DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Rejections - 35 USC § 112
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 2-20 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.
Claims 2, 4, 5-9, 11-14, and 19-20 are rejected under 35 U.S.C. § 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor regards as the invention.
Claim 2 recite “at least one of: Pl, RR, HbMet, or HbCO.” To properly introduce in the claim [antecedent basis] the perfusion index (PI), respiration rate (RR), methemoglobin (HbMet), and carboxyhemoglobin (HbCO), these abbreviations of parameters must be preceded by the articles “a” or “an”. Accordingly, in order to link the abbreviations, in claim 4, the abbreviation “PI” must be preceded by “the”; in claim 5, the abbreviation “PI” must be preceded by “the”; in claim 6, the abbreviation “HbMet” must be preceded by “the”; in claim 7, the first abbreviation “HbMet” must be preceded by a “the”; in claim 8, the abbreviation “RR” must be preceded by “the”; and in claim 9, the first abbreviation “RR” must be preceded by “the”.
Claim 11 recite “at least one of: SpO2, PR, Pl, RR, HbMet, or HbCO.” To properly introduce in the claims the parameters comprising of the oxygen saturation (SpO2), pulse rate (PR), perfusion index (PI), respiration rate (RR), methemoglobin (HbMet), and carboxyhemoglobin (HbCO), these abbreviations of parameters must be preceded by the articles “a” or “an”. Accordingly,
in claim 12, the abbreviation “PI” must be preceded by “the”; in claim 13, the abbreviation “HbMet” must be preceded by “the”; in claim 14, the abbreviation “RR” must be preceded by “the”.
In claims 19 and 20, to properly introduce in the claims the parameters methemoglobin (HbMet), and carboxyhemoglobin (HbCO), these abbreviations must be preceded by the articles “a” or “an”.
Claim 3 is rejected under 35 U.S.C. § 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor regards as the invention.
Claim 3 recites "the metric is a least one of: a parameter limit, a parameter trend, a parameter pattern, or a parameter variability." The phrase "a least one of" appears to be a typographical error for "at least one of." This renders the claim indefinite because it is unclear whether the claim requires the metric to be "a least one" (i.e., a minimum one) or "at least one" of the recited alternatives.
Claim 7 is rejected under 35 U.S.C. § 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor regards as the invention.
Claim 7 recites "pausing the drug administration device when HbMet is above HbMet limit." The term "HbMet limit" lacks proper antecedent basis. It is unclear whether this refers to a specific predetermined limit or an arbitrary limit. The claim should recite "an HbMet limit" to properly introduce this limitation.
Claim 10 is rejected under 35 U.S.C. § 112(b) as being indefinite for failing to particularly
point out and distinctly claim the subject matter which the inventor regards as the
invention.
Claim 10 recites "controlling a drug administration device bases upon the metric." The
word "bases" appears to be a typographical error for "based." As written, the claim is
grammatically incorrect and indefinite because it is unclear what "bases upon the metric"
means in the context of the claimed method step.
Claims 11-15 are rejected under 35 U.S.C. § 112(b) as being indefinite by virtue of their
dependency on claim 10.
Claim 11 is rejected under 35 U.S.C. § 112(b) as being indefinite for failing to particularly
point out and distinctly claim the subject matter which the inventor regards as the
invention.
Claim 11 recites "the physiological parameter is at least one of: SpO2, PR, P1, RR, HbMet, or
HbCo." The term "HbCo" is inconsistent with the term "HbCO" used in the specification
(see, e.g., paragraphs [0006], [0029], and [0031]) and in independent claim 2. It is unclear
whether "HbCo" refers to the same parameter as "HbCO" (carboxyhemoglobin) or a
different parameter. This inconsistency renders the claim indefinite.
Claims 12-15 are rejected under 35 U.S.C. § 112(b) as being indefinite by virtue of their dependency on claim 11.
