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 .
Claim Objections
Claim 1 is objected to because of the following informalities:
“hemodyamics” should read as “hemodynamics.”
Appropriate correction is required.
Claim Rejections - 35 USC § 103
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.
Claims 1-6, 9-14, and 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over:
Harrity (US 20170266379 A1) (disclosed by Applicant) (hereinafter – Harrity) in view of
Legangneux et al. (US 20110039818 A1) (hereinafter – Lagangneux).
Re. Claim 1: Harrity teaches a method for artificial intelligence enabled control of hemod[n]yamics (Claim 1: machine-automated control, i.e., non-human and artificially intelligent; Examiner further notes that, aside from recitation in the preamble, the limitations of claim 1 do not recite steps explicitly requiring artificial intelligence in the sense of, e.g., machine learning algorithms),
comprising:
providing a first dose of a blood pressure regulator to an individual (Abstract: “… means to infuse a vasopressor and/or a vasodilator at user determined rates as well as allow the device to automatically maintain a user determined arterial pressure…”),
determining an individualized sensitivity to the blood pressure regulator based on the individual’s response to the first dose (Paragraphs 0015, 0018: device addresses variable sensitivities specific to individual patients, and updates control parameters based on latency and response to provided doses); and
providing a second dose of the blood pressure regulator to the individual, wherein the second dose is based on the individualized sensitivity (Paragraph 0054: see any subsequent doses provided after the initial test dose, as described in: “The device will give a small test dose of each vasoactive solution in order to determine appropriate controller parameters. For example in the auto mode, an algorithm, PID controller, or similar controller analyzes the patient response to the drug and calculates a rate for drug infusion based on the user inputs for drug concentration. When the device is ready the user activates the auto mode and the device will maintain the user selected target pressure”).
Harrity discloses providing a “small test dose” as an initial step in determining a patient’s response to future doses in an automated infusion mode (Paragraph 0054). Harrity does not discuss that the first dose is based on a population averaged sensitivity.
Legangneux teaches analogous art in the technology of drug dosing (Abstract). Legangneux further teaches the invention wherein the first dose is based on a population averaged sensitivity (Paragraphs 0098-0103: initial treatment period involves providing a fraction of a therapeutic/standard daily dose; Examiner notes that a “standard daily dose” and/or “therapeutic dosage” is analogous to a dose “based on a population averaged sensitivity” since such terminology is understood to refer to a drug manufacturer’s dosage portioned to provide a therapeutic effect for, e.g., humans, since the United States Food and Drug Administration generally multiple-phase clinical trials (i.e., testing human sensitivity) to evaluate the efficacy for most pharmaceuticals).
It would have been obvious to one having skill in the art before the effective filing date to have modified Harrity have a “small test dose” be given to an individual to be based on a standard dose as taught by Legangneux, the motivation being doing so reduces possible negative side effects of a full dosage of a drug (Paragraphs 0005-0007) or overaccumulation of a drug in a patient since individual patients may have individualized responses to a drug relative to a population upon which the standard dosage of a drug is tested.
Re. Claim 2: Harrity as modified by Lagangneux teaches the invention according to claim 1. Harrity further teaches the invention wherein the blood pressure regulator is selected from a vasopressor and a vasodilator (Abstract: “… means to infuse a vasopressor and/or a vasodilator at user determined rates as well as allow the device to automatically maintain a user determined arterial pressure…”).
Re. Claim 3: Harrity as modified by Lagangneux teaches the invention according to claim 1. Legangneux, in teaching further details regarding the modification, further teaches the invention wherein the first dose is a fraction of a full dose of the blood pressure regulator (Paragraphs 0098-0103: an initial dose as suggested in the modification of Legangneux is a fraction of the standard/therapeutic dosage of the medication; incorporating such a modification would modify the “small test dose” of Harrity to be a fraction of a standard dose of a blood pressure regulator),
wherein a full dose is a population averaged amount of the blood pressure regulator to return the blood pressure to a target blood pressure (Paragraphs 0020, 0068-0069: the standard daily dosage is intended to be the dosage which provides a therapeutic effect for a tested population; in modification of Harrity, reference to a standard dosage would refer to a full dose of a blood pressure regulator which provides a therapeutic effect, e.g., returning blood pressure to a target blood pressure).
