CTNF 18/714,272 CTNF 100498 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. Information Disclosure Statement One of the references, NPL #1 (Guigui), does not appear to be attached with the submission for consideration. The reference is lined-through accordingly on the IDS, as it was not considered. Claim Objections 07-29-01 AIA Claim 5 is objected to because of the following informalities: there appears to be a typographical error in line 4, with an extra “on a” in the term “on a beat-to-beat basis” . Appropriate correction is required. Drawings 06-36 AIA The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “smart cable” and “smart hub” must be shown or the feature(s) canceled from the claim(s). No new matter should be entered. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance. 07-30-03-h AIA Claim Interpretation 07-30-03 AIA The following is a quotation of 35 U.S.C. 112(f): (f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof. The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph: An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof. 07-30-05 The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked. As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph: (A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function; (B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and (C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function. Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function. Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function. Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Claim Limitations that do not use the word “means” This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “pressure sensor receptor” to receive an arterial blood pressure signal in claim 1 (and its dependent claims). The claim limitation is interpreted according to paragraph [0031] with “a pressure sensor receptor (e.g., a pressure cable) 114.” The “pressure sensor receptor” is shown as “pressure sensor receptor” 114 in Figure 1. “arterial blood pressure monitor” to determine and transmit in claim 1 (and its dependent claims). The claim limitation is interpreted according to [0031] as “…arterial blood pressure monitor 100 may include a pressure bag 102 (e.g., containing a pressurized saline solution), a flush tubing 104,stopcocks 106, catheter tubing (e.g., pressure tubing) 108, an intra-arterial cannula 110, a pressure sensor (e.g., a pressure transducer) 112, a pressure sensor receptor (e.g., a pressure cable) 114, and a pressure signal processing/display unit (monitor) 116.” The “arterial blood pressure monitor” is shown as “arterial blood pressure monitor” 100 in Fig. 1. “smart cable” to perform a method in Claim 12 The claim limitation is interpreted according to [0054] as “As used herein the term "smart cable" refers to a power cable and/or a communication cable that includes software, firmware, and/or hardware adapted to monitor and/or control one or more devices communicatively coupled to such a smart cable.” The “smart cable” is not clearly shown in a figure. “smart hub” to perform a method in Claim 12 The claim limitation is interpreted according to [0053] as “the term "smart hub" refers to software, firmware, and/or hardware adapted to monitor and/or control a plurality of Internet-of-Things (IoT) devices.” The “smart hub” is not clearly shown in a figure. “server” to perform a method in Claim 12 The claim limitation is interpreted according to [0035] with “the arterial blood pressure management system 300 may include a server computer or a plurality of server computers (e.g., interconnected to form a server cluster, cloud computing resource, the like, and/or combinations thereof). “ The “server” is not clearly shown in a figure. “therapeutic device” to perform a method in Claim 12 The claim limitation is interpreted according to [0045] as being configured to monitor the delivery of a therapy, or “the therapeutic device 320 may be a ventilator coupled to the arterial blood pressure monitor 302 as a closed-loop control system.“ The “therapeutic device” is shown as block element “therapeutic device 320” in Fig. 3. “medical management device” to perform a method in Claim 12 The claim limitation is interpreted according to [0046] as being configured to monitor medication delivery or “the medical management device 322 may be a vasoactive medication delivery pump coupled to the arterial blood pressure monitor 302 as a closed-loop control system.” The “medical management device” is shown as block element “medical management device 322” in Fig. 3. Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. Claim Rejections - 35 USC § 112 07-30-01 AIA 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. 07-31-05 Claim 14 is rejected under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, because the claim purports to invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, but fails to recite a combination of elements as required by that statutory provision and thus cannot rely on the specification to provide the structure, material or acts to support the claimed function. As such, the claim recites a function that has no limits and covers every conceivable means for achieving the stated function, while the specification discloses at most only those means known to the inventor. Accordingly, the disclosure is not commensurate with the scope of the claim. 07-30-02 AIA 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. 07-34-01 Claims 1 - 2, 5 – 8, and 11 – 15 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 1 recites the limitation “a pressure sensor receptor configured to receive an arterial blood pressure signal detected by a pressure sensor; and an arterial blood pressure monitor…configured to”. Based on the 112f interpretation above of “arterial blood pressure monitor” [0031] and Fig 1 of Applicant’s specification, such the “arterial blood pressure monitor” encompasses all of the structures of a pressure bag, a flush tubing, stopcocks, catheter tubing, an intra-arterial cannula, a pressure sensor, a pressure sensor receptor, and a pressure signal processing/display unit (monitor), it is unclear if the recited “pressure sensor receptor” of Claim 1 is intended to be the pressure sensor receptor that is a part of the ”arterial blood pressure monitor”, or if it is an additional, separate pressure sensor receptor. It is additionally unclear if the recited “pressure sensor” in Claim 1 is intended to be the pressure sensor that is a part of the “arterial blood pressure monitor”, or if it an additional, separate pressure sensor. For the purposes of examination, the term “a pressure sensor receptor configured to receive an arterial blood pressure signal detected by a pressure sensor” recited before the arterial blood pressure monitor and “an arterial blood pressure monitor…configured to” is deemed to claim “an arterial blood pressure monitor, including a pressure sensor receptor and a pressure sensor, wherein the pressure sensor receptor is configured to receive an arterial blood pressure signal detected by the pressure sensor, the arterial blood pressure monitor being configured to:” Claims 2, 5 – 8, and 11 – 12 are similarly rejected due to their dependence on Claim 1. Claim 2 recites the limitation "the patient’s arterial blood pressure signal" in lines 2 - 3. There is insufficient antecedent basis for this limitation in the claim. There is no previously-recited patient, nor is there an arterial blood pressure signal attribute to a patient. For the purposes of examination, the term "the patient’s arterial blood pressure signal" is deemed to claim “the arterial blood pressure signal”. Claim 5, 7 - 8, and 11 each recite the term “The method of claim 1”. It appears that the dependence for each of these claims was changed specifically to Claim 1 (or claim 5 in the case of Claim 6). The statutory category of these claims is unclear, as they recite method steps that depend from Claim 1, which is an apparatus. For the purposes of examination, the term “The method of claim 1” is deemed to claim “The arterial blood pressure management system of claim 1, the arterial blood pressure monitor further configured to:”, followed by the remaining claim limitations in the form of “perform…extract…determine…” (For Claim 5), etc. Claim 6 is similarly rejected due to its dependence on Claim 5. Claim 6 recites the term “The method of claim 5”. As described above, the statutory category of these claims is unclear, as they recite method steps that depend from Claim 1, which is an apparatus. For the purposes of examination, and in light of the 112b interpretation above for Claim 5, the term “The