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 .
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant' s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
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 267-290 of US Application No. 18/989308 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-29 of U.S. Patent No. 12,214,130 in view of US 9004069 B2 to Efrati et al. (hereinafter, Efrati), claims 1-29 of U.S. Patent No. 11,904,095 in view of US 9004069 B2 to Efrati et al. (hereinafter, Efrati) and claims 1-49 of U.S. Patent No. 11,229,760 in view of US 9004069 B2 to Efrati et al. (hereinafter, Efrati).
Regarding Claim 267:
Application 18/989308
United States Patent 12,214,130
United States Patent 12,214,130
United States Patent 11,904,095
United States Patent 11,229,760
Claim 267
Claim 1
Claim 17
Claim 1
Claim 1
A medical system for assisting a rescuer during an airway procedure for a patient with an endotracheal (ET) tube implemented by a processor of a patient monitoring device, the system comprising:
A medical system for assisting a rescuer with an intubation procedure with an endotracheal (ET) tube for a patient, the system comprising:
A method, executed by a processor of a patient monitoring device, the patient monitoring device comprising the processor and a memory, for assisting a rescuer with an intubation procedure with an endotracheal (ET) tube for a patient, the method comprising:
A medical system for assisting a rescuer with an intubation procedure for a patient, the system comprising:
a medical system for assisting a rescuer with an intubation procedure for a patient, the system comprising:
one or more sensors configured to obtain data indicative of airflow in the patient's airway, comprising one or more capnography sensors configured to obtain CO2 information regarding airflow in the patient's lungs; and
one or more airflow sensors configured to obtain data indicative of airflow in the patient's airway and data indicative of inspiratory tidal volume and expiratory tidal volume; one or more physiological sensors to obtain configured to obtain physiological information regarding airflow in the patient's lungs; and
obtaining from one or more airflow sensors coupled to the patient monitoring device, and storing in the memory of the patient monitoring device, data indicative of airflow in the patient's airway and data indicative of inspiratory tidal volume and expiratory tidal volume; obtaining from one or more physiological sensors coupled to the patient monitoring device, and storing in the memory of the patient monitoring device, physiological information regarding airflow in the patient's lungs;
one or more airflow sensors configured to obtain data indicative of airflow in the patient's airway; one or more capnography sensors configured to obtain C02 information regarding airflow in the patient's lungs;
one or more airflow sensors configured to obtain data indicative of airflow in the patient's airway; one or more physiological sensors configured to obtain physiological information regarding airflow in the patient's lungs;
the patient monitoring device communicatively coupled to the one or more sensors, the patient monitoring device comprising: a user interface comprising a display, and
a patient monitoring device communicatively coupled to the one or more airflow sensors, the patient monitoring device comprising: a user interface comprising a display; and
one or more airflow sensors coupled to the patient monitoring device, and storing in the memory of the patient monitoring device,
a patient monitoring device communicatively coupled to the one or more airflow sensors and the one or more capnography sensors, the patient monitoring device comprising: a user interface comprising a display; and
a patient monitoring device communicatively coupled to the one or more airflow sensors and the one or more physiological sensors, the patient monitoring device comprising: a user interface comprising a display;
the processor configured to: receive the data indicative of the airflow in the patient’s airway,
at least one processor and memory configured to: receive the data indicative of airflow in the patient's airway
storing in the memory of the patient monitoring device, data indicative of airflow in the patient's airway
at least one processor and memory configured to: receive the data indicative of the airflow in the patient’s airway,
at least one processor and memory configured to: receive the data indicative of the airflow in the patient's airway,
receive the CO2 information regarding the airflow in the patient’s lungs,
and the physiological information regarding airflow in the patient's lungs,
and storing in the memory of the patient monitoring device, physiological information regarding airflow in the patient's lungs;
determine the presence of airflow in the patient’s airway based on the received data, receive the CO2 information regarding the airflow in the patient’s lungs
determine the presence of airflow in the patient's airway based on the received data, receive the physiological information regarding the airflow in the patient's lungs,
determine that a leak may be present in relation to the ET tube based at least in part on the received CO2 information, and
determine presence of airflow in the patient’s airway based on the data indicative of airflow, analyze the physiological information regarding airflow in the patient’s lungs to provide an indication of ET tube placement, determine that a leak may be present in relation to the ET tube based on an analysis of the expiratory tidal volume relative to the inspiratory tidal volume
determining presence of airflow in the patient's airway based on the data indicative of airflow in the patient's lungs; analyzing the physiological information regarding airflow in the patient's lungs to provide an indication of ET tube placement; determining that a leak may be present in relation to the ET tube based on an analysis of the expiratory tidal volume relative to the inspiratory tidal volume;
determine whether the ET tube remains properly placed based on the received CO2 information
determine a physiological baseline regarding airflow in the patient's lungs after placement of the ET tube, determine whether the ET tube remains properly placed based on a deviation from the physiological baseline,
present to the display of the user interface an output of the determination that the leak may be present.
based on the indication of ET tube placement and the determination that the leak may be present in relation to the ET tube output to the display of the user interface an alert to check the ET tube in relation to the leak that may be present
outputting based on the indication of ET tube placement and the determination that the leak may be present in relation to the ET tube, to a display of a user interface of the patient monitoring device, an alert to check the ET tube in relation to the leak that may be present.
present to the display of the user interface an output of the determination of whether the ET tube remains properly placed
present to the display of the user interface an output of the determination of whether the ET tube remains properly placed.
