DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim 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 1-22 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claim(s) recite(s) the processor is configured to determine minute ventilation (MV) and percent of MV predicted in real time based on the detected bioimpedance, wherein the percent of MV predicted is based on a ratio of the MV and a predicted MV of the patient; and wherein the at least one GUI outputs the determined percent of MV predicted in real time. These limitations, as drafted, are processes that, under their broadest reasonable interpretations, cover performances of these limitations in the mind but for the recitation of generic computer components. That is, other than reciting “a computing device”, “processor”, “GUI”, and “at least one sensor”, nothing in the claim element precludes the limitations from practically being performed in the mind. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
This judicial exception is not integrated into a practical application. In particular, the claim recites additional elements- “a computing device”, “processor”, “GUI”, and “at least one sensor” is recited at high-level of generality; these elements amount no more than mere instructions to apply the exception using a generic computer component. Accordingly, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. The claim(s) is directed to an abstract idea.
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional elements of using a sensor adapted to detect bioimpedance signals, and using a processor to process the detected signals; amount to no more than mere instructions to apply the exception using a generic biosensor and a generic computer component. Mere instructions to apply an exception using a sensor and a generic computer component cannot provide an inventive concept. The claim(s) is not patent eligible.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-22 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of U.S. Patent No. 11,723,542. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the instant application are broader than those of the Patent. As, such, any invention meeting the limitations of the claims of the Patent would necessarily meet those of the instant application as well.
Claims 1-22 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12,121,334. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the instant application are broader than those of the Patent. As, such, any invention meeting the limitations of the claims of the Patent would necessarily meet those of the instant application as well.
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.
Claim(s) 1-22 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Freeman et al. (USPN 2012/0302910-Cited by the Applicant).
Regarding claim 1, a respiratory monitoring system, comprising: a computing device, wherein the computing device comprises: a processor ([0039], [0016], [0046], [0060]]); at least one graphical user interface (GUI) in communication with the processor ([0039], [0016], [0046], [0060]]); and at least one sensor adapted to detect bioimpedance signals and in communication with the processor ([0039], [0016], [0046], [0060]]); wherein the processor is configured to determine minute ventilation (MV) and percent of MV predicted in real time based on the detected bioimpedance, wherein the percent of MV predicted is based on a ratio of the MV and a predicted MV of the patient ([0039], [0016], [0046], [0060]]); and wherein the at least one GUI outputs the determined percent of MV predicted in real time ([0039], [0016], [0046], [0060]]).
Regarding claim 2, the at least one GUI is configured to provide an indication of at least one of hyperventilation, normal ventilation, and hypoventilation ([0039], [0016], [0046], [0060]]).
Regarding claim 3, the at least one GUI is configured to provide an indication of at least one hypoventilation, change in respiratory signal waveform, change in inspiratory expiratory ratio, and development of an inspiratory plateau, based on opioid induced respiratory depression ([0039], [0016], [0046], [0060]]).
Regarding claim 4, the processor is configured to provide continuous measurement of ventilation within one minute of entering patient demographics into the computing device ([0039], [0016], [0046], [0060]]).
Regarding claim 5, the demographics are at least one of height, weight and gender of the patient ([0039], [0016], [0046], [0060]]).
Regarding claim 6, the processor is configured to provide continuous measurement of ventilation without the need for patient specific calibration to a ventilator or a baseline when the patient is breathing normally ([0039], [0016], [0046], [0060]]).
Regarding claim 7, the processor is configured to provide continuous measurement of ventilation as soon as the sensor is attached to the computing device while in use and without entering demographic data ([0039], [0016], [0046], [0060]]).
Regarding claim 8, the processor is configured to determine the MV and percent of MV predicted without requiring control over the patient's breathing ([0039], [0016], [0046], [0060]]).
Regarding claim 9, the processor is configured to determine the MV and percent of MV predicted without requiring calibration of the processor to a known ventilator, spirometer, or pneumotachometer reading ([0039], [0016], [0046], [0060]]).
Regarding claim 10, the computing device further comprises a HR-RR cutoff filter ([0072], [0081]).
Regarding claim 11, the HR-RR cutoff filter filters respiratory and cardiac signals based on a heat rate cutoff point ([0072], [0081]).
Regarding claim 12, the heart rate cutoff point is one of 30, 40, 50, or 60 beats per minute (bpm) ([0072], [0081]).
Regarding claim 13, the heart rate cutoff point is based on at least one of patient demographics, MV or percentages of predicted MV, and a rapid shallow breathing index ([0072], [0081]).
Regarding claim 14, the heart rate cutoff point is entered manually into the HR-RR filter or is automatically updated by the processor ([0072], [0081]).
Regarding claim 15, the HR-RR cutoff filter provides at least one of a measure of gain of the bioimpedance signals, a scaling factor for an absolute value of bioimpedance trace displayed on the at least one GUI, an indication of a decrease in tidal volume, an indication of sedation level, and a diagnosis of respiratory disease ([0072], [0081]).
Regarding claim 16, at least one audible or visual alarm ([0049]).
Regarding claim 17, the at least one audible or visual alarm is configured to issue an alert based on at least one of patient disease state, physician assessment, clinical or treatment environment, additional physiologic measurements, or an external reference ([0049]).
Regarding claim 18, the at least one audible or visual alarm is configured to be adaptive ([0049]).
Regarding claim 19, the predicted MV is based on patients' height, weight, and gender ([0039], [0016], [0046], [0060]]).
Regarding claim 20, the system is adapted for use on the patient when the patient is one of awake, unconscious, alert, in extremis, intubated on a ventilator, in respiratory distress, or after sedation ([0039], [0016], [0046], [0060]]).
Regarding claim 21, the system is for non-invasive use ([0039], [0016], [0046], [0060]]).
Regarding claim 22, the sensor is an electrode padset comprising a patient cable coupling the electrode padset to the computing device, wherein the patient cable is adapted to transmit a high frequency current to the patient via the electrode padset ([0039], [0016], [0046], [0060]]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARJAN FARDANESH whose telephone number is (571)270-5508. The examiner can normally be reached Monday-Friday 9:00-17:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jacqueline Cheng can be reached at (571)272-5596. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARJAN FARDANESH/Primary Examiner, Art Unit 3791
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