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 .
Response to Arguments
This office action is responsive to Request for Reconsideration filed on 02/09/2026. As directed by the amendment: claims 48 – 75 are pending, claims 56 – 57 & 59 were cancelled, claims 68 - 75 have been added & claims 48 – 55, 58 & 60 – 67 have been amended.
Applicant's arguments filed 02/09/2026 have been fully considered but they are not persuasive. The 112(b) rejection is upheld as the language of “one or more” and “at least one of” still allows options that overlap for the same reasons in the previous rejection.
Applicant’s arguments, see Page 7, filed 02/09/2026, with respect to claim objection have been fully considered and are persuasive. The objection of claim 64 has been withdrawn.
Applicant’s arguments, see Pages 7 - 10, filed 02/09/2026, with respect to the rejection(s) of claim 48 under 35 U.S.C. 101 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of new limitations being added to the claim that were not considered before, however, the applicant argues the human mind would not be able to determine a vector. This a clear mathematical equation that can be calculated by a person making an analogy or assigning a number to an observed measurement under the 2019 PEG. The human mind can take the data points and calculate a vector that is able to show the change in the respiratory index, specifically, the data points of the magnitude and a rate of change of the respiratory index and a direction of change of the respiratory index. These are elements that the human can determine by mathematical equations or observation. The applicant also argues the added limitations describe a specific improvement in the ability of a system for assessing a patient receiving respiratory support to determine a respiratory status, however it does not add any additional elements that make it so the human mind cannot achieve the method by themselves. The applicant argues the recitation od the one or more sensors and generation of a vector allow the system to improve accuracy of the determined patient respiratory status, however, based on the fact that the function of the sensors could easily be conducted by the human mind by observation and the determination of the vector with a mathematical equation it maintains an abstract idea.
Applicant’s arguments, see Page 11 & 12, filed 02/09/2026, with respect to the rejection(s) of claim(s) 48 under 35 U.S.C. 102 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of the new limitations added to the claims that were not considered prior.
Applicant’s arguments, see Page 12, filed 02/09/2026, with respect to the rejection(s) of claim(s) 49 – 55 & 60 – 67 under 35 U.S.C. 102 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of the new limitations added to the independent claim 1 that were not considered prior.
Applicant’s arguments, see Page 12, filed 02/09/2026, with respect to the rejection(s) of claim(s) 56 - 59 under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of the new limitations added to the independent claim 1 that were not considered prior.
Applicant’s arguments, see Page 12, filed 02/09/2026, with respect to the rejection(s) of claim(s) 62 - 63 under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of the new limitations added to the independent claim 1 that were not considered prior.
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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 52 recites the broad recitation “one or more of” and “at least one of”, and the claim also recites “a treatment session, a sub-session, or a length of time, wherein the length of time comprises at least one of a day, a part of the day, a night, or a part of the night” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
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 48 – 55, 58 & 60 - 75 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Claim 48
[Step 1] Regarding claim 48, the claim is a machine and is one of the four statutory categories.
[Step 2A, Prong One] The claim is directed to an abstract idea since the claim limitations are merely receiving a plurality of time points, determine a respiratory index from the one or more patient parameters for each of the plurality of time points, determine the patient respiratory status from a change in the respiratory index over time and determine the patient respiratory status. This can be done by a mental process and can be completed by a person simply observing the data that is being outputted which are mental processes under the 2019 PEG (i.e. mental processes). Determining a respiratory index can be completed a mathematical equation and/or can be determined in a mental process and can be completed by a person making an analogy or assigning a number to an observed measurement under the 2019 PEG. This is done by analyzing the data and determining the patient respiratory status with the change in the respiratory index can also be done using a mathematical equation under the 2019 PEG. The determination of a vector is a clear mathematical equation that can be calculated by a person making an analogy or assigning a number to an observed measurement under the 2019 PEG. The human mind can take the data points and calculate a vector that is able to show the change in the respiratory index, specifically, the data points of the magnitude and a rate of change of the respiratory index and a direction of change of the respiratory index.
[Step 2A, Prong Two] The claim does recite additional elements that integrate the judicial exception into a practical application which are one or more sensors, a controller and a display.
[Step 2B] The claim does not recite any additional structures that would make it significantly more than the judicial exception as it merely details conventional sensors, controller and display. Falk et al. (US 2017/0347917 A1) mentions the use of one or more sensors for acquiring time points and patient parameters (Paragraph 0004 & 0023). Also, the use of a controller to determine a respiratory status based on the data acquired by the sensors and a display to show the data acquired (Paragraph 0018, 0032 & 0034 & 0041). The component found in the claim is well known to be conventional in the art. Further, the claim does not apply the abstract idea in any particular manner which affects use of the apparatus. Thus, the claim as a whole does not amount to significantly more than the judicial exception.
