DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 10/30/2025 has been entered.
Preliminary Remarks
The amendment filed on 10/30/2025 has been entered. Claims 1-10 have been canceled, claim 11 has been amended, and no claims have been added. Therefore, claims 11-20 remain pending in the application.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/04/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Drawings
Applicant has submitted amendments to the drawings, in particular a “Replacement Sheet” for each drawing, noted by applicant replace Sheet 17 with the attached Replacement Sheet. Therefore, the objection to the drawings cited in the previously mailed Office Action is withdrawn.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 11-13, 15-16, and 18-19 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by CN107183005A-Bordisak et al. (hereinafter, Bordisak, all citations are made to the English machine translation).
Regarding claim 11, Bordisak discloses an invention relating to the management of donor organs and particularly to an apparatus and method of organ perfusion (pg. 1, paragraph 1). Further, Bordisak discloses the donor organ is a pair of lungs (pg. 3, paragraph 15). Bordisak discloses a transport container (device 100 includes disposable 108, pg. 4, paragraph 3) configured to receive a lung (organ 104, pg. 4, paragraph 3) and preserve the lung via static hypothermic preservation (Bordisak discloses supplying as protection solution to the organ through the infusion port, page 14, paragraph 10, line 1. Further, Bordisak discloses module 324 may also be configured to control the temperature of the perfusion fluid, page 5, paragraph 8, line 5; page 11, paragraph 6, lines 4-5);
“a lung adapter configured to seal to an airway of the lung;” (catheter 608-3, pg. 8, paragraph 6; pg. 10, paragraph 1).
“a gas source containing gas comprising oxygen;”: Bordisak discloses that the ventilation circuit is configured to connect the organ 104 and ventilator 600 which supplies gas to the ventilator 600, such as pure oxygen, air, or the like (pg. 9, paragraph 4).
“a pump configured to deliver the gas comprising oxygen from the gas source to the lung through the lung adapter to inflate the lung;”: Bordisak discloses that the ventilation circuit is configured to connect the organ 104 and ventilator 600 which supplies gas to the ventilator 600, such as pure oxygen, air, or the like (pg. 9, paragraph 4).
“and the pump configured to remove gas comprising carbon dioxide from the lung through the lung adapter to deflate the lung, wherein the pump is configured to cyclically inflate and deflate the lung during ex-vivo preservation such that gas exiting the lung through the lung adapter has a lower oxygen concentration than the gas delivered to the lung through the lung adapter.”: Bordisak discloses deoxygenation can be accomplished by injecting carbon dioxide (or any other suitable gas mixture) into the perfusate (pg. 5, paragraph 8), thus, the device and pump of Bordiask are capable of cyclically inflating and deflating the lung during ex-vivo preservation such that gas exiting the lung through the lung adapter has a lower oxygen concentration than the gas delivered to the lung through the lung adapter inflation via oxygen (pg. 9, paragraph 4) and deflate (pg. 5, paragraph 8).
Regarding claim 12, Bordisak discloses a sensor (oxygen partial pressure sensor 346, pg. 7, paragraph 2) configured to measure an oxygen concentration in the lung.
Regarding claim 13, Bordisak discloses a temperature controller (one or more conditioning devices for controlling the temperature, pg. 10, paragraph 1) configured to change a temperature in the transport container based on the oxygen concentration.
Regarding claim 15, Bordisak discloses a sensor (oxygen partial pressure sensor 346, pg. 7, paragraph 2) a sensor configured to measure an oxygen consumption rate in the lung.
Regarding claim 16, Bordisak discloses a temperature controller (one or more conditioning devices for controlling the temperature, pg. 10, paragraph 1) configured to change a temperature in the transport container based on the oxygen consumption rate.
Regarding claim 18, Bordisak discloses a sensor (carbon dioxide sensors, pg. 7, paragraph 2) configured to measure a carbon dioxide concentration in the lung.
Regarding claim 19, Bordisak discloses a sensor (one or more conditioning devices for controlling the temperature, pg. 10, paragraph 1) configured to measure a carbon dioxide concentration in the lung.
