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 .
Response to Amendment
The amendment filed 25 February 2026 has been entered. Claim(s) 1-9 remain pending in the application, claims 10-26 remain withdrawn.
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 1-9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-6, 8-9, and 21 of copending Application No. 19/064,510 (reference application) in view of Hassanein (US 20160374332).
Specifically, claim 1 is provisionally rejected as unpatentable over claim 1 of the reference, claims 1-2 are provisionally rejected as unpatentable over claim 2 of the reference, claims 1 and 3 are provisionally rejected as unpatentable over claim 3 of the reference, claims 1 and 4-5 are provisionally rejected as unpatentable over claim 5 of the reference, claims 1, 4, and 6 are provisionally rejected as unpatentable over claim 6 of the reference, claims 1 and 7 are provisionally rejected as unpatentable over claim 21 of the reference, claims 1 and 8 are provisionally rejected as unpatentable over claim 8 of the reference, and claims 1 and 9 are provisionally rejected as unpatentable over claim 9 of the reference, each in view of Hassanein.
Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant application and the reference application disclose transporting an ex vivo organ donor in a transport container; measuring, using an electrical probe, electrical activity in an ex vivo donor organ during transportation in a transport container while the ex vivo donor organ is in a resting state; and determining, using a processor configured to receive an electrical activity measurement from the electrical probe, viability of the ex vivo donor organ based at least partially on the electrical activity of the ex vivo donor organ in the resting state during transportation.
However, the reference claims do not explicitly disclose the transport container containing cooling material and the donor organ in hypothermic storage.
Hassanein discloses a system for transporting an ex vivo donor organ in a transport container wherein the transport container contains cooling material and the donor organ in hypothermic storage (Perfusion fluid 108; paragraph 0076-- the perfusion fluid being at a temperature of between about 25° C. and about 37° C). It would have been obvious to one having ordinary skill in the art at the time of filing to modify the transport system of the reference application to utilize cooling material and hypothermic storage as described by Hassanein as these elements are well known in the art of organ transport and preservation to aid in the preservation of viability of tissue when compared to a non-temperature controlled system.
It is additionally noted that paragraph 0031 of the instant specification recites “An ex vivo resting organ can be an organ that is not functioning or connected to a living organism. For example, an ex vivo resting organ can be an organ in hypothermic storage. An ex vivo, resting organ can be an arrested heart.”, such that the "arrested" heart of the reference application may be considered "in a resting state" as claimed in the instant application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Utilizing the two step process adopted by the Supreme Court (Alice Corp vs CLS Bank Int'l, US
Supreme Court, 110 USPQ2d 1976 (2014) and the recent 101 guideline Federal Register Vol. 84, No., Jan
2019)), determination of the subject matter eligibility under the 35 U.S.C. 101 is as follows: Specifically, the Step 1 requires claim belongs to one of the four statutory categories (process, machine, manufacture, or composition of matter). If Step 1 is satisfied, then in the first part of Step 2A (Prong One), identification of any judicial recognized exceptions in the claim is made. If any limitation in the claim is identified as judicial recognized exception, then in the second part of Step 2A (Prong Two), determination is made whether the identified judicial exception is being integrated into practical application. If the identified judicial exception is not integrated into a practical application, then in Step 2B, the claim is further evaluated to see if the additional elements, individually and in combination provide "inventive concept" that would amount to significantly more than the judicial exception. If the element and combination of elements do not amount to significantly more than the judicial recognized exception itself, then the claim is ineligible under the 35 U.S.C. 101.
Claims 1-9 are rejected under 35 U.S.C. 101.
Claim 1 is rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception, in this case an abstract idea, without significantly more. The claim recite(s) "determining, using a processor configured to receive an electrical activity measurement from the electrical probe, viability of the ex vivo donor organ based at least partially on the electrical activity of the ex vivo donor organ in the resting state in hypothermic storage during transportation". This judicial exception is not integrated into a practical application and the claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception.
Claim 1 satisfies Step 1, namely the claim is directed to one of the four statutory classes, process. Following Step 2A Prong one, any judicial exceptions are identified in the claims. In claim 1, the limitations "determining, using a processor configured to receive an electrical activity measurement from the electrical probe, viability of the ex vivo donor organ based at least partially on the electrical activity of the ex vivo donor organ in the resting state in hypothermic storage during transportation" are abstract ideas as they are directed to a mental process. With the identification of an abstract idea, the next phase is to proceed Step 2A, Prong Two, wherewith additional elements and taken as a whole, evaluation occurs of whether the identified abstract idea is integrated into a practical application.
