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 .
DETAILED ACTION
Election/Restrictions
Applicant's election of Group I, claims 1-4, 11, and 12, without traverse, filed February 20, 2026 is acknowledged and has been entered. Claims 19-25 have been amended. Applicant also elected Species a) liver and cells which read on claims 12 and 19. Claims 13-18 and 20-26 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being claims drawn to a non-elected invention and species based on election by original presentation. Accordingly, claims 1-4 and 11-26 are pending. Claims 1-4, 11, 12, and 19 are under examination.
Priority
2. Receipt is acknowledged of certified copies of foreign priority papers required by 37 CFR 1.55, which papers have been placed of record in the file.
3. Applicant’s claim for the benefit of a provisional application under 35 U.S.C. 111(a) and 37 C.F.R 1.53(b) is acknowledged. This application is a 371 National Stage application of PCT/US2021/017846 filed 02/12/2021, which claims the benefit of Provisional Application 63/032,454 filed 05/29/2020 and Provisional Application 62/976,591 filed 02/14/2020. Based on the filing receipt, the effective filing date of this 371 National Stage application is February 14,2020 which is the filing date of Provisional Application 62/976,591 from which the benefit of priority is claimed.
Claim Objections
4. Claim 1 is objected to in reciting “the reference level represents a level.” It should recite “the reference represents a level.” Appropriate correction is required.
5. Claim 1 is objected to in reciting “differs” as it applies to the level, activity, and/or status of cells of the selected type in the organ relative to a “reference” that represents a viable organ as recited in the claimed invention. The specification in paragraphs [0008] and [0070] defines “differs” only exemplified as “(e.g. differs significantly from)” the reference. As such, it appears that claim 1 should recite “identifying an organ that has a level … of cells of the selected type that differs significantly from the reference.”
6. Claim 1 is objected to in reciting “comparable” as it applies to the level, activity, and/or status of cells of the selected type in the organ relative to a “reference” that represents a viable organ as recited in the claimed invention. The term “comparable” as recited, is a subjective term lacking a comparative basis for defining its metes and bounds and the specification in paragraph [0008] defines “comparable” only exemplified as “(e.g. not significantly different from)” the reference. As such, it appears that claim 1 should recite “identifying an organ that has a level … of cells of the selected type that is not significantly different from the reference.”
7. Claim 11 is objected to in reciting “antibodies that bind to identifying cell surface antigens and or intracellular proteins.” It should recite “antibodies that bind to cell surface antigens and/or intracellular proteins.”
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.
8. Claims 1-4, 11, 12, and 19 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 1 lacks clear antecedent basis in reciting “the reference level represents a level.” Perhaps, Applicant intends “the reference represents a level.”
Claim 2 is vague and indefinite in reciting “the organ has been identified as having a level … below the reference level” because “below” is a subjective term lacking a comparative basis for defining its metes and bounds. Additionally, the specification in paragraphs [0009] and [0070] does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Claim 3 lacks clear antecedent basis in reciting “enriching the sample for cells from the organ” because it fails to clearly define what previous recitation of “cells” Applicant intends to encompass.
Claim 4, (a) is indefinite in reciting “the organ is liver and the cells are hepatocytes (HC)” because it fails to clearly define what previous recitation of “the cells” Applicant intends to encompass. Perhaps, Applicant intends “the organ is liver and the cells of the selected cell type are hepatocytes (HC).”
Regarding claim 12, the phrase "or other biomolecules" renders the claim indefinite because the claim includes elements not actually disclosed (those encompassed by "other biomolecules"), thereby rendering the scope of the claim unascertainable. See MPEP § 2173.05(d).
Claim 19, is indefinite in reciting “the organ is a liver and the cells are hepatocytes (HC)” because it fails to clearly define what previous recitation of “the cells” Applicant intends to encompass. Perhaps, Applicant intends “the organ is a liver and the cells of the selected cell type are hepatocytes (HC).”
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.
9. Claims 1-4, 11, 12, and 19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7, 9-11, 13, 26, and 28 of copending Application No. 18/063,901 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both inventions recite a method of determining or monitoring viability of an organ (biological tissue) for transplantation during perfusion (i.e. Machine Perfusion (MP)) comprising providing a sample of organ perfusate; detecting and measuring the identified cells from the organ perfusate for level, activity, and/or status of intracellular proteins such as mitochondria (mitochondrial ratios) by contacting the sample with antibodies or probe; and, determining the viability and suitability of the organ for transplant based on comparative reference levels (i.e. series); and wherein the organ is liver.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