Re. Claim 4: Harrity as modified by Lagangneux teaches the invention according to claim 3. Legangneux, in teaching further details regarding the modification, further teaches the invention wherein the fraction is at least 1/20 of the full dose (Paragraph 0071: initial dose may involve dosages “up to 80-fold less than the standard daily dosage e.g. up to 40-fold less than the standard daily dose, e.g. the therapeutic dose, e.g. up to 30-fold less, e.g. up to 20-fold less, e.g. up to 10-fold less e.g. up to 5-fold less or up to 3-fold less;” Paragraph 0100: “… during the initial 2 to 4 days of treatment the dosage… is not more than 1/80, 1/40, 1/30, 1/20 or 1/10, of the standard daily dose”).
Re. Claim 5: Harrity as modified by Lagangneux teaches the invention according to claim 3. Legangneux, in teaching further details regarding the modification, further teaches the invention wherein the fraction is selected from the group consisting of: 1/20, 1/15, 1/10, 1/9, 1/8, 1/7, 1/6, 1/5, 1/4, 1/3, and 1/2 of the full dose (see citation of rejection of claim 4).
Re. Claim 6: Harrity as modified by Lagangneux teaches the invention according to claim 2. Harrity further teaches the invention wherein the vasopressor is selected from the group consisting of phenylephrine and norepinephrine and wherein the vasodilator is selected from the group consisting of nitroglycerin and fentanyl (Paragraph 0056: “The ability of the device to use any available vasopressors or vasodilators, such as nitroglycerin, nitroprusside, nicardipine, epinephrine, norepinephrine, phenylephrine or newly developed medications etc. are alternative embodiments”).
Re. Claim 9: Harrity as modified by Lagangneux teaches the invention according to claim 1. Harrity further teaches the invention further comprising providing a third dose of the blood pressure regulator to the individual upon a deviation from a target pressure, wherein the third dose is based on the individualized sensitivity (Paragraph 0054: a small test dose is used to determine appropriate controller parameters to provide subsequent drug doses to maintain target pressure range).
Re. Claim 10: Harrity as modified by Lagangneux teaches the invention according to claim 1. Harrity further teaches the invention further comprising:
providing a first dose of a second blood pressure regulator to an individual, wherein the first dose of the second blood pressure regulator is based on a population averaged sensitivity (Paragraph 0018: “The controller in the present invention rapidly updates its parameters based on the latency and response to current doses as well [a]s test dosages in relation to the cardiovascular system and both vasoactive substances;” Examiner notes that Harrity uses both vasopressors and vasodilators (each having opposite effects) to maintain blood pressure within a certain range; in light of modification of Legangneux, a “small test dose” would be relative to a tested population’s response);
determining an individualized sensitivity to the second blood pressure regulator based on the individual’s response to the first dose of the second blood pressure regulator (see previous citation of Paragraph 0018: determination of response of either vasoactive compound; Paragraph 0054: both vasoactive compounds are connected to IV and a small test dose is used to determine controller parameters); and
providing a second dose of the second blood pressure regulator to the individual, wherein the second dose is based on the individualized sensitivity to the second blood pressure regulator (see previous citations of Paragraphs 0018, 0054: subsequent doses are based on response to test dose).
Re. Claim 11: Harrity as modified by Lagangneux teaches the invention according to claim 10. Harrity further teaches the invention wherein the blood pressure regulator is a vasopressor and the second blood pressure regulator is a vasodilator (Paragraphs 0018, 0054: use of both types of vasoactive compounds).
Re. Claim 12: Harrity as modified by Lagangneux teaches the invention according to claim 11. Harrity further teaches the invention wherein the vasopressor is selected from the group consisting of phenylephrine and norepinephrine and wherein the vasodilator is selected from the group consisting of nitroglycerin and fentanyl (Paragraph 0056: “The ability of the device to use any available vasopressors or vasodilators, such as nitroglycerin, nitroprusside, nicardipine, epinephrine, norepinephrine, phenylephrine or newly developed medications etc. are alternative embodiments”).
