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 .
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 22-37 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 12310357. 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. 12310357 with obvious wording variations.
Regarding claim 22, claim 1 of the ’357 patent teaches a system including a transport container; a container positioned within the transport container and configured to contain a lung; and a channel in fluid communication with an airway of the lung and extending from an exterior of the container to an interior of the container to permit gas to pass through the channel into the airway of the lung. Claim 1 further requires that the container permit gas passage between the exterior and interior of the container through the channel.
Present claim 22 differs principally in that it omits certain additional limitations recited in patented claim 1, including the pump, pressure relief valve, and lung adapter. It would have been obvious to one of ordinary skill in the art before the effective filing date to omit these additional elements where their corresponding functions were not required, thereby obtaining the more broadly recited organ-storage system of present claim 22. The omission of these elements represents no more than the predictable use of the remaining claimed components according to their established functions and does not render claim 22 patentably distinct from claim 1 of the ’357 patent.
Regarding claim 31, claim 10 of the ’357 patent teaches a method including positioning a lung inside a container; coupling an airway of the lung with a channel extending from an exterior of the container to an interior of the container such that gas may pass through the channel to the airway; configuring the container such that gas passes between the exterior and interior of the container through the channel; and placing the container within a transport container.
Present claim 31 differs principally in that it omits additional steps or components associated with the pump, pressure relief valve, and lung adapter recited in patented claim 10. It would have been obvious to one of ordinary skill in the art before the effective filing date to omit those additional elements where their associated functions were unnecessary while retaining the same basic method of positioning the lung, fluidically coupling the lung airway through the container, and placing the container within a transport container. Such omission would have yielded the predictable method recited in claim 31 and does not establish a patentable distinction over claim 10 of the ’357 patent.
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.
Claim 36 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 36 recites, in pertinent part, “compressing the lung in a cyclic pattern to provide pulsatile compressive force on the lung by inflating and deflating one or more inflatable cavities in a compressive sleeve using a second pump.”
The recitation of “a second pump” lacks proper antecedent basis. Neither claim 31, from which claim 36 depends, nor claim 36 previously introduces a first pump. Accordingly, it is unclear what relationship is intended by the term “second pump” and what structure constitutes the corresponding first pump.
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.
Claims 22-26, 29-33 and 37 are rejected under 35 U.S.C. 103 as being unpatentable over Judson et al. (US 2018/0352807 A1) in view of Bang et al. (US 2012/0111476 A1).
Regarding claim 22, Judson teaches a system for storage of an organ, the system comprising: a transport container (organ container 111 used for storage and transportation of bodily tissue, including lungs) (paras. [0002], [0038]-[0040]).
Judson further teaches a container configured to be positioned within the transport container, the container configured to contain a lung, wherein the organ container 111 includes one or more sterile bags or boxes configured to contain the organ and preservation fluid in a sterilized environment, and specifically teaches placing a lung within one or more sterile bags, including three concentric sterile bags (para. [0040]).
Judson further teaches a channel in fluid communication with an airway of the lung, wherein organ adapter 107 comprises a lumen that, when coupled to lung 103, is in fluid communication with the airways of the lung, and permits gas to move through the lumen into and out of the lung airways (paras. [0039], [0042]-[0043]).
Judson further teaches the channel configured to extend from an exterior of the container to an interior of the container to allow gas to pass through the channel into the airway of a lung. Specifically, Judson teaches that the organ adapter may be contained in or integral with the innermost sterile bag and coupled to a “through-the-bag-wall cannula” that traverses the sterile bags or containers. Judson further teaches that the bagged organ may thereby be connected to the accumulator and inflated, and that gas is permitted to flow through the organ adapter into the airways of lung 103 (paras. [0042]-[0044]).
Judson, however, does not expressly teach wherein the container is configured to only allow gas to pass between the exterior of the container and the interior of the container through the channel.
