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 .
Claims 1-26 are hereby under examination.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-11 and 13-26 are rejected under 35 U.S.C. 101 because the claimed invention is directed to abstract idea without significantly more.
Step 1 of the subject matter eligibility test (see MPEP 2106.03).
Claims 1-23 are directed to a “method”, which describes one of the four statutory categories of patentable subject matter, i.e., a process. Claims 24-26 are directed to a “device”, which describes one of the four statutory categories of patentable subject matter, i.e., a machine.
Step 2A of the subject matter eligibility test (see MPEP 2106.04)
Prong one: Claims 1-11 and 13-26 recite abstract idea, as follows:
(claim 1) “…generating a target mean arterial pressure (MAP) for a patient during a surgery, comprising: calculating the target MAP based on the age, biological sex, emergent surgery status, American Society of Anesthesiology (ASA) physical status (PS) class of the patient, and a predetermined intraoperative hypotension (IOH) risk benchmark for the surgery; and wherein: the target MAP is a MAP falling within the range of from 66 to 100 mmHg; and treating the patient to maintain a MAP at or above the target MAP during the surgery reduces a risk of IOH during the surgery, a risk of administering an unnecessary therapy to avoid IOH during the surgery, and a risk of not administering a therapeutic MAP-decreasing action during the surgery.”
Based on the broadest reasonable interpretation, generating a target MAP and calculating the target MAP based on the age, biological sex, emergent surgery status, American Society of Anesthesiology (ASA) physical status (PS) class of the patient, and a predetermined intraoperative hypotension (IOH) risk benchmark for the surgery can be done mentally with the aid of a pen and paper. A person can receive information about the patient’s age, biological sex, emergent surgery status, American Society of Anesthesiology (ASA) physical status (PS) class of the patient, and a predetermined intraoperative hypotension (IOH) risk benchmark for the surgery on a piece of paper in a table. Then the person calculate the target MAP using mathematical algorithms.
Prong two: Claims 1-11 and 13-26 do not include additional elements that integrate the abstract into a practical application.
The additional elements are as follows:
A computer, a hardware processor, system memory, computer-readable media (claims 23-26)
Hemodynamic sensor (claim 24)
Sensory alarm (claim 24)
Reciting a computer or computer components (computer, a hardware processor, system memory, computer-readable media) simply amounts to reciting a general processor to perform general functions of a computer as above to perform the mental processes of generating a target MAP and calculating the target MAP based on the age, biological sex, emergent surgery status, American Society of Anesthesiology (ASA) physical status (PS) class of the patient, and a predetermined intraoperative hypotension (IOH) risk benchmark for the surgery can be done mentally with the aid of a pen and paper are mere instructions to apply the judicial exception to general technology. Such elements do not integrate the exception into a practical application since they are merely instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea - see MPEP 2106.04(d) and MPEP 2106.05(f).
Reciting the interface sensory alarm do not integrate the exception into a practical application since it is merely insignificant extra-solution activity to the judicial exception, e.g., simply outputting the results of the algorithm in a high-level implementation.
Reciting hemodynamic sensor do not integrate the exception into a practical application since it is merely insignificant extra-solution activity to the judicial exception, e.g., mere data gathering at a higher level of generality.
Therefore, claims 1-11 and 13-26 are ineligible at step 2A, prong two.
Step 2B of the subject matter eligibility test (see MPEP 2106.05)
Reciting a computer or computer components (computer, a hardware processor, system memory, computer-readable media) simply amounts to reciting a general processor to perform general functions of a computer as above to perform the mental processes of generating a target MAP and calculating the target MAP based on the age, biological sex, emergent surgery status, American Society of Anesthesiology (ASA) physical status (PS) class of the patient, and a predetermined intraoperative hypotension (IOH) risk benchmark for the surgery can be done mentally with the aid of a pen and paper are mere instructions to apply the judicial exception to general technology.
Such elements do not qualify as significantly more because this limitation is simply appending well-understood, routine and conventional activities previously known in the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’l, 110 USPQ2d 1976 (2014)) and/or a claim to an abstract idea requiring no more than being stored on a computer readable medium which is a well-understood, routine and conventional activity previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’l, 110 USPQ2d 1976 (2014); SAP Am. v. InvestPic, 890 F.3d 1016 (Fed. Circ. 2018)).
Reciting the interface sensory alarm do not integrate the exception into a practical application since it is merely insignificant extra-solution activity to the judicial exception, e.g., simply outputting the results of the algorithm in a high-level implementation.
U.S. Patent Application Publication No. US 20210386382 A1 discloses that the interface sensory alarm are conventional: “[0070] Regarding the conventional sensitive alarm settings”
Reciting hemodynamic sensor do not integrate the exception into a practical application since it is merely insignificant extra-solution activity to the judicial exception, e.g., mere data gathering at a higher level of generality.