U.S. Patent No. 12,214,130 fails to claim that the physiological information is CO2 information, rather specifically claiming expiratory tidal volume relative to inspiratory tidal volume, and that determination that a leak may be present is based on CO2 information.
Efrati teaches receiving CO2 information regarding airflow in a patient’s lungs (Efrati: Col. 14, line 43-Col. 15; Col. 11, lines 43-55, Col. 25, lines 19-22, 52-53) and the determination that a leak is present based on said CO2 information (Efrati: Col. 8, lines 5-20, Col. 12, lines 21-40).
One of ordinary skill in the art at the time the invention was filed would have found it obvious to include the teachings of Efrati to evaluate several measures based on CO2 information beyond tidal volumes to detect leaks as taught by Efrati for early detection of leaks (Efrati: Col. 10, lines 56-64) and to minimize leakage occurrence (Efrati: Col. 3, lines 23-34).
U.S. Patent No. 12,214,130 fails to claim that the physiological information is CO2 information, rather specifically claiming expiratory tidal volume relative to inspiratory tidal volume, and that determination that a leak may be present is based on CO2 information.
Efrati teaches receiving CO2 information regarding airflow in a patient’s lungs (Efrati: Col. 14, line 43-Col. 15; Col. 11, lines 43-55, Col. 25, lines 19-22, 52-53) and the determination that a leak is present based on said CO2 information (Efrati: Col. 8, lines 5-20, Col. 12, lines 21-40).
One of ordinary skill in the art at the time the invention was filed would have found it obvious to include the teachings of Efrati to evaluate several measures based on CO2 information beyond tidal volumes to detect leaks as taught by Efrati for early detection of leaks (Efrati: Col. 10, lines 56-64) and to minimize leakage occurrence (Efrati: Col. 3, lines 23-34).
U.S. Patent No. 11,904,095 fails to claim determining that a leak may be present in relation to the ET tube based at least in part on the received CO2 information.
Efrati teaches determining that a leak may be present based at least in part on the received CO2 information (Efrati: Col. 8, lines 5-20, Col. 12, lines 21-40).
One of ordinary skill in the art at the time the invention was filed would have found it obvious to include the teachings of Efrati to evaluate several measures based on CO2 information specifically to detect leaks as taught by Efrati for early detection of leaks (Efrati: Col. 10, lines 56-64) and to minimize leakage occurrence (Efrati: Col. 3, lines 23-34).
U.S. Patent No. 11,229,760 fails to claim that the physiological information is CO2 information, and determination that a leak may be present based on the CO2 information.
Efrati teaches receiving CO2 information regarding airflow in a patient’s lungs (Efrati: Col. 14, line 43-Col. 15; Col. 11, lines 43-55, Col. 25, lines 19-22, 52-53) and the determination that a leak is present based on said CO2 information (Efrati: Col. 8, lines 5-20, Col. 12, lines 21-40).
One of ordinary skill in the art at the time the invention was filed would have found it obvious to include the teachings of Efrati to evaluate several measures based on CO2 information beyond tidal volumes to detect leaks as taught by Efrati for early detection of leaks (Efrati: Col. 10, lines 56-64) and to minimize leakage occurrence (Efrati: Col. 3, lines 23-34).