Claim 49
[Step 1] Regarding claim 49, dependent on claim 48, the claim is a machine and is one of the four categories.
[Step 2A, Prong One] The claim is directed to an abstract idea due to its dependency on claim 48 and amount to no more than generally linking the use of the abstract idea to a particular field of use because they’re merely incidental or token additions to the claims that do not alter or affect the process steps performed.
[Step 2A, Prong Two] The claim does not recite additional elements that integrate the judicial exception into practical application.
[Step 2B] The claim does not recite any additional structures that would make it significantly more than the judicial exception as it merely details of the steps needed to compute a respiratory index in order to use data to determine the respiratory status. Further, the claim does not apply the abstract idea in any particular manner which affects use of the computation of the respiratory status. Thus, the claim as a whole does not amount to significantly more than the judicial exception.
Claim 50
[Step 1] Regarding claim 50, dependent on claim 48, the claim is a machine and is one of the four categories.
[Step 2A, Prong One] The claim is directed to an abstract idea due to its dependency on claim 48 and amount to no more than generally linking the use of the abstract idea to a particular field of use because they’re merely incidental or token additions to the claims that do not alter or affect the process steps performed.
[Step 2A, Prong Two] The claim does not recite additional elements that integrate the judicial exception into practical application.
[Step 2B] The claim does not recite any additional structures that would make it significantly more than the judicial exception as it merely details of the steps needed to compute a health score in order to use data to determine the respiratory status. Further, the claim does not apply the abstract idea in any particular manner which affects use of the determination of the respiratory status. Thus, the claim as a whole does not amount to significantly more than the judicial exception.
Claim 51
[Step 1] Regarding claim 51, dependent on claim 48, the claim is a machine and is one of the four categories.
[Step 2A, Prong One] The claim is directed to an abstract idea due to its dependency on claim 48 and amount to no more than generally linking the use of the abstract idea to a particular field of use because they’re merely incidental or token additions to the claims that do not alter or affect the process steps performed.
[Step 2A, Prong Two] The claim does not recite additional elements that integrate the judicial exception into practical application.
[Step 2B] The claim does not recite any additional structures that would make it significantly more than the judicial exception as it merely details of the steps needed to compute a health score in order to use data to determine the respiratory status. Further, the claim does not apply the abstract idea in any particular manner which affects use of the determination of the respiratory status. Thus, the claim as a whole does not amount to significantly more than the judicial exception.
Claim 52
[Step 1] Regarding claim 52, dependent on claim 48, the claim is a machine and is one of the four categories.
[Step 2A, Prong One] The claim is directed to an abstract idea due to its dependency on claim 48 and amount to no more than generally linking the use of the abstract idea to a particular field of use because they’re merely incidental or token additions to the claims that do not alter or affect the process steps performed.
[Step 2A, Prong Two] The claim does not recite additional elements that integrate the judicial exception into practical application.
[Step 2B] The claim does not recite any additional structures that would make it significantly more than the judicial exception as it merely details of the steps needed to compute a health score in order to use data to determine the respiratory status. Further, the claim does not apply the abstract idea in any particular manner which affects use of the determination of the respiratory status. Thus, the claim as a whole does not amount to significantly more than the judicial exception.
Claim 53
[Step 1] Regarding claim 53, dependent on claim 48, the claim is a machine and is one of the four categories.
[Step 2A, Prong One] The claim is directed to an abstract idea due to its dependency on claim 48 and amount to no more than further limiting the parameters of claim 48, which both can be observed by a person. This can be done by generally linking the use of the abstract idea to a particular field of use because they’re merely incidental or token additions to the claims that do not alter or affect the process steps performed.
[Step 2A, Prong Two] The claim does not recite additional elements that integrate the judicial exception into practical application.
[Step 2B] The claim does not recite any additional structures that would make it significantly more than the judicial exception as it merely details of the steps needed to compute a health score in order to use data to determine the respiratory status. Further, the claim does not apply the abstract idea in any particular manner which affects use of the determination of the respiratory status. Thus, the claim as a whole does not amount to significantly more than the judicial exception.
Claim 54
[Step 1] Regarding claim 54, dependent on claim 53, the claim is a machine and is one of the four categories.
[Step 2A, Prong One] The claim is directed to an abstract idea due to its dependency on claim 53 and amount to no more than generally linking the use of the abstract idea to a particular field of use because they’re merely incidental or token additions to the claims that do not alter or affect the process steps performed.
[Step 2A, Prong Two] The claim does not recite additional elements that integrate the judicial exception into practical application.
