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 .
Claim Status
Claims 44-71 are pending.
Claims 44-71 are new pending
Claims 1-43 are cancelled.
Claims 44-71 have been examined.
Priority
This application is a CIP of 16/828,681 03/24/2020 ABN
16/828,681 is a CIP of 16/669,151 10/30/2019 ABN
16/669,151 is a CIP of 16/411,944 05/14/2019 ABN
16/411,944 is a DIV of 14/920,392 10/22/2015 PAT 10335452
14/920,392 has PRO 62/151,384 04/22/2015
14/920,392 has PRO 62/068,357 10/24/2014
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The prior art date of the instant claims is 11/25/2020 as the limitation of oxygen saturation is first disclosed in this instant application.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 2/17/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
Withdrawn Rejection
All rejections of record are withdrawn because all rejected claims have been cancelled.
New Ground of Rejection
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.
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.
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.
1. Claims 44-46, 48, 50-67, and 69-70 are rejected under 35 U.S.C. 103 as being unpatentable over Jamail et al. (US 2016/0113994 A1, previously cited 4/25/2023) in view of Boyer et al. (Journal of Hepatology. 2011; 55: 315-321, previously cited 11/7/2024), Rodriguez et al. (J Hepatol. 2014 May;60(5):955-61, previously cited 10/24/2023), NCT02770716 (Version 13, 2018-08-09), Lucassin (Ikaria, Inc. 2012, previously cited 10/24/2023), Wisniewski et al. (US 2016/0122386 A1, cited in PTO-892 dated 8/14/2025), and Alwadhi et al. (Indian Pediatr. 2017; 54: 729–734, previously cited 8/14/2025).
Claim 44 is drawn to a method of improving survival of a patient having type 1 hepatorenal syndrome (HRS-1) comprising
a) obtaining a serum creatinine (SCr) level< 5 mg/dl in the patient;
b) obtaining an acute-on-chronic liver failure (ACLF) grade < 3 in the patient;
c) administering a pharmaceutical composition comprising a dose of terlipressin to the patient until 24 hours after two consecutive SCr levels of ≤ 1.5 mg/dL are obtained from the patient two hours apart or for a maximum of 14 days;
d) monitoring the patient for fluid overload during administration of the pharmaceutical composition; and
e) monitoring the patient for oxygen saturation during the administration of the pharmaceutical composition using pulse oximetry;
wherein the patient with the SCr level < 5 mg/dl and the ACLF grade < 3 has reduced adverse events associated with terlipressin treatment than a patient with a SCr level ≥ 5 mg/dl and an ACLF grade ≥ 3. This wherein clause neither changes the structure or function of administered terlipressin nor adds a manipulated step to the claimed method. Thus, prior art references teach the steps (a) to (e) to administer terlipressin for treating a patient having type 1 hepatorenal syndrome (HRS-1) would be expected and/or necessary to meet the limitation of the wherein clause.
Jamail et al. teach method of treating patient with hepatorenal syndrome type I, HRS-1, (Title). Jamail et al. teach to avoid the unnecessary administration of drug to patients who are critically ill because of terlipressin is very effective in patients exhibiting certain criteria but is not effective in patients that do not meet this criteria. Possible warnings and precautions associated with terlipressin include ischemia. Ischemic events (cardiac, gastrointestinal, and skin) can occur following administration of terlipressin and may require temporary interruption, dose decrease, or permanent discontinuation. Since patients with HRS-1 are critically ill and terlipressin can have side-effects, to determine if a patient is likely to respond to terlipressin and only treating those patients can be extremely beneficial and even life-saving as terlipressin is known to be effective in 33-60% of HRS-1 patients. Jamail et al. teach adverse reaction in more than 10% patients included vomiting, abdominal pain, nausea, diarrhea, intestinal ischemia, dyspnea, sneezing, pulmonary edema and fluid overload known in the art. All conditions that could be severely detrimental to already fragile patients with HRS-1 [0022]. Thus, one of ordinary skill in the art would have found it obvious to (i) identify a patient likely to respond to terlipressin and only treat those selected patients expected to be beneficial and even life-saving with terlipressin as well as (ii) reduce the incidence of adverse events in critically ill HRS-1 patients associated with administered terlipressin by excluding patients unlikely to respond to terlipressin treatment, reading on a method of administering terlipressin to a selected patient population with hepatorenal syndrome and the method is capable of improving survival for the pre-selected patients by excluding patients unlikely to respond to terlipressin treatment.
Jamail et al. does not specify a patient with baseline serum creatinine < 5.0 mg/dl likely to respond to terlipressin treatment.
With respect to the limitation (a), Boyer et al. teach administration of terlipressin plus albumin is effective in reversing type 1 HRS as compared to albumin alone. However, only about 1 /3 of patients respond to treatment, therefore, predictors of response and survival would help identify the patients most likely to benefit from treatment (p315, col 1, Background & Aims), consistent with Jamail et al. [0022]. Boyer et al. teach the most consistent predictor of response to terlipressin and of survival is the baseline serum creatinine (SCr). Patients most likely to benefit from terlipressin have earlier onset renal failure with serum creatinine < 5.0 mg/dl (p315, col 1, Conclusions). Thus, one of ordinary skill in the art would have found it obvious to administer terlipressin only to a selected patient with baseline of SCr < 5.0 mg/dl.
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With respect to the limitation (b), Rodriguez et al. teach terlipressin and albumin is the standard of care for classical type-1 hepatorenal syndrome (HRS) not associated with active infections (p955, col 1, Background & Aims). Rodriguez et al. teach patients with associated severe ACLF (ACLF Grade = 3) are unlikely to respond to terlipressin treatment (p955, col 2, Conclusion; p960, col 2, para 4) shown as follows (p958, col 2, Table 3). Rodriguez et al. teach patients were carefully evaluated every day during treatment for early signs of side effects to terlipressin (p956, col 1, last para to col 2, para 1). Thus, one of ordinary skill in the art would have found it obvious to administer terlipressin only to a patient with baseline of ACLF grade < 3.
