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 .
Restriction/Election
Applicant’s election without traverse of claims 1-13 (Group I) in the reply filed on February 27,2026 is acknowledged. Claims 14-21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group II, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on February 27, 2026.
Drawing
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference characters not mentioned in the description:8A,8B,9A,9B,9C,9D,9E,9F,10A,10B,10C,10D,10E,12A,12B,12C,13A,13B, 13C, 13D, 14A,14B,14C, and 14D. These figures are not individually addressed in the brief drawing description. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference characters in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The brief drawing description section of the specification fails to individually address the following figures: 8A,8B,9A,9B,9C,9D,9E,9F,10A,10B,10C,10D,10E, 12A,12B,12C,13A,13B,13C, 13D,14A,14B,14C, and 14D.
Claim Objections
Claims 3-4 are objected to because of the following informalities: “infrahepatic inferior vena cava” should be –intrahepatic inferior vena cava--.
Claim 8 is objected to because of the following informalities: “alerting” should be –alert--. Appropriate correction is required.
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.
Claims 7-10 are 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 7 recites the limitation "the variable height" in line 1 of claim 7. There is insufficient antecedent basis for this limitation in claim 7. Claim 7 refers to “the variable height”; however, claim 1 from which claim 7 depends from fails to mention a variable height.. This issue can be easily corrected by amending claim 7 to depend directly from claim 6 instead of claim 1.
Claim 8 is rejected because it recites “the organ.” It is unclear if “the organ” recited in claim 8 is the same as the “extracorporeal organ” recited in claim 1. Dependent claims 9-10 fail to correct this indefinite issue.
Claim Rejections - 35 USC § 102
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, 5-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bacchetta (US 20190141985).
Bacchetta discloses a system comprising an organ chamber configured to hold an extracorporeal organ; and a cross-circulation circuit configured to connect the extracorporeal organ and a host organism to maintain the extracorporeal organ by perfusing veno-arterial venous (V-AV) blood (a perfusion solution) through the extracorporeal organ and the host organism, wherein the physiologic stability of the host organism is maintained (FIG 1A-FIG 6C, abstract, paragraphs 14,71-72,74-75 of Bacchetta) as in instant Claim 1. Bacchetta discloses that the extracorporeal organ is liver, lung, heart, limb, or tissue substrate (Paragraph 15 of Bacchetta) as in instant Claim 2. Bacchetta discloses that the system comprises a heater to keep the extracorporeal organ, the host organism, and the cross-circulation circuit at a constant temperature from 4 degrees Celsius to 40 degrees Celsius (FIG 3E, Paragraphs 27 and 75 of Bacchetta) as in instant Claim 5. Bacchetta discloses wherein the organ chamber is at a variable height based on a height of the host organism (FIG 1A-1B; FIG 6A-6C; Paragraphs 20,71-72,78,89, and 115) as in instant Claim 6. Bacchetta discloses wherein the variable height of the organ chamber keeps the organ and the host organ at a near physiologic pressure (FIGs 1A-1B; FIG 6A-6C; Paragraphs 20,71-72,78,89 and 115) as in instant Claim 7. Bacchetta discloses a plurality of sensors configured to detect changes in at least one parameter of the cross-circulation circuit, the organ and/or the host organism; and a monitoring device configured to monitor changes and alert a medical professional when changes are outside a pre-determined threshold (Paragraphs 83-84) as in instant Claim 8. Bacchetta discloses parameters that can be detected to include the blood flow rate (Claim 4 of Bacchetta), organ in-flow pressure (Paragraph 20 of Bacchetta), and organ out-flow (Paragraph 20 of Bacchetta) as in instant Claim 9. Bacchetta discloses a pump configured to pump blood from at least one vein of the host organism to at least one artery of the host organism; an oxygenator configured to oxygenate the blood before the blood enters the at least one artery of the host organism; and a heater, wherein the monitoring device controls at least one of the oxygenator, the pump, and the heater in response to detecting changes in the at least one parameter outside the pre-determined threshold