[Step 2B] The claim does not recite any additional structures that would make it significantly more than the judicial exception as it amounts to no more than further limiting the parameters of claim 53, which both can be observed by a person. It provides no more limitation to the steps needed to compute a health score in order to use data to determine the respiratory status. Further, the claim does not apply the abstract idea in any particular manner which affects use of the determination of the respiratory status. Thus, the claim as a whole does not amount to significantly more than the judicial exception.
Claim 55
[Step 1] Regarding claim 55, dependent on claim 53, the claim is a machine and is one of the four categories.
[Step 2A, Prong One] The claim is directed to an abstract idea due to its dependency on claim 53 and amount to no more than generally linking the use of the abstract idea to a particular field of use because they’re merely incidental or token additions to the claims that do not alter or affect the process steps performed.
[Step 2A, Prong Two] The claim does not recite additional elements that integrate the judicial exception into practical application.
[Step 2B] The claim does not recite any additional structures that would make it significantly more than the judicial exception as it merely details of the steps needed to compute a health score in order to use data to determine the respiratory status. Further, the claim does not apply the abstract idea in any particular manner which affects use of the determination of the respiratory status. Thus, the claim as a whole does not amount to significantly more than the judicial exception.
Claim 58
[Step 1] Regarding claim 58, dependent on claim 57, the claim is a machine system and is one of the four categories.
[Step 2A, Prong One] The claim is directed to an abstract idea due to its dependency on claim 57 and amount to no more than generally linking the use of the abstract idea to a particular field of use because they’re merely incidental or token additions to the claims that do not alter or affect the process steps performed.
[Step 2A, Prong Two] The claim does not recite any more additional elements other than the controller, which has been addressed in claim 48.
[Step 2B] The claim does not recite any additional structures that would make it significantly more than the judicial exception as it merely details of the steps needed to compute a health score in order to use data to determine the respiratory status. Further, the claim does not apply the abstract idea in any particular manner which affects use of the determination of the respiratory status. Thus, the claim as a whole does not amount to significantly more than the judicial exception.
Claim 60
[Step 1] Regarding claim 60, dependent on claim 48, the claim is a machine and is one of the four categories.
[Step 2A, Prong One] The claim is directed to an abstract idea due to its dependency on claim 48 and amount to no more than generally linking the use of the abstract idea to a particular field of use because they’re merely incidental or token additions to the claims that do not alter or affect the process steps performed.
[Step 2A, Prong Two] The claim does not recite additional elements that integrate the judicial exception into practical application.
[Step 2B] The claim does not recite any additional structures that would make it significantly more than the judicial exception as it merely details of the steps needed to compute a health score in order to use data to determine the respiratory status. Further, the claim does not apply the abstract idea in any particular manner which affects use of the determination of the respiratory status. Thus, the claim as a whole does not amount to significantly more than the judicial exception.
Claim 61
[Step 1] Regarding claim 61, dependent on claim 60, the claim is a machine and is one of the four categories.
[Step 2A, Prong One] The claim is directed to an abstract idea due to its dependency on claim 60 and amount to no more than generally linking the use of the abstract idea to a particular field of use because they’re merely incidental or token additions to the claims that do not alter or affect the process steps performed.
[Step 2A, Prong Two] The claim does not recite any more additional elements other than the display, which has been addressed in claim 48.
[Step 2B] The claim does not recite any additional structures that would make it significantly more than the judicial exception as it merely discloses the idea of displaying the change in the respiratory index based on the plurality of time points. Further, the claim does not apply the abstract idea in any particular manner which affects use of the determination of the respiratory status. Thus, the claim as a whole does not amount to significantly more than the judicial exception.
Claim 62
[Step 1] Regarding claim 62, dependent on claim 61, the claim is a machine and is one of the four categories.
[Step 2A, Prong One] The claim is directed to an abstract idea due to its dependency on claim 61 and amount to no more than generally linking the use of the abstract idea to a particular field of use because they’re merely incidental or token additions to the claims that do not alter or affect the process steps performed.
[Step 2A, Prong Two] The claim does not recite additional elements that integrate the judicial exception into practical application.
[Step 2B] The claim does not recite any additional structures that would make it significantly more than the judicial exception as it merely details of the steps needed to compute a health score in order to use data to determine the respiratory status. Further, the claim does not apply the abstract idea in any particular manner which affects use of the determination of the respiratory status. Thus, the claim as a whole does not amount to significantly more than the judicial exception.
Claim 63
[Step 1] Regarding claim 63, dependent on claim 48, the claim is a machine and is one of the four categories.