Regarding Claim 279:
Application 18/989308
United States Patent 12,214,130
United States Patent 12,214,130
United States Patent 11,904,095
United States Patent 11,229,760
Claim 279
Claim 1
Claim 17
Claim 1
Claim 1
A method for assisting a rescuer during an airway procedure for a patient with an endotracheal (ET) tube, executed by a processor of a patient monitoring device, the method comprising:
A medical system for assisting a rescuer with an intubation procedure with an endotracheal (ET) tube for a patient, the system comprising:
A method, executed by a processor of a patient monitoring device, the patient monitoring device comprising the processor and a memory, for assisting a rescuer with an intubation procedure with an endotracheal (ET) tube for a patient, the method comprising:
A medical system for assisting a rescuer with an intubation procedure for a patient, the system comprising:
a medical system for assisting a rescuer with an intubation procedure for a patient, the system comprising:
obtaining, from one or more sensors communicatively coupled to the patient monitoring device, the one or more sensors comprising one or more capnography sensors, data indicative of airflow in the patient's airway and CO2 information regarding airflow in the patient's lungs;
one or more airflow sensors configured to obtain data indicative of airflow in the patient's airway and data indicative of inspiratory tidal volume and expiratory tidal volume; one or more physiological sensors to obtain configured to obtain physiological information regarding airflow in the patient's lungs; and
obtaining from one or more airflow sensors coupled to the patient monitoring device, and storing in the memory of the patient monitoring device, data indicative of airflow in the patient's airway and data indicative of inspiratory tidal volume and expiratory tidal volume; obtaining from one or more physiological sensors coupled to the patient monitoring device, and storing in the memory of the patient monitoring device, physiological information regarding airflow in the patient's lungs;
one or more airflow sensors configured to obtain data indicative of airflow in the patient's airway; one or more capnography sensors configured to obtain C02 information regarding airflow in the patient's lungs;
one or more airflow sensors configured to obtain data indicative of airflow in the patient's airway; one or more physiological sensors configured to obtain physiological information regarding airflow in the patient's lungs;
determining a presence of the airflow in the patient's airway based on the obtained data indicative of the airflow in the patient's airway;
determine presence of airflow in the patient’s airway based on the data indicative of airflow,
determining presence of airflow in the patient's airway based on the data indicative of airflow in the patient's lungs; analyzing the physiological information regarding airflow in the patient's lungs to provide an indication of ET tube placement;
determine the presence of airflow in the patient’s airway based on the received data, receive the CO2 information regarding the airflow in the patient’s lungs
determine the presence of airflow in the patient's airway based on the received data, receive the physiological information regarding the airflow in the patient's lungs,
determining that a leak may be present in relation to the ET tube based at least in part on the obtained CO2 information;
analyze the physiological information regarding airflow in the patient’s lungs to provide an indication of ET tube placement, determine that a leak may be present in relation to the ET tube based on an analysis of the expiratory tidal volume relative to the inspiratory tidal volume
determining that a leak may be present in relation to the ET tube based on an analysis of the expiratory tidal volume relative to the inspiratory tidal volume;
determine whether the ET tube remains properly placed based on the received CO2 information
determine a physiological baseline regarding airflow in the patient's lungs after placement of the ET tube, determine whether the ET tube remains properly placed based on a deviation from the physiological baseline,
presenting, via a display of a user interface of the patient monitoring device, an output of the determination that the leak may be present.
based on the indication of ET tube placement and the determination that the leak may be present in relation to the ET tube output to the display of the user interface an alert to check the ET tube in relation to the leak that may be present
outputting based on the indication of ET tube placement and the determination that the leak may be present in relation to the ET tube, to a display of a user interface of the patient monitoring device, an alert to check the ET tube in relation to the leak that may be present.
present to the display of the user interface an output of the determination of whether the ET tube remains properly placed
present to the display of the user interface an output of the determination of whether the ET tube remains properly placed.
U.S. Patent No. 12,214,130 fails to claim that the physiological information is CO2 information, rather specifically claiming expiratory tidal volume relative to inspiratory tidal volume, and that determination that a leak may be present is based on CO2 information.
Efrati teaches receiving CO2 information regarding airflow in a patient’s lungs (Efrati: Col. 14, line 43-Col. 15; Col. 11, lines 43-55, Col. 25, lines 19-22, 52-53) and the determination that a leak is present based on said CO2 information (Efrati: Col. 8, lines 5-20, Col. 12, lines 21-40).
One of ordinary skill in the art at the time the invention was filed would have found it obvious to include the teachings of Efrati to evaluate several measures based on CO2 information beyond tidal volumes to detect leaks as taught by Efrati for early detection of leaks (Efrati: Col. 10, lines 56-64) and to minimize leakage occurrence (Efrati: Col. 3, lines 23-34).
U.S. Patent No. 12,214,130 fails to claim that the physiological information is CO2 information, rather specifically claiming expiratory tidal volume relative to inspiratory tidal volume, and that determination that a leak may be present is based on CO2 information.
Efrati teaches receiving CO2 information regarding airflow in a patient’s lungs (Efrati: Col. 14, line 43-Col. 15; Col. 11, lines 43-55, Col. 25, lines 19-22, 52-53) and the determination that a leak is present based on said CO2 information (Efrati: Col. 8, lines 5-20, Col. 12, lines 21-40).
One of ordinary skill in the art at the time the invention was filed would have found it obvious to include the teachings of Efrati to evaluate several measures based on CO2 information beyond tidal volumes to detect leaks as taught by Efrati for early detection of leaks (Efrati: Col. 10, lines 56-64) and to minimize leakage occurrence (Efrati: Col. 3, lines 23-34).
U.S. Patent No. 11,904,095 fails to claim determining that a leak may be present in relation to the ET tube based at least in part on the received CO2 information.
Efrati teaches determining that a leak may be present based at least in part on the received CO2 information (Efrati: Col. 8, lines 5-20, Col. 12, lines 21-40).
One of ordinary skill in the art at the time the invention was filed would have found it obvious to include the teachings of Efrati to evaluate several measures based on CO2 information specifically to detect leaks as taught by Efrati for early detection of leaks (Efrati: Col. 10, lines 56-64) and to minimize leakage occurrence (Efrati: Col. 3, lines 23-34).
