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 .
Response to Applicant's Arguments/Remarks
Applicant’s arguments, see Remarks, filed on 06/02/2026 with respect to amended claims are fully considered but are not persuasive. Explanations of how each and every claimed limitation is being met or rendered obvious are provided below.
Applicant argues that Fishman does not teach a pressure relief valve configured to release gas “while gas is directed into an airway of the lung from the gas source” because Fishman introduces maintenance gas during inhalation and subsequently opens relief valve 412 at the end of exhalation. Applicant further argues that incorporating Fishman’s relief valve into Judson would interfere with the intended operation of Fishman’s bellows or Judson’s expandable accumulator.
The claim language does not require the pressure relief valve to open during the same instantaneous inhalation stroke in which gas enters the lung, nor does the claim require gas to flow simultaneously through both the airway and the relief valve at every moment. Rather, the claim broadly requires a pressure relief valve configured to release gas while the system directs gas from a gas source into the airway and thereby maintains a desired internal lung pressure.
Fishman teaches an operating lung-ventilation system in which compression of bellows 408 causes gas to be inspired by lungs 404 and release of bellows 408 permits gas to be expired by the lungs (Fishman para [0068]). Fishman further teaches that relief valve 412 provides a controlled release of gas to the outside and reduces gas pressure within the ventilator gas loop (Fishman para [0071]). During Fishman’s pressure-maintenance cycle, additional gas is supplied to the circuit through trickle valve 212, and relief valve 412 exhausts excess gas until the desired PEEP is reached (Fishman para [0095]). Thus, Fishman teaches a gas-delivery system that directs gas to a lung circuit and releases excess gas through a pressure relief valve as part of the same ongoing pressure-maintenance operation to maintain a desired internal pressure.
Applicant’s interpretation would improperly limit the claimed term “while” to simultaneous instantaneous operation during a particular portion of a breathing cycle. No such requirement is recited. The claim does not specify that the pressure relief valve must remain open at the exact moment gas crosses the lung adapter, that the relief valve must open during inhalation, or that the gas source and relief valve must operate continuously and simultaneously. Fishman’s system supplies gas to the lung circuit and selectively releases excess gas during operation of the system to maintain the desired PEEP. Accordingly, Fishman teaches the disputed functional relationship under the broadest reasonable interpretation of the claim.
Applicant’s argument that the proposed combination would render Fishman’s bellows or Judson’s accumulator inoperable is also not persuasive. The rejection does not propose bodily incorporating Fishman’s complete bellows ventilation apparatus into Judson. Fishman is relied upon for the known use of a pressure relief valve in a lung gas system to release excess gas and maintain a desired pressure. The test for obviousness is what the combined teachings would have suggested to one of ordinary skill in the art, rather than whether the complete physical apparatus of one reference can be inserted unchanged into another.
Further, Judson’s expandable accumulator and Fishman’s pressure relief valve would perform complementary functions. Judson’s accumulator accommodates changes in gas volume resulting from changes in ambient pressure during transport, whereas Fishman’s pressure relief valve releases excess gas when the pressure exceeds the desired level. The addition of a pressure relief valve would therefore provide overpressure protection without eliminating or preventing operation of Judson’s accumulator. Both components would further Judson’s stated objective of maintaining a relatively constant internal pressure and preventing overinflation of the donor lung.
It would have been obvious to one of ordinary skill in the art before the effective filing date to incorporate Fishman’s pressure relief valve into Judson’s lung gas system because doing so would provide the predictable benefit of releasing excess gas when the lung gas-system pressure exceeds a desired level, thereby improving pressure regulation and reducing the risk of overinflation during gas delivery and transport.
Note: The Examiner further notes US 2004/0040563 A1 to Chu et al. as additional background information concerning pressure-regulating valves used in positive-airway-pressure gas systems. Chu teaches a positive-airway-pressure source connected to a mask through flexible tubing and a valve disposed at the mask or between the mask and the pressure source (Chu paras [0018]–[0021]). Chu further teaches that the valve continuously exhausts gas when pressure exceeds a threshold and thereby maintains a substantially constant pressure over a range of gas-flow rates (Chu paras [0025]–[0030]). In particular, Chu states that when pressure is above the valve threshold, gas is “continuously exhausted” through the valve and that this operation achieves substantially constant pressure (Chu para [0025]).
Chu is cited and made of record as background information only. Chu is provided for Applicant’s consideration in connection with any future amendment, interview, or further prosecution.
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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this 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 §§ 706.02(l)(1) - 706.02(l)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/forms/. The 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claim 24-43 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 12178206. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the instant application are generally broader than those of the patent. Thus, any invention meeting the limitations of the patent claims would necessarily meet those of the instant application as well. Further, all the claimed limitations recited in the present application are transparently found in the patent no. 12178206 with obvious wording variations. The instant application is a broader version of Patent No. 12178206. Everything in claim 24 of instant application is taught by claim 1 of the Patent application. Only thing claim 1 of the instant application doesn’t teach is a container configured to contain the lung for transportation. But, claim 12 of Patent No. 12178206 indeed does teach a container. So, claim 24 and 35 of the instant application is just a much broader version of Claim 1 and 12 of patent No. 12718206
Instant application 19004955
Patent No 12178206
24. A system for transport of a lung, the system comprising: a container configured to contain a lung and receive gas from a gas source; a pressure relief valve configured to release gas while gas is directed into an airway of the lung from the gas source; and a lung adapter configured to be in fluid communication with the gas source and the pressure relief valve and operable to seal with the airway of the lung, wherein the pressure relief valve is configured to maintain a desired internal pressure in the lung.