Bang teaches this missing container configuration. Bang teaches a container formed from plastic films sealed along a seam to define an internal volume, with a tube extending through an opening in the container wall. After the tube is sealed to the container walls, Bang expressly teaches that “a sealed liquid container 100 is provided where fluid connection between the exterior and the internal volume 102 may only be provided through the channel 108 defined by the tube 104” (para. [0115], Fig. 9). Bang further teaches that such bags may include medical bags such as urine bags and blood bags and that the tube is sealed between the plastic films to provide communication through the tube between the interior and exterior of the bag (para. [0003]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the sterile lung-containing bag of Judson such that the bag is sealed around Judson's through-the-bag-wall cannula in the manner taught by Bang, such that communication between the exterior and interior of the bag occurs only through the channel defined by the cannula. One of ordinary skill in the art would have been motivated to make such a modification to provide a reliable sealed interface around Judson's through-wall cannula, thereby preventing unintended leakage or communication through the remainder of the sterile bag while preserving Judson's intended controlled gas communication through the cannula to the lung airway. Bang expressly teaches forming such a sealed tube-to-bag interface to avoid leakage and provide a fluid-tight connection between the tube and container (paras. [0003]-[0004], [0014], [0020], [0115]).
Regarding claim 23, Judson further teaches “eutectic cooling material disposed within the transport container and outside the container, the eutectic cooling material configured to maintain a temperature of the lung.” Specifically, Judson teaches that the interior of the organ transport container may contain a tray configured to support cooling materials, such as frozen gel packs, and that the tray positions the cooling materials proximate to the organ for cooling while preventing the cooling materials from directly contacting the organ. Judson further teaches positioning the tray above the loaded organ within the organ container to hold the frozen gel packs off of the organ tissue surface (paras. [0077], [0086]; Fig. 15).
Because Judson separately teaches that the lung is contained within one or more sterile bags or boxes within the organ container (para. [0040]), the cooling materials supported within the organ transport container are disposed outside the sterile lung-containing container while remaining positioned to cool and maintain the temperature of the lung.
Regarding claim 24, Judson further teaches “wherein the airway of the lung is selected from a group consisting of a trachea or bronchus of the lung.” Specifically, Judson teaches that the organ adapter may be coupled to the airways of the lung “e.g., by the trachea or bronchus” (para. [0039]) and further teaches that at least a portion of the organ adapter may be inserted into a “trachea, bronchus, or other air passage of a lung” (para. [0043]).
Regarding claim 25, Judson further teaches “one or more sensors configured to sense a parameter within the system.” Specifically, Judson teaches that systems of the invention may include a variety of sensors configured to sense and report parameters including tissue temperature, preservation fluid or perfusate temperature, pressure within the closed air system, pressure within the fluid, or ambient pressure (para. [0079]).
Regarding claim 26, Judson further teaches “wherein the parameter is selected from a group consisting of temperature and pressure.” Specifically, Judson teaches sensors configured to sense and report temperature of the tissue or preservation fluid/perfusate, and pressure within the closed air system, pressure within the fluid, or ambient pressure (para. [0079]). Judson further teaches a temperature sensor positioned in the transport cavity (para. [0080]).
Regarding claim 29, Judson further teaches “a compressive sleeve operable to compress the lung.” Specifically, Judson teaches that constant or pulsatile compressive pressure may be applied to the organ to drive gas exchange, and that a constant compressive force may be applied through the use of an elastic sleeve around the organ. Judson further teaches that the constant compression of the sleeve may be used in combination with the compressed gas system to create cyclic flow of gas into and out of the lung tissue (para. [0084]; Fig. 38).
Judson also expressly states more generally that the organ may be slightly compressed, for example by being “fitted with an elastic sleeve,” to mimic natural pleural pressure on the tissue (para. [0011]).