In Step 2A, Prong Two, the claim does not recite any additional elements or evidence that amounts to significantly more than the judicial exception. Besides the abstract idea, the claim recites the additional elements “transporting an ex vivo donor organ in a transport container, the transport container containing cooling material; measuring, using an electrical probe, electrical activity in an ex vivo donor organ during transportation in a transport container while the ex vivo donor organ is in a resting state”. However, these components may be seen as the use of well-understood, routine, or conventional elements to perform a non-mental process in order to gather data for the mental process step, much like the example given in MPEP 2106.04(d)(2)(c), such that these limitations are extra-solution activity and thus do not integrate the judicial exception into a practical application. The measurement step leads to the final limitation of “determin[ing]” such that the end result of use of the system is only the generic determined viability which may include any generic output, or no output at all. As this determination is not defined as requiring any further action, such as a form of prophylaxis or treatment or an improvement to a computer or other technology, the claim limitations constitute mere generation of data, in this case the measurement of data relating to electrical activity, such that the claim does not integrate the judicial exception into any practical application. Regarding “a processor configured to receive an electrical activity measurement from the electrical probe”, the limitation amounts to nothing more than an instruction to apply the abstract idea using a generic computer, which does not render an abstract idea eligible. The steps performed by the processor are, as claimed, capable of being performed in the human mind similar to the examples given in MPEP 2106.04(a)(2)(III)(A)-(C), wherein it is described that “a claim to ‘collecting information, analyzing it, and displaying certain results of the collection and analysis’ where the data analysis steps are recited at a high level of generality such that they could practically be performed in the human mind” recites a mental process and that claims which merely use a computer as a tool to perform a mental process are not eligible when “there is nothing in the claims themselves that foreclose them from being performed by a human, mentally or with pen and paper” such as “mental processes of parsing and comparing data” when the steps are recited at a high level of generality and a computer is used merely as a tool to perform the processes. Under the broadest reasonable interpretation, the claim elements are recited with a high level of generality (as written, each claimed step of the process may be performed by a person in an undefined manner) that there are no meaningful limitations to the abstract idea. Consequently, with the identified abstract idea not being integrated into a practical application, the next step is Step 2B, evaluating whether the additional elements provide "inventive concept" that would amount to significantly more than the abstract idea.
In Step 2B, claim 1 does not include additional elements that are sufficient to amount to significantly more than the judicial exception. Besides the abstract idea, the claim recites the additional elements “transporting an ex vivo donor organ in a transport container, the transport container containing cooling material; measuring, using an electrical probe, electrical activity in an ex vivo donor organ during transportation in a transport container while the ex vivo donor organ is in a resting state”. The limitation constitutes extra-solution activity to the judicial exception, which does not amount to an inventive concept when the activity is well-understood, routine, or conventional, and are thus not indicative of integration into a practical application. The claim limitation constitutes adding a generic electrical sensor and transport container, which Hassanein (US 20160374332) describes as well-understood, routine or conventional in its description of “Organ preservation techniques typically involve hypothermic storage of the organ in a chemical perfusate solution” which necessitates some container (Paragraph 0002) as well as “Electrodes are used in some heart perfusion systems to measure the electrical activity of the explanted heart and to deliver defibrillation energy” (paragraph 0007-0008). The claim additionally recites a generic processor, which Guerrero (US 20020138013 A1), discloses as being well-understood, routine, or conventional in noting that “To analyze the ECG, real-time systems generally include a microprocessor in conjunction with the electronic storage device” (Paragraph 0012). As discussed above with respect to integration of the abstract idea into a practical application, the present elements amount to no more than mere indications to apply the exception.
In Summary, claim 1 recites abstract idea without being integrated into a practical application, and does not provide additional elements that would amount to significantly more. As such, taken as a whole, the claim and is ineligible under the 35 U.S.C. 101.
Claims 2-9 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception, in this case an abstract idea, without significantly more. As each of these claims depends from claim 1, which was rejected under 35 U.S.C. 101 in paragraph 7 of this action, these claims must be evaluated on whether they sufficiently add to the practical application of claim 1, or comprise significantly more than the limitations of claim 1.
