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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 13-20, in the reply filed on 12/8/2025 is acknowledged. Newly added claims 34-37 are encompassed by Group I.
Information Disclosure Statement
Three information disclosure statements (IDS) were received on 8/4/2025, 12/10/2025, and 1/6/2026 citing 399 US references, 95 foreign references, and 42 non-patent literature references. All references have been considered, however, due to the voluminous number of references in the IDS’s they have only been briefly considered. It is noted that it is desirable to avoid the submission of long lists of documents if it can be avoided and eliminate clearly irrelevant and marginally pertinent cumulative information (MPEP § 2004). The applicant is encouraged to highlight the relevance of any particular documents which have been specifically brought to the applicant’s attention and/or are known to be of most significance (MPEP § 2004).
Specification
The use of the terms savENRG (para. 0082), XEON E7 (para. 0098), and OPTERON 6200 (para. 0098), which are trade names or a marks used in commerce, have been noted in this application. The terms should be accompanied by the generic terminology; furthermore the terms should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Objections
Applicant is advised that should claim 13 be found allowable, claim 14 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). Claim 14 does not specify a further structural limitation of the subject matter claimed, as claim 13 (which claim 14 depends on) already recites cooling material configured to be received by the tray in lines 6-7.
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.
Claim 16 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 16 recites “a raised portion configured to be positioned beneath the organ when the organ is supported on the first support surface”. It is unclear whether the organ is resting on the raised portion or resting on the first support surface, as the claim recites both simultaneously. This configuration does not make sense as the organ cannot be both resting on a raised portion and the first support surface if the raised portion is positioned beneath the organ. Therefore, the scope of the claim is indefinite.
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.
Claims 13-20, 34-35, and 37 are rejected under 35 U.S.C. 103 as being unpatentable over LeClair et al. (US 2011/0173023 A1) (already of record) in view of Wilson (US 2007/0193297 A1).
Regarding claim 13, LeClair et al. teaches a system for transport of an organ (abstract), the system comprising: a transport container (Fig. 1H outer case 11); an organ container configured to be positioned in the transport container, the organ container comprising a first support surface configured to support an organ (Fig. 1H inner caddy 50); a lid configured to seal with the transport container to form an insulated environment (Fig. 1H lid shown as part of 11 outer case, above reference number 40; para. 0038 “insulation to prevent the transmittal of external heat”) such that the cooling material is positioned between the second support surface of the tray and the lid (Fig. 1H cooling element 47 between inner caddy 50 which houses the organ and the lid when closed); and a temperature sensor configured to be positioned within the transport container (Fig. 1F probe 92; para. 0044 “monitor… temperature”).
LeClair et al. teaches a cooling material positioned above the organ and not in direct contact with the organ in the transport container (Fig. 1H cooling element 47 on top of inner caddy 50), but does not teach a tray positioned above the organ configured to receive cooling material on a top surface of the tray. However, Wilson teaches a tray positioned above the organ comprising a support surface configured to hold cooling material (Fig. 10 refrigerant tray 900 with top surface 902; para. 0106 “refrigerant tray 900 is dimensioned to sit within the lower rim 1002 (Fig. 11) of the container”). Wilson teaches that the shape and size of the refrigerant tray holds refrigeration material appropriate for the desired temperature level (para. 0106).
It would have been obvious to a person of ordinary skill in the art to use the Wilson configuration of a tray positioned above the organ configured to receive cooling material on a top surface of the tray in LeClair et al.’s device with a reasonable expectation that it would hold refrigeration material appropriate for the desired temperature level. This method for improving LeClair et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Wilson. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of LeClair et al. and Wilson to obtain the invention as specified in claim 13.
Regarding claim 14, LeClair et al. teaches a system for transport of an organ comprising cooling material (Fig. 1H cooling element 46, 46’, 47, 47’), but does not teach a tray which the cooling material is configured to be received by. However, Wilson teaches a tray positioned above the organ comprising a support surface configured to hold cooling material (Fig. 10 refrigerant tray 900 with top surface 902; para. 0106 “refrigerant tray 900 is dimensioned to sit within the lower rim 1002 (Fig. 11) of the container”). Wilson teaches that the shape and size of the refrigerant tray holds refrigeration material appropriate for the desired temperature level (para. 0106).
It would have been obvious to a person of ordinary skill in the art to use the Wilson configuration of a tray positioned above the organ configured to receive cooling material on a top surface of the tray in LeClair et al.’s device with a reasonable expectation that it would hold refrigeration material appropriate for the desired temperature level. This method for improving LeClair et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Wilson. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of LeClair et al. and Wilson to obtain the invention as specified in claim 14.
Regarding claim 15, LeClair et al. teaches a system for transport of an organ wherein the cooling material is configured to maintain an in-transit temperature of between 2° C and 10° C (para. 0030 “between 1° C and 10° C”). It has been held that in the case where the claimed ranges overlap or lie inside ranges disclosed by the prior art, a prima facie case of obviousness exists (MPEP § 2144.05). The claimed range is obvious in view of LeClair et al. because LeClair et al. discloses a range of between 1° C and 10° C, which overlaps the claimed range of between 2° C and 10° C. LeClair et al. also discloses that maintaining organs at a temperature between 1° C and 10° C preserves the integrity and quality of the organs (para. 0030). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select the claimed range from the broader prior art range because the prior art teaches the same utility (thermally preserving an organ ex vivo) over the entire range.
Regarding claim 16, LeClair et al. teaches a system for transport of an organ further comprising a raised portion configured to be positioned beneath the organ when the organ is supported on the first support surface (Fig. 1H cooling element 47’).
