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 II, claims 31-48 in the reply filed on 02/03/2026 is acknowledged.
Claims 1-30 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 02/03/2026.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 09/12/2022 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
The disclosure is objected to because of the following informalities: the cross-reference to related applications in paragraph 1 needs to be updated to account for the instant application being the National Stage of PCT/US2021/021525.
Appropriate correction 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 31, 39, 40, 43, 44 and 47 are rejected under 35 U.S.C. 102a1 as being anticipated by Murfee et al. (WO 2019/200411 A1 – hereafter ‘411).
‘411 discloses a cell culture system that includes the following limitations for claim 31:
“A system for ex vivo tissue analysis”: ‘411 discloses a system that is used for tissue that is perfused ex vivo and maintains perfusion up to 48 hours (page 54 lines 26-30).
“a perfusion chamber having an inlet, an outlet, and internal volume between the inlet and outlet”: ‘411 discloses a bioreactor (Fig. 2; page 8, lines 9-17) that holds the tissue, i.e. an internal volume with an inlet and outlet (pate 18 lines 29-31).
“a sample platform having a tissue mount section and a chamber mount section coupled to the tissue mount section ”: ‘411 discloses a culture chamber (Fig. 2; page 8, lines 9-17) that has a filter membrane (Fig. 7) that supports the tissue and threaded rods, i.e. the chamber mount, that holds the tissue in a desired orientation (page 27 lines 20-22).
“the tissue mount section being constructed for mounting of a resected tissue portion thereon”: This filter is constructed to support the tissue.
“the chamber mount section being constructed to releasably support the sample platform with respect to the perfusion chamber such that the resected tissue portion is positioned within the internal volume of the perfusion chamber”: The threaded bolts are attached to the bioreactor by knurled nuts (page 9, lines 3-9) that allow the rods and base to releasably support the tissue.
“wherein the tissue mount section of the sample platform has an opening that exposes a backside of the mounted resected tissue portion such that both a frontside and a backside of the mounted resected tissue portion are exposed to perfusate within the perfusion chamber.”: ‘411 further discloses that the base piece (Fig. 5, piece 5) has an opening that would allow the backside of the tissue to be exposed to a perfusate in the culture chamber (Fig. 2; page 9, lines 3-9).
For claim 39, ‘411 discloses a pump that moves perfusate through the internal volume of the culture chamber through the inlet and outlet (Fig. 2; page 8, lines 9-17).
For claim 40, ‘411 discloses that the pump is part of a fluidic circuit that connects the inlet, outlet and a media reservoir (Fig. 2; page 8, lines 9-17).
For claim 43, ‘411 discloses using a plurality of outlets (page 18, line 29 through page 19, line 2). These outlets are fully capable as functioning as a sampling port since these outlets are used to remove perfusate media from the chamber and circuit.
For claim 44, ‘411 discloses placing the culture chamber within an incubator (page 9, line 13; page 20, lines 26-28; Fig. 9) that maintains the temperature at 37°C, i.e. a predetermined temperature.
For claim 47, ‘411 discloses an imaging system, i.e. platform, that receives the culture chamber and can use a microscope to image the tissue (Fig. 1; page 8 lines 6-8).
Therefore, ‘411 meets the limitations of claims 31, 39, 40, 43, 44 and 47.
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 36, 37 and 41-42 are rejected under 35 U.S.C. 103 as being unpatentable over Murfee et al. (WO 2019/200411 A1 – hereafter ‘411) in view of Steen et al. (US 2011/0065169 A1 – hereafter ‘169).
For claims 36 and 37, ‘411 does not explicitly disclose the inlet being at a height relative to the bottom of the perfusion chamber with respect to the outlet where the inlet is higher than the outlet.