Besides the abstract idea of claim 1, claim 2-7 recites further limitations of the additional elements of extra-solution activity; claims 8 and 9 recite further limitations of the abstract idea which are themselves abstract ideas. The claim element of claim 1 of a method for electrical monitoring of a donor organ is recited with a high level of generality (as written, the actions of the processing circuitry may be carried out by a person alone or with a generic computer in any undefined manner). The limitations of the dependent claims provide no practical application, nor do they provide meaningful limitations to the abstract idea.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1 and 3-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hassanein (US 20160374332) in view of Guerrero (US 20020138013 A1).
Regarding claim 1, Hassanein discloses method for electrical monitoring of a donor organ (Paragraph 0008-0014), the method comprising:
Transporting an ex vivo donor organ in a transport container (Organ chamber assembly 104; paragraph 0032), the transport container containing cooling material (Perfusion fluid 108; paragraph 0076-- the perfusion fluid being at a temperature of between about 25° C. and about 37° C);
measuring, using an electrical probe, electrical activity in the ex vivo donor organ during transportation in a transport container while the ex vivo donor organ is in a resting state (Paragraph 0008, 0027—measure the electrical activity of an explanted heart; Paragraph 0015-0018—assemblies for monitoring organ electrical activity; paragraph 0032-0033, 0039-0042— a perfusion system 10 is depicted, which includes an organ chamber assembly 104 for containing the heart 102 (not shown) during ex-vivo maintenance…perfusion system 10 also includes a plurality of sensors, including without limitation:…sensor/defib electrodes 12, 50, and 52… the system 10 allows monitoring of heart 102 [the heart is there, just need to add 102 to the figure] electrical activity in a perfusion system as well as the delivery of defibrillation energy or pacing signals) in hypothermic storage (paragraph 0076-- the perfusion fluid being at a temperature of between about 25° C. and about 37° C); and
determining viability of the ex vivo donor organ based at least partially on the electrical activity of the ex vivo donor organ in the resting state in hypothermic storage during transportation (Paragraph 0011, 0041— In addition to sensing and detecting ECG signals, the right atrial electrode, in combination with a left ventricle electrode, is used to deliver defibrillation energy and/or pacing signals to the explanted heart after being placed in a perfusion system to ensure the heart is beating normally before the organ chamber is sealed. After the heart is beating normally, the left ventricle electrode may be moved aside, such that fewer elements are in contact with the heart that may cause irritation to the tissue. However, it is envisioned that in some embodiments, the left ventricle electrode may be left in place after a normal heart beat is achieved so defibrillation energy and/or pacing signals may be delivered to the heart after the organ chamber is sealed without the need for further manipulating the electrode through the membrane; Paragraph 0048-- After explantation, defibrillation energy and/or pacing signals may be necessary to restore a normal heart beat during transport to a donor site. In addition to detecting ECG signals from the heart 102, the right atrial electrode 52, in conjunction with a left ventricle electrode 50, may be used to provide defibrillation energy and/or pacing signals to the explanted heart 102; paragraph 0076-- paragraph 0076-- the perfusion fluid being at a temperature of between about 25° C. and about 37° C). It is noted that as the methods of Hassanein include determining a need or lack of need for defibrillation energy or pacing signals to the explanted heart based on the measured electrical activity, the method is thus determining the viability of the explanted heart. It is further noted that storage at temperatures between 1° C and 35° C may be considered hypothermic conditions.
However, Hassanein does not explicitly disclose using a processor configured to receive an electrical activity measurement from the electrical probe.
Guerrero, in the same field of endeavor of a method for monitoring electrical activity of a heart (Paragraph 0002), discloses that “to analyze the ECG, real-time systems generally include a microprocessor in conjunction with the electronic storage device” (Paragraph 0012). It would have been obvious to one having ordinary skill in the art at the time of filing to modify the method of Hassanein to utilize a processor to receive signals from the probe as disclosed by Guerrero in order to predictably allow for the receipt, analysis, and storage of signals measured by the electrical probe as is known in the art.