Re. Claim 13: Harrity as modified by Lagangneux teaches the invention according to claim 10. Harrity further teaches the invention wherein the blood pressure regulator is a vasodilator and the second blood pressure regulator is a vasopressor (see citations of rejection of claim 10; Examiner notes that the claims do not require providing the second blood pressure regulator in, e.g., a particular order relative to the blood pressure regulator; regardless, providing either a vasopressor or vasodilator in particular order is dependent on a patient’s present condition (i.e., the skilled artisan would recognize that a declining blood pressure value would require the use of a vasopressor); designation of either a vasodilator or vasopressor as a second blood pressure regulator does not modify the steps of the process).
Re. Claim 14: Harrity as modified by Lagangneux teaches the invention according to claim 1. Harrity further teaches the invention wherein the vasopressor is selected from the group consisting of phenylephrine and norepinephrine and wherein the vasodilator is selected from the group consisting of nitroglycerin and fentanyl (Paragraph 0056: “The ability of the device to use any available vasopressors or vasodilators, such as nitroglycerin, nitroprusside, nicardipine, epinephrine, norepinephrine, phenylephrine or newly developed medications etc. are alternative embodiments”).
Re. Claim 17: Harrity as modified by Lagangneux teaches the invention according to claim 1. Harrity further teaches the invention wherein the individual is undergoing surgery and on anesthesia (Examiner notes that claim 17 is a recitation of a context of intended use; regardless, Harrity teaches use of the invention in both anesthetic contexts (Paragraphs 0013, 0017, 0018) and surgical contexts (Paragraph 0029); claiming the context of use of the invention does not explicitly modify the method steps).
Re. Claim 18: Harrity as modified by Lagangneux teaches the invention according to claim 1. Harrity further teaches the invention wherein the individual being treated for a serious condition in an Intensive Care Unit or emergency room (Examiner notes that claim 18 is a recitation of a context of intended use; usage in a particular room does not substantively modify the method steps).
Re. Claim 19: Harrity as modified by Lagangneux teaches the invention according to claim 1. Harrity further teaches the invention further comprising updating the individualized sensitivity to the blood pressure regulator (Paragraph 0018: updating controller parameters relative to current doses; Paragraph 0054: analysis of patient response to adjust rate of drug infusion to maintain selected target pressure).
Claims 7 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over:
Harrity (US 20170266379 A1) (disclosed by Applicant) (hereinafter – Harrity) in view of
Legangneux et al. (US 20110039818 A1) (hereinafter – Lagangneux) in further view of
Sia et al. (US 20130226138 A1) (hereinafter – Sia).
Re. Claim 7: Harrity as modified by Legangneux teaches the invention according to claim 1, but does not teach the invention wherein the first dose is provided when a blood pressure of the individual deviates from a target pressure. Instead, Harrity teaches operation of the invention in an “auto” mode which requires a test dose to be administered prior to determining parameters for maintaining a user-selected target blood pressure controlled dosing (Paragraph 0054).
Sia teaches analogous art in the technology of systems for controlling blood pressure (Abstract). Sia further teaches the invention wherein the first dose is provided when a blood pressure of the individual deviates from a target pressure (Claim 14; Figs. 1, 2: initiation of drug infusion when blood pressure is outside of predetermined thresholds).
It would have been obvious to one having skill in the art before the effective filing date to have modified Harrity as modified by Legangneux to initiate a dosing protocol upon detection of a blood pressure deviating from a target range as taught by Sia, the motivation being that doing so does not cause a test dose of the medication to be administered until conditions require delivery of a dosing protocol, thus reducing unnecessary administration of medication.
Re. Claim 8: Harrity as modified by Legangneux and Sia teaches the invention according to claim 7. Harrity further teaches the invention wherein the second dose returns the blood pressure to a target blood pressure range (Paragraph 0054: subsequent doses after a test dose are intended to maintain a target blood pressure range, and alerts are provided if the device is incapable of maintaining a target value).
Claims 15 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over:
Harrity (US 20170266379 A1) (disclosed by Applicant) (hereinafter – Harrity) in view of
Legangneux et al. (US 20110039818 A1) (hereinafter – Lagangneux) in further view of
Ho et al. (US 20190121935 A1) (disclosed by Applicant) (hereinafter – Ho).
Re. Claim 15: Harrity as modified by Lagangneux teaches the invention according to claim 1. Harrity as modified by Lagangneux teaches identifying an individual’s response to a blood pressure regulator and controlling blood pressure by providing subsequent doses based on such a response, but does not identify a subject’s response by constructing a phenotypic response surface (PRS).
