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 .
Status of the Application
Preliminary amendment has been acknowledged and accepted. Claims 21-42 have been examined in this application. This communication is the first action on the merits.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/05/2024 is being considered by the examiner. The submission is in compliance with the provisions of 37 CFR 1.97.
Specification
Applicant is reminded of the proper content of an abstract of the disclosure.
A patent abstract is a concise statement of the technical disclosure of the patent and should include that which is new in the art to which the invention pertains. The abstract should not refer to purported merits or speculative applications of the invention and should not compare the invention with the prior art.
If the patent is of a basic nature, the entire technical disclosure may be new in the art, and the abstract should be directed to the entire disclosure. If the patent is in the nature of an improvement in an old apparatus, process, product, or composition, the abstract should include the technical disclosure of the improvement. The abstract should also mention by way of example any preferred modifications or alternatives.
Where applicable, the abstract should include the following: (1) if a machine or apparatus, its organization and operation; (2) if an article, its method of making; (3) if a chemical compound, its identity and use; (4) if a mixture, its ingredients; (5) if a process, the steps.
Extensive mechanical and design details of an apparatus should not be included in the abstract. The abstract should be in narrative form and generally limited to a single paragraph within the range of 50 to 150 words in length.
See MPEP § 608.01(b) for guidelines for the preparation of patent abstracts.
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because it includes numerous reference numbers. While international (PCT) and European (EPO) practices permit reference numbers in parentheses in the abstract, US domestic practice omits them. Under MPEP 608.01(b) the abstract must be a concise, standalone narrative in a single paragraph (150 words or less) that allows the public and the examiner to quickly understand the gist of the technical disclosure. Also, “(Fig. 1)” is not a part of the abstract and violates the rule that the abstract sheet may contain no other material. Figure references belong in the brief description of the drawings or detailed description.
A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
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 21-27, 30, 32-40 and 42 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter.
In determining whether a claim falls within an excluded category, the Examiner is guided by the Court’s two-part framework, described in Mayo and Alice. Id. at 217-18 (citing Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 75-77 (2012)); Bilski v. Kappos, 561 U.S. 593, 611 (2010); 2019 Revised Patent Subject Matter Eligibility Guidance, 84 Fed. Reg. 50 (Jan. 7, 2019); the October 2019 Update of the 2019 Revised Guidance (Oct. 17, 2019); 2024 Guidance Update on Patent Subject Matter Eligibility, Including on Artificial Intelligence (July 17, 2024), and the USPTO’s Paten Subject Matter Eligibility Memorandums of August 4, 2025 and December 5, 2025.
Step 1
Claims are eligible for patent protection under § 101 if they are in one of the four statutory categories and not directed to a judicial exception to patentability (i.e., laws of nature, natural phenomena, and abstract ideas). Alice Corp. v. CLS Bank Int'l, 573 U. S. ____ (2014).
Claim 21 is directed to a statutory category, because a series of recited steps satisfies the requirements of a process (a series of acts).
Claim 32. For the purposes of examination, the Examiner assumes that Claim 32 is directed to a non-transitory computer-readable medium. As such, a non-transitory computer-readable medium is a statutory category, because a non-transitory computer-readable medium comprising computer-readable instructions satisfies the requirements of a product.
Claim 33 is directed to a statutory category, because a non-transitory computer-readable medium comprising computer-readable instructions satisfies the requirements of a product.
The broadest reasonable interpretation of claim 34 encompasses a computer system (e.g., hardware such as a processor and memory) that implements the recited functions. If the system comprises a device or set of devices, then the system is directed to a machine, which is a statutory category of invention. (Step 1: Yes).
Next, the claim is analyzed to determine whether it is directed to a judicial exception.
Step 2A – Prong 1
Claim 21 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more of calculating net CO2 exchange.