U.S. Patent No. 11,229,760 fails to claim that the physiological information is CO2 information, and determination that a leak may be present based on the CO2 information.
Efrati teaches receiving CO2 information regarding airflow in a patient’s lungs (Efrati: Col. 14, line 43-Col. 15; Col. 11, lines 43-55, Col. 25, lines 19-22, 52-53) and the determination that a leak is present based on said CO2 information (Efrati: Col. 8, lines 5-20, Col. 12, lines 21-40).
One of ordinary skill in the art at the time the invention was filed would have found it obvious to include the teachings of Efrati to evaluate several measures based on CO2 information beyond tidal volumes to detect leaks as taught by Efrati for early detection of leaks (Efrati: Col. 10, lines 56-64) and to minimize leakage occurrence (Efrati: Col. 3, lines 23-34).
Claim Objections
Claim 288 is objected to because of the following informalities:
Claim 288, ‘comprising determining that the baseline as a dynamic baseline’ should read ‘comprising determining the baseline as a dynamic baseline’.
Appropriate correction is required.
Claim Rejections - 35 USC § 101
Claims 267-290 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Each of Claims 267-290 has been analyzed to determine whether it is directed to any judicial exceptions.
Step 2A, Prong 1
Each of Claims 267-290 recites at least one step or instruction for obtaining data, making determinations based on the obtained data, and outputting the determination made, which is grouped as a mental process under the 2019 PEG or a certain method of organizing human activity under the 2019 PEG.
Accordingly, each of Claims 267-290 recites an abstract idea.
Specifically,
Claim 267: A medical system for assisting a rescuer during an airway procedure for a patient with an endotracheal (ET) tube, implemented by a processor of a patient monitoring device, the system comprising: one or more sensors configured to obtain data indicative of airflow in the patient's airway (Observation), comprising one or more capnography sensors configured to obtain CO2 information regarding airflow in the patient's lungs (Observation); and the patient monitoring device communicatively coupled to the one or more sensors, the patient monitoring device comprising: a user interface comprising a display, and the processor configured to:
receive the data indicative of the airflow in the patient's airway (Observation),
determine a presence of the airflow in the patient's airway based on the received data indicative of the airflow in the patient's airway (Observation, Judgement, Evaluation/Opinion),
receive the CO2 information regarding the airflow in the patient's lungs (Observation),
determine that a leak may be present in relation to the ET tube based at least in part on the received CO2 information (Observation, Judgement, Evaluation/Opinion), and
present to the display of the user interface an output of the determination that the leak may be present (Observation).
Claim 279: A method for assisting a rescuer during an airway procedure for a patient with an endotracheal (ET) tube, executed by a processor of a patient monitoring device, the method comprising:
obtaining, from one or more sensors communicatively coupled to the patient monitoring device, the one or more sensors comprising one or more capnography sensors, data indicative of airflow in the patient's airway and CO2 information regarding airflow in the patient's lungs (Observation);
determining a presence of the airflow in the patient's airway based on the obtained data indicative of the airflow in the patient's airway (Judgement, Evaluation/Opinion);
determining that a leak may be present in relation to the ET tube based at least in part on the obtained CO2 information (Judgement, Evaluation/Opinion); and
presenting, via a display of a user interface of the patient monitoring device, an output of the determination that the leak may be present (Observation).
The underlined portions of which are grouped as a mental process under the 2019 PEG, annotated with abstract ideas grouped as a mental process under the 2019 PEG such as observation, judgement, evaluations and opinions. The additional elements used to perform the abstract ideas are seen as generically recited elements conducting extra solution activity and are annotated via bold text: (additional element); (Observation) (Judgement) (Evaluation/Opinion)
Further, dependent Claims 268-278 & 280-290 merely include limitations that either further define the abstract idea (and thus don’t make the abstract idea any less abstract) or amount to no more than generally linking the use of the abstract idea to a particular technological environment or field of use because they’re merely incidental or token additions to the claims that do not alter or affect how the process steps are performed.
Accordingly, as indicated above, each of the above-identified claims recites an abstract idea.
Step 2A, Prong 2
The above-identified abstract idea in each of independent Claims 267 & 279 (and their respective dependent Claims 268-278 & 280-290) is not integrated into a practical application under 2019 PEG because the additional elements (identified above in independent Claims 267 & 279), either alone or in combination, generally link the use of the above-identified abstract idea to a particular technological environment or field of use. More specifically, the additional elements of: endotracheal tube; a processor; patient monitoring device; one or more sensors; one or more capnography sensors; a user interface; display are generically recited computer elements in independent Claims 267 & 279 (and their respective dependent claims) which do not improve the functioning of a computer, or any other technology or technical field. Nor do these above-identified additional elements serve to apply the above-identified abstract idea with, or by use of, a particular machine, effect a transformation or apply or use the above-identified abstract idea in some other meaningful way beyond generally linking the use thereof to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception. Furthermore, the above-identified additional elements do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. For at least these reasons, the abstract idea identified above in independent Claims 267 & 279 (and their respective dependent claims) is not integrated into a practical application under 2019 PEG.