Such a concept is known from, Ho, commonly-assigned to the present Applicant. Ho further teaches the invention further comprising:
constructing a phenotypic response surface (PRS) describing the individual’s response to the blood pressure regulator (claim 1: “A method comprising: deriving an initial phenotypic map for a patient subjected to an initial therapeutic regimen including a first drug, based on values of a therapeutic outcome for the patient and corresponding values of a dose of the first drug administered to the patient…;” Paragraph 0051); and
controlling the blood pressure of the individual by providing at least one additional dose of the blood pressure regulator to the individual based on the physiological response described in the PRS (claim 1: particularly, “identifying a value of the dose of the first drug to be administered to the patient subjected to the updated therapeutic regimen”).
It would have been obvious to one having skill in the art before the effective filing date to have modified Harrity as modified by Lagangneux to utilize the concept of forming a phenotypic response surface and refinement thereof to assess an individual’s response to a drug to provide future doses as taught by Ho, the motivation being that provides an algorithmic method to determine optimized dosing for both single and combination drug therapies (Paragraph 0003), especially pertinent to the dosing protocol of Harrity which uses two differing medications (vasopressors and vasodilators).
Re. Claim 16: Harrity as modified by Lagangneux and Ho teaches the invention according to claim 15. Ho, in teaching further details regarding the modification, teaches the invention further comprising updating the PRS based on additional physiological response to the blood pressure regulator (claim 1: particularly, “receiving an updated value of the therapeutic outcome for the patient subjected to the updated therapeutic regimen; re-calibrating the initial phenotypic map according to the updated value of the therapeutic outcome”).
Claims 20, 22, and 24-28 are rejected under 35 U.S.C. 103 as being unpatentable over:
Harrity (US 20170266379 A1) (disclosed by Applicant) (hereinafter – Harrity) in view of
Ho et al. (US 20190121935 A1) (disclosed by Applicant) (hereinafter – Ho).
Re. Claim 20: Harrity teaches an artificial intelligence enabled system for hemodynamic control, comprising:
a physiological monitor configured to measure at least one blood pressure component of an individual (Paragraph 0055: “In an alternative embodiment the device operates without the use of invasive blood pressure readings via a blood pressure cuff or one of the new continuous noninvasive blood pressure measuring devices;” Paragraph 0058: “In all of the embodiments the blood pressure measurements can be recorded locally on the device with removable memory or accessible via conventional USB or other connectors”);
at least one pump configured to administer a blood pressure regulator to the individual (Fig. 1, as described in Paragraph 0025: “FIG. 1 is an overview of the device 10 showing vasodilator solution bag 12, carrier solution bag 14, vasoconstrictor solution bag 16 each with its own access tubing entering the intravenous line housing 18 on the right hand side of the device 10 that houses three separate IV pump channels;” Paragraph 0054: “Each solution line has a channel as in standard intravenous pumps”); and
a computing device in communication with the physiological monitor and the pump (Fig. 1: computer 10 communicating with vasoconstrictor solution bag 16 and vasodilator solution bag 12, each having IV pumps (see Paragraph 0054) and monitor 26 and/or device interface 54 as shown in Fig. 4);
wherein the computing device is configured to administer a dose of the blood pressure regulator via the at least one pump upon a change in the at least one blood pressure component measured by the physiological monitor (Paragraph 0029: device 10 is capable of a manual mode configured to administer a bolus when a medical professional recognizes a need to deliver a preselected dosage based on an observed sudden blood pressure decrease: “If things are happening quickly for example, say the surgeon just lifted the heart up and the blood pressure plummeted and the anesthesiologist needed a quick bolus the user could push one of the buttons and the device would deliver a quick bolus that the user has preselected a dosage for;” Paragraph 0054: “In auto mode the device will require an incoming arterial transducer line 21 with means to enable the device to read the arterial pressure signal, alternatively this will come from a ‘Y’ arterial line and separate transducer and line that will interface with the device. From this transducer line 21 the arterial waveform and derived systolic pressure will be displayed on the arterial pressure tracing and arterial pressure reading 48… In auto mode the user inputs a target systolic pressure with a range above and below the target value 40. The device will give a small test dose of each vasoactive solution in order to determine appropriate controller parameters. For example in the auto mode, an algorithm, PID controller, or similar controller analyzes the patient response to the drug and calculates a rate for drug infusion based on the user inputs for drug concentration. When the device is ready the user activates the auto mode and the device will maintain the user selected target pressure”).