Claim 16 is rejected under 35 U.S.C. § 112(b) as being indefinite for failing to particularly
point out and distinctly claim the subject matter which the inventor regards as the
invention.
Claim 16 recites "one or more processors that generate a control output" and subsequently recites "a drug administration device responsive to one or more control outputs." There is an inconsistency between "a control output" (singular) and "one or more control outputs" (potentially plural). It is unclear whether the "one or more control outputs" to which the drug administration device is responsive are the same as or different from "a control output" generated by the processors. This lack of clear antecedent basis renders the scope of the claim indefinite.
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 2, 3, 4, and 5 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Bollish (US 5,957,885) in view of Hager et al. ("The Perfusion Index Measured by a Pulse Oximeter Indicates Pain Stimuli in Anesthetized Volunteers," 2004).
Independent claim 2 discloses a drug administration method comprising:
(a) measuring a physiological parameter in response to a sensor attached to a patient;
(b) deriving a metric corresponding to the physiological parameter; and
(c) controlling a drug administration device based upon the metric, wherein the physiological parameter is at least one of: PI [perfusion index], RR, HbMet, or HbCO."
In relation to independent claim 2, Bollish discloses a drug administration method comprising:
(a) measuring a physiological parameter in response to a sensor attached to a patient:
"Connected to pulse oximetry unit 150B is pulse oximetry sensor 136 which is also
attached to a section of a patient's veinous tissue, such as the digit, where sensor 136 can
send and receive various signals... From these signals, pulse oximetry unit 150B can
determine the patient's percentage blood oxygen saturation and pulse rate" (col. 5, lines
50-59).
(b) deriving a metric corresponding to the physiological parameter:
"The clinician may specify a minimum or maximum percentage blood oxygen saturation
and a minimum or maximum pulse rate" (col. 6, lines 53-55).
(c) controlling a drug administration device based upon the metric:
"In response, microprocessor 264 may activate audio alarm 260, send a visual alarm to
display 102, and/or shut off PCA unit 150A to cease all further administration of
analgesics" (col. 6, lines 60-63).
Bollish does not explicitly disclose wherein the physiological parameter is at least one of:
PI, RR, HbMet, or HbCO. However, Hager et al. teaches that the Perfusion Index (PI) measured by a pulse oximeter indicates pain stimuli in anesthetized volunteers:
"The perfusion index is able to independently indicate a pain stimulus in anesthetized volunteers... Thus it may be of clinical value to assess pain." (Hager et al., Conclusion)
Based on the above comments, it would have been obvious to one of ordinary skill in the art at the time of the invention to have modified the system of Bollish to use the Perfusion Index (PI) as taught by Hager et al. as an additional physiological parameter for controlling the PCA pump. The motivation to combine is that both references relate to monitoring patients receiving analgesics. Hager et al. explicitly state that PI may be of "clinical value to assess pain," and an ordinarily skilled artisan would have recognized that incorporating a direct pain indicator like PI into Bollish's closed-loop PCA system would be a logical improvement for automating pain management.
In relation to claim 3, depends from claim 2 and further recites "the metric is a least
one of: a parameter limit, a parameter trend, a parameter pattern, or a parameter variability". Bollish discloses using a parameter limit as a metric:
"The clinician may specify a minimum or maximum percentage blood oxygen saturation
and a minimum or maximum pulse rate" (col. 6, lines 53-55).
Bollish does not explicitly disclose applying a parameter limit to PI. However, Hager et al. teaches that PI is a quantifiable parameter measured by a pulse oximeter, and as such, a parameter limit can be applied to it. For the reasons provided in the rejection of claim 2, it would have been obvious to apply this metric to the PI parameter.
