Prosecution Insights
Last updated: April 19, 2026
Application No. 17/907,395

PROGNOSTIC MARKERS OF DISEASE RECURRENCE IN LIVER TRANSPLANT RECIPIENTS WITH HEPATOCELLULAR CARCINOMA

Non-Final OA §103§DP
Filed
Sep 26, 2022
Examiner
FRITCHMAN, REBECCA M
Art Unit
1758
Tech Center
1700 — Chemical & Materials Engineering
Assignee
UNIVERSITEIT GENT
OA Round
3 (Non-Final)
46%
Grant Probability
Moderate
3-4
OA Rounds
4y 6m
To Grant
82%
With Interview

Examiner Intelligence

Grants 46% of resolved cases
46%
Career Allow Rate
294 granted / 642 resolved
-19.2% vs TC avg
Strong +36% interview lift
Without
With
+35.9%
Interview Lift
resolved cases with interview
Typical timeline
4y 6m
Avg Prosecution
94 currently pending
Career history
736
Total Applications
across all art units

Statute-Specific Performance

§101
10.9%
-29.1% vs TC avg
§103
50.4%
+10.4% vs TC avg
§102
8.4%
-31.6% vs TC avg
§112
23.7%
-16.3% vs TC avg
Black line = Tech Center average estimate • Based on career data from 642 resolved cases

