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 filing dated February 17, 2026.
Status of Claims
Amendment of claims 14, 16-18 and 20; cancellation of claim 21 and addition of claims 22-23 is acknowledged.
Claims 14-20 and 22-23 are currently pending and are the subject of this office action.
Claims 14-20 and 22-23 are presently under examination.
Priority
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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Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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to Applicant’s arguments have been addressed immediately after the corresponding rejections, or in the section: Withdrawn Rejections and/or Objections, if the rejection was withdrawn.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 § 112 (New Rejection Not Necessitated by Amendment).
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 14-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The term “approximately” in claim 1 is a relative term which renders the claim indefinite. The term “approximately” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
For prior art examination any amount within 15% of 40 mg (34 mg to 46 mg), will be considered “approximately 40 mg”.
Claim Rejections - 35 USC § 102 (Modified Rejection)
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 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.
Claim(s) 14-19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hegade et. al. (Lancet (2017) 389:1114-1123, cited by Applicant).
For claims 14 and 16-17, Hegade teaches a method of treating cholestatic pruritus in humans suffering from primary biliary cholangitis (PBC), comprising the oral administration of a composition comprising the compound GSK2330672 (Linerixibit):
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(see title, abstract and discussion).
The compound GSK2330672 was administered in an amount of 45 mg (i.e. approximately 40 mg, see 112(b) above) twice per day (see page 1116, right column, third paragraph from the top).
For claim 15, Hegade teaches that the method resulted in improvement in itch (see for example page 1120, right column, first sentence of first paragraph).
For claims 18 and 19, Hegade teaches that the treatment changed baseline itch scores of -57% (at least -0.5; at least – 0.9).
Response to Applicant’s arguments related to the above rejection
Applicant's arguments have been fully considered but are not persuasive.
First, as it is clear now, based on the 112(b) rejection, the term approximately 40 mg is being interpreted as encompassing a range from 34 mg to 46 mg.
Second, the fact that Hegade teaches that 40 mg twice daily lasted only 3 days is irrelevant, since claims 14-19 do not have a time limitation, as such 40 mg twice daily for 3 days anticipate the structural limitations of claims 14-19.
Third, the fact that the intention of the prior art might have been ”to allow for certain tolerance around this dose” (as stated by Applicant) and might have not recognized that this dose could treat the disease, is completely irrelevant since the same compound (GSK2330672) is administered to the same patients (patients suffering from pruritus in primary biliary cholangitis) in the same amount (approximately 40 mg twice daily).
In other words, even the prior art the prior art might have been silent or might have not recognized that there was a treatment of cholestatic pruritus in humans suffering from primary biliary cholangitis, “treatment of cholestatic pruritus in humans suffering from primary biliary cholangitis” will inevitably flow from the teachings of Hegade, since the same compound (GSK2330672) is administered to the same patients (patients suffering from pruritus in primary biliary cholangitis) in the same amount (approximately 40 mg twice daily). In other words, products of identical composition cannot exert mutually exclusive properties when administered under the same circumstances.
In other words, even though the prior art is silent regarding “treatment of cholestatic pruritus in humans suffering from primary biliary cholangitis”, by practicing the method of Hegade: “the administration of approximately 40 mg twice daily of GSK2330672 to a patients suffering from pruritus in primary biliary cholangitis", one will also be “treating of cholestatic pruritus in humans suffering from primary biliary cholangitis”, even though the prior art might have not been aware of it.
Apparently, Applicant has discovered a new property or advantage ("treating of cholestatic pruritus in humans suffering from primary biliary cholangitis”) of the method anticipated by Hegade (“the administration of approximately 40 mg twice daily of GSK2330672 to a patient suffering from pruritus in primary biliary cholangitis").
MPEP 2112 I states: “The discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus, the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).”
Claim Rejections - 35 USC § 103 (Modified Rejection).
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.
Claim(s) 14-20 and 22-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hegade et. al. (Lancet (2017) 389:1114-1123, cited by Applicant).
For claims 14 and 16-17, Hegade teaches a method of treating cholestatic pruritus in humans suffering from primary biliary cholangitis (PBC), comprising the oral administration of a composition comprising the compound GSK2330672 (Linerixibit):
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(see title, abstract and discussion).
Hegade does not teach that the compound GSK2330672 was administered in an amount of approximately 40 mg, twice daily. However, Hegade teaches that the compound GSK2330672 was administered in an amount of 45 mg (which is very close and or overlaps with “approximately 40 mg) twice per day (see page 1116, right column, third paragraph from the top).
