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 .
Status of the Claims
Claims 1-10 and 21-30 are pending.
Claim 1 is newly amended.
Claims 1-10 and 21-30 are under examination.
Withdrawn Objections & Rejections
The objections and rejections presented herein represent the full set of objections and rejections currently pending in the application. Any objections or rejections not specifically reiterated are hereby withdrawn.
The rejection of claims 1-10 and 21-30 under 35 USC 103 are maintained but modified to address the claims as amended. A new grounds of rejection is made under 35 USC 102 in order to address the claims as amended.
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.
Claims 1, 3-6, 8-9, and 21-28 are rejected under 35 U.S.C. 102(a)(1) or 35 U.S.C. 102(a)(2) as being anticipated by Hassanein et al. (US20160374332A1, 2016, on IDS 03/06/2025, previously cited) as evidenced by Guerrero (US20020138013A1, 2002, on IDS 03/06/2025, previously cited).
In regards to claim 1, the claim is drawn to a “system for transporting a biological sample”, and thus, is a composition.
Structurally, the composition (the system) comprises “a transport container . . . an electrical sensor . . . and a processor”.
The transport container, electrical sensor, and processor are each “configured” to “contain a heart for a preservation time”, “measure electrical activity in the heart during ex vivo transportation, and “receive a measurement from the electrical sensor during the preservation time, wherein the heart is arrested throughout the preservation time”, respectively as amended.
The processor is further configured to “determine a parameter of the heart based on the measurement; and determine the viability of the heart based on the parameter.”
It is noted that the claim does not require method steps and does not require a heart (arrested or otherwise). Specifically, it does not require steps of transporting a biological sample, does not require that the transport container comprise a heart, does not require a preservation time, and does not require measuring electrical activity, receive measurements, or determine a parameter or viability.
Instead, the claim only requires that the system and specifically, the transport container, electrical sensor, and processor are “configured” to be able to do so.
Turning to the art, Hassanein discloses a system for transporting or preserving an organ (a biological system) (claims 1, 8, and 11; paragraph [0002]). Hassanein discloses that the system comprises an organ chamber (container), an electrode (electrical sensor) disposed in the transport container, and a controller (processor) (Abstract; claims 1, 8, and 11; paragraphs [0008-0010]).
Hassanein discloses that the organ chamber is configured to contain a heart (claims 1, 8, and 11; paragraph [0002]). As the system is for transporting a heart for transplantation (paragraphs [0002-0003]), a person of ordinary skill in the art would have recognized that the transport container configured to contain a heart is specifically configured to contain that heart “for a preservation time”.
Hassanein discloses that the electrode (electrical sensor) is configured to measure electrical activity in a heart over transportation (thus ex vivo) (Abstract; claims 1, 8, and 11; paragraphs [0008-0010]).
Hassanein discloses that the controller (processor) is configured to retrieve signals (measurements) from the electrical sensors (claims 1 and 8; paragraphs [0008-0011]; e.g., ECG signals) and provide responses to those signals (paragraph [0078]).
Continuing, in embodiments, Hassanein discloses that the controller (processor), upon retrieving signals (measurements) from the electrical sensors, can provide defibrillation energy as necessary to the heart based on those signals (claims 1 and 8; paragraphs [0008-0010]) (thus, determine a parameter of the heart based on the measurement).
A person of ordinary skill in the art would have recognized that the controller (processor) receiving signals (e.g., ECG signals) and provide responses to those signals (e.g., whether it is necessary to provide defibrillation energy) indicates that the controller is configured to determine the viability.
In regards to “wherein the heart is arrested throughout the preservation time” as discussed above, the claim does not require an arrested heat or a specific preservation time.
This is an intended use of the system, and a prior art structure which is capable of performing the intended use as recited in the preamble meets the claim. See, e.g., In re Schreiber, 128 F.3d 1473, 1477, 44 USPQ2d 1429, 1431 (Fed. Cir. 1997) (see MPEP 2111.02).
Therefore, since as above, the system of Hassanein is for transporting hearts and can determine heart viability, it is capable of doing so with a heart that is arrested over a preservation time.
Furthermore, because since the system of Hassanein can provide defibrillation energy to heart based on that determination, it suggests that the processor of Hassanein in fact receives a measurement during the preservation time wherein the heart is arrested throughout the preservation time (i.e., the processor determines that it is necessary to defibrillate an arrested heart).
In regards to claims 3, 5, 6, and 23, Hassanein discloses that the container comprises an artery connector configured to couple with an artery of the heart and that the electrical sensor is near the artery connector (Fig. 2, 158; paragraph [0040]); that the electrical sensor is placed on the right atrium (paragraph [0038]; Fig. 2), which is near the sinoatrial node; and that the electrical sensor is placed on the left ventricle (paragraph [0038]; Fig. 2), which is near the apex.
In regards to claim 4, as above, Hassanein discloses that a parameter can be ECG signal (claim 8; paragraphs [0010-0011]), which are measures of electrical activity.
In regards to claim 8, Hassanein discloses that ECG signals can be measured (claim 8; paragraphs [0010-0011, 0042-0049]). As evidence by Guerrero the QRS complex (depolarization of a heart’s ventricles) is part of an ECG measurement (Fig. 1).
In regards to claim 9, as above, Hassanein discloses that sensors are configured to measure hearts during transportation (which comprise time) and provide a defibrillation energy to the heart based on those signals (and thus, based on a change in a parameter to an arrested heart) (Abstract; paragraph [0007]).
In regards to claim 21, Hassanein discloses that an electrode (an electrical sensor) can be placed in the flow of aortic perfusion fluid (a preservation fluid) (Abstract; paragraph [0027]), which implies both that it is submerged in a preservation fluid and not in direct contact with the heart.
In regards to claim 22, Hassanein discloses that the sensor can comprise at least two electrodes (claim 1, paragraphs [0049-0050]).
In regards to claim 24, Hassanein discloses that the system can run on various operating parameters (instructions) and that the controller (processor) can at least automatically regulate gas flow from the oxygenator in dependence on the perfusion of fluid oxygen content as measured at the sensor (paragraphs [0034-0035]), which a person of ordinary skill in the art would have recognized comparison to a threshold in order to trigger automatic regulation.