In relation to claim 4, depends from claim 3 and further recites "enabling the drug administration device when PI is trending downward as a marker of pain stimulus". Bollish discloses controlling a drug administration device based on physiological parameters. Bollish does not explicitly disclose enabling the device when PI is trending downward as a marker of pain stimulus. Hager et al. teaches that a downward trend in PI is a marker of a pain stimulus:
"Painful stimulus caused a significant decline of the perfusion index 5.42 +/- 2.39 (p<0.001)." (Hager et al., Results)
Based on the above comments, it would have been obvious to one of ordinary skill in the art to modify the control logic of the Bollish system to enable the drug administration device when PI is trending downward, as Hager et al. teach that a decline in PI indicates the patient is experiencing pain and requires analgesia. The motivation is to automate the delivery of pain medication in direct response to an objective, non-invasive indicator of pain.
In relation to claim 5, this claim depends from claim 4 and further recites "pausing the drug
administration device when PI is not trending downward". The combination of Bollish and Hager et al. teaches enabling the drug administration device when PI is trending downward (indicating pain), as established in the rejection of claim 4. Bollish does not explicitly disclose pausing the device when PI is not trending downward.
Based on the above comments, it would have been an obvious and logical corollary to one of ordinary skill in the art to pause the drug administration device when PI is not trending downward as this would indicate the absence of a pain stimulus and therefore no need for additional analgesia. This
is a simple, binary control logic (enable when pain is indicated, pause when it is not) that would have been apparent to an ordinarily skilled artisan seeking to automate pain management based on the combined teachings.
Claims 6 and 7 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Bollish (US 5,957,885) in view of the publication Hager et al. ("The Perfusion Index Measured by a Pulse Oximeter Indicates Pain Stimuli in Anesthetized Volunteers," 2004), as disclosed above, and in further view of Faber et al. (US 2005/0267346A1; hereinafter “Faber”).
In relation to claim 6, this claim depends from claim 3 and further recites "pausing the drug
administration device when HbMet is trending upward". Bollish in view of Hager et al., as applied to claim 3 above, teaches a drug administration method where a device is controlled based on physiological parameter metrics. The combination of Bollish and Hager et al. does not explicitly disclose monitoring methemoglobin (HbMet) or pausing the device when HbMet is trending upward.
Faber teaches a non-invasive optical system for measuring various blood analytes, including methemoglobin:
"Non-invasive, optical apparatus and methods for the direct measurement of hemoglobin derivatives and other analyte concentration levels in blood... for the subsequent determination of the blood analytes concentrations such as...methemoglobin (metHb)..." (Faber; Abstract).
Based on the above comments, it would have been obvious to one of ordinary skill in the art to further modify the system of Bollish and Hager et al. to include the non-invasive measurement of methemoglobin (HbMet) as taught by Faber and to pause drug administration when HbMet is trending upward. The motivation is to enhance patient safety, as elevated HbMet levels (methemoglobinemia) can be a serious side effect of certain drugs and indicate reduced oxygen-carrying capacity of the blood. An ordinarily skilled artisan would have found it desirable to add a safety interlock to the PCA system to pause drug administration if HbMet levels were rising, thereby preventing a potentially dangerous adverse drug reaction.
In relation to claim 7, this claim depends from claim 3 and further recites "pausing the drug
administration device when HbMet is above HbMet limit". Bollish in view of Hager et al., as applied to claim 3 above, teaches using parameter limits as a metric for controlling a drug administration device. The combination does not explicitly disclose monitoring HbMet or pausing the device when HbMet exceeds a limit. Faber teaches the non-invasive measurement of methemoglobin (metHb), as cited in the rejection of claim 6.
Based on the above comments, it would have been obvious to one of ordinary skill in the art to further modify the system of Bollish and Hager et al. to include the non-invasive measurement of HbMet as taught by Faber and to pause drug administration when HbMet exceeds a predetermined limit.
This is a basic threshold-based safety control that is directly analogous to the SpO2 and pulse rate limits already taught by Bollish (col. 7, lines 34-37). The motivation is the same as stated for claim 6: to prevent a potentially dangerous adverse drug reaction.
