DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 20 March 2026 has been entered.
Comments
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . 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.
Claims 1, 3-4, 6-12, and 16-24 are pending and examined in the instant Office action.
Information Disclosure Statement
The document of Bon et al. on the IDS submitted 3/27/2026 has been crossed out because applicant did not provide the entire document of Bon et al. The entire document of Bon et al. is provided with the instant Office action, and Bon et al. is cited on the attached 892 form.
Withdrawn Rejections
The rejections under 35 U.S.C. 112 are withdrawn in view of amendments to the claims filed on 20 March 2026.
Claim Objection
Claims 1 and 23 and objected to because of the following informalities:
Line 4 of claim 1 recites “a perfusate of a liver as donor organ tissue”.
Line 4 of claim 1 should recite “a perfusate of a liver of donor organ tissue”.
Line 6-7 of claim 1 recite “a group comprising FMN, FAD, NADH”.
Line 6-7 of claim 1 should recite “a group comprising FMN, FAD, and NADH”.
Claim 23 recites “the concentration of the at least one marker molecule in the perfusate can be used as a predictor for the quality of organ tissue prior transplantation of the organ tissue and to group the organ tissue into risk groups.”
Claim 23 should recite “the concentration of the at least one marker molecule in the perfusate can be used as a predictor for the quality of organ tissue prior to transplantation of the organ tissue and to group the organ tissue into risk groups.”
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b) - Indefiniteness
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
The following rejections are newly applied:
Claims 1, 3-4, 6-12, and 16-24 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
In lines 4-5 of claim 1, the claim recites that “the donor tissue is ischemic damaged / injured”. It is unclear if this limitation signifies that the donor tissue is ischemic damaged and the donor tissue is ischemic injured OR that the donor tissue is ischemic damaged or the donor tissue is ischemic injured. For the purpose of examination, it is interpreted that the donor tissue is ischemic damaged or the donor tissue is ischemic injured.
Claim 22 recites the limitation "the amount of FMN" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. Claim 22 does not recite an amount of FMN prior to the aforementioned citation. For the purpose of examination, it is interpreted that the amount of FMN is equivalent to eh concentration of FMN.
Claim 22 recites the limitation "the amount of FMN present in the blood after ischemic heart injury" in lines 2-3. There is insufficient antecedent basis for this limitation in the claim. Claim 22 does not recite an amount of FMN present in the blood after ischemic heart injury prior to the aforementioned citation. For the purpose of examination, it is interpreted that “the amount of FMN present in the blood after ischemic heart injury” is equivalent to a “concentration of FMN present in the blood after ischemic heart injury”.
Claim 22 recites the limitation "the degree of injury of the ischemic tissue" in lines 3-4. There is insufficient antecedent basis for this limitation in the claim. Claim 22 does not recite a degree of injury of the ischemic tissue prior to the aforementioned citation. For the purpose of examination, it is interpreted that “degree of injury of the ischemic tissue” is equivalent to “degree of organ tissue damage” recited in line 22 of claim 1.
Claim 23 recites the limitation "the quality of the organ tissue" in line 3. There is insufficient antecedent basis for this limitation in the claim. Claim 23 does not recite a quality of the organ tissue prior to the aforementioned citation. For the purpose of examination, it is interpreted that quality of organ tissue is inversely related to the degree of damage to the organ tissue.
Claim 23 recites “the concentration of the at least one marker molecule in the perfusate CAN BE USED as a predictor for the quality of organ tissue prior [to] transplantation of the organ tissue and to group the organ tissue into risk groups.” In this limitation, it is unclear as to whether the uses of the concentration of the at least one marker molecule in the perfusate are required or optional. For the purpose of examination, it is interpreted that these recited uses are optional.
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.
The following rejection is reiterated for claims 1, 3-4, 6-12, and 16-21 and is newly applied for claims 22-24:
Claim(s) 1, 3-4, 6-12, and 16-24 is/are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea/law of nature/natural phenomenon without significantly more. Claims 1, 3-4, 6-12, and 16-24 are drawn to devices.
In accordance with MPEP § 2106, claims found to recite statutory subject matter (Step 1 : YES) are then analyzed to determine if the claims recite any concepts that equate to an abstract idea, law of nature or natural phenomenon (Step 2A, Prong 1). In the instant application, the claims recite the following limitations that equate to an abstract idea:
Claim 1 recites the mental step of using the measured concentration of the marker molecule in the perfusate in at least one algorithm for generating at least one success score.