1. A system for transport of a lung, the system comprising: a pump configured to direct gas into an airway of a lung to inflate a cavity of the lung with gas, the gas configured to maintain inflation of the lung; a pressure relief valve configured to release gas when pressure within the cavity of the lung is above a high-pressure threshold while the pump is directing gas into the airway of the lung; and a lung adapter configured to be in fluid communication with the pump, the pressure relief valve, and the airway of the lung, wherein the pressure relief valve and the pump are configured to maintain a desired internal pressure in the cavity of the lung.
35. A method for transport of a lung, the method comprising: directing gas into an airway of a lung, wherein the lung is positioned in a lung container and coupled to a lung adapter, and wherein the lung adapter is in fluid communication with a gas source that supplies gas into the airway; and maintaining a desired internal pressure in the lung via a pressure relief valve, wherein the pressure relief valve releases gas while gas is directed into the airway of the lung from the gas source.
12. A method for transport of a lung, the method comprising: providing a lung container comprising a lung adapter, a pump configured to direct gas into an airway of a lung to inflate a cavity of the lung with gas, the gas configured to maintain inflation of the lung, and a pressure relief valve configured to release gas when pressure within the cavity of the lung is above a high-pressure threshold while the pump is directing gas into the airway of the lung, the lung adapter configured to be in fluid communication with the pump and the pressure relief valve; coupling the airway of the lung to the lung adapter to form a closed air system; and maintaining a desired internal pressure in the cavity of the lung via the pump and the pressure relief valve.
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.
Claim(s) 24-27, 34-36, 38 and 43 is/are rejected under 35 U.S.C. 103 as being unpatentable over Judson et al (US 2018/0352807) in view of Fishman et al (US 2009/0197241).
Per claim 24, Judson teaches a system for transport of a lung, the system comprising (abstract teaches a system for transport of lung):
a container configured to contain a lung and receive gas from a gas source (0040 teaches organ container may include one or more boxes or bags configured to contain both the organ. 0051 teaches the inlet being connected to a gas source and the gas source may comprise a pump. 0051 further teaches the valve is opened, gas flows into the airways containing closed system);
[a pressure relief valve configured to release gas while gas is directed into an airway of the lung from the gas source]; and
a lung adapter configured to be in fluid communication with the gas source and the pressure relief valve and operable to seal with the airway of the lung (0039 teaches organ adapter 107 coupled to the airways (by the trachea or bronchus) of a lung. 0039 further teaches the organ adapter may comprise a lumen that is in fluid communication with the airways of the lung. 0047 teaches to form an air-tight seal between the lumen of the organ and the lumen of the adapter).
[wherein the pressure relief valve is configured] to maintain a desired internal pressure in the lung (0050 teaches maintaining a desired pressure setpoint…system may be configured to maintain about a 15 cm H2O gauge pressure inside the organ).
Judson further teaches transport pressure stabilization mainly via an expandable accumulator and inlet/valve control, but Judson does not explicitly teach a pressure relief value that releases/vents gas while gas is being directed into the airway from a gas source.
In an analogous art, Fishman teaches system and method for lung care (abstract). Fishman further teaches a pressure relief value that releases/vents gas while gas is being directed into the airway from a gas source (0071 teaches relief valve 412 provides for controlled release of gas to be expired to the outside, serving to reduce gas pressure within the ventilator gas loop. 0068 teaches lung gas delivery during operation such as compressing the bellows causes gas to be inspired by lungs. 0095 teaches relief/venting coordinated with gas introduction to the circuit: during inhalation…trickle valve 212 opens…allowing gas into the circuit and relief valve 412 opens to exhaust excess gas until the desired PEEP is reached.
Therefore, before the effective filling date of the invention, it would have been obvious to one of ordinary skill in the art to modify Judson’s lung transport pressure system to include Fishman’s relief-valve venting arrangement because Fishman’s relief valve provides the predictable technical benefit of venting excess gas to reduce pressure and hold a setpoint (“desired PEEP”) which aligns with Judson’s objective of maintaining a desired inflation/pressure level during storage/transport (e.g., ~15 cm H2O).
Per claim 25, Judson teaches wherein the lung adapter is operable to seal with a trachea or bronchus of the lung (0039).
Per claim 26, Judson teaches comprising one or more sensors configured to sense a parameter within the system (0039 teaches variety of sensors).
Per claim 27, Judson teaches comprising a cooling element (0077 teaches cooling material).