Regarding claim 30, Judson further teaches “wherein the eutectic cooling material comprises one or more pouches of phase change material (PCM) for surrounding and cooling the transport container.” Specifically, Judson teaches that the cooling blocks may comprise eutectic cooling media or other phase change material (PCM), and that the PCM may be contained in pouches. Judson further teaches that multiple PCM-containing pouches may be joined side-to-side to form a band of coupled PCM pouches, and that such a band may be manipulated to “wrap around the circumference of a cylindrical storage container” to provide cooling thereto (paras. [0065]-[0066]).
Regarding claim 31, Judson teaches “a method for storage of an organ” including “positioning a lung inside a container.” Specifically, Judson teaches placing a lung in one or more sterile bags or boxes, including three concentric sterile bags, for storage and transportation within an organ container (paras. [0040], [0044]).
Judson further teaches “coupling a channel with an airway of the lung such that the airway of the lung is in fluid communication with the channel, the channel configured to extend from an exterior of the container to an interior of the container.” Judson teaches an organ adapter having a lumen in fluid communication with an airway of the lung, including the trachea or bronchus, and further teaches that the organ adapter may be contained in or integral with the innermost sterile bag and coupled to a through-the-bag-wall cannula traversing the sterile bag or bags (paras. [0039], [0043]-[0044]).
Judson further teaches gas passing through the channel into the airway of the lung. In particular, Judson teaches that, when the valve is open, gas flows from the inlet through the valve and organ-adapter lumen and finally into the airways of lung 103 (para. [0042]).
Judson further teaches “placing the container in a transport container.” Judson describes the sterile lung-containing bags as being used within the organ container for storage and transportation of the lung, and the organ container itself is configured for transport of the stored organ (paras. [0038], [0040], [0044]).
Judson, however, does not expressly teach “wherein the container is configured to only allow gas to pass between the exterior of the container and the interior of the container through the channel.”
Bang teaches this missing limitation. Bang teaches forming a sealed container from plastic films and sealing a tube into an opening in the container wall such that “fluid connection between the exterior and the internal volume 102 may only be provided through the channel 108 defined by the tube 104” (para. [0115], Fig. 9).
It would have been obvious to one of ordinary skill in the art before the effective filing date to form and seal Judson’s sterile lung-containing bag around the through-the-bag-wall cannula in the manner taught by Bang, such that communication between the exterior and interior of the bag occurs only through the channel defined by the cannula. One of ordinary skill would have been motivated to make such a modification to provide a reliable sealed interface around Judson’s cannula, thereby preventing unintended leakage or communication through the remainder of the sterile bag while maintaining controlled communication through the cannula to the lung airway. Bang expressly teaches forming such a sealed tube-to-bag interface to provide a liquid-tight connection and avoid leakage around the tube (paras. [0003]-[0004], [0014], [0020], [0115]).
Regarding claim 32, Judson further teaches “arranging eutectic cooling material within the transport container and outside the container, the eutectic cooling material configured to maintain a temperature of the lung.” Specifically, Judson teaches positioning cooling materials, including frozen gel packs and eutectic/phase-change cooling materials, within the organ transport container and proximate to the organ so as to cool the organ while preventing direct contact between the cooling materials and the organ. Judson further teaches positioning the cooling materials outside the sterile organ-containing bag/container but within the transport container (paras. [0065]-[0066], [0077], [0086]).
Regarding claim 33, Judson further teaches “wherein the airway of the lung is selected from a group consisting of a trachea or bronchus of the lung.” Specifically, Judson teaches coupling the organ adapter to the airways of the lung, including by the trachea or bronchus (para. [0039]), and further teaches insertion of the organ adapter into a “trachea, bronchus, or other air passage of a lung” (para. [0043]).
Regarding claim 37, Judson further teaches “wherein the eutectic cooling material comprises one or more pouches of phase change material (PCM) arranged around the container.” Specifically, Judson teaches cooling media including phase change material (PCM) contained in pouches, and further teaches that multiple PCM-containing pouches may be joined together to form a flexible band or array that can be positioned around a storage container to provide cooling (paras. [0065]-[0066]).