The claim recites:
21. A method for controlling carbon dioxide [CO2] removal in a device for extracorporeal blood gas exchange, wherein the device comprises an oxygenator including a membrane acting as a gas-liquid barrier enabling CO2 transfer between a bloodstream and a sweep gas flow through the oxygenator, comprising the steps of:
measuring (S12a) a pre-oxygenator fraction of CO2 [FCO2in] in the sweep gas flow upstream of the oxygenator;
measuring (S12b) a pre-oxygenator sweep gas flow rate (Vin) of the sweep gas flow upstream of the oxygenator;
measuring (S12c) a post-oxygenator fraction of CO2 [FCO2₀uₜ] in the sweep gas flow downstream of the oxygenator;
measuring (S12d) a post-oxygenator sweep gas flow rate (Vout) of the sweep gas flow downstream of the oxygenator; and
calculating (S12e) a net CO2 exchange [VCO2net] over the membrane based on measured FCO2in, Vin, FCO2out and Vout.
The recited limitations, as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitation in the mind and mathematical concepts, which may be practically performed in the human mind using observation, evaluation, judgment, and opinion (MPEP 2106.04(a)(2), subsection III), and/or certain methods of organizing human activity, such as following rules or instructions, but for the recitation of generic computer components. That is, other than reciting “by a processor,” nothing in the claim element precludes the step from practically being performed in the mind, and/or performed as organized human activity. Aside from the general technological environment (addressed below), it covers purely mental concepts and/or mathematical concepts (“calculating (S12e) a net CO2 exchange” step), and the mere nominal recitation of a generic network appliance (e.g. a device, various sensors, a computer) does not take the claim limitation out of the “Mental Processes” and/or “Mathematical Concepts” and/or “Certain Methods Of Organizing Human Activity” groupings of abstract ideas.
Specifically, the utilizing statistical tools to process data and to output the estimated values - said functions could be performed by a human using mental steps or basic critical thinking, which are types of activities that have been found by the courts to represent abstract ideas (e.g., mental comparison regarding a sample or test subject to a control or target data in Ambry, Myriad CAFC, or the diagnosing an abnormal condition by performing clinical tests and thinking about the results in In re Grams, 888 F.2d 835 (Fed. Cir. 1989) (Grams)). In Grams, the recited functions require obtaining data or patient information (from sensors), and analyze that data to ascertain the existence and identity of an abnormality or estimated responses, and possible causes thereof. While said functions are performed by a computer, they are in essence a mathematical algorithm, in that they represent "[a] procedure for solving a given type of mathematical problem." Gottschalk v. Benson, 409 U.S. 63, 65, 93 S.Ct. 253, 254, 34 L.Ed.2d 273 (1972). Moreover, the Federal Circuit has held, “without additional limitations, a process that employs mathematical algorithms to manipulate existing information to generate additional information is not patent eligible.” Digitech Image Techs., LLC v. Elecs. for Imaging, Inc., 758 F.3d 1344, 1351 (Fed. Cir. 2014). Further, “analyzing information by steps people go through in their minds, or by mathematical algorithms, without more, [are] essentially mental processes within the abstract-idea category.” Elec. Power, 830 F.3d at 1354; see also Synopsys, Inc. v. Mentor Graphics Corp., 839 F.3d 1138, 1146 (Fed. Cir. 2016). “[T]he fact that the required calculations could be performed more efficiently via a computer does not materially alter the patent eligibility of the claimed subject matter.” Bancorp Servs., L.L.C. v. Sun Life Assurance Co. of Can. (U.S.), 687 F.3d 1266, 1278 (Fed. Cir. 2012).
As to “carbon dioxide removal” recitation, the Supreme Court has concluded “if a claim is directed essentially to a method of calculating, using a mathematical formula, even if the solution is for a specific purpose, the claimed method is [patent-ineligible subject matter].” Parker v. Flook, 437 U.S. 584, 595 (1978) (quoting In re Rickman, 563 F.2d 1026, 1030 (CCPA 1977).
All these cases describe the significant aspects of the claimed invention, albeit at another level of abstraction. See Apple, Inc. v. Ameranth, Inc., 842 F.3d 1229, 1240-41 (Fed. Cir. 2016) ("An abstract idea can generally be described at different levels of abstraction. As the Board has done, the claimed abstract idea could be described as generating menus on a computer, or generating a second menu from a first menu and sending the second menu to another location. It could be described in other ways, including, as indicated in the specification, taking orders from restaurant customers on a computer.").
