DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant’s response to restriction requirement filed on June 30, 2026, has been received and entered. Claims 1-20 are pending in the instant application.
Election/Restrictions
Applicants’ election without traverse of claims 1-9, 17-20 (group I) in the reply filed on June 30, 2026, is acknowledged.
Claims 10-16 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on June 302, 2026.
Priority
This application claims priority from US provisional applications 63/500,896 filed on 05/08/2023, US 63/488,750 filed on 03/06/2023 and US 63/488,760 filed on 03/06/2023.
Claims 1-9, 17-20 are under consideration.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim 17 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chang et al (Journal of Bio photonics, 2020, 1-13).
Claims are directed to a method of monitoring a condition of a heart, using extracorporeal membrane oxygenation (ECMO) to monitor oxygenation levels in circulation; and integrating an optical device to monitor a physiological baseline of the heart.
With respect to claim 17, Chang teaches a method of monitoring oxygenation level in heart, said method comprising using extracorporeal membrane oxygenation (ECMO) to monitor oxygenation levels in circulation and integrating near-infrared spectroscopy (NIRS), an optical device to monitor and detect level of oxygenated blood. The high temporal resolution of NIRS allows physicians to monitor changes in blood oxygen concentration in real time (abstract, page 2, col. 1, para. 2, fig. 5-6).
Accordingly, Chang anticipates claim 17.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
Claim limitation: (i) optical device are configured to monitor a physiological baseline of the donor organ during transport (claim 2), (ii) computational models to optimally match recipient baseline pre-and-post organ transplant (claim 5), (iii) Computational models to predict lifetime expectancy and rejection rates (claim 6), (iv) method is configured to monitor for cardiotoxic medication overdose (claim 19) and method is configured to monitor for perioperative myocardial infarctions, or configured to monitor for organ rejection during organ transplant (claim 20) have been evaluated under the three-prong test set forth in MPEP § 2181, subsection I, but the result is inconclusive. Thus, it is unclear whether this limitation should be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because there appears to be no corresponding structure is disclosed in the specification that performs the claimed function. The specification generally provides the description similar to functional language without specifying the structure of the mean to perform the function. The claims do not provide any structure for performing the claimed function. No structure that allows the claimed optical device or method to be configured to perform the claimed function is recited in the claim.
The boundaries of this claim limitation are ambiguous; therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
In response to this rejection, applicant must clarify whether this limitation should be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. Mere assertion regarding applicant’s intent to invoke or not invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph is insufficient. Applicant may:
(a) Amend the claim to clearly invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, by reciting “means” or a generic placeholder for means, or by reciting “step.” The “means,” generic placeholder, or “step” must be modified by functional language, and must not be modified by sufficient structure, material, or acts for performing the claimed function;
(b) Present a sufficient showing that 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, should apply because the claim limitation recites a function to be performed and does not recite sufficient structure, material, or acts to perform that function;
(c) Amend the claim to clearly avoid invoking 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, by deleting the function or by reciting sufficient structure, material or acts to perform the recited function; or
(d) Present a sufficient showing that 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, does not apply because the limitation does not recite a function or does recite a function along with sufficient structure, material or acts to perform that function.
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.
Claims 1-2, 8 are rejected under 35 U.S.C. 103 as being unpatentable over Hassanein et al (US 20070190636 or 7651835) and Burman et al (US 20200118679A1, dated 04/16/2020) as evidenced by Yokokawa et al (Biomed Microdevice, 2012, 14, 791-797).
Claims are directed to a method for monitoring a condition of a donor organ using an optical device, comprising:
providing a reservoir of normothermic fluid,
providing a perfusion circuit for the normothermic fluid,
providing a pump in fluid communication with the perfusion circuit,
providing an oxygenator for oxygenating the normothermic fluid during circulation through the perfusion circuit to perfuse the donor organ with oxygenated blood,
providing an optical device integrated within the reservoir, or the pump or the oxygenator, or in-line flow-based within the perfusion circuit through which the normothermic fluid flows; and using total internal reflection for the optical device.
Claim interpretation: claim is interpreted to encompass active step of providing various part of the organ care system without any active step of measuring, detecting or monitoring any biomarker indicative of any condition of the donor organ. Further, measuring oxygen saturation (SpO₂) functions is interpreted as physiological and clinical biomarker.