Claims 27 and 34 are rejected under 35 U.S.C. 103 as being unpatentable over Judson et al. (US 2018/0352807 A1) in view of Bang et al. (US 2012/0111476 A1), and further in view of Garafolo et al. (US 2017/0259088 A1).
Regarding claim 27, Judson further teaches a compressed gas source for supplying gas to the airways of a stored lung and expressly teaches that the gas provided to the lung may be cooled to maintain a desired preservation temperature (paras. [0010]-[0011], [0064]). Judson also teaches eutectic cooling media, including eutectic cooling blocks and phase-change material (PCM), for maintaining a desired low temperature during organ storage (paras. [0065]-[0066]).
Judson, however, does not expressly teach “wherein the eutectic cooling material is in-line between a pump and the airway of the lung and operable to cool gas traveling therebetween.”
Garafolo teaches cooling respiratory gas in the flow path before the gas reaches the lungs. Specifically, Garafolo teaches an air-temperature modifying element configured such that air passes over the cooling element, is cooled, and is thereafter supplied to a respiration zone for inhalation into the lungs (paras. [0041], [0044]-[0046]). Garafolo further teaches embodiments using a fan to move the air across the cooling element and toward the user's respiratory system (paras. [0049], [0062], [0064]-[0066]). Garafolo expressly states that, when cooling, air is transferred over the air-temperature modifying element, cooled, supplied to the respiration zone, and then breathed into the lungs, with a fan drawing the air over the cooling element (paras. [0064]-[0066]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to position Judson's known eutectic cooling material in the gas-flow path between Judson's gas source/pump and the lung airway, in the manner taught by Garafolo, such that gas passes over or through the cooling material before reaching the lung. One of ordinary skill would have been motivated to make such a modification because Judson expressly teaches both that the gas supplied to the lung may be cooled to maintain the desired preservation temperature and that eutectic cooling material is suitable for providing controlled cooling, while Garafolo teaches the predictable arrangement of placing a cooling element directly in the respiratory gas path to cool gas before it reaches the lungs.
Regarding claim 34, Judson further teaches supplying gas from a gas source to the airway of a lung through the organ adapter. However, Judson does not expressly teach “cooling gas traveling between a pump and the airway of the lung with an in-line cooling element.”
Garafolo teaches cooling respiratory gas in the flow path before the gas reaches the lungs. Specifically, Garafolo teaches an air-temperature modifying element positioned such that air passes over the cooling element, is cooled, and is thereafter supplied to a respiration zone for inhalation into the lungs (paras. [0041], [0044]-[0046]). Garafolo further teaches using a fan to draw or move air across the cooling element and toward the respiratory system (paras. [0049], [0062], [0064]-[0066]). In particular, Garafolo states that, when cooling, air is transferred over the air-temperature modifying element, cooled, supplied to the respiration zone, and then breathed into the lungs (paras. [0064]-[0066]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to provide an in-line cooling element in Judson’s gas-flow path between the gas source/pump and the lung airway, as taught by Garafolo, in order to cool the gas before delivery to the lung. Garafolo teaches the predictable arrangement of moving respiratory gas across a cooling element before the cooled gas is supplied to the lungs.
Claims 28 and 35 are rejected under 35 U.S.C. 103 as being unpatentable over Judson et al. (US 2018/0352807 A1) in view of Bang et al. (US 2012/0111476 A1), and further in view of Bath et al. (US 2014/0202460 A1).
Regarding claim 28, Judson teaches a gas source/pump configured to supply gas to the airway of the lung through the organ adapter. However, Judson does not expressly teach “a humidifying element in-line between a pump and the airway of the lung and operable to humidify gas traveling therebetween.”