Therefore, if a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it falls within the “Mental Processes” and/or “Certain Methods of Organizing Human Activity” grouping of abstract ideas. Accordingly, the claim recites an abstract idea. (Step 2A – Prong 1: Yes).
Step 2A – Prong 2
In Prong Two, the Examiner determines whether claim 21, as a whole, recites additional elements that integrate the judicial exception into a practical application of the exception, i.e., whether the additional elements apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such that the claim is no more than a drafting effort designed to monopolize the judicial exception. See Guidance, 84 Fed. Reg. at 54-55. If the additional elements do not integrate the judicial exception into a practical application, then the claim is directed to the judicial exception. See id., 84 Fed. Reg. at 54. “An additional element [that] reflects an improvement in the functioning of a computer, or an improvement to other technology or technical field” is indicative of integrating a judicial exception into a practical application. See Guidance, 84 Fed. Reg. at 55.
The Examiner determined that this judicial exception is not integrated into a practical application, because there are no meaningful limitations that transform the exception into a patent eligible application. In particular, the claim recites additional elements – using a device to perform the recited steps However, the additional elements are only generically claimed. These components are described in the Specification at a high level of generality (a device, a control computer or controller, a memory, etc.). The Examiner fails to see how this generic recitation of the most basic computer components and/or of a system so integrates the judicial exception as to "impose[] a meaningful limit on the judicial exception, such that the claim is more than a drafting effort designed to monopolize the judicial exception." Guidance, 84 Fed. Reg. at 53. Merely confining the abstract idea to a particular technological environment does not establish a practical application. See Guidance, 84 Fed. Reg. at 54. "A claim does not cease to be abstract for section 101 purposes simply because the claim confines the abstract idea to a particular technological environment in order to effectuate a real-world benefit." In re Mohapatra, 842 F. App'x 635, 638 (Fed. Cir. 2021).
Thus, while the additional elements have and execute instructions to perform the abstract idea itself, this also does not serve to integrate the abstract idea into a practical application as it merely amounts to instructions to "apply it." The claim only manipulates abstract data elements into another form, and does not set forth improvements to another technological field or the functioning of the computer itself and, instead, uses computer elements as tools in a conventional way to improve the functioning of the abstract idea identified above.
The recited steps do not control or improve operation of a machine (MPEP 2106.05(a)), do not effect a transformation or reduction of a particular article to a different state or thing (MPEP 2106.05(c)), and do not apply the judicial exception with, or by use a particular machine (MPEP 2106.05(b)), but, instead, require receiving, storing, comparing and outputting data.
Further, looking at the limitations as an ordered combination 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. None of the additional elements "offers a meaningful limitation beyond generally linking 'the use of the [method] to a particular technological environment,' that is, implementation via computers." Alice Corp., slip op. at 16 (citing Bilski v. Kappos, 561 U.S. 610, 611 (U.S. 2010)).
Therefore, claim 21 as a whole, outputs only data structure, - everything remains in the form of a code stored in the computer memory. Accordingly, even in combination, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. Accordingly, the claim is directed to an abstract idea. (Step 2A – Prong 2: No).
Step 2B
If a claim has been determined to be directed to a judicial exception under revised Step 2A, examiners should then evaluate the additional elements individually and in combination under Step 2B to determine whether the provide an inventive concept (i.e., whether the additional elements amount to significantly more than the exception itself). "[T]he relevant question is whether the claims here do more than simply instruct the practitioner to implement the abstract idea on a generic computer." Alice, 573 U.S. at 225. They do not.
The Examiner determined that the claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional element of using a “device” to perform the recited steps amount to no more than mere instructions to apply the exception using a generic computer component. The claim is now re-evaluated in Step 2B to determine if it is more than what is well-understood, routine, conventional activity in the field.
The method would require a processor and memory in order to perform basic computer functions of receiving information, storing the information in a database, retrieving information from the database, comparing data, and outputting said information. These components are not explicitly recited and therefore must be construed at the highest level of generality. Based on the Specification, the invention utilizes conventional sensors and generic processors, which can be found in mobile devices or desktop computers, conventional memory and display devices, and the functions performed by said generic computer elements are basic functions of a computer - performing a mathematical operation, receiving, storing, comparing and outputting data - have recognized by the courts as routine and conventional activity.