to return the least one parameter to within the predetermined threshold (FIGs 1A-Figure 6C; Paragraphs 18,71-73,75,77-78,84 of Bacchetta) as in instant Claim 10. Bacchetta discloses wherein the cross-circulation circuit further comprises: a pump configured to be connected to at least one vein or artery of the extracorporeal organ, and at least one artery of the host organism via at least one tube (FIG 1A-1B; Figure 7C; Paragraphs 18-19,71-73,75,77,79,81-82,84; claims 4-5 of Bacchetta) as in instant Claim 11. Bacchetta discloses wherein the pump is configured to use negative pressure to pull blood from the at least one vein of the host organism and to use positive pressure to push the blood into the at least one artery of the host organism and the at least one vein or artery of the extracorporeal organ, wherein a flow regulator is configured to control the rate of blood pumped into the at least one artery of the host and the rate of blood pumped into the at least one vein or artery of the extracorporeal organ (FIG 1A-1B,3A-3E, Paragraphs 71-73, and 75 of Bacchetta as in instant Claim 12. Bacchetta discloses wherein the cross-circulation circuit further comprises an oxygenator configured to maintain a physiologic level of oxygen in the blood perfusing the extracorporeal organ and the host organ (FIG 1A-1B, Paragraphs 20, 71-73 of Bacchetta) as in instant Claim 13.
The reference anticipates the claimed invention.
Claim Rejections - 35 USC § 103
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 1-13 are rejected under 35 U.S.C. 103 as being unpatentable over Bacchetta (US 20190141985) in view of Friend (US 7,410,474)
Bacchetta applies as above to teach claims 1-2,5-13. Bacchetta teaches that its extracorporeal organ system encompasses a “cuff device with a native aortic arch (from the donor organism) in fluid communication with at least one head vessel port accommodating a sensor to monitor a condition of the perfusion fluid (blood) with the cross circulation circuit (e.g. pressure, flow, temperature, blood chemistry) (Paragraph 23). Bacchetta further teaches that, “the biologic cuff device may further comprise at least one other donor vascular component (e.g. thoracic aorta with superior mesenteric artery, inferior vena cava, portal vein, etc.) to provide a customizable system for support of a specific extracorporeal organ type (Paragraph 24 of Bacchetta). Bacchetta teaches that the host can be connected to the extracorporeal organ through peripheral or central veins of the host organs (Paragraph 141 of Bacchetta). Figure 2 of Bacchetta shows that the host and extracorporeal organ are connected through circuitry that includes a pump and oxygenator. This set up allows for a perfusion solution such as blood to flow from the host to an extracorporeal organ in a circuit. Although Bacchetta teaches that its extracorporeal organ system can be used on livers, it does not teach specifically how the liver is affixed to its system.
However, Friend teaches specifically how the liver is attached in an extracorporeal organ system. Figure 1 of Friend shows attachments/cannulations when attaching a liver to an extracorporeal organ system occur at the portal vein, hepatic artery, and the interior vena cava of the liver. Figure 1 of Friend also shows that a pump is present and helps to distribute the solution through the liver. An oxygenator is also present which helps to distribute oxygen through the system (Figure 1 of Friend).
It would have been obvious to an artisan of ordinary skill in the art to have included the liver attachment of Friend with the apparatus setup of Bacchetta because it would allow the perfused solution to successfully flow through the liver (Figure 1). An artisan would have been motivated to have used the perfusion liver attachment of Friend because it allows for the successfully perfusion of the liver (Figure 1 of Friend). Because Friend’s method of perfusion can allow for the successfully distribution of the targeted solution throughout the liver, there would have been a high expectation for success (Figure 1 of Friend) as in instant Claims 3-4.
Dependent Claims taught by Friend
Friend teaches wherein the extracorporeal organ is liver (Abstract) as in instant Claim 2. Friend teaches a perfusion process at a temperature of 37 or 39°C (Column 5, line 30-35) as in instant Claim 5. Friend teaches a oxygenator configured to maintain a physiologic level of oxygen in the blood perfusing the extracorporeal organ (Figure 1 and Column 2, line 62) as in instant Claim 13.