Claim 1 recites the mental step of constraining the markers to FMN, FAD, and/or NADH.
Claim 1 recites the mental step requiring the success score to be defined based on at least one parameter value of at least one predefined parameter.
Claim 1 recites the mental step of acquiring at least one parameter value after transplantation of the organ tissue.
Claim 1 recites the mental step requiring the success score to be based on at least one signal generated for facilitating a decision of whether the organ tissue is suitable for transplantation or not.
Claim 1 recites the mental step of constraining the success score to reflect tumor damage.
Claim 1 recites the mental step of constraining the prediction algorithm to be a regression or classification algorithm, wherein the pre-defined parameters used by the at least one prediction algorithm are pre-transplanted information and post-transplant parameters.
Claim 3 recites the mental step of requiring machine learning and artificial intelligence to be applied for characterizing the condition of the organ tissue.
Claim 4 recites the mental step of requiring the at least one success score to correspond to the concentration of at least one marker molecule in the perfusate.
Claim 4 recites the mental step requiring a previously determined threshold value of the at least one marker molecule to be used for generating the at least one signal and/or at least one set of data for facilitating the decision of an organ tissue transplantation prior to the organ tissue transplantation.
Claim 6 recites the mental step of the model encompassing a corresponding set of prediction algorithms, each of which may have been learned on a unique pool of information of previously available pre-transplant information along with a set of the corresponding post-transplant parameter of interest of previous transplantation.
Claim 7 recites the mental step of combining the set of predicted post-transplant parameters and map those into a success score, and the success score is used to facilitate the decision process.
Claim 8 recites the mental step of constraining the database to comprise pre-transplant parameters and post-transplant parameters.
Claim 9 recites the mental step of constraining the types of marker molecules that are measured.
Claim 11 recites the mental step of comprises basing at least a subset of parameters on patient-specific demographic data.
Claim 12 recites the mental step of constraining the types of post-treatment data.
Claim 16 recites the mental step of constraining the type of data in the databased.
Claim 17 recites the mental step of using the database to refine the prediction algorithm.
Claim 18 recites the mental step of using data of previous transplant cases to train for predicting the transplant outcome of a new case.
Claim 19 recites the mental step of determining a success rate of an organ transplant after a period of time.
Claim 20 recites the mental step of constraining the type of data and time frame of the regression calculation.
Claim 21 recites the mental step of refining the prediction algorithm as more data becomes available.
Claim 22 recites the mental steps relating concentration of FMN to tissue damage or reperfusion injury and correlating this concentration of FMN present in the blood after ischemic heart injury positively correlates with the degree of organ tissue damage.
Claim 23 recites the mental step requiring the concentration of the at least one marker molecule in the perfusate to be predictive of quality of organ tissue prior to transplantation.
Claim 23 recites the mental step requiring the concentration of the at least one marker molecule in the perfusate to be used to group the organ tissue into risk groups.
These recitations are similar to the concepts of collecting information, analyzing it and displaying certain results of the collection and analysis in Electric Power Group, LLC, v. Alstom (830 F.3d 1350, 119 USPQ2d 1739 (Fed. Cir. 2016)), organizing and manipulating information through mathematical correlations in Digitech Image Techs., LLC v Electronics for Imaging, Inc. (758 F.3d 1344, 111 U.S.P.Q.2d 1717 (Fed. Cir. 2014)) and comparing information regarding a sample or test to a control or target data in Univ. of Utah Research Found. v. Ambry Genetics Corp. (774 F.3d 755, 113 U.S.P.Q.2d 1241 (Fed. Cir. 2014)) and Association for Molecular Pathology v. USPTO (689 F.3d 1303, 103 U.S.P.Q.2d 1681 (Fed. Cir. 2012)) that the courts have identified as concepts that can be practically performed in the human mind or mathematical relationships. Therefore, these limitations fall under the “Mental process” and “Mathematical concepts” groupings of abstract ideas. Merely reciting that a mental process is being performed in a generic computer environment does not preclude the steps from being performed practically in the human mind or with pen and paper as claimed. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then if falls within the “Mental processes” grouping of abstract ideas. As such, claim(s) 1, 3-4, 6-12, and 16-24 recite(s) an abstract idea/law of nature/natural phenomenon (Step 2A, Prong 1 : YES).