‘169 discloses an apparatus for housing an organ such as lungs for the ex vivo evaluation and preservation of the organ in a liquid solution (Abstract) that for claims 36 and 37, includes a perfusion chamber (vessel 10; Fig. 1) that has a drain (drain 12) at the bottom of the vessel ([0034]) and where the inlet line (line 16; Fig. 1; [0035]) is connected to the organ via a catheter (catheter 17; Fig. 1) at a height above the floor of the vessel. Furthermore, the placement of the inlet is at a height different from the outlet of ‘169 (Fig. 1).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to include the outlet being at a lower height than the inlet as suggested by ‘169 within ‘411 in order to have a built in reservoir for the preservation solution. The suggestion for doing so at the time would have been in order to collect the solution from the organ (0033]).
‘411 differs from the instant claim 41 and 42 regarding a gas exchanger.
‘169 discloses for claims 41 and 42 using an oxygenator ([0034]) that would remove carbon dioxide from the perfusate while oxygenating the perfusate. This allows for the system to provided topical extracorporeal membrane oxygenation (ECMO) to the lung ([0042]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to include the gas exchanger/oxygenator of ‘169 within ‘411 in order to oxygenate the perfusate. The suggestion for doing so at the time would have been to provide ECMO to the lung as this functions well for the preservation of the lungs ([0042]).
Allowable Subject Matter
Claims 32-35, 38, 45, 46 and 48 are 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 32, the prior art taken either singly or in combination fails to teach or reasonably suggest the following limitation when taken in context of the claim as a whole where the tissue mount section comprises an annular platform having a first outer diameter, the chamber mount section comprises a circular base having a second outer diameter greater than the first outer diameter, and the sample platform comprises one or more arms that extend between and connect the annular platform to the circular base.
Claims 33-35 would be allowable for the same reasons as claim 32.
For claim 38, the prior art taken either singly or in combination fails to teach or reasonably suggest the following limitation when taken in context of the claim as a whole a system for ex vivo tissue analysis that includes an oxygen-generating biomaterial (OGB) disposed within the perfusion chamber, the OGB being constructed to release oxygen into perfusate within the internal volume of the perfusion chamber.
For claim 45, the prior art taken either singly or in combination fails to teach or reasonably suggest the following limitation when taken in context of the claim as a whole a system for ex vivo tissue analysis that includes a passive structure that agitates or mixes perfusate within the perfusion chamber, an active structure that agitates or mixes perfusate within the perfusion chamber, or any combination of the foregoing.
Claim 46 would be allowable for the same reasons as claim 45.
For claim 48, the prior art taken either singly or in combination fails to teach or reasonably suggest the following limitation when taken in context of the claim as a whole a system for ex vivo tissue analysis where the imaging platform holder comprises: a first member having a threaded shaft, a through-hole extending through a center of the threaded shaft, and a top surface with a pair of securing arms on opposite sides of the through- hole; a second member having a through-hole with threads complementary to that of the threaded shaft of the first member and constructed to receive the threaded shaft therein; and a locking member constructed to be disposed between the chamber mount section of the sample platform and the securing arms to releasably couple the sample platform to the first member, wherein a diameter of the through-hole of the first member is greater than an outer diameter of the tissue mount section and less than an outer diameter of the chamber mount section.
The closest prior art is Murfee et al. (WO 2019/200411 A1) that discloses a tissue cultivation system that includes cannulated organs within a bioreactor within a cell culture chamber. However, Murfee does not teach or fairly suggest the claim limitations of claims 32-35, 38, 45, 46 and 48.
The next closest prior art is Steen et al. (US 2011/0065169 A1) which discloses an apparatus for housing an organ such as lungs for the ex vivo evaluation and preservation of the organ in a liquid solution, however, Steen does not teach or fairly suggest the limitations of claims 32-35, 38, 45, 46 and 48.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Gurtner (US 2004/0247567 A1) discloses a system for the ex-vivo modification of mammalian tissue.
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.
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.
/MICHAEL L HOBBS/Primary Examiner, Art Unit 1799