DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: first measure of variability and second measure of variability.
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 1-12, 14, 16-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more.
Step 1
Claims 1-12, 14, and 16-19 recite a process and claim 20 recites a machine.
Step 2A, Prong 1
Claims 1 and 20 recite the limitations of determining a first measure of variability from at least a ratio of a pulsatile component to a nonpulsatile component of the signal, the pulsatile component being responsive to variable absorption in a blood volume in the tissue and the nonpulsatile component being responsive to static absorption in the blood volume in the tissue; and determining that the first measure of variability indicates a need for the patient to receive a liquid solution based on a comparison of the first measure of variability to a threshold. These steps given their broadest reasonable interpretation, can be practically performed in the human mind. Namely, a person can mentally determine the first measure of variability by calculating a ratio of the pulsatile component to the nonpulsatile component, and mentally determine if the first measure of variability falls below a threshold indicating a need for the patient. Therefore, the claims recite mental processes which are abstract ideas.
Step 2A, Prong 2
Claims 1 and 20 do not include any additional elements that integrate the idea into a practical application.
Claim 1 includes the additional elements of one or more hardware processors; noninvasively detecting, with a detector of an optical sensor, light attenuated by a tissue of the patient at a measurement site; outputting, with the optical sensor, a signal responsive to the light; and outputting a first infusion indication for presentation to a caregiver, the first infusion indication configured to guide a first adjustment of an infusion device by the caregiver to a flow of the liquid solution delivered by and infusion device to the patient. The processors are generically claimed such that it amounts to a generic computer implementing the abstract idea; detecting light with a detector is gathering data pertaining to light which amounts to the insignificant, extra-solution activity of data gathering; outputting a signal amounts to the insignificant, extra-solution activity of displaying results; and guiding a first adjustment by a caregiver to a flow of the liquid solution delivered by an infusion device is linking the use of a judicial exception to a particular technological environment or field of use (although no actual adjusting is positively recited), as discussed in MPEP 2106.05(h). Therefore, none of these elements amount to integrating the abstract idea into a practical application.
Claim 20 includes the additional elements of a non-transitory physical computer storage comprising computer-executable instructions stored thereon; receiving a signal generated by a detector of an optical sensor, the signal being responsive to light attenuated by a tissue of a patient at a measurement site; and outputting a first infusion indication for presentation to a caregiver, the first infusion indication guiding adjustment of an infusion device to administer the liquid solution to the patient. The computer storage is generically claimed such that it amounts to a generic computer implementing the abstract idea; receiving signal by a detector amounts to the insignificant, extra-solution activity of data gathering; outputting the first infusion indication to a caregiver amounts to the insignificant, extra-solution activity of displaying results; and guiding adjustment by the caregiver to a flow of the liquid solution delivered by an infusion device is linking the use of a judicial exception to a particular technological environment or field of use (although no actual adjustment by the caregiver is positively recited), as discussed in MPEP 2106.05(h). Therefore, none of these elements amount to integrating the abstract idea into a practical application.
Step 2B
Claims 1 and 20 do not include any additional elements that amount to significantly more than the abstract idea.
Claim 1 includes the additional elements of noninvasively detecting, with a detector of an optical sensor, light attenuated by a tissue of the patient at a measurement site; outputting, with the optical sensor, a signal responsive to the light; outputting a first infusion indication for presentation to a caregiver; and guiding adjustment of an infusion device to administer the liquid solution to the patient. Detecting light with a detector is gathering data pertaining to light which amounts to the insignificant, extra-solution activity of data gathering; outputting a signal amounts to the insignificant, extra-solution activity of displaying results; and guiding a first adjustment by a caregiver to a flow of the liquid solution delivered by an infusion device is linking the use of a judicial exception to a particular technological environment or field of use (although no actual adjusting is positively recited), as discussed in MPEP 2106.05(h). Therefore, none of these elements alone or in combination amount to significantly more than the abstract idea itself.
Claim 20 includes the additional elements of a non-transitory physical computer storage comprising computer-executable instructions stored thereon; receiving a signal generated by a detector of an optical sensor, the signal being responsive to light attenuated by a tissue of a patient at a measurement site; outputting a first infusion indication for presentation to a caregiver; and guiding adjustment of an infusion device to administer the liquid solution to the patient. The computer storage is generically claimed such that it amounts to a generic computer implementing the abstract idea; receiving signal by a detector amounts to the insignificant, extra-solution activity of data gathering; outputting the first infusion indication to a caregiver amounts to the insignificant, extra-solution activity of displaying results; and guiding adjustment of an infusion device and guiding adjustment by the caregiver to a flow of the liquid solution delivered by an infusion device is linking the use of a judicial exception to a particular technological environment or field of use (although no actual adjustment by the caregiver is positively recited), as discussed in MPEP 2106.05(h). Therefore, none of these elements alone or in combination amount to significantly more than the abstract idea itself.