Regarding claim 3, the combination of Hassanein and Guerrero teaches the method of claim 1. Hassanein additionally discloses further comprising connecting an artery of the ex vivo donor organ to an artery connector of the transport container, wherein the electrical probe is located near the artery connector (Paragraph 0040-- An aortic electrode 12 is placed in the aortic bloodpath for use in detecting ECG signals from the heart 102 during transport as blood travels to or from the aorta 158; Fig. 2, see aorta 158 connected to some connector of the transport container while the aortic electrode 12 is located nearby).
Regarding claim 4, the combination of Hassanein and Guerrero teaches the method of claim 1. Hassanein additionally discloses wherein the ex vivo donor organ is a heart (Paragraph 0008-0011, Fig. 2).
Regarding claim 5, the combination of Hassanein and Guerrero teaches the method of claim 1. Hassanein additionally discloses wherein the heart is placed such that the electrical probe is located near a sinoatrial node of the heart (Paragraph 0038—right atrium electrode 52…placed epicardially on the explanted heart; Fig. 2—the electrode 52 is placed on the right atrium, which is near the sinoatrial node).
Regarding claim 6, the combination of Hassanein and Guerrero teaches the method of claim 1. Hassanein additionally discloses wherein the heart is placed such that the electrical probe is located near an apex of the heart (Paragraph 0038—left ventricle electrode 50 placed epicardially on the explanted heart; Fig. 2—the electrode 50 is placed on the left ventricle, which is near the apex of the heart).
Regarding claim 7, the combination of Hassanein and Guerrero teaches the method of claim 1. Hassanein additionally discloses further comprising submerging the ex vivo donor organ in a preservation solution (Fig. 1-2, organ chamber assembly 104 includes perfusion fluid 108 of the reservoir which is monitored by sensor 140; paragraph 0033-0035, 0076), wherein the electrical probe is submerged in the preservation solution and not in direct contact with the ex vivo donor organ (paragraph 0027-0029-- A third electrode is placed in the flow of the aortic perfusion fluid).
Regarding claim 8, the combination of Hassanein and Guerrero teaches the method of claim 4. Hassanein additionally discloses that ECG signals can be measured (paragraphs 0010-0011, 0040-- placement of an electrode in the aortic bloodpath supplies a more stable position for the sensing and detection of electrocardiogram (ECG) signals from the heart). It is noted that measuring an ECG signal typically requires measuring a QRS wave.
However, Hassanein fails to explicitly disclose identifying a presence of a potential QRS-like wave in the heart in the resting state.
However, a person of ordinary skill in the art would have been motivated by Guerrero, in the same field of endeavor of a method for monitoring electrical activity of a heart (Paragraph 0002), to specifically measure a ORS wave in order to determine if premature depolarization has occurred, characterized by abnormal QRS, which can be a symptom of arrhythmia (paragraphs 0024, 0037-0038-- QRS is the ECG representation of ventricular depolarization which cause ventricular contraction… The second beat is a premature depolarization characterized by abnormal QRS… template matching method is probably good enough for ventricular and other gross forms of arrhythmia, which manifest themselves by millivolt range changes in the QRS). Furthermore, because Guerrero teaches that QRS can be measured by an ECG (Fig. 1, paragraph 0024), it could have been done with predictable results and a reasonable expectation of success. Therefore, the combined teachings of Hassanein and Guerrero renders the invention unpatentable as claimed.
Regarding claim 9, the combination of Hassanein and Guerrero teaches the method of claim 1. Hassanein additionally discloses wherein viability of the ex vivo donor organ is based at least partially on a change in the electrical activity of the ex vivo donor organ over time in the resting state during transportation (paragraph 0007, 0009, 0013, 0029, 0037-0042, 0045—After explantation, an explanted heart 102 is perfused and transported to a donor site under sterile conditions while being monitored by a plurality of electrodes; paragraph 0027, 0030, 0041, 0048--After explantation, defibrillation energy and/or pacing signals may be necessary to restore a normal heart beat during transport to a donor site. This would necessarily include measurements over time, and are configured to provide a pacing signal or defibrillation energy based on the measured signals over the course of transportation, thus making determinations of viability based at least partially on a change in the electrical activity).
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hassanein in view of Guerrero, further in view of Anderson (US 20140349273 A1).