In regards to claims 25-27, Hassanein discloses the system can comprise a temperature sensor which is integrated with the sensor which controls (by a processor) maintenance (thus viability) of the heart (Abstract; paragraph [0033]; Fig. 1).
In regards to claim 28, as above, Hassanein discloses that the that a parameter can be ECG signal (claim 8; paragraphs [0010-0011]), which are measures of electrical activity, and measures voltage of a heart.
Therefore, Hassanein anticipates the invention as claimed.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Hassanein et al. (US20160374332A1, 2016, on IDS 03/06/2025, previously cited) in view of Yufera et al. (IEEE, 2005, previously cited).
Hassanein anticipates claim 1 as discussed above.
In regards to claim 7, as discussed above, Hassanein teaches that the electrical stimulator can be configured to provide defibrillation energy based on parameters (Abstract; paragraph [0007]), but is silent on measuring impedance specifically.
However, a person of ordinary skill in the art would have been motivated to measure impedance because Yufera teaches that impedance is a useful parameter for determining the properties of biological samples, and in the heart can detect ischemia (Title, Abstract, Introduction, p2620).
Furthermore, because Yufera teaches that impedance can be in hearts with electrode-based sensors (Abstract, Fig. 2, p2620), and Hassanein and Yufera are in the same technical field of measuring heart parameters, it could have been done with predictable results and a reasonable expectation of success.
Therefore, the combined teachings of Hassanein and Yufera renders the invention unpatentable as claimed.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Hassanein et al. (US20160374332A1, 2016, on IDS 03/06/2025, previously cited) in view of Chi et al. (Physics Procedia, 2012, previously cited).
Hassanein anticipates claim 1 as discussed above.
In regards to claim 10, Hassanein teaches that the system, which measures ECG signals can comprise an operator interface and display controlling the system (Fig. 1; paragraph [0034]).
While Hassanein is silent on whether the interface or display is configured to display the electrical activity of the heart, a person of ordinary skill in the art would have been motivated to specifically display is configured to display the electrical activity of the heart in order to, as taught by Chi, monitor the ECG signal in real-time (Abstract, p765). They would have been further motivated to display electrical activity of the heart in order to provide visual feedback for users.
Furthermore, because Chi teaches portable display devices for monitoring ECG signals (Figs. 6 and 7, p772), it could have been done with predicable results and a reasonable expectation of success.
Therefore, the combined teachings of Hassanein and Chi renders the invention unpatentable as claimed.
Claims 1-6, 8-9, and 21-30 are rejected under 35 U.S.C. 103 as being unpatentable over Anderson et al. (US20140349273A1, 2014, on IDS 03/06/2025, previously cited) in view of Hassanein et al. (US20160374332A1, 2016, on IDS 03/06/2025, previously cited) as evidenced by Guerrero (US20020138013A1, 2002, on IDS 03/06/2025, previously cited).
In regards to claims 1, 4, and 9, the claims are drawn to a “system for transporting a biological sample”, and thus, is a composition, as recited in independent claim 1.
Structurally, the composition (the system) comprises “a transport container . . . an electrical sensor . . . and a processor”.
The transport container, electrical sensor, and processor are each “configured” to “contain a heart for a preservation time”, “measure electrical activity in the heart during ex vivo transportation, and “receive a measurement from the electrical sensor during the preservation time, wherein the heart is arrested throughout the preservation time”, respectively as amended.
The processor is further configured to “determine a parameter of the heart based on the measurement; and determine the viability of the heart based on the parameter.”
It is noted that the claim (claim 1) does not require method steps and does not require a heart (arrested or otherwise). Specifically, it does not require steps of transporting a biological sample, does not require that the transport container comprise a heart, does not require a preservation time, and does not require measuring electrical activity, receive measurements, or determine a parameter or viability.
Instead, the claim only requires that the system and specifically, the transport container, electrical sensor, and processor are “configured” to do so.
Turning to the art, Anderson teaches a system for transporting and preserving a biological sample (claims 1 and 12; paragraphs [0002-0004]).
Anderson teaches that the system comprises a chamber (a transport container) (Claim 1); an electric sensor disposed in the transport container (e.g., electric oxygen sensor, pressure, or temperatures sensors) (paragraphs [0137-1038, 0198-0199]; 1040 in Fig. 34); and a processor (paragraph [0141]).
Anderson teaches that the transport container is configured to contain a heart (claims 1 and 12; paragraphs [0002-0004]). As the system is for transporting or preserving a heart for transplantation (claim 1; paragraphs [0003-0004]), a person of ordinary skill in the art would have recognized that the transport container configured to contain a heart is specifically configured to contain that heart “for a preservation time”.
Anderson teaches electrical sensors is configured for detecting information associated with heart during ex vivo transportation, such as a measurements associated with the tissue (paragraphs [0142, 0198-199]; Fig. 18; e.g., oxygen consumption or temperature).
Anderson teaches that the processor configured to receive a measurement from the electrical sensor, determine a parameter of the heart based on the measurement, and determine viability based on the parameter (Figs. 17 and 18; paragraphs [0141]; e.g., measure chamber pressure and calculate heart flow rate).
As above, since the system is for transporting or preserving a heart for transplantation (claim 1; paragraphs [0003-0004]), a person of ordinary skill in the art would have recognized that the processor is configured to receive measurements “during a preservation time”.
The difference between the system of Anderson and the claimed invention is (1) the electrical signal of Anderson is not explicitly configured to measure electrical activity in the heart (instead, as above, it measures environmental conditions or the physical properties of the heart), and (2) Anderson is silent as to whether the processor is configured to measure a heart arrested throughout the preservation time.
However, systems for transporting hearts comprising electrical sensors configured to measure electrical activity in a heart and processors configured to receive measurements from electrical sensors during preservation time wherein the heart is arrested throughout the preservation time were known in the art before the effective filing date.