Therefore, claims 1 and 20 are not patent eligible.
Claim 2 merely further defines the abstract idea, namely determining a second measure of variability and the lack of need; recites outputting a second infusion indication to the caregiver which amounts to the insignificant, extra-solution activity of displaying results; and repeats guiding adjustment of the infusion device linking the use of a judicial exception to a particular technological environment or field of use.
Claims 3, 4, and 9 merely further defines displaying results, namely visually presenting the first and second infusion indication in various ways.
Claim 5 recites an audibly presentation which amounts to the equivalent of an insignificant, extra-solution activity of displaying results, since it merely relays information to a user.
Claims 6 and 7 recite comparing the measures of variability with a threshold and determining a ratio, which can be accomplished by a human mind and merely further defines the abstract idea.
Claim 8 merely further defines the abstract idea by further defining the first measure of variability.
Claim 10 recites administering the liquid solution to the patient which is applying the exception in a generic way (MPEP 2106.04(d)(2), see example a, “The particularity Or Generality of The Treatment or Prophylaxis”).
Claim 11 further defines the infusion device which is linking the use of a judicial exception to a particular technological environment or field of use, as discussed in MPEP 2106.05(h).
Claim 12 recites comparing the first measure of variability with a threshold which can be accomplished by a human mind and merely further defines the abstract idea.
Claim 14 merely further defines the abstract idea, namely further defining the determining the first measure of variability.
Claim 16 recites irradiating, with one or more emitters of the optical sensor, the tissue with red and infrared wavelengths which is considered part of obtaining data related to the light, which merely further defines the insignificant, extra-solution activity of data gathering.
Claim 17 recites determining a parameter measurement from a signal which is equivalent to obtaining information for the parameter, which amounts to the insignificant, extra-solution activity of data gathering.
Regarding claim 18, although the liquid solution does not appear to be positively recited, the liquid solution appears to merely further define the outputting and/or is considered linking the use of a judicial exception to a particular technological environment or field of use, as discussed in MPEP 2106.05(h).
Claim 19 merely further defines the data gathering, namely giving details of the measurement site from which the light is measured, the data of the light measurements being considered data gathering as previously mentioned.
Claim Rejections - 35 USC § 112
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.
Claims 2 and 4-6 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 2 recites “determining… a second measure of variability… determining… that the second measure of variability does not indicate a further need to provide the liquid solution; and in response to determining that the second measure of variability does not indicate the further need, outputting a second infusion indication…” Examiner submits that the second measure of variability determining that the administration of liquid is not further needed is not supported or mentioned in the original specification. For the purpose of examination and until the language is clarified, the second measure of variability will be assumed to be a measurement that indicates that infusion should be stopped.
Claims 5 and 6 are rejected under 112(a) by virtue of depending from a rejected base claim.
Claim 4 recites a first adjustment comprising increasing or starting flow of the liquid solution and a second adjustment comprising decreasing or stopping flow of the liquid solution. However, given that neither a first or second adjustment is mentioned in the original specification, there does not appear to be support for any equivalent first adjustment specifically tied to increasing or starting flow and there does not appear to be support for any equivalent second adjustment specifically tied to decreasing or stopping flow. Clarification is required.
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.
Claims 1-12, 14, and 16-20 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 first infusion indication configured to guide a first adjustment, by the caregiver, to a flow of the liquid solution delivered by an infusion device to the patient.” First, it is unclear what is meant by an “indication” being capable of guiding an adjustment by a caregiver. It is unclear if the indication is performing the action or if the caregiver is meant to perform the action in response to the indication. Second, it is unclear if the infusion device is actually being adjusted, the phrase “guide an adjustment” itself it unclear, since it is unclear how either the indication can “guide” an adjustment or if the caregiver is the one being guided. Third, it is unclear how an indication is capable of guiding an adjustment “to the flow of the liquid solution…” If the intention is for the caregiver to adjust the flow, it should be plainly stated. Fourth, given the term “to a flow of the liquid solution delivered by the infusion device,” it is unclear if the infusion device actually administers a liquid or if it merely capable of delivery. For the purpose of examination, the first infusion indication will be interpreted as any indication which is capable of presenting information to a caregiver, where the caregiver will have the option of making an adjustment or not.