Office Action

§103 §DP
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 Summary This is the Non-Final Office Action based on application 17/907395 RCE filed 12/02/2025. Claims 1-12 & 21-28 have been examined and fully considered. Claims 13-20 have been cancelled. Claims 21-28 have been newly added. Continued Examination Under 37 CFR 1.114 A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/02/2025 has been entered. 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 1-12 & 21-28 are rejected on the ground of non-statutory double patenting as being unpatentable over claims 1-5 & 13 of U.S. Patent No. 10571462 in view of VERHELST and DECAENS and VERHELST 2 as shown in the below rejections. US Patent No.10571462 claims a process of selecting a liver graft for transplantation, the process comprising: determining the amount of N-glycan asialo-agalacto-fucosylated biantennary oligosaccharide (NGA2F) and/or N-Glycan agalactosylated, core-α-1,6-fucosylated bisecting biantennary oligosaccharide (NGA2FB) and/or the N-glycan mono galactosylated, core-α-1,6-fucosylated biantennary oligosaccharide (NG1A2F) in a perfusate from the liver graft, comparing the amount of NGAF2 and/or NGAF2B and/or NG1A2F with the amount of NGAF2 and/or NGAF2B and/or NG1A2F in a perfusate from a control liver graft that is a liver graft that, after transplantation, does not result in primary non-function, and selecting the liver graft for transplantation, wherein the selected liver does not have an increased amount of NGAF2 and/or NGAF2B and/or NG1A2F in comparison to the amount determined in the control liver graft, respectively. US Patent No.10571462 does not teach of detecting hepatocellular carcinoma recurrence following liver transplantation, however does claim all of the same associated biomarkers for liver disease and management of a transplantation (liver graft). Further- VERHELST in view of DECAENS is used to remedy this and make this obvious. VERHELST teaches of a method of detecting and studying glycome patterns of perfusate in livers before transplantation that are associated with primary nonfunction- which is a rate complication after liver transplantation that requires urgent re-transplantation (Page 1362, column 1, lines 1-3). Specifically, VERHELST teaches of detecting N-glycans which include NGA2F, NGA2FB, NA3, agalacto, and NA3Fbc as biomarkers (Page 1363, Figure 1 and description thereof). Though VERHELST teaches of focusing on using a perfusate sample, they teach of measuring the N- glycans also in serum (Page 1365, column 1, paragraph 1 & column 2, paragraph 5, line 1). VERHELST further teaches of measuring the N-glycans by multi-capillary electrophoresis and of comparing the glycan patterns between patients with versus without PNF (primary nonfunction-which again requires urgent re-transplantation) (the without group is the control group which is compared to) of transplanted livers (Page 1362, column 1, last 3 lines). VERHELST further teaches of measuring the N-glycans by multi-capillary electrophoresis- based ABI3130 sequencer (Page 1362, column 1, last 3 lines). VERHELST further teaches of measuring the N-glycans by DNA sequencer-assisted fluorophore assisted capillary electrophoresis- based ABI3130 sequencer (Page 1365, column 1, paragraph 1, first 3 lines). VERHELST further teaches of performing liver transplantation for patients with hepatocellular carcinoma (Page 1362, column 1, line 3). It would have been obvious to one of ordinary skill to determine liver transplant recurrence using the markers in VERHELST in US Patent No.10571462 since it is known to be a negative issue in the art (VERHELST, abstract). Though VERHELST teaches does teach the obviousness of using serum samples as claimed for the glycans, however if this is not apparent, another reference is used to remedy. Nor does VERHELST specifically call out recurrence of the specifically claimed liver cancer—but instead it calls out necessity for the re-transplantation after one transplantation of the liver. DECAENS is used to remedy this. DECAENS teaches of a method of determining blood (which includes serum) derived biomarkers for predicting tumor recurrence after liver transplantation (method and results). It would have been obvious to one of ordinary skill in the art to determine if the patient would have recurrence of cancer and need transplant again since hepatocellular cancer is the leading etiology for liver transplantation and due to the advantage this would offer for assessing risk factors (Background and Aims & Aim section). VERHELST 2 teaches of a method of measuring an N-glycome profile in serum by capillary electrophoresis (abstract). VERHELST 2 further teaches of the sample being a pre-transplant serum sample (since some patients got liver transplant post measurement so this can be considered pre-transplant in the liver recipient) (Page 2755, Figure 4 description & column 2, paragraph 3). It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention and one would have had reasonable expectation of success in measuring a serum sample in a pre-transplantation patient as is done in VERHELST 2 in the methods of VERHELST an DECAENS due to the advantages this offers for providing a successful outcome and in that it is cost effective and shows reduction in mortality rates (VERHELST 2, Page 2750, column 2, 8 lines from bottom). 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 non-obviousness. 