Claims found to recite a judicial exception under Step 2A, Prong 1 are then further analyzed to determine if the claims as a whole integrate the recited judicial exception into a practical application or not (Step 2A, Prong 2). This judicial exception is not integrated into a practical application because the claims do not recite an additional element that reflects an improvement to technology or applies or uses the recited judicial exception to affect a particular treatment for a condition. Rather, the instant claims recite additional elements that amount to mere instructions to implement the abstract idea in a generic computing environment or mere instructions to apply the recited judicial exception via a generic treatment. While performing an organ transplantation may be considered a form of treatment, there is no active limitation of performing an organ transplant in the claims.
As such, these limitations equate to mere instructions to implement the abstract idea on a generic computer that the courts have stated does not render an abstract idea eligible in Alice Corp., 573 U.S. at 223, 110 USPQ2d at 1983. See also 573 U.S. at 224, 110 USPQ2d at 1984. As such, claims 1, 3-4, 6-12, and 16-24 is/are directed to an abstract idea/law of nature/natural phenomenon (Step 2A, Prong 2 : NO).
Claims found to be directed to a judicial exception are then further evaluated to determine if the claims recite an inventive concept that provides significantly more than the judicial exception itself (Step 2B). The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims recite additional elements that equate to mere instructions to apply the recited exception in a generic way or in a generic computing environment.
The document of Yamada et al. [US PGPUB 2017/0108424 A1; on 892 form of 8/7/2025] studies an X-ray fluorescence spectrometer and X-ray fluorescence analyzing method [title]. The cover figure of Yamada et al. illustrates that it is routine and conventional for the fluorescence spectrometer to communicate with a computer.
The document of Banks et al. [US PGPUB 2016/0033507 A1; on IDS] studies use of ACY-1 marker of ischemia/reperfusion, delayed graft function, and graft variability [title]. Paragraph 145 of Banks et al. teaches that it is routine and conventional for a mass spectrometer to communicate with a perfusion apparatus. The document of Banks et al. also teaches that it is routine and conventional to measure perfusion markers.
As discussed above, there are no additional limitations to indicate that the claimed analysis engine requires anything other than generic computer components in order to carry out the recited abstract idea in the claims. Claims that amount to nothing more than an instruction to apply the abstract idea using a generic computer do not render an abstract idea eligible. Alice Corp., 573 U.S. at 223, 110 USPQ2d at 1983. See also 573 U.S. at 224, 110 USPQ2d at 1984. MPEP 2106.05(f) discloses that mere instructions to apply the judicial exception cannot provide an inventive concept to the claims. The additional elements do not comprise an inventive concept when considered individually or as an ordered combination that transforms the claimed judicial exception into a patent-eligible application of the judicial exception. Therefore, the claims do not amount to significantly more than the judicial exception itself (Step 2B : No). As such, claims 1, 3-4, 6-12, and 16-24 is/are not patent eligible.
Response to arguments:
Applicant's arguments filed 20 March 2026 have been fully considered but they are not persuasive.
Applicant amended to statutory class of the claims from methods to spectroscopic analysis units. Applicant argues that if the spectroscopic analysis unit claim 13 of the claim listing of 8 March 2022 was found to be subject matter eligible, then the same reasoning applied the instant set of claims results in claims that are subject matter eligible. This argument is not persuasive because claim 13 of the claim listing of 8 March 2022 is drawn to a spectroscopic analysis unit with the data analysis algorithm as an intended use of the spectroscopic analysis unit. An intended use of the spectroscopic analysis unit does not differentiate spectroscopic analysis unit from any other generic spectroscopic analysis unit. Conversely, while the instant amended claims are also drawn to spectroscopic analysis units, these spectroscopic analysis units are particular spectroscopic analysis units configured to perform a specific data analysis algorithm. Consequently, the specific data analysis algorithm is a necessary part of these specific spectroscopic analysis units. The judicial exceptions recited in the data analysis without a practical application results in subject matter ineligibility.
While applicant cites pages 3 and 5 of the specification as support for giving practical applications to the judicial exceptions, the alleged improvements of degree of success and economic costs to the patient are general assertions. Without specific evidence (i.e. either from the specification or an affidavit) giving a detailed analysis of the improvements with a nexus to recited claim limitations, these arguments are not persuasive.
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.
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.
The following rejection is reiterated for claims 1, 3-4, 6-12, and 16-21 and is newly applied for claims 22-24:
Claim(s) 1, 3-4, 6-12, and 16-24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Becker et al. [WO 2019/141809 A1; on IDS] in view of Elster et al. [US PGPUB 2014/0122382 A1; on IDS].
