DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
The action is in response to the application filed on 09/19/2024. Claims 1-20 are pending and examined below.
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.
Regarding claims 1-6, the claims are rejected under 35 U.S.C. 101 because the claimed invention is directed to receiving and manipulating data without significantly more.
Claim 1 recites “. A system, comprising: an output device; a processing system comprising one or more processors; and memory storing instructions that, when executed by the processing system, cause the processing system to: compare a variation in a blood pressure of a received blood pressure signal during a window of time to a blood pressure threshold; after the window of time and in response to determining that the variation meets or exceeds the blood pressure threshold, determine an index value of autoregulation based on the received blood pressure signal and a received oxygen saturation signal; determine an autoregulation status of a patient during a patient monitoring session based on the index value; and send a signal indicative of the autoregulation status of the patient to the output device during the patient monitoring session.”
This falls into a mental process grouping of abstract ideas. These limitations are either capable of being performed mentally by looking at measurements and making mental assessments thereafter or considered insignificant extra-solution activity.
The step of comparing a variation in a blood pressure of a received blood pressure signal during a window of time to a blood pressure threshold in a human mind or by a pencil and paper by a skilled clinician.
The step of after the window of time and in response to determining that the variation meets or exceeds the blood pressure threshold, determining an index value of autoregulation based on the received blood pressure signal and a received oxygen saturation signal in a human mind or by a pencil and paper by a skilled clinician.
The step of determining an autoregulation status of a patient during a patient monitoring session based on the index value in a human mind or by a pencil and paper by a skilled clinician.
The step of sending a signal indicative of the autoregulation status of the patient to the output device during the patient monitoring session is insignificant extra-solution activity (mere data presentation).
Additionally the judicial exception is not integrated into a practical application because the additional element of a processor, memory, and output for performing the steps is, at its broadest reasonable interpretation, a generic computer structure for performing the generic computer function of data processing, which does not qualify as an integration of the abstract idea into a practical application.
Finally, the claims analyzed as a whole do not provides any element, or combination of elements, sufficient to amount to significantly more than the mental process as only a processor, memory, and output are claimed. As noted previously, the addition of a generic computer structure for performing the generic computer function of data processing, does not qualify as significantly more than the abstract idea itself.
Regarding dependent claims 2-6, the claims also fail to add something more to the abstract independent claims as they merely further limit the abstract idea or provide insignificant extra solution activity.
Regarding claims 7-9, the claims are rejected under 35 U.S.C. 101 because the claimed invention is directed to receiving and manipulating data without significantly more.
Claim 7 recites “A method comprising: determining, via a processing system, an index value of autoregulation based on a received blood pressure signal and a received oxygen saturation signal; determining, via the processing system, an autoregulation status of a patient during a patient monitoring session based on the index value and a previous stored index value of autoregulation; and outputting, via the processing system and a display, an indication of the autoregulation status of the patient during the patient monitoring session”
This falls into a mental process grouping of abstract ideas. These limitations are either capable of being performed mentally by looking at measurements and making mental assessments thereafter or considered insignificant extra-solution activity.
The step of determining an index value of autoregulation based on a received blood pressure signal and a received oxygen saturation signal in a human mind or by a pencil and paper by a skilled clinician.
The step of determining an autoregulation status of a patient during a patient monitoring session based on the index value and a previous stored index value of autoregulation in a human mind or by a pencil and paper by a skilled clinician.
The step of outputting an indication of the autoregulation status of the patient during the patient monitoring session is insignificant extra-solution activity (mere data presentation).
Additionally the judicial exception is not integrated into a practical application because the additional element of a processor, memory, and output for performing the steps is, at its broadest reasonable interpretation, a generic computer structure for performing the generic computer function of data processing, which does not qualify as an integration of the abstract idea into a practical application.
Finally, the claims analyzed as a whole do not provides any element, or combination of elements, sufficient to amount to significantly more than the mental process as only a processor, memory, and output are claimed. As noted previously, the addition of a generic computer structure for performing the generic computer function of data processing, does not qualify as significantly more than the abstract idea itself.
Regarding dependent claims 8-9, the claims also fail to add something more to the abstract independent claims as they merely further limit the abstract idea or provide insignificant extra solution activity.
Regarding claims 10-20, the claims are rejected under 35 U.S.C. 101 because the claimed invention is directed to receiving and manipulating data without significantly more.
Claim 10 recites “A system comprising: an output device; a processing system comprising one or more processors; and memory storing instructions that, when executed by the processing system, cause the processing system to: determine an instantaneous cerebral oximetry index value of a patient during a patient monitoring session based on a received oxygen saturation signal and a received blood pressure signal; determine an autoregulation status of the patient based on the instantaneous cerebral oximetry index value and a previous stored cerebral oximetry index value; and send a signal indicative of the autoregulation status of the patient to the output device during the patient monitoring session.”