With respect to claim 1-2, 8, Hassanein teaches a method of caring for an organ by monitoring (temperature and/or oxygenation), said method comprising providing an organ chamber assembly for containing an organ (heart), a reservoir for containing a volume of perfusion fluid (blood and/or blood substitute) , a perfusion fluid pump for pumping/circulating perfusion fluid to and from the harvested heart; an oxygenator for re-oxygenating the perfusion fluid subsequent to it being expelled by the heart; a sensor subsystem for monitoring, for example, temperature, pressure, flow rate and/or oxygenation of the perfusion fluid (see para. 11 and 12). It is disclosed that the perfusion fluid is blood-product based containing red blood cells (see para. 14) that is maintained at or near physiological temperatures therefore the perfusate is interpreted as normothermic fluid. Hassanein further teaches integrating an in-line cuvette through which the perfusion fluid passes, an optical device for directing light at the perfusion fluid passing through the cuvette, for measuring an optical quality of the perfusion fluid passing through the cuvette (see para 40, 177). Hassanein teaches monitoring one or more physiologic characteristics of the heart including rate at which the heart is beating, the pumping characteristic includes a rate at which the pulsatile pump pumps, and the method includes adjusting the rate of the pulsatile pump in response to the rate at which the heart is beating (claims in ‘636) and an optical-based measurement of oxygen saturation (see para. 99).
While Hassanein teaches conventional optical devices that monitors physiological baseline for oxygen saturation under continuous perfusion condition in a heart but differs from claimed invention by not integrating an optical device that is configured to monitor physiological baseline that uses total internal reflection (TIR).
However, before the effective filing date of instant application, Burman teaches an optical sensor including at least the following components: an IR light source, an internal reflection element (IRE) and an IR photo detector (see para. 37). Burman teaches that the optical characteristics of the blood/interstitial fluid are analyzed to detect the presence of the biomarker which can serve as an indicator of a progression of obstructive coronary artery disease. Burman teaches that the body fluid is analyzed dynamically during the body fluid being transported by the subject’s body (see para. 39, 42). The use of TIR for optical devices in a perfusion circuit would be further obvious in view of Yokokawa who reported integrating an optical device that enables in situ total internal reflection fluorescence microscopy (TIRFM) under continuous medium perfusion.to detect changes in intracellular Ca2+ concentration (abstract). It is further disclosed that this system offers higher signal-to noise (S/N) ratio (see abstract).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art to modify the method of Hassanein by substituting the optical device with another optical device having TIR as disclosed in Burman as a matter of design choice, in the method of monitoring a condition in the heart, as instantly claimed, with a reasonable expectation of success, before the effective filing date of the instant invention. Said design choice amounting to combining prior art elements according to known methods to yield predictable results. One of ordinary skill in the art would be motivated to do so as use of TIR for optical devices in a perfusion circuit offers higher signal-to noise (S/N) ratio (see above). One of skill in the art would have been expected to have a reasonable expectation of success in monitoring the condition of an organ as prior art successfully reported using TIR for the optical device for detection of presence of an occlusion in the vessel based on the detection of the predetermined biomarker in the biofluid including troponin. . It should be noted that the KSR case forecloses the argument that a specific teaching, suggestion, or motivation is required to support a finding of obviousness See the recent Board decision Ex parte Smith, --USPQ2d--, slip op. at 20, (Bd. Pat. App. & Interf. June 25, 2007) (citing KSR, 82 USPQ2d at 1396) (available at http: www. uspto.gov/web/offices/dcom/bpai/prec/fd071925.pdf).
Claims 1, 9 are rejected under 35 U.S.C. 103 as being unpatentable over Hassanein et al (US 20070190636 or 7651835) and Burman et al (US US20200118679A1, dated 04/16/2020) as evidenced by Yokokawa et al (Biomed Microdevice, 2012, 14, 791-797) as applied above in view of Veltz {US 20170173262, 06/22/2017) and Goldner {U.S. Pub. No. 2021/0391081).
The teaching of Hassanein, Burman as evidenced by Yokokawa have been described above and relied in same manner. The combination of references differs from claimed invention by not disclosing the method of using inframarker based analysis and dosage modulation in the donor organ; and wherein levels of cryoprotective agents are analyzed in relation to organ health, and wherein a therapeutic response is initiated, or the levels of cryoprotective agents are adjusted, in real-time to avoid organ toxicity (limitation of claim 9).