Claim 1 is drawn to a spectroscopic analysis unit. The unit comprises at least one fluorescence spectrometer. The spectrometer is configured to determine the concentration of at least one marker molecule in a perfusate of a liver of donor organ tissue wherein the donor organ tissue is ischemic damaged or ischemic injured. The at least one marker molecule is selected from a group comprising FMN, FAD, and NADH. The spectrometer comprises at least one computer processor. The processor carries out a method for evaluating damage of the ischemic damage or injury of an organ tissue. The method comprises predicting the success of transplantation of the organ tissue. The method comprises measuring the concentration of at least one marker molecule in the perfusate of the organ tissue. The method comprises generating at least one success score for transplantation of the organ. The method requires that the measured concentration of the at least one marker molecule in the perfusate is used as pre-transplant information in the at least one computer based prediction algorithm for generating the at least one success score for transplantation of the organ. The method requires that the success score reflects a degree of organ tissue damage. The method requires that the success score has been previously defined based on values of pre-defined parameters. The method requires that the computer-based prediction algorithm is a regression algorithm or a classification algorithm. The method requires that the pre-defined parameters using by the algorithm include measured concentration of the marker molecule in the perfusate and further pre-transplant information about the donor and/or recipient of the organ tissue determined before transplantation of the organ tissue and post-transplant parameters determined after previous transplantations. The method requires that based on the at least one success score or at least one set of data is generated for facilitating the decision, if the organ tissue is suitable for transplantation or not.
Claim 24 requires that the spectroscopic analysis unit is combined with at least one perfusion machine and/or at least one perfusion loop.
The document of Becker et al. studies a perfusion loop assembly for an ex-vivo liver perfusion and a method for ex-vivo liver perfusion [title]. The cover figure of Becker et al. illustrates a perfusion loop. The abstract of Becker et al. teaches measuring markers in a liver to characterize ischemic injury. Page 12, lines 12-27 of Becker et al. teaches a fluorescence flow cell (i.e. a fluorescence spectrometer is communication with a computer) and UV/Vis absorbance spectroscopy technology. Page 12, lines 12-22 of Becker et al. teaches measuring FMN fluorescence as a marker to determine ischemic injury prior to transplantation. Page 12, lines 12-22 of Becker et al. teaches using FMN fluorescence as a success score to evaluate the degree of reperfusion injury of the organ, and assists in making the determination of whether the organ should be transplanted. Consequently, Page 12, lines 12-22 of Becker et al. relates FMN fluorescence to ischemic injury. Page 12, lines 12-22 of Becker et al. teach relating FMN fluorescence to survival and quality of life after the transplantation. Figure 15 of Becker et al. illustrates a pool of regression algorithms. Page 12, lines 12-22 of Becker et al. teaches pre-defined parameters and post-transplant parameters.
While Becker et al. uses biomarker (e.g. FMN) concentration is assist in predicting the outcome of transplantation, this is not a direct prediction algorithm. Becker et al. does not teach all of the computer automation of the claims.
The document of Elster et al. studies Bayesian modeling of pre-transplant variables accurately predicts kidney graft survival [title]. The abstract of Elster et al. teaches a Bayesian Belief Network model as a prediction algorithm for predicting the success of renal grafts from only pre-transplant data. Figures 7-8 of Elster et al. illustrate the computer automation of the claims.
With regard to claim 3, Figure 15 of Becker et al. teaches using machine learning and artificial intelligence to characterize condition of organ tissue.
With regard to claim 4, Example 2 of Becker et al. teaches comparing biomarker concentration signals to calibration curves and threshold data to determine whether the transplantation should occur.
With regard to claim 6, Figure 15 of Becker et al. illustrates a pool of regression algorithms. Page 12, lines 12-22 of Becker et al. teaches pre-defined parameters and post-transplant parameters.
With regard to claim 7, Figures 5-9 of Becker et al. maps post-transplantation success scores as compared to the desired threshold ranges.
With regard to claim 8, page 45 of Becker et al. comprises a database of parameters evaluates pre-transplantation and post-transplantation.
With regard to claim 9, Figures 8, 10, and 11 of Becker et al. illustrate glucose, AST, and ALT. Page 12, lines 12-22 of Becker et al. teaches FMN.
With regard to claim 10, page 12, lines 12-22 of Becker et al. teaches real-time measurement of FMN.
