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 .
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 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12,295,361. Although the claims at issue are not identical, they are not patentably distinct from each other because the claimed subject matter is recited or suggested in the claims of the ‘361 patent as follows:
Claim 1
Claims of ‘361 patent
A device for perfusing an organ, said device comprising:
Claim 11: A device for perfusing an organ, said device comprising:
a fluid container containing perfusion fluid;
Claim 11: a fluid container;
a common channel having a common
inlet fluidly connected to the fluid container, and a separator splitting the common channel into a first channel with a first outlet fluidly connected to the fluid container, and a second channel with a second outlet fluidly connected to the fluid container,
Claim 11: a common fluid channel having a common inlet fluidly connected to the fluid container; a separator configured to separate the common fluid channel into a first fluid channel leading to a first outlet fluidly connected to the fluid container, and a second fluid channel leading to a second outlet fluidly connected to the fluid container, wherein the first outlet is separate from the second outlet;
wherein the first outlet has a first diameter that is at least 25% smaller than a second diameter of the second outlet;
Claim 15: The device of claim 11, wherein the first outlet has a smaller diameter than a diameter of the second outlet.
a first pump configured to circulate fluid in the fluid container from the common inlet to the first outlet; a second pump configured to circulate the fluid in the fluid container from the common inlet to the second outlet; and
Claim 16: The device of claim 11, further comprising a first pump on the first fluid channel, a second pump on the second fluid channel, and a third pump on the common fluid channel, wherein the first, second, and third pumps are configured to be adjusted independently of one another.
an oxygenation means configured to increase a concentration of oxygen dissolved in the perfusion fluid.
Claim 11: a means for oxygenating fluid positioned on the first or second fluid channel, the means for oxygenating fluid configured to create a difference in oxygenation of fluid between the first outlet and the second outlet;
While claim 11 of the ‘361 patent does not explicitly recite that the first outlet has a first diameter that is at least 25% smaller than a second diameter of the second outlet, it is proper under MPEP 804(II)(B)(1) to use the specification as a guide to learn the meaning of a term in the claim. Further, the scope of the claims is to be determined not solely on the basis of the claim language, but upon giving claims their broadest reasonable construction in light of the specification as it would be interpreted by one of ordinary skill in the art. The portions of the specification which provide support for the reference claims may also be examined and considered when addressing the issue of whether a claim in the application defines an obvious variation of an embodiment disclosed in the reference patent or application which provides support for the claim in the reference patent or application. In this case, it is proper to consider the specification when considering the meaning and scope of “smaller diameter” as recited the claims. Claim 15 of the ‘361 patent as viewed in light of col. 6, lines 44-47 of its specification suggests the limitation of the first outlet having a first diameter that is at least 25% smaller than a second diameter of the second outlet as recited in claim 1.
The limitations of claim 2 are recited in claim 11 of the ‘361 patent.
The limitations of claim 3 are recited in claim 2 of the ‘361 patent.
The limitations of claims 4 and 5 are recited in claim 4 of the ‘361 patent.
The limitations of claim 6 are recited in claim 14 of the ‘361 patent.
The limitations of claim 7 are recited in claim 7 of the ‘361 patent.
The limitations of claim 8 are recited in claim 16 of the ‘361 patent.
The limitations of claim 10 are recited in claim 17 of the ‘361 patent.
The limitations of claim 11 are recited in claim 11 of the ‘361 patent.
The limitations of claim 12 are suggested by the combined teachings of claims 11 and 14 of the ‘361 patent.
The limitations of claim 13 are recited in claim 11 of the ‘361 patent.
The limitations of claim 14 are recited in claim 12 of the ‘361 patent.
The limitations of claim 15 are recited in claim 13 of the ‘361 patent.
The limitations of claim 16 are recited in claim 15 of the ‘361 patent.
The limitations of claim 17 are recited in claim 16 of the ‘361 patent.
The limitations of claim 18 are recited in claims 17 and 18 of the ‘361 patent.
The limitations of claim 19 are recited in claim 19 of the ‘361 patent.
The limitations of claim 20 are suggested by the combined teachings of claims 20 and 11 of the ‘361 patent.
Claim 9 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12,295,361 in view of claims 10 and 11 of U.S.Patent No. 11,576,371. The combined teachings of the claims of the ‘361 and claims 10 and 11 of the ‘371 patent suggest the claimed invention.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KURT FERNSTROM whose telephone number is (571)272-4422. The examiner can normally be reached M-F 10-6.
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, Peter Vasat can be reached at 571-270-7625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KURT FERNSTROM/Primary Examiner, Art Unit 3715
October 8, 2026
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