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 .
Specification
The objection to the specification is withdrawn in light of the amendments.
Claim Objections
Claims 1 and 27-29 are objected to because of the following informalities:
Regarding claim 1, in line 23, the phrase “a status of the extracorporeal body tissue” could be “the status of the extracorporeal body tissue” to refer back to claim 1, line 5.
Regarding claim 27, in line 1, the phrase “the sensor” should be “the at least one sensor”.
Regarding claim 28, in line 2, the phrase “the sensor” should be “the at least one sensor”.
Regarding claim 29, in line 1, the phrase “the sensor” should be “the at least one sensor”.
Appropriate correction is required.
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.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited 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.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
“at least one adjuster operable to adjust a property of the extracorporeal body tissue and/or the environment surrounding the extracorporeal body tissue” of claim 6; and,
“at least one adjuster operable to adjust a property of the extracorporeal body tissue and/or the environment surrounding the extracorporeal body tissue” of claim 8; and,
“the adjuster to adjust at least one of: (i) a flow of a persufflation fluid to the extracorporeal body tissue, and (ii) a pressure of a persufflation fluid flowing through the extracorporeal body fluid” of claim 8.
Because these claim limitations are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, claims 6 and 8 are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. A review of the specification as filed shows that the following appears to be the corresponding structures, materials, or acts described in the specification as filed for the following 35 U.S.C. § 112(f) limitations:
“the adjuster may be configured to adjust … temperature, e.g. it may be a heater/cooler. The adjuster may be configured to control … a pressure and/or flow rate … the system 100 may include one or more controllable valves …”, instant specification, pg. 25, lines 4-9
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 17 and 27 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.
Regarding claim 17, a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 17 recites the broad recitation: “wherein the status output signal includes the identified subsets of the sensor data”, and the claim also recites the limitations of parent claim 16: “wherein the status output signal includes each the identified subsets of the sensor data” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 27 recites the limitation “the fluid flow” in line 2. There is insufficient antecedent basis for this limitation in the claim. There is a form of antecedent basis in another dependent claim, claim 26; however, no antecedent basis occurs in independent claim 1.
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 1, 3-17, and 26-29 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claims recite:
A body tissue preservation system for storage and preservation of a body tissue, wherein the body tissue preservation system comprises:
a container unit configured to store and preserve extracorporeal body tissue;
a body tissue monitor for monitoring the extracorporeal body tissue to determine a status of the extracorporeal body tissue, wherein the body tissue monitor comprises:
at least one sensor configured to obtain sensor data based on a plurality of measurements of the extracorporeal body tissue disposed within the container unit and/or an environment surrounding the extracorporeal body tissue within the container unit; and
a controller arranged to receive the sensor data from the at least one sensor, wherein the controller is configured to:
detect one or more trigger events in the sensor data, wherein each of the one or more trigger events comprises sensor data which satisfies a first threshold criterion;
select, for each of the one or more trigger events, a window of the sensor data associated with the trigger event;
identify, for each of the one or more selected windows, a subset of the sensor data corresponding to the selected window;
determine, for each of the one or more selected windows, whether the corresponding identified subset of the sensor data satisfies a second threshold criterion;
determine a status of the extracorporeal body tissue based on identified subsets which satisfied the second threshold criterion; and
provide a status output signal based on the determined status of the extracorporeal body tissue.
The limitations recite a structure that, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components. That is, other than reciting “a controller” and “at least one sensor” nothing in the claim element precludes the step from practically being performed in the mind. For example, “detect” “select” “identify” and “determine” in the context of this claim encompasses the user manually calculating or identifying the sensor data information. Therefore, the limitation covers performance of the limitation in the mind but for the recitation of generic computer components. 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 it falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claim recites an abstract idea. See MPEP § 2106.04(a)(2)(III) “Mental Processes”.
This judicial exception is not integrated into a practical application. The generically recited computer elements do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. In particular, the claim only recites three additional elements – using a container unit, a controller, and at least one sensor to perform the detection, selection, identification, and determination steps. The controller in these steps is recited at a high-level of generality such that it amounts no more than mere instructions to apply the exception using a generic computer component. Accordingly, this additional element does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. Thus the claim is directed to an abstract idea.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional element of using a controller to perform the steps above amounts to no more than mere instructions to apply the exception using a generic computer component. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept. The additional container unit of the system is well-understood, routine, and/or conventional as evidenced by prior art Steinman (US 20140017663). Thus the claim is not patent eligible.
Regarding the dependent claims, the additional elements of the system are well-understood, routine, and/or conventional as evidenced by prior art Steinman (US 20140017663) in view of Templeman (US 20100330547).