With respect to the limitation (c), Jamail et al. teach terlipressin dosage is 1 mg administered intravenously every 6 hours as a slow bolus injection over 2 minutes [0149]. Similarly, NCT02770716 teach IV administration of 1 ml terlipressin acetate via bolus injection (p7, Assigned Interventions). NCT02770716 teach HRS reversal defined as 2 consecutive SCr values ≤ 1.5 mg/dL at least 2 hours apart up to 14 days (p7, Primary Outcome Measures). Thus, one of ordinary skill in the art would administer terlipressin to the pre-selected patients with hepatorenal renal syndrome until reversal of HRS defined as 2 consecutive SCr values ≤ 1.5 mg/dL at least 2 hours apart taught by NCT02770716 up to 14 days.
With respect to the limitation (d), Jamail et al. teach intestinal ischemia and fluid overload are adverse events of terlipressin treatment [0022]. Similarly, Lucassin shows fluid overload is a common adverse event of terlipressin (p8, Table 2; p9, Table 3; p10, Table 4). LUCASSIN teaches patients were monitored for up to 180 days after administration of first dose (p3, para 2). LUCASSIN teaches closely monitoring electrolytes, fluid balance (reading fluid overload) and cardiovascular system to avoid adverse events and overdose of terlipressin (p11, last para to p12, para 1). Lucassin further teaches management of suspected adverse drug reactions may require temporary interruption and/or dose reduction (p11, Dosage and Administration, para 3). Thus, one of ordinary skill in the art would have found it obvious to closely monitoring the common adverse event of fluid overload during terlipressin treatment to avoid adverse events and overdose of terlipressin as taught by LUCASSIN.
With respect to the limitation (e), Jamail et al. teach possible warnings and precautions associated with terlipressin include ischemia. Ischemic events (cardiac, gastrointestinal, and skin) can occur following administration of terlipressin and may require temporary interruption, dose decrease, or permanent discontinuation [0022]. ). Lucassin further teaches (i) terlipressin should not be used in patients with unstable angina or recent acute myocardial infarction and (ii) ischaemic events (cardiac, gastrointestinal, and skin) have occurred following administration of terlipressin resulting in reducing blood supply to tissue causing tissue damage (defined as ischemia) and may require temporary interruption, dose decrease or permanent discontinuation of terlipressin (p6, Ischaemic Events). Lucassin further teaches terlipressin and other vasopressin analogues reduced blood flow to tissues resulting in tissue damage such as ischaemia in various tissues (p9, Table 3) due to hypoxia causing insufficient oxygen in body tissue and blood (p7, para 2) and further evidenced by Wisniewski et al. showing adverse events of hypoxia and ischemia as an adverse event of administering terlipressin known in the art [0020], consistent with Lucassin. Alwadhi et al. teach Oxygen saturation (SpO2) was measured by a pulse oximeter and a clinical predictor of hypoxia is SpO2 <90% (p729, col 1, Methods). Thus, one of ordinary skill in the art would have found it obvious to measure baseline of SpO2 and administer terlipressin only to a patient with baseline of SpO2 ≥ 90% to avoid terlipressin administration to a patient with hypoxia and/or ischemia as measured by pulse oximeter.
Because (I) Boyer et al. teach the most consistent predictor of response to terlipressin and of survival is the baseline serum creatinine (SCr). Patients most likely to benefit from terlipressin have earlier onset renal failure with serum creatinine < 5.0 mg/dl (p315, col 1, Conclusions) and (II) Rodriguez et al. teach patients with associated severe ACLF (ACLF Grade = 3) are unlikely to respond to terlipressin treatment (p955, col 2, Conclusion; p960, col 2, para 4; p958, col 2, Table 3), one of ordinary skill in the art would expect the pre-selected patient group (SCr level < 5 mg/dl and ACLF grade < 3) likely to respond to terlipressin treatment to reduce adverse events associated with terlipressin treatment than a patient with a SCr level ≥ 5 mg/dl and an ACLF grade ≥ 3.
One of ordinary skill in the art before the effective filing date of this invention would have found it obvious to combine (i) Jamail et al. and (ii) Boyer et al. in view of Rodriguez et al. and NCT02770716 because (a) Jamail et al. teach patients with HRS-1 are critically ill and terlipressin can have side-effects, to determine if a patient is likely to respond to terlipressin and only treating those patients can be extremely beneficial and even life-saving as terlipressin is known to be effective in 33-60% of HRS-1 patients [0022], (b) Boyer et al. teach patients most likely to benefit from terlipressin have earlier onset renal failure with serum creatinine < 5.0 mg/dl (p315, col 1, Conclusions), and (c) Rodriguez et al. teach patients with associated severe ACLF (ACLF Grade = 3) are unlikely to respond to terlipressin treatment (p955, col 2, Conclusion; p960, col 2, para 4; p958, col 2, Table 3). The combination would have reasonable expectation of success because all references teach administration of terlipressin to a pre-selected patient group likely to respond to terlipressin treatment. NCT02770716 is further cited to show terlipressin is capable of treating a patient with hepatorenal renal syndrome type 1 (HRS-1) and HRS-1 reversal is defined as 2 consecutive SCr values ≤ 1.5 mg/dL at least 2 hours apart up to 14 days (p7, Primary Outcome Measures).