Therefore, the reference of Bordisak meet the limitations of 11-13, 15-16, and 18-19.
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 14, 17 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over CN107183005A-Bordisak et al. (hereinafter, Bordisak, all citations are made to the English machine translation), as applied to the claims 12, 15, and 18, respectively above, and further in view of JP2000279519A-Sugiura et al. (hereinafter Sugiura, all citations are made to the English machine translation).
Regarding claim 14, Bordisak teaches the invention discussed above in claim 12. Further, Bordisak teaches a ventilator of the device, also, discussed above. However, Bordisak does not explicitly teach a frequency of the inflation and deflation is based on the oxygen concentration.
For claim 14, Sugiura teaches an invention relating to a ventilator, which is suitable when the lung function is in a defective state, and more preferably a high frequency ventilator which is suitable for oxygen inhalation in patients with severe lung disease (para. [0001]), and Sugiura teaches a high-frequency ventilator 12 includes the second mixing device 85 and the oxygen sensor 83, and has a configuration in which new oxygen is added based on the detected oxygen concentration of the exhaled breath. It is possible to constantly inhale oxygen at a constant oxygen concentration (para. [0077]), which reads on the instant claim limitation of a frequency of the inflation and deflation is based on the oxygen concentration.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the device of Bordisak to include a frequency of the inflation and deflation is based on the oxygen concentration, as taught by Sugiura, in order to allow for efficient oxygen concentration of the lung ex vivo. Further, Sugiura teaches when oxygen is inhaled, generally, oxygen (inhalation) is supplied to the patient after being humidified and heated in advance in order to prevent the respiratory system of the patient from drying and the decrease in body temperature (para. [0075]).
Regarding claim 17, Bordisak teaches the invention discussed above in claim 15. Further, Bordisak teaches a ventilator of the device, also, discussed above. However, Bordisak does not explicitly teach a frequency of the inflation and deflation is based on the oxygen consumption rate.
For claim 17, Sugiura teaches an invention relating to a ventilator, which is suitable when the lung function is in a defective state, and more preferably a high frequency ventilator which is suitable for oxygen inhalation in patients with severe lung disease (para. [0001]), and Sugiura teaches a high-frequency ventilator 12 includes the second mixing device 85 and the oxygen sensor 83, and has a configuration in which new oxygen is added based on the detected oxygen concentration of the exhaled breath. It is possible to constantly inhale oxygen at a constant oxygen concentration (para. [0077]), which reads on the instant claim limitation of a frequency of the inflation and deflation is based on the oxygen consumption rate.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the device of Bordisak to include a frequency of the inflation and deflation is based on the oxygen consumption rate, as taught by Sugiura, in order to allow for efficient oxygen concentration of the lung ex vivo. Further, Sugiura teaches when oxygen is inhaled, generally, oxygen (inhalation) is supplied to the patient after being humidified and heated in advance in order to prevent the respiratory system of the patient from drying and the decrease in body temperature (para. [0075]).
Regarding claim 20, Further, Bordisak teaches a ventilator of the device, also, discussed above. However, Bordisak does not explicitly teach a frequency of the inflation and deflation is based on the carbon dioxide concentration.
For claim 20, Sugiura teaches an invention relating to a ventilator, which is suitable when the lung function is in a defective state, and more preferably a high frequency ventilator which is suitable for oxygen inhalation in patients with severe lung disease (para. [0001]), and Sugiura teaches high frequency ventilator 12 includes the canister 7 and the reused breath supply unit 8, it is possible to remove the carbon dioxide contained in the breath having a high oxygen concentration and reuse it (para. [0073]), which reads on the instant claim limitation of a frequency of the inflation and deflation is based on the carbon dioxide concentration.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the device of Bordisak to include a frequency of the inflation and deflation is based on the carbon dioxide concentration as taught by Sugiura, in order to allow for optimal and efficient preservation of the organ of the device.
