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
This office action is in response to Applicant’s reply filed on March 6, 2026.
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Status of Claims
Amendment of claims 1 and 71 is acknowledged.
Claims 1, 5, 9-10, 13, 20-24, 27-33, 37-38, 42-44, 48, 50, 52, 58-61, 63 and 65-68 and 71 are currently pending and are the subject of this office action.
Claim 9-10, 13, 20, 32-33, 37-38, 42-44 and 65-68 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on July 18, 2023.
Claims 1, 5, 21-24, 27-31, 48, 50, 52, 58-61, 63 and 71 are presently under examination.
Priority
The present application claims priority to provisional application No. 63/315,762 filed on 03/02/2022 and 63/276,480 filed on 11/05/2021.
Rejections and/or Objections and Response to Arguments
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated (Maintained Rejections and/or Objections) or newly applied (New Rejections and/or Objections, Necessitated by Amendment or New Rejections and/or Objections not Necessitated by Amendment). They constitute the complete set presently being applied to the instant application.
Responses to Applicant’s arguments have been addressed immediately after the corresponding rejections, or in the section: Withdrawn Rejections and/or Objections, if the rejection was withdrawn.
Claim Rejections - 35 USC § 103 (Modified Rejection Necessitated by Amendment).
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 nonobviousness.
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.
1) Claim(s) 1, 5, 21-24, 27-31, 48, 50, 52, 58, 60-61, 63 and 71 stand rejected under 35 U.S.C. 103 as being unpatentable over Jaecklin (WO 2020/167981, August 2020, cited by Applicant, cited in prior office action).
CLAIM INTERPRETATION:
claim 1 recites:
“Measuring event-free survival (EFS) of the subject at 18 months following the first dose of the IBAT inhibitor by measuring one or more of: a) total bilirubin (TB); b) total serum bile acids (sBA), and c) pruritus score as measured by an Itch Reported Outcome (ItchRO) and/or ItchRO (Obs) severity assessment tool”
This is being interpreted as follows:
Measuring any of the following: a) total bilirubin (TB), b) total serum bile acids (sBA) or c) pruritus score as measured by an Itch Reported Outcome (ItchRO) and/or ItchRO (Obs) severity assessment tool, is equivalent to measuring event-free survival (EFS).
CLAIM INTERPRETATION:
claim 1 recites:
“wherein the EFS comprises survival in the absence of hepatic decompensation or surgical biliary diversion”
This is being interpreted as follows:
After the first EFS measurement (18 months following the first dose of the IBAT inhibitor) the subjects do not suffer from hepatic decompensation or surgical biliary diversion.
For claims 1, 27, 29-30, 5, 60 and 71, Jaecklin teaches (See example 4 on pages 153-161, ICONIC study, NCT02160782):
a method of treating Alagille syndrome (ALGS, a form of cholestatic liver disease) in children (i.e. pediatric) suffering from ALGS, comprising the oral administration of a composition comprising the administration of an effective amount of the IBAT inhibitor (Or ASBT inhibitor) Maralixibat Chloride (SHP625/LUM001) for 4 years, which is very close to 5 years (see [0810], i.e. long-term extension) and measuring sBA (total serum Bile Acids) and ItchRO (Obs) (pruritus score) (see [00801]), wherein the dose of the IBAT inhibitor maralixibat is 400 micrograms/kg once a day (see [00798] and [00800]) and 800 micrograms/kg/day (i.e., 400 micrograms/kg twice a day (see [00800] and [00810]) (both amounts: 400 micrograms/kg and 800 micrograms/kg/day anticipate the instantly claimed range of 280 micrograms/kg/day to about 1,400 micrograms/kg/day).
The treatment reduces sBA by 31% (see [00804]) which were maintained during the long-term extension (i.e. 4 years). Since the sBA baseline for the long-term extension participants was 259.0 micromol/L (see Table 14 on [00803]), it means a reduction to about 178.7 micromol/L (which anticipates the instantly claimed range of “200 micromol/L or below”). The treatment also reduces the ItchRO (Obs) score (i.e. pruritus score) by 1.7 points (See [00806], which anticipates “at least 1 point” required by the instant claim. Reductions in sBA concentration and pruritus score continued and were further improved during the extension (see [00807]). All this means that “the sBA and the pruritus score are reduced as compared to the time of first administration of the IBAT inhibitor”.