Claims 8 and 9 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Bollish (US 5,957,885) in view of the publication Hager et al. ("The Perfusion Index Measured by a Pulse Oximeter Indicates Pain Stimuli in Anesthetized Volunteers," 2004), as disclosed above, and in further view of Vanderveen (US 2003/0106553A1).
In relation to claim 8, this claim depends from claim 3 and further recites "pausing the drug administration device when RR is trending downward". Bollish, as applied to claim 3 above, teaches a drug administration system controlled by physiological parameters (SpO2, pulse rate) using parameter limits. Bollish does not explicitly disclose monitoring respiration rate (RR) or pausing the device when RR is trending downward. Vanderveen teaches monitoring respiration rate and controlling a drug pump based on changes in the data:
"the microprocessor controller 264 would include program instructions for monitoring the changes in the CO2 concentration data or other data generated by the capnography unit 150B and to make decisions on whether to interfere with the patient's control of the pump module 150A based upon the changes in the monitored data." (para. [0056])
Based on the above comments, it would have been obvious to one of ordinary skill in the art to combine the teachings of Bollish and Vanderveen. Both references are concerned with the safe administration of analgesics using a PCA pump with physiological monitoring. Respiratory depression is a well-known risk of opioid administration. Vanderveen explicitly teaches monitoring respiration rate to mitigate this risk. A person skilled artisan would have been motivated to incorporate the respiration rate monitoring from Vanderveen into the multiparameter system of Bollish and to pause the device when RR is trending downward to prevent respiratory depression.
In relation to claim 9, this claim depends from claim 3 and further recites "pausing the drug administration device when RR is less than a RR limit". Bollish, as applied to claim 3 above, teaches using parameter limits as a metric. Bollish does not explicitly disclose monitoring RR or pausing the device when RR is less than a limit. Vanderveen teaches setting limits for respiration rate and shutting off the pump when the rate is outside those limits:
"The clinician may specify a minimum and/or maximum value for ETCO2, respiration rate, and/or other monitored parameters which thereby effectively sets a range of acceptable values for those parameters." (para. [0055])
"In the event that the patient's ETCO2 value or respiration rate are outside the maximum and minimum levels set by the clinician, the central interface unit 100 immediately shuts off the PCA pump unit 150A, and thereby stops further administration of any background infusion and bolus doses." (para. [0067])
Based on the above comments, it would have been obvious to one of ordinary skill in the art to combine the teachings of Bollish and Vanderveen for the same reasons articulated in the rejection of claim 8. Pausing the device when RR falls below a clinician-set minimum is a direct and obvious application of the threshold-based control logic already taught by Bollish, applied to the RR parameter taught by Vanderveen.
Claims 10, 11, and 15 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Bollish (US 5,957,885) in view of Lynn (US 2003/0000522A1).
Independent claim 10 discloses a drug administration method comprising:
(a) measuring a physiological parameter in response to a sensor attached to a patient;
(b) deriving a metric corresponding to the physiological parameter; and
(c) controlling a drug administration device bases upon the metric, wherein the metric is at least one of: a parameter trend, a parameter pattern, or a parameter variability".
In relation to independent claim 10, Bollish discloses a drug administration method comprising:
(a) measuring a physiological parameter in response to a sensor attached to a patient:
"Connected to pulse oximetry unit 150B is pulse oximetry sensor 136 which is also
attached to a section of a patient's veinous tissue, such as the digit, where sensor 136 can
send and receive various signals... From these signals, pulse oximetry unit 150B can
determine the patient's percentage blood oxygen saturation and pulse rate." (col. 5, lines
50-59)
(b) deriving a metric corresponding to the physiological parameter; and
"The clinician may specify a minimum or maximum percentage blood oxygen saturation
and a minimum or maximum pulse rate." (col. 6, lines 53-55)
(c) controlling a drug administration device bases upon the metric, wherein the metric is at least one of: a parameter trend, a parameter pattern, or a parameter variability".