Moreover, the above-identified abstract idea is not integrated into a practical application under 2019 PEG because the claimed method and system merely implements the above-identified abstract idea (e.g., mental process and certain method of organizing human activity) using rules (e.g., computer instructions) executed by a computer (e.g., processor as claimed). In other words, these claims are merely directed to an abstract idea with additional generic computer elements which do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. Additionally, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. That is, like Affinity Labs of Tex. v. DirecTV, LLC, the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution. Thus, for these additional reasons, the abstract idea identified above in independent Claims 267 & 279 (and their respective dependent claims) is not integrated into a practical application under the 2019 PEG.
Accordingly, independent Claims 267 & 279 (and their respective dependent claims) are each directed to an abstract idea under 2019 PEG.
Step 2B
None of Claims 267-290 include additional elements that are sufficient to amount to significantly more than the abstract idea for at least the following reasons.
These claims require the additional elements of: endotracheal tube; a processor; patient monitoring device; one or more sensors; one or more capnography sensors; a user interface; display.
The above-identified additional elements are generically claimed computer components which enable the above-identified abstract idea(s) to be conducted by performing the basic functions of automating mental tasks. The courts have recognized such computer functions as well understood, routine, and conventional functions when claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity. See, Versata Dev. Group, Inc. v. SAP Am., Inc. , 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); and OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93.
Per Applicant’s specification, endotracheal tube (Para. [0003]); a processor (Para. [0051-0052]); patient monitoring device (Para. [0018-0019]); one or more sensors (Para. [0005-0007], [0015-0016]); one or more capnography sensors (Para. [0015-0016]); a user interface (Para. [0014]); display (Para. [0014]).
Accordingly, in light of Applicant’s specification, the claimed term processor is reasonably construed as a generic computing device. Like SAP America vs Investpic, LLC (Federal Circuit 2018), it is clear, from the claims themselves and the specification, that these limitations require no improved computer resources, just already available computers, with their already available basic functions, to use as tools in executing the claimed process.
Furthermore, Applicant’s specification does not describe any special programming or algorithms required for the processor. This lack of disclosure is acceptable under 35 U.S.C. §112(a) since this hardware performs non-specialized functions known by those of ordinary skill in the computer arts. By omitting any specialized programming or algorithms, Applicant's specification essentially admits that this hardware is conventional and performs well understood, routine and conventional activities in the computer industry or arts. In other words, Applicant’s specification demonstrates the well-understood, routine, conventional nature of the above-identified additional elements because it describes these additional elements in a manner that indicates that the additional elements are sufficiently well-known that the specification does not need to describe the particulars of such additional elements to satisfy 35 U.S.C. § 112(a) (see Berkheimer memo from April 19, 2018, (III)(A)(1) on page 3). Adding hardware that performs “‘well understood, routine, conventional activit[ies]’ previously known to the industry” will not make claims patent-eligible (TLI Communications).
The recitation of the above-identified additional limitations in Claims 267-290 amounts to mere instructions to implement the abstract idea on a computer. Simply using a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) or simply adding a general purpose computer or computer components after the fact to an abstract idea (e.g., a fundamental economic practice or mathematical equation) does not provide significantly more. See Affinity Labs v. DirecTV, 838 F.3d 1253, 1262, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016) (cellular telephone); and TLI Communications LLC v. AV Auto, LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (computer server and telephone unit). Moreover, implementing an abstract idea on a generic computer, does not add significantly more, similar to how the recitation of the computer in the claim in Alice amounted to mere instructions to apply the abstract idea of intermediated settlement on a generic computer.
A claim that purports to improve computer capabilities or to improve an existing technology may provide significantly more. McRO, Inc. v. Bandai Namco Games Am. Inc., 837 F.3d 1299, 1314-15, 120 USPQ2d 1091, 1101-02 (Fed. Cir. 2016); and Enfish, LLC v. Microsoft Corp., 822 F.3d 1327, 1335-36, 118 USPQ2d 1684, 1688-89 (Fed. Cir. 2016). However, a technical explanation as to how to implement the invention should be present in the specification for any assertion that the invention improves upon conventional functioning of a computer, or upon conventional technology or technological processes. That is, the disclosure must provide sufficient details such that one of ordinary skill in the art would recognize the claimed invention as providing an improvement. Here, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. Instead, as in Affinity Labs of Tex. v. DirecTV, LLC 838 F.3d 1253, 1263-64, 120 USPQ2d 1201, 1207-08 (Fed. Cir. 2016), the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution.
For at least the above reasons, the systems and methods of Claims 267-290 are directed to applying an abstract idea as identified above on a general purpose computer without (i) improving the performance of the computer itself, or (ii) providing a technical solution to a problem in a technical field. None of Claims 267-290 provides meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that these claims amount to significantly more than the abstract idea itself.