MPEP 2144.05 states: In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575,
16 USPQ2d 1934 (Fed. Cir. 1990). Even a slight overlap in range establishes a prima
facie case of obviousness. In re Peterson, 65 USPQ2d 1379, 1382 (Fed. Cir. 2003).
"A prior art reference that discloses a range encompassing a somewhat narrower claimed range is sufficient to establish a prima facie case of obviousness." In re
Peterson, 315 F.3d 1325, 1330, 65 USPQ2d 1379, 1382-83 (Fed. Cir. 2003). >See also
In re Harris, 409 F.3d 1339, 74 USPQ2d 1951 (Fed. Cir. 2005).
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.).”
All this will result in the practice of claims 14 and 16-17 with a reasonable expectation of success.
For claim 15, Hegade teaches that the method resulted in improvement in itch (see for example page 1120, right column, first sentence of first paragraph), thus resulting in the practice of claim 15, with a reasonable expectation of success.
For claims 18 and 19, Hegade teaches that the treatment changed baseline itch scores of -57% (at least -0.5; at least – 0.9), thus resulting in the practice of claims 18 and 19, with a reasonable expectation of success.
Hegade teaches all the limitations of claim 20 except for the treatment lasting 12 weeks.
However, Hegade teaches a treatment that lasts 2 weeks: 45 mg twice a week for days 1-3 and then 90 mg twice a week daily for 14 days (see for example Figure 1: Trial Design). Hegade teaches that this study was Phase 2a, double blind, randomized, placebo controlled, crossover trial. The primary endpoints were safety of GSK2330672, assessed using clinical and laboratory parameters. The secondary parameters were changes in pruritus scores, primary biliary cholangitis, itch domain score and 5-D itch scale, changes in serum total bile acids and 7 alpha hydroxy-cholesten-3-one, and changes in PK parameters of ursodeoxycholic acid and its conjugates (see Summary under methods and findings). The authors conclude: In patients with primary biliary cholangitis with pruritus, 14 days of ileal bile acid transporter inhibition by GSK2330672 was generally well tolerated without serious adverse events and demonstrated efficacy in reducing pruritus severity (see Summary under Interpretation).
Dose regimen optimization is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize given the guidance of the prior art. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ.
Moreover, the determination of known effective amounts of known active agents to be administered to treat the same disease is considered well in the competence level of an ordinary skilled artisan in pharmaceutical science, involving merely routine skill in the art. It has been held that it is within the skill in the art to select optimal parameters, such as amounts of ingredients, in a composition in order to achieve a beneficial effect. As Hegade teaches a dose regimen for the treatment of cholestatic pruritus in patients suffering from PBC, the dose regimen is considered a result effective variable. Thus, it would also have been obvious to have chosen a dose regimen from among those known to be effective in methods of treating cholestatic pruritus in humans suffering from primary biliary cholangitis.
Discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art. See In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
A prima facie case of obviousness may be established even though a prior art reference does not disclose any particular dose regimen but teaches that the claimed parameters are known to affect results or properties.
In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980) (“Discovery of an optimum value of a result effective variable…is ordinarily within the skill of the art.”).
As such, 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 determine the optimal dose regimen to achieve the best result for a particular patient, thus resulting in the practice of claim 20 with a reasonable expectation of success.
Hegade teaches all the limitations of claim 22 except for the compound being administered in an amount of 40 mg, twice daily. However, as stated above, Hegade teaches a treatment that lasts 2 weeks: 45 mg twice a week for days 1-3 and then 90 mg twice a week daily for 14 days (see for example Figure 1: Trial Design). Hegade teaches that this study was Phase 2a, double blind, randomized, placebo controlled, crossover trial. The primary endpoints were safety of GSK2330672,
Dose regimen optimization is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize given the guidance of the prior art. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ.
Moreover, the determination of known effective amounts of known active agents to be administered to treat the same disease is considered well in the competence level of an ordinary skilled artisan in pharmaceutical science, involving merely routine skill in the art. It has been held that it is within the skill in the art to select optimal parameters, such as amounts of ingredients, in a composition in order to achieve a beneficial effect. As Hegade teaches a dose regimen for the treatment of cholestatic pruritus in patients suffering from PBC, the dose regimen is considered a result effective variable. Thus, it would also have been obvious to have chosen a dose regimen from among those known to be effective in methods of treating cholestatic pruritus in humans suffering from primary biliary cholangitis.
Discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art. See In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
A prima facie case of obviousness may be established even though a prior art reference does not disclose any particular dose regimen but teaches that the claimed parameters are known to affect results or properties.