One of ordinary skill in the art before the effective filing date of this invention would have found it obvious to combine (i) Jamail et al. in view of Boyer et al., Rodriguez et al. and NCT02770716 with (ii) Lucassin in view of Wisniewski et al. and Alwadhi et al. because (a) Jamail et al. in view of Boyer et al., Rodriguez et al. and NCT02770716 teach administration of terlipressin only to a pre-selected patient group likely to respond to terlipressin treatment to reduce risk of developing adverse events including fluid overload and ischemia, (b) Lucassin further teaches terlipressin and other vasopressin analogues reducing blood flow to tissues resulting in tissue damage such as ischaemia in various tissues (p9, Table 3) due to hypoxia causing insufficient oxygen in body tissue and blood (p7, para 2) and further evidenced by Wisniewski et al. showing adverse events of hypoxia and ischemia as a result of administering terlipressin known in the art [0020], and (c) Alwadhi et al. teach Oxygen saturation (SpO2) was measured by a pulse oximeter and a clinical predictor of hypoxia is SpO2 <90% (p729, col 1, Methods). The combination would have reasonable expectation of success because exclusion of administering terlipressin to a patient with oxygen saturation (SpO2 < 90%) measured by Alwadhi’s pulse oximetry would be expected to reduce the risk of developing hypoxia and/or ischaemia resulting from adverse events of terlipressin.
With respect to claims 45-46, both Jamil et al. [0022] and LUCASSIN (p8, Table 2; p9, Table 3; p10, Table 4) teach fluid overload as an adverse event of terlipressin treatment. Jamil et al. Jamil et al. teach if dosing was interrupted (reading on discontinuation) due to a non-ischemic adverse event, terlipressin may be restarted at the same or lower dose [0098]. Similarly, Lucassin teaches management of suspected adverse drug reactions may require temporary interruption (reading on discontinuation) and/or dose reduction (p11, Dosage and Administration, para 3).
With respect to claim 48, Jamil et al. teach patients treated with terlipressin or terlipressin and albumin [0085]. Rodriguez et al. teach terlipressin and albumin is the standard of care for classical type-1 hepatorenal syndrome (HRS) not associated with active infections (p955, col 1, Background & Aims).
With respect to claim 50, Lucassin teaches each vial of LUCASSIN contains 0.85 mg terlipressin free base in acetate salt reconstituted with 5 ml of 0.9% sodium chloride injection prior to use (p1, Description, para 1).
With respect to claims 51-52, Lucassin teaches adverse events of terlipressin comprising ischaemic events and respiratory effects (p7, Adverse Events) including ischaemia, respiratory failure, and fluid overload (p8, Table 2; p10, Table 4).
With respect to claim 53, see rejection of claim 44 above. In particular, NCT02770716 teach HRS reversal defined as 2 consecutive SCr values ≤ 1.5 mg/dL at least 2 hours apart up to 14 days (p7, Primary Outcome Measures). Thus, one of ordinary skill in the art would administer terlipressin to the pre-selected patients with hepatorenal renal syndrome until reversal of HRS defined as 2 consecutive SCr values ≤ 1.5 mg/dL 2 hours apart taught by NCT02770716.
With respect to claim 54, Jamail et al. teach a patient likely to respond to terlipressin treatment exhibits at least two of the following three criteria shown as follows [0025-0027].
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With respect to claims 55-56, Jamail et al. teach terlipressin administered intravenously every 6 hours as a slow bolus injection over 2 minutes [0149].
With respect to claim 57, Jamail et al. teach determining a baseline serum creatinine level for the first patient within 2 days prior to starting the administration of terlipressin [0051]. Boyer et al. teach the most consistent predictor of response to terlipressin and of survival is the baseline serum creatinine (SCr). Patients most likely to benefit from terlipressin have earlier onset renal failure with serum creatinine < 5.0 mg/dl (p315, col 1, Conclusions). Thus, one of ordinary skill in the art would have found it obvious to measure the baseline SCr of a patient and select a patient with baseline of SCr < 5.0 mg/dl, likely to respond to terlipressin treatment, for treatment.
With respect to claims 58-60, Jamail et al. teach if on day 4 of therapy (after a minimum of 10 doses), SCr had decreased, but by less than 30% from the baseline value, the dose may be increased [0098].
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With respect to claims 61-62, Jamail et al. teach discontinuation of terlipressin treatment if serum creatine has not diseased from the baseline SCr level [Fig 1, 0033, 0052] shown as follows.
With respect to claims 63-64, Jamail et al. teach the patient is continued for an additional 3 days to 12 days beyond the initial 4 days if the patient exhibits a decrease in the serum creatinine level. Jamail et al. teach decrease in the serum creatinine level may be at least 25% from baseline [0154], reading on decrease of SCr level more than 30% from the baseline.
With respect to claim 65, see rejection of claim 44 above. In particular, Lucassin teaches each vial of LUCASSIN contains 0.85 mg terlipressin free base in acetate salt reconstituted with 5ml of 0.9% sodium chloride injection prior to use (p1, Description, para 1). NCT02770716 teach HRS reversal defined as 2 consecutive SCr values ≤ 1.5 mg/dL at least 2 hours apart up to 14 days (p7, Primary Outcome Measures).
With respect to claims 66-67, both Jamil et al. [0022] and LUCASSIN (p8, Table 2; p9, Table 3; p10, Table 4) teach fluid overload as an adverse event of terlipressin treatment. Jamil et al. Jamil et al. teach if dosing was interrupted (reading on discontinuation) due to a non-ischemic adverse event, terlipressin may be restarted at the same or lower dose [0098]. Similarly, Lucassin teaches management of suspected adverse drug reactions may require temporary interruption (reading on discontinuation) and/or dose reduction (p11, Dosage and Administration, para 3).
With respect to claim 69, Jamil et al. teach patients treated with terlipressin or terlipressin and albumin [0085]. Rodriguez et al. teach terlipressin and albumin is the standard of care for classical type-1 hepatorenal syndrome (HRS) not associated with active infections (p955, col 1, Background & Aims).
With respect to claim 70, Jamil et al. teach Jamil et al. teach administering 1 gram albumin per 1 kg of patient weight up to a maximum of 100 g per day of albumin to a patient [00120].