U.S. Patent Application Publication No. US 20060241357 A1 discloses that hemodynamic sensor are conventional: “[0017] conventional hemodynamic sensors”
In view of the above, the additional elements individually do not integrate the exception into a practical application and do not amount to significantly more than the above-judicial exception (the abstract idea). Looking at the limitations as an ordered combination (that is, as a whole) adds nothing that is not already present when looking at the elements taking individually. There is no indication that the combination of elements improves the functioning of a computer, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements includes a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome. Rather, the collective functions of the claimed invention merely provide conventional computer implementation, i.e., the computer is simply a tool to perform the process.
Therefore, claims 1-11 and 13-26 are ineligible at step 2B.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-5, 7-8, 12-22, and 26 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WESSELINK et al., "Intraoperative hypotension and the risk of postoperative outcomes: a systematic review," Br J Anaesth. 121.4: 706-721, 2018, cited by Applicant and hereto referred as Wesselink.
As to claims 1, 13-18 and 26, Wesselink teaches a method of generating a target mean arterial pressure (MAP) for a patient during a surgery, comprising: calculating the target MAP based on the age, biological sex, emergent surgery status, American Society of Anesthesiology (ASA) physical status (PS) class of the patient, and a predetermined intraoperative hypotension (IOH) risk benchmark for the surgery (Wesselink, table 2, showing associations of age, sex, etc., and MAP; table 3, calculating correlations of MAP and postoperative adverse outcomes);
and wherein: the target MAP is a MAP falling within the range of from 66 to 100 mmHg (Wesselink, pg. 719, "a target MAP of 80–95 mm Hg");
and treating the patient to maintain a MAP at or above the target MAP during the surgery reduces a risk of IOH during the surgery, a risk of administering an unnecessary therapy to avoid IOH during the surgery, and a risk of not administering a therapeutic MAP-decreasing action during the surgery (Wesselink, pg. 719, "Vasopressor therapy and a fluid management protocol based on stroke volume variation were used to adjust MAP."; the examiner notes, reduces a risk of IOH during the surgery, a risk of administering an unnecessary therapy to avoid IOH during the surgery, and a risk of not administering a therapeutic MAP-decreasing action during the surgery is intended use and does not have patentable weight).
As to claims 13-18, the claims recite intended use of rest of claim 1, and is merely describing the effects of the steps recited in claim 1. See MPEP 2111.02 (II).
As to claim 2, Wesselink teaches the IOH comprises a MAP of 65 mmHg or less (Wesselink, pg. 718, "Increased durations for MAP <65-60 mm Hg or for any exposure <55-50 mm Hg were associated with moderately or highly elevated risks.").
As to claim 3, Wesselink teaches the IOH comprises a systolic blood pression of 100 mmHg or less, and/or a decrease in blood pressure of at least 20% during surgery compared to preoperative blood pressure in the patient (Wesselink, pg. 708, “For example, Monk and colleagues reported a relative risk (RR) of 1.036 per min that SBP was <80 mm Hg”).
As to claim 4, Wesselink teaches the target MAP is a MAP falling within the range of from 65 to 100 mmHg (Wesselink, pg. 719, "a target MAP of 80-95 mm Hg").
As to claim 5, Wesselink teaches the target MAP is a MAP falling within the range of from 69 to 90 mmHg (Wesselink, pg. 719, "a target MAP of 80-95 mm Hg").
As to claim 7, Wesselink teaches the surgery comprises MAP-modulating action comprising a therapy that increases or decreases MAP in the patient (Wesselink, pg. 719, "Vasopressor therapy and a fluid management protocol based on stroke volume variation were used to adjust MAP.").
As to claim 8, Wesselink teaches treating the patient to maintain the MAP of the patient at or above the target MAP during the surgery comprises administering or increasing a MAP-increasing therapy and/or reducing a MAP-decreasing therapy in an amount effective to maintain the MAP of the patient at or above the target MAP (Wesselink, pg. 719, "Vasopressor therapy and a fluid management protocol based on stroke volume variation were used to adjust MAP.").
As to claim 12, Wesselink teaches conducting the surgery on the patient and treating the patient to maintain the MAP of the patient at or above the target MAP during the surgery (Wesselink, pg. 719, "This study showed that achieving a systolic blood pressure within 10% of the reference value by using continuous vasopressor infusion may prevent postoperative organ dysfunction")
As to claims 19-20, Wesselink teaches the target MAP is calculated according to the patient status and target MAP ranges (Wesselink, table 2; pg. 719, "This study showed that a target MAP of 80–95 mm Hg, compared with lower (65–79 mm Hg) and higher targets (96–110 mm Hg) can decrease the incidence of AKI.”) Wesselink does not necessarily teach that the target MAP is calculated according to the patient status and target MAP ranges in the table included in claim 19 and in claim 20. However, It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Wesselink to include that the target MAP is calculated according to the patient status and target MAP ranges in the table included in claim 19 and in claim 20 because Wesselink already teaches a method of calculating the target MAP based on patient characteristics, and it would be obvious to try the different combinations of emergent surgery, ASA PS class, sex, age, and target MAP that would result in least postoperative damage since the range of these variable is limited to the levels pertinent to human body.