Veltz teaches a personalized assistance system comprising a medical system, continuous monitoring and health condition management comprising one or more sensors associated with one or more actuators (see para. 5-7).): an infrasensor device adapted to collect input data from a subject and (para. 41-42) discuss sensor determines the concentration of an analyte and/or a biomarker and can include an infrared sensor; a controller configured to receive the input data, the controller being adapted to selectively execute one or more machine learning modules (para. 75, 118, 181-183). Veltz teaches extracting one or more inframarkers from the input data discuss data can be extracted from data streams information can be provided by a sensor to monitor continuously or discretely a user body parameter such as a heartbeat rate or a blood cholesterol level or a blood alcohol level or a blood analyte level((para. 51, 98).
Veltz further teaches determining respective changes in the one or more inframarkers in real-time, including deviations from a respective baseline measurement customized for the subject (para. 98, 106). Veltz teaches determining the one or more inframarkers and the respective changes, via the one or more machine learning modules (para. 118, 161), and reported user interactivity and machine behavior can be defined by user-defined preferences or by machine learning or driven by rules retrieved from the network. The assessed state of a user or patient can indeed drive the interactivity model, and rules can handle specific (see para. 182) execute at least one action when a predefined threshold is met (para. 161-162). Veltz does not teach executing at least one recommendation including dosage modulation instructions
Goldner teaches executing the at least one recommendation includes dosage modulation instructions and reported monitoring process includes biometrics can include heart rate, blood pressure, skin temperature, blood glucose and other subcutaneous analytes, and others and system can continuously or periodically update and/or adapt, identify, manage, monitor, and/or provide recommendations relating to d hypertension, body function (e.g., lung functions, heart functions, etc.), effects of medication levels (see para. 25-26, 36, 47).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art to modify the method of Hassanein by further including one or more inframarkers as disclosed in Veltz, and wherein executing the at least one recommendation includes dosage modulation instructions, as taught by Goldner as a matter of design choice, in the method of monitoring a condition in the heart, as instantly claimed, with a reasonable expectation of success, before the effective filing date of the instant invention. Said design choice amounting to combining prior art elements according to known methods to yield predictable results. One of ordinary skill in the art would be motivated to do so order to improve systems and methods for biomonitoring and/or providing healthcare recommendations or information for the treatment of chronic conditions. (Goldner, para. 13). One of skill in the art would have been expected to have a reasonable expectation of success in monitoring the condition of an organ as prior art successfully reported incorporating one or more inframarkers in the perfusion circuit It should be noted that the KSR case forecloses the argument that a specific teaching, suggestion, or motivation is required to support a finding of obviousness See the recent Board decision Ex parte Smith, --USPQ2d--, slip op. at 20, (Bd. Pat. App. & Interf. June 25, 2007) (citing KSR, 82 USPQ2d at 1396) (available at http: www. uspto.gov/web/offices/dcom/bpai/prec/fd071925.pdf).
Claims 1, 3-6 are rejected under 35 U.S.C. 103 as being unpatentable over Hassanein et al (US 20070190636 or 7651835) and Burman et al (US 20200118679A1, dated 04/16/2020) as evidenced by Yokokawa et al (Biomed Microdevice, 2012, 14, 791-797), Veltz {US 2017 0173262 Al) and Wager (WO2015/160973, dated 10/22/2015).
The teachings of Hassanein, Burman, Yokokawa and Veltz have been described above and relied on in same manner. Veltz teaches the infrasensor device includes an optical sensor configured to provide an optical fingerprint of a biomarker, the optical sensor being adapted to be in transdermal contact with the subject It is disclosed that the system comprises a transcutaneous analyte sensor system which includes an applicator for inserting the transdermal analyte sensor and the sensor determines the concentration of an analyte and/or a biomarker and includes an optical position sensor (para. Veltz 18, 39, 42, 252).
The combination of references differs from claimed invention by not disclosing (i) donor organ’s physiological baseline is established pre-transport; and organ selected from a group of a heart, a liver, a lung, or a kidney, (ii) a donor organ’s physiological baseline is established pre-transport via transdermal measurements in a donor organ and (iii) using computational models on one of pre-transplant transdermal or transmembrane baselines to optimally match recipient baseline pre-and-post organ transplant or (iv).predict lifetime expectancy and rejection rates.
Wagner teaches establishing CO-Hb input values, which include a baseline oxygen saturation and a baseline carboxyhemoglobin (CO Hgb) level, wherein the organ is kidney or heart (see page 16, lines 27, 20, lines 18-20, page 33, lines 25-26) (limitation of claim 4).