Taking the additional elements individually and in combination, the additional elements do not provide significantly more. Specifically, when viewed individually, the above-identified additional elements in independent Claims 267 & 279 (and their dependent claims) do not add significantly more because they are simply an attempt to limit the abstract idea to a particular technological environment. That is, neither the general computer elements nor any other additional element adds meaningful limitations to the abstract idea because these additional elements represent insignificant extra-solution activity. When viewed as a combination, these above-identified additional elements simply instruct the practitioner to implement the claimed functions with well-understood, routine and conventional activity specified at a high level of generality in a particular technological environment. As such, there is no inventive concept sufficient to transform the claimed subject matter into a patent-eligible application. When viewed as whole, the above-identified additional elements do not provide meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that the claims amount to significantly more than the abstract idea itself. Thus, Claims 267-290 merely apply an abstract idea to a computer and do not (i) improve the performance of the computer itself (as in Bascom and Enfish), or (ii) provide a technical solution to a problem in a technical field (as in DDR).
Therefore, none of the Claims 267-290 amounts to significantly more than the abstract idea itself. Accordingly, Claims 267-290 are not patent eligible and rejected under 35 U.S.C. 101.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(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.
Claim(s) 267-269, 271, 276-277, 279-281, 283 and 288-289 is/are rejected under 35 U.S.C. 102(a)(1) as anticipated by US 9004069 B2 to Efrati et al. (hereinafter, Efrati)
Regarding Claim 267, Efrati discloses a medical system for assisting a rescuer during an airway procedure for a patient with an endotracheal (ET) tube, implemented by a processor (Efrati: Col. 8, lines 5-20) of a patient monitoring device (Efrati: Abstract), the system comprising:
one or more sensors configured to obtain data indicative of airflow in the patient's airway (Efrati: Col. 14, line 43-Col. 15, line 9; Col. 11, lines 43-55, Col. 25, lines 19-22),
comprising one or more capnography sensors configured to obtain CO2 information regarding airflow in the patient's lungs (Efrati: Col. 14, line 63-Col. 15, line 9; Col. 25, lines 19-22, 52-53); and
the patient monitoring device communicatively coupled to the one or more sensors (Efrati: Col. 23, lines 1-10),
the patient monitoring device comprising: a user interface comprising a display (Efrati: Col. 23, lines 25-29), and
the processor Efrati: (Col. 8, lines 5-20) configured to:
receive the data indicative of the airflow in the patient's airway (Efrati: Col. 14, lines 20-56 ‘the leakage-indicating measure can be any quantity whose level is in correlation with leakage of secretions past cuff to the lungs… The partial CO.sub.2 pressure exhaled of the lungs is typically 30-40 mm Hg (in a healthy person), while the ambient partial CO.sub.2 pressure is about 0.26-0.32 mm Hg. As shown in FIG. 4b, there are different pressure drops between different locations along the path starting from the cuff and ending at the ambient environment (as function of the leaking the volumetric leaking rate).’; Fig. 4a-b; Col. 25, lines 19-22; Fig. 3a),
determine a presence of the airflow in the patient's airway based on the received data indicative of the airflow in the patient's airway (Efrati: Col. 25, lines 19-22),
receive the CO2 information regarding the airflow in the patient's lungs (Efrati: Col. 12, lines 21-34; Fig. 3a, step 35),
determine that a leak may be present in relation to the ET tube based at least in part on the received CO2 information (Efrati: Col. 12, lines 21-23), and
present to the display of the user interface an output of the determination that the leak may be present (Efrati: Col. 5, lines 22-30, Col. 12, line 66-Col. 13, line 11, Col. 23, line 30-33; Note: The optimal level defines the threshold for leak detection, and the alerting unit produces an alert when the level of the measure exceeds the optimal level (i.e., a leakage determination)).
Regarding Claim 279, Efrati discloses a method for assisting a rescuer during an airway procedure for a patient with an endotracheal (ET) tube, executed by a processor (Efrati: Col. 8, lines 5-20) of a patient monitoring device (Efrati: Abstract), the method comprising:
obtaining, from one or more sensors communicatively coupled to the patient monitoring device, the one or more sensors comprising one or more capnography sensors (Efrati: Col. 14, line 63-Col. 15, line 9; Col. 25, lines 19-22, 52-53), data indicative of airflow in the patient's airway and CO2 information regarding airflow in the patient's lungs (Efrati: Col. 14, line 20-Col. 15, line 9 ‘the leakage-indicating measure can be any quantity whose level is in correlation with leakage of secretions past cuff to the lungs… The partial CO.sub.2 pressure exhaled of the lungs is typically 30-40 mm Hg (in a healthy person), while the ambient partial CO.sub.2 pressure is about 0.26-0.32 mm Hg. As shown in FIG. 4b, there are different pressure drops between different locations along the path starting from the cuff and ending at the ambient environment (as function of the leaking the volumetric leaking rate).’; Fig. 4a-b; Col. 25, lines 19-22);
determining a presence of the airflow in the patient's airway based on the obtained data indicative of the airflow in the patient's airway (Efrati: Col. 25, lines 19-22);
determining that a leak may be present in relation to the ET tube based at least in part on the obtained CO2 information (Efrati: Col. 12, lines 21-23); and
presenting, via a display of a user interface of the patient monitoring device, an output of the determination that the leak may be present (Efrati: Col. 5, lines 22-30, Col. 12, line 66-Col. 13, line 11, Col. 23, line 30-33; Note: The optimal level defines the threshold for leak detection, and the alerting unit produces an alert when the level of the measure exceeds the optimal level (i.e., a leakage determination)).