Specifically, Hassanein teaches a system for transporting a heart in a container (Abstract; claims 1, 8, and 11; paragraph [0008]). Hassanein teaches that this container comprises an electrode (electrical sensor) configured to measure electrical activity in the heart (Abstract; claims 1, 8, and 11; paragraphs [0008-0010]). Hassanein also teaches a controller (processor) configured to retrieve signals (measurements) from the electrical sensors (claims 1 and 8; paragraphs [0008-0011]; e.g., ECG signals) and provide responses to those signals (paragraph [0078]).
In specific embodiments Hassanein teaches that the electrical sensor can measure ECG signals or provide defibrillation energy to the heart as necessary (claims 1 and 8; paragraphs [0008-0011]).
Therefore, person of ordinary skill in the art would have been motivated to modify the container as taught by Anderson and include an electrical sensor specifically configured to measure electrical activity in the heart during ex vivo transportation, and configure the processor to receive a measurement from the electrical sensor during the preservation time, wherein the heart is arrested throughout the preservation time, in order to be able to determine the heart rate or pace (as indicated by ECG signals) or provide defibrillation energy to the heart as necessary (e.g., when a heart arrests).
Furthermore, because Hassanein teaches an electrode (electrical sensor) configured to measure electrical activity in the heart (Abstract; claims 1, 8, and 11; paragraphs [0008-0010]), since the system of Hassanein may already contain “a suite of sensor” (paragraph [0013]), and since Anderson and Hassanein are in the same technical field of making systems for transporting hearts comprising containers with electric sensors and processors configured to measure heart viability, a person of ordinary skill in the art could have combined the prior art with predictable results and a reasonable expectation of success.
In regards to “wherein the heart is arrested throughout the preservation time” as discussed above, the claim does not require an arrested heat or a specific preservation time.
As above, this is an intended use of the system, and a prior art structure which is capable of performing the intended use as recited in the preamble meets the claim. See, e.g., In re Schreiber, 128 F.3d 1473, 1477, 44 USPQ2d 1429, 1431 (Fed. Cir. 1997) (see MPEP 2111.02).
Therefore, since as above, the system of Anderson is for transporting hearts and can determine heart viability, it is capable of doing so with a heart that is arrested over a preservation time.
Furthermore, because since the system of Anderson as modified Hassanein can provide defibrillation energy to heart based on that determination, it suggests that the processor of Anderson as modified by Hassanein in fact receives a measurement during the preservation time wherein the heart is arrested throughout the preservation time (i.e., the processor determines that it is necessary to defibrillate an arrested heart).
In regards to claim 2, Anderson teaches that the container maintains hearts between 2°C and 8°C (claims 1, 12, 14, 15; paragraphs [0012, 0065]), which overlaps with the range of 2-10°C as in claim 2.
In regards to claims 3, 5, 6, and 23, as above, the heart container of Anderson as modified by Hassanein results in an electrical sensor configured to measure electrical activity in a heart (see claim 1 as discussed above).
In regards to the arrangement and placement of the electrical sensors, Hassanein teaches that the container comprises an artery connector configured to couple with an artery of the heart and that the electrical sensor is near the artery connector (Fig. 2, 158; paragraph [0040]); that the electrical sensor is placed on the right atrium (paragraph [0038]; Fig. 2), which is near the sinoatrial node; and that the electrical sensor is placed on the left ventricle (paragraph [0038]; Fig. 2), which is near the apex.
A person of ordinary skill in the art would have been motivated to arrange electrical sensors in this manner because Hassanein teaches that this configuration is suitable for measuring signals from the heart and providing defibrillation energy or pacing signals to the heart (paragraphs [0008-0011]).
Furthermore, because Hassanein teaches these specific configurations for sensing heart signals and provide defibrillation energy or pacing signals to the heart (paragraphs [0008-0011]), it could have been done with predictable results and a reasonable expectation of success
In regards to claim 8, Hassanein teaches that ECG signals can be measured (claim 8; paragraphs [0010-0011, 0042-0049]). As evidence by Guerrero the QRS complex (depolarization of a heart’s ventricles) is part of an ECG measurement (Fig. 1). A person of ordinary skill in the art would have been motivated to measure a QRS complex (which again, is part of an ECG measurement) in an arrested heart in order to determine whether the heart is beating. Furthermore, because Hassanein teaches that ECG signals can be measured (of which the QRS complex is a well-known feature), it could have been done with predictable results and a reasonable expectation of success.
In regards to claim 21, Anderson teaches that the chamber of the transportation container comprises preservation solution (claims 1).
In regards to placement of the electrical sensor, Hassanein teaches that this can be placed in the flow of aortic perfusion fluid (a preservation fluid) (Abstract; paragraph [0027]), which implies both that it is submerged in a preservation fluid and not in direct contact with the heart. A person of ordinary skill in the art would have been motivated to submerge the electrical sensor in preservation solution while not in direct contact with the heart to get more accurate readings while not causing damage to the heart tissue. Indeed, Hassanein explicitly teaches that contact with the heart may cause irritation of the tissue (paragraph [0011]).
Furthermore, because Hassanein teaches that the sensor can be placed in the flow of aortic perfusion fluid, it could have been done with predictable results and a reasonable expectation of success.
In regards to claim 22, Hassanein teaches that the sensor can comprise at least two electrodes (claim 1, paragraphs [0049-0050]). A person of ordinary skill in the art would have been motivated to use at least two electrodes in order to gather more information about the state of the heart. Furthermore, because Hassanein teaches that the sensor can comprise at least two electrodes, it could have been done with predictable results and a reasonable expectation of success. Moreover, the duplication of parts is prima facie obvious absent unexpected results (see MPEP 2144.04(VI)(B), In reHarza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960)).
