Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
The current application has the effective filing date of 06/22/2017 according to the priority date on the record.
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.
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Claims 1-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 12,207,937 (Pat’937). Although the claims at issue are not identical, they are not patentably distinct from each other because the invention of the current application is wholly encompassed by the claimed invention of Pat’937, see overlapping limitation italicized as follows:
App. 19/038149
Pat’937
1. An infant warming system comprising:
a platform for supporting an infant;
a pulse oximeter device configured to determine an SpO2 for the infant;
a processor configured to:
determine one or more activation thresholds for the infant, wherein the one or more activation thresholds represent one or more target saturation levels over a period of time for the infant;
compare the SpO2 for the infant to the one or more target saturation levels;
adjust a display of the SpO2 on a display device based on the comparison; and
generate a first care instruction for a first care stage via a user interface based on the SpO2 of the infant, wherein the first care instruction is based on the one or more activation thresholds.
1. An infant warming system comprising: a platform for supporting an infant;
a heating system for warming the infant on the platform;
at least two chest electrodes configured to connect to and detect cardiac potentials from a chest of the infant;
an ECG monitor configured to receive the cardiac potentials from the at least two chest electrodes and determine a heart rate based on the cardiac potentials;
a pulse oximeter device configured to determine an SpO2 for the infant;
a processor configured to:
determine one or more activation thresholds for the infant, wherein the one or more activation thresholds represent one or more target saturation levels over a period of time for the infant;
compare the heart rate for the infant to a first heart rate threshold and compare the SpO2 for the infant to the one or more target saturation levels;
adjust a display of the heart rate or the SpO2 on a display device based on the comparisons; and
generate a first care instruction for a first care stage via a user interface based on the SpO2 of the infant, wherein the first care instruction is based on the one or more activation thresholds;
determine a second care stage following execution of the first care instruction when the SpO2 remains below the one or more target saturation levels;
generate a second care instruction based on the second care stage; and
wherein the first care instruction and the second care instruction represent guidance for caring for the infant.
2. The infant warming system of claim 1, wherein the processor is configured to: determine a second care stage following execution of the first care instruction, wherein the SpO2 remains below the one or more target saturation levels; and generate a second care instruction based on the second care stage.
1. An infant warming system comprising: a platform for supporting an infant; a heating system for warming the infant on the platform; at least two chest electrodes configured to connect to and detect cardiac potentials from a chest of the infant; an ECG monitor configured to receive the cardiac potentials from the at least two chest electrodes and determine a heart rate based on the cardiac potentials; a pulse oximeter device configured to determine an SpO2 for the infant; a processor configured to: determine one or more activation thresholds for the infant, wherein the one or more activation thresholds represent one or more target saturation levels over a period of time for the infant; compare the heart rate for the infant to a first heart rate threshold and compare the SpO2 for the infant to the one or more target saturation levels; adjust a display of the heart rate or the SpO2 on a display device based on the comparisons; and generate a first care instruction for a first care stage via a user interface based on the SpO2 of the infant, wherein the first care instruction is based on the one or more activation thresholds; determine a second care stage following execution of the first care instruction when the SpO2 remains below the one or more target saturation levels; generate a second care instruction based on the second care stage; and wherein the first care instruction and the second care instruction represent guidance for caring for the infant.
3. The infant warming system of claim 1, wherein the processor is configured to receive acknowledgment of execution of the first care instruction.
4. The infant warming system of claim 1, wherein the processor is configured to receive acknowledgment of execution of the first care instruction.
4. The infant warming system of claim 1, wherein the one or more activation thresholds are preset values set within software executed by the processor or values established upon configuration of the software within the infant warming system.
5. The infant warming system of claim 1, wherein the one or more activation thresholds are preset values set within software executed by the processor or values established upon configuration of the software within the infant warming system.
5. The infant warming system of claim 1, wherein the processor is configured to calculate the one or more activation thresholds based at least in part on a time of life of the infant.
6. The infant warming system of claim 1, wherein the processor is configured to calculate the one or more activation thresholds based at least in part on a time of life of the infant.
6. The infant warming system of claim 2, wherein the user interface includes a speaker and the first care instruction, the second care instruction, or a combination thereof comprises an audible instruction of the SpO2 of the infant.
2. The infant warming system of claim 1, wherein the user interface includes a speaker and the first care instruction, the second care instruction, or a combination thereof comprises an audible instruction of the SpO2 of the infant.
7. The infant warming system of claim 1, wherein the processor is further configured to automatically suppress audio annunciation of one or more threshold alarms
7. The infant warming system of claim 1, wherein the processor is further configured to automatically suppress audio annunciation of one or more threshold alarms.
8. The infant warming system of claim 2, wherein the first care instruction, the second care instruction, or a combination thereof includes a visual instruction.