Per claim 34, Judson teaches wherein the desired internal pressure is 10-15 cm H20 (0050 teaches maintaining a desired pressure setpoint…system may be configured to maintain about a 15 cm H2O gauge pressure inside the organ).
Per claim 35 is a method of claim 24, see rejection of claim 34.
Per claim 36, Judson teaches comprising directing gas into a trachea or bronchus of the lung (0039).
Per claim 38, Judson teaches comprising pumping gas to the airway of the lung from the gas source with a pump (0051 teaches using a pump as the gas source used to deliver gas into the closed airway system).
Per claim 43, see rejection of claim 34.
Claim(s) 28 and 37 is/are rejected under 35 U.S.C. 103 as being unpatentable over Judson et al (US 2018/0352807) in view of Fishman et al (US 2009/0197241) as applied to claim 24 and further in view of Zimmermann (WO 01/03505 A1).
Per claim 28 and 37, Judson in view of Fishman does not explicitly teach wherein the cooling element is configured to be in- line between the gas source and the airway of the lung and operable to cool gas traveling therebetween.
However, in an analogous art, Zimmerman teaches preserving and prolonging viability of organs (abstract). Zimmerman further teaches wherein the cooling element is configured to be in- line between the gas source and the airway of the lung and operable to cool gas traveling therebetween (Fig. 1, page 7, lines 264-278 teaches cooling element 7 in-line between gas lines to cool traveling gas). Therefore, before the effective filling date of the invention, it would have been obvious to one of ordinary skill in the art to employ the cooling element of Zimmerman upon the system of Judson. The rationale would be to directly cool air entering the system and lower the lung temperature to a desired cold temperature.
Claim(s) 29 and 39 is/are rejected under 35 U.S.C. 103 as being unpatentable over Judson et al (US 2018/0352807) in view of Fishman et al (US 2009/0197241) as applied to claim 24 and further in view of Baylor College of Medicine (WO 2015/126853 A1).
Per claim 29 and 39, Judson in view of Fishman does not explicitly teach comprising a humidifying element configured to be in-line between the gas source and the airway of the lung and operable to humidify gas traveling therebetween.
However, in an analogous art, Baylor teaches a system comprising a humidifying element configured to be in-line between the gas source and the airway of the lung and operable to humidify gas traveling therebetween (Fig. 2, paragraph 0025 teaches gas lines coupled to a humidifier to humidify gas before contact with the lungs).
Therefore, before the effective filling date of the invention, it would have been obvious to one of ordinary skill in the art to have employed the humidifying of Baylor upon the method of Judson. The rationale would be to prevent drying out or damaging the organ tissue with cold dry air.
Claim(s) 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Judson et al (US 2018/0352807) in view of Fishman et al (US 2009/0197241) as applied to claim 24 and further in view of Fahy (US 5586438).
Per claim 30, Judson in view of Fishman does not explicitly teach comprising insulated tubing configured to connect the gas source to the lung adapter.
However, in an analogous art, Fahy teaches a system of preserving organs (abstract). Fahy further teaches comprising insulated tubing configured to connect the gas source to the lung adapter (Fig. 5, col 13, lines 11-15 teaches insulating tubing 249). Therefore, before the effective filling date of the invention, it would have been obvious to one of ordinary skill in the art to have employed the insulated tubing of Fahy upon the system of Judson. The rationale would be to prevent temperature loss to the gas as the gas travels through the system to the organ.
Claim(s) 31-33 and 40-42 is/are rejected under 35 U.S.C. 103 as being unpatentable over Judson et al (US 2018/0352807) in view of Fishman et al (US 2009/0197241) as applied to claim 24 and 35 and further in view of Eth Zurich (WO 2018/015548 A1).
Per claim 31 and 40, Judson in view of Fishman does not explicitly teach a compressive sleeve operable to compress the lung.
However, in an analogous art, Eth teaches a liver perfusion and chamber assembly (abstract). Eth further teaches a compressive sleeve operable to compress the lung (Fig. 7, page 28 lines 11-19, item 17a). Therefore, before the effective filling date of the invention, it would have been obvious to one of ordinary skill in the art to employ the compressive sleeve of Eth upon the system of Judson. The rationale would be to control fluid flow through the lung and prevent damage during transit.
Per claim 32 and 41, Eth teaches wherein the compressive sleeve comprises one or more inflatable cavities (Fig. 7, cavity of inflatable cushions of 17a).
Per claim 33 and 42, Eth teaches wherein the pump is configured to inflate and deflate the one or more inflatable cavities in a cyclic pattern to provide pulsatile compressive force on the lung (Fig. 7, pages 28, lines 11-19 inflating and deflating pump).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Anderson et al (US 2015/0017627) Fig. 2 and 7
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 extension fee 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 OMEED ALIZADA whose telephone number is (571)270-5907. The examiner can normally be reached Monday-Friday, 9:30 am until 5:30 pm.
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, Brian Zimmerman can be reached on 571-272-3059. 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.
/OMEED ALIZADA/Primary Examiner, Art Unit 2686
Prosecution Insights