In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980) (“Discovery of an optimum value of a result effective variable…is ordinarily within the skill of the art.”).
As such, 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 determine the optimal dose regimen to achieve the best result for a particular patient, thus resulting in the practice of claim 22 with a reasonable expectation of success.
Hegade teaches all the limitations of claim 23 except for the treatment lasting 12 weeks.
However, Hegade teaches a treatment that lasts 2 weeks: 45 mg twice a week for days 1-3 and then 90 mg twice a week daily for 14 days (see for example Figure 1: Trial Design). Hegade teaches that this study was Phase 2a, double blind, randomized, placebo controlled, crossover trial. The primary endpoints were safety of GSK2330672, assessed using clinical and laboratory parameters. The secondary parameters were changes in pruritus scores, primary biliary cholangitis, itch domain score and 5-D itch scale, changes in serum total bile acids and 7 alpha hydroxy-cholesten-3-one, and changes in PK parameters of ursodeoxycholic acid and its conjugates (see Summary under methods and findings). The authors conclude: In patients with primary biliary cholangitis with pruritus, 14 days of ileal bile acid transporter inhibition by GSK2330672 was generally well tolerated without serious adverse events and demonstrated efficacy in reducing pruritus severity (see Summary under Interpretation).
Dose regimen optimization is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize given the guidance of the prior art. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ.
Moreover, the determination of known effective amounts of known active agents to be administered to treat the same disease is considered well in the competence level of an ordinary skilled artisan in pharmaceutical science, involving merely routine skill in the art. It has been held that it is within the skill in the art to select optimal parameters, such as amounts of ingredients, in a composition in order to achieve a beneficial effect. As Hegade teaches a dose regimen for the treatment of cholestatic pruritus in patients suffering from PBC, the dose regimen is considered a result effective variable. Thus, it would also have been obvious to have chosen a dose regimen from among those known to be effective in methods of treating cholestatic pruritus in humans suffering from primary biliary cholangitis.
Discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art. See In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
A prima facie case of obviousness may be established even though a prior art reference does not disclose any particular dose regimen but teaches that the claimed parameters are known to affect results or properties.
In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980) (“Discovery of an optimum value of a result effective variable…is ordinarily within the skill of the art.”).
As such, 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 determine the optimal dose regimen to achieve the best result for a particular patient, thus resulting in the practice of claim 23 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.
Most of the issues of the 103 rejection were addressed in the response to the 102 rejection above.
Double Patenting (Maintained Rejections)
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 14-20 and 22-23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 12 of U.S. Patent No. 11,186,558. Although the claims at issue are not identical, they are not patentably distinct from each other because: Claims 1 and 12 of the ‘558 patent disclose the compound: GSK2330672, which according to the specification is effective in treating pruritus in patients suffering from PBC (see for example column 10, lines 9-14).
According to MPEP 804 B. 1:
In AbbVie Inc. v. Kennedy Institute of Rheumatology Trust, 764 F.3d 1366, 112 USPQ2d 1001 (Fed. Cir. 2014), the court explained that it is also proper to look at the disclosed utility in the reference disclosure to determine the overall question of obviousness in a nonstatutory double patenting context. See Sun Pharm. Indus., Ltd. v. Eli Lilly & Co., 611 F.3d 1381, 95 USPQ2d 1797 (Fed. Cir. 2010); Pfizer, Inc. v. Teva Pharm. USA, Inc., 518 F.3d 1353, 86 USPQ2d 1001 (Fed. Cir. 2008); Geneva Pharmaceuticals Inc. v. GlaxoSmithKline PLC, 349 F3d 1373, 1385-86, 68 USPQ2d 1865, 1875 (Fed. Cir. 2003).
Response to Applicant’s arguments related to the above rejection
Applicant's arguments have been fully considered but are not persuasive.
Most of the issues of the 103 rejection were addressed in the response to the 102 rejection above
2) Claims 14-20 and 22-23 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 21-34 of copending Application No. 18/258,572 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because: both, the instant application and the co-pending application disclose methods of treating cholestatic pruritus in a patient with PBC comprising administering to the patient orally an effective amount of the compound linerixibat (GSK2330672). Claim 27 of the copending application teaches a 40 mg dose.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Applicant’s arguments related to the above rejection
Applicant's arguments have been fully considered but are not persuasive.
Claims 21-34 are still present in the last claim version dated 12/19/2023.
Conclusion
No claims are allowed.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy L. Clark can be reached on 571 272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARCOS L SZNAIDMAN/
Primary Examiner, Art Unit 1628
February 18, 2026.