Regarding claim 2, the combination of Hassanein and Guerrero teaches the method of claim 1. Hassanein additionally discloses that conventional organ preservation typically involves hypothermic conditions (Paragraph 0002--In the case of a heart, it is typically arrested, and cooled with a cardioplegic solution until it reaches a hypothermic, non-functioning state and then is stored in or perfused with a cold preservation solution) but that these methods include an increasing risk of ischemic injury with time, reducing the amount of time of viability of an explanted organ (Paragraph 0002-0003-- in the case of a heart, typically it may be maintained ex-vivo for only 4-6 hours before it becomes unusable for transplantation).
However, Hassanein fails to specifically disclose the transport container is a hypothermic static transport container configured to store the ex vivo donor organ within a temperature range of 2-10°C.
Andersen, in the same field of endeavor of a method for preserving an extracorporeal organ during transport (Abstract), discloses that it is known in the art that current procedures dictate that hearts cannot be transplanted after four hours of ischemia (paragraph 0004) and that typical preservation involves simple hypothermic (less than 10°C; paragraph 0005) storage, because of the lack of oxygen and nutrients, and fluctuation in temperatures, organs experience greater heart tissue damage due to hypoxia (paragraphs 0004-0009). Anderson teaches a hypothermic heart storage system that maintains hearts between 2°C and 8°C (Paragraph 0016) to address shortcomings of current hypothermic transport systems (claims 1, 12, 14, 15; paragraphs 0012, 0065-- The disclosed system for hypothermic transport overcomes the shortcomings of the prior art by providing a sterile, temperature-stabilized environment for the samples while providing the ability to monitor the temperature of the samples during transport… tissue can include a group of tissues forming an organ, such as, for example, the skin, lungs, cochlea, heart), which overlaps with the range of 2-10°C as in claim 2. A person of ordinary skill in the art would have been motivated modify the system of Hassanein and incorporate hypothermic storage that overlaps with the range of 2-10°C because Anderson teaches that this improved system will greatly expand the window of time for organ transportation, will make many more organs available for donation, will result in hearts that are healthier upon arrival, as compared to state-of-the-art transport methods (paragraph 0011).
Furthermore, because Anderson teaches that hearts can be stored and transported in hypothermic temperatures, teaches specific systems for transporting hearts at hypothermic temperatures, and because both Anderson and Hassanein are in the same technical field of using transportable heart storage systems that utilize electric sensors to provide information about the condition of the heart (see paragraphs 0013, 0136-0141), such a modification could have been done with predictable results and a reasonable expectation of success.
Claim(s) 1-7 and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hassanein in view of Anderson (US 20140349273 A1).
Regarding claim 1, Hassanein discloses method for electrical monitoring of a donor organ (Paragraph 0008-0014), the method comprising:
Transporting an ex vivo donor organ in a transport container (Organ chamber assembly 104; paragraph 0032), the transport container containing cooling material (Perfusion fluid 108; paragraph 0076-- the perfusion fluid being at a temperature of between about 25° C. and about 37° C);
measuring, using an electrical probe, electrical activity in the ex vivo donor organ during transportation in a transport container while the ex vivo donor organ is in a resting state (Paragraph 0008, 0027—measure the electrical activity of an explanted heart; Paragraph 0015-0018—assemblies for monitoring organ electrical activity; paragraph 0032-0033, 0039-0042— a perfusion system 10 is depicted, which includes an organ chamber assembly 104 for containing the heart 102 (not shown) during ex-vivo maintenance…perfusion system 10 also includes a plurality of sensors, including without limitation:…sensor/defib electrodes 12, 50, and 52… the system 10 allows monitoring of heart 102 [the heart is there, just need to add 102 to the figure] electrical activity in a perfusion system as well as the delivery of defibrillation energy or pacing signals) in hypothermic storage (paragraph 0076-- the perfusion fluid being at a temperature of between about 25° C. and about 37° C); and
determining viability of the ex vivo donor organ based at least partially on the electrical activity of the ex vivo donor organ in the resting state in hypothermic storage during transportation (Paragraph 0011, 0041— In addition to sensing and detecting ECG signals, the right atrial electrode, in combination with a left ventricle electrode, is used to deliver defibrillation energy and/or pacing signals to the explanted heart after being placed in a perfusion system to ensure the heart is beating normally before the organ chamber is sealed. After the heart is beating normally, the left ventricle electrode may be moved aside, such that fewer elements are in contact with the heart that may cause irritation to the tissue. However, it is envisioned that in some embodiments, the left ventricle electrode may be left in place after a normal heart beat is achieved so defibrillation energy and/or pacing signals may be delivered to the heart after the organ chamber is sealed without the need for further manipulating the electrode through the membrane; Paragraph 0048-- After explantation, defibrillation energy and/or pacing signals may be necessary to restore a normal heart beat during transport to a donor site. In addition to detecting ECG signals from the heart 102, the right atrial electrode 52, in conjunction with a left ventricle electrode 50, may be used to provide defibrillation energy and/or pacing signals to the explanted heart 102; paragraph 0076-- paragraph 0076-- the perfusion fluid being at a temperature of between about 25° C. and about 37° C). It is noted that as the methods of Hassanein include determining a need or lack of need for defibrillation energy or pacing signals to the explanted heart based on the measured electrical activity, the method is thus determining the viability of the explanted heart. It is further noted that storage at temperatures between 1° C and 35° C may be considered hypothermic conditions.
