventilator settings to patients with acute respiratory illness is merely referring to the relevant pre-existing audience of doctors who used supplemental oxygen or adjusting ventilator settings to treat patients suffering from acute respiratory illnesses. The step of administering supplementary oxygen to the subject or adjusting ventilator settings to the subject were known to doctors, and was routinely and conventionally used to treat acute respiratory illnesses at the time the application was filed as evidenced by the non-patent literature of record in the application; Sward KA, Newth CJL. Computerized Decision Support Systems for Mechanical Ventilation in Children. J Pediatr Intensive Care. 2016 Sep;5(3):95-100. doi: 10.1055/s-0035-1568161. Epub 2015 Nov 18. PMID: 31110892; PMCID: PMC6512768; Tehrani et al., Intelligent decision support systems for mechanical ventilation, Artificial Intelligence in Medicine, Volume 44, Issue 3, 2008. Pages 171-182, ISSN 0933-3657, https://doi.org/10.1016/j.artmed.2008.07.006; Rosen, Acute Respiratory Failure and Chronic Obstructive Lung Disease, Medical Clinics of North America, Volume 70, Issue 4, 1986, Pages 895-907, ISSN 0025-7125, https://doi.org/10.1016/S0025-7125(16)30930-0; Terzano C, Di Stefano F, Conti V, Di Nicola M, Paone G, et al. (2012) Mixed Acid-Base Disorders, Hydroelectrolyte Imbalance and Lactate Production in Hypercapnic Respiratory Failure: The Role of Noninvasive Ventilation. PLOS ONE 7(4): e35245. doi.org/10.1371/journal.pone.0035245; Ranjit S. Acute respiratory failure and oxygen therapy. Indian J Pediatr. 2001 Mar;68(3):249-55. doi: 10.1007/BF02723202. PMID: 11338223. “Examples of limitations that the courts have described as merely indicating a field of use or technological environment in which to apply a judicial exception include: i. A step of administering a drug providing 6-thioguanine to patients with an immune-mediated gastrointestinal disorder, because limiting drug administration to this patient population did no more than simply refer to the relevant pre-existing audience of doctors who used thiopurine drugs to treat patients suffering from autoimmune disorders, Mayo Collaborative Servs. v. Prometheus Labs. Inc., 566 U.S. 66, 78, 101 USPQ2d 1961, 1968 (2012)”, See MPEP 2106.04(d)(2) & MPEP 2106.05(h). A clinician knowledgeable in treating acute respiratory illnesses would have known to and be capable to perform the routine and conventionally used treatments of administering supplementary oxygen to the subject or adjusting ventilator settings (see page 4 of the specification). Therefore, the step of performing a therapeutic action comprising at least one of administering supplementary oxygen to the subject or adjusting ventilator settings is merely an instruction to “apply” the measure indicative of the degree to which the arterial blood sample has been modified by the presence of the transient increase or decrease in the ventilation using well-understood, routine, or conventional techniques in the field.
Furthermore, the Examiner notes that independent claim 8 has not been amended, therefore the rejection under 35 U.S.C. 101 of claims 8-9 and 11 are maintained.
Inventorship
This application currently names joint inventors. Applicant is advised that the inventorship of the new limitation “g) performing an action …” is unclear because there is only one common inventor between the instant application and the cited non-patent literature incorporated by reference (see pages 13-14 of the specification and arguments filed November 5th, 2025).
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 1 (Claims 2-7 and 12-13 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.
The specification as originally filed at the time of the effective filing date does not explicitly disclose “performing an action of therapeutic character comprising at least one of (i) administering supplementary oxygen to the subject or (ii) adjusting ventilator settings to the subject …”. Rather, the instant application specification discloses on page 4 lines 13-27 “diagnosis may then be followed by an action of therapeutic character, if needed”. An action of therapeutic character is broader than an action of therapeutic ventilation protocol comprising at least one of (i) administering supplementary oxygen to the subject or (ii) adjusting ventilator settings to the subject. Therefore, the limitation “performing an action of therapeutic character comprising at least one of (i) administering supplementary oxygen to the subject or (ii) adjusting ventilator settings to the subject …” fails to comply with the written description requirement.