[Step 2A, Prong One] The claim is directed to an abstract idea due to its dependency on claim 48 and amount to no more than generally linking the use of the abstract idea to a particular field of use because they’re merely incidental or token additions to the claims that do not alter or affect the process steps performed.
[Step 2A, Prong Two] The claim does not recite any more additional elements other than the display, which has been addressed in claim 48, that integrate the judicial exception into practical application.
[Step 2B] The claim does not recite any additional structures that would make it significantly more than the judicial exception as it merely details of the steps needed to compute a health score in order to use data to determine the respiratory status. Further, the claim does not apply the abstract idea in any particular manner which affects use of the determination of the respiratory status. Thus, the claim as a whole does not amount to significantly more than the judicial exception.
Claim 64
[Step 1] Regarding claim 64, dependent on claim 48, the claim is a machine and is one of the four categories.
[Step 2A, Prong One] The claim is directed to an abstract idea due to its dependency on claim 48 and amount to no more than generally linking the use of the abstract idea to a particular field of use because they’re merely incidental or token additions to the claims that do not alter or affect the process steps performed.
[Step 2A, Prong Two] The claim does not recite any more additional elements other than the controller and the display, which has been addressed in claim 48,that integrate the judicial exception into practical application.
[Step 2B] The claim does not recite any additional structures that would make it significantly more than the judicial exception as it merely details of the steps needed to compute a health score in order to use data to determine the respiratory status. Further, the claim does not apply the abstract idea in any particular manner which affects use of the determination of the respiratory status. Thus, the claim as a whole does not amount to significantly more than the judicial exception.
Claim 65
[Step 1] Regarding claim 65, dependent on claim 48, the claim is a machine and is one of the four categories.
[Step 2A, Prong One] The claim is directed to the new abstract idea of communicating the change in the respiratory index and amount to no more than generally linking the use of the abstract idea to a particular field of use because they’re merely incidental or token additions to the claims that do not alter or affect the process steps performed.
[Step 2A, Prong Two] The claim does not recite additional elements that integrate the judicial exception into practical application.
[Step 2B] The claim does not recite any additional structures that would make it significantly more than the judicial exception as it merely discloses displaying the change of the respiratory index. Further, the claim does not apply the abstract idea in any particular manner which affects use of the determination of the respiratory status. Thus, the claim as a whole does not amount to significantly more than the judicial exception.
Claim 66
[Step 1] Regarding claim 66, dependent on claim 65, the claim is a machine and is one of the four categories.
[Step 2A, Prong One] The claim is directed to an abstract idea due to its dependency on claim 65 and amount to no more than generally linking the use of the abstract idea to a particular field of use because they’re merely incidental or token additions to the claims that do not alter or affect the process steps performed.
[Step 2A, Prong Two] The claim does not recite any more additional elements other than the controller, sensors and respiratory support apparatus, which has been addressed in claim 48.
[Step 2B] The claim does not recite any additional structures that would make it significantly more than the judicial exception as it merely details of the steps needed to compute a health score in order to use data to determine the respiratory status. Further, the claim does not apply the abstract idea in any particular manner which affects use of the determination of the respiratory status. Thus, the claim as a whole does not amount to significantly more than the judicial exception.
Claim 67
[Step 1] Regarding claim 67, dependent on claim 48, the claim is a machine and is one of the four categories.
[Step 2A, Prong One] The claim is directed to an abstract idea due to its dependency on claim 48 and amount to no more than generally linking the use of the abstract idea to a particular field of use because they’re merely incidental or token additions to the claims that do not alter or affect the process steps performed.
[Step 2A, Prong Two] The claim recites additional elements such as a respiratory apparatus, a mobile device or a remote monitoring system that integrate the judicial exception into practical application.
[Step 2B] The claim recites additional structures such as a respiratory apparatus, a mobile device or a remote monitoring system. Falk et al. (US 2017/0347917 A1) discloses the use of an apparatus and a remote monitoring device showing the use of these limitations are known in the art. (Paragraph 0017 & 0038).However, these elements do not add anything significantly more than the judicial exception as it merely details what the apparatus comprises. Further, the claim does not apply the abstract idea in any particular manner which affects use of the determination of the respiratory status. Thus, the claim as a whole does not amount to significantly more than the judicial exception.
Claim 68
[Step 1] Regarding claim 68, dependent on claim 48, the claim is a machine and is one of the four categories.
[Step 2A, Prong One] The claim is directed to an abstract idea due to its dependency on claim 48 and further includes the abstract idea of comparing the vector against a threshold which can still be done in a person’s head.
[Step 2A, Prong Two] The claim does not recite additional elements that integrate the judicial exception into practical application.