However, Hassanein does not explicitly disclose using a processor configured to receive an electrical activity measurement from the electrical probe.
Andersen, in the same field of endeavor of a method for preserving an extracorporeal organ during transport (Abstract), discloses the method including using a processor configured to receive an measurements (Paragraph 0136-- the control system 500 includes a processor 502; paragraph 0140-0142-- The processor 502 is configured to receive information associated with the pressure in the pumping chamber 325 and in the canister 390 via the sensors 510, 506, respectively… The processor 502 is configured to calculate the flow rate and resistance, as illustrated in FIG. 18. Flow rate is a measure of the tissue's compliance to fluid flow around the tissue (e.g. blood flow), and can be a significant indicator of tissue viability…). It would have been obvious to one having ordinary skill in the art at the time of filing to modify the method of Hassanein to utilize a processor to receive signals from the probe as disclosed by Andersen in order to predictably allow for the receipt, analysis, and storage of signals measured by the probe as is known in the art and which would predictably improve the functioning of the method by .
Regarding claim 2, the combination of Hassanein and Andersen teaches the method of claim 1. Hassanein additionally discloses that conventional organ preservation typically involves hypothermic conditions (Paragraph 0002--In the case of a heart, it is typically arrested, and cooled with a cardioplegic solution until it reaches a hypothermic, non-functioning state and then is stored in or perfused with a cold preservation solution) but that these methods include an increasing risk of ischemic injury with time, reducing the amount of time of viability of an explanted organ (Paragraph 0002-0003-- in the case of a heart, typically it may be maintained ex-vivo for only 4-6 hours before it becomes unusable for transplantation).
However, Hassanein fails to specifically disclose the transport container is a hypothermic static transport container configured to store the ex vivo donor organ within a temperature range of 2-10°C.
Andersen, in the same field of endeavor of a method for preserving an extracorporeal organ during transport (Abstract), discloses that it is known in the art that current procedures dictate that hearts cannot be transplanted after four hours of ischemia (paragraph 0004) and that typical preservation involves simple hypothermic (less than 10°C; paragraph 0005) storage, because of the lack of oxygen and nutrients, and fluctuation in temperatures, organs experience greater heart tissue damage due to hypoxia (paragraphs 0004-0009). Anderson teaches a hypothermic heart storage system that maintains hearts between 2°C and 8°C (Paragraph 0016) to address shortcomings of current hypothermic transport systems (claims 1, 12, 14, 15; paragraphs 0012, 0065-- The disclosed system for hypothermic transport overcomes the shortcomings of the prior art by providing a sterile, temperature-stabilized environment for the samples while providing the ability to monitor the temperature of the samples during transport… tissue can include a group of tissues forming an organ, such as, for example, the skin, lungs, cochlea, heart), which overlaps with the range of 2-10°C as in claim 2. A person of ordinary skill in the art would have been motivated modify the system of Hassanein and incorporate hypothermic storage that overlaps with the range of 2-10°C because Anderson teaches that this improved system will greatly expand the window of time for organ transportation, will make many more organs available for donation, will result in hearts that are healthier upon arrival, as compared to state-of-the-art transport methods (paragraph 0011).