Regarding claims 5-6, Wagner teaches the method comprises using a computer system controls the dose of CO delivered to a patient, based on the determined DLco and a desired CO endpoint and duration to reach the endpoint, as well as duration to maintain the CO endpoint (see page 17, lines 1-5). Wagner further teaches that the computer system that controls adjustment of the CO dose based on said calculation based on a CO-Hb measurement taken first CO dose; and the DLco calculation is used to predict the dose of CO needed to hit the desired CO-Hb level within a specified period of time (see claims 28-30 in ‘693).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art to modify the method of Hassanein by further including one or more inframarkers as disclosed in Veltz and use computer system that controls adjustment of the CO dose based on said calculation based on a CO-Hb measurement taken first CO dose; and the DLco calculation is used to predict the dose of CO needed, as taught by Wagner as a matter of design choice, in the method of monitoring a condition in the heart, as instantly claimed, with a reasonable expectation of success, before the effective filing date of the instant invention. Said design choice amounting to combining prior art elements according to known methods to yield predictable results. One of ordinary skill in the art would be motivated to do so order to improve systems and methods for biomonitoring and/or predicting healthcare recommendations or information based on computational modeling. One of skill in the art would have been expected to have a reasonable expectation of success in using computer system to predict lifetime expectancy as prior art successfully reported using computer system that controls adjustment of the CO dose based on said calculation It should be noted that the KSR case forecloses the argument that a specific teaching, suggestion, or motivation is required to support a finding of obviousness See the recent Board decision Ex parte Smith, --USPQ2d--, slip op. at 20, (Bd. Pat. App. & Interf. June 25, 2007) (citing KSR, 82 USPQ2d at 1396) (available at http: www. uspto.gov/web/offices/dcom/bpai/prec/fd071925.pdf).
Claims 1, 7 are rejected under 35 U.S.C. 103 as being unpatentable over Hassanein et al (US 20070190636 or 7651835) and Burman et al (US 20200118679A1, dated 04/16/2020) as evidenced by Yokokawa et al (Biomed Microdevice, 2012, 14, 791-797), Veltz {US 2017 0173262 Al) and Uygun (US20210195891 Al).
The teachings of Hassanein, Burman, Yokokawa and Veltz have been described above and relied on in same manner. The combination of references differs from claimed invention by not disclosing that method comprising detecting levels of cryoprotective agents.
Uygun teaches a method, wherein the organ selected for transplantation, during transport and storage of the organ, the organ being preserved with at least one cryoprotective agent (see para. 8, 15, 75). And wherein executing the at least one recommendation includes modulating a level of the at least one cryoprotective agent based on the one or more inframarkers (para. 23, 25, 41]. Uygun teaches measuring one or more of a tissue adenosine triphosphate (ATP) to adenosine monophosphate (AMP) ratio, a tissue ATP to adenosine diphosphate (ADP) ratio, lactate clearance, potassium concentration, urea concentration, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) concentrations, and terminal deoxynucleotidyl transferase dUTP nick end labeling (TUNEL.).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art to modify the method of Hassanein by using the organ for transplantation, that is being preserved with at least one cryoprotective agent and wherein executing the at least one recommendation includes modulating a level of the at least one cryoprotective agent based on the one or more infra markers, as taught by Uygunas, a matter of design choice, in the method of monitoring a condition in the heart, as instantly claimed, with a reasonable expectation of success, before the effective filing date of the instant invention. Said design choice amounting to combining prior art elements according to known methods to yield predictable results. One of ordinary skill in the art would be motivated to do so order to improve the outcome of preservation of biological samples. (Uygun para. 57). . One of skill in the art would have been expected to have a reasonable expectation of success as prior art successfully reported using the organ for transplantation, that is being preserved with at least one cryoprotective agent. It should be noted that the KSR case forecloses the argument that a specific teaching, suggestion, or motivation is required to support a finding of obviousness See the recent Board decision Ex parte Smith, --USPQ2d--, slip op. at 20, (Bd. Pat. App. & Interf. June 25, 2007) (citing KSR, 82 USPQ2d at 1396) (available at http: www. uspto.gov/web/offices/dcom/bpai/prec/fd071925.pdf).
Claims 17, 18 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Chang et al (Journal of Bio photonics, 2020, 1-13), Burman et al (US 20200118679A1, dated 04/16/2020) as evidenced by Yokokawa et al (Biomed Microdevice, 2012, 14, 791-797),
Claims are directed to a method of monitoring a condition of a heart, using extracorporeal membrane oxygenation (ECMO) to monitor oxygenation levels in circulation; and integrating an optical device to monitor a physiological baseline of the heart.