[Step 2B] The claim does not recite any additional structures that would make it significantly more than the judicial exception as it merely discloses comparing the vector against a threshold which can still be done in a person’s head. Further, the claim does not apply the abstract idea in any particular manner which affects use of the determination of the respiratory status. Thus, the claim as a whole does not amount to significantly more than the judicial exception.
Claim 69
[Step 1] Regarding claim 69, dependent on claim 48, the claim is a machine and is one of the four categories.
[Step 2A, Prong One] The claim is directed to an abstract idea due to its dependency on claim 48 and amount to no more than generally linking the use of the abstract idea to further define the threshold.
[Step 2A, Prong Two] The claim does not recite additional elements that integrate the judicial exception into practical application.
[Step 2B] The claim does not recite any additional structures that would make it significantly more than the judicial exception as it merely discloses further defining the threshold. Further, the claim does not apply the abstract idea in any particular manner which affects use of the determination of the respiratory status. Thus, the claim as a whole does not amount to significantly more than the judicial exception.
Claim 70
[Step 1] Regarding claim 70, dependent on claim 48, the claim is a machine and is one of the four categories.
[Step 2A, Prong One] The claim is directed to an abstract idea due to its dependency on claim 48 and amount to no more than generally linking the use of the abstract idea to determining a plurality of instantaneous vectors over time.
[Step 2A, Prong Two] The claim does not recite any more additional elements other than the controller, which has been addressed in claim 48, that integrate the judicial exception into practical application.
[Step 2B] The claim does not recite any additional structures that would make it significantly more than the judicial exception as it merely discloses determining a plurality of instantaneous vectors over time. Further, the claim does not apply the abstract idea in any particular manner which affects the determination of the respiratory status .Thus, the claim as a whole does not amount to significantly more than the judicial exception.
Claim 71
[Step 1] Regarding claim 71, dependent on claim 48, the claim is a machine and is one of the four categories.
[Step 2A, Prong One] The claim is directed to an abstract idea due to its dependency on claim 48 and amount to no more than generally linking the use of the abstract idea to determine that respiratory support changes are required based on the patients respiratory status.
[Step 2A, Prong Two] The claim does not recite any more additional elements other than the controller, which has been addressed in claim 48, that integrate the judicial exception into practical application.
[Step 2B] The claim does not recite any additional structures that would make it significantly more than the judicial exception as it merely discloses determining that respiratory support changes are required based on the patient’s respiratory status. Further, the claim does not apply the abstract idea in any particular manner which affects the determination of the respiratory status .Thus, the claim as a whole does not amount to significantly more than the judicial exception.
Claim 72
[Step 1] Regarding claim 72, dependent on claim 48, the claim is a machine and is one of the four categories.
[Step 2A, Prong One] The claim is directed to an abstract idea due to its dependency on claim 48 and amount to no more than generally linking the use of the abstract idea to further define the respiratory index.
[Step 2A, Prong Two] The claim does not recite additional elements that integrate the judicial exception into practical application.
[Step 2B] The claim does not recite any additional structures that would make it significantly more than the judicial exception as it merely further defines the respiratory index. Further, the claim does not apply the abstract idea in any particular manner which affects the determination of the respiratory status .Thus, the claim as a whole does not amount to significantly more than the judicial exception.
Claim 73
[Step 1] Regarding claim 73, dependent on claim 48, the claim is a machine and is one of the four categories.
[Step 2A, Prong One] The claim is directed to an abstract idea due to its dependency on claim 48 and amount to no more than generally linking the use of the abstract idea to define how the vector is calculated.
[Step 2A, Prong Two] The claim does not recite additional elements that integrate the judicial exception into practical application.
[Step 2B] The claim does not recite any additional structures that would make it significantly more than the judicial exception as it merely further define how the vector is calculated. Further, the claim does not apply the abstract idea in any particular manner which affects the determination of the respiratory status. Thus, the claim as a whole does not amount to significantly more than the judicial exception.
Claim 74
[Step 1] Regarding claim 74, dependent on claim 48, the claim is a machine and is one of the four categories.
[Step 2A, Prong One] The claim is directed to an abstract idea due to its dependency on claim 48 and amount to no more than generally linking the use of the abstract idea to define the graphical representation.
[Step 2A, Prong Two] The claim does not recite additional elements that integrate the judicial exception into practical application.
[Step 2B] The claim does not recite any additional structures that would make it significantly more than the judicial exception as it merely further defines the graphical representation. Further, the claim does not apply the abstract idea in any particular manner which affects the determination of the respiratory status. Thus, the claim as a whole does not amount to significantly more than the judicial exception.
Claim 75
[Step 1] Regarding claim 75, dependent on claim 72, the claim is a machine and is one of the four categories.