"In response, microprocessor 264 may activate audio alarm 260, send a visual alarm to
display 102, and/or shut off PCA unit 150A to cease all further administration of
analgesics" (col. 6, lines 60-63)
Bollish does not explicitly disclose wherein the metric is at least one of: a parameter trend, a parameter pattern, or a parameter variability. However, Lynn teaches a centralized monitoring system that analyzes physiological signals to identify patterns of instability and automatically controls medication infusion based on these patterns. Lynn explicitly teaches using trends, patterns, and variability as metrics:
"The present inventors recognized that these adverse events occur not only due to improper dosage of medications or the administration of drug to the wrong patient, as has been recently highlighted in the medical literature and press, but also due to failure to recognize complex patterns along monitored outputs (such as those shown in FIG. 2) indicative of patient instability before, during, and after the administration of such medications." (para. [0003])
"It is further the purpose of the present invention to provide a system, which automatically triggers lockout of medication infusion based on the recognition of an adverse pattern of instability along at least one timed dataset output." (para. [0031])
Based on the above comments, it would have been obvious to one of ordinary skill in the art to modify the system of Bollish to incorporate the advanced pattern recognition capabilities taught by Lynn. The motivation is clear: Lynn explicitly addresses the shortcomings of simple threshold alarms (as used in Bollish) and teaches a more sophisticated method of detecting patient instability by analyzing trends, patterns, and variability. An ordinarily skilled artisan would have recognized the significant safety benefit of upgrading the Bollish system with Lynn's pattern-based control logic to provide earlier and more reliable detection of adverse drug reactions.
In relation to claim 11, this claim depends from claim 10 and further recites "the physiological
parameter is at least one of: SpO2, PR, P1, RR, HbMet, or HbCo".
Bollish discloses measuring SpO2 and pulse rate (PR):
"pulse oximetry unit 150B can determine the patient's percentage blood oxygen saturation and pulse rate." (col. 5, lines 38-40)
Lynn further teaches monitoring oxygen saturation and pulse rate:
"upper airway instability and/or ventilation instability is detected by recognizing these cluster patterns along one or more of the timed plots of: ... pulse rate and or RR interval (by oximetry, and/or EKG or other method), pulse amplitude and/or pulse transit time... oxygen saturation (by pulse oximetry..." (para. [0071])
The combination of Bollish and Lynn discloses measuring SpO2 and PR, which are among the parameters recited in claim 11. Therefore, since this enhancement was well-known in the art, its implementation in the invention would have been considered an obvious alternative in the design of the administration methodology.
In relation to claim 15, this claim depends from claim 11 and further recites "pausing the drug
administration device when a number of cyclical desaturations over a given timeframe is greater than a predetermined threshold".
Bollish does not explicitly disclose monitoring for cyclical desaturations or pausing the
device based on a number of such events exceeding a threshold. However, Lynn teaches identifying cyclical desaturations (referred to as "airway instability clusters"):
"such collapse occurs in dynamic cycles called airway instability clusters affecting a range of physiologic signals" (para. [0005])
Lynn further teaches automatically locking out medication infusion based on the
recognition of such patterns:
"It is further the purpose of the present invention to provide a system, which automatically triggers lockout of medication infusion based on the recognition of an adverse pattern of instability along at least one timed dataset output." (para. [0031])
Lynn also teaches grading the severity of such clusters:
"a graded indicator or alarm can be provided, indicative of the severity of the clusters and of airway or ventilation instability" (para. [0215])
Based on the above comments, it would have been obvious to one of ordinary skill in the art to incorporate Lynn's teaching of monitoring for cyclical desaturation clusters into the Bollish system. The motivation is that Lynn explicitly teaches that such clusters are indicative of dangerous airway instability,
and that locking out medication infusion upon recognition of such patterns is a critical safety measure.