The specification as originally filed at the time of the effective filing date also does not explicitly disclose that the processors perform the action of therapeutic character. Rather the specification as originally filed at the time of the effective filing date does disclose, on page 4 lines 13-27 that the present invention is intended for assisting or guiding e.g., the clinician in making decisions of a therapeutic and/or diagnostic character and is merely to provide intelligent information and assists or guides the clinician in making decisions of therapeutic and/or diagnostic character and further that the clinician executes the subsequent steps. Therefore, the specification as originally filed at the time of the effective filing date does not adequately support that the processor is able to perform the action of therapeutic character (administering supplementary oxygen or adjusting ventilator settings) and therefore does not adequately support the limitation ““g) performing an action of therapeutic character comprising …”.
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 11 is 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 11 recites the limitation "use of the clinical decision support system according to claim 8, for determining the degree in which the arterial blood sample has been modified by the presence of the transient increase or decrease in ventilation of the subject", which merely recites a use without any active, positive steps delimiting how this use is actually practiced. Therefore, claim 11 is rendered indefinite.
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 1-9 and 11-13 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Claims 1-9 and 12-13 are all within one of the four categories.
Independent Claim 1 recites:
a) determining, from a venous blood sample that has been obtained from the subject, venous blood values that correspond to an acid-base status of the subject by at least one of measuring and estimating; b) providing a value of at least one of measured and estimated arterial oxygenation (SO2m, SO2A, SpO2) from the subject; c) converting 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);d) providing second reference acid-base status and oxygenation values of arterial blood (2_ABG) from the subject; e) implementing a ventilation disturbance model using 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 (AtCO2,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); f) using the ventilation disturbance model to provide a measure indicative of the degree to which the arterial blood sample has been modified by the presence of the transient increase or decrease in the ventilation of the subject; g) outputting, to a clinician that has determined that the subject is experiencing or has been experiencing a transient increase or decrease in ventilation, the measure indicative of a degree to which the arterial blood sample has been modified by the presence of the transient increase or decrease in the ventilation; and g) performing an action of therapeutic character comprising at least one of (i) administering supplementary oxygen to the subject or (ii) adjusting ventilator settings to the subject either of which is based on the measure indicative of the degree to which the arterial blood sample has been modified by the presence of the transient increase or decrease in the ventilation.
Independent Claim 8 recites:
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 from the subject; b) at least one of receive and provide a value of at least one of measured and estimated arterial oxygenation (SO2M, SO2A, SpO2) 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);d) at least one of receive and provide second reference acid-base status and oxygenation values of arterial blood (2_ABG) from the subject; and 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 (AtCO2,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); and an output cooperative with the one or more processors and configured to inform a clinician of the measure from the ventilation disturbance model that is indicative of the degree to which the arterial blood sample has been modified by the presence of the transient increase or decrease in the ventilation of the subject.
The above claim limitations (determin[ing], convert[ing], implement[ing], using) constitute an abstract idea that is part of the Mathematical Concepts and/or Mental Processes group identified in the 2019 Revised Patent Subject Matter Eligibility Guidance published in the Federal Register (84 FR 50) on January 7, 2019.
“A mathematical relationship is a relationship between variables or numbers. A mathematical relationship may be expressed in words ….” October 2019 Update: Subject Matter Eligibility, II. A. i. “[T]here are instances where a formula or equation is written in text format that should also be considered as falling within this grouping.” Id. at II. A. ii. “[A] claim does not have to recite the word “calculating” in order to be considered a mathematical calculation.” Id. at II. A. iii. See for example, SAP Am., Inc. v. InvestPic, LLC, 898 F.3d 1161, 1163-65 (Fed. Cir. 2018).