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 1-12 & 21-28 are rejected under 35 U.S.C. 103 as being obvious over VERHELST in Glycome Patterns of Perfusate in Livers Before Transplantation Associate with Primary Nonfunction (as cited on IDS dated 09/28/2022) in view of DECAENS in Factors associated with tumor recurrence after liver transplantation for hepatocellular carcinoma (as cited on IDS dated 09/28/2022) and further in view of VERHELST 2 in A Glycomics-Based Test Predicts the Development of Hepatocellular Carcinoma in Cirrhosis (as cited on IDS 09/28/2022). With respect to Claims 1, VERHELST teaches of a method of detecting and studying glycome patterns of perfusate in livers before/pre-transplantation that are associated with primary nonfunction- which is a rate complication after liver transplantation that requires urgent re-transplantation (Page 1362, column 1, lines 1-3). Specifically, VERHELST teaches of detecting N-glycans which include NGA2F, NGA2FB, NA3, agalacto, and NA3Fbc as biomarkers (Page 1363, Figure 1 and description thereof). Though VERHELST teaches of focusing on using a perfusate sample, they teach of measuring the N- glycans also in serum (Page 1365, column 1, paragraph 1 & column 2, paragraph 5, line 1). VERHELST further teaches of measuring the N-glycans by multi-capillary electrophoresis and of comparing the glycan patterns between patients with versus without PNF (primary nonfunction-which again requires urgent re-transplantation) (the without group is the control group which is compared to) of transplanted livers (Page 1362, column 1, last 3 lines). VERHELST further teaches of performing liver transplantation for patients with hepatocellular carcinoma (Page 1362, column 1, line 3). Though VERHELST teaches does teach the obviousness of using serum samples as claimed for the glycans, however if this is not apparent, another reference is used to remedy. Nor does VERHELST specifically call out recurrence of the specifically claimed liver cancer—but instead it calls out necessity for the re-transplantation after one transplantation of the liver. DECAENS is used to remedy this. DECAENS teaches of a method of determining blood (which includes serum) derived biomarkers for predicting tumor recurrence after liver transplantation (method and results). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention and one would have had reasonable expectation of success to determine if the patient would have recurrence of cancer and need transplant again since hepatocellular cancer is the leading etiology for liver transplantation and due to the advantage this would offer for assessing risk factors (Background and Aims & Aim section). Since VERHELST in view of DECAENS teach of measurement of the claimed biomarkers in perfusate pre-transplantation, and also teach of measurement in serum, this makes measurement of pre-transplantation serum obvious to one of ordinary skill. If this is not apparent to one of ordinary skill in the art however, VERHELST 2 is used to remedy. VERHELST 2 teaches of a method of measuring an N-glycome profile in serum by capillary electrophoresis (abstract). VERHELST 2 further teaches of the sample being a pre-transplant serum sample (since some patients got liver transplant post measurement so this can be considered pre-transplant in the liver recipient) (Page 2755, Figure 4 description & column 2, paragraph 3). It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention and one would have had reasonable expectation of success in measuring a serum sample in a pre-transplantation patient as is done in VERHELST 2 in the methods of VERHELST an DECAENS due to the advantages this offers for providing a successful outcome and in that it is cost effective and shows reduction in mortality rates (VERHELST 2, Page 2750, column 2, 8 lines from bottom). With respect to Claim 2, VERHELST teaches of detecting N-glycans which include NGA2F, NGA2FB, NA3, agalacto, NA3Fbc and NA3Fc as biomarkers (Page 1363, Figure 1 and description thereof). Though VERHELST teaches of focusing on using a perfusate sample, they teach of measuring the N- glycans also in serum (Page 1365, column 1, paragraph 1 & column 2, paragraph 5, line 1). VERHELST further teaches of measuring the N-glycans by multi-capillary electrophoresis and of comparing the glycan patterns between patients with versus without PNF (primary nonfunction-which again requires urgent re-transplantation) (the without group is the control group which is compared to) of transplanted livers (Page 1362, column 1, last 3 lines). VERHELST further teaches of monitoring the levels of these compounds in comparison to a control to indicate positive or negative prediction of cancer reoccurrence (Figure 1, associated description, See Tables 2 & 3 for statistical analysis and results). This makes the instant claims obvious. With respect to Claim 3, VERHELST further teaches of measuring the N-glycans by multi-capillary electrophoresis (Page 1362, column 1, last 3 lines). With respect to Claim 4, VERHELST further teaches of measuring the N-glycans by multi-capillary electrophoresis- based ABI3130 sequencer (Page 1362, column 1, last 3 lines). VERHELST further teaches of measuring the N-glycans by DNA sequencer-assisted fluorophore assisted capillary electrophoresis- based ABI3130 sequencer (Page 1365, column 1, paragraph 1, first 3 lines). With respect to Claim 6, VERHELST further teaches of measuring the N-glycans by multi-capillary electrophoresis (Page 1362, column 1, last 3 lines). With respect to Claim 7, VERHELST further teaches of measuring the N-glycans by multi-capillary electrophoresis- based ABI3130 sequencer (Page 1362, column 1, last 3 lines). VERHELST further teaches of measuring the N-glycans by DNA sequencer-assisted fluorophore assisted capillary electrophoresis- based ABI3130 sequencer (Page 1365, column 1, paragraph 1, first 3 lines). With respect to Claims 5 & 8-12, VERHELST teaches that some patients have no PNF (primary nonfunction which requires urgent re-transplantation) (Table 1). VERHELDST does not teach of the patients not having recurrence of hepatocellular cancer. DECAENS is used to remedy this and it teaches that only 11.56 % of transplanted livers/patients with them had tumors/cancer come back meaning that 100-11.56 percent of the patients with transplants did not have the tumors/cancer come back. DECAENS further teaches of the transplant occurring in the patients (Page S200, column 2, line 14). It would have been obvious to one of ordinary skill in the art to determine if the patient would have recurrence of cancer and need transplant again, and perform the transplant, since hepatocellular cancer is the leading etiology for liver transplantation and due to the