DETAILED ACTION
Status of the Application
Receipt is acknowledged of Applicants’ Amendments and Remarks, filed 12 January 2026, in the matter of Application N° 18/501,402. Said documents have been entered on the record. The Examiner further acknowledges the following:
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim 80 has been canceled and the lower limit of 20 µg/kg/day has been added to independent claim 54.
Claim54 has been amended to recite “wherein the subject is administered the pharmaceutical formulation at a dosage of about 20 to about 40 µg/kg/day of odevixibat, or a pharmaceutically acceptable salt thereof”. Support is provided in the originally-filed disclosure.
Claims 128 and 129 have been added. The claims respectively recite dosage amounts of about 20 µg/kg/day of odevixibat and 30 µg/kg/day of odevixibat.
No new matter has been added.
Thus, claims 54, 79, 82, 83, 101-104, 107-109, 111, 115, 117, 121 and 124-129 now represent all claims currently under consideration.
Information Disclosure Statement
No new Information Disclosure Statements (IDS) have been filed for consideration.
Allowable Subject Matter
Newly added claims 128 and 129 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Maintained Rejections
The following rejections are maintained from the previous Office Correspondence dated 12 September 2025 since the art that was previously cited continues to read on the amended and previously recited limitations.
Claim Rejections - 35 USC §102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 54, 79, 82, 83, 101-104, 107-109, 111, 115, 117, 121 and 124-127 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Gillberg et al. (US Pre-Grant Publication Nº 2022/0143043 A1; IDS/ISR reference). [emphasis added to reflect canceled claim]
The instantly claimed invention is directed to a method of treating pruritus associated with Alagille Syndrome (ALGS) in a subject in need thereof, comprising the oral administration of a therapeutically effective amount of a composition comprising odevixibat, or a pharmaceutically acceptable salt thereof, wherein the subject exhibits a reduction in pruritus score relative to baseline following administration of the composition for at least eight (8) weeks.
In weighing the instantly recited method, the Examiner broadly and reasonably considers the claimed invention to be drawn to a method of treating pruritus (the presenting symptom) in a patient in need of such treatment comprising the oral administration of odevixibat. That the symptom is caused by or associated with such a condition as ALGS or progressive familial intrahepatic cholestasis (PFIC), for instance, is not considered to contribute to the overall patentability of the claimed method, notably in view of the recited functional limitation that the method exhibits a reduction in pruritis score. Thus, the broadest reasonable interpretation of the claimed method is that it is drawn to treating the symptom instead of the underlying genetic condition.
Gillberg discloses a method for treating pruritus associated with progressive familial intrahepatic cholestasis (PFIC) in a subject in need thereof, the method comprising orally administering to the subject a therapeutically effective amount of a pharmaceutical formulation comprising odevixibat, or a pharmaceutically acceptable salt thereof, wherein following administration of the pharmaceutical formulation, the subject exhibits a reduction in mean monthly pruritus score (see e.g., claims 1, 70, and 71).
Claim 75 further discloses that the mean monthly score occurs following the administration of the formulation for at least 8 weeks, at least 12 weeks, at least 16 weeks, at least 20 weeks, or at least 24 weeks (see also claim 7).
Claim 110 discloses that the subject is a pediatric subject.
Claim 112 discloses administering the subject an amount of 40 µg/kg/day of odevixibat.
Claim 114 discloses that the pharmaceutical formulation of odevixibat, or a pharmaceutically acceptable salt thereof, comprises a plurality of particles, wherein each particle is between about 0.1 and about 1.5 mm in size and comprises odevixibat, or a pharmaceutically acceptable salt thereof, in an amount of from about 0.1% w/w to about 5.0% w/w based on the total weight of the particle.
Claim 115 discloses that each particle comprises odevixibat, or a pharmaceutically acceptable salt thereof, in an amount of from about 0.5% w/w to about 2.0% w/w based on the total weight of the particle.
Claims 132 and 133 respectively disclose that the administered odevixibat is in the form of a hydrate that is the sesquihydrate form.
Claim 134 discloses that the administered odevixibat is present as a crystalline hydrate form of the drug.
Claim 135 discloses that odevixibat is present as crystal modification 1 of odevixibat.
Claim 136 discloses that crystal modification 1 of odevixibat has an X-ray powder diffraction (XRPD) pattern, obtained with CuKα1-radiation, with at least specific peaks at °2θ positions 5.6±0.2, 6.7±0.2 and/or 12.1±0.2.
Claims 1-6 disclose that the odevixibat formulation, whose use is for treating pruritus, is orally administered and, per claim 3, is used to reduce the mean monthly pruritis score. Claims 4-6 disclose that the monthly mean reduction is, for instance, at least 2.0, or is about 1.2 to about 2.0, or is about 1.6.
Figure 5A depicts that patients that were administered odevixibat presented with a baseline pruritus score ranging from about 2.7-3.1, thereby meeting the range limitation of instant claim 111.