Finally, Jaecklin does not mention that during or after treatment with the IBAT inhibitor Maralixibat Chloride any of the patients suffered from hepatic decompensation or surgical biliary diversion, which is another way of saying that the “EFS comprises survival in the absence of hepatic decompensation or surgical biliary diversion” (see CLAIM INTERPRETATION above).
In other words, Jaecklin teaches all the structural limitations of claims 1, 27, 29-30, 58, 60 and 71, except for the treatment lasting “at least 5 years”. However, as stated above, Jaecklin teaches that the treatment lasted for 4 years, which is very close to 5 years.
MPEP 2144.05 states: “A prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985) (Court held as proper a rejection of a claim directed to an alloy of “having 0.8% nickel, 0.3% molybdenum, up to 0.1% iron, balance titanium” as obvious over a reference disclosing alloys of 0.75% nickel, 0.25% molybdenum, balance titanium and 0.94% nickel, 0.31% molybdenum, balance titanium.).”
Even though the statements of claim 1:
“wherein the TB, the sBA, or the pruritus score is reduced as compared to the first-time administration of the IBAT inhibitor,” and
“wherein the EFS comprises survival in the absence of hepatic decompensation or surgical biliary diversion”,
were properly addressed above, one can also say that:
the statements:
“wherein the TB, the sBA, or the pruritus score is reduced as compared to the first-time administration of the IBAT inhibitor”, and
“wherein the EFS comprises survival in the absence of hepatic decompensation or surgical biliary diversion”,
do not require additional steps to be performed and simply expresses the intended result of carrying the process made obvious by the prior art: “a method of treating cholestatic liver disease (i.e., ALGS) comprising the administration of a composition comprising an effective amount of the IBAT inhibitor maralixibat for 5 years ".
MPEP 2114.04 states: “Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure. However, examples of claim language, although not exhaustive, that may raise a question as to the limiting effect of the language in a claim are:
(A) “ adapted to ” or “adapted for ” clauses;
(B) “ wherein ” clauses; and
(C) “ whereby ” clauses.
The determination of whether each of these clauses is a limitation in a claim depends on the specific facts of the case. In Hoffer v. Microsoft Corp., 405 F.3d 1326, 1329, 74 USPQ2d 1481, 1483 (Fed. Cir. 2005), the court held that when a “whereby’ clause states a condition that is material to patentability; it cannot be ignored in order to change the substance of the invention.” Id. However, the court noted (quoting Minton v. Nat ’l Ass ’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)) that a “whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.” (Emphasis added).
In the instant case: “wherein the TB, the sBA, or the pruritus score is reduced as compared to the first time administration of the IBAT inhibitor” and “wherein the EFS comprises survival in the absence of hepatic decompensation or surgical biliary diversion”, appear to be the result of the process made obvious by the prior art: “a method of treating cholestatic liver disease (i.e. ALGS) comprising the administration of a composition comprising an effective amount of the IBAT inhibitor maralixibat for 5 years ", e. g. the intended result of a process step positively recited.
Finally, regarding the statement in claim 1:
“wherein the treatment increases EFS (event-free survival) of the subject by reducing one or more of a) TB, b) sBA and c) pruritus score”, Jaecklin is silent regarding an “increase in EFS”. However, Jaecklin teaches the reduction of b) sBA and c) pruritus score.
Apparently, Applicant discovered that an “increase in EFS” is associated with a reduction in one or more of a) TB, b) sBA and c) pruritus score.
Apparently, Applicant has discovered a new mechanism of action or correlation (i.e. an increase in EFS is associated with a reduction in one or more of a) TB, b) sBA and c) pruritus score) of an obvious invention (“a method of treating cholestatic liver disease (i.e. ALGS) comprising the administration of a composition comprising an effective amount of the IBAT inhibitor maralixibat for 5 years "). The explanation of an effect or mechanism of action or correlation (e.g. increase in EFS is associated with a reduction in one or more of a) TB, b) sBA and c) pruritus score) cannot confer novelty on an obvious process (a method of treating cholestatic liver disease (i.e. ALGS) comprising the administration of a composition comprising an effective amount of the IBAT inhibitor maralixibat for 5 years) if the skilled artisan was already aware of the occurrence of the desired therapeutic effect. Though new properties of a compound or their mechanism of action are no doubt important contributions to scientific and pharmaceutical development, the assessment of patentability is based upon the therapeutic applications and effects of the compounds, not the mechanism, properties or correlations by which they exert such a therapeutic effect.