[Step 2A, Prong One] The claim is directed to an abstract idea due to its dependency on claim 48 and amount to no more than generally linking the use of the abstract idea to a particular mathematical equation, which can still be done in a person’s mind.
[Step 2A, Prong Two] The claim does not recite additional elements that integrate the judicial exception into practical application.
[Step 2B] The claim does not recite any additional structures that would make it significantly more than the judicial exception as it merely further defines a mathematical equation. Further, the claim does not apply the abstract idea in any particular manner which affects the determination of the respiratory status. Thus, the claim as a whole does not amount to significantly more than the judicial exception.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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) 48 – 71 & 73 are rejected under 35 U.S.C. 103 as being unpatentable over Falk et al. (US 2017/0347917 A1) in view of Perez et al. (US 20160242675 A1) & Prashant et al. (US 10987066 B2)
Regarding claim 48, A system for assessing a patient receiving respiratory support during a session to determine a respiratory status (Abstract), the system comprising:
one or more sensors (Paragraph 0018), or inputs for one or more sensors (Paragraph 0007) , for receiving for a plurality of time points (Paragraph 0004 & 0018 / Figure 6), one or more patient parameters for the patient (Paragraph 0023),
wherein the one or more patient parameters comprises at least one respiratory parameter (Paragraph 0023), and
a controller 122 configured to;
determine, for each time point, a respiratory index from the one or more patient parameters (Paragraph 0018, 0032 & 0034 / Figure 6)
a display 46 (Paragraph 0018).
Falk does not disclose determine a vector showing a change in the respiratory index, wherein the vector comprises a magnitude representing a rate of change of the respiratory index and a direction of change of the respiratory index;
Display a combined graphical representation of:
the respiratory index,
one or more components of the respiratory index, and the vector.
Perez discloses determine a vector showing a change in the respiratory index, wherein the vector comprises a magnitude representing a rate of change of the respiratory index and a direction of change of the respiratory index determine, from the vector, a patient respiratory status.
(Paragraph 0030 & 0058).
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date to modify the controller of Falk to include the determination a vector showing a change in the respiratory index, wherein the vector comprises a magnitude representing a rate of change of the respiratory index and a direction of change of the respiratory index determine, from the vector, a patient respiratory status.
as it would allow a threshold to be determined that would allow a warning to be generated that indicated that health of the patient is likely to be deteriorating. (Paragraph 0030)
Prashanth discloses display, on a display, a combined graphical representation. (Column 6, lines 52 – 61) )
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date to modify the display of Falk to display a combined graphical representation of: the respiratory index, one or more components of the respiratory index, and the vector as it would allow able to provide direct visual information to a user of various aspects of the patient's oxygen state. (Abstract)
Regarding claim 49, Modified Falk discloses the system as claimed in claim 48.
Modified Flak discloses wherein the patient is receiving the respiratory support (Paragraph 0022).
Regarding claim 50, Modified Falk discloses the system as claimed in claim 48.
Modified Falk discloses wherein the apparatus is configured to provide the respiratory support (Paragraph 0015).
Regarding claim 51, Modified Falk discloses the system as claimed in claim 48.
Modified Falk discloses wherein the respiratory support comprises high flow respiratory support (Paragraph 0022).
Regarding claim 52, Modified Falk discloses the system as claimed in claim 48.
Modified Falk discloses wherein the session comprises one or more of:
a treatment session,
a sub-session, or
a length of time, wherein the length of time comprises at least one of a day, a part of the day, a night, or a part of the night (Claim 19).
Regarding claim 53, Modified Falk discloses the system as claimed in claim 48.
Modified Falk discloses wherein the one or more patient parameters 90 – 96 comprise one or more lung mechanics parameters 92 and one or more oxygenation parameters 96 (Figure 6 discloses 168 – 170 & Paragraph 0034).
Regarding claim 54, Modified Falk discloses the system as claimed in claim 53.
Modified Falk wherein the one or more lung mechanics parameters 92 comprise one or more of: a respiratory rate, an expiratory time, or a minute ventilation (Paragraph 0038).
Regarding claim 55, Modified Falk discloses the system as claimed in claim 53, Modified Falk discloses wherein the one or more oxygenation parameters 96 comprise one or more of: FiO2, FdO2, 02 fraction, or SpO2 (Paragraph 0034).
Regarding claim 58, Modified Falk discloses the system as claimed in claim 54.
Modified Falk wherein the respiratory rate is determined from the one or more patient parameters by the controller 122. (Falk, Paragraph 0033)
Regarding claim 60, Modified Falk discloses the system as claimed in claim 48.
Modified Falk discloses wherein determining the change in the respiratory index over time comprises determining a change in the respiratory index over time for each of the plurality of time points (Paragraph 0038).