In regards to claim 24, in regards to the processor comprising a memory configured to store a threshold level of electrical activity and instructions for the processor to compare recorded electrical activity to a threshold level, Hassanein teaches that the system can run on various operating parameters (instructions) and that the controller (processor) can at least automatically regulate gas flow from the oxygenator in dependence on the perfusion of fluid oxygen content as measured at the sensor (paragraphs [0034-0035]), which a person of ordinary skill in the art would have recognized comparison to a threshold in order to trigger automatic regulation. A person of ordinary skill in the art would have been motivate to apply this same process to an electrical signal in order to determine whether a defibrillation energy is needed in the case of cardiac arrest or arrhythmia. Furthermore, because Hassanein teaches that the system can run on various operating parameters (instructions) and that the controller (processor) can at least automatically regulate oxygen, it could have been done with predictable results and a reasonable expectation of success.
In regards to claims 25 and 26, Anderson teaches that the sensor can be configured to measure temperature which can be used to determine if the tissue experiences a favorable environment (thus, viability).
In regards to claim 27, in regards to combining electrical and temperature sensors, it is prima facie obvious to integrate temperature sensor and electrical sensors. In re Larson, 340 F.2d 965, 968, 144 USPQ 347, 349 (CCPA 1965) (A claim to a fluid transporting vehicle was rejected as obvious over a prior art reference which differed from the prior art in claiming a brake drum integral with a clamping means, whereas the brake disc and clamp of the prior art comprise several parts rigidly secured together as a single unit. The court affirmed the rejection holding, among other reasons, “that the use of a one piece construction instead of the structure disclosed in [the prior art] would be merely a matter of obvious engineering choice” (see MPEP 2144.04(IV)(B)).
It would have been predicably obvious to combine sensors in order to simplify the system and avoid unnecessary contacting with the heart. Indeed, Hassanein explicitly teaches that contact with the heart may cause irritation of the tissue (paragraph [0011]).
In regards to claim 28, as above, Hassanein teaches that the that a parameter can be ECG signal (claim 8; paragraphs [0010-0011]), which are measures of electrical activity, and measures voltage of a heart. A person of ordinary skill in the art would have been motivated to measure voltage (an ECG signal) because Hassanein teaches that it can provide signals in order to provide a defibrillation energy to the stored heart. Furthermore, because Hassanein teaches that an ECG signal can be measured, it could have been done with predictable results and a reasonable expectation of success.
In regards to claims 29 and 30, Anderson teaches that heart transport devices can be configured to create an alert when certain thresholds are met (paragraph [0200]). It would have been obvious to establish thresholds above and below certain electrical activities in order to alert transportation or medical staff to critical changes in the electrical status of the heart.
Therefore, the combined teachings of Anderson and Hassanein renders the invention unpatentable as claimed.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Anderson et al. (US20140349273A1, 2014, on IDS 03/06/2025, previously cited) in view of Hassanein et al. (US20160374332A1, 2016, on IDS 03/06/2025, previously cited), as applied to claim 1 above, and in further view of Yufera et al. (IEEE, 2005, previously cited).
In regards to claim 7, as discussed above, Hassanein teaches that the electrical stimulator can be configured to provide defibrillation energy based on parameters (Abstract; paragraph [0007]), but is silent on measuring impedance specifically.
However, a person of ordinary skill in the art would have been motivated to measure impedance because Yufera teaches that impedance is a useful parameter for determining the properties of biological samples, and in the heart can detect ischemia (Title, Abstract, Introduction, p2620).
Furthermore, because Yufera teaches that impedance can be in hearts with electrode-based sensors (Abstract, Fig. 2, p2620), and Hassanein and Yufera are in the same technical field of measuring heart parameters, it could have been done with predictable results and a reasonable expectation of success.
Therefore, the combined teachings of Anderson, Hassanein, and Yufera renders the invention unpatentable as claimed.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Anderson et al. (US20140349273A1, 2014, on IDS 03/06/2025, previously cited) in view of Hassanein et al. (US20160374332A1, 2016, on IDS 03/06/2025, previously cited), as applied to claim 1 above, and in further view of Chi et al. (Physics Procedia, 2012, previously cited).
In regards to claim 10, Anderson teaches that the container can comprise a display (paragraph 0136]).
In regards to a display configured specifically to display electrical activity of the heart, a person of ordinary skill in the art would have been motivated to specifically display is configured to display the electrical activity of the heart in order to, as taught by Chi, monitor the ECG signal in real-time (Abstract, p765). They would have been further motivated to display electrical activity of the heart in order to provide visual feedback for users.
Furthermore, because Chi teaches portable display devices for monitoring ECG signals (Figs. 6 and 7, p772), it could have been done with predicable results and a reasonable expectation of success.
Therefore, the combined teachings Anderson, Hassanein and Chi renders the invention unpatentable as claimed.
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 1-6, 8, and 21-38 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6, 8-16, and 18-20 of U.S. Patent No. 12,245,586 in view of Hassanein et al. (US20160374332, 2016, on IDS 03/06/2025, previously cited) as evidenced by Guerrero (US20020138013A1, 2002, on IDS 03/06/2025, previously cited).
Claim 7 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6, 8-16, and 18-20 of U.S. Patent No. 12,245,586 in view of Hassanein et al. (US20160374332, 2016, on IDS 03/06/2025, previously cited), as applied to claim 1 above, and further in view of Yufera et al. (IEEE, 2005, previously cited).
Claim 10 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6, 8-16, and 18-20 of U.S. Patent No. 12,245,586 in view of Hassanein et al. (US20160374332, 2016, on IDS 03/06/2025, previously cited), as applied to claim 1 above, and further in view of Chi et al. (Physics Procedia, 2012, previously cited).
Claims 29-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6, 8-16, and 18-20 of U.S. Patent No. 12,245,586 in view of Hassanein et al. (US20160374332, 2016, on IDS 03/06/2025, previously cited), as applied to claim 1 above, and further in view of Anderson et al. (US20140349273A1, 2014, on IDS 03/06/2025, previously cited).
Although the claims at issue are not identical, they are not patentably distinct from each other because both claims are drawn to systems for transport of an organ (a biological sample), that comprise sensors for determining temperature wherein the temperature is 2-10°C and the container can comprise a display.
While the patent does not explicitly teach that the system can be configured for a heart, a person of ordinary skill in the art would have been motivated to configure the system for a heart in order to provide hearts from donors to transplant recipients as taught by Hassanein (paragraph [0002]). Furthermore, because Hassanein teaches systems for transportation of donor hearts (claims 1), it could have been done with predictable results and a reasonable expectation of success.