Response to Arguments
Applicant's arguments filed 10/30/2025 have been fully considered but they are not persuasive. On the top of page 6 of applicant’s remarks, applicant discussed the status of the claims. Further, applicant discussed the objections to the drawings on the bottom of page 6 and the top and middle of page 7 of applicant’s remarks. As discussed above in the beginning of the rejection, the objections to the drawings is withdrawn.
On the bottom of page 7 and the top of page 8, applicant state claims 11-13, 15-16, and 18-19 were rejected under U.S.C. 102 over the prior art of Bordisak. Applicant asserts that “Bordisak does not describe a transport container configured to receive a lung and preserve the lung via static hypothermic preservation, as recited in amended claim 11. Rather, Bordisak at page 5, paragraph 8, describes injecting gas into liquid perfusate that is used to actively perfuse the lung, causing a reduced oxygen concentration in the vasculature of the lung. This differs from static hypothermic preservation as recited in claim 11. Applicant submits that cyclically inflating and deflating the lung during hypothermic preservation, in which the lung vasculature is not being actively pumped with fluid, differs from the system described in Bordisak, which relies on the perfusate to carry carbon dioxide from the lung.”
In response, the latter argument is found to be persuasive because as discussed in above in the rejection, as well as in the disclosure, Bordisak does disclose an invention relating to the management of donor organs and particularly to an apparatus and method of organ perfusion (pg. 1, paragraph 1). Further, Bordisak discloses the donor organ is a pair of lungs (pg. 3, paragraph 15). Bordisak discloses a transport container (device 100 includes disposable 108, pg. 4, paragraph 3) configured to receive a lung (organ 104, pg. 4, paragraph 3) and preserve the lung via static hypothermic preservation (Bordisak discloses supplying as protection solution to the organ through the infusion port, page 14, paragraph 10, line 1.
Further, Bordisak discloses module 324 may also be configured to control the temperature of the perfusion fluid, page 5, paragraph 8, line 5; page 11, paragraph 6, lines 4-5). Additionally, static hypothermic preservation is common method of organ preservation well known in the art, which entails keeping an organ cooled with a solution for keeping a hypothermic environment of the storage and transport of organs. The Bordisak reference discloses a hydrostatic gradient (page 13, paragraphs 2 and 3). Moreover, as discussed above in this section, the device 100 of Bordisak correlates to a transport container as cited in the claimed invention. Also, applicant asserts Bordisak requires the perfusate to carry carbon dioxide from the lung. However, in the last paragraph of Bordisak, on page 5, the reference discloses any other suitable gas mixture can be used. Also, as discussed above in the rejection, Bordisak also discloses a pump head module for the device.
On the middle and bottom of page 8 of applicant’s remarks, applicant discussed the U.S.C. 103 rejection of claims 14, 17, and 20 as it applied to the combination of the references of Sugiura and Bordisak. Applicant provides a portion of paragraph [0001] of Sugiura. Applicant asserts Sugiura does not describe “a transport container configured to receive a lung and preserve the lung via static hypothermic preservation” as recited in claim 11. Applicant asserts Sugiura nor Bordisak discloses static hypothermic preservation. In response, as discussed above in this section, the primary reference, Bordisak, does disclose transport container, that is, device 100 includes a disposable assembly 108, where Fig. 1 of Bordisak is depicts device 100 receiving a pair of lungs (page 3, paragraph 2 at the bottom of the page).
Moreover, applicant asserts they are different solutions to different problems. The latter argument is also found to be not persuasive as indicated in the discussion of Bordisak above in this section. Both references indicate the measurement of oxygen, in Bordisak, as indicated above in this section, another gas, such as oxygen can be used in the perfusate and an oxygen sensor may be used as well. Also, the reference of Bodisak includes an apparatus which comprises the elements as recited in claim 11 of the apparatus claims of the claimed invention. For the reasons discussed above in this section, as well as in the rejection above, claims 11-20 stand rejected.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LENORA A. ABEL whose telephone number is (571)272-8270. The examiner can normally be reached Monday-Friday 7:00am-4:00pm.
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/LENORA A ABEL/Examiner, Art Unit 1799
/MICHAEL L HOBBS/Primary Examiner, Art Unit 1799