Response to Arguments
Applicant's arguments filed 2/17/2026 have been fully considered but they are not persuasive because the arguments do not apply to the new ground of rejection described above.
2. Claims 44-48, 50-67, and 69-70 are rejected under 35 U.S.C. 103 as being unpatentable over Jamail et al. in view of Boyer et al., Rodriguez et al., NCT02770716, Lucassin, Wisniewski et al., and Alwadhi et al. as applied to claims 44-46, 48, 50-67, 69-70 and further in view of Mcpherson et al. (WO 2018/208684 A1).
Claims 47 and 68 are drawn to administration of diuretics to the patient suffering from fluid overload.
Jamail et al. in view of Lucassin teach pulmonary oedema and fluid overload resulting from adverse events of terlipressin treatment.
Jamail et al. in view of Boyer et al., Rodriguez et al., NCT02770716, Lucassin, Wisniewski et al., and Alwadhi et al. do not specify administration of diuretics to treat fluid overload.
Mcpherson et al. teach hospitalized fluid overload patients are typically treated with fluid restriction, IV diuretics, inotropes (e.g., milrinone or dobutamine) and combination therapies. The loop diuretic furosemide is the most frequently prescribed diuretic for treatment of volume overload in HF [0085], reading on claims 47 and 68.
One of ordinary skill in the art before the effective filing date of this invention would have found it obvious to combine (i) Jamail et al. in view of Boyer et al., Rodriguez et al., NCT02770716, Lucassin, Wisniewski et al., and Alwadhi et al. with (ii) Mcpherson et al. because (a) Jamail et al. in view of Lucassin teach pulmonary oedema and fluid overload resulting from adverse events of terlipressin treatment and (b) Mcpherson et al. teach hospitalized fluid overload patients are typically treated with fluid restriction, IV diuretics, inotropes (e.g., milrinone or dobutamine) and combination therapies. The loop diuretic furosemide is the most frequently prescribed diuretic for treatment of volume overload in HF [0085]. The combination would have reasonable expectation of success because Mcpherson et al. teach volume overload can be treated by a loop diuretic furosemide.
Response to Arguments
Applicant's arguments filed 2/17/2026 have been fully considered but they are not persuasive because the arguments do not apply to the new ground of rejection described above.
3. Claims 44-46, 48-49, 50-67, and 69-71 are rejected under 35 U.S.C. 103 as being unpatentable over Jamail et al. in view of Boyer et al., Rodriguez et al., NCT02770716, Lucassin, Wisniewski et al., and Alwadhi et al. as applied to claims 44-46, 48, 50-67, 69-70 and further in view of Pulimood et al. (Crit Care 2000, 4:151–155).
Claims 49 and 71 are drawn to discontinuation of albumin administration to a patient with adverse event of fluid overload.
Jamail et al. in view of Boyer et al., Rodriguez et al., NCT02770716, Lucassin, Wisniewski et al., and Alwadhi et al. teach administration of terlipressin and albumin to treat pre-selected patients with type 1 hepatorenal syndrome.
Jamail et al. in view of Boyer et al., Rodriguez et al., NCT02770716, Lucassin, Wisniewski et al., and Alwadhi et al. do not specify administration when to discontinue administration of albumin.
Pulimood et al. teach administration of albumin can result in fluid overload (p153, col 1, para 2) and further suggest death with albumin might be fluid overload (p154, col 2, para 1). Because albumin can cause fluid overload leading to death, one of ordinary skill in the art would have found it obvious to discontinue administration of albumin after the patient experiences fluid overload, reading on claims 49 and 71.
One of ordinary skill in the art before the effective filing date of this invention would have found it obvious to combine (i) Jamail et al. in view of Boyer et al., Rodriguez et al., NCT02770716, Lucassin, Wisniewski et al., and Alwadhi et al. with (ii) Pulimood et al. because (a) Jamail et al. in view of Boyer et al., Rodriguez et al., NCT02770716, Lucassin, Wisniewski et al., and Alwadhi et al. teach administration of terlipressin and albumin to treat pre-selected patients with type 1 hepatorenal syndrome and (b) Pulimood et al. teach administration of albumin can result in fluid overload (p153, col 1, para 2) and further suggest death with albumin might be fluid overload (p154, col 2, para 1). The combination would have reasonable expectation of success because discontinuation of albumin administration is able to eliminate albumin-mediated fluid overload and death in patients.
Response to Arguments
Applicant's arguments filed 2/17/2026 have been fully considered but they are not persuasive because the arguments do not apply to the new ground of rejection described above.
New Ground of Rejection
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 44-46, 48, 50-67, and 69-70 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 5-6 of U.S. Patent No. 10,335,452 B2 (the ‘452 patent) in view of Jamail et al., Boyer et al., Rodriguez et al., NCT02770716, Lucassin, Wisniewski et al., and Alwadhi et al.
Claim 1 of the ‘452 patent disclosed administration of an amount of terlipressin to treat type 1 hepatorenal syndrome.
Claims 5-6 of the ‘452 patent disclosed administered terlipressin in the range of about 0.5 mg to about 2.0 mg every 4 to 6 hours.
Claims 1 and 5-6 of the ‘452 patent do not teach measuring a baseline serum creatinine (SCr) level in the patient.
The relevancy of Jamail et al. in view of Boyer et al., Rodriguez et al., NCT02770716, Lucassin, Wisniewski et al., and Alwadhi et al. as applied to claims 44-46, 48, 50-67, and 69-70 described above not repeated here.
Because Jamail et al. in view of Boyer et al., Rodriguez et al., NCT02770716, Lucassin, Wisniewski et al., and Alwadhi et al. teach beneficial administration of terlipressin taught by claims 1 and 5-6 of the ‘452 patent to a pre-selected patient group likely to respond to terlipressin treatment, one of ordinary skill in the art would have found it obvious to combine claims 1 and 5-6 of the ‘452 patent and Jamail et al. in view of Boyer et al., Rodriguez et al., NCT02770716, Lucassin, Wisniewski et al., and Alwadhi et al.