3. The infant warming system of claim 1, wherein the first care instruction, the second care instruction, or a combination thereof includes a visual instruction.
9. The infant warming system of claim 1, wherein the processor is further configured to: determine a plurality of care instructions based on the SpO2 of the infant; and display the plurality of care instructions on the display device.
Implicitly rejected by claim 1 which recites a “display device” and steps for determine and generate “a first care instruction,” and “a second care instruction”
10. The infant warming system of claim 9, wherein the infant warming system further comprises a microphone to record audible inputs from a user; and wherein the processor is further configured to: detect an acknowledgment of execution of the plurality of care instructions, wherein the detecting the acknowledgement of execution comprises detecting an audible care instruction selection recorded by the microphone.
8. The infant warming system of claim 1, wherein the infant warming system further comprises a microphone to record audible inputs from a user; and wherein the processor is further configured to: detect an acknowledgment of execution of the plurality of care instructions, wherein the detecting the acknowledgement of execution comprises detecting an audible care instruction selection recorded by the microphone.
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.
Claim 9 is 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 9 recites “determine a plurality of care instructions based on the SpO2 of the infant; and display the plurality of care instructions on the display device”; it is unclear whether the “a plurality of care instructions” is the same or different from the recited “a first care instruction” in claim 1, and/or “a second care instruction” in claim 2.
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.
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 1-10 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter of an abstract idea, including mental processes, mathematical concepts or organized human activities, without significantly more.
The framework for establishing a prima facie case of lack of subject matter eligibility requires that the Examiner determine: (1) Does the claim fall within the four categories of patent eligible subject matter; (2a) prong 1: Does the claim recite an abstract idea, law of nature, or natural phenomenon and (2a) prong 2: Does the claim recite additional elements that integrate the judicial exception into a practical application; and (2b) Does the claim recite additional elements that amount of significantly more than the judicial exception.
Under Step (1): claim 1 is directed to an infant warming system; thus fall under one of the four patent eligible categories, i.e. product.
To Step 2(a) prong 1:
Claim 1 recites:
An infant warming system comprising:
a platform for supporting an infant;
a pulse oximeter device configured to determine an SpO2 for the infant;
a processor configured to:
determine one or more activation thresholds for the infant, wherein the one or more activation thresholds represent one or more target saturation levels over a period of time for the infant;
compare the SpO2 for the infant to the one or more target saturation levels;
adjust a display of the SpO2 on a display device based on the comparison; and
generate a first care instruction for a first care stage via a user interface based on the SpO2 of the infant, wherein the first care instruction is based on the one or more activation thresholds.
As shown above, the italicized portions in claim 1 above, recite various steps which can be performed wholly in a mentally or manually by a person. For example, a person can visually observe an SpO2 (or saturation) measurement and make a mental comparison with one or more known/target threshold, the person can then manually write or verbally announce the comparison result so as to display the comparison result, and finally, the person can then mentally determine first care instructions and manually write the first care instructions onto paper or verbally announce the first care instruction.
Although the claim recites the structures: “infant warming system”, but this system merely comprises: “platform”, “pulse oximeter” and “processor”; these devices merely define the field of use of the recited method steps, and are thus treated as insignificant extra-solution activity.
When the claims, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it is still in the mental processes grouping unless the claim limitation cannot practically be performed in the mind. Likewise, performance of a claim limitation using generic computer components does not preclude the claim limitation from being in the mathematical concepts grouping or the certain methods of organizing human activity grouping.
As for dependent claims 2-10, these claims recite additional steps which can be further implemented by a person via mental or manual steps under the same rationale as discussed to claim 1 above; and are thus regarded as directed to an abstract idea.
Under Step 2(a) prong 2: The Court defines the phrase “integration into a practical application” to require an additional element or a combination of additional elements in the claim to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such that it is more than a drafting effort designed to monopolize the exception.
This judicial exception is not integrated into a practical application because claim 1 merely recite steps of generating a first care instruction, but these steps are non-specific as it is based on a simple mathematical comparison and the care instruction does not include any actual care/resuscitation step; as such, it is unclear as to whether the recited care instructions fall under specific diagnosis or prophylactic treatment under MPEP 2106.05(e).
This judicial exception is not integrated into a practical application because claim 2-10 do not provide improvements to the functioning of a computer or to any the technical field under MPEP 2106.05(a).
Under Step 2b: The claims do not include any additional elements that are sufficient to amount to significantly more than the judicial exception because claim 1-10 merely recite: “infant warming system”, “platform”, “pulse oximeter” and “processor”; which are no more than generic patient care devices and generic computer components, which are well-understood, routine and conventional activities previously known in the industry.
Under the Berkheimer guidance, the following reference sets the standard for well-understood, routine and conventional activities for the recited structures:
Varshneya et al. US 2003/0095263 A1 Fig. 2 discloses a monitoring system comprising a crib to support an infant, and a portable device comprising a processor, display and user interface, and sensor for monitoring the infant.
