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 .
Preliminary Remarks
The amendment filed on 04/03/2026 has been entered. Claims 1-10 were canceled previously, claim 11 has been amended, no claims have been added. Therefore, claims 11-20 remain pending in the application.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 04/09/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
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 in a first direction from the gas source to the airway of 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 a gas exhaust in fluid communication with the lung adapter, the gas exhaust configured to allow gas comprising carbon dioxide to exit from the airway of the lung in a second direction through the lung adapter to deflate the lung,”: Bordisak discloses an exhaust valve 612 in communication with the vent circuit (pg. 10, paragraph 1, line 1), where the exhaust valve 612 is capable of performing the function of deflating the lung.
“and the pump configured to remove gas comprising carbon dioxide from the lung through the lung adapter to deflate the lung, wherein the pump are 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 an exhaust valve 612 in communication with the vent circuit (pg. 10, paragraph 1, line 1), where the exhaust valve 612 is capable of inflating and deflating the lung. Further, Bordisak discloses an adapter (catheter 608-3, discussed above).
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 04/03/2026 have been fully considered but they are not persuasive. Applicant’s remarks begin on the bottom of page 4 and the top of page 5 their remarks. On the bottom of page 4 of applicant’s remarks, applicant recites amended claim 11 of the instant application and asserts that Bordisak does not describe a gas exhaust and pump arrangement configured to inflate and deflate a lung during ex-vivo preservation to inflate the lung with gas having a higher oxygen concentration and deflate the lung by exhausting gas with a lower oxygen concentration. Applicant asserts “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. Amended claim 11 relates to gas inflating and deflating the lung through an airway, not a system of perfusing a vessel with oxygenated liquid. Further, Applicant submits that the gas exhaust of amended claim 11, including the limitations on the directions in which gas passes to and from the airway of the lung, is not disclosed by Bordisak or obvious in view of Bordisak or the other cited portions of the cited references.”
In response, as discussed above in the rejection of amended claim 11, Bordisak teaches a ventilation circuit which comprises an adapter (that is, gas conduit catheters 608-1, 608-2, and 608-3), and an exhaust valve 612. Exhaust valve 612 is capable of performing the function of inflating and deflating the lung in conjunction with the ventilation circuit, which also comprises a pump, also disclosed and discussed above in the rejection of claim 11.
On the bottom of 5 and the top of page 6 of applicant’s remarks, applicant discusses the U.S.C. 103 rejection of claims 14, 17, and 20. Applicant recites paragraph [0001] of the secondary reference, Sugiura. Applicant asserts the cited references neither alone nor in combination, disclose, or suggest the features of amended claim 11 of the instant application.
In response, applicant has not provided any specific arguments against the secondary reference cited in the previously mailed Office Action. As discussed above in this section, Bordisak discloses a gas exhaust valve capable of performing the function of the claimed gas exhaust, in conjunction with the ventilation circuit and pump of the disclosed invention. Therefore, claims 11-20 of the instant application stand rejected.
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.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Marcheschi can be reached at (571) 272-1374. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/L.A.A./Examiner, Art Unit 1799
/MICHAEL L HOBBS/Primary Examiner, Art Unit 1799
Prosecution Insights