This falls into a mental process grouping of abstract ideas. These limitations are either capable of being performed mentally by looking at measurements and making mental assessments thereafter or considered insignificant extra-solution activity.
The step of determining an instantaneous cerebral oximetry index value of a patient during a patient monitoring session based on a received oxygen saturation signal and a received blood pressure signal in a human mind or by a pencil and paper by a skilled clinician.
The step of determining an autoregulation status of the patient based on the instantaneous cerebral oximetry index value and a previous stored cerebral oximetry index value in a human mind or by a pencil and paper by a skilled clinician.
The step of sending a signal indicative of the autoregulation status of the patient to the output device during the patient monitoring session is insignificant extra-solution activity (mere data presentation).
Additionally the judicial exception is not integrated into a practical application because the additional element of a processor, memory, and output for performing the steps is, at its broadest reasonable interpretation, a generic computer structure for performing the generic computer function of data processing, which does not qualify as an integration of the abstract idea into a practical application.
Finally, the claims analyzed as a whole do not provides any element, or combination of elements, sufficient to amount to significantly more than the mental process as only a processor, memory, and output are claimed. As noted previously, the addition of a generic computer structure for performing the generic computer function of data processing, does not qualify as significantly more than the abstract idea itself.
Regarding dependent claims 11-20, the claims also fail to add something more to the abstract independent claims as they merely further limit the abstract idea or provide insignificant extra solution activity.
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.
Claim(s) 1-2 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20110105912 A1 (hereinafter referred to as “Wildman”).
Regarding claim 1, Wildman teaches a system (abstract), comprising:
an output device (114; paragraph [0025]; Figure 1);
a processing system comprising one or more processors (paragraph [0026]); and
memory storing instructions that, when executed by the processing system (paragraph [0026]), cause the processing system to:
compare a variation in a blood pressure of a received blood pressure signal during a window of time to a blood pressure threshold (paragraph [0047]);
after the window of time and in response to determining that the variation meets or exceeds the blood pressure threshold, determine an index value of autoregulation based on the received blood pressure signal and a received oxygen saturation signal (paragraph [0047]);
determine an autoregulation status of a patient during a patient monitoring session based on the index value (paragraph [0047]); and
send a signal indicative of the autoregulation status of the patient to the output device during the patient monitoring session (paragraph [0025]).
Regarding claim 2, Wildman teaches wherein the index value comprises a cerebral oximetry index value (paragraph [0047]).
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.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wildman as applied to claim 1 above, and further in view of US 20120253211 A1 (hereinafter referred to as “Brady”)
Regarding claim 4, Wildman does not explicitly teach wherein the index value comprises a mean velocity index value, a pressure reactivity index value, a vascular reactivity index value, or a gradient-based metric value.
Brady teaches wherein the index value comprises a mean velocity index value, a pressure reactivity index value, a vascular reactivity index value, or a gradient-based metric value (paragraph [0022]). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Wildman, to have the index value comprises mean velocity index value, as taught by Brady, because doing so allows for the user to determine autoregulation. Making this modification merely combines prior art elements according to known methods well known in the industry (see MPEP 2143, KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007)).
Claim(s) 7-10, 12-13, 15-16, 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wildman, in view of US 20140073930 A1 (hereinafter referred to as “Sethi ‘930”).
Regarding claim 7, Wildman teaches A method (abstract) comprising:
determining, via a processing system, an index value of autoregulation based on a received blood pressure signal and a received oxygen saturation signal (paragraph [0047]);
determining, via the processing system, an autoregulation status of a patient during a patient monitoring session based on the index value (paragraph [0047]); and
outputting, via the processing system and a display, an indication of the autoregulation status of the patient during the patient monitoring session (paragraphs [0025], [0047]);
but does not explicitly teach determining, via the processing system, an autoregulation status of a patient during a patient monitoring session based on the index value and a previous stored index value of autoregulation.
However, Sethi ‘930 teaches determining, via the processing system, an autoregulation status of a patient during a patient monitoring session based on the index value and a previous stored index value of autoregulation (paragraph [0030]). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Wildman, to determine autoregulation based on a comparison of stored values, as taught by Sethi ‘930, because doing so provides an autoregulation status.
Regarding claim 8, Wildman, in view of Sethi ‘930, teaches comprising:
setting, via the processing system, the index value to the previous stored index value based on determining that a confidence level associated with the index value is below a threshold (paragraphs [0029]-[0032]; as taught by Sethi ‘930); and
outputting, via the processing system and the display, a second indication of the previous stored index value and the autoregulation status of the patient (paragraphs [0029]-[0032; as taught by Sethi ‘930).