method of claim 5” is deemed to claim “The arterial blood pressure management system of claim 5, the arterial blood pressure monitor further configured to:”. Claim 6 recites the term “a beat-to-beat basis associated with each pulse” in lines 1 – 2. It is unclear if this is intended to be the same or different than the previously-recited “a beat-to-beat bases associated with each pulse” in Claim 5, from which this claim depends. For the purposes of examination, the term “a beat-to-beat basis associated with each pulse” is deemed to claim “the beat-to-beat basis associated with each pulse”. Claim 12 recites “The method of claim 1, wherein the method is performed via one or more of a server, a smart hub, a smart cable, an arterial blood pressure monitor, a therapeutic device, and a medical management device.” As claim 1 is not a method, but a system that is performed with a recited arterial blood pressure monitor, it is unclear what method is being performed by which of the Claim 12 elements. Claim 12 depends from Claim 1, which is a system (as described above), and is performed by an “arterial blood pressure monitor being configured to: determine…transmit…determine…determine…and determine.” It is unclear what each of the hardware pieces are intended to perform in Claim 1, as the “arterial blood pressure monitor”. It is also unclear if the server, smart hub, smart cable, therapeutic device, and medical management device are supposed to be parts of the already-recited arterial blood pressure monitor. For the purposes of examination, Claim 12 is interpreted to recite “The arterial blood pressure management system of claim 1, wherein the system includes one or more of”. Claim 12 recites “an arterial blood pressure monitor” in line 2. It is unclear if this is intended to be the same or different than the previously-recited arterial blood pressure monitor in Claim 1, from which this claim depends. For the purposes of examination, the term “an arterial blood pressure monitor” is deemed to claim “the arterial blood pressure monitor”. Claim 13 recites “implement the method according to claim 3”. Claim 3 is cancelled. It is unclear if this claim is intended to depend from a different claim or not. The metes and bounds of the claim cannot be ascertained. Claim 14 recites the term “An apparatus, comprising: means for performing the method according to claim 4”. The “4” of Claim 4 in the claim appears to be specifically left in the claim, but Claim 4 is cancelled. It is unclear to which claim this claim is intended to depend. Further, the term “means for performing the method” is interpreted according to 112f. However, it is unclear what the method of claim 4 is, so it is unknown what the metes and bounds are of what structure or equivalents are necessary to “perform the method”. A single element claim cannot rely on section 112(f) to incorporate the structure from the specification. Without the benefit of the section 112(f) construction, the BRI of this claim element extends to all ways of performing a method, those known and unknown to the inventor, and amounts to pure functional claiming without boundaries. Thus the scope of the claim is unclear and indefinite. The metes and bounds of this claim are unclear. Claim 15 recites the term “A method of an arterial blood pressure monitor”. It is unclear which statutory category the claim is intended to be, as “an arterial blood pressure monitor” is a system (apparatus), and “a method of” is a method. For the purposes of examination, the term “A method of an arterial blood pressure monitor” is deemed to claim “A method of monitoring arterial blood pressure”. 07-36 AIA The following is a quotation of 35 U.S.C. 112(d): (d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers. The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph: Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers. 07-36-01 AIA Claim s 12 – 14 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Based on the 112(b) rejections above, Claim 12 requires “ one or more of…an arterial blood pressure monitor”, such that the metes and bounds of the claim would be satisfied with only the arterial blood pressure monitor. Claim 12 is dependent on Claim 1, which already says that it uses a blood pressure monitor configured to perform its functions, so the claims are not further limited. Claims 13 and 14 do not further limit the claims from which they depend because they depend from cancelled claims 3 and 4, respectively . Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements. Claim Rejections - 35 USC § 101 07-04-01 AIA 07-04 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 – 2, 5 – 8, and 11 – 15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Claims 5 – 8 and 11 – 12 are 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, looking to the 112(b) rejection above, the claims each recite a “method of Claim 1” (or 5), but Claim 1 from which they depend is an apparatus “arterial blood pressure management system”. As a result, the claimed statutory category is unclear. The claims should be amended to recite “The arterial blood pressure system of Claim 1” (or Claim 5) as described above, with the remaining portions of the claims as “further configured to perform…” etc, as described above. The forthcoming 101 analysis regarding Claims 5 – 8 and 11 - 12 is provided assuming that the amendment to clarify the statutory category is made. Claim 13 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 a “machine readable storage”, which can be considered either software per se or signals per se, which are not one of the statutory categories of invention. The claim should be amended to recite “non-transitory computer readable medium”, and the forthcoming 101 analysis regarding Claim 13 is provided assuming that this amendment is made. Claim 15 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 a “A method of an arterial blood pressure monitor”. Looking to the 112(b) rejection above, the term is unclear regarding the statutory category, whether it is a method or an apparatus of an arterial blood pressure monitor. The claim should be amended to recite “A method of operating an arterial blood pressure monitor”, and the forthcoming 101 analysis regarding Claim 15 is provided assuming that this amendment is made. Regarding Claim 1, the claim recites an apparatus, which is one of the statutory categories of invention (Step 1). The claim is then analyzed to determine whether it is directed to any judicial exception (Step 2A, Prong 1). Regarding Claim 15, the claim recites "an act or step, or series of acts or steps" and is therefore a process, which is a statutory category of invention (Step 1). The claim is then analyzed to determine whether it is directed to any judicial exception (Step 2A, Prong 1). Each of Claims 1 – 2, 5 – 8, and 11 – 15 has been analyzed to determine whether it is directed to any judicial exceptions. Step 2A, Prong 1 Each of Claims 1 – 2, 5 – 8, and 11 – 15 recites at least one step or instruction for observations, evaluations, judgments, and opinions, which are grouped as a mental process under the 2019 PEG. The claimed invention involves making observations, evaluations, judgments, and opinions, which are concepts performed in the human mind under the 2019 PEG. Accordingly, each of Claims 1 – 2, 5 – 8, and 11 – 15 recites an abstract idea. Specifically, Claims 1 – 2, 5 – 8, and 11 – 15 recite ( underlined are observations, judgments, evaluations, or opinions, which are grouped as a mental process under the 2019 PEG) ( additional elements bolded, see Step 2A, prong 2); Claim 1 An arterial blood pressure management system, comprising: a pressure sensor receptor configured to receive an arterial blood pressure signal detected by a pressure sensor; and an arterial blood pressure monitor communicatively coupled to the pressure sensor receptor , the arterial blood pressure monitor being configured to: determine whether an arterial blood pressure signal damping event is occurring based on the arterial blood pressure signal, transmit an instruction to an electronically controllable valve to control the valve to automatically flush a catheter tubing in response to a determination that the arterial blood pressure signal damping event is occurring, determine whether the arterial blood pressure signal damping event is resolved in response to the automatic flush of the catheter tubing based on the arterial blood pressure signal, wherein the determination that the arterial blood pressure signal damping event is occurring is based on a first criterion and a determination that the arterial blood pressure signal damping event