As to claim 21, Wesselink teaches the surgery comprises ear-nose-throat surgery, trauma surgery, urological surgery, neurosurgery, orthopedic surgery, vascular surgery, thoracic surgery, pediatric surgery, cardiac surgery, OB- GYN surgery, ophthalmologic surgery, transplant surgery, general surgery, plastic surgery, colon and rectal surgery, gynecologic oncology surgery, oral and maxillofacial surgery, critical care procedures comprising inhalation anesthetics, and dental surgical services or dental surgical services (Wesselink, pg. 716, " abdominal surgery").
As to claim 22, Wesselink teaches treating the patient to maintain a MAP at or above the target MAP during the surgery comprises administering or modifying administration of fluids, a vasoactive agent, a vasodilator agent, an anesthetic agent, an opioid, a hypnotic, and/or an ancillary agent with known cardiovascular effects, to the patient (Wesselink, pg. 719, "Vasopressor therapy and a fluid management protocol based on stroke volume variation were used to adjust MAP.").
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.
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.
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.
Claims 6, 23, and 25-26 are rejected under 35 U.S.C. 103 as being unpatentable over Wesselink as applied to claim 1 above, and further in view of US20190046122A1 (Schnetz et. al), hereto referred as Schnetz.
Claim 1 is taught as above.
As to claim 6, Wesselink teaches the surgery is a non-cardiac surgery under general anesthesia (Wesselink, pg. 706, "relative intraoperative hypotension definitions and their associations with postoperative adverse outcomes after noncardiac surgery") Schnetz teaches relevant art of determining index for monitoring hypotension (Schnetz, [0005]), and teaches including general anesthesia (Schnetz, [0049], “In some embodiments, the inhalation anesthetic is a general anesthetic”). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Wesselink in view of Schnetz to include general anesthesia so that the patient undergoes surgery safely.
As to claims 23 and 25-26, Wesselink teaches calculating the target MAP based on the age, biological sex, emergent surgery status, and ASA physical status class of the patient, but does not necessarily teach using a computer. Schnetz teaches a calculation is performed at least in part using a computer (Schnetz, [0013], “In additional embodiments, computer systems, and computer readable media are provided that are configured to execute instructions to perform a method as described herein.”) It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified Wesselink in view of Schnetz to include that the calculation is performed using a computer because that is a known method of calculating.
Claims 6, 23, and 25-26 are rejected under 35 U.S.C. 103 as being unpatentable over Wesselink as applied to claim 1 above, and further in view of US20180020989A1 (Hatib et. al), hereto referred as Hatib.
Claim 1 is taught as above.
As to claim 24, Wesselink teaches a system for monitoring a patient during a surgery, comprising administering treatment when a MAP below the target MAP is measured for the patient during the surgery and a target mean arterial pressure (MAP) for the patient during the surgery stored in the system memory and calculated according to the method of claim 1 (Wesselink, pg. 719, "Vasopressor therapy and a fluid management protocol based on stroke volume variation were used to adjust MAP."; pg. 719, "a target MAP of 80–95 mm Hg").
However, Wesselink does not teach details of the hardware. Hatib teaches relevant art of analyzing MAP during surgery (Hatib, abstract). Hatib teaches a hardware unit including a hardware processor and system memory (Hatib, claim 15, "A computer-readable non-transitory medium having stored thereon instructions, which when executed by a hardware processor”);
a hemodynamic sensor coupled to the hardware unit (Hatib, Fig. 2A, cuff 240a);
a sensory alarm (Hatib, claim 15, “invoking a sensory alarm”);
and wherein the hardware processor is configured to activate the sensory alarm (Hatib, [0016], "to provide sensory alarm 128 if a risk score predictive of a future hypotension event of living subject 130 satisfies a predetermined risk criteria").
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Wesselink in view of Hatib to include the hardware unit, sensor, sensory alarm, and the hardware processor is configured to activate the sensory alarm if a MAP below the target MAP is measured for the patient during the surgery since Wesselink teaches administering fluid management to maintain target MAP, and using an alarm would notify the healthcare profession to administer the fluid management.
Allowable Subject Matter
Claims 9-11 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The closest prior art of record, Wesselink, does not teach the predetermined IOH risk benchmark is an IOH risk of from 1% to 15% for historical patients with comparable surgery and age, biological sex, emergent surgery status, and ASA PS class as the patient for the current surgery, or the predetermined IOH risk benchmark is an IOH risk of 5% or less for historical patients with comparable surgery and age, biological sex, emergent surgery status, and ASA PS class as the patient for the current surgery, or the predetermined IOH risk benchmark is calculated as the percent of MAP readings between 65- 100 mmHg followed by at least 1 MAP <65 mmHg within 10 minutes of their measurement for historical patients with comparable surgery and age, biological sex, emergent surgery status, and ASA PS class as the patient for the current surgery, along with other claimed elements or steps.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELINA S JANG whose telephone number is (571)272-7019. The examiner can normally be reached M-F 9:00 am - 6:00 pm.
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/ELINA SOHYUN JANG/Examiner, Art Unit 3791
/JENNIFER ROBERTSON/Supervisory Patent Examiner, Art Unit 3791
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