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 4-7, 9-17, and 28 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Steinman (US 20140017663).
Regarding claim 1, Steinman discloses a body tissue preservation system (abstract) for storage and preservation of a body tissue (abstract and paragraph [0001]), wherein the body tissue preservation system (abstract) comprises:
a container unit (paragraph [0012] “cradle”) configured to store and preserve extracorporeal body tissue (abstract and paragraphs [0001]);
a body tissue monitor (paragraphs [0026] and [0028]-[0029]) for monitoring the extracorporeal body tissue (paragraph [0011] for types of organs or tissue) to determine a status of the body tissue (paragraph [0032] “warning” for shocks to the system which may cause damage to the system and/or organ), wherein the body tissue monitor comprises:
at least one sensor (paragraph [0029]) configured to obtain sensor data based on a plurality of measurements of the extracorporeal body tissue disposed within the container unit (paragraph [0012] “organ 20 is disposed within the cradle”) and/or an environment surrounding the extracorporeal body tissue within the container unit (paragraph [0012]) (shock and/or tilt detectors); and
a controller (paragraph [0030]) arranged to receive the sensor data from the at least one sensor (paragraph [0030]), wherein the controller is configured to:
detect one or more trigger events in the sensor data (paragraph [0030]), wherein each of the one or more trigger events comprises sensor data which satisfies a first threshold criterion (paragraph [0030] “generates a signal”);
select, for each of the one or more trigger events, a window of the sensor data associated with the trigger event (paragraph [0030], the signal must be detected by the
controller in a window of time; paragraph [0030] “a predetermined of [sic] time”);
identify, for each of the one or more selected windows, a subset of the sensor data corresponding to the selected window (paragraph [0030], the signal is detected by the controller within a window of time; paragraph [0030] “a predetermined of [sic] time”);
determine, for each of the one or more selected windows (paragraph [0030] “a predetermined of [sic] time”), whether the corresponding identified subset of the sensor data satisfies a second threshold criterion (paragraph [0030], the signal indicates the attitude of the apparatus has changed by more than a predetermined angle relative to a normal operating attitude or position);
determine a status of the extracorporeal body tissue based on identified subsets which satisfied the second threshold criterion (paragraph [0032] sums the shocks that occur to determine if the sum may have caused damage to the apparatus and/or the organ); and
provide a status output signal based on the determined status of the extracorporeal body tissue (paragraph [0032] a record is accessible by a user).
Regarding claim 4, Steinman discloses wherein the extracorporeal body tissue is a body tissue for a transplant (paragraph [0002]), and the system is configured to monitor the extracorporeal body tissue for the transplant during storage and/or transport (paragraph [0032]); and
wherein the status output signal provides an indication of a viability of the extracorporeal body tissue for the transplant (paragraph [0032] “The controller may also sum shocks that occur, and this sum may be used to determine if the sum of shocks may have caused damage to the apparatus 10 and/or the organ. A record of shocks may be accessible by a user”).
Regarding claim 5, Steinman discloses wherein the container unit comprises the at least one sensor (paragraph [0011]).
Regarding claim 6, Steinman discloses wherein the system includes at least one adjuster (paragraph [0012] “thermo electric cooler or a refrigerant loop” or even, broadly, “passive cooling medium similar to ice or ice water” or “ice or ice water”) operable to adjust a property of the extracorporeal body tissue and/or the environment surrounding the extracorporeal body tissue (paragraph [0012]).
In addition, regarding claim 6, Steinman discloses wherein the system includes at least one adjuster (paragraphs [0030]-[0031] “pump” and/or “the pinch valves”) operable to adjust a property of the body tissue and/or the environment surrounding the body tissue (paragraphs [0030]-[0031] “perfusion” depending on the tilt of the apparatus).
Regarding claim 7, Steinman discloses wherein the controller (paragraph [0031]) is configured to control operation of the at least one adjuster (paragraphs [0030]-[0031] “pump” and/or “pinch valves”) to adjust the property of the extracorporeal body tissue and/or the environment surrounding the extracorporeal body tissue (paragraphs [0030]-[0031] “perfusion” depending on the tilt of the apparatus) in the event that it determines that an identified subset of the sensor data satisfies the second threshold criterion (paragraph [0031]).
Regarding claim 9, Steinman discloses wherein selecting the window of the sensor data associated with the trigger event comprises selecting a time window of the sensor data (paragraph [0029] “continuously or periodically monitor and/or record the state of the apparatus” and paragraph [0030] “a predetermined of [sic] time”).