Also, the claim does not involve a non-conventional and non-generic arrangement of known, conventional pieces by receiving information from an external source of data such as various sensors. The receiving of data from a data source over a network can fairly be characterized as insignificant extra-solution activity that does not receive patentable weight. See Bilski, 545 F.3d 943, 963 (Fed. Cir. 2008) (en banc), aff’d sub nom Bilski v. Kappos, 561 U.S. 593 (2010) (characterizing data gathering steps as insignificant extra-solution activity). Similar to Content Extraction, 776 F.3d at 1347; Ultramercial, Inc. v. Hulu, LLC, 772 F.3d 709, 715 (Fed. Cir. 2014): “And we have recognized that merely presenting the results of abstract processes of collecting and analyzing information, without more (such as identifying a particular tool for presentation), is abstract as an ancillary part of such collection and analysis.” Here, the claims are clearly focused on the combination of those abstract-idea processes. The advance they purport to make is a process of gathering and analyzing information of a specified content, then displaying the results, and not any particular asserted inventive technology for performing those functions. They are therefore directed to an abstract idea. As such, the additional elements, considered individually and in combination with the other claim elements, do not make the claim as a whole significantly more than the abstract idea itself. Accordingly, a conclusion that the recited steps are well-understood, routine, conventional activity is supported under Berkheimer Option 2. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept.
Further, similar to Electric Power Group v Alstom S.A. (Fed Cir, 2015-1778, 8/1/2016) (Power Group), claim’ invocation of computers, networks, and displays does not transform the claimed subject matter into patent-eligible applications. Claim 21 does not require any nonconventional computer, network, or display components, or even a “non-conventional and non-generic arrangement of known, conventional pieces,” but merely call for performance of the claimed information collection, analysis, and output functions on a set of generic computer components and display devices. Nothing in the claim, understood in light of the specification, requires anything other than off-the-shelf, conventional computer, network, and display technology for gathering, sending, and presenting the desired information. Analogous to Power Group, claim 21 does not even require a new source or type of information, or new techniques for analyzing it. As a result, the claim does not require an arguably inventive set of components or methods, such as measurement devices or techniques that would generate new data. The claim does not invoke any assertedly inventive programming. Merely requiring the selection and manipulation of information - to provide a “humanly comprehensible” amount of information useful for users - by itself does not transform the otherwise-abstract processes of information collection and analysis into patent eligible subject matter. Merely obtaining and selecting information, by content or source, for collection, analysis, and display does nothing significant to differentiate a process from ordinary mental processes, whose implicit exclusion from § 101 undergirds the information-based category of abstract ideas. Therefore, the recited steps represent implementing the abstract idea on a generic computer, or “reciting a commonplace business method aimed at processing business information despite being applied on a general purpose computer” Versata, p. 53; Ultramerical, pp. 11-12.
Furthermore, the recited functions do not improve the functioning of computers itself, including of the processor(s). There are no physical improvements in the claim, like a faster processor or more efficient memory, and there is no operational improvement, like mathematical computation that improve the functioning of the computer. The claim does not recite unconventional data structures, improved signal processing, reduced processor usage, improved sensor operations, or any technical solution to a technical problem. Even when considering the ordered combination as a whole, the recited elements of monitoring carbon dioxide exchange are routine.
Further, while a preamble recites “A method for controlling carbon dioxide removal…”, the body of the claim has no recitation of any controlling action. The claim end with “calculating…” step. There is no recitation of, e.g., adjusting sweep-gas flow; changing sweep-gas composition, changing blood flow; changing oxygenator operating conditions, and/or controlling the oxygenator based on VCO2net. As such, claim 21 does not actually control CO2 removal; the claim merely measures parameters and calculates a value.