Claim 12 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Bollish (US 5,957,885) in view of Lynn (US 2003/0000522A1), as discussed above, and in further view of the publication Hager et al. ("The Perfusion Index Measured by a Pulse Oximeter Indicates Pain Stimuli in Anesthetized Volunteers," 2004)
In relation to claim 12, this claim depends from claim 11 and further recites "enabling the drug
administration device when PI is trending downward".
The combination of Bollish and Lynn, as applied to claims 10 and 11 above, teaches a drug administration method using trends as a metric for controlling a drug device. The combination does not explicitly disclose using PI as the monitored parameter or enabling the device when PI is trending downward.
Hager et al. teaches that a downward trend in PI is a marker of a pain stimulus:
"Painful stimulus caused a significant decline of the perfusion index 5.42 +/- 2.39 (p<0.001)." (Hager et al., Results)
"The perfusion index is able to independently indicate a pain stimulus in anesthetized volunteers... Thus it may be of clinical value to assess pain." (Hager et al., Conclusion)
Based on the above comments, it would have been obvious to one of ordinary skill in the art to further modify the system of Bollish and Lynn to incorporate PI as taught by Hager et al. as a monitored parameter and to enable drug administration when PI is trending downward (indicating pain). The
motivation is that Hager et al. demonstrate PI as a clinically valuable pain indicator, and incorporating it into a trend-based drug control system would allow automated, objective pain-responsive drug delivery.
Claim 13 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Bollish (US 5,957,885) in view of Lynn (US 2003/0000522A1), as discussed above, and in further view of Faber et al. (US 2005/0267346A1; hereinafter “Faber”).
In relation to claim 13, this claim depends from claim 11 and further recites "pausing the drug
administration device when HbMet is trending upward". The combination of Bollish and Lynn, as applied to claims 10 and 11 above, teaches a drug administration method using trends as a metric for controlling a drug device. The combination does not explicitly disclose using methemoglobin (HbMet) as the monitored parameter.
Faber et al. teaches a non-invasive optical system for measuring various blood analytes,
including methemoglobin:
"Non-invasive, optical apparatus and methods for the direct measurement of hemoglobin derivatives and other analyte concentration levels in blood... for the subsequent determination of the blood analytes concentrations such as... methemoglobin (metHb)..." (Faber, Abstract)
Based on the above comments, it would have been obvious to one of ordinary skill in the art to further modify the system of Bollish and Lynn to include the non-invasive measurement of methemoglobin (HbMet) as taught by Faber et al. and to pause drug administration when HbMet is trending upward. The motivation is to enhance patient safety, as elevated methemoglobin levels can be a serious side effect of certain drugs and indicate reduced oxygen-carrying capacity of the blood. An ordinarily skilled artisan would have found it desirable to add this safety interlock to prevent a potentially dangerous adverse drug reaction.
Claim 14 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Bollish (US 5,957,885) in view of Lynn (US 2003/0000522A1), as discussed above, and in further view of Vanderveen (US 2003/0106553A1).
In relation to claim 14, this claim depends from claim 11 and further recites "pausing the drug
administration device when RR is trending downward". The combination of Bollish and Lynn, as applied to claims 10 and 11 above, teaches a drug administration method using trends as a metric for controlling a drug device. The combination does not explicitly disclose using respiration rate (RR) as the monitored parameter or pausing the device when RR is trending downward.
Vanderveen teaches monitoring respiration rate and controlling a drug pump based on changes in the data:
"the microprocessor controller 264 would include program instructions for monitoring the changes in the CO2 concentration data or other data generated by the capnography unit 150B and to make decisions on whether to interfere with the patient's control of the pump module 150A based upon the changes in the monitored data." (para. [0056])
Based on the above comments, it would have been obvious to one of ordinary skill in the art to further modify the system of Bollish and Lynn to incorporate the respiration rate monitoring taught by Vanderveen and to pause the device when RR is trending downward. The motivation is that respiratory
depression is a well-known risk of opioid administration, and Vanderveen explicitly teaches monitoring respiration rate to mitigate this risk.