advantage this would offer for assessing risk factors (Background and Aims & Aim section). With respect to Claim 21, VERHELST teaches of detecting N-glycans which include NGA2F, NGA2FB, NA3, agalacto, and NA3Fbc as biomarkers (Page 1363, Figure 1 and description thereof). VERHELST further teaches of measuring the N-glycans by multi-capillary electrophoresis and of comparing the glycan patterns between patients with versus without PNF (primary nonfunction-which again requires urgent re-transplantation) (the without group is the control group which is compared to) of transplanted livers (Page 1362, column 1, last 3 lines). VERHELST further teaches of monitoring the levels of these compounds in comparison to a control to indicate positive or negative prediction of cancer reoccurrence (Figure 1, associated description, See Tables 2 & 3 for statistical analysis and results). Further VERHELST teaches of comparison/comparing to determine whether the levels of these biomarkers are different in that they are increased or decreased (determination of an increase, also teaches of determining if there is an increase or decrease) in comparison to a control (Page 1361, column 1, results & Tables 2 & 3). This makes the instant claims obvious. With respect to Claim 22, VERHELST teaches of detecting N-glycans which include NGA2F, NGA2FB, NA3, agalacto, and NA3Fbc as biomarkers (Page 1363, Figure 1 and description thereof). Though VERHELST teaches of focusing on using a perfusate sample, they teach of measuring the N- glycans also in serum (Page 1365, column 1, paragraph 1 & column 2, paragraph 5, line 1). With respect to Claim 23, VERHELST further teaches of measuring the N-glycans by multi-capillary electrophoresis and of comparing the glycan patterns between patients with versus without PNF (primary nonfunction-which again requires urgent re-transplantation) (the without group is the control group which is compared to) of transplanted livers (Page 1362, column 1, last 3 lines). With respect to Claim 24, VERHELST further teaches of measuring the N-glycans by multi-capillary electrophoresis- based ABI3130 sequencer (Page 1362, column 1, last 3 lines). VERHELST further teaches of measuring the N-glycans by DNA sequencer-assisted fluorophore assisted capillary electrophoresis- based ABI3130 sequencer (Page 1365, column 1, paragraph 1, first 3 lines). With respect to Claim 25, VERHELST teaches of detecting N-glycans which include NGA2F, NGA2FB, NA3, agalacto, and NA3Fbc as biomarkers (Page 1363, Figure 1 and description thereof). This reads on a glycan profile. Though VERHELST teaches of focusing on using a perfusate sample, they teach of measuring the N- glycans also in serum (Page 1365, column 1, paragraph 1 & column 2, paragraph 5, line 1). With respect to Claim 26, VERHELST further teaches of measuring the N-glycans by multi-capillary electrophoresis- based ABI3130 sequencer (Page 1362, column 1, last 3 lines). VERHELST further teaches of measuring the N-glycans by DNA sequencer-assisted fluorophore assisted capillary electrophoresis- based ABI3130 sequencer (Page 1365, column 1, paragraph 1, first 3 lines). To perform the detection, VERHELST performs on-membrane deglycosylation- which reads on the instantly claimed “releasing,” of the n-glycans (Page 1363, column 2, paragraph 1, lines 4-5 & also paragraph 1, lines 9-11) and then they are labeled with 8-aminopyrene-1,3,6-trisulphonic acid (paragraph 1, lines 11-13), and then separated by the multi-capillary electrophoresis based sequencer (paragraph 1, lines 19-22). With respect to Claim 27, VERHELST teaches of detecting N-glycans which include NGA2F, NGA2FB, NA3, agalacto, and NA3Fbc as biomarkers (Page 1363, Figure 1 and description thereof). To perform the detection, VERHELST performs on-membrane deglycosylation- which reads on the instantly claimed “releasing,” of the n-glycans (Page 1363, column 2, paragraph 1, lines 4-5). With respect to Claim 28, VERHELST teaches of detecting N-glycans which include NGA2F, NGA2FB, NA3, agalacto, and NA3Fbc as biomarkers (Page 1363, Figure 1 and description thereof). This reads on a glycan profile. Though VERHELST teaches of focusing on using a perfusate sample, they teach of measuring the N- glycans also in serum (Page 1365, column 1, paragraph 1 & column 2, paragraph 5, line 1). Response to Arguments Applicant's arguments filed 12/02/2025 have been fully considered but they are not persuasive. With respect to the Double Patenting rejection, applicant argues that the Callewaert patent is expired. The examiner see this, so this rejection with respect to the double patenting rejection with respect to U.S. 7,335,512 is dropped. The examiner notes that this reference could still be used as prior art in the future. Applicant argues with respect to the VLIERBERGHE patent, 10, 571, 462 and therefore. This rejection remains on the record as well. Applicant notes that this patent is specific to PNF and not claim measuring in pre-transplant serum. The examiner sees these differences, but has maintained the rejection for the time being, as will review to see if this is the case if/when the application moves to allowance. With respect to the prior 112 rejections, amendments dated 12/02/2025 have overcome them. With respect to the prior art, applicant argues makes arguments A-G. Argument A is that the Verhelst reference concerns perfusate glycomics and predicts primary nonfunction, not recipient serum or recurrence. The examiner disagrees. First of all the examiner notes that due to the instantly made amendments, another prior art reference was added, VERHELST 2 as shown above. This reference reads on the serum sample claimed--- though the examiner maintains that the first Verhelst reference still makes this obvious as shown in the rejection above. Further the examiner notes that what the method “predicts,” is no longer commensurate in scope with the claims, as the instant claims do not predict anything, but instead are a method of measuring. Argument B is that Verhelst teaches the opposite biomarker relationship. With respect to this, the examiner disagrees