The claimed steps of implement[ing] recite a mathematical concept (i.e., mathematical relationships, mathematical formulas or equations, and mathematical calculations).
The step of “implement a ventilation disturbance model … calculates a measure indicative of …” in independent Claims 1 and 8 is a mathematical relationship to derive blood-acid base status and oxygenation status into first estimated arterial blood values.
Referring to page 4 lines 29 - page 5 lines 1-12 of the specification, “implementing a ventilation disturbance model … calculating a measure indicative of …” can be computed from a difference in the total carbon dioxide content between the first estimated blood arterial values and the second reference values of arterial blood.
The claimed steps of determin[ing], convert[ing], implement[ing], using, can be practically performed in the human mind using mental steps or basic critical thinking, which are types of activities that have been found by the courts to represent abstract ideas.
“[T]he ‘mental processes’ abstract idea grouping is defined as concepts performed in the human mind, and examples of mental processes include observations, evaluations, judgments, and opinions.” MPEP 2106.04(a)(2) III. The pending claims merely recite steps for determining the degree to which the arterial blood sample has been modified by the presence of a transient change in ventilation that include observations, evaluations, and judgments.
Examples of ineligible claims that recite mental processes include:
a claim to “collecting information, analyzing it, and displaying certain results of the collection and analysis,” where the data analysis steps are recited at a high level of generality such that they could practically be performed in the human mind, Electric Power Group, LLC v. Alstom, S.A.;
claims to “comparing BRCA sequences and determining the existence of alterations,” where the claims cover any way of comparing BRCA sequences such that the comparison steps can practically be performed in the human mind, University of Utah Research Foundation v. Ambry Genetics Corp.
a claim to collecting and comparing known information, which are steps that can be practically performed in the human mind, Classen Immunotherapies, Inc. v. Biogen IDEC.
See p. 7-8 of October 2019 Update: Subject Matter Eligibility.
Regarding the dependent claims, the dependent claims are directed to either 1) steps that are also abstract or 2) additional data output that is well-understood, routine and previously known to the industry. Although the dependent claims are further limiting, they do not recite significantly more than the abstract idea. A narrow abstract idea is still an abstract idea and an abstract idea with additional well-known equipment/functions is not significantly more than the abstract idea.
Claims 2-7, 9 and 11-13 are directed to more abstract ideas and further limitations on abstract ideas is already recited.
This judicial exception (abstract idea) in Claims 1-9 and 11-13 is not integrated into a practical application because:
The abstract idea amounts to simply implementing the abstract idea on a computer. For example, the recitations regarding the generic computing components for determin[ing], convert[ing], implement[ing], using, merely invoke a computer as a tool.
The data-gathering step (measuring, estimating, receiving, providing) and the data-output step (output) do not add a meaningful limitation to the method as they are insignificant extra-solution activity.
There is no improvement to a computer or other technology. “The McRO court indicated that it was the incorporation of the particular claimed rules in computer animation that "improved [the] existing technological process", unlike cases such as Alice where a computer was merely used as a tool to perform an existing process.” MPEP 2106.05(a) II. The claims recite a computer that is used as a tool for determin[ing], convert[ing], implement[ing], using.
The claims do not apply the abstract idea to affect a particular treatment or prophylaxis for a disease or medical condition. Rather, the abstract idea is utilized to determine a relationship among data to determine the degree to which the arterial blood sample has been modified by the presence of a transient change in the ventilation.
The claims do not apply the abstract idea to a particular machine. “Integral use of a machine to achieve performance of a method may provide significantly more, in contrast to where the machine is merely an object on which the method operates, which does not provide significantly more.” MPEP 2106.05(b). II. “Use of a machine that contributes only nominally or insignificantly to the execution of the claimed method (e.g., in a data gathering step or in a field-of-use limitation) would not provide significantly more.” MPEP 2106.05(b) III. The pending claims utilize a computer for determin[ing], convert[ing], implement[ing], using. The claims do not apply the obtained calculation to a particular machine. Rather, the data is merely output in a post-solution step.