Claims 16 and 17 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Bollish (US 5,957,885) in view of Lynn (US 2003/0000522A1).
Claim 16 recites a drug administration controller comprising:
(a) at least one sensor that generates at least one sensor signal in response to a physiological state of a living being;
(b) at least one physiological measurement device that generates measurements of at least one physiological parameter in response to the at least one sensor signal;
(c) one or more processors that generate a control output in response to the measurements of the at least one physiological parameter; and
(d) a drug administration device responsive to one or more control outputs so as to affect a treatment of the living being including at least one of: initiating, pausing, halting, or adjusting a dosage of administered drugs.
In relation to independent claim 16, Bollish discloses a drug administration controller comprising:
(a) at least one sensor that generates at least one sensor signal in response to a physiological state of a living being:
"Connected to pulse oximetry unit 150B is pulse oximetry sensor 136 which is also attached to a section of a patient's veinous tissue, such as the digit, where sensor 136 can send and receive various signals." (col. 5, lines 50-53)
(b) at least one physiological measurement device that generates measurements of at least one physiological parameter in response to the at least one sensor signal:
"pulse oximetry unit 150B can determine the patient's percentage blood oxygen saturation and pulse rate." (col. 5, lines 57-59)
(c) one or more processors that generate a control output in response to the measurements:
"microprocessor 264 may activate audio alarm 260, send a visual alarm to display 102,
and/or shut off PCA unit 150A to cease all further administration of analgesics" (col. 6,
lines 61-63)
(d) a drug administration device responsive to one or more control outputs so as to affect a treatment of the living being including at least one of: initiating, pausing, halting, or adjusting a dosage of administered drugs:
"In the event that the patient's percent blood oxygen saturation and pulse rate is outside
of the maximum and minimum levels set by the clinician, central interface unit 100
immediately shuts-off PCA unit 150A, and thereby stops further administration of any
background infusion and bolus doses." (col. 8, lines 42-47)
Bollish does not explicitly disclose generating the control output based on derived metrics such as trends, patterns, or rules (as opposed to simple threshold comparisons). Lynn teaches generating a control output based on the recognition of patterns of instability:
"It is further the purpose of the present invention to provide a system, which automatically triggers lockout of medication infusion based on the recognition of an adverse pattern of instability along at least one timed dataset output." (para. [0031])
"the processor can be programmed to take action such as lock out a medication, adjust the flow of oxygen, change the positive pressure or tidal volume of a ventilator, or provide an indication, such as an alarm" (para. [0093])
Based on the above comments, it would have been obvious to one of ordinary skill in the art to modify the controller of Bollish to incorporate the pattern-based control logic taught by Lynn. The motivation is that Lynn explicitly teaches the advantages of recognizing complex patterns of instability over simple threshold alarms for safer drug administration, and an ordinarily skilled artisan would have recognized the significant safety benefit of this improvement.
In relation to claim 17, this claim depends from claim 16 and further recites "the drug
administration device is one of: a drug infusion device, or a medical gas inhalation device".
Bollish discloses a drug infusion device (a PCA pump):
"PCA unit 150A provides PCA administration" (col. 6, line 51)
This teaching satisfies the limitation of a drug infusion device. Therefore, since this enhancement was well-known in the art, its implementation in the invention would have been considered an obvious alternative in the design of the administration system.
Claim 18 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Bollish (US 5,957,885) in view of Lynn (US 2003/0000522A1), as discussed above, and in further view of the publication Scanlon (“Acoustic Sensor for Health Monitoring,” 1998).
In relation to claim 18, this claim depends from claim 17 and further recites "the at least one sensor comprises: an optical sensor attached to a tissue site so as to measure at least one blood parameter; and a sound sensor attached proximate to a neck site so as to measure respiration rate".