Harrity does not teach the computing device operating an artificial intelligence enabled phenotypic response surface (AI-PRS) platform and
calculates an individualized sensitivity of the individual to the blood pressure regulator;
wherein the AI-PRS platform constructs a phenotypic response surface (PRS) describing the physiologic response of the individual in reaction to the at least one of the blood pressure regulator.
Ho teaches the invention operating an artificial intelligence enabled phenotypic response surface (AI-PRS) platform (akin to the rejection of claim 1, machine-automated control is considered to encompass the term “artificial intelligence”, i.e., non-human and artificially intelligent; Ho teaches that the platform is automated machine code (Paragraph 0067); Examiner further notes that, aside from recitation in the preamble, the limitations of claim 1 do not recite steps explicitly requiring artificial intelligence in the sense of, e.g., machine learning algorithms; even further, the updating of a phenotypic response map as described in claim 1 of Ho can be considered a learning algorithm without further clarification of the usage of the phrase “artificial intelligence enabled” in the claims) and
calculates an individualized sensitivity of the individual to the blood pressure regulator (Paragraph 0054: sensitivity adjustment used to optimize regimen changes);
wherein the AI-PRS platform constructs a phenotypic response surface (PRS) describing the physiologic response of the individual in reaction to the at least one of the blood pressure regulator (claim 1: “A method comprising: deriving an initial phenotypic map for a patient subjected to an initial therapeutic regimen including a first drug, based on values of a therapeutic outcome for the patient and corresponding values of a dose of the first drug administered to the patient…;” Paragraph 0051); and
It would have been obvious to one having skill in the art before the effective filing date to have modified Harrity as modified by Lagangneux to utilize the concept of forming a phenotypic response surface and refinement thereof to assess an individual’s response to a drug to provide future doses as taught by Ho, the motivation being that provides an algorithmic method to determine optimized dosing for both single and combination drug therapies (Paragraph 0003), especially pertinent to the dosing protocol of Harrity which uses two differing medications (vasopressors and vasodilators).
Re. Claim 22: Harrity as modified by Ho teaches the invention according to claim 20. Harrity further teaches the invention wherein the computing device is configured to maintain a target range of the at least one blood pressure component (Paragraph 0017: “By combining the technologies behind auto-pilots in aircraft with interactive ‘smart’ intravenous pumps, arterial wave form monitoring, and a combination of vasodilator and vasoconstrictive intravenous drugs, a useful device will be able to automatically control arterial systolic blood pressure or mean arterial blood pressure to a user defined target value and continue to maintain that pressure within a user set range; Fig. 4: see target and range window 40).
Re. Claim 24: Harrity as modified by Ho teaches the invention according to claim 20. Ho, in teaching further details of the modification, further teaches the invention wherein the computing device updates the PRS based on continually monitoring physiological responses to the administration of the blood pressure regulator (Paragraph 0052: “The quadratic map of the therapeutic outcome and the optimized doses of drug 1 and drug 2 can be continually updated over the course of treatment using a moving time window approach, such that time-varying phenotypic responses of the test subject can be accommodated, and the drug doses can be optimized according to the latest or current phenotype of the test subject;” see modification in context of blood pressure regulation in Harrity).
Re. Claim 25: Harrity as modified by Ho teaches the invention according to claim 20. Ho, in teaching further details of the modification, further teaches the invention wherein the computing device updates the individualized sensitivity based on continually monitoring physiological responses to the administration of the blood pressure regulator (see citation of rejection of claim 24 – the PRS can be considered a measure of sensitivity particular to an individual; Paragraph 0054: sensitivity adjustment and phenotypic map shift; additionally or alternatively, Harrity also discloses continuously monitoring updated patient responses to modify control parameters at Paragraph 0054).