Furthermore, while U.S. Patent No. 12,245,586 does not explicitly teach that the system comprises an electrical sensor configured to measure electrical activity of a heart, receive and determine parameters of a heart (in an arrested state), and determine viability of the heart, Hassanein teaches a system for transporting a heart in a container (Abstract; claims 1, 8, and 11; paragraph [0008]). Hassanein teaches that this container comprises an electrode (electrical sensor) configured to measure electrical activity (Abstract; claims 1, 8, and 11; paragraphs [0008-0010]). Hassanein also teaches a controller (processor) configured to retrieve signals (measurements) from the electrical sensors and provide a defibrillation energy to the heart based on those signals (claims 1 and 8; paragraphs [0008-0010]; thus, also based on electrical activity as a parameter and based on a change in a parameter over time), which a person of ordinary skill in the art would have recognizes requires determining a parameter of the heart based on the measurement and determining the viability of the heart based on that parameter.
A person of ordinary skill in the art would have been motivated to modify the container and include an electrical sensor configured to measure electrical activity in the heart during ex vivo transportation in order to be able to provide defibrillation energy and pacing signals to the heart.
In regards to configuring a processor receiving a measurement from the electrical sensor while the heart is arrested, it is noted that the claim does not require either a heart nor an arrested heart in particular. Rather, the claim only requires that the processor is configured to receive a measurement from an electrical sensor while the heart is arrested.
Because system of Hassanein can provide defibrillation energy when needed, it necessarily implies that arrested hearts are being transported in the system of Hassanein, and is therefore, capable of performing this intended use.
Furthermore, because Hassanein teaches an electrode (electrical sensor) configured to measure electrical activity in the heart (Abstract; claims 1, 8, and 11; paragraphs [0008-0010]), it could have been done with predictable results and a reasonable expectation of success.
In regards to limitations of the dependent claims, in particular the configuration of the electrical sensor, Hassanein teaches that the container comprises an artery connector configured to couple with an artery of the heart and that the electrical sensor is near the artery connector (Fig. 2, 158; paragraph [0040]); that the electrical sensor is placed on the right atrium (paragraph [0038]; Fig. 2), which is near the sinoatrial node; and that the electrical sensor is placed on the left ventricle (paragraph [0038]; Fig. 2), which is near the apex.
A person of ordinary skill in the art would have been motivated to arrange electrical sensors in this manner because Hassanein teaches that this configuration is suitable for measuring signals from the heart and providing defibrillation energy or pacing signals to the heart (paragraphs [0008-0011]).
Furthermore, because Hassanein teaches these specific configurations for sensing heart signals and provide defibrillation energy or pacing signals to the heart (paragraphs [0008-0011]), it could have been done with predictable results and a reasonable expectation of success
In regards to a QRS signal, Hassanein teaches that ECG signals can be measured (claim 8; paragraphs [0010-0011, 0042-0049]). As evidence by Guerrero the QRS complex (depolarization of a heart’s ventricles) is part of an ECG measurement (Fig. 1). A person of ordinary skill in the art would have been motivated to measure a QRS complex (which again, is part of an ECG measurement) in an arrested heart in order to determine whether the heart is beating. Furthermore, because Hassanein teaches that ECG signals can be measured (of which the QRS complex is a well-known feature), it could have been done with predictable results and a reasonable expectation of success.
In regards to submerging the electrical sensor in a preservation solution and not in direct contact with the heart, Hassanein teaches that this can be placed in the flow of aortic perfusion fluid (a preservation fluid) (Abstract; paragraph [0027]), which implies both that it is submerged in a preservation fluid and not in direct contact with the heart. A person of ordinary skill in the art would have been motivated to submerge the electrical sensor in preservation solution while not in direct contact with the heart to get more accurate readings while not causing damage to the heart tissue. Indeed, Hassanein explicitly teaches that contact with the heart may cause irritation of the tissue (paragraph [0011]).
Furthermore, because Hassanein teaches that the sensor can be placed in the flow of aortic perfusion fluid, it could have been done with predictable results and a reasonable expectation of success.
In regards to multiple sensors, Hassanein teaches that the sensor can comprise at least two electrodes (claim 1, paragraphs [0049-0050]). A person of ordinary skill in the art would have been motivated to use at least two electrodes in order to gather more information about the state of the heart. Furthermore, because Hassanein teaches that the sensor can comprise at least two electrodes, it could have been done with predictable results and a reasonable expectation of success. Moreover, the duplication of parts is prima facie obvious absent unexpected results (see MPEP 2144.04(VI)(B), In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960)).
In regards to the processor comprising a memory configured to store a threshold level of electrical activity and instructions for the processor to compare recorded electrical activity to a threshold level, Hassanein teaches that the system can run on various operating parameters (instructions) and that the controller (processor) can at least automatically regulate gas flow from the oxygenator in dependence on the perfusion of fluid oxygen content as measured at the sensor (paragraphs [0034-0035]), which a person of ordinary skill in the art would have recognized comparison to a threshold in order to trigger automatic regulation. A person of ordinary skill in the art would have been motivate to apply this same process to an electrical signal in order to determine whether a defibrillation energy is needed in the case of cardiac arrest or arrhythmia. Furthermore, because Hassanein teaches that the system can run on various operating parameters (instructions) and that the controller (processor) can at least automatically regulate oxygen, it could have been done with predictable results and a reasonable expectation of success.
In regards to combining electrical and temperature sensors, it is prima facie obvious to integrate temperature sensor and electrical sensors. In re Larson, 340 F.2d 965, 968, 144 USPQ 347, 349 (CCPA 1965) (A claim to a fluid transporting vehicle was rejected as obvious over a prior art reference which differed from the prior art in claiming a brake drum integral with a clamping means, whereas the brake disc and clamp of the prior art comprise several parts rigidly secured together as a single unit. The court affirmed the rejection holding, among other reasons, “that the use of a one piece construction instead of the structure disclosed in [the prior art] would be merely a matter of obvious engineering choice” (see MPEP 2144.04(IV)(B)).
