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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 01/23/2026 has been entered.
Status of the Claims
Claims 1-10 and 21-30 are pending.
Claims 1 and 8-9 are 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Withdrawn Objections & Rejections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 Any objections or rejections not specifically reiterated are hereby withdrawn.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, 3-6, 9, and 21-28 under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Hassanein et al. (US20160374332, 2016, on IDS 03/06/2025, previously cited) is withdrawn upon further consideration and in order to address the claims as amended.
The rejection of claims 2 and 29-30 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 Anderson et al. (US20140349273A1, 2014, on IDS 03/06/2025, previously cited) is withdrawn upon further consideration and in order to address the claims as amended.
The rejection of 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 (IEEE, 2005, previously cited) is withdrawn upon further consideration and in order to address the claims as amended.
The rejection of claim 8 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IDS 03/06/2025, previously cited) in view of Guerrero (US20020138013A1, 2002, on IDS 03/06/2025, previously cited) is withdrawn upon further consideration and in order to address the claims as amended.
The rejection of claim 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) is withdrawn upon further consideration and in order to address the claims as amended.
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.
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, Anderson teaches a system for transporting a biological sample configured to contain a heart (claims 1 and 12; paragraphs [0002-0004]).
Anderson teaches that the transport container comprises electrical sensors to detect information associated with the tissue, such as a measurement associated with the tissue, including heart rate (paragraphs [0142, 0198]; Fig. 18).
Anderson also teaches that the container can comprise a processor configured to receive a measurement from the electrical sensor, determine a parameter of the heart based on the measurement, and determine viability (Figs. 17 and 18; paragraphs [0141]).
While Anderson does not explicitly teach an electrical sensor configured to measure electrical activity in the heart during ex vivo transportation and that the processor is configured to receive a measurement from that particular electrical sensor, systems for measuring the electrical activity in hearts in transportable containers was 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 (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 pacing signal or 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 as taught by Anderson and include an electrical sensor configured to measure electrical activity in the heart during ex vivo transportation in order 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 (thus, if) the heart is arrested.
In this regards, Hassanein teaches that typical techniques that transport hearts when arrested can result in ischemia and tissue damage (paragraph [0002]).
Therefore, a person of ordinary skill in the art would have been motivated to configure the processor to detect heart arrest and provide defibrillation energy in order to prevent damage to the heart tissue.
Furthermore, because Hassanein teaches that hearts are frequently in an arrested state during transportation and teaches that sensors can be configured to measure electrical activity in the heart during ex vivo transportation in order to provide defibrillation energy (a well-known technique for providing electrical shock and returning a to a normal rhythm during heart arrest), it could have been done with predictable results and a reasonable expectation of success.
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 pacing signal or 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 cam comprise a display.
While U.S. Patent No. 12,245,586 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 pacing signal or 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 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 (thus, if) the heart is arrested.
In this regards, Hassanein teaches that typical techniques that transport hearts when arrested can result in ischemia and tissue damage (paragraph [0002]).
Therefore, a person of ordinary skill in the art would have been motivated to configure the processor to detect heart arrest and provide defibrillation energy in order to prevent damage to the heart tissue.
Furthermore, because Hassanein teaches that hearts are frequently in an arrested state during transportation and teaches that sensors can be configured to measure electrical activity in the heart during ex vivo transportation in order to provide defibrillation energy (a well-known technique for providing electrical shock and returning a to a normal rhythm during heart arrest), 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 pacing signal or 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; 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 (thus, if) the heart is arrested.
While the processor of the copending application is configured to measure a resting heart, Hassanein teaches that typical techniques that transport hearts when arrested can result in ischemia and tissue damage (paragraph [0002]).
Therefore, a person of ordinary skill in the art would have been motivated to configure the processor to detect heart arrest in order to prevent damage to the heart tissue.
Furthermore, because Hassanein teaches that the electrical sensor configured to measure electrical activity in the heart during ex vivo transportation in order to provide defibrillation energy (a well-known technique for providing electrical shock and returning a to a normal rhythm during heart arrest), 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 U.S. Patent No. 12,245,586 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 pacing signal or 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 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 (thus, if) the heart is arrested.
In this regards, Hassanein teaches that typical techniques that transport hearts when arrested can result in ischemia and tissue damage (paragraph [0002]).
Therefore, a person of ordinary skill in the art would have been motivated to configure the processor to detect heart arrest and provide defibrillation energy in order to prevent damage to the heart tissue.
Furthermore, because Hassanein teaches that hearts are frequently in an arrested state during transportation and teaches that sensors can be configured to measure electrical activity in the heart during ex vivo transportation in order to provide defibrillation energy (a well-known technique for providing electrical shock and returning a to a normal rhythm during heart arrest), 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 pacing signal or 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 Hassanein does not anticipates the claims (Remarks p4-5). Specifically, Applicant argues that Hassanein does not disclose “a processor configured to: receive a measurement from the electrical sensor while the heart is arrested” (Remarks, p4-5).
Applicant’s arguments, see p4-5, filed 01/23/2026 with respect to the rejection of claim 1 under 35 USC 102(a)(1) or 35 USC 102(a)(2) has been fully considered and are persuasive. Therefore, the specific rejection of over Hassanein has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made over Anderson in view of Hassanein as discussed in depth above.
In regards to Applicant’s specific argument that Hassanein does not disclose (or teach) a processor configured to: receive a measurement from the electrical sensor while the heart is arrested, Applicant’s arguments have been fully considered but are not found persuasive.