Re. Claim 26: Harrity as modified by Ho teaches the invention according to claim 20. Harrity further teaches the invention wherein the at least one pump is at least two pumps, wherein a first pump is configured to administer a vasopressor and a second pump is configured to administer a vasodilator (Fig. 1; Paragraph 0054: “In operation the device will be powered on and specialized vasoactive line tubing will be spiked into the vasoconstrictor solution bag 16 and vasodilator solution bag 12 as well as the carrier solution 14. Each solution line has a channel as in standard intravenous pumps”).
Re. Claim 27: Harrity as modified by Ho teaches the invention according to claim 20. Harrity further teaches the invention wherein the blood pressure regulator is a vasopressor selected from the group consisting of phenylephrine and norepinephrine (Paragraph 0056: “The ability of the device to use any available vasopressors or vasodilators, such as nitroglycerin, nitroprusside, nicardipine, epinephrine, norepinephrine, phenylephrine or newly developed medications etc. are alternative embodiments”).
Re. Claim 28: Harrity as modified by Ho teaches the invention according to claim 20. Harrity further teaches the invention wherein the blood pressure regulator is a vasodilator selected from the group consisting of nitroglycerin and fentanyl (Paragraph 0056: “The ability of the device to use any available vasopressors or vasodilators, such as nitroglycerin, nitroprusside, nicardipine, epinephrine, norepinephrine, phenylephrine or newly developed medications etc. are alternative embodiments”).
Double Patenting
Claims 1-28 of this application is patentably indistinct from claims of Application No. 17/755,669. Pursuant to 37 CFR 1.78(f), when two or more applications filed by the same applicant or assignee contain patentably indistinct claims, elimination of such claims from all but one application may be required in the absence of good and sufficient reason for their retention during pendency in more than one application. Applicant is required to either cancel the patentably indistinct claims from all but one application or maintain a clear line of demarcation between the applications. See MPEP § 822.
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over:
copending Application No. 17/755,669 (hereinafter – “the ‘669 application”) in view of
Legangneux et al. (US 20110039818 A1) (hereinafter – Lagangneux).
This is a provisional nonstatutory double patenting rejection.
Re. Claim 1: The ‘669 application teaches a method for artificial intelligence enabled control of hemody[n]amics (claim 1, lines 1-2, verbatim),
comprising:
providing a first dose of a blood pressure regulator to an individual (claim 1, lines 3-4),
determining an individualized sensitivity to the blood pressure regulator based on the individual’s response to the first dose (claim 1, lines 5-12); and
providing a second dose of the blood pressure regulator to the individual, wherein the second dose is based on the individualized sensitivity (claim 1, lines 13-21).
Claim 1 of the ‘669 application does not teach the invention wherein the first dose is based on a population averaged sensitivity.
Such an aspect is taught by Lagangneux. See prior art rejections above. Motivation to modify claim 1 of the ‘669 application with the teachings of Lagangneux is identical.
Claims 2-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over:
copending Application No. 17/755,669 (hereinafter – “the ‘669 application”) in view of
Legangneux et al. (US 20110039818 A1) (hereinafter – Lagangneux) in view of
Prior art references utilized in rejections under 35 U.S.C. 103 above.
Re. Claims 2-19: See claims 2-12 of the ‘669 application as modified by Lagangneux in view of each other prior art reference in the prior rejections under 35 U.S.C. 103.
Claims 20-28 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over:
claims 13-20 of copending Application No. 17/755,669 (hereinafter – “the ‘669 application”).
Although the claims at issue are not identical, they are not patentably distinct from each other.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Re. Claim 20: Claim 13 of the ’669 application encompasses each limitation of claim 20.
Re. Claim 21: Claim 14 of the ’669 application encompasses each limitation of claim 21.
Re. Claim 22: Claim 15 of the ’669 application encompasses each limitation of claim 22.
Re. Claim 23: Claim 16 of the ’669 application encompasses each limitation of claim 23.
Re. Claims 24 and 25: Claim 17 of the ’669 application encompasses each limitation of claims 24 and 25.
Re. Claim 26: Claim 18 of the ’669 application encompasses each limitation of claim 26.
Re. Claim 27: Claim 19 of the ’669 application encompasses each limitation of claim 27.
Re. Claim 28: Claim 20 of the ’669 application encompasses each limitation of claim 28.
Conclusion
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/JUSTIN XU/Primary Examiner, Art Unit 3791