It would have been predicably obvious to combine sensors in order to simplify the system and avoid unnecessary contacting with the heart. Indeed, Hassanein explicitly teaches that contact with the heart may cause irritation of the tissue (paragraph [0011]).
In regards to measuring voltage, Hassanein teaches that the that a parameter can be ECG signal (claim 8; paragraphs [0010-0011]), which are measures of electrical activity, and measures voltage of a heart. A person of ordinary skill in the art would have been motivated to measure voltage (an ECG signal) because Hassanein teaches that it can provide signals in order to provide a defibrillation energy to the stored heart. Furthermore, because Hassanein teaches that a ECG signal can be measured, it could have been done with predictable results and a reasonable expectation of success.
In regards to measuring impedance in claim 7, Hassanein teaches that the electrical stimulator can be configured to provide defibrillation energy based on parameters (Abstract; paragraph [0007]). Additionally, a person of ordinary skill in the art would have been motivated to measure impedance because Yufera teaches that impedance is a useful parameter for determining the properties of biological samples, and in the heart can detect ischemia (Title, Abstract, Introduction, p2620).
Furthermore, because Yufera teaches that impedance can be in hearts with electrode-based sensors (Abstract, Fig. 2, p2620), and Hassanein and Yufera are in the same technical field of measuring heart parameters, it could have been done with predictable results and a reasonable expectation of success.
In regards to a display configured specifically to display electrical activity of the heart in claim 10, a person of ordinary skill in the art would have been motivated to specifically display is configured to display the electrical activity of the heart in order to, as taught by Chi, monitor the ECG signal in real-time (Abstract, p765). They would have been further motivated to display electrical activity of the heart in order to provide visual feedback for users.
Furthermore, because Chi teaches portable display devices for monitoring ECG signals (Figs. 6 and 7, p772), it could have been done with predicable results and a reasonable expectation of success.
In regards to the alerts in claims 29-30, Anderson teaches that heart transport devices can be configured to create an alert when certain thresholds are met (paragraph [0200]). It would have been obvious to establish thresholds above and below certain electrical activities in order to alert transportation or medical staff to critical changes in the electrical status of the heart.
Claims 1-10 and 21-28 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-26 of copending Application No. 19/064,519 (reference application, previously cited).
Claims 29-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 19/064,519 (reference application, previously cited), and further in view of Anderson et al. (US20140349273A1, 2014, on IDS 03/06/2025, previously cited).
Although the claims at issue are not identical, they are not patentably distinct from each other because both claims are drawn to electrical monitoring of a donor heart in a hypothermic transport container (2-10°C) with an electrical sensor configured to measure electricidal activity ex vivo while the heart is being transported; determining viability of the heart; placing electrodes near the sinoatrial node or apex of the heart; submerging the heart and electrical probe in a preservation solution wherein the electrical probe is not in direct contact with the heart; identifying a potential QRS-like wave; providing stimulation when electrical activity is above or below threshold levels; measuring impedance; and displaying electrical activity on a screen.
In regards to configuring a processor receiving a measurement from the electrical sensor while the heart is arrested, it is noted that the claim does not require either a heart nor an arrested heart in particular. Rather, the claim only requires that the processor is configured to receive a measurement from an electrical sensor while the heart is arrested.
However, Hassanein teaches a system for transporting a heart in a container (Abstract; claims 1, 8, and 11; paragraph [0008]). Hassanein teaches that this container comprises an electrode (electrical sensor) configured to measure electrical activity (Abstract; claims 1, 8, and 11; paragraphs [0008-0010]). Hassanein also teaches a controller (processor) configured to retrieve signals (measurements) from the electrical sensors and provide a defibrillation energy to the heart based on those signals (claims 1 and 8; paragraphs [0008-0010]; thus, also based on electrical activity as a parameter and based on a change in a parameter over time), which a person of ordinary skill in the art would have recognizes requires determining a parameter of the heart based on the measurement and determining the viability of the heart based on that parameter.
A person of ordinary skill in the art would have been motivated to modify the container and include an electrical sensor configured to measure electrical activity in the heart during ex vivo transportation in order to be able to provide defibrillation energy and pacing signals to the heart.
In regards to configuring a processor receiving a measurement from the electrical sensor while the heart is arrested, it is noted that the claim does not require either a heart nor an arrested heart in particular. Rather, the claim only requires that the processor is configured to receive a measurement from an electrical sensor while the heart is arrested.
Because system of Hassanein can provide defibrillation energy, it necessarily implies that arrested hearts are being transported in the system of Hassanein, and is therefore, capable of performing this intended use.
Furthermore, because Hassanein teaches an electrode (electrical sensor) configured to measure electrical activity in the heart (Abstract; claims 1, 8, and 11; paragraphs [0008-0010]), it could have been done with predictable results and a reasonable expectation of success.
In regards to the alerts in claims 29-30, Anderson teaches that heart transport devices can be configured to create an alert when certain thresholds are met (paragraph [0200]). It would have been obvious to establish thresholds above and below certain electrical activities in order to alert transportation or medical staff to critical changes in the electrical status of the heart.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-6, 8, and 21-38 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Application No. 19/229,803 in view of Hassanein et al. (US20160374332, 2016, on IDS 03/06/2025, previously cited) as evidenced by Guerrero (US20020138013A1, 2002, on IDS 03/06/2025, previously cited).
Claim 7 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Application No. 19/229,803 in view of Hassanein et al. (US20160374332, 2016, on IDS 03/06/2025, previously cited), as applied to claim 1 above, and further in view of Yufera et al. (IEEE, 2005, previously cited).
Claim 10 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Application No. 19/229,803 in view of Hassanein et al. (US20160374332, 2016, on IDS 03/06/2025, previously cited), as applied to claim 1 above, and further in view of Chi et al. (Physics Procedia, 2012, previously cited).
Claims 29-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Application No. 19/229,803 in view of Hassanein et al. (US20160374332, 2016, on IDS 03/06/2025, previously cited), as applied to claim 1 above, and further in view of Anderson et al. (US20140349273A1, 2014, on IDS 03/06/2025, previously cited).