The additional elements are identified as follows: clinical decision support system; non-transitory computer readable medium; processor(s); computer program product; performing an action of therapeutic character.
Those in the relevant field of art would recognize the above-identified additional elements as being well-understood, routine, and conventional means for data-gathering and computing, as demonstrated by
Applicant’s specification (e.g., page 6 lines 25-30 & page 14 lines 23-32) which discloses that the processor(s) comprise generic computer components that are configured to perform the generic computer functions (e.g., determin[ing], implement[ing], converting) that are well-understood, routine, and conventional activities previously known to the pertinent industry.
Applicant’s Background in the specification; and
The prior art of record: Catiller (US 20170212739 A1) discloses, in para. [0003], conventional processors, such as Intel micro-processors and ARM micro-processors are well known;
The prior art of record: Forsythe (US 8515846 B1) discloses, in col. 2 lines 59-60, computer program products 174 such as a conventional floppy disk or CD-ROM or other nonvolatile storage media;
Roy (US 20190335999 A1) discloses, in para. [0047], conventional systems like clinical decision support systems (CDSS);
The non-patent literature of record in the application;
Sward KA, Newth CJL. Computerized Decision Support Systems for Mechanical Ventilation in Children. J Pediatr Intensive Care. 2016 Sep;5(3):95-100. doi: 10.1055/s-0035-1568161. Epub 2015 Nov 18. PMID: 31110892; PMCID: PMC6512768.
Tehrani et al., Intelligent decision support systems for mechanical ventilation, Artificial Intelligence in Medicine, Volume 44, Issue 3, 2008. Pages 171-182, ISSN 0933-3657, https://doi.org/10.1016/j.artmed.2008.07.006;
Rosen, Acute Respiratory Failure and Chronic Obstructive Lung Disease, Medical Clinics of North America, Volume 70, Issue 4, 1986, Pages 895-907, ISSN 0025-7125, https://doi.org/10.1016/S0025-7125(16)30930-0;
Terzano C, Di Stefano F, Conti V, Di Nicola M, Paone G, et al. (2012) Mixed Acid-Base Disorders, Hydroelectrolyte Imbalance and Lactate Production in Hypercapnic Respiratory Failure: The Role of Noninvasive Ventilation. PLOS ONE 7(4): e35245. https://doi.org/10.1371/journal.pone.0035245;
Ranjit S. Acute respiratory failure and oxygen therapy. Indian J Pediatr. 2001 Mar;68(3):249-55. doi: 10.1007/BF02723202. PMID: 11338223.
Thus, the claimed additional elements “are so well-known that they do not need to be described in detail in a patent application to satisfy 35 U.S.C. § 112(a).” Berkheimer Memorandum, III. A. 3.
Furthermore, the court decisions discussed in MPEP § 2106.05(d)(lI) note the well-understood, routine and conventional nature of such additional generic computer components as those claimed. See option III. A. 2. in the Berkheimer memorandum.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the units associated with the steps do not add meaningful limitation to the abstract idea. A computer, processor, computer program product, or equivalent hardware is merely used as a tool for executing the abstract idea(s). The process claimed does not reflect an improvement in the functioning of the computer.
When considered in combination, the additional elements (i.e., the generic computer functions and conventional equipment/steps) do not amount to significantly more than the abstract idea. Looking at the claim limitations as a whole adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation.
Claim 11 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim does not fall within at least one of the four categories of patent eligible subject matter because the claim recites “use of the clinical decision support system” and does not purport to claim a process, machine, manufacture, or composition.
Conclusion
THIS ACTION IS MADE FINAL. 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 ANDREW ELI HOFFPAUIR whose telephone number is (571)272-4522. The examiner can normally be reached Monday-Friday 8:00-5:00.
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, 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.
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.
/A.E.H./Examiner, Art Unit 3791
/AURELIE H TU/Primary Examiner, Art Unit 3791