Mahony et al. US 2005/0215845 A1 Figs. 1 and 2 discloses an incubator to support an infant, and a monitoring unit comprising sensor, display, processor and user interface.
Watson, Jr. US 2007/0276273 A1 Figs. 1-4 illustrates an infant monitoring system comprising oxygen saturation sensor, the system further comprises at least a processor, display.
Coelho US 2012/0232357 A1/US 8,727,980 disclose an infant warming system for providing resuscitation to an infant comprising ECG and oxygenation monitoring, the system comprises an umbilical sensor, processor, display and user inface as shown in Figs. 2-3.
Accordingly, claims 1-10 are thus rejected under 35 USC 101 for disclosing patent-ineligible subject matter as they also fail to provide additional elements that meet the significantly more prong.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
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, 3-4, 7 and 9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gibson et al. US 2008/0281168 (hereinafter “Gibson”).
Regarding claim 1, Gibson discloses an infant warming system (see abstract: ambulatory bedside monitor 20 exemplary shown in Fig. 1. Also see [0091: 3rd sentence from end of paragraph, 0129] and Figs. 29-30 sensors sizing and monitoring mode can be adapted for neonatal or pediatric) comprising:
a platform for supporting an infant (hospital bed/support as shown in Figs.10-13);
a pulse oximeter device (SpO2 sensor assembly 32) configured to determine an SpO2 for the infant;
a processor (CPU 174, [0094]) configured to:
determine one or more activation thresholds for the infant, wherein the one or more activation thresholds represent one or more target saturation levels over a period of time for the infant (see [0134] “…Alarms are provided (upper and lower limits) for each of heart rate/pulse rate, respiration, NIBP (systolic, diastolic and mean) and SpO.sub.2…” Fig. 38: upper limit is interpreted as a first of the “activation threshold”, and lower limit is interpreted as a second of the “activation threshold” as recited in the claim; see [0171] provides that Fig. 38 corresponds to setting the “activation threshold” for SpO2 over a predetermined period of time, e.g. spot check time period, also see [0174]);
compare the SpO2 for the infant to the one or more target saturation levels ([0007: last 3 sentences] heart rate and SpO2 compared with respective thresholds, neonatal/pediatric thresholds profiles are used according to a selected monitoring mode; [0104: last 4 sentences] settings for alarms and alerts, time limits, data trends etc. [0112-0113] determining and alarm/alert condition including comparison of ECG, and SpO2 to respective set threshold values. Fig. 22 is exemplary view for setting SpO2 thresholds);
adjust a display of the SpO2 on a display device based on the comparison ([0014] SpO2 and heart rate are both displayed; see Figs. 1 and 7 for exemplary display of both ECG, heart rate and SpO2); and
generate a first care instruction for a first care stage via a user interface based on the SpO2 of the infant, wherein the first care instruction is based on the one or more activation thresholds (Note: “care instruction” is not defined in the claim. Visual and/or audible alarm, or suspending alarm, are interpreted to encompass “first care instruction” in the claim. The alarm setting is according to clinician’s settings for each parameter described in Figs. 60-61 and [0181-0187]).
Regarding claim 3, Gibson discloses the infant warming system of claim 1, wherein the processor is configured to receive acknowledgment of execution of the first care instruction. ([0179] “…Still referring to FIG. 59, acknowledgement of the alert by the user is made by highlighting the acknowledge option 864 at the bottom of the display screen and pressing the SELECT button 96…”)
Regarding claim 4, Gibson discloses the infant warming system of claim 1, wherein the one or more activation thresholds are preset values set within software executed by the processor or values established upon configuration of the software within the infant warming system. ([0005:3rd sentence] “…the preset upper and lower alarm limits for all physiologic parameters can be automatically changed simultaneously a single time by a user simultaneously by a specified percentage (e.g., 20 percent)...”[0186: last 4 sentences ] “… selective alarm management setting feature permits both upper and lower alarm limits to be preset accordingly and then used selectively by the clinician/nurse” [0187: 2nd to last sentence] “…SpO.sub.2 and respiration rate limits can be similarly adjusted wherein the amount from factory (default) preset value alarm limit values can be adjusted, depending on the patient mode…”)
Regarding claim 7, Gibson discloses the infant warming system of claim 1, wherein the processor is further configured to automatically suppress audio annunciation of one or more threshold alarms. ([0177, 0181-0183] option to suspend alarm; [0187: first 3 sentences] “…the user can temporarily silence an alarm through use of the alarm silence/resume button 108 provided on the user interface 92…the alarm will go off again momentarily depending on the default settings of the monitoring device 20 (e.g., 90 seconds). Second, the user can suspend the alarm tone for a patient for a predetermined period of time…”)
Regarding claim 9, Gibson discloses the infant warming system of claim 1, wherein the processor is further configured to: determine a plurality of care instructions based on the SpO2 of the infant (see [0172, 0179] SpO2 alerts, based on continuously monitored SpO2); and display the plurality of care instructions on the display device. ([0179: last 2 sentences] displays alert; also see Fig. 59: 252)
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 2, 6 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Gibson as applied to claim 1, and further in view of Lynn et al. US 2013/0338459 A1 (hereinafter “Lynn”).
