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 .
Response to Amendment
Applicant’s amendment filed 04/16/2026 is acknowledged. Claims 1, 5, 14, 16, 18, 40-43, 71 and 72 are amended, claims 12 and 20 are newly canceled and claims 74 and 75 are new.
Claims 1, 5, 14, 16-19, 40-43, 47 and 71-75 are under examination.
Objection/Rejections Withdrawn
Any previous rejections of claims 12 and 20 are hereby withdrawn in response to Applicant’s cancelation of those claims.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Specification
The objection to the disclosure for informalities is withdrawn in response to Applicant’s amendment of Table 5 of the instant specification removing the shading that that rendered many of the correlation coefficients illegible.
Claim Objections
The objection to claims 1, 47, 71 and 72 for minor informalities is withdrawn in response to Applicant’s amendment correcting the typographical errors in the claims.
Claim Rejections - 35 USC § 112(b)
The rejections of claims 1, 5, 14, 16, 17, 19, 40-43, 47 and 71-73 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or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention is withdrawn in response to Applicant’s amendment removing the indefinite language outlined at pages 10-12 of the Office action mailed 12/17/2025.
Claim Rejections - 35 USC § 112(a) – Enablement
The rejection of claims 1, 5, 14, 16-19, 40-43, 47 and 71-73 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement is withdrawn in response to Applicant’s amendment and upon further consideration. Specifically, Applicant has amended claims 1 and 47 to add a wherein clause listing the parameter values: “wherein for each biomarker, the one or more parameter values are selected from a concentration of each of the biomarkers, a rate of increase of the concentration of each of the biomarkers, a ratio of the concentration of each of the biomarkers relative to a control biomarker level, and/or a fold change in the concentration of each of the biomarkers in a subsequent perfusate sample relative to an earlier perfusate sample”. Applicant has also amended claim 1 to recite “an algebraic calculation or model” and claim 47 to recite “a ranking score indicative of unacceptable outcome/risk”. In addition, Applicant’s arguments at pages 15-18 of the Remarks filed 04/16/2026 with regard to the disclosed examples is persuasive.
Claim Rejections - 35 USC § 112(a) – Written Description
The rejection of claims 1, 5, 14, 16-19, 40-43, 47 and 71-73 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement is withdrawn in response to Applicant’s amendment and upon further consideration. Specifically, Applicant has amended claims 1 and 47 to add a wherein clause listing the parameter values: “wherein for each biomarker, the one or more parameter values are selected from a concentration of each of the biomarkers, a rate of increase of the concentration of each of the biomarkers, a ratio of the concentration of each of the biomarkers relative to a control biomarker level, and/or a fold change in the concentration of each of the biomarkers in a subsequent perfusate sample relative to an earlier perfusate sample”. Applicant has also amended claim 1 to recite “an algebraic calculation or model” and claim 47 to recite “a ranking score indicative of unacceptable outcome/risk”. In addition, Applicant’s arguments at pages 15-18 of the Remarks filed 04/16/2026 with regard to the disclosed examples is persuasive.
Claim Rejections - 35 USC § 101
The rejection of claims 1, 5, 14, 16-19, 40-43, 47 and 71-73 under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more is withdrawn in response to Applicant’s amendment of the claims. Considering the claim as a whole, the claims require a particular treatment of the lung tissue whether or not it is transplanted.
Objection Maintained/Rejections Maintained/New Rejection
Claim Objections
The objection to claim 5 for minor informalities is maintained. Specifically, the optional clauses of claim 5 recite both “PO variable score” and “PO score”. For the sake of parallel construction and consistency, use a single phrase.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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.
The rejection of claim 18 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 is maintained for reasons of record and the following. The amendment removing the exemplary language is acknowledged. However, claim 18 still recites a number of distinct alternatives after which EVLP perfusate samples are collected separated by “and/or”, namely “after or at about 45 min of EVLP…and/or after or at about 4 hours”. The use of “and/or” in this context is indefinite because the alternatives are mutually exclusive.
Response to Arguments
Applicant argues at p. 14, 6th paragraph that more than one sample could be taken at more than one time, and is therefore definite.
This has been fully considered, but is not found persuasive. The claim recites “one or more samples”, which reads on an alternative in which a single sample is collected. A single sample cannot be collected at both 45 minutes of EVLP and after or about 4 hours of EVLP. The claim leads to confusion as to when the EVLP perfusate is collected.
New Rejection
Claims 1, 5, 14, 16-19, 40-43, 47 and 71-75 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. This rejection was necessitated by amendment.
Amended claims 1, 47 and 74 recite alternative listings, which are known as Markush groups. Claims 1 and 47 are amended to add a wherein clause listing the parameter values: “wherein for each biomarker, the one or more parameter values are selected from a concentration of each of the biomarkers, a rate of increase of the concentration of each of the biomarkers, a ratio of the concentration of each of the biomarkers relative to a control biomarker level, and/or a fold change in the concentration of each of the biomarkers in a subsequent perfusate sample relative to an earlier perfusate sample”. The term “and/or” should not be used in a Markush grouping. See MPEP 2173(h)(I), which provides guidance regarding acceptable Markush language. For example, alternatives may be set forth as “a material selected from the group consisting of A, B, and C” or “wherein the material is A, B, or C”.
New claim 74 recites the “biochemical data comprises at least one of” followed by a listing of alternatives. A Markush grouping is a closed group of alternatives, i.e., the selection is made from a group “consisting of” (rather than “comprising” or “including”) the alternative members. Abbott Labs., 334 F.3d at 1280, 67 USPQ2d at 1196. If claims recite Markush groupings requiring a material selected from an open list of alternatives (e.g., selected from the group “comprising” or “consisting essentially of” the recited alternatives), the claims are indefinite because it is unclear what other alternatives are intended to be encompassed by the claim.
Claims 1, 5, 14, 16-19, 40-43, and 71-74 are hereby included for depending upon an indefinite claim.
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.
The provisional rejection of claims 1, 5, 12, 14, 16-20, 40-43, 47 and 71-73 on the ground of nonstatutory double patenting as being unpatentable over claims 1-7, 9, 13-24, 26, 28 and 31 of copending Application No. 18/842,351 in view of Nakajima al. and Andreasson et al. is maintained for reasons of record and the following. In addition, new claims 74 and 75 are hereby included in this rejection.
Response to Arguments
Applicants’ request deferral of this issue at p.11 of the Remarks filed 11/10/2025 until other issues of patentability are resolved in their response filed 11/10/2025 is noted. However, deferral of arguments is not proper; an argument after the claims have been found otherwise allowable that obviousness type double patenting does not exist will not be considered timely. Accordingly, the rejections on the ground of nonstatutory double patenting are maintained.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTINA M BORGEEST whose telephone number is (571)272-4482. The examiner can normally be reached M-F 9-5:30 EDT.
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, Jeffrey Stucker can be reached at 5712720911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHRISTINA M BORGEEST/Primary Examiner, Art Unit 1675
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