With respect to claim 17, Chang teaches a method of monitoring oxygenation level in heart, said method comprising using extracorporeal membrane oxygenation (ECMO) to monitor oxygenation levels in circulation and integrating near-infrared spectroscopy (NIRS), an optical device to monitor and detect level of oxygenated blood. The high temporal resolution of NIRS allows physicians to monitor changes in blood oxygen concentration in real time (abstract, page 2, col. 1, para. 2, fig. 5-6). Chang differs from claimed invention by not explicitly disclosing the optical device using TIR.
However, before the effective filing date of instant application, Burman teaches use of an optical sensor including at least the following components: an IR light source, an internal reflection element (IRE) and an IR photo detector (see para. 37) (limitation of claim 18). Burman teaches that the optical characteristics of the blood/interstitial fluid are analyzed to detect the presence of the biomarker which can serve as an indicator of a progression of obstructive coronary artery disease. Burman teaches that the body fluid is analyzed dynamically during the body fluid being transported by the subject’s body (see para. 39, 42). Burman teaches a system comprising an optical sensor; and a controller coupled with the optical sensor to receive a sensor signal from the optical sensor, the controller configured to: detect a predetermined biomarker in a biofluid in a vessel that is being monitored by the optical sensor in a non-invasive manner, the predetermined biomarker detected using reflected light in a predetermined spectral range; detect presence of an occlusion in the vessel based on the detection of the predetermined biomarker in the biofluid., wherein he predetermined biomarker is a combination of proteins that comprises troponin I (cTnI) and fatty acid binding protein-3 (FABP3) (claims 1, 7 of ‘679).
Regarding claim 20, Burman teaches the system is capable of detecting an occurrence of a heart attack (myocardial infraction) (see para. 50, 20).
The use of TIR for optical devices in a perfusion circuit would be further obvious in view of Yokokawa who reported integrating an optical device that enables in situ total internal reflection fluorescence microscopy (TIRFM) under continuous medium perfusion.to detect changes (abstract). It is further disclosed that this system offers higher signal-to noise (S/N) ratio (see abstract).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art to modify the method of Chang by substituting the optical device with another optical device having TIR as disclosed in Burman as a matter of design choice, in the method of monitoring a condition in the heart, as instantly claimed, with a reasonable expectation of success, before the effective filing date of the instant invention. Said design choice amounting to combining prior art elements according to known methods to yield predictable results. One of ordinary skill in the art would be motivated to do so as use of TIR for optical devices in a perfusion circuit offers higher signal-to noise (S/N) ratio (see above). One of skill in the art would have been expected to have a reasonable expectation of success in monitoring a condition of heart as prior art successfully reported using TIR for the optical device for detection of presence of an occlusion in the vessel based on the detection of the predetermined biomarker in the biofluid including troponin. It should be noted that the KSR case forecloses the argument that a specific teaching, suggestion, or motivation is required to support a finding of obviousness See the recent Board decision Ex parte Smith, --USPQ2d--, slip op. at 20, (Bd. Pat. App. & Interf. June 25, 2007) (citing KSR, 82 USPQ2d at 1396) (available at http: www. uspto.gov/web/offices/dcom/bpai/prec/fd071925.pdf).
Claims 17, 19 are rejected under 35 U.S.C. 103 as being unpatentable over Chang et al (Journal of Bio photonics, 2020, 1-13), Burman et al (US 20200118679A1, dated 04/16/2020) as evidenced by Yokokawa et al (Biomed Microdevice, 2012, 14, 791-797), and Kim {US 20200241019, dated 07/30/2020).
The teaching of Chang, Burman and Yokokawa have been described above and relied in same manner. The combination of reference teaches a method of monitoring oxygenation level in heart, said method comprising using extracorporeal membrane oxygenation (ECMO) to monitor oxygenation levels in circulation and integrating near-infrared spectroscopy (NIRS), an optical device to monitor and detect level of oxygenated blood. The high temporal resolution of NIRS allows physicians to monitor changes in blood oxygen concentration in real time (abstract, page 2, col. 1, para. 2, fig. 5-6). Burman teaches a system comprising an optical sensor; and a controller coupled with the optical sensor to receive a sensor signal from the optical sensor, the controller configured to: detect a predetermined biomarker in a biofluid in a vessel that is being monitored by the optical sensor in a non-invasive manner, the predetermined biomarker detected using reflected light in a predetermined spectral range; detect presence of an occlusion in the vessel based on the detection of the predetermined biomarker in the biofluid. Including troponin, I (cTnI) and fatty acid binding protein-3 (FABP3) (claims 1, 7 of ‘679).