Claims 2 and 20 are rejected for similar reasons as set forth above regarding claim 1.
Claims 3-12, 14, and 16-19 are rejected under 112(b) by virtue of being dependent on a rejected base claim.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-3, 5-8, 10, 12, 14, and 18-20 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over U.S. Patent Publication No. 2007/0032732 to Shelley et al. (“Shelley”), in view of U.S. Patent No. 5,277,181 to Mendelson et al. (“Mendelson”), U.S. Patent Publication No. 2004/0176690 to Brabrand.
Regarding claim 1, Shelley teaches a method of managing a blood volume of a patient, the method comprising noninvasively detecting, with a detector (16) of an optical sensor, light attenuated by a tissue of the patient at a measurement site ([0095]), outputting, with the optical sensor, a signal responsive to the light ([0095], low-level current), determining, with one or more hardware processors (14), a first measure of variability ([0048], blood volume responsiveness) that indicates a need for the patient to receive a liquid solution ([0063], loss of blood), and in response to determining that the first measure of variability indicates the need, outputting a first infusion indication for presentation to a caregiver ([0061], alarm), the first infusion indication configured to guide a first adjustment, by the caregiver, to a flow of the liquid solution delivered to the patient ([0063], alarm signals the need for blood replacement therapy), but does not teach the particulars of determining the first measure of variability, an explicit mention of a threshold, and the actual infusion device.
Mendelson teaches determining, with one or more hardware processors, a first measure of variability based at least in part on a ratio (column 4, lines 47-49) of a pulsatile component (AC) to a nonpulsatile component (DC) of the signal, the pulsatile component being responsive to variable absorption in a blood volume in the tissue and the nonpulsatile component being responsive to static absorption in the blood volume in the tissue (column 4, lines 26-34), and determining that the first measure of variability indicates a need for the patient to receive liquid solution based on a comparison of the first measure of variability to a threshold ([0061], a quantity where is it affecting the arterial system). It would be obvious to one of ordinary skill in the art at the time the invention was made to have substituted the determining of the first measure of variability and associated indication of need of Shelley with the determining of the first measure of variability and associated indication of need of Mendelson since both methods of determining would be considered a simple substitution of one art-recognized alternative for another to yield the predictable result of ascertaining an amount of blood volume or hemoglobin in a patient and indicating a need when blood loss falls below a threshold.
Brabrand teaches an example of an infusion device (10/11, Fig. 1) to administer a liquid solution to the patient. It would be obvious to one of ordinary skill in the art at the time the invention was made to have used the infusion device of Brabrand as the means of administering liquid of Shelley for the predictable result of providing liquid to the user.
Regarding claim 2, Shelley, Mendelson, and Brabrand teach the method of claim 1, Brabrand teaching the infusion device, Mendelson further teaching determining, with the one or more hardware processors, a second measure of variability from at least the ratio of the pulsatile component to the nonpulsatile component of the signal (column 3, lines 8-11). It would be obvious to one of ordinary skill in the art at the time the invention was made to have incorporated determining a second measure of variability in the method of Shelley and Mendelson as taught by Mendelson to determine blood hematocrit and hemoglobin content (column 3, lines 11-13).
Shelley further teaching determining, with the one or more hardware processors, that the second measure of variability does not indicate a further need to provide the liquid solution ([0062], when the body can still compensate) and in response to determining that the second measure of variability does not indicate the further need, outputting a second infusion indication for presentation to the caregiver, the second infusion indication configured to guide a second adjustment, by the caregiver, to the flow of the liquid solution delivered by the infusion device to the patient ([0062], during the “early warning” phase, no infusion would be necessary while the body can still compensate).
Regarding claim 3, Shelley, Mendelson, and Brabrand teach the method of claim 2 as shown above, Shelly further teaching visually presenting the first infusion indication ([0061] display equivalent to “alarm” phase) and the second infusion indication to the caregiver on a display ([0062] display indicative of the “early warning” phase).
Regarding claim 5, Shelley, Mendelson, and Brabrand the method of claim 2 as shown above, Shelly further teaching audibly presenting the first infusion indication ([0014] teaches alarms that are audible and [0061] describes the alarm that indicates blood loss) to the caregiver.