Claim 77 discloses a method for treating pruritus associated with progressive familial intrahepatic cholestasis (PFIC) in a subject in need thereof, the method comprising orally administering to the subject a therapeutically effective amount of a pharmaceutical formulation comprising odevixibat, or a pharmaceutically acceptable salt thereof, wherein following administration of the pharmaceutical formulation, the subject exhibits a reduction in mean serum bile acid concentration.
Claim 80 discloses further that the reduction in mean serum bile acid concentration is about 50 μmol/L to about 180 μmol/L relative to baseline.
Claims 34 and 102 disclose that odevixibat is orally administered for use in improving a liver parameter in the subject to whom it is administered (e.g., PFIC patient presenting pruritus).
Claims 35 and 103 disclose that the liver parameter that is improved is selected from the group consisting of autotaxin level, plasma C4 level, total bilirubin level, serum alanine aminotransferase (ALT) level, and serum aspartate transaminase (AST) level.
Claims 36 and 104 disclose that improvement in the liver parameter occurs following administration of the odevixibat formulation for at least 24 weeks, at least 28 weeks, at least 32 weeks, at least 36 weeks, at least 40 weeks, or at least 48 weeks.
Lastly, Figure 17B, ¶[0043], and ¶[0076] disclose that the subjects to whom odevixibat are administer demonstrate a reduction in pruritus score relative to baseline scores for about 36 weeks and longer.
The reference is thus considered to meet each of the limitations of the instantly claimed invention.
Response to Arguments
Applicants’ arguments with regard to the rejection of claims 54, 79, 82, 83, 101-104, 107-109, 111, 115, 117, 121 and 124-127 under pre-AIA 35 USC 102(a)(1)/(a)(2) as being anticipated by Gillberg et al. (US Pre-Grant Publication Nº 2022/0143043 A1) have been fully considered, but are not persuasive.
Applicants argue that the amendment to claim 54 is sufficient in overcoming the rejection of record.
The Examiner, in response, respectfully disagrees and submits that the reference continues to meet the amended dosing range as discussed above (i.e., about 40 µg/kg/day).
Thus, for these reasons, Applicants’ arguments are found unpersuasive. The above rejection is hereby maintained.
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 54, 79, 82, 83, 101, 102, 107-109, 126, and 127 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4-7, 12-14, 16, 25, 26, and 29 of Gillberg et al. (USPN 11,583,539 B2) (reference claims). [emphasis added to reflect canceled claim 80] Although the claims at issue are not identical, they are not patentably distinct from each other.
The limitations of instant claims 54 and 82 are discussed above. Reference claims 1, 7, and 29 are considered to teach the instantly recited limitations of orally treating pruritus with a composition comprising odevixibat and demonstrating a reduction in pruritus score relative to a baseline reading after at least eight weeks of treatment.
Reference claim 12 discloses the limitations of claim 79.
Reference claim 14 discloses the amended range recited by instant claim 54.
Reference claim 16 discloses the limitations of instant claim 83.
Reference claims 25 and 26 disclose the limitations of instant claims 101 and 102.
Reference claims 4-6 disclose the limitations recited by instant claims 107-109.
Reference claim 7 discloses the limitations recited by instant claims 126 and 127.
The reference ‘539 patent is available as prior art and is therefore considered to expressly meet the limitations of the instantly claimed method. The published version of the application for the reference patent is applied as prior art above, thereby lending further support to the Examiner’s position that a person of ordinary skill in the art before the effective filing date would have considered the reference patent to read on the instantly claimed method.
Response to Arguments
Applicants’ filed response to the rejection of claims 54, 79, 82, 83, 101, 102, 107-109, 126, and 127 on the grounds of nonstatutory double patenting over the copending/patented teachings of Gillberg et al. (USPN 11,583,539 B2) has been fully considered, but is not persuasive.
No Terminal Disclaimer has been filed. Instead, Applicants traverse the rejection on the same grounds as discussed above. Specifically, it is asserted that the amendment to claim 54 narrowing the dosing range of odevixibat to a range about 20 µg/kg/day to about 40 µg/kg/day is sufficient in overcoming the rejection.
The Examiner respectfully submits that the amendment is still read on by the cited reference as discussed above.
Thus, for these reasons, Applicants’ arguments are found unpersuasive. The above rejection is hereby maintained.
All claims under consideration remain rejected; no claims are allowed.
Conclusion
THIS ACTION IS MADE FINAL. Applicants are 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 mailing date of this final action.
Correspondence
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Jeffrey T. Palenik whose telephone number is (571) 270-1966. The Examiner can normally be reached on 9:30 am - 7:00 pm; M-F (EST).
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s supervisor, Robert A. Wax can be reached on (571) 272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Jeffrey T. Palenik/
Primary Examiner, Art Unit 1615
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