Further, MPEP 2145 states: “Mere recognition of latent properties in the prior art (i.e. an increase in EFS is associated with a reduction in one or more of a) TB, b) sBA and c) pruritus score) does not render non-obvious an otherwise known invention. In re Wiseman, 201 USPQ 658 (CCPA 1979). Granting a patent on the discovery of an unknown but inherent function would remove from the public that which is in the public domain by virtue of its inclusion in, or obviousness from, the prior art. In re Baxter Travenol Labs, 21 USPQ2d 1281 (Fed. Cir. 1991)”.
Further, one also can say that the statement “wherein the treatment increases EFS (event-free survival) of the subject by reducing one or more of a) TB, b) sBA and c) pruritus score”, does not require additional steps to be performed and simply expresses the intended result of carrying the process made obvious by the prior art: “a method of treating cholestatic liver disease (i.e., ALGS) comprising the administration of a composition comprising an effective amount of the IBAT inhibitor maralixibat for 5 years ".
MPEP 2114.04 states: “Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure. However, examples of claim language, although not exhaustive, that may raise a question as to the limiting effect of the language in a claim are:
(A) “ adapted to ” or “adapted for ” clauses;
(B) “ wherein ” clauses; and
(C) “ whereby ” clauses.
The determination of whether each of these clauses is a limitation in a claim depends on the specific facts of the case. In Hoffer v. Microsoft Corp., 405 F.3d 1326, 1329, 74 USPQ2d 1481, 1483 (Fed. Cir. 2005), the court held that when a “whereby’ clause states a condition that is material to patentability; it cannot be ignored in order to change the substance of the invention.” Id. However, the court noted (quoting Minton v. Nat ’l Ass ’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)) that a “whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.” (Emphasis added).
In the instant case “wherein the treatment increases EFS of the subject by reducing one or more of a), b) and c)”, appears to be the result of the process made obvious by the prior art: “a method of treating cholestatic liver disease (i.e. ALGS) comprising the administration of a composition comprising an effective amount of the IBAT inhibitor maralixibat for 5 years ", e. g. the intended result of a process step positively recited.
All this will result in the practice of claims 1, 27, 29-30, 58, and 71 with a reasonable expectation of success.
For claim 5, Jaecklin teaches that the sBA levels were measured at 18 weeks (see [00804]), thus resulting in the practice of claim 5 with a reasonable expectation of success.
For claims 21-22, Jaecklin does not mention that during or after treatment with the IBAT inhibitor Maralixibat Chloride any of the patients had liver transplantation, which is another way of saying that the EFS comprises survival in the absence of liver transplantation (see CLAIM INTERPRETATION above), thus resulting in the practice of claims 21-22 with a reasonable expectation of success.
For claim 23, Jaecklin teaches an improvement and reduction of pruritus (see [00806]), thus resulting in the practice of claim 23 with a reasonable expectation of success.
For claim 24, Jaecklin does not teach: “wherein the administration is sufficient to result in EFS of the subject for at least 18 months following the first dose of the IBAT inhibitor”.
However, the statement: “wherein the administration is sufficient to result in EFS of the subject for at least 18 months following the first dose of the IBAT inhibitor”, does not require additional steps to be performed and simply expresses the intended result of carrying the process anticipated by the prior art: “a method of treating cholestatic liver disease (i.e., ALGS) comprising the administration of a composition comprising an effective amount of the IBAT inhibitor maralixibat ".
MPEP 2114.04 states: “Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure. However, examples of claim language, although not exhaustive, that may raise a question as to the limiting effect of the language in a claim are:
(A) “ adapted to ” or “adapted for ” clauses;
(B) “ wherein ” clauses; and
(C) “ whereby ” clauses.
The determination of whether each of these clauses is a limitation in a claim depends on the specific facts of the case. In Hoffer v. Microsoft Corp., 405 F.3d 1326, 1329, 74 USPQ2d 1481, 1483 (Fed. Cir. 2005), the court held that when a “whereby’ clause states a condition that is material to patentability; it cannot be ignored in order to change the substance of the invention.” Id. However, the court noted (quoting Minton v. Nat ’l Ass ’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)) that a “whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.” (Emphasis added).