Regarding claim 6, Shelley, Mendelson, and Brabrand teach the method of claim 2 as shown above, Mendelson further teaching comparing the second measure of variability with the threshold to determine whether the second measure of variability indicates the need ([0062]).
Regarding claim 7, Shelley, Mendelson, and Brabrand teach the method of claim 1 as shown above, Mendelson further teaching determining the ratio of the pulsatile component to the nonpulsatile component from a sliding time window of values determined from the signal (column 3, lines 8-10, the signals, and associated ratio, are at least measured at two times, the two times being forming a time window). It would be obvious to one of ordinary skill in the art at the time the invention was made to have incorporated determining a second measure of variability in the method of Shelley and Mendelson as taught by Mendelson to determine blood hematocrit and hemoglobin content (column 3, lines 11-13).
Regarding claim 8, Shelley, Mendelson, and Brabrand teach the method of claim 1 as shown above, Shelley further teaching the first measure of variability is responsive to a dehydration condition of the patient or a hemorrhaging condition of the patient ([0073]).
Regarding claim 10, Shelley, Mendelson, and Brabrand teach the method of claim 1 as shown above, Shelley further teaching administering the liquid solution to the patient subsequent to the outputting the first infusion indication for presentation to the caregiver ([0063], blood replacement therapy).
Regarding claim 11, Shelley, Mendelson, and Brabrand teach the method of claim 10 as shown above, Shelly further teaching a patient monitor (30) comprising the one or more hardware processors (14), Brabrand further teaching the infusion device (10/11, Fig. 1) being separate from a patient monitor.
Regarding claim 12, Shelley, Mendelson, and Brabrand teach the method of claim 1 as shown above, Shelley further teaching comparing the first measure of variability with a threshold to determine whether the first measure of variability indicates the need ([0061]).
Regarding claim 14, Shelley, Mendelson, and Brabrand the method of claim 1 as shown above, Mendelson further teaching the determining the first measure of variability based at least in part on the ratio of the pulsatile component to the nonpulsatile component comprises determining the first measure of variability responsive to a change in the ratio (column 3, lines 8-10, signal is measured at different times, which indicates a change in the ratio) of the pulsatile component (AC) to the nonpulsatile component (DC).
Regarding claim 18, Shelley, Mendelson, and Brabrand teach the method of claim 1 as shown above, Shelley further teaching the liquid solution comprises blood products or nutrient fluids ([0063], blood replacement therapy is a blood product).
Regarding claim 19, Shelley, Mendelson, and Brabrand teach the method of claim 1 as shown above, Shelley further teaching the measurement site comprises a finger (12, [0095]).
Regarding claim 20, Shelley teaches a non-transitory physical computer storage comprising computer-executable instructions stored thereon that, when executed by one or more hardware processors (the processor inherently includes storage in order to execute the process), are configured to implement a process comprising receiving a signal generated by a detector of an optical sensor, the signal being responsive to light attenuated by a tissue of a patient at a measurement site ([0095]), determining a first measure of variability ([0048], blood volume responsiveness) that indicates a need for the patient to receive a liquid solution ([0063], loss of blood), and in response to determining that the first measure of variability indicates the need, outputting a first infusion indication for presentation to a caregiver ([0061], alarm), the first infusion indication configured to guide adjustment, by the caregiver, to a flow of the liquid solution delivered by an infusion device ([0063], alarm signals the need for blood replacement therapy), but does not teach the particulars of determining the first measure of variability and the actual infusion device.
Mendelson teaches determining, with one or more hardware processors, a first measure of variability based at least in part on a ratio (column 4, lines 47-49) of a pulsatile component (AC) to a nonpulsatile component (DC) of the signal, the pulsatile component being responsive to variable absorption in a blood volume in the tissue and the nonpulsatile component being responsive to static absorption in the blood volume in the tissue (column 4, lines 26-34), and determining, based on a comparison of the first measure of variability to a threshold, that the first measure of variability indicates a need for the patient to receive a liquid solution ([0061], a quantity where it is affecting the arterial system). It would be obvious to one of ordinary skill in the art at the time the invention was made to have substituted the determining of the first measure of variability of Shelley with the determining of the first measure of variability of Mendelson since both methods of determining would be considered a simple substitution of one art-recognized alternative for another to yield the predictable result of ascertaining an amount of blood volume or hemoglobin in a patient.
Brabrand teaches an example of an infusion device (10/11, Fig. 1) to administer a liquid solution to the patient. It would be obvious to one of ordinary skill in the art at the time the invention was made to have used the infusion device of Brabrand as the means of administering liquid of Shelley for the predictable result of providing liquid to the user.