Regarding claim 9, Wildman, in view of Sethi ‘930, teaches wherein determining, via the processing system, the index value comprises:
comparing, via the processing system, a variation in a blood pressure of the received blood pressure signal during a window of time of the patient monitoring session to a blood pressure threshold (paragraph [0047]; as taught by Wildman); and
determining, via the processing system, the index value after the window of time and in response to determining that the variation meets or exceeds the blood pressure threshold (paragraph [0047]; as taught by Wildman).
Regarding claim 10, Wildman teaches a system (abstract) comprising:
an output device (114; paragraph [0025]; Figure 1);
a processing system comprising one or more processors (paragraph [0026]); and
memory storing instructions that, when executed by the processing system (paragraph [0026]), cause the processing system to:
determine an instantaneous cerebral oximetry index value of a patient during a patient monitoring session based on a received oxygen saturation signal and a received blood pressure signal (paragraph [0047]);
determine an autoregulation status of the patient based on the instantaneous cerebral oximetry index value (paragraph [0047]); and
send a signal indicative of the autoregulation status of the patient to the output device during the patient monitoring session (paragraph [0047]);
but does not explicitly teach determine an autoregulation status of the patient based on the instantaneous cerebral oximetry index value and a previous stored cerebral oximetry index value.
However, Sethi ‘930 teaches determine an autoregulation status of the patient based on the instantaneous cerebral oximetry index value and a previous stored cerebral oximetry index value (paragraph [0030]). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Wildman, to determine autoregulation based on a comparison of stored values, as taught by Sethi ‘930, because doing so provides an autoregulation status.
Regarding claim 12, Wildman, in view of Sethi ‘930, teaches wherein the instructions, when executed by the processing system, cause the processing system to set the instantaneous cerebral oximetry index value as the previous stored cerebral oximetry index value based on determining that the instantaneous cerebral oximetry index value and the previous stored cerebral oximetry index value do not match (paragraphs [0029]-[0032]; as taught by Sethi ‘930).
Regarding claim 13, Wildman, in view of Sethi ‘930, teaches wherein the instructions, when executed by the processing system, cause the processing system to set the instantaneous cerebral oximetry index value as the previous stored cerebral oximetry index value based on determining a confidence level associated with the instantaneous cerebral oximetry index value is below a threshold value (paragraphs [0029]-[0032]; as taught by Sethi ‘930).
Regarding claim 15, Wildman, in view Sethi ‘930, teaches wherein the instructions, when executed by the processing system, cause the processing system to determine the autoregulation status based on determining that a number of blood pressure measurements of the received blood pressure signal exceeds a threshold value (paragraph [0047]; as taught by Wildman).
Regarding claim 16, Wildman, in view of Sethi ‘930, teaches wherein the instructions, when executed by the processing system, cause the processing system to determine the autoregulation status based on determining that a number of previously stored cerebral oximetry index values exceeds a threshold value (paragraphs [0029]-[0032]; as taught by Sethi ‘930).
Regarding claim 20, Wildman, in view of Sethi ‘930, teaches wherein the instructions, when executed by the processing system, cause the processing system to set a respective instantaneous cerebral oximetry index value for each blood pressure measurement of the received blood pressure signal during the patient monitoring session (paragraph [0047]; as taught by Wildman).
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wildman, in view of Sethi ‘930, as applied to claim 10 above, and further in view of US 20140073888 A1 (hereinafter referred to as “Sethi ‘888”).
Regarding claim 11, Wildman, in view of Sethi ‘930, does not explicitly teach wherein the instructions, when executed by the processing system, cause the processing system to determine the instantaneous cerebral oximetry index value based on a linear correlation between blood pressure measurements of the received blood pressure signal and oxygen saturation measurements of the received oxygen saturation signal over a window of time.
However, Sethi ‘888 teaches wherein the instructions, when executed by the processing system, cause the processing system to determine the instantaneous cerebral oximetry index value based on a linear correlation between blood pressure measurements of the received blood pressure signal and oxygen saturation measurements of the received oxygen saturation signal over a window of time (paragraphs [0028]-[0029]). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Wildman, in view of Sethi ‘930, to use a linear correlation to determine autoregulation, as taught by Sethi ‘888, because doing so provides a meaningful indicator if the autoregulation is impaired.
Double Patenting
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.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. US 12,121,370 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the Instant Application are broader than that of US 12,121,370 B2 and thus necessarily meets the limitations of the claims of the Instant Application.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. US 10736578 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the Instant Application are broader than that of US 10736578 B2 and thus necessarily meets the limitations of the claims of the Instant Application.
Conclusion
Claims 3, 5, 6 14, 17, 18, and claims dependent thereof, are rejected under a Double Patenting Rejection and a 35 USC 101 rejection, but contain subject matter not found in the prior art search.
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