Thus, claims 1 and 5-6 of the ‘452 patent in view of Jamail et al., Boyer et al., Rodriguez et al., NCT02770716, Lucassin, Wisniewski et al., and Alwadhi et al. are obvious to the instant claims 44-46, 48, 50-67, and 69-70.
Response to Arguments
Applicant's arguments filed 2/17/2026 have been fully considered but they are not persuasive because applicant’s request this rejection held in abeyance until all other rejections have been overcome does not overcome this ODP rejection of record.
Claims 44-71 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 55-57 of copending Application No. 17/340,765 (the ‘765 application, 3/24/2026) in view of Jamil et al., Lucassin, Rodriguez et al. and Boyer et al.
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Claim 53 of the ‘765 application disclosed a method of treating a pre-selected patient group with hepatorenal syndrome capable of increasing life expectancy of the treated pre-selected patients shown as follows.
Claim 53 of the ‘765 application did not specify the use of pulse oximetry to measure oxygenation saturation level (SpO2).
The relevancy of Jamail et al. in view of Boyer et al., Rodriguez et al., NCT02770716, Lucassin, Wisniewski et al., and Alwadhi et al. as applied to claims 44-46, 48, 50-67, and 69-70 described above not repeated here.
Because Jamail et al. in view of Boyer et al., Rodriguez et al., NCT02770716, Lucassin, Wisniewski et al., and Alwadhi et al. teach beneficial administration of terlipressin taught by claim 53 of the ‘765 application to a pre-selected patient group likely to respond to terlipressin treatment, one of ordinary skill in the art would have found it obvious to combine claim 53 of the ‘765 application and Jamail et al. in view of Boyer et al., Rodriguez et al., NCT02770716, Lucassin, Wisniewski et al., and Alwadhi et al.
Thus, claim 53 of the ‘765 application in view of Jamail et al., Boyer et al., Rodriguez et al., NCT02770716, Lucassin, Wisniewski et al., and Alwadhi et al. are obvious to the instant claims 44-46, 48, 50-67, and 69-70.
Claim 56 of the ‘765 application disclosed after the patient experiences fluid overload, administration of the albumin is discontinued, satisfying the instant claims 49 and 71.
Claim 57 of the ‘765 application disclosed after the patient experiences fluid overload, the patient is administered diuretics, satisfying the instant claims 47 and 68.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicant's arguments filed 2/17/2026 have been fully considered but they are not persuasive because applicant’s request this rejection held in abeyance until all other rejections have been overcome does not overcome this provisional ODP rejection of record.
Claims 44-46, 48, 50-67, and 69-70 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 23-24 of copending Application No. 17/587,442 (the ‘442 application, 9/30/2025) in view of Jamail et al., Boyer et al., Rodriguez et al., NCT02770716, Lucassin, Wisniewski et al., and Alwadhi et al.
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Claim 23 of ‘442 application disclosed a method of administering terlipressin for improving renal function shown as follows.
Claim 24 of the ‘442 application disclosed terlipressin administered every 6 hours.
Claims 23-24 of the ‘442 application did not teach administration of terlipressin to a pre-selected patient group with type 1 hepatorenal syndrome.
The relevancy of Jamail et al. in view of Boyer et al., Rodriguez et al., NCT02770716, Lucassin, Wisniewski et al., and Alwadhi et al. as applied to claims 44-46, 48, 50-67, and 69-70 described above not repeated here.
Because Jamail et al. in view of Boyer et al., Rodriguez et al., NCT02770716, Lucassin, Wisniewski et al., and Alwadhi et al. teach beneficial administration of terlipressin taught by claims 23-24 of the ‘442 application to a pre-selected patient group likely to respond to terlipressin treatment, one of ordinary skill in the art would have found it obvious to combine claims 23-24 of the ‘442 application and Jamail et al. in view of Boyer et al., Rodriguez et al., NCT02770716, Lucassin, Wisniewski et al., and Alwadhi et al.
Thus, claims 23-24 of the ‘442 application in view of Jamail et al., Boyer et al., Rodriguez et al., NCT02770716, Lucassin, Wisniewski et al., and Alwadhi et al. are obvious to the instant claims 44-46, 48, 50-67, and 69-70.
Response to Arguments
Applicant's arguments filed 2/17/2026 have been fully considered but they are not persuasive because applicant’s request this rejection held in abeyance until all other rejections have been overcome does not overcome this ODP rejection of record.
Claims 44-46, 48, 50-67, and 69-70 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 23-24 of copending Application No. PCT/US22/32511 (the ‘511 application, 6/7/2022) in view of Jamail et al., Boyer et al., Rodriguez et al., NCT02770716, Lucassin, Wisniewski et al., and Alwadhi et al.
Claim 1 of the ‘511 application disclosed a method of treating a patient with hepatorenal syndrome type 1 as follows.
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Claim 1 of the ‘511 application did not disclosed the use of pulse oximetry to measure oxygenation saturation level (SpO2).
The relevancy of Jamail et al. in view of Boyer et al., Rodriguez et al., NCT02770716, Lucassin, Wisniewski et al., and Alwadhi et al. as applied to claims 44-46, 48, 50-67, and 69-70 described above not repeated here.
Because Alwadhi et al. teach beneficial use of pulse oximetry to measure oxygenation saturation level (SpO2) and exclude a patient with SpO2 < 90% from terlipressin treatment to reduce the risk of developing adverse events of hypoxia and/or ischemia, one of ordinary skill in the art would have found it obvious to combine terlipressin taught by claim 1 of the ‘511 application in view of Jamail et al., Boyer et al., Rodriguez et al., NCT02770716, Lucassin, Wisniewski et al., and Alwadhi et al.