Regarding claim 2, Gibson discloses the infant warming system of claim 1 comprising setting upper and lower limits for SpO2 alarm, e.g. 90 % and 100% (as shown in Figs. 38-39), but does not explicitly disclose: determine a second care stage following execution of the first care instruction, wherein the SpO2 remains below the one or more target saturation levels; and generate a second care instruction based on the second care stage.
Lynn, another prior art reference in the analogous art discloses setting “a different threshold for the fall and the rise and/or for a rise following a fall a specified period (such as a time period)” ([0356]). Lynn provides that setting different threshold associated with respect to a time period can be taken to infer severity of desaturation in the patient ([0356]). Accordingly, it would have been obvious to a person of ordinary skill in the art at the time of invention to modify Gibson to include Lynn’s plurality of threshold and associated time period, so as to determine a second care stage following execution of the first case instruction, wherein the SpO2 remains below the one or more target saturation levels, and to generate a second are instruction based on the second care stage; the motivation for doing so is to determine severity levels and to then apply issue the appropriate alarm. (Lynn: [0356-0357] issue alarm based on threshold and time factor; also see Lynn [0226: last sentence] “These are provided in a graphical format to be immediately available to the nurse and physician at the bedside during the resuscitation efforts so that the physician is immediately aware if hyperventilation, or oxygen desaturation preceded the arrhythmia (which can mean that alternative therapy is indicated.”)
Regarding claim 6, Gibson modified discloses the infant warming system of claim 2, wherein the user interface includes a speaker (speaker 161) and the first care instruction, the second care instruction, or a combination thereof comprises an audible instruction of the SpO2 of the infant. (Gibson: [0177] audible alarm)
Regarding claim 8, Gibson modified discloses the infant warming system of claim 2, wherein the first care instruction, the second care instruction, or a combination thereof includes a visual instruction. (Gibson: [0181: last sentence] visual alarm indicators)
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Gibson as applied to claim 1, and further in view of Baker Jr. US 2009/0171167 A1 (hereinafter “Baker”).
Regarding claim 5, Gibson discloses the infant warming system of claim 1, wherein the processor is to detect SpO2, and comparing the detected SpO2 to a pre-determined or physician determined threshold; Gibson does not disclose wherein the system calculate the one or more activation thresholds based at least in part on a time of life of the infant.
Baker, another prior art reference in the analogous art of pulse oximetry monitoring devices, discloses a device for determining patient-specific alarm threshold for monitoring a patient’s physiological parameters. Baker discloses calculating, for a neonate, a high saturation alarm threshold, based on gestational age or weight ([0036]). It would have been obvious to a person of ordinary skill in the art at the time of invention to modify Gibson’s predetermine saturation threshold levels in view of Baker, to recalculate based on a neonate’s gestation age and weight; the motivation for doing so is because neonates have different physiology compared to adults, and thus require different alarm settings accordingly (Baker: [0036]).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Gibson as applied to claim 1 above, and further in view of John et al. US 2007/0213600 A1 (hereinafter “John”).
Regarding claim 10, Gibson discloses the infant warming system of claim 9, wherein the processor is further configured to: detect an acknowledgment of execution of the one or more care instruction; wherein the detecting comprises detecting an audible care option selection recorded by the microphone ([0179] and Fig. 59: 864). Gibson does not disclose wherein the infant care station further comprises a microphone to record audible inputs from a user.
John, a prior art reference in the analogous field of monitoring devices, discloses a medical alarm system adapted for communicating a patient’s alarm condition to a physician, the system comprising a microphone for recording voice, messages, and for receiving verbal commands (via speech recognition software) from a physician or patient of the system, see [0035]. It would have been obvious to a person of ordinary skill in the art at the time of invention to modify Gibson to include a microphone and having speech to text processing in view of John, the motivation for doing so is to verbally receive the command of a user. This is because it is known that during emergency or alarm condition, an operator’s hand (such as a physician) would be occupied-preventing him/her from manually controlling the monitoring device. Thus, implementing a microphone for receiving verbal commands would be more convenient in emergency situations.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHIRLEY X JIAN whose telephone number is (571)270-7374. The examiner can normally be reached M-F 8:00-4:00.
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/SHIRLEY X JIAN/ Primary Examiner, Art Unit 3792
June 22, 2026
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