Furthermore, there is no transformation recited in the claim as understood in view of 35 USC 101. The recited steps merely represent abstract ideas which cannot meet the transformation test because they are not physical objects or substances. Bilski, 545 F.3d at 963. Said steps are nothing more than mere manipulation or reorganization of data, which does not satisfy the transformation prong. It is further noted that the underlying idea of the recited steps could be performed via pen and paper or in a person's mind. Moreover, “We agree with the district court that the claimed process manipulates data to organize it in a logical way such that additional fraud tests may be performed. The mere manipulation or reorganization of data, however, does not satisfy the transformation prong.” and “Abele made clear that the basic character of a process claim drawn to an abstract idea is not changed by claiming only its performance by computers, or by claiming the process embodied in program instructions on a computer readable medium. Thus, merely claiming a software implementation of a purely mental process that could otherwise be performed without the use of a computer does not satisfy the machine prong of the machine-or-transformation test”. CyberSource, 659 F.3d 1057, 100 U.S.P.Q.2d 1492 (Fed. Cir. 2011)
Therefore, the claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception, because, when considered separately and in combination, the claim elements do not add significantly more to the exception. Considered separately and as an ordered combination, the claim elements do not provide an improvement to another technology or technical field; do not provide an improvement to the functioning of the computer itself; do not apply the judicial exception by use of a particular machine that is integral to the claim in non-conventional way; do not effect a transformation or reduce a particular article to a different state or thing; and do not add a specific limitation other than what is well-understood, routine and conventional in the operation of a generic computer, and do not provide an unconventional arrangement of known elements that yields a technological solution to a technological problem. None of the hardware recited "offers a meaningful limitation beyond generally linking 'the use of the [method] t a particular technological environment,' that is, implementation via computers." Id., slip op. at 16 (citing Bilski v. Kappos, 561 U.S. 610, 611 (U.S. 2010)). As per “wherein the device comprises an oxygenator including a membrane…” recitations, these limitations do not add significantly more because they are simply an attempt to limit the abstract idea to a particular technological environment, that is, implementation via computers." Id., slip op. at 16 (citing Bilski v. Kappos, 561 U.S. 610, 611 (U.S. 2010)). Limiting the claims to the particular technological environment is, without more, insufficient to transform the claim into patent-eligible applications of the abstract idea at their core.
Accordingly, claim 21 is not directed to significantly more than the exception itself, and is not eligible subject matter under § 101. (Step 2B: No).
Further, although the Examiner takes the steps recited in the independent claim as exemplary, the Examiner points out that limitations recited in dependent claims 22-27 and 30 further narrow the abstract idea but do not make the claims any less abstract. Dependent claims 22-27 and 30 each merely add further details of the abstract steps recited in claim 21 without including an improvement to another technology or technical field, an improvement to the functioning of the computer itself, or meaningful limitations beyond generally linking the use of an abstract idea to a particular technological environment. These claims "add nothing of practical significance to the underlying idea," and thus do not transform the claimed abstract idea into patentable subject matter. Ultramercial, 772 F.3d at 716. Therefore, dependent claims 22-27 and 30 are also directed to non-statutory subject matter.
Because Applicant’s computer-readable medium claims 32-33, and apparatus claims 34-40 and 42 and add nothing of substance to the underlying abstract idea, they too are patent ineligi-ble under §101.
Claim 32 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter.
Claim 32 is directed to a computer-readable medium which covers both transitory/signal and non-transitory medium, and could read on a “signal” which is not statutory subject matter. Therefore, the following is applied to claim 32:
Subject Matter Eligibility of Computer Readable Media
The United States Patent and Trademark Office (USPTO) is obliged to give claims their broadest reasonable interpretation consistent with the specification during proceedings before the USPTO. See In re Zletz, 893 F.2d 319(Fed. Cir. 1989)(during patent examination the pending claims must be interpreted as broadly as their terms reasonably allow). The broadest reasonable interpretation of a claim drawn to a computer readable medium (also called machine readable medium and other such variations) typically covers forms of non-transitory tangible media and transitory propagating signals per se in view of the ordinary and customary meaning of computer readable media, particularly when the specification is silent. See MPEP 2111.01. When the broadest reasonable interpretation of a claim covers a signal per se, the claim must be rejected under 35 U.S.C. 101 as covering non-statutory subject matter. See In re Nuijten, 500 F.3d 1346, 1356-57 (Fed. Cir. 2007) (transitory embodiments are not directed to statutory subject matter) and Interim Examination Instructions for Evaluating Subject Matter Eligibility Under 35 U.S.C. 101, Aug. 24, 2009; p. 2.