Regarding claim 61, Modified Falk discloses the system as claimed in claim 60.
Modified Falk discloses wherein the controller 122 is further configured to display, on the display: the change in the respiratory index over time for each of the plurality of time points. (Paragraph 0038 & 0049 / Figure 6).
Regarding claim 62, Modified Falk discloses the system as claimed in claim 61.
Modified Falk does not disclose wherein the change in the respiratory index over time comprises a trend represented with one or more trend parameters, wherein the one or more trend parameters comprise the magnitude and/or the direction.
Perez discloses wherein the change in the respiratory index over time comprises a trend represented with one or more trend parameters, wherein the one or more trend parameters comprise the magnitude and/or the direction. (Paragraph 0033)
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date to modify Falk wherein the change in the respiratory index over time comprises a trend represented with one or more trend parameters, wherein the one or more trend parameters comprise a magnitude and/or a direction as comparing the magnitude of the trend with the predetermined threshold will allow knowing if the trend ever exceeds the threshold and will make it easier to determine what the patient’s health currently looks like and can begin the warning process. (Paragraph 0033)
Regarding claim 63, Modified Falk discloses the system as claimed in claim 48.
Modified Falk discloses wherein determining the patient respiratory status from the change in the respiratory index over time (Paragraph 0038 & 0041)
Modified Falk does not expressly disclose comprises the controller calculating and comparing the change in the respiratory index over time to relationship information.
Perez discloses comprises the controller calculating and comparing the change in the respiratory index over time to relationship information. (Paragraph 0022 – 0023)
It would have been obvious to one of ordinary skill in the art prior to the effective filing date to modify Falk wherein comprises the controller calculating and comparing the change in the respiratory index over time to relationship information as it would allow the indicate a trend analysis and determine a characteristic respiratory rate that is measured over the days. This may be able to generate a warning that can inform if the change may indicate a health scare for the patient. (Paragraph 0022 – 0023)
Regarding claim 64, Modified Falk discloses the system as claimed in claim 48.
Modified Falk discloses wherein the controller 122 is further configured display on the display a respiratory index threshold and/or a change indicator threshold (Paragraph 0041).
Regarding claim 65, Modified Falk discloses the system as claimed in claim 48.
Modified Falk discloses wherein the controller 122 is further configured to communicate the change in the respiratory index to one or both of:
a clinician, or a respiratory support apparatus (Paragraph 0032 & 0049 / Figure 6).
Regarding claim 66, Modified Falk discloses the system as claimed in claim 65.
Modified Falk discloses wherein the one or more sensors comprise at least one of:
the one or more sensors arranged to sense a flow path of the respiratory support apparatus (Paragraph 0005), or the one or more sensors arranged to sense the one or more patient parameters (Paragraph 0023);
wherein the controller 122 is further configured to receive the one or more patient parameters from the one or more sensors (Paragraph 0025).
Regarding claim 67, Modified Falk discloses the system as claimed in claim 48.
Modified Falk discloses wherein the apparatus comprises one or more of:
a respiratory apparatus 40, a mobile device, or a remote monitoring system , either alone or integrated (Paragraph 0017 & 0038).
Regarding claim 68, Modified Falk discloses the system as claimed in claim 48.
Modified Falk discloses wherein determining the patient respiratory status, comprises comparing the vector against a threshold. (as claimed in claim 48 / Perez, (Paragraph 0030)
Regarding claim 69, Modified Falk discloses the system as claimed in 68.
Modified Falk discloses wherein the threshold is a threshold that indicates risk of respiratory failure. (as claimed in claim 48 / Paragraph 0030)
Regarding claim 70, Modified Falk discloses the system as claimed in claim 48.
Modified Falk discloses wherein the controller is further configured to determine a plurality of instantaneous vectors over time, each instantaneous vector indicating the change in the respiratory index at a point in time. (Perez, Paragraph 0030 & 0058)
Regarding claim 71, Modified Falk discloses the system as claimed in claim 48.
Perez further discloses wherein the controller 122 is further configured to determine that respiratory support changes are required based on the patient respiratory status. (Paragraph 0022)
It would have been obvious to one of ordinary skill in the art prior to the effective filing date to further modify controller of Falk to determine that respiratory support changes are required based on the patient respiratory status as the warning determines if the patient is declining therefore, it would determine that the respiratory support change is required in order to improve the patient’s status. (Paragraph 0022)
Regarding claim 73, Modified Falk discloses the system as claimed in claim 48.
Modified Falk does not disclose wherein the vector is calculated between two consecutive respiratory index values.