Although the claims at issue are not identical, they are not patentably distinct from each other because both claims are drawn to systems for transport of an organ (a biological sample), that comprise sensors for determining temperature wherein the temperature is 2-10°C.
While the copending Application does not explicitly teach that the system can be configured for a heart, a person of ordinary skill in the art would have been motivated to configure the system for a heart in order to provide hearts from donors to transplant recipients as taught by Hassanein (paragraph [0002]). Furthermore, because Hassanein teaches systems for transportation of donor hearts (claims 1), it could have been done with predictable results and a reasonable expectation of success.
Additionally, while the copending Application does not explicitly teach that the system comprises an electrical sensor configured to measure electrical activity of a heart, receive and determine parameters of a heart (in an arrested state), and determine viability of the heart, Hassanein teaches a system for transporting a heart in a container (Abstract; claims 1, 8, and 11; paragraph [0008]). Hassanein teaches that this container comprises an electrode (electrical sensor) configured to measure electrical activity (Abstract; claims 1, 8, and 11; paragraphs [0008-0010]). Hassanein also teaches a controller (processor) configured to retrieve signals (measurements) from the electrical sensors and provide a defibrillation energy to the heart based on those signals (claims 1 and 8; paragraphs [0008-0010]; thus, also based on electrical activity as a parameter and based on a change in a parameter over time), which a person of ordinary skill in the art would have recognizes requires determining a parameter of the heart based on the measurement and determining the viability of the heart based on that parameter.
A person of ordinary skill in the art would have been motivated to modify the container and include an electrical sensor configured to measure electrical activity in the heart during ex vivo transportation in order to be able to provide defibrillation energy and pacing signals to the heart.
In regards to configuring a processor receiving a measurement from the electrical sensor while the heart is arrested, it is noted that the claim does not require either a heart nor an arrested heart in particular. Rather, the claim only requires that the processor is configured to receive a measurement from an electrical sensor while the heart is arrested.
Because system of Hassanein can provide defibrillation energy, it necessarily implies that arrested hearts are being transported in the system of Hassanein, and is therefore, capable of performing this intended use.
Furthermore, because Hassanein teaches an electrode (electrical sensor) configured to measure electrical activity in the heart (Abstract; claims 1, 8, and 11; paragraphs [0008-0010]), it could have been done with predictable results and a reasonable expectation of success.
In regards to limitations of the dependent claims, in particular the configuration of the electrical sensor, Hassanein teaches that the container comprises an artery connector configured to couple with an artery of the heart and that the electrical sensor is near the artery connector (Fig. 2, 158; paragraph [0040]); that the electrical sensor is placed on the right atrium (paragraph [0038]; Fig. 2), which is near the sinoatrial node; and that the electrical sensor is placed on the left ventricle (paragraph [0038]; Fig. 2), which is near the apex.
A person of ordinary skill in the art would have been motivated to arrange electrical sensors in this manner because Hassanein teaches that this configuration is suitable for measuring signals from the heart and providing defibrillation energy or pacing signals to the heart (paragraphs [0008-0011]).
Furthermore, because Hassanein teaches these specific configurations for sensing heart signals and provide defibrillation energy or pacing signals to the heart (paragraphs [0008-0011]), it could have been done with predictable results and a reasonable expectation of success
In regards to a QRS signal, Hassanein teaches that ECG signals can be measured (claim 8; paragraphs [0010-0011, 0042-0049]). As evidence by Guerrero the QRS complex (depolarization of a heart’s ventricles) is part of an ECG measurement (Fig. 1). A person of ordinary skill in the art would have been motivated to measure a QRS complex (which again, is part of an ECG measurement) in an arrested heart in order to determine whether the heart is beating. Furthermore, because Hassanein teaches that ECG signals can be measured (of which the QRS complex is a well-known feature), it could have been done with predictable results and a reasonable expectation of success.
In regards to submerging the electrical sensor in a preservation solution and not in direct contact with the heart, Hassanein teaches that this can be placed in the flow of aortic perfusion fluid (a preservation fluid) (Abstract; paragraph [0027]), which implies both that it is submerged in a preservation fluid and not in direct contact with the heart. A person of ordinary skill in the art would have been motivated to submerge the electrical sensor in preservation solution while not in direct contact with the heart to get more accurate readings while not causing damage to the heart tissue. Indeed, Hassanein explicitly teaches that contact with the heart may cause irritation of the tissue (paragraph [0011]).
Furthermore, because Hassanein teaches that the sensor can be placed in the flow of aortic perfusion fluid, it could have been done with predictable results and a reasonable expectation of success.
In regards to multiple sensors, Hassanein teaches that the sensor can comprise at least two electrodes (claim 1, paragraphs [0049-0050]). A person of ordinary skill in the art would have been motivated to use at least two electrodes in order to gather more information about the state of the heart. Furthermore, because Hassanein teaches that the sensor can comprise at least two electrodes, it could have been done with predictable results and a reasonable expectation of success. Moreover, the duplication of parts is prima facie obvious absent unexpected results (see MPEP 2144.04(VI)(B), In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960)).
In regards to the processor comprising a memory configured to store a threshold level of electrical activity and instructions for the processor to compare recorded electrical activity to a threshold level, Hassanein teaches that the system can run on various operating parameters (instructions) and that the controller (processor) can at least automatically regulate gas flow from the oxygenator in dependence on the perfusion of fluid oxygen content as measured at the sensor (paragraphs [0034-0035]), which a person of ordinary skill in the art would have recognized comparison to a threshold in order to trigger automatic regulation. A person of ordinary skill in the art would have been motivate to apply this same process to an electrical signal in order to determine whether a defibrillation energy is needed in the case of cardiac arrest or arrhythmia. Furthermore, because Hassanein teaches that the system can run on various operating parameters (instructions) and that the controller (processor) can at least automatically regulate oxygen, it could have been done with predictable results and a reasonable expectation of success.