is resolved is based on a second criterion that is different than the first criterion, determine, with regard to the first criterion, whether the arterial blood pressure signal damping event is occurring based on a pattern change of the arterial blood pressure signal within a specified time window and beyond one or more specified threshold values, and determine, with regard to the second criterion, whether the arterial blood pressure signal occurring before a specified pre-flush time window compared to the arterial blood pressure signal occurring after a specified post-flush time window goes beyond one or more specified flush effectiveness threshold values, wherein the one or more specified flush effectiveness threshold values comprise a systolic arterial blood pressure threshold value, a pulse arterial blood pressure threshold value, and an arterial blood pressure waveform slope threshold value. Claim 15 A method of an arterial blood pressure monitor, the method comprising: determining whether an arterial blood pressure signal damping event is occurring based on an arterial blood pressure signal detected by a pressure sensor, transmitting an instruction to an electronically controllable valve to control the valve to automatically flush a catheter tubing in response to a determination that the arterial blood pressure signal damping event is occurring, determining whether the arterial blood pressure signal damping event is resolved in response to the automatic flush of the catheter tubing based on the arterial blood pressure signal, wherein the determination that the arterial blood pressure signal damping event is occurring is based on a first criterion and a determination that the arterial blood pressure signal damping event is resolved is based on a second criterion that is different than the first criterion, determining, with regard to the first criterion, whether the arterial blood pressure signal damping event is occurring based on a pattern change of the arterial blood pressure signal within a specified time window and beyond one or more specified threshold values, and determining, with regard to the second criterion, whether the arterial blood pressure signal occurring before a specified pre-flush time window compared to the arterial blood pressure signal occurring after a specified post-flush time window goes beyond one or more specified flush effectiveness threshold values, wherein the one or more specified flush effectiveness threshold values comprise a systolic arterial blood pressure threshold value, a pulse arterial blood pressure threshold value, and an arterial blood pressure waveform slope threshold value. (observation, judgment or evaluation, which is grouped as a mental process under the 2019 PEG); These underlined limitations describe a mathematical calculation and/or a mental process, as a skilled practitioner is capable of performing the recited limitations and making a mental assessment thereafter. Examiner notes that nothing from the claims suggests that the limitations cannot be practically performed by a human with the aid of a pen and paper, or by using a generic computer as a tool to perform mathematical calculations and/or mental process steps in real time. Examiner additionally notes that nothing from the claims suggests and undue level of complexity that the mathematical calculations and/or the mental process steps cannot be practically performed by a human with the aid of a pen and paper, or using a generic computer as a tool to perform mathematical calculations and/or mental process steps. For example, in Independent Claims 1 and 15, these limitations include: Observation and judgment whether an arterial blood pressure signal damping event is occurring based on the arterial blood pressure signal Observation and judgment to transmit an instruction to an electronically controllable valve to control the valve to automatically flush a catheter tubing in response to a determination that the arterial blood pressure signal damping event is occurring, Observation and judgment whether the arterial blood pressure signal damping event is resolved in response to the automatic flush of the catheter tubing based on the arterial blood pressure signal, wherein the Observation and judgment that the arterial blood pressure signal damping event is occurring is based on a first criterion Observation and judgment that the arterial blood pressure signal damping event is resolved is based on a second criterion that is different than the first criterion Observation and judgment with regard to the first criterion, whether the arterial blood pressure signal damping event is occurring based on a pattern change of the arterial blood pressure signal within a specified time window and beyond one or more specified threshold values Observation and judgment with regard to the second criterion, whether the arterial blood pressure signal occurring before a specified pre-flush time window compared to the arterial blood pressure signal occurring after a specified post-flush time window goes beyond one or more specified flush effectiveness threshold values, wherein the one or more specified flush effectiveness threshold values comprise a systolic arterial blood pressure threshold value, a pulse arterial blood pressure threshold value, and an arterial blood pressure waveform slope threshold value. all of which are grouped as mental processes under the 2019 PEG. Similarly, the dependent Claims include the following abstract limitations, in addition the aforementioned limitations in Independent Claims 1 and 15 (underlined observation, judgment or evaluation , which is grouped as a mental process under the 2019 PEG): extracting pulse features from the arterial blood pressure signal; Observation and judgment to extract pulse features from the arterial blood pressure signal; determining a signal quality on a on a beat-to-beat basis associated with each pulse. Observation and judgment of a signal quality on a on a beat-to-beat basis associated with each pulse. determining whether there is a continuous decrease from beat-to-beat in a systolic arterial blood pressure based on a first one of the one or more specified threshold values; Observation and judgment whether there is a continuous decrease from beat-to-beat in a systolic arterial blood pressure based on a first one of the one or more specified threshold values; determining whether there is a continuous decrease from beat-to-beat in a difference between the systolic arterial blood pressure and a diastolic arterial blood pressure based on a second one of the one or more specified threshold values; Observation and judgment whether there is a continuous decrease from beat-to-beat in a difference between the systolic arterial blood pressure and a diastolic arterial blood pressure based on a second one of the one or more specified threshold values; determining whether a mean arterial blood pressure is consistent over time based on a third one of the one or more specified threshold values; Observation and judgment whether a mean arterial blood pressure is consistent over time based on a third one of the one or more specified threshold values; determining whether the diastolic arterial blood pressure is consistent over time based on a fourth one of the one or more specified threshold values; and Observation and judgment whether the diastolic arterial blood pressure is consistent over time based on a fourth one of the one or more specified threshold values; determining whether a percentage of pulses with a signal quality beyond a signal quality threshold value within the specified time window is beyond a fifth one of the one or more specified threshold values. Observation and judgment whether a percentage of pulses with a signal quality beyond a signal quality threshold value within the specified time window is beyond a fifth one of the one or more specified threshold values. transferring a damping event notification to a user interface associated with a care provider in response to the determination that the arterial blood pressure signal damping event is occurring, wherein a blood pressure limit alarm is suppressed in response to the transfer of the damping event notification to the user interface. Observation and judgment to transfer a damping event notification to a user interface associated with a care provider in response to the Observation and judgment that the arterial blood pressure signal damping event is occurring, wherein a blood pressure limit alarm is suppressed in response to the transfer of the damping event notification to the user interface. transferring an unresolve flush