In regards to configuring a processor receiving a measurement from the electrical sensor while the heart is arrested, as discussed above, 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 (thus, if) the heart is arrested.
In this regards, Hassanein teaches that typical techniques that transport hearts when arrested can result in ischemia and tissue damage (paragraph [0002]).
Therefore, a person of ordinary skill in the art would have been motivated to configure the processor to detect heart arrest and provide defibrillation energy in order to prevent damage to the heart tissue.
Furthermore, because Hassanein teaches that hearts are frequently in an arrested state during transportation and teaches that sensors can be configured to measure electrical activity in the heart during ex vivo transportation in order to provide defibrillation energy (a well-known technique for providing electrical shock and returning a to a normal rhythm during heart arrest), it could have been done with predictable results and a reasonable expectation of success.
Relatedly, Applicant argues that none of Anderson, Yufera, Guerrero, or Chi remedies the deficiencies of Hassanein with respect to claim 1 as amended (Remarks, p5).
Applicant’s arguments filed 01/23/2023 have been fully considered but are moot because the rejection of the claims under 35 USC 102(a)(1) or 35 USC 102(a)(2) over Hassanein has been withdrawn.
Applicant argues that claim 2 is patentable (Remarks, p5-6). Specifically, Applicant argues that since Hassanein teaches that the system maintains a heart at or near physiological temperature, the modification to incorporate hypothermic storage as taught by Anderson into the system of Hassanein would change the principle of Hassanein and render the system of Hassanein unsatisfactory for its intended purpose (Remarks, p5-7). Applicant argues that Hassanein teaches away from cold storage (Remarks, p7-8).
Applicant’s arguments, see p5-8, filed 01/23/2026 with respect to the rejection of claim 2 under 35 USC 103 has been fully considered and are persuasive. Therefore, the specific rejection of Hassanein in view of Anderson has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made over Anderson in view of Hassanein as discussed in depth above.
As above, Anderson also teaches that the container can comprise a processor configured to receive a measurement from the electrical sensor, determine a parameter of the heart based on the measurement, and determine viability (Figs. 17 and 18; paragraphs [0141]).
While Anderson does not explicitly teach an electrical sensor configured to measure electrical activity in the heart during ex vivo transportation and that the processor is configured to receive a measurement from that particular electrical sensor, 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 pacing signal or 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 as taught by Anderson and include an electrical sensor configured to measure electrical activity in the heart during ex vivo transportation in order to provide defibrillation energy and pacing signals to the heart.
Additionally, while in the specific system of Hassanein, Hassanein prefers transporting hearts around physiological temperatures , Hassanein still teaches an electrical sensor mechanism for providing pace setting and defibrillation energy, that is independent of Hassanein’s preference for transporting hearts near physiological temperature (see Fig. 1, defibrillation sensors/mechanism (12, 50, 52, and 143) are separate structure from the temperature sensors or heating mechanism (120, 122, and 124); paragraph [0033]).
Therefore, while Hassanein prefers transporting hearts at physiological temperature, a person of ordinary skill in the art could have modified the container as taught by Anderson to incorporate the electrical sensor mechanism as taught by Hassanein with predictable results and a reasonable expectation of success.
Indeed, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
Furthermore, issues associated with cold storage or transportation of hearts are addressed directly Anderson. As taught by Anderson, while hearts are typically stored/transported in hypothermic conditions (because it protects them from hypoxic damage) (paragraph [0005]), because the temperatures are uncontrolled, it risks freeze damage (when at 0°C) or resultant hypoxic damage (when temperatures range from 10-15° C) (paragraphs [0006-0007]).
However, the storage device of Anderson specifically addresses this by providing a temperature-stabilized environment (paragraph [0012]) and by keeping hearts at a constant temperature range of 2-8°C (claim 13).
Therefore, even though Hassanein has concerns with hypothermic storage/transportation of hearts, because the container of Anderson directly addresses these concerns, a person of ordinary skill in the art could have applied the teachings of Hassanein to the system of Anderson with predictable results and a reasonable expectation of success.
Applicant argues that claim 8 is patentable (Remarks, p8). Specifically, Applicant argues that Guerrero measures a QRS-like wave while a heart is beating and not in an arrested state (Remarks, p8).
Applicant's arguments filed 01/23/2026 have been fully considered but they are not persuasive.
The contained as taught by Anderson and as modified by Hassanein is still configured to receive a measurement from the electrical sensor while the heart is arrested as discussed above.
Hassanein discloses that ECG signals can be measured (claim 8; paragraphs [0010-0011]), and as evidenced by Guerrero the QRS complex (depolarization of a heart’s ventricles) is part of an ECG measurement (Fig. 1). Therefore, a potential QRS-like wave is still a property the processor is configured to make.
Applicant requests that the double patenting rejection over co-pending Application 19/064,519 be held in abeyance (Remarks, p8).
Applicant’s request is 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.
In regards to the double patenting rejection over U.S. Patent No. 12,245,586, Applicant argues that the rejection should be withdrawn for the same reasons as discussed above (Remarks, p8).
Applicant's arguments filed 01/23/2026 have been fully considered but they are not persuasive.
The rejection of the instant claims over those of U.S. Patent No. 12,245,586 is modified but maintained as discussed in depth above.
Conclusion
No claims are allowed.
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