The combination of Bollish and Lynn, as applied to claims 16 and 17 above, teaches a drug administration controller with an optical sensor (pulse oximeter) attached to a tissue site to measure blood parameters (SpO2, pulse rate):
"Connected to pulse oximetry unit 150B is pulse oximetry sensor 136 which is also attached to a section of a patient's veinous tissue, such as the digit" (Bollish, col. 5, lines 28-31)
The combination of Bollish and Lynn does not explicitly disclose a sound sensor attached proximate to a neck site so as to measure respiration rate. However, Scanlon teaches an acoustic (sound) sensor that can be placed on a patient's neck to monitor sounds and aid in the assessment of respiratory functions, including breath rates:
"When the sensor pad is in contact with a patient's thorax, neck, or temple region, sounds can be immediately and continuously monitored. This can aid in the assessment, diagnosis, and treatment of cardiac and respiratory functions, as well as provide human stress and performance indicators such as heart and breath rates" (Scanlon, p. 1)
Based on the above teachings, it would have been obvious to one of ordinary skill in the art to further modify the system of Bollish and Lynn to include an acoustic sensor at the neck as taught by Scanlon for measuring respiration rate. The motivation is that respiratory depression is a primary risk of opioid-based PCA therapy, and Scanlon teaches that an acoustic sensor at the neck can reliably and continuously monitor breath rates, providing a direct, non-invasive means of monitoring respiration rate to enhance patient safety.
Claims 19 and 20 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Bollish (US 5,957,885) in view of Lynn (US 2003/0000522A1) and Scanlon, as discussed above, and in further view of Faber et al. (US 2005/0267346A1; hereinafter “Faber”).
In relation to claim 19, this claim depends from claim 18 and further recites "the at least one
blood parameter comprises at least one of: HbMet or HbCO". The combination of Bollish, Lynn, and Scanlon, as applied to claim 18 above, teaches a drug administration controller with an optical sensor (pulse oximeter) that measures SpO2 and pulse rate. The combination does not explicitly disclose measuring HbMet or HbCO as a blood parameter. However, Faber teaches a non-invasive optical system for measuring various blood analytes, including both methemoglobin and carboxyhemoglobin:
"Non-invasive, optical apparatus and methods for the direct measurement of hemoglobin derivatives and other analyte concentration levels in blood... for the subsequent determination of the blood analytes concentrations such as... carboxyhemoglobin (COHb)... methemoglobin (metHb)..." (Faber, Abstract).
Based on the above teachings, it would have been obvious to one of ordinary skill in the art to further modify the optical sensor of the combined system to measure HbMet and HbCO as taught by Faber et al. The motivation is to enhance patient safety by monitoring for drug-induced methemoglobinemia and carbon monoxide exposure, both of which reduce the oxygen carrying
capacity of the blood and can be dangerous during drug administration.
In relation to claim 20, this claim depends from claim 19 and further recites "at least one metric
derived from the at least one physiological parameter; and at least one rule relating the at least one metric to the control output". The combination of Bollish, Lynn, Scanlon, and Faber, as applied to claim 19 above, teaches a drug administration controller with multiple sensors and parameters.
Lynn teaches deriving metrics (e.g., patterns, trends) from physiological parameters and
applying rules to generate control outputs:
"It is further the purpose of the present invention to provide a system, which automatically triggers lockout of medication infusion based on the recognition of an adverse pattern of instability along at least one timed dataset output." (para. [0031])
"the processor can be programmed to take action such as lock out a medication, adjust the flow of oxygen, change the positive pressure or tidal volume of a ventilator, or provide an indication, such as an alarm" (para. [0094])
Based on the above teachings, it would have been obvious to one of ordinary skill in the art to include at least one metric derived from the physiological parameters and at least one rule relating the metric to the control output, as taught by Lynn. The motivation is that Lynn teaches the use of derived
metrics and rules as a more sophisticated and effective method of controlling drug administration in response to patient physiological conditions, improving upon simple threshold-based alarms.
Conclusion
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Respectfully submitted,
/MANUEL A MENDEZ/ Primary Examiner, Art Unit 3783