The combination of reference differs from claimed invention by not disclosing the method is configured to monitor for cardiotoxic medication overdose.
Kim teaches a controller being adapted to assess cardiotoxicity in the subject based in part on the one or more infra markers (para.2) and reported fatty acid and protein biomarkers to diagnose the risk of chemotherapy-induced cardiotoxicity are detected using various detection methods including mass spectrometry and immunoassay.
Therefore, it would have been prima facie obvious to one of ordinary skill in the art to modify the method of Chang and Burman to include, the controller being adapted to assess cardiotoxicity in the subject based in part on the one or more infra markers, as disclosed in Kim, as a matter of design choice, in the method of monitoring a condition in the heart, as instantly claimed, with a reasonable expectation of success, before the effective filing date of the instant invention. Said design choice amounting to combining prior art elements according to known methods to yield predictable results. One of ordinary skill in the art would be motivated to do so order to detect a heart issue or heart failure as a result of chemotherapy treatment. (Kim para. 4). One of skill in the art would have been expected to have a reasonable expectation of success in monitoring a condition of heart as prior art successfully reported using controller being adapted to assess cardiotoxicity in the subject based in part on the one or more infra markers as in Kim . It should be noted that the KSR case forecloses the argument that a specific teaching, suggestion, or motivation is required to support a finding of obviousness See the recent Board decision Ex parte Smith, --USPQ2d--, slip op. at 20, (Bd. Pat. App. & Interf. June 25, 2007) (citing KSR, 82 USPQ2d at 1396) (available at http: www. uspto.gov/web/offices/dcom/bpai/prec/fd071925.pdf).
Claim Rejections - 35 USC § 112
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.
Claims 1-9, 18-20 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.
Claim 1 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential steps, such omission amounting to a gap between the steps. See MPEP § 2172.01. In the instant case, claim is directed to a method of “monitoring a condition of a donor organ”, however none of the subsequent active step require detecting the condition of donor organ nor does claim recite any device configured to detect and/or monitor any biomarker in the donor organ that is indicative of conditions of the organ. The omitted steps are detecting biomarkers to monitor the condition of the donor organ. The claim further recites using TIR without any active, positive steps delimiting how this use is actually practiced. Claims 2-9 directly or indirectly depend from the rejected base claim. Appropriate correction and/or clarification are required.
Claim 3 is vague and indefinite to the extent, it is unclear as to how recitation of phrase “wherein a donor organ’s physiological baseline is established pre-transport” relates to the “monitoring a condition of a donor organ”. There is no nexus between “a donor organ’s physiological baseline” as set forth in claim 3 and “a condition of a donor organ” of claim 1. Is donor organ’s physiological baseline of claim 3 is same or different from donor organ of claim 1 (heart and liver or heart and heart). Appropriate correction and/or clarification is required.
Claim 18 is vague and indefinite to the extent it recites use of total internal reflection (TIR) without any active, positive steps delimiting how this use is actually practiced. The claims 19-20 do not provide any structure for performing the recited function. No structure that allows the claimed method to be configured to perform the claimed function. Claims 19-20 directly or indirectly depend from the rejected base claim 18. Appropriate correction and/or clarification are required.
Claim 4 is vague and indefinite to the extent, it is unclear as to how recitation of phrase “wherein a donor organ’s physiological baseline is established pre-transport via transdermal measurements in a donor organ” relates to the “monitoring a condition of a donor organ”. There is no nexus between “a donor organ’s physiological baseline” as set forth in 4 and “monitoring a condition of a donor organ” of claim 1. Is donor organ’s physiological baseline of claim 4 is same or different from donor organ of claim 1. Appropriate correction and/or clarification is required.
Claims 5 and 6 are vague and indefinite to the extent there is no nexus between active step of monitoring a condition of a donor organ” of claim 1 and using computational models to optimally match recipient baseline pre-and-post organ transplant as set forth in claim 5 or predict lifetime expectancy and rejection rates of claim 6. It is unclear how method of claim 5 and 6 relates to monitoring of a donor organ that may be for persevering organ in donor bank. None of the claims require any transplant or any recipient to optimally match recipient baseline pre-and-post organ transplant to predict lifetime expectancy and rejection rates. Is baseline estimation is in same organ for the organ recipient as the organ for monitoring recited in claim 1. Appropriate correction and/or clarification is required.