Regarding claim 17, LeClair et al. teaches a system for transport of an organ further comprising an indention in an interior wall of the organ container (Fig. 1H shows hand cutouts in inner caddy 50; para. 0047).
Regarding claim 18, LeClair et al. teaches a system for transport of an organ comprising cooling material (Fig. 1H cooling element 46, 46’, 47, 47’), but does not teach a tray comprising a plurality of walls configured to limit movement of the cooling material. However, Wilson teaches a shelf (Fig. 9 refrigerant tray 900) comprising walls on at least two sides extending vertically from the second support surface (Fig. 9 vertical extension of tray down from top surface 902). Wilson teaches that the shape and size of the refrigerant tray holds refrigeration material appropriate for the desired temperature level (para. 0106).
It would have been obvious to a person of ordinary skill in the art to use the Wilson configuration of a shelf in LeClair et al.’s device with a reasonable expectation that it would hold refrigeration material appropriate for the desired temperature level. This method for improving LeClair et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Wilson. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of LeClair et al. and Wilson to obtain the invention as specified in claim 18.
Regarding claim 19, LeClair et al. teaches a system for transport of an organ further comprising a data logger (Fig. 1F data-logging device 91) configured to connect wirelessly with a display configured to display the measurements (para. 0044 “data-logging device 91… may connect with a computer wirelessly”).
Regarding claim 20, LeClair et al. teaches a system for transport of an organ further comprising a second cooling material configured to be positioned along an interior surface of the transport container (Fig. 1H cooling elements 46, 46’, 47, 47’).
Regarding claim 34, LeClair et al. teaches a system for transport of an organ wherein the temperature sensor is configured to connect with a display (para. 0044 “probe 92… connected to a computer docking station for downloading the data, or may connect with a computer wirelessly. The data may be downloaded into suitable software to produce a graph showing the trend in the measured parameter”).
Regarding claim 35, LeClair et al. teaches a system for transport of an organ further comprising a handle (Fig. 1B telescopic handle 19) and wheels (Fig. 1B wheel assembly 16, 16’) disposed on a back wall of the transport container.
Regarding claim 37, LeClair et al. teaches a system for transport of an organ wherein the transport container comprises a plurality of latches configured to secure to a plurality of protrusions of the lid (Fig. 1B twist latches 30, 30’).
Claim 36 is rejected under 35 U.S.C. 103 as being unpatentable over LeClair et al. (US 2011/0173023 A1) (already of record) in view of Wilson (US 2007/0193297 A1) as applied to claim 13 above, and further in view of Peralta (US 2018/0000068 A1) (already of record).
Regarding claim 36, LeClair et al. teaches a system for transport of an organ further comprising three layers of concentric containers containing an organ (Fig. 1H inner caddy 50, waterproof open well 40, outer case 11), but does not teach three sterile bags configured to concentrically contain the organ. However, Peralta teaches a biological sample contained in a bag (Fig. 2). Peralta teaches that containing the sample in a bag improves transmission of ultrasound (para. 0059) to reduce cell damage (abstract).
It would have been obvious to a person of ordinary skill in the art to use the Peralta configuration of a bag containing a biological sample in LeClair et al.’s device with a reasonable expectation that it would improve transmission of ultrasound to reduce cell damage. This method for improving LeClair et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Peralta. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of LeClair et al. and Peralta to obtain the invention as specified in claim 36.
Citation of Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Wenrich (US 2005/0153271 A1) discloses an organ preservation apparatus comprising a basket for holding the organ inside the organ container and cooling material disposed inside the organ container; Affleck et al. (US 2015/0204598 A1) discloses a portable cryogenic workstation comprising an inner housing for holding biological material and cooling material disposed proximate to the inner housing.
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 conflicting claims 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); 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 nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined 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 § 2146 et seq. 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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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 www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 13-15, 18, and 34-37 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 13, 16, 20, 23-24, and 26-27 of copending Application No. 19/248,101 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because:
Regarding claim 13, claim 13 of the reference application recites the same subject matter.
Regarding claim 14, claim 13 of the reference application recites the same subject matter.
Regarding claim 15, claim 20 of the reference application recites the same subject matter.
Regarding claim 18, claim 16 of the reference application recites the same subject matter.
Regarding claim 34, claim 27 of the reference application recites the same subject matter.
Regarding claim 35, claim 26 of the reference application recites the same subject matter.
Regarding claim 36, claim 23 of the reference application recites the same subject matter.
Regarding claim 37, claim 24 of the reference application recites the same subject matter.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 19 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 27 of copending Application No. 19/248,101 in view of LeClair et al. (US 2011/0173023 A1) (already of record).
Regarding claim 19, claim 27 of the reference application recites the same subject matter of a datalogger connected to a display, but does not recite that the datalogger is connected wirelessly to a display. However, LeClair et al. discloses a data-logging device which connects wirelessly to a display (para. 0044 “data-logging device 91… may connect with a computer wirelessly”) to download the data obtained and produce a graph showing the trend in the measured parameter over time (para. 0044). It would have been obvious to a person of ordinary skill in the art to use the LeClair et al. configuration of a wireless connection in the reference application’s device based on the teachings of LeClair et al.
This is a provisional nonstatutory double patenting rejection.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ASHLEY LOPEZLIRA whose telephone number is (703)756-5517. The examiner can normally be reached Mon - Fri: 8:30-5:00.
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/ASHLEY LOPEZLIRA/Examiner, Art Unit 1799
/MICHAEL A MARCHESCHI/Supervisory Patent Examiner, Art Unit 1799