Regarding claim 10, Steinman discloses wherein the system comprises a plurality of sensors (paragraph [0029]), each configured to obtain sensor data based on a plurality of measurements (paragraph [0029] “tilt” and “shock”) for the extracorporeal body tissue and/or the environment surrounding the body tissue (paragraph [0029]).
Regarding claim 11, Steinman discloses wherein the controller (paragraph [0030]) is configured to determine whether an identified subset of sensor data from a first sensor (paragraphs [0029]-[0030]) satisfies the second threshold criterion based also on sensor data from a second sensor (paragraphs [0029]-[0030]).
Regarding claim 12, Steinman discloses wherein in the event that the controller (paragraph [0030]) detects a trigger event in sensor data from the first sensor (paragraph [0029]-[0030]), the controller is configured to select a window associated with the trigger event (paragraph [0030] “a predetermined of [sic] time”) in both the sensor data from the first sensor (paragraphs [0029]-[0030]) and the sensor data from the second sensor (paragraphs [0029]-[0030]).
Regarding claim 13, Steinman discloses wherein the controller (paragraphs [0030]-[0032]) is configured to detect that sensor data satisfies the first threshold criterion in the event that at least one of: (i) the sensor data is outside a selected range (paragraph [0032] “upper limit”), (ii) a change in the sensor data is above a threshold amount (paragraph [0032] “sum of shocks”), and (iii) a time threshold has been reached (paragraph [0030] “predetermined time”).
Regarding claim 14, Steinman discloses wherein the controller (paragraphs [0030]-[0032]) is configured to determine that an identified subset of the sensor data satisfies the second threshold criterion in the event that at least one of: (i) the sensor data is outside a selected range for a threshold period of time within a selected time window (paragraph [0030], when the angle exceeds the predetermined angle for a predetermined of [sic] time), (ii) the sensor data changes more than a threshold amount within a selected time window (paragraph [0032], for shock detection “predetermined threshold may be in the range of 2G to 3G”), and (iii) one or more selected patterns are identified in the sensor data within a selected time window (paragraph [0032] “sum of shocks” and/or “recorded shocks”).
Regarding claim 15, Steinman discloses wherein the controller is configured to output an alert in the event that it is determined that a corresponding identified subset of the sensor data satisfies the second threshold criterion (paragraph [0032] “warning to the user”).
Regarding claim 16, Steinman discloses wherein the status output signal includes each identified subset of the sensor data which satisfied the second threshold criterion (paragraph [0032] “The apparatus 10 may record shocks based upon a first threshold for shocks that will not displayed and record shocks based upon a second threshold for shocks that will be displayed”).
Regarding claim 17, Steinman discloses wherein the status output signal includes the identified subsets of the sensor data (paragraph [0032] “The apparatus 10 may record shocks based upon a first threshold for shocks that will not displayed and record shocks based upon a second threshold for shocks that will be displayed”).
Regarding claim 28, Steinman discloses comprising a base unit (paragraph [0011], “apparatus includes a basin 30”) for receiving the container unit (paragraph [0011], “basin 30 may hold a cradle on which the organ 20 is disposed”) wherein the sensor is carried by the base unit (paragraph [0011] “basin 30 or apparatus 10 may include multiple temperature sensors”).
Claim Rejections - 35 USC §§ 102 | 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 29 is rejected under 35 U.S.C. 102(a)(1) as anticipated by Steinman (US 20140017663) as applied to claim 1 or, in the alternative, under 35 U.S.C. 103 as obvious over Steinman (US 20140017663).
Regarding claim 29, arguably, Steinman discloses wherein the sensor comprises a
movement sensor (paragraphs [0029]-[0030]) configured to sense one or more properties of movement of the container unit (paragraphs [0008] and [0032] “shocks experienced by the apparatus” and “a shock …. to damage the apparatus 10 and/or the organ”).
In the event that Steinman does not disclose that the movement sensor is configured to sense one or more properties of movement of the container unit, Steinman certainly discloses disclose that the movement sensor is configured to sense one or more properties of movement of the apparatus (paragraph [0032]).
Regarding this limitation, rearrangement of the movement sensor to detect the movement of the container unit rather than the apparatus as a whole, would have been obvious to one of ordinary skill in the art as an obvious matter of design choice and would not have modified the operation of the device. MPEP § 2144.04(VI)(C). Additionally, it would have been obvious to one skilled in the art before the effective filing date to modify the at least one movement sensor of Steinman to be located to be able to sense the container unit in order to determine the damage to the apparatus and/or the organ (Steinman, paragraph [0032]).