Furthermore, because Anderson teaches that hearts can be stored and transported in hypothermic temperatures, teaches specific systems for transporting hearts at hypothermic temperatures, and because both Anderson and Hassanein are in the same technical field of using transportable heart storage systems that utilize electric sensors to provide information about the condition of the heart (see paragraphs 0013, 0136-0141), such a modification could have been done with predictable results and a reasonable expectation of success.
Regarding claim 3, the combination of Hassanein and Andersen teaches the method of claim 1. Hassanein additionally discloses further comprising connecting an artery of the ex vivo donor organ to an artery connector of the transport container, wherein the electrical probe is located near the artery connector (Paragraph 0040-- An aortic electrode 12 is placed in the aortic bloodpath for use in detecting ECG signals from the heart 102 during transport as blood travels to or from the aorta 158; Fig. 2, see aorta 158 connected to some connector of the transport container while the aortic electrode 12 is located nearby).
Regarding claim 4, the combination of Hassanein and Andersen teaches the method of claim 1. Hassanein additionally discloses wherein the ex vivo donor organ is a heart (Paragraph 0008-0011, Fig. 2).
Regarding claim 5, the combination of Hassanein and Andersen teaches the method of claim 1. Hassanein additionally discloses wherein the heart is placed such that the electrical probe is located near a sinoatrial node of the heart (Paragraph 0038—right atrium electrode 52…placed epicardially on the explanted heart; Fig. 2—the electrode 52 is placed on the right atrium, which is near the sinoatrial node).
Regarding claim 6, the combination of Hassanein and Andersen teaches the method of claim 1. Hassanein additionally discloses wherein the heart is placed such that the electrical probe is located near an apex of the heart (Paragraph 0038—left ventricle electrode 50 placed epicardially on the explanted heart; Fig. 2—the electrode 50 is placed on the left ventricle, which is near the apex of the heart).
Regarding claim 7, the combination of Hassanein and Andersen teaches the method of claim 1. Hassanein additionally discloses further comprising submerging the ex vivo donor organ in a preservation solution (Fig. 1-2, organ chamber assembly 104 includes perfusion fluid 108 of the reservoir which is monitored by sensor 140; paragraph 0033-0035, 0076), wherein the electrical probe is submerged in the preservation solution and not in direct contact with the ex vivo donor organ (paragraph 0027-0029-- A third electrode is placed in the flow of the aortic perfusion fluid).
Regarding claim 9, the combination of Hassanein and Andersen teaches the method of claim 1. Hassanein additionally discloses wherein viability of the ex vivo donor organ is based at least partially on a change in the electrical activity of the ex vivo donor organ over time in the resting state during transportation (paragraph 0007, 0009, 0013, 0029, 0037-0042, 0045—After explantation, an explanted heart 102 is perfused and transported to a donor site under sterile conditions while being monitored by a plurality of electrodes; paragraph 0027, 0030, 0041, 0048--After explantation, defibrillation energy and/or pacing signals may be necessary to restore a normal heart beat during transport to a donor site. This would necessarily include measurements over time, and are configured to provide a pacing signal or defibrillation energy based on the measured signals over the course of transportation, thus making determinations of viability based at least partially on a change in the electrical activity).
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hassanein in view of Andersen, further in view of Guerrero.
Regarding claim 8, the combination of Hassanein and Andersen teaches the method of claim 4. Hassanein additionally discloses that ECG signals can be measured (paragraphs 0010-0011, 0040-- placement of an electrode in the aortic bloodpath supplies a more stable position for the sensing and detection of electrocardiogram (ECG) signals from the heart). It is noted that measuring an ECG signal typically requires measuring a QRS wave.
However, Hassanein fails to explicitly disclose identifying a presence of a potential QRS-like wave in the heart in the resting state.
However, a person of ordinary skill in the art would have been motivated by Guerrero, in the same field of endeavor of a method for monitoring electrical activity of a heart (Paragraph 0002), to specifically measure a ORS wave in order to determine if premature depolarization has occurred, characterized by abnormal QRS, which can be a symptom of arrhythmia (paragraphs 0024, 0037-0038-- QRS is the ECG representation of ventricular depolarization which cause ventricular contraction… The second beat is a premature depolarization characterized by abnormal QRS… template matching method is probably good enough for ventricular and other gross forms of arrhythmia, which manifest themselves by millivolt range changes in the QRS). Furthermore, because Guerrero teaches that QRS can be measured by an ECG (Fig. 1, paragraph 0024), it could have been done with predictable results and a reasonable expectation of success. Therefore, the combined teachings of Hassanein and Guerrero renders the invention unpatentable as claimed.