and maintains that especially as claimed—wherein it is not required that an increased level actually be detected. As claimed it is only required that one look to see if the biomarkers are increased or decreased and this does in fact happen in Verhelst. Specifically, Verhelst teaches of comparison/comparing to determine whether the levels of these biomarkers are different in that they are increased or decreased (determination of an increase, also teaches of determining if there is an increase or decrease) in comparison to a control (Page 1361, column 1, results & Tables 2 & 3). This makes the instant claims obvious. Argument C is that Decaens does not supply the missing element. The examiner disagrees with this, but again notes that another reference Verhelst 2 is also used herein, which teaches of what applicant calls the missing element---though the examiner maintains that it is made obvious by the first two references. Specifically, VERHELST teaches does teach the obviousness of using serum samples as claimed for the glycans, however if this is not apparent, another reference is used to remedy. Nor does VERHELST specifically call out recurrence of the specifically claimed liver cancer—but instead it calls out necessity for the re-transplantation after one transplantation of the liver. DECAENS is used to remedy this. DECAENS teaches of a method of determining blood (which includes serum) derived biomarkers for predicting tumor recurrence after liver transplantation (method and results). Argument D is that there is no motivation to combine and that there is hindsight reconstruction in the rejection. The examiner disagrees. It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention and one would have had reasonable expectation of success in measuring a serum sample in a pre-transplantation patient as is done in VERHELST 2 in the methods of VERHELST an DECAENS due to the advantages this offers for providing a successful outcome and in that it is cost effective and shows reduction in mortality rates (VERHELST 2, Page 2750, column 2, 8 lines from bottom). Just because the examiners reason for combination might differ from what applicant may do, does not mean it’s not a reason for combination. In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). With respect to this--- the examiner maintains that their judgement was made only using the level of one of ordinary skill. Argument E is that there is no reasonable expectation of success. Applicant argues that this is the case since they think there is a missing element, since Verhelst focuses their methods on perfusate and not serum. The examiner maintains that though perfusate might be the focus for the n-glycan analysis in Verhelst, the word serum is used about 20 times throughout the reference, therefore making using it obvious for this reason. Further- the examiner notes again that a third reference, Verhelst 2 was used which also teaches of detection in serum. Argument F is that strong unexpected results support non-obviousness. With respect to this applicant is arguing subject matter which is not in the claims. Applicant argues that the unexpected result is that decreased NGA2F and NGA2FB in recipients who experienced recurrence, in combination with increased NA3, NA3Fbc, and NA3Fc. Further applicant argues that this pattern was not predictable from any prior art. With respect to this, the examiner notes that applicant does not claim this so is not convinced and this argument is not commensurate in scope with the claims. What applicant is arguing seems to be more of a scientific discovery than a patent eligible claim. The examiner notes that what is claimed is a method of measuring the level of the claimed biomarkers and determining if they are increased or decreased in comparison to a control. The prior art references absolutely make what is claimed obvious. What is claimed is not unexpected or surprising, but instead is made obvious by the prior art. Argument G is that the examiner’s concessions confirm the art does not teach of the claimed invention. The examiner disagrees with this. The examiner only added a secondary and third reference to clear up the record on what prior art is out there. No concessions are made. It is unfortunate that most of the prior art used is by the instant inventor, however it remains applicable prior art. Applicant suggested in their comments having an interview with the examiner if the filed application 12/02/2025 is not successful in reaching allowance. The examiner is happy to hold such interview if applicant would like to suggest further amendments after receival of this office action and if applicant thinks it will help forward prosecution. All claims remain rejected. Conclusion The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US 7,335,512. Any inquiry concerning this communication or earlier communications from the examiner should be directed to REBECCA M FRITCHMAN whose telephone number is (303)297-4344. The examiner can normally be reached 9:30-4:30 MT Monday-Friday. 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, Maris Kessel can be reached on 571-270-7698. 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. /REBECCA M FRITCHMAN/Primary Examiner, Art Unit 1758
Read full office action

Prosecution Timeline

Sep 26, 2022
Application Filed
Jun 06, 2025
Non-Final Rejection — §103, §DP
Sep 09, 2025
Response Filed
Sep 22, 2025
Final Rejection — §103, §DP
Nov 17, 2025
Response after Non-Final Action
Dec 02, 2025
Request for Continued Examination
Dec 03, 2025
Response after Non-Final Action
Dec 13, 2025
Non-Final Rejection — §103, §DP (current)

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Study what changed to get past this examiner. Based on 5 most recent grants.

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Prosecution Projections

3-4
Expected OA Rounds
46%
Grant Probability
82%
With Interview (+35.9%)
4y 6m
Median Time to Grant
High
PTA Risk
Based on 642 resolved cases by this examiner. Grant probability derived from career allow rate.

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