notification to a user interface associated with a care provider in response to determining that the arterial blood pressure signal damping event is unresolved, wherein a blood pressure limit alarm is suppressed in response to the transfer of the unresolve flush notification to the user interface. Observation and judgment to transfer an unresolve flush notification to a user interface associated with a care provider in response to the Observation and judgment that the arterial blood pressure signal damping event is unresolved, wherein a blood pressure limit alarm is suppressed in response to the transfer of the unresolve flush notification to the user interface. all of which are grouped as mental processes under the 2019 PEG. Accordingly, as indicated above, each of the above-identified claims recite an abstract idea. Step 2A, Prong 2 The above-identified abstract ideas in each of Independent Claims 1 and 15 (and their respective Dependent Claims) are not integrated into a practical application under 2019 PEG because the additional elements (identified above in Independent Claims 1 and 15), either alone or in combination, generally link the use of the above-identified abstract ideas to a particular technological environment or field of use. More specifically, the additional elements of: “pressure sensor receptor” “arterial blood pressure monitor” “electronically controllable valve” “catheter tubing” “user interface” “server” “smart hub” “smart cable” “therapeutic device” “medical management device” “machine-readable storage” Additional elements recited include an “pressure sensor receptor”, “arterial blood pressure monitor”, “electronically controllable valve”, “catheter tubing”, “user interface”, “server”, “smart hub”, “smart cable”, “therapeutic device”, “medical management device”, “machine-readable storage” in the Independent Claims 1 and 15, their dependent claims . These component are recited at a high level of generality, , i.e., as a generic pressure sensor performing a generic function of detecting pressure. These generic hardware component limitations for “pressure sensor receptor”, “arterial blood pressure monitor”, “electronically controllable valve”, “catheter tubing”, “user interface”, “server”, “smart hub”, “smart cable”, “therapeutic device”, “medical management device”, “machine-readable storage” are no more than mere instructions to apply the exception using generic computer and hardware components. As such, these additional elements do not impose any meaningful limits on practicing the abstract idea. Further additional elements from Independent Claims 1 and 15 include pre-solution activity limitations, such as: a pressure sensor receptor configured to receive an arterial blood pressure signal detected by a pressure sensor; and an arterial blood pressure monitor communicatively coupled to the pressure sensor receptor In addition the aforementioned extra-solution activity limitations in Independent Claims 1 and 15, additional extra-solution activity limitations recited in the Dependent Claims include: performing pulse detection to generate the arterial blood pressure signal; further comprising the pressure sensor configured to sense the patient’s arterial blood pressure signal and the electronically controllable valve configured to automatically flush the catheter tubing. wherein the pulse features are extracted on a beat-to- beat basis associated with each pulse, and wherein the pulse features include one or more of: an inter- beat pulse interval, an instantaneous arterial blood pressure value, an averaged arterial blood pressure value an instantaneous maximum arterial blood pressure slope, and an averaged maximum arterial blood pressure slope. the method is performed via one or more of a server, a smart hub, a smart cable, an arterial blood pressure monitor, a therapeutic device, and a medical management device. These pre-solution measurement elements are insignificant extra-solution activity, setting up the parameters of the system, and serve as data-gathering for the subsequent steps . The “pressure sensor receptor”, “arterial blood pressure monitor”, “electronically controllable valve”, “catheter tubing”, “user interface”, “server”, “smart hub”, “smart cable”, “therapeutic device”, “medical management device”, “machine-readable storage” as recited in Independent Claims 1 and 15 and their dependent claims are generically recited computer and hardware elements which do not improve the functioning of a computer, or any other technology or technical field. Nor do these above-identified additional elements serve to apply the above-identified abstract idea with, or by use of, a particular machine, effect a transformation or apply or use the above-identified abstract idea in some other meaningful way beyond generally linking the use thereof to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception. Furthermore, the above-identified additional elements do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. For at least these reasons, the abstract ideas identified above in Independent Claims 1 and 15 (and their respective dependent claims) is not integrated into a practical application under 2019 PEG. Moreover, the above-identified abstract idea is not integrated into a practical application under 2019 PEG because the claimed method and system merely implements the above-identified abstract idea (e.g., mental process and certain method of organizing human activity) using rules (e.g., computer instructions) executed by a computer processor as claimed. In other words, these claims are merely directed to an abstract idea with additional generic computer elements which do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. Additionally, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. That is, like Affinity Labs of Tex. v. DirecTV, LLC, the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution. Thus, for these additional reasons, the abstract idea identified above in Independent Claims 1 and 15 (and their respective dependent claims) is not integrated into a practical application under the 2019 PEG. Accordingly, Independent Claims 1 and 15 (and their respective dependent claims) are each directed to an abstract idea under 2019 PEG. Step 2B – None of Claims 1 – 2, 5 – 8, and 11 – 15 include additional elements that are sufficient to amount to significantly more than the abstract idea for at least the following reasons. These claims require the additional elements of: “pressure sensor receptor”, “arterial blood pressure monitor”, “electronically controllable valve”, “catheter tubing”, “user interface”, “server”, “smart hub”, “smart cable”, “therapeutic device”, “medical management device”, “machine-readable storage” as recited in Independent Claims 1 and 15 and their dependent claims. The additional elements of the “pressure sensor receptor”, “arterial blood pressure monitor”, “electronically controllable valve”, “catheter tubing”, “user interface”, “server”, “smart hub”, “smart cable”, “therapeutic device”, “medical management device”, “machine-readable storage” Claims 1 – 2, 5 – 8, and 11 – 15, as discussed with respect to Step 2A Prong Two, amounts to no more than mere instructions to apply the exception using generic computer and hardware components. The same analysis applies here in 2B, i.e., mere instructions to apply an exception using a generic computer component cannot integrate a judicial exception into a practical application at Step 2A or provide an inventive concept in Step 2B. The above-identified additional elements are generically claimed computer components which enable the above-identified abstract idea(s) to be conducted by performing the basic functions of automating mental tasks. The courts have recognized such computer functions as well understood, routine, and conventional functions when claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity. See, Versata Dev. Group, Inc. v. SAP Am. , Inc. , 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); and OIP Techs. , 788 F.3d at 1363, 115 USPQ2d at 1092-93. Per Applicant’s specification, the “pressure sensor receptor” is described at [0031] with “a pressure sensor receptor (e.g., a pressure cable) 114.” The “pressure sensor receptor” is shown as “pressure sensor receptor” 114 in Figure 1. Per Applicant’s specification, the “arterial blood pressure monitor” is defined generically at [0031] as “…arterial blood pressure monitor 100 may include a pressure bag 102 (e.g., containing a pressurized saline solution), a flush tubing 104,stopcocks 106, catheter tubing (e.g., pressure tubing) 108, an intra-arterial cannula 110, a pressure