In the instant case: “the administration is sufficient to result in EFS of the subject for at least 18 months following the first dose of the IBAT inhibitor” appears to be the result of the process anticipated by the prior art: “a method of treating cholestatic liver disease (i.e. ALGS) comprising the administration of a composition comprising an effective amount of the IBAT inhibitor maralixibat ", e. g. the intended result of a process step positively recited.
All this will result in the practice of claim 24 with a reasonable expectation of success.
For claim 28, Jaecklin teaches a method of treating Primary Sclerosing Cholangitis (PSC) (a cholestatic liver disease) comprising the administration of the IBAT inhibitor Maralixibat to adults aged 18-80 years old (See example 3 on page 151). The pruritus score improved (i.e. was reduced) by 3 points (see [00791]) and sBA levels decreased by 38% (See [00792]), thus resulting in the practice of claim 28 with a reasonable expectation of success.
For claim 31, Jaecklin teaches that the SBA comprises cholic acid (CA), deoxycholic acid (DCA), lithocholic acid (LCA), etc. (See [00802]), thus resulting in the practice of claim 31 with a reasonable expectation of success.
For claim 48, Jaecklin teaches that the IBAT was administered once daily (See [00800]), thus resulting in the practice of claim 48 with a reasonable expectation of success.
For claim 50, Jaecklin teaches that the age of the children being treated is between 1 and 15 years (See Table 12) and the amount administered is 400 micrograms/kg once daily (See [00800] for example]). The average weight for a 1-year-old is approximately10 kg, and the average weight for a 15-year-old is approximately 50 kg. Since the amount administered is 400 micrograms/kg per dose, for a 1-year-old this results in 4 mg per dose (400 micrograms/kg x 10 kg) and for a 15-year-old results in 20 mg per dose (400 micrograms/kg x 50 kg). Both amounts anticipate the instantly claimed range of 0.1 mg per dose to about 100 mg per dose.
All this will result in the practice of claim 50 with a reasonable expectation of success.
For claim 52, Jaecklin teaches the administration of 400 micrograms/kg once a day (see [00800]) and 800 micrograms/kg/day (i.e., 400 micrograms/kg twice a day, see also [00800] and [00810]), thus resulting in the practice of claim 52 with a reasonable expectation of success.
For claim 61, Jaecklin teaches that the patient can be between 1 and 15 years of age (See Table 12 for example), which anticipates the instantly claimed range (0 to 18 years of age), thus resulting in the practice of claim 61 with a reasonable expectation of success.
For claim 63, Jaecklin does not teach that “less than 10% of the IBAT inhibitor is systemically absorbed”
However, the statement: “wherein less than 10% of the IBAT inhibitor is systemically absorbed”, does not require additional steps to be performed and simply expresses the intended result of carrying the process anticipated by the prior art: “a method of treating cholestatic liver disease (i.e., ALGS) comprising the administration of a composition comprising an effective amount of the IBAT inhibitor maralixibat ".
MPEP 2114.04 states: “Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure. However, examples of claim language, although not exhaustive, that may raise a question as to the limiting effect of the language in a claim are:
(A) “ adapted to ” or “adapted for ” clauses;
(B) “ wherein ” clauses; and
(C) “ whereby ” clauses.
The determination of whether each of these clauses is a limitation in a claim depends on the specific facts of the case. In Hoffer v. Microsoft Corp., 405 F.3d 1326, 1329, 74 USPQ2d 1481, 1483 (Fed. Cir. 2005), the court held that when a “whereby’ clause states a condition that is material to patentability; it cannot be ignored in order to change the substance of the invention.” Id. However, the court noted (quoting Minton v. Nat ’l Ass ’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)) that a “whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.” (Emphasis added).
In the instant case: “wherein less than 10% of the IBAT inhibitor is systemically absorbed” appear to be the result of the process anticipated by the prior art: “a method of treating cholestatic liver disease (i.e., ALGS) comprising the administration of a composition comprising an effective amount of the IBAT inhibitor maralixibat ", e. g. the intended result of a process step positively recited.
All this will result in the practice of claim 63 with a reasonable expectation of success.