Thus, claim 1 of the ‘511 application in view of Jamail et al., Boyer et al., Rodriguez et al., NCT02770716, Lucassin, Wisniewski et al., and Alwadhi et al. are obvious to the instant claims 44-46, 48, 50-67, and 69-70.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicant's arguments filed 2/17/2026 have been fully considered but they are not persuasive because applicant’s request this rejection held in abeyance until all other rejections have been overcome does not overcome this provisional ODP rejection of record.
Claims 44-46, 48, 50-67, and 69-70 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 28 of copending Application No. 17/976,502 (the ‘502 application, 3/24/2026) in view of Jamil et al., Boyer et al., Rodriguez et al., NCT02770716, Lucassin, Wisniewski et al., and Alwadhi et al.
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Claim 28 of the ‘502 application disclosed a method of administer terlipressin to a patient having type 1 hepatorenal syndrome (HRS-1) for improving survival in a patient comprising the steps as follows.
Claim 28 of the ‘502 application did not disclosed the use of pulse oximetry to measure oxygenation saturation level (SpO2).
The relevancy of Jamail et al. in view of Boyer et al., Rodriguez et al., NCT02770716, Lucassin, Wisniewski et al., and Alwadhi et al. as applied to claims 44-46, 48, 50-67, and 69-70 described above not repeated here.
Because Alwadhi et al. teach beneficial use of pulse oximetry to measure oxygenation saturation level (SpO2) and exclude a patient with SpO2 < 90% from terlipressin treatment to reduce the risk of developing adverse events of hypoxia and/or ischemia, one of ordinary skill in the art would have found it obvious to combine terlipressin taught by claim 28 of the ‘502 application in view of Jamail et al., Boyer et al., Rodriguez et al., NCT02770716, Lucassin, Wisniewski et al., and Alwadhi et al.
Thus, claim 28 of the ‘502 application in view of Jamail et al., Boyer et al., Rodriguez et al., NCT02770716, Lucassin, Wisniewski et al., and Alwadhi et al. are obvious to the instant claims 44-46, 48, 50-67, and 69-70.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicant's arguments filed 2/17/2026 have been fully considered but they are not persuasive because applicant’s request this rejection held in abeyance until all other rejections have been overcome does not overcome this provisional ODP rejection of record.
Claims 44-46, 48, 50-67, and 69-70 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 9 and 19 of copending Application No. 17/976,606 (the ‘606 application, 3/24/2026) in view of Jamil et al., Boyer et al., Rodriguez et al., NCT02770716, Lucassin, Wisniewski et al., and Alwadhi et al.
Claim 9 of the ‘606 application disclosed a method for improving kidney function in an adult patient with hepatorenal syndrome with rapid reduction in kidney function as follows.
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Claim 19 of the ‘606 application disclosed the method further comprising monitoring the patient for intravascular volume overload during administration; reducing or discontinuing the administration of the dose of the composition if the patient has intravascular volume overload; and resuming the administration of the dose of the composition when the intravascular volume overload has improved.
Claims 9 and 19 of the ‘606 application do not teach measuring a baseline serum creatinine (SCr) level in the patient.
The relevancy of Jamail et al. in view of Boyer et al., Rodriguez et al., NCT02770716, Lucassin, Wisniewski et al., and Alwadhi et al. as applied to claims 44-46, 48, 50-67, and 69-70 described above not repeated here.
Because Jamail et al. in view of Boyer et al., Rodriguez et al., NCT02770716, Lucassin, Wisniewski et al., and Alwadhi et al. teach beneficially measuring a baseline serum creatinine, monitoring fluid overload and administering terlipressin to patients with ACLF Grade< 3 and the baseline SCr is < 5 mg/dl to improve treatment of type 1 hepatorenal syndrome, one of ordinary skill in the art would have found it obvious to combine claims 9 and 19 of the ‘606 application and Jamail et al. in view of Boyer et al., Rodriguez et al., NCT02770716, Lucassin, Wisniewski et al., and Alwadhi et al.
Thus, claims 9 and 19 of the ‘606 application in view of Jamail et al., Boyer et al., Rodriguez et al., NCT02770716, Lucassin, Wisniewski et al., and Alwadhi et al. are obvious to the instant claims 44-46, 48, 50-67, and 69-70.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicant's arguments filed 2/17/2026 have been fully considered but they are not persuasive because applicant’s request this rejection held in abeyance until all other rejections have been overcome does not overcome this provisional ODP rejection of record.
Claims 44-46, 48, 50-67, and 69-70 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 32 and 33 of copending Application No. 18/416,231 (the ‘231 application, 1/23/2026) in view of Jamil et al., Boyer et al., Rodriguez et al., NCT02770716, Lucassin, Wisniewski et al., and Alwadhi et al.
Claim 32 of the ‘231 application is drawn to a method comprising administering terlipressin to a pre-selected patient group with a baseline model end stage liver disease (MELD) score < 35, a serum creatinine (SCr)level < 5 mg/dL, an oxygenation level (SpO2) > 90%, and an acute-on-chronic liver failure (ACLF) Grade < 3.
Claim 33 of the ‘231 application is drawn to the administered composition comprising 1 mg terlipressin acetate.
Claims 32-33 of the ‘231 application did not disclosed the use of pulse oximetry to measure oxygenation saturation level (SpO2).
The relevancy of Jamail et al. in view of Boyer et al., Rodriguez et al., NCT02770716, Lucassin, Wisniewski et al., and Alwadhi et al. as applied to claims 44-46, 48, 50-67, and 69-70 described above not repeated here.