sensor (e.g., a pressure transducer) 112, a pressure sensor receptor (e.g., a pressure cable) 114, and a pressure signal processing/display unit (monitor) 116.” The “arterial blood pressure monitor” is shown as “arterial blood pressure monitor” 100 in Fig. 1. Per Applicant’s specification, the “electronically controllable valve” is defined generically at [0040] as “an automated valve 106 (e.g., an electronically controllable valve, such as a computer controlled electric fluid value)”. It is shown as automated valve 106 in Fig. 1. Per Applicant’s specification, the “catheter tubing” is generically described on [0031] with “catheter tubing (e.g., pressure tubing) 108.” The “catheter tubing” is shown as catheter tubing 108 in Fig. 1. Per Applicant’s specification, the “user interface” is described generically on [0043] “a user interface 326 (e.g., one or more user interfaces 326 may be associated with a user), the like (e.g., a patient monitor) and/or combinations thereof. “ The “user interface” is shown as “user interface 326” block in Fig. 3. Per Applicant’s specification, the “server” is described generically on [0035] with “the arterial blood pressure management system 300 may include a server computer or a plurality of server computers (e.g., interconnected to form a server cluster, cloud computing resource, the like, and/or combinations thereof). “ The “server” is not clearly shown in a figure. Per Applicant’s specification, the “smart hub” is described generically at [0053] as “the term "smart hub" refers to software, firmware, and/or hardware adapted to monitor and/or control a plurality of Internet-of-Things (IoT) devices.” The “smart hub” is not clearly shown in a figure. Per Applicant’s specification, the “smart cable” is described at [0054] as “As used herein the term "smart cable" refers to a power cable and/or a communication cable that includes software, firmware, and/or hardware adapted to monitor and/or control one or more devices communicatively coupled to such a smart cable.” The “smart cable” is not clearly shown in a figure. Per Applicant’s specification, the “therapeutic device” is described at [0045] as being configured to monitor the delivery of a therapy, or “the therapeutic device 320 may be a ventilator coupled to the arterial blood pressure monitor 302 as a closed-loop control system.“ The “therapeutic device” is shown as block element “therapeutic device 320” in Fig. 3. Per Applicant’s specification, the “medical management device” is described at [0046as being configured to monitor medication delivery or “the medical management device 322 may be a vasoactive medication delivery pump coupled to the arterial blood pressure monitor 302 as a closed-loop control system.” The “medical management device” is shown as block element “medical management device 322” in Fig. 3. Per Applicant’s specification, the “machine-readable storage” is described at [00160] as “a machine- readable storage 802 that may also include logic 804…machine- readable storage 802 may be implemented as a non-transitory machine-readable storage…the logic 804 may be implemented as machine-readable instructions, such as software….” The “machine-readable storage” is shown as generic block element “machine-readable storage” 802 in Fig. 8. Accordingly, in light of Applicant’s specification, the claimed terms “pressure sensor receptor”, “arterial blood pressure monitor”, “electronically controllable valve”, “catheter tubing”, “user interface”, “server”, “smart hub”, “smart cable”, “therapeutic device”, “medical management device”, “machine-readable storage” are reasonably construed as a generic computing and hardware devices. Like SAP America vs Investpic, LLC (Federal Circuit 2018), it is clear, from the claims themselves and the specification, that these limitations require no improved computer resources, just already available computers, with their already available basic functions, to use as tools in executing the claimed process. Furthermore, Applicant’s specification does not describe any special programming or algorithms required for the “pressure sensor receptor”, “arterial blood pressure monitor”, “electronically controllable valve”, “catheter tubing”, “user interface”, “server”, “smart hub”, “smart cable”, “therapeutic device”, “medical management device”, “machine-readable storage”. This lack of disclosure is acceptable under 35 U.S.C. §112(a) since this hardware performs non-specialized functions known by those of ordinary skill in the computer arts. By omitting any specialized programming or algorithms, Applicant's specification essentially admits that this hardware is conventional and performs well understood, routine and conventional activities in the computer industry or arts. In other words, Applicant’s specification demonstrates the well-understood, routine, conventional nature of the above-identified additional elements because it describes these additional elements in a manner that indicates that the additional elements are sufficiently well-known that the specification does not need to describe the particulars of such additional elements to satisfy 35 U.S.C. § 112(a) (see Berkheimer memo from April 19, 2018, (III)(A)(1) on page 3). Adding hardware that performs “ ‘well understood, routine, conventional activit[ies]’ previously known to the industry” will not make claims patent-eligible ( TLI Communications ). The recitation of the above-identified additional limitations in Claims 1 – 2, 5 – 8, and 11 – 15 amounts to mere instructions to implement the abstract idea on a computer. Simply using a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) or simply adding a general-purpose computer or computer components after the fact to an abstract idea (e.g., a fundamental economic practice or mathematical equation) does not provide significantly more. See Affinity Labs v. DirecTV , 838 F.3d 1253, 1262, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016) (cellular telephone); and TLI Communications LLC v. AV Auto , LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (computer server and telephone unit). Moreover, implementing an abstract idea on a generic computer, does not add significantly more, similar to how the recitation of the computer in the claim in Alice amounted to mere instructions to apply the abstract idea of intermediated settlement on a generic computer. A claim that purports to improve computer capabilities or to improve an existing technology may provide significantly more. McRO, Inc. v. Bandai Namco Games Am. Inc. , 837 F.3d 1299, 1314-15, 120 USPQ2d 1091, 1101-02 (Fed. Cir. 2016); and Enfish, LLC v. Microsoft Corp. , 822 F.3d 1327, 1335-36, 118 USPQ2d 1684, 1688-89 (Fed. Cir. 2016). However, a technical explanation as to how to implement the invention should be present in the specification for any assertion that the invention improves upon conventional functioning of a computer, or upon conventional technology or technological processes. That is, the disclosure must provide sufficient details such that one of ordinary skill in the art would recognize the claimed invention as providing an improvement. Here, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. Instead, as in Affinity Labs of Tex. v. DirecTV, LLC 838 F.3d 1253, 1263-64, 120 USPQ2d 1201, 1207-08 (Fed. Cir. 2016) , the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution. For at least the above reasons, the apparatus and method of Claims 1 – 2, 5 – 8, and 11 – 15 are directed to applying an abstract idea as identified above on a general-purpose computer without (i) improving the performance of the computer itself, or (ii) providing a technical solution to a problem in a technical field. None of Claims 1 – 2, 5 – 8, and 11 – 15 provides meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that these claims amount to significantly more than the abstract idea itself. Claim Rejections - 35 USC § 103 07-06 AIA 15-10-15 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. 07-20-aia AIA 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. 07-23-aia AIA The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows: 1. Determining the scope and contents of the prior art. 2. Ascertaining the differences between the prior art and the claims at issue. 3. Resolving the level of ordinary skill in the pertinent art. 4. Considering objective evidence present in the application indicating obviousness or nonobviousness. 07-20-02-aia AIA This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention. 