In regards to combining electrical and temperature sensors, it is prima facie obvious to integrate temperature sensor and electrical sensors. In re Larson, 340 F.2d 965, 968, 144 USPQ 347, 349 (CCPA 1965) (A claim to a fluid transporting vehicle was rejected as obvious over a prior art reference which differed from the prior art in claiming a brake drum integral with a clamping means, whereas the brake disc and clamp of the prior art comprise several parts rigidly secured together as a single unit. The court affirmed the rejection holding, among other reasons, “that the use of a one piece construction instead of the structure disclosed in [the prior art] would be merely a matter of obvious engineering choice” (see MPEP 2144.04(IV)(B)).
It would have been predicably obvious to combine sensors in order to simplify the system and avoid unnecessary contacting with the heart. Indeed, Hassanein explicitly teaches that contact with the heart may cause irritation of the tissue (paragraph [0011]).
In regards to measuring voltage, Hassanein teaches that the that a parameter can be ECG signal (claim 8; paragraphs [0010-0011]), which are measures of electrical activity, and measures voltage of a heart. A person of ordinary skill in the art would have been motivated to measure voltage (an ECG signal) because Hassanein teaches that it can provide signals in order to provide a defibrillation energy to the stored heart. Furthermore, because Hassanein teaches that a ECG signal can be measured, it could have been done with predictable results and a reasonable expectation of success.
In regards to measuring impedance in claim 7, Hassanein teaches that the electrical stimulator can be configured to provide defibrillation energy based on parameters (Abstract; paragraph [0007]). Additionally, a person of ordinary skill in the art would have been motivated to measure impedance because Yufera teaches that impedance is a useful parameter for determining the properties of biological samples, and in the heart can detect ischemia (Title, Abstract, Introduction, p2620).
Furthermore, because Yufera teaches that impedance can be in hearts with electrode-based sensors (Abstract, Fig. 2, p2620), and Hassanein and Yufera are in the same technical field of measuring heart parameters, it could have been done with predictable results and a reasonable expectation of success.
In regards to a display configured specifically to display electrical activity of the heart in claim 10, a person of ordinary skill in the art would have been motivated to specifically display is configured to display the electrical activity of the heart in order to, as taught by Chi, monitor the ECG signal in real-time (Abstract, p765). They would have been further motivated to display electrical activity of the heart in order to provide visual feedback for users.
Furthermore, because Chi teaches portable display devices for monitoring ECG signals (Figs. 6 and 7, p772), it could have been done with predicable results and a reasonable expectation of success.
In regards to the alerts in claims 29-30, Anderson teaches that heart transport devices can be configured to create an alert when certain thresholds are met (paragraph [0200]). It would have been obvious to establish thresholds above and below certain electrical activities in order to alert transportation or medical staff to critical changes in the electrical status of the heart.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant argues that the prior art does not disclose the elements of claim 1 (Remarks, p5).
Specifically, Applicant argues that using electrodes to detect heart arrest and provide defibrillation energy in order to prevent damage to the heart tissue (the system of Hassanein, as argued by Applicant, a system that can determine that an active perfusion element is not working and applying defibrillation as a result) is different from “a processor configured to: receive a measurement from the electrical sensor during the preservation time, wherein the heart is arrested throughout the preservation time; determine a parameter of the heart based on the measurement; and determine viability of the heart based on the parameter” as presently recited in Claim 1 (Remarks, p5).
Applicant also argues Hassanein does not teach a processor for measuring the electrical activity of a heart that is “arrested throughout the preservation time,” nor does it teach that this data can be used to determine viability (Remarks, p5).
Applicant’s arguments filed 08/03/2026 have been fully considered but are not found persuasive.
In regards to Hassanein, as discussed above, discloses that the controller (processor) is configured to retrieve signals (measurements) from the electrical sensors (claims 1 and 8; paragraphs [0008-0011]; e.g., ECG signals) and provide responses to those signals (paragraph [0078]).
Continuing, in embodiments, Hassanein discloses that the controller (processor), upon retrieving signals (measurements) from the electrical sensors, can provide defibrillation energy as necessary to the heart based on those signals (claims 1 and 8; paragraphs [0008-0010]) (thus, determine a parameter of the heart based on the measurement).
A person of ordinary skill in the art would have recognized that the controller (processor) receiving signals (e.g., ECG signals) and provide responses to those signals (e.g., whether it is necessary to provide defibrillation energy) indicates that the controller is configured to determine the viability.
In regards to “wherein the heart is arrested throughout the preservation time” as discussed above, the claim does not require an arrested heat or a specific preservation time.
As above, this is an intended use of the system, and a prior art structure which is capable of performing the intended use as recited in the preamble meets the claim. See, e.g., In re Schreiber, 128 F.3d 1473, 1477, 44 USPQ2d 1429, 1431 (Fed. Cir. 1997) (see MPEP 2111.02).
Therefore, since as above, the system of Hassanein is for transporting hearts and can determine heart viability, it is capable of doing so with a heart that is arrested over a preservation time.
Furthermore, since the system of Hassanein can provide defibrillation energy to heart based on that determination, it suggests that the processor of Hassanein in fact receives a measurement during the preservation time wherein the heart is arrested throughout the preservation time (i.e., the processor determines that it is necessary to defibrillate an arrested heart).
Applicant argues that none of Guerrero, Yufera, or Chi remedies the deficiencies of Anderson or Hassanein (Remarks, p5-6).
Applicant’s arguments filed 08/03/2026 have been fully considered but are not found persuasive because Anderson and Hassanein are not deficient as discussed above.
In regards to the cited U.S. Patents or copending Applications, Applicant argues these rejections be withdrawn (or held in abeyance) citing the deficiencies identified above (Remarks, p6).
Applicant’s arguments filed 08/03/2026 have been fully considered but are not found persuasive because Anderson and Hassanein are not deficient as discussed above.
In regards to Applicant’s request to hold the rejections in abeyance noted. However, Applicant’s request is not a proper response to the rejections of record as it neither traverses the grounds of rejection by providing specific arguments, nor indicates that a terminal disclaimer has been filed to overcome the rejection. As such, the rejections of record stand.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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