Regarding Claims 268 & 280, Efrati discloses the system of claim 267/method of claim 279, Efrati further discloses wherein the processor is configured to:
determine an ETCO2 baseline (Efrati: Col. 3, lines 39-43),
determine that the ETCO2 has deviated from the baseline by greater than a predetermined amount (Efrati: Col. 12, line 66-Col. 13, line 11), and
based at least in part on the determination that the ETCO2 has deviated from the baseline by greater than the predetermined amount, determine that the leak may be present (Efrati: Col. 5, lines 22-30, Col. 12, line 66-Col. 13, line 11, Col. 23, line 30-33; Note: The optimal level defines the threshold for leak detection, and the alerting unit produces an alert when the level of the measure exceeds the optimal level (i.e., a leakage determination)).
Regarding Claims 269 & 281, Efrati discloses the system of claim 268/method of claim 280, Efrati further discloses wherein the determination that the ETCO2 has deviated from the baseline by greater than the predetermined amount comprises determining a difference between an initial ETCO2 baseline and a current measured ETCO2 value (Efrati: Col. 4, lines 45-49).
Regarding Claim 271 & 283, Efrati discloses the system of claim 268/method of claim 281, Efrati further discloses wherein the predetermined amount comprises an amount of pressure (Efrati: Col. 4, lines 45-49).
Regarding Claim 276 & 288, Efrati discloses the system of claim 268/method of claim 280, Efrati further discloses wherein the ETCO2 baseline as a dynamic baseline (Efrati: Col. 3, lines 39-48).
Regarding Claim 277 & 289, Efrati in view of discloses the system of claim 276/method of claim 288, Efrati further discloses determining the dynamic baseline based on multiple ETCO2 values measured during the airway procedure (Efrati: Col. 3, lines 39-48; Col. 11, line 64-Col. 12, line 3).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 270, 272, 274-275, 282, 284 and 286-287 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 9004069 B2 to Efrati et al. (hereinafter, Efrati) in view of Schmalisch et al. (hereinafter, Schmalisch) Effect of endotracheal tube leak on capnographic measurements in a ventilated neonatal lung model 2012 Physiol. Meas. 33 1631 https://iopscience.iop.org/article/10.1088/0967-3334/33/10/1631/meta
DOI 10.1088/0967-3334/33/10/1631.
Regarding Claims 270 & 282, Efrati discloses the system of claim 268/method of claim 281, Efrati is silent on the predetermined amount comprising a percentage.
However, Schmalisch teaches wherein the predetermined amount comprises a percentage (Schmalisch: Pg. 1636-1637, ‘The effect of an ET leak on the magnitude of the exhaled CO2 is shown in figure 4. In ET leaks of up to 60% the PeCO2 error is independent on the respiratory rate, and in ET leaks of up to 20% cause an underestimation of the true PetCO2 <10% which may be tolerable for the most clinical applications.’, Fig. 4 ‘Relationship between the measuring error of the magnitude of the exhaled CO2 and the size of the ET leak.’.).
One of ordinary skill in the art at the time the invention was filed would have found it obvious to modify the system/method of Efrati to include representing the predetermined amount as a percentage a simple alternative to measured units of partial pressure to make graphical comparisons and for large ET leaks >60% the magnitude of the measured PeCO2 is lower than the half of the true value as taught by Schmalisch (Schmalisch: Pg. 1636-1637, ‘For large ET leaks >60% the magnitude of the measured PeCO2 is lower than the half of the true value’, Fig. 4).
Regarding Claim 272 & 284, Efrati in view of Schmalisch disclose the system of claim 270/method of claim 282, Efrati is silent on the predetermined amount being a percentage between 10% and 50%.
However, Schmalisch teaches wherein the percentage comprises a percentage between 10% and 50% (Schmalisch: Pg. 1636-1637, ‘The effect of an ET leak on the magnitude of the exhaled CO2 is shown in figure 4. In ET leaks of up to 60% the PeCO2 error is independent on the respiratory rate, and in ET leaks of up to 20% cause an underestimation of the true PetCO2 <10% which may be tolerable for the most clinical applications.’, Fig. 4 ‘Relationship between the measuring error of the magnitude of the exhaled CO2 and the size of the ET leak.’; Note the magnitude errors are expressed as percentages that are within the required range.).