07-21-aia AIA Claims 1 - 2, 5 - 7, 12 and 15 are r ejected under 35 U.S.C. 103 as being unpatentable over R obinson et. al., (US 2011/0152642 A1) in view of Zong et. al. (“Reduction of false arterial blood pressure alarms using signal quality assessment and relationships between the electrocardiogram and arterial blood pressure”). R egarding Claims 1 and 15, Robinson discloses For Claim 1: An arterial blood pressure management system ([Abstract]; [0040] “standard blood pressure transducer in a standard clinical configuration”; Fig. 17; Fig. 7) , comprising: a pressure sensor receptor (lines in Figure 17 connected to “pressure sensor”) configured to receive an arterial blood pressure signal detected by a pressure sensor ([0040] “standard blood pressure transducer in a standard clinical configuration…waveform recordings…”; Fig. 17 “pressure sensor”; Fig. 7) ; and an arterial blood pressure monitor (Fig 7, “Automated Measurement System”; Fig 17) communicatively coupled to the pressure sensor receptor (Fig 7, “Monitor—continuously display your child’s blood pressure”, connected to the lines connected to “sensor”, “monitor”, and “bubble detector”; Fig 17) , the arterial blood pressure monitor (Fig 7, “Automated Measurement System”; Fig 17) being configured to: For Claim 15: A method of an arterial blood pressure monitor ([Abstract]; [0040] “standard blood pressure transducer in a standard clinical configuration”)(See 112b interpretation above) , the method comprising: For both Claims 1 and 15: determining whether an arterial blood pressure signal damping event is occurring ([0005] “…air bubble…increase the damping coefficient…”) based on an arterial blood pressure signal detected by a pressure sensor (Fig 3; [0017] “Gardner's wedge showing the relationship between damping and frequency.”; Fig 17, “Bubble Detector”; [0005] “ The presence of an air bubble adds undesirable compliance to the system…decrease the resonant frequency and increase the damping coefficient…damping increases…“; ([0040] “standard blood pressure transducer …waveform recordings…”; Fig. 7 “sensor”) ; transmitting an instruction to an electronically controllable valve (Fig 17; Pump system with “stopcock valve” and “one-way valves” outlet from “blood pump” and “flush pump” of “Pump system”; [0046]; [0049])(Examiner notes that the motion of the valves is broadly electronically controlled by the electronic control of the pumps during the automatic bubble clearing control actions.) to control the valve to automatically flush a catheter tubing in response to a determination that the arterial blood pressure signal damping event is occurring (Fig 17; [0049] “If a bubble is detected…blood pump can push fluid toward the patient while the flush pump pulls fluid away from the patient…moving a bubble located between the pumps and the T-junction to a waste channel…”; [0005] “presence of an air bubble…damping”; [0046] “the system can automatically clear the bubble.”) , determining whether the arterial blood pressure signal damping event is resolved in response to the automatic flush of the catheter tubing based on the arterial blood pressure signal ([0049] “After an appropriate volume has been pumped…conduct a waveform comparison…”; [0005]; Fig. 17) , wherein the determination that the arterial blood pressure signal damping event is occurring is based on a first criterion ([0046] “…power spectral density (PSD)…Changes in heart rate will cause changes in the lower frequencies where a bubble will introduce additional frequencies in the 10 Hz range…more power in the range between 10 and 30 Hz…increase of this nature can be indicative of a bubble…”; [0005] “…air bubble…increase the damping coefficient…”; [0007])(Examiner notes that this first criterion is the evaluation before a bubble has already been detected once.) and a determination that the arterial blood pressure signal damping event is resolved is based on a second criterion that is different than the first criterion ([0049] “After an appropriate volume has been pumped…conduct a waveform comparison…”; [0005]; Fig. 17; [0049] “If there is still evidence of a bubble then the likely location of the bubble is in the tubing between the bubble detector and the T-junction…”; [0007])(Examiner notes that the second criterion is the evaluation of bubbles after a flush has already been made. It differs from the first criterion it is the dual condition of whether a pump has already occurred and if there is a bubble currently present. If a bubble is found again in the condition that a flush has already been performed, the evaluation can trigger a different pumping action to occur or a clinician resolution of the situation can be initiated.) , determining, with regard to the first criterion ([0046] “…power spectral density (PSD)… a bubble will introduce additional frequencies in the 10 Hz range…more power in the range between 10 and 30 Hz…increase of this nature can be indicative of a bubble…”; [0007])(Examiner notes that this first criterion is the evaluation before a bubble has already been detected once.) , whether the arterial blood pressure signal damping event is occurring based on a pattern change of the arterial blood pressure signal ([0046] “…power spectral density (PSD)…Changes in heart rate will cause changes in the lower frequencies where a bubble will introduce additional frequencies in the 10 Hz range…more power in the range between 10 and 30 Hz…increase of this nature can be indicative of a bubble…”; [0005] “ The presence of an air bubble…damping increases…“)(Examiner notes that this is a change in the PSD pattern that expects 1- 2 Hz heart rate frequency outputs without bubbles.) within a specified time window ([0046] “a limited time of several minutes will comprise changes of less than 10 beats/minute…”) and beyond one or more specified threshold values ([0046] “a bubble will introduce additional frequencies in the 10 Hz range.”) , and determining, with regard to the second criterion ([0049] “…if there is still evidence of a bubble…”; “After an appropriate volume has been pumped the system can conduct a waveform comparison…”; [0007])(See Examiner notes above about the second criterion) whether the arterial blood pressure signal occurring before a specified pre-flush time window (Fig 16, ‘baseline arterial waveform”; [0042] “waveform with a 20 µL bubble…comparison”; [0048] “baseline arterial waveform…procure a second waveform and compare…indicates likelihood of bubble…system can automatically manage the bubble…”) compared to the arterial blood pressure signal occurring after a specified post-flush time window (Fig 16, “post-measurement arterial waveform obtained”, “Repeat process”; [0049] “After an appropriate volume has been pumped the system can conduct a waveform comparison like those described elsewhere herein.”; [0048] “baseline arterial waveform data…used for future comparisons…”, “baselines arterial waveform…second waveform and compare…”; [0049] “If there is still evidence of a bubble…To remove this bubble, the system can withdraw fluid…”) goes beyond one or more specified flush effectiveness threshold values (([0049] “After an appropriate volume has been pumped…conduct a waveform comparison…”; [0049] “evidence of a bubble…”; [0046] “frequencies in the 10 Hz range…”; [0049] “if there is still evidence of a bubble…”)(Examiner notes that the flush effectiveness is found if there is no longer value evidence of a bubble.) , where in the one or more specified flush effectiveness threshold values ([0049] “After an appropriate volume has been pumped… a waveform comparison…evidence of a bubble”)(Examiner notes that effectiveness is based on the comparative values associated with the presence of a bubble”); comprise a systolic arterial blood pressure threshold value ([0040] “a 5 mm Hg measurement error for the 10 μL bubble in the systolic pressure readings.”; [0007] “air…underestimation of systolic blood pressure”; Figs 8 and 9; [0042] “a simple threshold comparison…to detect the potential presence of a bubble.”) . Robinson does not specifically disclose a pulse arterial blood pressure threshold value, and an arterial blood pressure waveform slope threshold value. Robinson does disclose at least one of the specified flush effectiveness values, a systolic arterial blood pressure threshold value, as described above. For additional flush effectiveness values, Zong teaches reduction of false arterial blood pressure alarms using signal quality assessment to determining if a blood pressure signal is corrupted by artifacts, including using blood pressure measurement thresholds such as arterial blood pressure waveform slope and pulse arterial blood pressure. Specifically for Claims 1 and 15, Zong teaches a pulse arterial blood pressure threshold value ([“2.3.2. ABP waveform feature