Bacchetta teaches a cross-circulation platform for an extracorporeal organ that involves a perfusion circuit that maintains an extracorporeal organ by connecting it to a host organism and moving a perfusion solution between the extracorporeal organ and the host in a circuit. Bacchetta teaches that it’s device can be used with different types of organs including livers. However, Bacchetta does not teach how to attach livers to such a platform. An artisan would have been motivated to have combined the teachings of Friend with those of Bacchetta since Friend teaches how to attach a liver in a perfusion circuit in a manner that allows for the perfusion solution to effectively flow though the liver. Given the teachings of the cited references and the level of skill of an ordinary skilled artisan at the time of applicants’ invention, it must be considered , absent evidence to the contrary, that the ordinary skilled artisan would have had a reasonable expectation of success in practicing the claimed invention.
All the claimed elements were known in the prior art, and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention (See KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007)). People of ordinary skill in the art will be highly educated individuals, possessing advanced degrees, including M.D.s and Ph.D.s. They will be medical doctors, scientists, or engineers. Thus, these people most likely will be knowledgeable and well-read in the relevant literature and have the practical experience in molecular biology, cell culture, and perfusion. Therefore, the level of ordinary skill in the art is high.
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 1-2,6-7 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1,5-6 of U.S. Patent No. 11,968,974. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 of Patent 11,968,974 is actually a species of instant claim 1. Claim 1 of 11,968,974 also recites a structure with an organ chamber that is configured to hold an extracorporeal organ; and a cross-circulation circuit configured to connect the extracorporeal organ and a host organism to maintain the extracorporeal organ by perfusing blood, wherein the physiologic stability of the host organism is maintained. Claim 1 of Patent 11,968,974 also mentions a time and temperature controlled humidifier and misting spray, various pressure sensors, a controller that controls a circulation pump. Instant claim 2 corresponds to claim 6 of Patent 11,968,974. Instant claims 6-7 correspond to claim 5 of Patent 11,968,974.
Claims 1-2,5-7 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1,7-8,13,16 of U.S. Patent No. 12,446,572. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 of Patent 12,446,572 is actually a species of instant claim 1. Claim 1 of 12,446,572 recites an apparatus that also has an organ chamber that is configured to hold an extracorporeal organ; and has a cross-circulation circuit configured to connect the extracorporeal organ and a host organism to maintain the extracorporeal organ by perfusing blood, wherein the physiologic stability of the host organism is maintained. Claim 1 of Patent 12,446,572 also possesses a time and temperature controlled humidifier that controls a mist spray onto an organ. Instant claim 2 corresponds to claims 7-8 of Patent 12,446,572. Instant claim 5 corresponds to claim 13 of Patent 12,446,572. Instant claims 6-7 correspond to claim 16 of Patent 12,446,572.
Claims 1-2,5-7 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 40,46-48,52,55 of copending Application No. 19/343,412 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because claim 40 of Application 19/343,412 is a species of instant claim 1. Claim 40 recites limitations present in instant claim 1 and also requires an extracorporeal organ chamber which has a humid environment. Instant claim 2 corresponds to claims 46-48 of Application 19/343,412. Instant claim 5 corresponds to claim 52 of Application 19/343,412. Instant claims 6-7 corresponds to claim 55 of Application 19/343,412. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 20 of copending Application No. 19/355,648(reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because claim 20 of 19/355,648 is a species of instant claim 1. Claim 20 of Application 19/355,648 recites the limitations present in instant claim 1 and also recites that the organ chamber comprises a time and temperature controlled humidifier and misting spray that maintain a humid environment. Claim 20 of Application 19/355,648 also mentions arterial and venous pressure sensors and a controlled circulating pump. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
All claims stand rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAUREN K VAN BUREN whose telephone number is (571)270-1025. The examiner can normally be reached M-F:9:30am-5:40pm; 9:00-10:00pm.
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LAUREN K. VAN BUREN
Examiner
Art Unit 1638
/Tracy Vivlemore/Supervisory Primary Examiner, Art Unit 1638
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