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.
Claims 5 and 6 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Claims 5 and 6 are drawn to a method for monitoring the condition of a donor organ such as heart or lung, said method using computational models on one of pre-transplant transdermal or transmembrane baselines to optimally match recipient baseline pre-and-post organ transplant or using computational models on one of pre-transplant transdermal or transmembrane baselines to predict lifetime expectancy and rejection rates. Thus, the claims are directed to a process, which is one of the statutory categories of invention.
Step 2A Prong One:
In the instant case, the method of claims 5 and 6 require following abstract idea (i) using computational models on one of pre-transplant transdermal or transmembrane baselines (claim 5), using computational models on one of pre-transplant transdermal or transmembrane baselines to predict lifetime expectancy and rejection rates (claim 6), A generic recitation of using a computational model is interpreted as series of mathematical relationships, algorithms, and formulas that involves collecting information on baseline, looking for patterns, and predicting lifetime expectancy of the donor organ and rejection rates of the donor organ. Such prediction could be made by a human mind and therefore the limitation also falls into the "mental process" groupings of abstract ideas. Accordingly, the limitation of claim 5 and 6 recites a judicial exception (an abstract idea that falls within the group of mathematical concept and mental processes).
Step 2A Prong Two:
This evaluation is performed by (a) identifying whether there are any additional elements recited in the claim beyond the judicial exception, and (b) evaluating those additional elements individually and in combination to determine whether the claim as a whole integrates the exception into a practical application. Besides the abstract idea, the claims recites providing a reservoir of normothermic fluid; providing a perfusion circuit for the normothermic fluid; providing a pump in fluid communication with the perfusion circuit; providing an oxygenator for oxygenating the normothermic fluid during circulation through the perfusion circuit to perfuse the donor organ with oxygenated blood; providing an optical device integrated within the reservoir, or the pump or the oxygenator, or in-line flow-based within the perfusion circuit through which the normothermic fluid flows.
Although these additional steps require providing a system to monitor a condition of a donor organ using an optical device, it does not provide any information as to how to use the computational models on one of pre-transplant transdermal or transmembrane baselines to optimally match recipient baseline pre-and-post for the same or different organ transplant or predict lifetime expectancy and rejection rates. The additional limitation is recited at a high level of generality and the additional elements in the independent claims are not integrated into a practical application because the additional elements (i.e., the limitations not identified as part of the abstract idea) amount to no more than limitations which amount to mere instructions to apply an exception. for example, the recitation of providing reservoir of normothermic fluid; a perfusion circuit; a pump; an oxygenator, See Specification (para. 22, 25, 26) (See MPEP 2106.05(f)). The claims do not include additional elements that are sufficient to amount to “significantly more” than the judicial exception because, the additional elements (i.e., the elements other than the abstract idea) amount to no more than limitations which amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields, as demonstrated by the specification that the additional elements are well-understood, routine, and conventional in nature (see specification para. 22, 25, Chang et al (Journal of Bio photonics, 2020, 1-13), Burman et al (US 20200118679A1)
Thus, taken alone, the additional elements do not amount to “significantly more” than the above identified abstract idea. Furthermore, looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually, and there is no indication that the combination of elements improves any other technology, and their collective functions merely provide conventional computer implementation. Mere instructions to apply an exception cannot provide an inventive concept (Step 2B: NO). The claims are not eligible.