extraction:” Section] “maximum duration above threshold (MDAT) (which was the maximum duration that the ABP signal stayed above a threshold)…pulse blood pressure (PBP)”; Fig 4, Assessment of ABP signal quality using ABP itself”) , and an arterial blood pressure waveform slope threshold value ( “2.3.1. ABP Pulse detection algorithm” Section] “regional slope feature of the low-pass filtered ABP signal…slope sum function (SSF)”, “adaptive thresholding of the SSF signal to detect SSF pulses of appropriate amplitude...pulse accepted”) . Zong provides a motivation to combine at [Page 2, Right Column, 1 st Full Paragraph] with “if the ABP signal was corrupted by artifacts (as identified by human experts) resulting from events such as catheter flush, patient movement or a clot-blocked transducer, the alarm was annotated as a false alarm…” and [“5 Conclusions” Section] “Sometimes, artifacts appear similar to real physiological changes; thus additional information from other related signals is crucial.” A person having ordinary skill in the art before the effective filing date of the claimed invention would recognize that applying motion artifact-removing signal processing techniques to ensure a clean signal following turbulent activities like catheter flushing (such as activating pumps to remove a bubble as in Robinson) would be useful to evaluate if the remaining blood pressure signal is biofidelic, or if signal damping events like bubbles are still present. Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the invasive blood pressure measurement system with bubble detection from arterial blood pressure signals disclosed in Robinson with signal processing techniques of pulse arterial blood pressure and arterial blood pressure waveform slope thresholds that indicate a stable measurement taught by Zong, creating a single invasive blood pressure measurement device that can detect a bubble-related arterial blood pressure signal damping event in the system, pump the lines to remove bubbles, and re-evaluate the signal for bubbles with processing to determine that a motion-related signal is obtained, leading to more accurate blood pressure measurements. Regarding Claim 2, Robinson in view of Zong discloses as described above, The arterial blood pressure management system of claim 1. For the remainder of Claim 2, Robinson discloses further comprising the pressure sensor configured to sense the patient’s arterial blood pressure signal ([0040] “standard blood pressure transducer in a standard clinical configuration…waveform recordings…”; Fig. 7 “sensor”) ; and the electronically controllable valve configured to automatically flush the catheter tubing (Fig 17 “flush pump” in Pump System” and one-way valve/stopcock valve; [0049] “…automated blood analyte measurement system…the system has the ability to move the bubble…flush pump…operating the pumps…”) . Regarding Claim 5, Robinson in view of Zong discloses as described above, The method of claim 1. For the remainder of Claim 5, Robinson discloses performing pulse detection to generate the arterial blood pressure signal ([0046] “the heart rate will appear as a frequency in the 1 to 2 hertz range.”; Figs 8 and 9; Fig 15; [0040] " A standard blood pressure transducer in a standard clinical configuration…waveform recordings”) ; extracting pulse features from the arterial blood pressure signal ( ([0046] “the heart rate will appear as a frequency in the 1 to 2 hertz range.”; [0040] “a 5 mm Hg measurement error for the 10 μL bubble in the systolic pressure readings.”; [0007] “air…underestimation of systolic blood pressure”; Figs 8 and 9; [0042] “a simple threshold comparison…to detect the potential presence of a bubble.”; [0046] “PSD”) ; and determining a signal quality on a beat-to-beat basis associated with each pulse [0040] “a 5 mm Hg measurement error for the 10 μL bubble in the systolic pressure readings.”; [0007] “air…underestimation of systolic blood pressure”; Figs 8 and 9; [0042] “a simple threshold comparison…to detect the potential presence of a bubble.”;)(Examiner notes that this discrepancy is shown on a beat in Figure 9 and is disclosed to demonstrate that there is a bubble in the system, indicating a blood pressure signal quality that is erroneously low, not accurate to the patient’s actual blood pressure.) ;. Regarding Claim 6, Robinson in view of Zong discloses as described above, The method of claim 5. For the remainder of Claim 6, Robinson discloses wherein the pulse features are extracted on a beat-to- beat basis associated with each pulse ([0046] “the heart rate will appear as a frequency in the 1 to 2 hertz range.”; Figs 8 and 9)( Examiner notes that this discrepancy is shown on a beat feature of the pressure value relative to time in Figure 9 and is disclosed to demonstrate that there is a bubble in the system.) ;. and wherein the pulse features include one or more of: an inter- beat pulse interval, an instantaneous arterial blood pressure value (Figs 8 and 9, pressure per time; [0040] “a 5 mm Hg measurement error for the 10 μL bubble in the systolic pressure readings.”; [0007] “air…underestimation of systolic blood pressure”; [0046] “the heart rate will appear as a frequency in the 1 to 2 hertz range.”)(Examiner notes that the instantaneous pressure at a given time is shown on the graph in Figure 9.) , an averaged arterial blood pressure value, an instantaneous maximum arterial blood pressure slope, and an averaged maximum arterial blood pressure slope. Regarding Claim 7, Robinson in view of Zong discloses as described above, The method of claim 1. For the remainder of Claim 7, Robinson discloses wherein determination of whether the arterial blood pressure signal damping event is occurring (See citation above in Claim 1) is further based on one or more of: determining whether there is a continuous decrease from beat-to-beat (Figs 8 and 9)(Examiner notes that the data are obtained as continuous data, and there is an evident bubble-related decrease described in this continuous data.) in a systolic arterial blood pressure based on a first one of the one or more specified threshold values ([0040] “a 5 mm Hg measurement error for the 10 μL bubble in the systolic pressure readings.”; [0007] “air…underestimation of systolic blood pressure”; Figs 8 and 9; [0042] “a simple threshold comparison…to detect the potential presence of a bubble.”) determining whether there is a continuous decrease from beat-to-beat in a difference between the systolic arterial blood pressure and a diastolic arterial blood pressure based on a second one of the one or more specified threshold values; determining whether a mean arterial blood pressure is consistent over time based on a third one of the one or more specified threshold values; determining whether the diastolic arterial blood pressure is consistent over time based on a fourth one of the one or more specified threshold values; and determining whether a percentage of pulses with a signal quality beyond a signal quality threshold value within the specified time window is beyond a fifth one of the one or more specified threshold values Regarding Claim 12, Robinson in view of Zong discloses as described above, The method of claim 1 (See citation in Claim 1 above) . For the remainder of Claim 12, Robinson discloses wherein the method is performed via one or more of a server, a smart hub, a smart cable, an arterial blood pressure monitor ([Abstract]; [0040] “standard blood pressure transducer in a standard clinical configuration”; Fig. 17) , a therapeutic device, and a medical management device . 