With regard to claim 11, Table 1 of Elster et al. lists demographic data of the donors and recipients.
With regard to claim 12, page 12, lines 12-22 of Becker et al. teaches analyzing survival and quality of life of the recipient.
With regard to claim 16, paragraph 22 of Elster et al. teaches obtaining health data from all of the patients.
With regard to claim 17, paragraph 28 of Elster et al. teaches obtaining transplant data from 7,418 new patients.
With regard to claim 18, the abstract of Elster et al. teaches using machine learning trained on conditions and outcomes of prior transplant cases to predict outcomes of new transplant cases.
With regard to claim 19, paragraph 10 of Elster et al. teaches predicting patient and organ graft survival after one year of the organ transplant.
With regard to claim 20, Figure 15 of Becker et al. illustrates regression for Factor V after 48 hours of the transplant.
With regard to claim 21, paragraph 41 of Elster et al. teaches adding transplant data to the analysis every year after the data becomes available.
With regard to claims 22-23, Figures 14-15 of Becker et al. teach a positive correlation between FMN concentration and degree of organ tissue damage.
It would have been obvious to someone of ordinary skill in the art at the time of the effective filing date of the instant application to modify the prediction of transplant success based on biomarker concentration of Becker et al. by substituting the mathematical prediction algorithm of Elster et al. because both the concentration and the mathematical prediction algorithm are analogously used to give analysis of post-transplantation success before the transplantation occurs.
It would have been obvious to someone of ordinary skill in the art at the time of the effective filing date of the instant application to modify the prediction of transplant success based on biomarker concentration of Becker et al. by use of the demographic data of Elster et al. wherein the motivation would have been that the additional data facilitates the prediction of transplantation success [Table 1 of Elster et al.].
There would have been a reasonable expectation of success in combining Becker et al. and Elster et al. because both studies analogously predict transplant success based only on pre-transplant conditions and parameters.
Response to arguments:
Applicant's arguments filed 20 March 2026 have been fully considered but they are not persuasive.
Applicant argues that Becker et al. does not teach all of the computer limitations of the claims. Assuming (en arguendo) that Becker et al. does not teach all of the computer limitations of the claims, it is obvious to automate a manual activity for increased accuracy and efficiency [In re Venner, 262 F.2d 91, 95, 120 USPQ 193, 194 (CCPA 1958)]. In addition, Figures 7-8 of Elster et al. illustrate computers and computer automation.
Applicant argues that Becker et al. does not teach using a defined algorithm for predicting transplantation outcome. Absent a recitation of limitation requiring a high level of complexity of this prediction algorithm, the algorithm is broadly interpreted to be simple such that the increasing amplitude of the FMN signal intensity correlates with the increasing degree of reperfusion injury of the organ [page 12, lines 12-27 of Becker et al.].
Applicant argues that Elster et al. does not overcome the alleged deficiencies of Becker et al. This argument is not persuasive because the document of Becker et al. is not deficient.
E-mail Communications Authorization
Per updated USPTO Internet usage policies, Applicant and/or applicant’s representative is encouraged to authorize the USPTO examiner to discuss any subject matter concerning the above application via Internet e-mail communications. See MPEP 502.03. To approve such communications, Applicant must provide written authorization for e-mail communication by submitting the following statement via EFS-Web (using PTO/SB/439) or Central Fax (571-273-8300):
Recognizing that Internet communications are not secure, I hereby authorize the USPTO to communicate with the undersigned and practitioners in accordance with 37 CFR 1.33 and 37 CFR 1.34 concerning any subject matter of this application by video conferencing, instant messaging, or electronic mail. I understand that a copy of these communications will be made of record in the application file.
Written authorizations submitted to the Examiner via e-mail are NOT proper. Written authorizations must be submitted via EFS-Web (using PTO/SB/439) or Central Fax (571-273-8300). A paper copy of e-mail correspondence will be placed in the patent application when appropriate. E-mails from the USPTO are for the sole use of the intended recipient, and may contain information subject to the confidentiality requirement set forth in 35 USC § 122. See also MPEP 502.03.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Russell Negin, whose telephone number is (571) 272-1083. This Examiner can normally be reached from Monday through Thursday from 8 am to 3 pm and variable hours on Fridays.
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s Supervisor, Larry Riggs, Supervisory Patent Examiner, can be reached at (571) 270-3062.
/RUSSELL S NEGIN/ Primary Examiner, Art Unit 1686 31 March 2026