Because Alwadhi et al. teach beneficial use of pulse oximetry to measure oxygenation saturation level (SpO2) and exclude a patient with SpO2 < 90% from terlipressin treatment to reduce the risk of developing adverse events of hypoxia and/or ischemia, one of ordinary skill in the art would have found it obvious to combine terlipressin taught by claims 32-33 of the ‘231 application in view of Jamail et al., Boyer et al., Rodriguez et al., NCT02770716, Lucassin, Wisniewski et al., and Alwadhi et al.
Thus, claims 32-33 of the ‘231 application in view of Jamail et al., Boyer et al., Rodriguez et al., NCT02770716, Lucassin, Wisniewski et al., and Alwadhi et al. are obvious to the instant claims 44-46, 48, 50-67, and 69-70.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicant's arguments filed 2/17/2026 have been fully considered but they are not persuasive because applicant’s request this rejection held in abeyance until all other rejections have been overcome does not overcome this provisional ODP rejection of record.
Claims 44-46, 48, 50-67, and 69-70 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 17 of copending Application No. 18/431,587 (the ‘587 application, 10/13/2025) in view of Jamil et al., Boyer et al., Rodriguez et al., NCT02770716, Lucassin, Wisniewski et al., and Alwadhi et al.
Claim 17 of ‘587 application is shown as follows.
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Claim 17 of the ‘587 application do not teach monitoring the patient for fluid overload during administration of the terlipressin.
The relevancy of Jamail et al. in view of Boyer et al., Rodriguez et al., NCT02770716, Lucassin, Wisniewski et al., and Alwadhi et al. as applied to claims 44-46, 48, 50-67, and 69-70 described above not repeated here.
Because Jamail et al. in view of Boyer et al., Rodriguez et al., NCT02770716, Lucassin, Wisniewski et al., and Alwadhi et al. teach beneficially measuring a baseline serum creatinine, monitoring fluid overload and administering terlipressin to patients with ACLF Grade< 3 and the baseline SCr is < 5 mg/dl to improve treatment of type 1 hepatorenal syndrome, one of ordinary skill in the art would have found it obvious to combine claims 1 and 5 of the ‘587 application and Jamail et al. in view of Boyer et al., Rodriguez et al., NCT02770716, Lucassin, Wisniewski et al., and Alwadhi et al.
Thus, claim 17 of the ‘587 application in view of Jamail et al., Boyer et al., Rodriguez et al., NCT02770716, Lucassin, Wisniewski et al., and Alwadhi et al. are obvious to the instant claims 44-46, 48, 50-67, and 69-70.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicant's arguments filed 2/17/2026 have been fully considered but they are not persuasive because applicant’s request this rejection held in abeyance until all other rejections have been overcome does not overcome this provisional ODP rejection of record.
Claims 44-46, 48, 50-67, and 69-70 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 5-6 of copending Application No. 18/783,546 (the ‘546 application, 1/20/2026) in view of Jamil et al., Boyer et al., Rodriguez et al., NCT02770716, Lucassin, Wisniewski et al., and Alwadhi et al.
Claim 5 of the ‘546 application disclosed a method comprising administering terlipressin to treat a patient having hepatorenal syndrome and having at least two of the three systemic inflammatory response syndrome.
Claim 6 of the ‘546 application disclosed terlipressin administered by slow bolus injection over 2 minutes.
Claims 5-6 of the ‘546 application do not disclose administration of terlipressin to a pre-selected patient group with type 1 hepatorenal syndrome.
The relevancy of Jamail et al. in view of Boyer et al., Rodriguez et al., NCT02770716, Lucassin, Wisniewski et al., and Alwadhi et al. as applied to claims 44-46, 48, 50-67, and 69-70 described above not repeated here.
Because Jamail et al. in view of Boyer et al., Rodriguez et al., NCT02770716, Lucassin, Wisniewski et al., and Alwadhi et al. teach beneficial administration of terlipressin taught by claims 5-6 of the ‘546 application to a pre-selected patient group likely to respond to terlipressin treatment, one of ordinary skill in the art would have found it obvious to combine claims 5-6 of the ‘546 application and Jamail et al. in view of Boyer et al., Rodriguez et al., NCT02770716, Lucassin, Wisniewski et al., and Alwadhi et al.
Thus, claims 5-6 of the ‘546 application in view of Jamail et al., Boyer et al., Rodriguez et al., NCT02770716, Lucassin, Wisniewski et al., and Alwadhi et al. are obvious to the instant claims 44-46, 48, 50-67, and 69-70.
Response to Arguments
Applicant's arguments filed 2/17/2026 have been fully considered but they are not persuasive because applicant’s request this rejection held in abeyance until all other rejections have been overcome does not overcome this ODP rejection of record.
Claims 44-46, 48, 50-67, and 69-70 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 5-6 of copending Application No. 18/783,572 (the ‘572 application, 10/23/2025) in view of Jamil et al., Boyer et al., Rodriguez et al., NCT02770716, Lucassin, Wisniewski et al., and Alwadhi et al.
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Claim 13 of the ‘572 application is drawn to a method comprising administering terlipressin to a pre-selected patient group with hepatorenal syndrome shown as follows.
Claim 13 of the ‘572 application did not disclosed the use of pulse oximetry to measure oxygenation saturation level (SpO2).
The relevancy of Jamail et al. in view of Boyer et al., Rodriguez et al., NCT02770716, Lucassin, Wisniewski et al., and Alwadhi et al. as applied to claims 44-46, 48, 50-67, and 69-70 described above not repeated here.
Because Alwadhi et al. teach beneficial use of pulse oximetry to measure oxygenation saturation level (SpO2) and exclude a patient with SpO2 < 90% from terlipressin treatment to reduce the risk of developing adverse events of hypoxia and/or ischemia, one of ordinary skill in the art would have found it obvious to combine terlipressin taught by claim 13 of the ‘572 application and Jamail et al. in view of Boyer et al., Rodriguez et al., NCT02770716, Lucassin, Wisniewski et al., and Alwadhi et al.