07-21-aia AIA Claim s 8 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Robinson et. al., (US 2011/0152642 A1) in view of Zong et. al. (“Reduction of false arterial blood pressure alarms using signal quality assessment and relationships between the electrocardiogram and arterial blood pressure”), further in view of Kurscheidt et. al. (United States Patent US 5,343,868) . Regarding Claim 8, Robinson in view of Zong discloses as described above, The method of claim 1. For the remainder of Claim 8, Robinson discloses further comprising: transferring a damping event notification to a user interface ([0051] “display system…provide waveform information to the…display”; Fig 16) associated with a care provider ([0036] “…nurse or clinician…examine the arterial waveform for artifacts…”) in response to the determination that the arterial blood pressure signal damping event is occurring ([0049] “If such a test continued to indicate evidence of a bubble then the process can be repeated or an alarm initiated such that clinician resolution of the situation was initiated.”; Fig 16), wherein a blood pressure limit alarm ([0049] “…alarm”) Robinson does not specifically disclose is suppressed in response to the transfer of the damping event notification to the user interface. Kurscheidt teaches a method of detecting artifacts in a blood pressure measuring system, including flushing an invasive blood pressure measuring system, that disables related alarms if there are artifact-related false-positives in the blood pressure signal. Specifically for Claim 8, Kurscheidt teaches wherein a blood pressure limit alarm is suppressed ([Col 5, Lines 54 – 57] “…artifact indication is used to suppress or disable an alarm, such that the above described problem of false-positive alarms is reduced or eliminated…”; [Col 9, Lines 6 – 10] “wherein said artificial artifact indicating signal is fed to said alarm generating means causing the alarm generating means to suppress alarms as long as said artificial artifact indicating signal is in its active state.”) in response to the transfer of the damping event ([Col 2, Lines 37 – 44] “…over-or underdamped tubing system, catheter flushing, etc…”) notification to the user interface ([Col 6, Lines 31 – 34] “successful in the detection of artifacts caused by sampling or catheter flushing in an invasive blood pressure measuring system.”; [Col 15, Lines 55 – 66] “… front end channels or modules 78a to 78c are connected with an interface 79…front end devices…blood pressure channel…78b…communicate via interface 79, with a CPU…”; Fig. 7) . Kurscheidt provides a motivation to combine at [Col 5, Lines 54 - 57] with “Advantageously, the artifact indication is used to suppress or disable an alarm, such that the above described problem of false-positive alarms is reduced or eliminated,” and [Col 6, Lines 38 – 42] “...clinical reliability is one of the most important advantages...” A person having ordinary skill in the art before the effective filing date of the claimed invention would recognize that using suppressing blood pressure alarms that would be triggered by non-blood pressure-related signal characteristics, like flushes (or bubbles) would be useful for eliminating false-positives, increasing clinical reliability of the blood pressure data from the device. Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the invasive blood pressure measurement system with an alarm notification triggered by bubble detection from arterial blood pressure signals disclosed in Robinson with Kurscheidt’s taught blood pressure alert alarm suppression upon detection of artifacts (from flushing, movement, etc) the invasive blood pressure measurement system, creating a single invasive blood pressure measurement device that can suppress blood pressure alert alarms when an erroneous blood pressure signal is detected and attributed to artifact effects (as with flushing, bubbles, etc), increasing clinical reliability of the device. Regarding Claim 11, Robinson in view of Zong discloses as described above, The method of claim 1. For the remainder of Claim 11, Robinson discloses further comprising: transferring an unresolve flush notification to a user interface ([0051] “display system…provide waveform information to the…display”; Fig 16; [0049] “if there is still evidence of a bubble…”) associated with a care provider ([0036] “…nurse or clinician…examine the arterial waveform for artifacts…”) in response to determining that the arterial blood pressure signal damping event is unresolved ([0049] “If such a test continued to indicate evidence of a bubble then the process can be repeated or an alarm initiated such that clinician resolution of the situation was initiated.”; Fig. 16), wherein a blood pressure limit alarm ([0049] “…alarm”) Robinson does not specifically disclose is suppressed in response to the transfer of the unresolve flush notification to the user interface. Kurscheidt teaches wherein a blood pressure limit alarm is suppressed ([Col 5, Lines 54 – 57] “…artifact indication is used to suppress or disable an alarm, such that the above described problem of false-positive alarms is reduced or eliminated…”; [Col 9, Lines 6 – 10] “wherein said artificial artifact indicating signal is fed to said alarm generating means causing the alarm generating means to suppress alarms as long as said artificial artifact indicating signal is in its active state.”) in response to the transfer of the unresolve flush ([Col 2, Lines 37 – 44] “…catheter flushing etc.”) notification to the user interface ([Col 6, Lines 31 – 34] “successful in the detection of artifacts caused by sampling or catheter flushing in an invasive blood pressure measuring system.”; [Col 15, Lines 55 – 66] “… front end channels or modules 78a to 78c are connected with an interface 79…front end devices…blood pressure channel…78b…communicate via interface 79, with a CPU…”; Fig. 7) . The motivation for Claim 11 to combine Robinson and Kurscheidt is the same as that described in more detail above in Claim 8. In summary, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the invasive blood pressure measurement system with an alarm notification triggered by bubble detection from arterial blood pressure signals disclosed in Robinson with Kurscheidt’s taught blood pressure alert alarm suppression upon detection of artifacts (from flushing, movement, etc) the invasive blood pressure measurement system, creating a single invasive blood pressure measurement device that can suppress blood pressure alert alarms when an erroneous blood pressure signal is detected and attributed to artifact effects (as with flushing, bubbles, etc), increasing clinical reliability of the device. Conclusion In light of the current 112(b) rejections, no prior art rejection is currently able to be applied to Claims 13 and 14. Any inquiry concerning this communication or earlier communications from the examiner should be directed to MELISSA J MONTGOMERY whose telephone number is (571)272-2305. The examiner can normally be reached Monday - Friday 7:30 - 5:00 ET. 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, Alexander Valvis can be reached at (571) 272 - 4233. 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. /MELISSA JO MONTGOMERY/Examiner, Art Unit 3791 /PATRICK FERNANDES/Primary Examiner, Art Unit 3791 Application/Control Number: 18/714,272 Page 2 Art Unit: 3791 Application/Control Number: 18/714,272 Page 3 Art Unit: 3791 Application/Control Number: 18/714,272 Page 4 Art Unit: 3791 Application/Control Number: 18/714,272 Page 5 Art Unit: 3791 Application/Control Number: 18/714,272 Page 6 Art Unit: 3791 Application/Control Number: 18/714,272 Page 7 Art Unit: 3791 Application/Control Number: 18/714,272 Page 8 Art Unit: 3791 Application/Control Number: 18/714,272 Page 9 Art Unit: 3791 Application/Control Number: 18/714,272 Page 10 Art Unit: 3791 Application/Control Number: 18/714,272 Page 11 Art Unit: 3791 Application/Control Number: 18/714,272 Page 12 Art Unit: 3791 Application/Control Number: 18/714,272 Page 13 Art Unit: 3791 Application/Control Number: 18/714,272 Page 14 Art Unit: 3791 Application/Control Number: 18/714,272 Page 15 Art Unit: 3791 Application/Control Number: 18/714,272 Page 16 Art Unit: 3791 Application/Control Number: 18/714,272 Page 17 Art Unit: 3791 Application/Control Number: 18/714,272 Page 18 Art Unit: 3791 Application/Control Number: 18/714,272 Page 19 Art Unit: 3791 Application/Control Number: 18/714,272 Page 20 Art Unit: 3791 Application/Control Number: 18/714,272 Page 21 Art Unit: 3791 Application/Control Number: 18/714,272 Page 22 Art Unit: 3791 Application/Control Number: 18/714,272 Page 23 Art Unit: 3791 Application/Control Number: 18/714,272 Page 24 Art Unit: 3791 Application/Control Number: 18/714,272 Page 25 Art Unit: 3791 Application/Control Number: 18/714,272 Page 26 Art Unit: 3791 Application/Control Number: 18/714,272 Page 27 Art Unit: 3791 Application/Control Number: 18/714,272 Page 28 Art Unit: 3791 Application/Control Number: 18/714,272 Page 29 Art Unit: 3791 Application/Control Number: 18/714,272 Page 30 Art Unit: 3791 Application/Control Number: 18/714,272 Page 31 Art Unit: 3791 Application/Control Number: 18/714,272 Page 32 Art Unit: 3791 Application/Control Number: 18/714,272 Page 33 Art Unit: 3791 Application/Control Number: 18/714,272 Page 34 Art Unit: 3791 Application/Control Number: 18/714,272 Page 35 Art Unit: 3791 Application/Control Number: 18/714,272 Page 36 Art Unit: 3791 Application/Control Number: 18/714,272 Page 37 Art Unit: 3791 Application/Control Number: 18/714,272 Page 38 Art Unit: 3791 Application/Control Number: 18/714,272 Page 39 Art Unit: 3791 Application/Control Number: 18/714,272 Page 40 Art Unit: 3791