Response to Arguments
The double patenting rejection is held in abeyance per applicant’s request; the rejection has been updated to reflect the amendments to the claims.
Applicant's arguments filed 25 February 2026 regarding the rejection of the claims under 35 U.S.C. 101 have been fully considered but they are not persuasive.
In particular, applicant argues that if the claims are seen to recite an abstract idea, the abstract idea is integrated into a practical application where the claim limitations recite a particular machine or manufacture that is integral to the claim. Applicant additionally states that “Step 2A specifically excludes consideration of whether the additional elements represent well-understood, routine, conventional activity” in response to the analysis of the previous office action.
In response it is noted that consideration of whether the additional elements represent well-understood, routine, conventional activity was performed in Step 2B of the analysis. As described in the previous office action and above, the analysis of step 2A being cited by applicant is in reference to the additional elements reciting non-mental processes which gather data for the mental process step and which thus fail to integrate the judicial exception into a practical application as the limitations are extra-solution activity.
Furthermore, the transport container as claimed is not seen as a particular machine and thus does not integrate the abstract idea of claim 1 into a practical application. The inclusion of cooling material and specification of hypothermic conditions is generic to the field of ex vivo organ transport and the current claim language does not clarify how the particular container itself is involved in the implementation of the abstract idea when the abstract idea is implemented with a generic “processor” which may be seen as invoking a generic computer environment.
Applicant further argues that measuring electrical activity while the ex vivo donor organ is in a resting state in hypothermic storage is not extra-solution activity as it is not well-understood, routine, or conventional and instead amount to significantly more than any abstract idea, specifically citing a paragraph of Hassanein which recites maintaining a heart “at or near physiologic temperature”.
However, the description of “cold preservation techniques” precluding the ability to evaluate and assess an organ ex-vivo do not preclude the evaluation of an organ ex-vivo in hypothermic storage specifically, which is further supported by “hypothermic storage” being encompassed by the description of “at or near physiologic temperature”. As Hassanein demonstrates that hypothermic storage of an organ in solution and electrodes for measuring electrical activity of an explanted heart are known in the art (see above) and that storage “near physiologic temperature” can in fact be in a hypothermic temperature range (see above), applicant’s arguments are not persuasive.
The claims remain rejected under 35 U.S.C. 101.
Applicant's arguments filed 25 February 2026 regarding the rejection of the claims under 35 U.S.C. 103 have been fully considered but they are not persuasive.
Applicant argues that measuring electrical activity while the ex vivo donor organ is in a resting state in hypothermic storage is not disclosed by Hassanein, citing the teaching of Hassanein of the heart and perfusion fluid as “at or near physiologic temperature”.
However, Hassanein, cited above, states that this temperature “at or near physiologic temperature” may fall in a range between “25° C. and about 37° C” which thus includes hypothermic storage temperatures. See Ma (“Advanced biomaterials in cell preservation: Hypothermic preservation and cryopreservation”) which states that “hypothermic preservation at 1 °C~35 °C to maintain short-term cell viability that is useful in cell diagnosis and transport” (Abstract). As a result, the temperature of Hassanein is not modified and would not change the principle of operation.
Applicant additionally argues that the teachings of Hassanein differ from “measuring, using an electrical probe, electrical activity in the ex vivo donor organ during transportation in the transport container while the ex vivo donor organ is in a resting state in hypothermic storage” specifically citing paragraph 0035 of Hassanein which states that the perfusion fluid “may cause the heart 102 to resume beating in its natural fashion”.
As it is described above that Hassanein itself describes hypothermic storage of the heart in the perfusion fluid, applicant’s argument is not persuasive. As stated previously, the applicant’s own definition of “at rest” encompasses the condition of the ex vivo heart of Hassanein.
The claims remain rejected under 35 U.S.C. 103.
As claims 1-9 have not yet been indicated as allowable, claims 10-26 remain withdrawn and are not yet rejoined or addressed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANNA ROBERTS whose telephone number is (571)272-7912. The examiner can normally be reached M-F 8:30-4:30 EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alexander Valvis can be reached at (571) 272-4233. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ANNA ROBERTS/Examiner, Art Unit 3791