2) Claim(s) 50, 59 and 63 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jaecklin (WO 2020/167981, August 2020, cited by Applicant, cited in prior office action) as applied to claims 1, 5, 21-24, 27-31, 48, 50, 52, 58, 60-61, 63 and 71 above, further in view of Gedulin et. al. (US 2013/0108573, cited in prior office action)
For claim 50, Gedulin teaches the treatment of cholestatic liver diseases comprising the administration of IBAT inhibitors (or ASBTI) (see [0003]), wherein the amount of IBAT administered is a single dose from about 0.1 mg/kg to about 100 mg/kg (See [0511]), thus resulting in the practice of claim 50 with a reasonable expectation of success.
Jaecklin teaches all the limitations of claim 59, except for the IBAT being Volixibat potassium. However, Gedulin teaches that Volixibat potassium (see [0252] is an IBAT inhibitor like Maralixibat (see [0247], second compound form the top) that is also effective in treating cholestatic liver diseases (see [0003] for example)
Before the effective filing date of the claimed invention, it would have been prima facie obvious for a person of ordinary skill in the art to substitute one functional equivalence (any IBAT inhibitor like Maralixibat) for another (Volixibat potassium) with an expectation of success, since the prior art establishes that both function in similar manner, thus resulting in the practice of claim 59, with a reasonable expectation of success.
Jaecklin teaches all the limitations of claim 63, except for the IBAT inhibitor being less than 10% systemically absorbed. However, Gedulin teaches methods of treating cholestatic liver diseases comprising the administration of IBAT inhibitors (or ASBTI) (see [0003]), wherein the ASBTI is less than 10% systemically absorbed (see [0019}, thus resulting in the practice of claim 63, with a reasonable expectation of success.
Response to Applicant’s arguments related to the above rejection
Applicant's arguments have been fully considered but are not persuasive.
This modified rejection addressed all the issued presented by Applicant.
As stated in the above rejection, the only structural difference between the instant claims and the prior art is that the treatment lasts 5 years instead of 4.
Also, as discussed in the above rejection, the discovery that EFS is correlated to the decrease of one or more of: a) TB, b) sBA and c) pruritus score, does not confer novelty to the claims.
Double Patenting (Modified Rejections Necessitated by Amendment).
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.
1) Claims 1, 5, 21-24, 27-31, 48, 50, 52, 58-61, 63 and 71 stand rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 11/229,647. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant application and the US patent recite similar methods of treating cholestatic liver diseases comprising the administration of a composition comprising an effective amount of an IBAT inhibitor.
The ‘647 patent recites the administration of maralixibat for at least 3 years, which overlaps with the instantly claimed range of at least 5 years.
2) Claims 1, 5, 21-24, 27-31, 48, 50, 52, 58-61, 63 and 71 stand rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 11/497,745. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant application and the US patent recite similar methods of treating cholestatic liver diseases comprising the administration of a composition comprising an effective amount of an IBAT inhibitor.
The ‘745 patent recites the administration of maralixibat for at least 3 years, which overlaps with the instantly claimed range of at least 5 years.
3) Claims 1, 5, 21-24, 27-31, 48, 50, 52, 58-61, 63 and 71 stand provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-4, 8, 24, 27-28 and 113 of copending Application No.17/430,125 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both applications recite similar methods of treating cholestatic liver diseases comprising the administration of a composition comprising an effective amount of an IBAT inhibitor. The ‘125 application recites the administration of maralixibat for at least one year, which overlaps with the instantly claimed range of at least 5 years.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
4) Claims 1, 5, 21-24, 27-31, 48, 50, 52, 58-61, 63 and 71 stand provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 103, 105-118 and 121-124 of copending Application No.17/960,669 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both applications recite similar methods of treating cholestatic liver diseases comprising the administration of a composition comprising an effective amount of an IBAT inhibitor. The ‘669 application recites the administration of maralixibat for at least 3 years, which overlaps with the instantly claimed range of at least 5 years.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are 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 extension fee 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 date of this final action.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARCOS L SZNAIDMAN whose telephone number is (571)270-3498. The examiner can normally be reached Flexing M-F 7 AM-7 PM.
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/MARCOS L SZNAIDMAN/
Primary Examiner, Art Unit 1628
March 11, 2026.
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