Claim 4 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Shelley, Mendelson, and Brabrand as applied to claim 2 above, and further in view of U.S. Patent Publication No. 2009/0076462 to Kiani.
Regarding claim 4, Shelley, Mendelson, and Brabrand teach the method of claim 2 as shown above, Shelly further teaching the first adjustment comprises increasing a flow rate of the flow of the liquid solution delivered by the infusion device to the patient ([0063], blood volume replacement therapy, but do not explicitly teaching stopping the infusion.
Kiani teaches stopping the flow of the liquid solution administered by the infusion device to the patient ([0017]). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided a second adjustment to stop the infusion in the method of Shelley, Mendelson, and Brabrand as taught by Kiani to yield the predictable result of stopping infusion when additional infusion is no longer necessary, as the indication that infusion is not necessary has already been shown by Mendelson above.
Claim 9 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Shelley, Mendelson, and Brabrand as applied to claim 1 above, and further in view of U.S. Patent Publication No. 2005/0055242 to Bello et al. (“Bello”).
Regarding claim 9, Shelley, Mendelson, and Brabrand teach the method of claim 2, but do not show the visual presentations.
Bello teaches visually presenting the first infusion indication to the caregiver on a display to start the flow of the liquid solution delivered by the infusion device to the patient (Fig. 25, administer infusion). It would be obvious to one of ordinary skill in the art at the time the invention was made to have incorporated visual indications in Shelley and Mendelson as taught by Bello to yield the predictable result of allowing a user to control aspects of infusion to suit the particular circumstances or treatment plan for efficient patient care given that such controls are common and necessary to start or stop infusion treatments.
Claim 16 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Shelley, Mendelson, and Brabrand as applied to claim 1 above, and further in view of U.S. Patent Publication No. 2008/0167541 to Takala et al. (“Takala”).
Regarding claim 16, Shelley, Mendelson, and Brabrand teach the method of claim 1, Shelley further teaching irradiating, with one or more emitters of the optical sensor, the tissue with infrared wavelengths ([0079]) but does not teach red wavelengths.
Takala taches irradiating the tissue with red and infrared wavelengths ([0004]). It would be obvious to one of ordinary skill in the art at the time the invention was made to have used both red and infrared wavelengths in Shelley as taught by Takala in order to distinguish between different species of hemoglobin ([0004]).
Claim 17 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Shelley, Mendelson, and Brabrand as applied to claim 1 above, and further in view of U.S. Patent Publication No. 2009/0043179 to Melker et al. (“Melker”), as evidenced by U.S. Patent Publication No. 2002/0161291 to Kianl et al. (“Kianl”).
Regarding claim 17, Shelley, Mendelson, and Brabrand teach the method of claim 1, Shelley further teaching determining, with the one or more hardware processors (14), a parameter measurement from the signal, the parameter measurement comprising hemoglobin ([0014]), but does not teach a parameter measurement of carboxyhemoglobin or methemoglobin.
Melker teaches determining a parameter measurement comprising carboxyhemoglobin or methemoglobin. It would be obvious to one of ordinary skill in the art at the time the invention was made to have modified Shelley to further determine carboxyhemoglobin or methemoglobin in addition to hemoglobin itself, in order to identify and distinguish various species of hemoglobin to obtain additional information pertaining to the user and allow for greater accuracy for hemoglobin detection, since the presence of carboxyhemoglobin can lead to inaccurate measurements as evidenced by Kianl ([0069]).
Response to Arguments
No arguments or amendments with respect to 101 rejections have been presented, therefore the 101 rejections stand.
Applicant’s arguments and amendments with respect to 112(a) rejections have been fully considered and are persuasive in-part. The 112(a) rejections of claims 4, 5, and 9 have been withdrawn, however the 112(a) rejection of claim 2 is maintained as shown above.
Applicant’s arguments and amendments with respect to 112(b) rejections have been fully considered and are persuasive. The 112(b) rejections of claims have been withdrawn. However, new 112(b) rejections have been issued as shown above in response to the new amendments.
Applicant's arguments and amendments with respect to art rejections have been fully considered and are not persuasive. Applicant argues that Shelley fails to teach comparing the first measure of variability to a threshold. However, as shown above, such a limitation is taught by Mendelson. The rejection is maintained.
Conclusion
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/B.K./Examiner, Art Unit 3783 /THEODORE J STIGELL/Primary Examiner, Art Unit 3783