However it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date to further modify Falk wherein the vector is calculated between two consecutive respiratory index values as it is known in the art that by using two consecutive points the vector is able to represent a trending analysis in the calculations.
Claim 72 is rejected under 35 U.S.C. 103 as being unpatentable over Falk et al. (US 2017/0347917 A1) in view of Perez et al. (US 20160242675 A1) & Prashant et al. (US 10987066 B2) as claimed in claim 48, in view of ‘American Journal of Respiratory and Critical Care Medicine, Volume 199, Number 11, Page 9, June 1 2019’
Regarding claim 72, Modified Falk discloses the system as claimed in claim 48, Modified Falk does not disclose wherein the respiratory index is a ROX index, wherein the components of the ROX index include one or more of respiratory rate (RR), SpO2 or FiO2.
Roca discloses wherein the respiratory index is a ROX index, determined from one or more of respiratory rate, FiO2 or SpO2. (Page 2, Column 1, Paragraph 1 - 2)
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date to further modify Falk wherein the respiratory index is a ROX index, determined from one or more of respiratory rate, FiO2 or SpO2 as it is commonly known that the ROX index is defined as the ratio of oxygen saturation as measured by pulse oximeter/FiO2 to respiratory rate. This would make it an ordinary skill in the art to know the components of the ROX index normally comprises FiO2 and a respiratory rate. (Page 2, Column 1, Paragraph 1 - 2)
Claim 74 is rejected under 35 U.S.C. 103 as being unpatentable over Falk et al. (US 2017/0347917 A1) in view of Perez et al. (US 20160242675 A1) & Prashant et al. (US 10987066 B2) as claimed in claim 48, in view of Tatkov, Stanislav. “ROX vector to complement ROX index during nasal high flow therapy of hypoxemic patients.” Journal of Critical Care, vol. 58, Aug. 2020, p. 129, doi:10.1016/j.jcrc.2019.08.012. [Retrieved June 9 2026]
Regarding claim 74, Modified Falk discloses the system as claimed in claim 48.
Modified Falk does not disclose wherein the combined graphical representation of the one or more components comprises a graphical representation of respiratory rate versus FiO2 or respiratory rate versus SpO2/FiO2.
Tatkov discloses wherein the combined graphical representation of the one or more components comprises a graphical representation of respiratory rate versus FiO2. (Column 1, Paragraph 2)
It would have been obvious to one of ordinary skill in the art prior to the effective filing date to further modify Falk wherein the combined graphical representation of the one or more components comprises a graphical representation of respiratory rate versus FiO2 as the XY plot is complementary to the ROX index by showing a trend of its key components in the vector form. The index depends primarily on the FiO2 and RR, which are both denominators in the ROX equation. (Column 1, Paragraph 2)
Claim 75 is rejected under 35 U.S.C. 103 as being unpatentable over Falk et al. (US 2017/0347917 A1) in view of Perez et al. (US 20160242675 A1), Prashant et al. (US 10987066 B2) & Roca et al. ‘American Journal of Respiratory and Critical Care Medicine, Volume 199, Number 11, Page 9, June 1 2019’ as claimed in claim 72, in view of Kramer, V. [Respiratory Rate – OXYGENATION (ROX) INDEX CORRELATION WITHHIGH-FLOW NASAL CANNULA OUTCOME IN COVID-19 RESPIRATORYFAILURE: A SINGLE CENTER EXPERIENCE]. Oct. 10 2022. [online]: RESPIRATORY RATE – OXYGENATION (ROX) INDEX CORRELATION WITH HIGH-FLOW NASAL CANNULA OUTCOME IN COVID-19 RESPIRATORY FAILURE: A SINGLE CENTER EXPERIENCE - PMC. (Retrieved on: June 8 2026).
Regarding claim 75, Modified Falk discloses the system as claimed in claim 72.
Modified Falk does not disclose wherein the ROX index is determined using the formula (SpO2/FiO2)/RR.
Kramer discloses wherein the ROX index is determined using the formula (SpO2/FiO2)/RR. (Page 1, last paragraph)
It would have been prima facie to one of ordinary skill in the art prior to the effective filing date to further modify Falk wherein the ROX index is determined using the formula (SpO2/FiO2)/RR as it is a known tool found to predict intubation in patients with AHRF. (Page 1, last paragraph)
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GRACIELA NATALIA LEBRON DE JESUS whose telephone number is (571)270-3892. The examiner can normally be reached Mon - Fri 8:00-5:00 CST.
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, Kendra Carter can be reached at 571-272-9034. 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.
/GRACIELA NATALIA LEBRON DE JESUS/Examiner, Art Unit 3785
/KENDRA D CARTER/Supervisory Patent Examiner, Art Unit 3785
Prosecution Insights