10. Claims 1-4, 11, 12, and 19 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Wilson et al. (US 2022/0341946).
Wilson et al. teach a method of determining viability of liver (i.e. explant organ viability) for transplantation during (undergoing) or after Machine Perfusion (MP), specifically, Hypothermic Perfusion (Abstract; [0010, 0011, 0138, 0193, 0194, 0217, 0219, 0224]; Example 1). Watson et al. teach providing a sample of liver perfusate from the MP; detecting whole cells from the liver perfusate, and determining the identity, level, activity and/or status, of selected cell types in the sample using immunoassay techniques [0013-0021, 0190, 0228-0234, 0241, 0245]. Watson et al. teach comparing the identity, level, activity and/or status the cells of the selected type from the liver to that of a reference liver organ (predetermined value), wherein the reference represents a level, activity and/or status in a viable clinical liver organ. With respect to detecting and determining the identity, level, activity and/or status, of selected cell types in the sample, Wilson et al. teach: detecting and determining the level of Th2 helper cell and mast cell (cell types) production (activity) of human IL-5 protein [0228, 0236]; detecting and determining the level of liver dendritic cell (DC), macrophage, neutrophil, and human B-lymphoblastoid cell production of human IL-12 protein [0229, 0236]; detecting and determining the level of lymphocyte production of human IL-16 protein [0230, 0237]; detecting and determining the level of liver dendritic cell (DC) and macrophage secretion (activity) of human IL-15 protein [0231, 0237]; detecting and determining the level of hepatocyte (liver cell) synthesis (activity) of C-reactive protein (CRP) [0232, 0239]; detecting and determining the level of VEGF-A protein produced in liver sinusoidal endothelial cell (LSEC) activation (status) [0233, 0238]; and detecting and determining the level of stromal cell secretion of human IL-7 protein [0234]. Wilson et al. teach identifying that the liver having a level, activity and/or status of cells of the selected type that is significantly higher or elevated (i.e. differs) than the reference identity, level, activity and/or status as unsuitable for transplant (discarded livers) ([0024-0033, 0138, 0190, 0228-0234, 0236-0239]; Example 1). In this case, IL-2, IL-5, IL-7, IL-15, IL-12, IL-16, and IL-18 production or secretion by specific cells including liver dendritic cells are significantly higher in unsuitable liver transplant organs (discarded livers) [0401, 0402]. Wilson et al. further teach that a level or concentration of the proteins of the selected type below the reference level or predetermined value or comparable to the reference identity, level, activity and/or status provides indication of suitability of the transplant (clinical livers) ([0023-0034, 0138, 0190, 0236-0239, 0401, 0402]; Example 1).
Wilson et al. teach determining the identity, level, activity, and/or status of selected cell types such as Kupffer cells and dendritic cells expressing VCAM-1, liver sinusoidal cells (LESC) expressing ICAM-1 and VEGF-A in the liver perfusate sample by contacting the sample with antibodies that bind to VCAM-1, ICAM-1, and VEGF-A cell surface antigens and/or intracellular proteins on/in the liver Kupffer cells, DCs, and LSECs, and quantifying the cells that are bound to the antibodies [0138, 0152, 0153, 0167, 0169, 0241, 0245]. Wilson et al. show enriching and storing selected cell types from liver organ perfusate [0380-0383]. Wilson et al. further teach that determining the identity, level, activity, and/or status of selected cell types in the sample comprises quantification of proteins such as IL-2, IL-5, IL-7, IL-15, IL-12, IL-16, and IL-18, and their methylation (activation) status that indicate identity, level, activity and/or status of their corresponding cells [0138, 0152, 0153, 0169, 0241, 0245]. The method as taught by Wilson et al. comprises preparing the organ for transplant and transplanting the organ into a suitable recipient [0171, 0172].
Accordingly, Wilson et al. appears to read on Applicant’s claimed invention.
11. No claims are allowed.
Remarks
12. Prior art made of record are not relied upon but considered pertinent to the applicants' disclosure:
Watson et al. (From “Gut Feeling” to Objectivity: Machine Preservation of the Liver as a Tool to Assess Organ Viability. Current Transplantation Reports. 5: 72-81 (2018) IDS) teach that livers undergoing normothermic perfusion have been investigated using parameters similar to those used to evaluate liver in vivo for use in measuring organ viability (Abstract).
Yarmush et al. (US 2014/0030231) disclose a method for determining viability of an organ for transplant during or after Machine Perfusion (MP) comprising providing a sample perfusate from a liver organ; detecting whole cells from the liver; and determining the identity, level, activity, and/or status of hepatocytes (cells of a selected cell type) in the liver(Abstract; [0227, 0228, 0531, 0532].
Connolly et al. (In Hepatic Fibrosis, Liver Sinusoidal Endothelial Cells (LSEC) Acquire Enhanced Immunogenicity. The Journal of Immunology. J. Immunol., 185 (4): 2200-2208 (August 2010) IDS) teach that LSEC CD45-CD146+ cell surface phenotype makes ex vivo purification from bulk hepatic nonparenchymal cells (NPCs) feasible (Abstract; p. 2200).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GAILENE R. GABEL whose telephone number is (571)272-0820. The examiner can normally be reached Monday, Tuesday, and Thursday 5:30 AM to 4:00 PM.
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/GAILENE GABEL/Primary Examiner, Art Unit 1678
March 5, 2026