One of ordinary skill in the art at the time the invention was filed would have found it obvious to modify the system/method of Efrati to include representing the predetermined amount as a percentage a simple alternative to measured units of partial pressure to make graphical comparisons and for large ET leaks >60% the magnitude of the measured PeCO2 is lower than the half of the true value as taught by Schmalisch (Schmalisch: Pg. 1636-1637, ‘For large ET leaks >60% the magnitude of the measured PeCO2 is lower than the half of the true value’, Fig. 4).
Regarding Claim 274 & 286, Efrati discloses the system of claim 268/method of claim 280, Efrati is silent on a drop in the ETCO2.
However, Schmalisch teaches determine that a drop in the ETCO2 has occurred, determine that the drop in the ETCO2 exceeds a predetermined threshold, based at least in part on the drop in the ETCO2 exceeding the predetermined threshold, determine that the leak may be present (Schmalisch: Pg. 1635-1636, ‘in ET leaks of up to 20% cause an underestimation of the true PetCO2 <10% which may be tolerable for the most clinical applications. For large ET leaks (>40%) the magnitude of the capnogram was distinctly reduced and PetCO2 falls to zero because the CO2 of the sample chamber of the CO2 was washed out by the leak flow.’; Fig. 3).
One of ordinary skill in the art at the time the invention was filed would have found it obvious to modify the system/method of Efrati by determining a drop in ETCO2 exceeding a predetermined threshold as taught by Schmalisch because a reduced exhaled CO2 and a PetCO2 near zero may indicate a large leak around the endotracheal tube (Schmalisch: Pg. 1638, ‘a reduced exhaled CO2 and a PetCO2 near zero may indicate a large leak around the endotracheal tube’).
Regarding Claim 275 & 287, Efrati discloses the system of claim 274/method of claim 286, Efrati is silent on a drop in the ETCO2.
However, Schmalisch teaches wherein the drop in the ETCO2 is to 5 mm Hg or lower. (Schmalisch: Pg. 1635-1636, ‘in ET leaks of up to 20% cause an underestimation of the true PetCO2 <10% which may be tolerable for the most clinical applications. For large ET leaks (>40%) the magnitude of the capnogram was distinctly reduced and PetCO2 falls to zero because the CO2 of the sample chamber of the CO2 was washed out by the leak flow.’; Fig. 3).
One of ordinary skill in the art at the time the invention was filed would have found it obvious to modify the system/method of Efrati by determining a drop in ETCO2 exceeding a predetermined threshold as taught by Schmalisch because a reduced exhaled CO2 and a PetCO2 near zero may indicate a large leak around the endotracheal tube (Schmalisch: Pg. 1638, ‘a reduced exhaled CO2 and a PetCO2 near zero may indicate a large leak around the endotracheal tube’).
Claim(s) 273 & 285 is/are rejected under 35 U.S.C. 103 as being unpatentable over Efrati in view of US 20170266399 A1 to Campana et al. (hereinafter, Campana).
Regarding Claim 273 & 285, Efrati discloses the system of claim 268/method of claim 280, Efrati is silent on determining a trend in the ETCO2.
However, Campana teaches wherein the processor is configured to: determine a trend in the ETCO2 (Campana: Para. [0224], [0334-0335]),
determine that the trend in the ETCO2 exceeds a predetermined threshold (Campana: Para. [0224], [0334-0335]), and
based at least in part on the trend in the ETCO2 exceeding the predetermined threshold, determine that the leak may be present (Campana: Para. [0224], [0334-0335]).
One of ordinary skill in the art at the time the invention was filed would have found it obvious to modify the system of Efrati to include trend determination as taught by Campana because trends may assist in determining whether a provided treatment is working and inspiratory and expiratory volumes will noticeably differ in the presence of a leak (Campana: Para. [0335, [0224])
Claim(s) 278 & 290 is/are rejected under 35 U.S.C. 103 as being unpatentable over Efrati in view of EP 3334340 B1 to Orr et al. (hereinafter, Orr).
Regarding Claim 278 & 290, Efrati discloses the system of claim 277/method of claim 289, While Efrati discloses determining the dynamic baseline (Efrati: Col. 3, lines 39-48), Efrati is silent on the dynamic baseline being based on a moving average.
However, Orr teaches determining a dynamic moving average of the multiple ETCO2 values (Orr: Para. [0032]).
One of ordinary skill in the art at the time the invention was filed would have found it obvious to modify the continuous PCO2/ETCO2 baseline monitoring and leak-detection system/method of Efrati by incorporating the moving-average filtering of successive CO2 values taught by Orr to reduce noise in the measurement signals (Orr: Para. [0011]).
Conclusion
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/SHAWN CURTIS BROUGHTON/Examiner, Art Unit 3791
/PATRICK FERNANDES/Primary Examiner, Art Unit 3791
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