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 17-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 16-23 of US Patent application no 18596210 (now U.S. Patent No12733843) in view of Kim {US 20200241019, dated 07/30/2020). The subject matter claimed in the instant application is fully disclosed in the patent and is covered by the patent since the patent and the application are claiming common subject matter, as follows: In the instant case, claims are directed to a method for monitoring a condition of a heart or lung, comprising using extracorporeal membrane oxygenation (ECMO) to monitor oxygenation levels in circulation; and integrating an optical device to monitor a physiological baseline of the heart or lung, further comprising: using total internal reflection for the optical device (claim 18). Claims 19-20 limit the method for monitoring a condition of a heart or lung of claim 18, wherein the method is configured to monitor for cardiotoxic medication overdose or wherein the method is one of: configured to monitor for perioperative myocardial infarctions or configured to monitor for organ rejection during organ transplant. In contrast, claims in method of claims in ‘843 is directed to a method for operating a personalized assistance system of monitoring and providing controlled responses to a physiological state of a subject, the system having a controller with a processor and tangible, non-transitory memory on which instructions are recorded, the method comprising: collecting input data from a subject via an infrasensor device electronically coupled with the controller, the infrasensor device having an infrared source configured to emit infrared light and an internal reflection element (IRE) optically coupled to the infrared source, the IRE being formed of a material having a refractive index that defines a critical angle for the infrared light; operating the infrasensor device such that the infrared light is incident on an interface of the IRE at an angle equal to or less than the critical angle to produce total internal reflection, and such that the totally internally reflected infrared light penetrates an epidermis of the subject to a depth determined by the refractive index of the IRE, the refractive index of the epidermis, and a wavelength of the infrared light transmitting the input data to the controller; extracting one or more inframarkers from the input data from the infrasensor device, via execution of a software application by the controller, wherein the inframarkers are optical infrared signatures indicating a single one or a combination of biomarkers representing the physiological state of the subject, the physiological state including myocardial injury and/or myocardial stress; determining respective changes in the one or more inframarkers in real-time, via the controller, including deviations from a respective baseline measurement customized for the subject; determining at least one recommendation based in part on the one or more inframarkers and the respective changes, via execution of one or more machine learning modules by the controller; and executing the at least one recommendation when a predefined threshold is met. Dependent claim 17 limits the method of claim 16, further comprising: incorporating a transdermal sensor in the infrasensor device, the transdermal sensor being configured to be in transdermal contact with the subject. Claim 19 is directed to method further comprising: selectively connecting an extracorporeal membrane oxygenation (ECMO) apparatus to the subject, the ECMO apparatus including a pump and an oxygenator; positioning the infrasensor device upstream or downstream of the ECMO apparatus or within respective components of the ECMO apparatus; and generating automatic threshold-based trigger notifications to the ECMO apparatus based in part on the respective changes in the one or more inframarkers. Claims 20-23 further limits the method, further comprising calculating a dosage level for a therapeutic medication appropriate to a detected acuity level of the one or more inframarkers, via the controller; and automatically administering the therapeutic medication, via an injection device, when the detected acuity level exceeds a threshold, the therapeutic medication including at least one of thrombolytics, anticoagulants, and thrombolytics coupled with antiplatelets., using infrasensor device is adapted to employ infrared spectroscopy (claim 21), he infrasensor device is adapted to perform one or more transdermal scans of the subject; and the controller is adapted to analyze optical measurement features from the transdermal scans (claim 22 and 23). As such, the ‘843 claims represent a species of instant broader claims. It is well established that a species of a claimed invention renders the genus obvious. In re Schaumann, 572 F.2d 312, 197 USPQ 5 (CCPA 1978). The ‘843 differs from claimed invention by not disclosing monitoring a condition of a heart or lung of claim 18, wherein the method is configured to monitor for cardiotoxic medication overdose or wherein the method is one of: configured to monitor for perioperative myocardial infarctions. Kim cire the deficiency by teaching use of a controller being adapted to assess cardiotoxicity in the subject based in part on the one or more infra markers (para.2) and reported fatty acid and protein biomarkers to diagnose the risk of chemotherapy-induced cardiotoxicity are detected using various detection methods including mass spectrometry and immunoassay.
Therefore, it would have been prima facie obvious to one of ordinary skill in the art to modify the method of ‘843 to include, the controller being adapted to assess cardiotoxicity in the subject based in part on the one or more infra markers, as disclosed in Kim, as a matter of design choice, in the method of monitoring a condition in the heart, as instantly claimed, with a reasonable expectation of success, before the effective filing date of the instant invention. One of ordinary skill in the art would be motivated to do so order to detect a heart issue or heart failure as a result of chemotherapy treatment. (Kim para. 4). Therefore, instant claims broadly encompass the method specifically claimed in US Patent 12733843.
Conclusion
No claims allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Sahani ({U.S. Pat. No. 11969577) teaches wherein executing the at least one recommendation includes automatic adjustment (Col. lines 42-45 and Col 6 lines 64-67) reported real-time health care treatment may additionally include providing a treating physician with one or more recommended treatment options and drug delivery device is configured for automatic adjustment of dosage responsive to hemoglobin count sensed by the hemoglobin sensor for transdermal administration of medication for management of chronic kidney disease.).
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/ANOOP K SINGH/ Primary Examiner, Art Unit 1632
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