The USPTO recognizes that applicants may have claims directed to computer readable media that cover signals per se, which the USPTO must reject under 35 U.S.C. 101 as covering both non-statutory subject matter and statutory subject matter. In an effort to assist the patent community in overcoming a rejection or potential rejection under 35 U.S.C. 4 101 in this situation, the USPTO suggests the following approach. A claim drawn to such a computer readable medium that covers both transitory and non-transitory embodiments may be amended to narrow the claim to cover only statutory embodiments to avoid a rejection under 35 U.S.C. 101 by adding the limitation "non-transitory" to the claim. Cf. Animals -Patentability, 1077 0ff. Gaz. Pat. Office 24 (April 21, 1987) (suggesting that applicants add the limitation "non-human" to a claim covering a multi-cellular organism to avoid a rejection under 35 U.S.C. 101). Such an amendment would typically not raise the issue of new matter, even when the specification is silent because the broadest reasonable interpretation relies on the ordinary and customary meaning that includes signals per se. The limited situations in which such an amendment could raise issues of new matter occur, for example, when the specification does not support a non-transitory embodiment because a signal per se is the only viable embodiment such that the amended claim is impermissibly broadened beyond the supporting disclosure. See, e.g., Gentrv Gallery, Inc. v. Berkline Corp., 134 F.3d 1473 (Fed. Cir. 1998).
Allowable Subject Matter
Claims 28, 29 and 31 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Citations of pertinent art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
“Guidance for Cardiopulmonary Bypass Oxygenators 510(k) Submissions; Final Guidance for Industry and FDA Staff” U.S. Department of Health and Human Services Food and Drug Administration; Center for Devices and Radiological Health; November 13, 2000; pp. 1-23 (Guidance) discloses sweep/gas flow through oxygenator; an upstream/inlet and downstream/outlet gas; measuring inlet and outlet CO2; determining the CO2 difference; using a gas flow rate; and calculating CO2 transfer rate. However, while Guidance calculates the CO2 transfer rate as multiplying gas flow rate by the change in carbon dioxide concentration between the inlet and outlet flow (F x (%CO2out - %Co2in), Guidance does not disclose calculating a net CO2 exchange [VCO2net] based on measured FCO2in, Vin, FCO2out and Vout (VCO2net = FCO2in x Vin - FCO2out x Vout).
Lukitsch et al. “Suitable CO2 Solubility Models for Determination of the CO2 Removal Performance of Oxygenators” Bioengineering (Basel) 2021 Mar 2;8(3):33. doi: 10.3390/bioengineering8030033; pp. 1-25, discloses that in the sweep-flow method, the amount of CO2 is calculated using flow rate and the CO2 concentration difference between the inlet and outlet of the membrane in the extracorporeal oxygenator.
Jeffries et al. - US 10549022 B2 – discloses CO2 removal from blood in extracorporeal gas-exchange devices, including measuring of existing sweep-gas CO2, and calculating of a CO2 removal rate from the existing sweep-gas data.
Federspiel et al. - US 9814821 B2 – discloses extracorporeal CO2 removal; measuring CO2 removal rates.
Distinguishable Subject Matter
The present claims remain distinguishable from the prior art of record. The prior art of record, while disclosing sweep/gas flow through oxygenator; an upstream/inlet and downstream/outlet gas; measuring inlet and outlet CO2; determining the CO2 difference; using a gas flow rate; and calculating CO2 transfer rate, fails to disclose measuring a pre-oxygenator and a post-oxygenator fractions of CO2 in combination with recited limitations as specifically recited in the claims. Thus, the Examiner has not made a prior art rejection under 35 USC §102 or §103.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Igor Borissov whose telephone number is 571-272-6801. If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor Kambiz Abdi can be reached on 571-272-6702. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/IGOR N BORISSOV/ Primary Examiner, Art Unit 3685 8/25/2026
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