Claims 26-27 are rejected under 35 U.S.C. 102(a)(1) as anticipated by Steinman (US 20140017663) as applied to claim 1 or, in the alternative, under 35 U.S.C. 103 as obvious over Steinman (US 20140017663) as applied to claim 1, in view of Templeman (US 20100330547).
Regarding claim 26, Steinman discloses comprising at least one channel (paragraphs [0016]-[0017] and [0022]-[0023] “flow path”, e.g. “hepatic flow path 130 connected to the hepatic artery of a liver”) arranged to enable fluid flow so that fluid may be delivered to the extracorporeal body tissue and out of the extracorporeal body tissue, the sensor data including measurement values for at least one property of the fluid flow (paragraph [0016], especially [0017] “a pressure sensor” or [0023] “flow sensors”).
If it is deemed that the term “fluid” is only to be used in terms of gaseous persufflation rather than liquidic perfusion of the extracorporeal body tissue, Templeman discloses comprising at least one channel arranged to enable fluid flow so that fluid may be delivered to the extracorporeal body tissue (paragraphs [0049] and [0057]) and out of the extracorporeal body tissue (inherent to the administration of the extracorporeal body tissue’s system of blood vessels that there would be an outlet to blood vessels that would release fluid), the sensor data including measurement values for at least one property of the fluid flow (paragraph [0048]).
In the analogous art of perfusing an organ with gas, it would have been obvious to one skilled in the art before the effective filing date to modify the apparatus of Steinman with the persufflation structures and functions of Templeman in order to provide oxygen to cells, gaseous hydrogen (which may act to protect cells by its antioxidant and antiapoptotic properties), gaseous carbon monoxide (which may have anti-inflammatory and antiapoptotic effects), and to improve the quality of the organ during preservation (Templeman, paragraphs [0030]-[0031]).
Regarding claim 27, arguably, Steinman discloses wherein the sensor (paragraph [0017]) is coupled to the extracorporeal body tissue (abstract and paragraphs [0001]) via the fluid flow (Fig. 1, elements 90, 138 and paragraphs [0017] and [0026] “a pressure sensor”).
If it is deemed that Steinman does not disclose this limitation, Templeman discloses wherein the sensor is coupled to the extracorporeal body tissue via the fluid flow (paragraph [0048]; Fig. 2, element 165 “%O2” and “oxygen concentration sensor 165 may be positioned along line 161 downstream of filter 163”).
In the analogous art of perfusing an organ with gas, it would have been obvious to one skilled in the art before the effective filing date to modify the apparatus of Steinman with the persufflation structures and functions of Templeman in order to provide oxygen to cells, gaseous hydrogen (which may act to protect cells by its antioxidant and antiapoptotic properties), gaseous carbon monoxide (which may have anti-inflammatory and antiapoptotic effects), and to improve the quality of the organ during preservation (Templeman, paragraphs [0030]-[0031]).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 3 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Steinman (US 20140017663) as applied to claim 1, in view of Templeman (US 20100330547).
Regarding claim 3, Steinman does not disclose wherein the system is configured to persufflate the extracorporeal body tissue in the container unit. Templeman discloses wherein the system is configured to persufflate the extracorporeal body tissue in the container unit (abstract, paragraphs [0029]-[0030]).
In the analogous art of perfusing an organ with gas, it would have been obvious to one skilled in the art before the effective filing date to modify the apparatus of Steinman with the persufflation structures and functions of Templeman in order to provide oxygen to cells, gaseous hydrogen (which may act to protect cells by its antioxidant and antiapoptotic properties), gaseous carbon monoxide (which may have anti-inflammatory and antiapoptotic effects), and to improve the quality of the organ during preservation (Templeman, paragraphs [0030]-[0031]).
Regarding claim 8, Steinman does not disclose wherein the system includes at least one adjuster operable to adjust a property of the extracorporeal body tissue and/or the environment surrounding the extracorporeal body tissue, and wherein the controller is configured to control the at least one adjuster to adjust at least one of: (i) a flow of a persufflation fluid to the extracorporeal body tissue, and (ii) a pressure of a persufflation fluid flowing through the extracorporeal body tissue.
Templeman discloses wherein the system includes at least one adjuster (paragraphs [0048]-[0049]) operable to adjust a property of the extracorporeal body tissue and/or the environment surrounding the extracorporeal body tissue (paragraph [0049] oxygenation of the organ), and wherein the controller is configured to control the at least one adjuster to adjust at least one of: (i) a flow of a persufflation fluid to the extracorporeal body tissue (paragraph [0048]; Fig. 2, elements 177-1, 177-2, and 177-3), and (ii) a pressure of a persufflation fluid flowing through the extracorporeal body tissue (paragraph [0048]; Fig. 2, elements 167 and 173 “pressure transducer gauge”).