Bath teaches a respiratory apparatus including a flow generator or blower configured to generate a supply of breathable gas, a humidifier positioned downstream of the flow generator and configured to humidify the gas, and a patient interface positioned downstream of the humidifier. Bath further teaches a first gas flow path extending from the flow generator to the humidifier and a second gas flow path extending from the humidifier to the patient interface, such that gas generated by the flow generator passes through the humidifier before being delivered to the patient airway (paras. [0006], [0025], [0058]-[0059], [0063], [0066]; Fig. 3).
It would have been obvious to one of ordinary skill in the art before the effective filing date to provide a humidifying element in the gas-flow path of Judson between the gas source/pump and the lung airway, as taught by Bath, in order to humidify the gas before delivery to the airway and thereby reduce drying of airway tissue during delivery of gas. Bath expressly teaches positioning the humidifier between the flow generator and the patient airway for this purpose (paras. [0006], [0025]).
Regarding claim 35, Judson further teaches supplying gas from a gas source to the airway of a lung through the organ adapter. However, Judson does not expressly teach “humidifying gas traveling between a pump and the airway of the lung with an in-line humidifying element.”
Bath teaches a respiratory gas-delivery system including a flow generator, a humidifier positioned downstream of the flow generator, and a patient interface positioned downstream of the humidifier. Bath teaches a first gas flow path leading from the flow generator to the humidifier and a second gas flow path leading from the humidifier to the patient interface, such that gas generated by the flow generator is humidified before being delivered to the patient airway (paras. [0006], [0025], [0058]-[0059], [0063], [0066]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to position a humidifying element in Judson’s gas-flow path between the gas source/pump and the lung airway, as taught by Bath, in order to humidify the gas before delivery to the airway and thereby reduce drying of airway tissue during gas delivery. Bath expressly teaches placing the humidifier between the flow generator and the patient airway for this purpose (paras. [0006], [0025]).
Claim 36 is rejected under 35 U.S.C. 103 as being unpatentable over Judson et al. (US 2018/0352807 A1) in view of Bang et al. (US 2012/0111476 A1), and further in view of Hassanein et al. (US 2015/0342177 A1).
Regarding claim 36, Judson further teaches “compressing the lung cyclically to provide a pulsatile compressive force.” Specifically, Judson teaches slightly compressing the lung, including by fitting the organ with an elastic sleeve, to mimic natural pleural pressure, and teaches using compression to create pulsatile or cyclic flow into and out of the lung (paras. [0010]-[0011]). Judson further teaches emulating pleural pressure by inflating a cavity in or between storage bags surrounding the tissue, wherein the external pressure may itself be pulsatile by adding and removing fluid from the tissue-surrounding cavities (para. [0014]).
Judson, however, does not expressly teach “inflating and deflating inflatable cavities in a compressive sleeve using a second pump.”
Hassanein teaches an ex vivo organ-care system specifically configured to periodically compress an organ. Hassanein teaches a contact-pressure system using a wrap and/or bladder to apply pressure to an ex vivo organ (para. [02858]). Hassanein further teaches positioning an inflatable bladder adjacent the organ and using a pump to inflate and deflate the bladder, wherein inflation of the bladder causes the bladder to exert pressure against the organ (para. [02859]). Hassanein further teaches applying this pressure periodically to mimic natural diaphragm pressure, including at a rate corresponding to human breathing, such as approximately 12–15 times per minute (para. [02860]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify Judson's compressive sleeve to include one or more inflatable cavities operated by a pump, as taught by Hassanein, thereby cyclically inflating and deflating the cavities to provide pulsatile compression of the lung. One of ordinary skill would have been motivated to make such a modification because Judson expressly seeks to mimic natural pleural pressure and contemplates pulsatile external compression of the lung, while Hassanein teaches a predictable pneumatic implementation for accomplishing substantially the same physiological objective—periodically compressing an ex vivo organ to mimic natural diaphragm pressure.
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. 1-4
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/OMEED ALIZADA/Primary Examiner, Art Unit 2686
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