Thus, claim 13 of the ‘572 application in view of Jamail et al., Boyer et al., Rodriguez et al., NCT02770716, Lucassin, Wisniewski et al., and Alwadhi et al. are obvious to the instant claims 44-46, 48, 50-67, and 69-70.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicant's arguments filed 2/17/2026 have been fully considered but they are not persuasive because applicant’s request this rejection held in abeyance until all other rejections have been overcome does not overcome this provisional ODP rejection of record.
Claims 44-46, 48, 50-67, and 69-70 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 22 of copending Application No. 19/213,363 (the ‘363 application, 12/22/2025) in view of Jamil et al., Boyer et al., Rodriguez et al., NCT02770716, Lucassin, Wisniewski et al., and Alwadhi et al.
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Claim 22 of the ‘363 application did not disclosed the use of pulse oximetry to measure oxygenation saturation level (SpO2).
The relevancy of Jamail et al. in view of Boyer et al., Rodriguez et al., NCT02770716, Lucassin, Wisniewski et al., and Alwadhi et al. as applied to claims 44-46, 48, 50-67, and 69-70 described above not repeated here.
Because Alwadhi et al. teach beneficial use of pulse oximetry to measure oxygenation saturation level (SpO2) and exclude a patient with SpO2 < 90% from terlipressin treatment to reduce the risk of developing adverse events of hypoxia and/or ischemia, one of ordinary skill in the art would have found it obvious to combine terlipressin taught by claim 22 of the ‘363 application and Jamail et al. in view of Boyer et al., Rodriguez et al., NCT02770716, Lucassin, Wisniewski et al., and Alwadhi et al.
Thus, claim 22 of the ‘363 application in view of Jamail et al., Boyer et al., Rodriguez et al., NCT02770716, Lucassin, Wisniewski et al., and Alwadhi et al. are obvious to the instant claims 44-46, 48, 50-67, and 69-70.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicant's arguments filed 2/17/2026 have been fully considered but they are not persuasive because applicant’s request this rejection held in abeyance until all other rejections have been overcome does not overcome this provisional ODP rejection of record.
Claims 44-46, 48, 50-67, and 69-70 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 19/244,769 (the ‘769 application, 6/30/2025) in view of Jamil et al., Boyer et al., Rodriguez et al., NCT02770716, Lucassin, Wisniewski et al., and Alwadhi et al.
Claim 1 of the ‘769 application disclosed a formulation of terlipressin acetate.
Claim 1 of the ‘769 application did not disclosed administration of terlipressin to treat a patient with hepatorenal syndrome.
The relevancy of Jamail et al. in view of Boyer et al., Rodriguez et al., NCT02770716, Lucassin, Wisniewski et al., and Alwadhi et al. as applied to claims 44-46, 48, 50-67, and 69-70 described above not repeated here.
Because Jamail et al. in view of Boyer et al., Rodriguez et al., NCT02770716, Lucassin, Wisniewski et al., and Alwadhi et al. teach beneficially measuring a baseline serum creatinine, monitoring fluid overload and administering terlipressin to patients with ACLF Grade< 3 and the baseline SCr is < 5 mg/dl to improve treatment of type 1 hepatorenal syndrome, one of ordinary skill in the art would have found it obvious to combine claim 1 of the ‘769 application and Jamail et al. in view of Boyer et al., Rodriguez et al., NCT02770716, Lucassin, Wisniewski et al., and Alwadhi et al.
Thus, claim 1 of the ‘769 application in view of Jamail et al., Boyer et al., Rodriguez et al., NCT02770716, Lucassin, Wisniewski et al., and Alwadhi et al. are obvious to the instant claims 44-46, 48, 50-67, and 69-70.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicant's arguments filed 2/17/2026 have been fully considered but they are not persuasive because applicant’s request this rejection held in abeyance until all other rejections have been overcome does not overcome this provisional ODP rejection of record.
Claims 44-46, 48, 50-67, and 69-70 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 19/244,777 (the ‘777 application, 6/30/2025) in view of Jamil et al., Boyer et al., Rodriguez et al., NCT02770716, Lucassin, Wisniewski et al., and Alwadhi et al.
Claim 1 of the ‘777 application disclosed a formulation of terlipressin acetate.
Claim 1 of the ‘777 application did not disclosed administration of terlipressin to treat a patient with hepatorenal syndrome.
The relevancy of Jamail et al. in view of Boyer et al., Rodriguez et al., NCT02770716, Lucassin, Wisniewski et al., and Alwadhi et al. as applied to claims 44-46, 48, 50-67, and 69-70 described above not repeated here.
Because Jamail et al. in view of Boyer et al., Rodriguez et al., NCT02770716, Lucassin, Wisniewski et al., and Alwadhi et al. teach beneficially measuring a baseline serum creatinine, monitoring fluid overload and administering terlipressin to patients with ACLF Grade< 3 and the baseline SCr is < 5 mg/dl to improve treatment of type 1 hepatorenal syndrome, one of ordinary skill in the art would have found it obvious to combine claim 1 of the ‘777 application and Jamail et al. in view of Boyer et al., Rodriguez et al., NCT02770716, Lucassin, Wisniewski et al., and Alwadhi et al.
Thus, claim 1 of the ‘777 application in view of Jamail et al., Boyer et al., Rodriguez et al., NCT02770716, Lucassin, Wisniewski et al., and Alwadhi et al. are obvious to the instant claims 44-46, 48, 50-67, and 69-70.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicant's arguments filed 2/17/2026 have been fully considered but they are not persuasive because applicant’s request this rejection held in abeyance until all other rejections have been overcome does not overcome this provisional ODP rejection of record.
Conclusion
No claim is allowed.
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.
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/J.L/Examiner, Art Unit 1658
15-April-2026
/Melissa L Fisher/ Supervisory Patent Examiner, Art Unit 1658
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