In the analogous art of perfusing an organ with gas, it would have been obvious to one skilled in the art before the effective filing date to modify the apparatus of Steinman with the persufflation structures and functions of Templeman in order to provide oxygen to cells, gaseous hydrogen (which may act to protect cells by its antioxidant and antiapoptotic properties), gaseous carbon monoxide (which may have anti-inflammatory and antiapoptotic effects), and to improve the quality of the organ during preservation (Templeman, paragraphs [0030]-[0031]).
Response to Arguments
Applicant’s arguments filed 09/29/2025 have been fully considered but they are not persuasive.
Regarding pgs. 7-8 of Applicant Remarks, a rejection under 35 U.S.C. § 101 stands because the additional component of “a container” is considered a well-understood, routine, and conventional (WURC) component of the art, as evidentiarily supported by Steinman in view of Templeman.
Regarding pg. 9 of Applicant Remarks, Steinman discloses claim 1 in its entirety as currently claimed, see rejection above.
Although the Applicant remarks discuss that “neither feedback loop in Steinman amounts to anything more than determining whether or not a particular event has occurred in the received sensor data”, it is clear from Steinman that the sensor can do the claimed controller limitations. Specifically, the following limitations can be rejected using Steinman’s disclosure (claimed material italicized, emphasized portions bolded):
select, for each of the one or more trigger events, a window of the sensor data associated with the trigger event (paragraph [0029], “The shock and/or tilt detector(s) 150 may be used to continuously or periodically monitor and/or record the state of the apparatus 10” and paragraph [0030], “The controller 400 may utilize one or more signal generated by the shock and/or tilt detector(s) 150 to make decisions regarding controlling any components of the perfusion circuit, for example controlling the pump 80 and/or pinch valves 122, 132, 142. For example, if the accelerometer 150 generates a signal indicating that the attitude of the apparatus 10 has changed by more than a predetermined angle relative to a normal operating attitude or position, the controller 400 may generate a signal that stops the pump 80. … The controller 400 may immediately change operation of the apparatus 10 when the attitude of the apparatus exceeds the predetermined angle, or the controller 400 may change operation of the apparatus 10 when the angle exceeds the predetermined angle for a predetermined of time).
identify, for each of the one or more selected windows, a subset of the sensor data corresponding to the selected window (paragraph [0030] “The controller 400 may immediately change operation of the apparatus 10 when the attitude of the apparatus exceeds the predetermined angle, or the controller 400 may change operation of the apparatus 10 when the angle exceeds the predetermined angle for a predetermined of time” or in paragraph [0031]: “beyond the predetermined angle by more than a predetermined amount and/or for more than a predetermined period of time because the extended period of time may make it more likely that undesirable substances have entered the perfusate path and/or organ.”)
determine, for each of the one or more selected windows, whether the corresponding identified subset of the sensor data satisfies a second threshold criterion (paragraph [0030] “The controller 400 may immediately change operation of the apparatus 10 when the attitude of the apparatus exceeds the predetermined angle, or the controller 400 may change operation of the apparatus 10 when the angle exceeds the predetermined angle for a predetermined of time”);
determine a status of the extracorporeal body tissue based on identified subsets which satisfied the second threshold criterion (paragraph [0032] “A warning that an upper limit for shock was exceeded may generate a warning to the user. The controller may also sum shocks that occur, and this sum may be used to determine if the sum of shocks may have caused damage to the apparatus 10 and/or the organ. A record of shocks may be accessible by a user”); and
provide a status output signal based on the determined status of the extracorporeal body tissue (paragraph [0032] “A record of shocks may be accessible by a user”).
The specific argument “There is nothing in Steinman that discloses or suggests determining whether a status of the extracorporeal body tissue has identified a second threshold criteria, let alone any actions taken in Steinman if the second threshold criteria is satisfied” can be rebutted with the following disclosure about the second threshold and a status of the extracorporeal body tissue; see Steinman, paragraph [0032]: “A warning that an upper limit for shock was exceeded may generate a warning to the user. The controller may also sum shocks that occur, and this sum may be used to determine if the sum of shocks may have caused damage to the apparatus 10 and/or the organ”.
Regarding pg. 9-10 of 11 of the Applicant Remarks, the arguments can be rebutted with the information given above.
Regarding pg. 10 of 11 of the Applicant Remarks about the dependent claims 3 and 8, these claims are rejected for the same reason as the base claim upon which they depend.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/N.G.E./Examiner, Art Unit 1799
/MICHAEL A MARCHESCHI/Supervisory Patent Examiner, Art Unit 1799