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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Specification
The amendment to the specification filed on 09/05/2023 has been considered and entered for the record.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 09/05/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
The information disclosure statement (IDS) submitted on 03/25/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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 6 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 6 recites the limitation "the tubes in the plurality of sets" in line 3. There is insufficient antecedent basis for this limitation in the claim. It is recommended to change the dependency of claim 6 from claim 1 to claim 4.
Appropriate corrective action is required.
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 2 and 4-8 are rejected under 35 U.S.C. 102a1 as being anticipated by Steen et al. (US 2015/0342178 A1 – hereafter ‘178).
‘178 discloses an apparatus for the evaluation, preservation and perfusion of an organ (Abstract) that includes the following limitations for claim 1:
“An organ preservation container for preserving an organ in vitro”: ‘178 discloses a container for the preservation of an organ ([0004]) that would be in vitro since this preservation takes place outside a person or animal.
“a container body including a bottom plate and a side wall, the side wall extending upward from an outer peripheral edge of the bottom plate”: ‘178 discloses that the container includes three parts including a bottom portion (portion 13; Fig. 1; 0049]) that has a bottom or bottom plate and sidewall that extend upward from the edge of the bottom (Fig. 1).
“a through hole penetrating the side wall”: ‘178 discloses a through hole in the side wall (Fig. 1) that allows tubes to be connected to an organ within the interior of the container ([0049]); [0053]; Fig. 2; Fig. 3; hole 20).
“a joint provided in the through hole”: ‘178 discloses a seal (seal 96; Fig. 5; [0064]) that seals the tube to the container and is being interpreted as the joint of the instant application.
“a tube having one end connected to the joint from an inner side of the container body and the other end insertable into a blood vessel in an organ.”: ‘178 discloses two tubes (tube 94 & tube 91) that extend from the through hole where one of the tubes (tube 91) is connected to a pulmonary artery of the organ ([0063]; Fig. 5).
For claim 2, the tube extends in a normal direction from the side wall to the organ (Fig. 2; Fig. 3; [0063]).
For claim 4, ‘178 discloses that there a plurality of through holes (Fig. 1; Fig. 17; [0064]), a plurality of tubes and joints or seals for the tube sets (seals 96 and 104; [0074]).
For claim 5, the joints and tubes are arranged in an up and down direction (Fig. 1; Fig. 17) where this is being interpreted as a vertical orientation.
For claim 6, ‘178 discloses that the plurality of tube sets include a short tube (tube 94; Fig. 5) and a long tube (tube 17; Fig. 5; [0064]; [0074]) where the long tube has a length equal or greater than a width or diameter of the container.
For claim 7, the seals of ‘178 can function as a plug.
For claim 8, ‘178 includes using connectors (connector 99; Fig. 1; [0064]) that is placed within the through hole and has a passage that allows for a tube to be passed through or to be connected to the interior of the container.
Therefore, ‘178 meets the limitations of claims 1, 2 and 4-8.
Allowable Subject Matter
Claim 3 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: for claim 3, the prior art fails to teach or fairly suggest where the joint is located at a height of 30 mm or more and 100 mm or less from an upper surface of the bottom plate.
The closest prior art is Steen et al. (US 2015/0342178 A1 ) which discloses an organ preservation device that includes tubes extending from a side wall of the container and that includes tube connectors and sealers that maintain the tubes in position with an organ while preventing perfusion media from leaking out of the container. However, Steen does not specifically disclose the height at which the through-holes are disposed and while it may be implied that through holes are at the specified height, this is not explicitly taught by Steen. Furthermore, Steen does not suggest that the reason for the placement of the through holes is to have the tubes arranged at a height suitable for blood vessels of the preserved organ. Again, while this may be implicit within Steen, there is no discussion of this within the applied reference.
The next closest prior art is Eiji et al. (WO 2016/044354 A1) which discloses an organ preservation device with a tube connector on the side of the container (Fig. 10). However, Eiji does not specify the height for the pipe holding unit nor does Eiji provide a suggestion or teaching as to why the pipe holding unit is placed in relation to a preserved organ.
Therefore, the closest prior art does not teach or fairly suggest the limitation of claim 3.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Hassanein et al. (US 2015/0342177 A1) discloses a preservation device.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL L HOBBS whose telephone number is (571)270-3724. The examiner can normally be reached Variable, but generally 8AM-5PM M-F.
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/MICHAEL L HOBBS/Primary Examiner, Art Unit 1799