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 .
Status of the Claims
Claims 2 and 6-14 are pending.
Applicants’ arguments filed on 08/28/2026, have been fully considered. Rejections and/or objections not reiterated from previous Office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set of rejections and/or objections presently being applied to the instant application.
Applicants’ amendments, filed on 08/28/2026, have each been entered into the record. Applicants have amended claims 2 and 6-12. Applicants have canceled claims 1 and 3-5. Applicants have newly added claims 13-14. Therefore, claims 2 and 6-14 are subject of the Office action below.
Applicants’ amendments of the specification, filed on 08/28/2026, have each been entered into the record.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 06/17/2026, was in compliance with the provisions of 37 CFR 1.97 and 37 CFR 1.98. The IDS documents were considered. A signed copy of Form PTO-1449 is enclosed herewith.
Claim Objections-Withdrawn
The objection to claim 8 under 37 CFR 1.71(a), is withdrawn because claim 8 is amended to recite “iatrogenic”.
Withdrawn Rejections
The rejection of claims 1 and 3-5 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is withdrawn because claims 1 and 3-5 are cancelled.
The rejection of claims 1-5 and 9-12 under 35 U.S.C. 102(a)(1) as being anticipated by Hwang of record (IAP&T, 2020), is overcome by the Applicants’ amendments and is hereby withdrawn. For example: i) claims 1 and 3-5 have been cancelled; and ii) Applicants have amended to claims 2, 6 and 9 to introduce the limitation of “administering by injection”.
The rejection of claims 6-8 under 35 U.S.C. 103 as being unpatentable over Hwang of record (IAP&T, 2020) in view of Hamada of record (J, Gastroenterol, 2019), is overcome by the Applicants’ amendments and is hereby withdrawn. For example, claim 6 has been amended to introduce the limitation of “administering by injection”.
Claim Objections
Applicant is advised that should claim 8 be found allowable, claim 14 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). Appropriate correction is required.
Claim Rejections - 35 USC § 112
New Grounds of Rejection, Necessitated by Applicants’ Amendments
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 7-8 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.
Each of claims 7-8 recites the limitation “the bleeding”. There is insufficient antecedent basis for this limitation in the claim. Claims 7-8 lack antecedent basis because claim 6 from which claims 7-8 depend, recites “gastrointestinal bleeding”. It is recommended that Applicants amend claims 7-8 to recite “the gastrointestinal bleeding” (as correctly recited in newly added claims 13-14), in order to overcome the rejections. Appropriate correction is required.
Claim Rejections - 35 USC § 103
New Grounds of Rejection, Necessitated by Applicants’ Amendments
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.
Claims 2 and 9-13 are rejected under 35 U.S.C. 103 as being unpatentable over Hwang of record (IAP&T, 2020) in view of Kim et al (hereinafter “Kim”, U.S. Pub. No. 20190031609, published 01/31/2019).
Independent claim 2 is drawn to a method for preventing or treating GI disease in a subject in need thereof, comprising administering by injecting 10-30 mg/day of a compound of Formula 1:
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(fexuprazan, DWP14012) or a pharmaceutically acceptable salt thereof, to the subject.
Similar to claim 2, independent claim 9 is directed to a method for preventing bleeding in a subject in need thereof, comprising administering by injecting 30-50 mg compound of Formula 1 or a pharmaceutically acceptable salt thereof, to the subject, followed by maintenance therapy at 1-10 mg/h for 24 hours or more.
A subject in need of prevention from GI disease (claim 2) or bleeding (claim 9), would not have the disease or bleeding.
Regarding claims 2 and 9-13, Hwang (see abstract and § 2.1), teaches a method comprising orally administering to healthy human subjects:
i) 20 mg/day of fexuprazan (addressing claim 2); and
ii) 40 mg of fexuprazan and continue at 40 mg/day (1.7 mg/h) for 7 consecutive days, which is more than 24 hours (see addressing claim 9).
The subjects in Hwang are not disclosed as having GI disease.
The 20 mg/day is within the range of 10-30 mg/day recited in claim 2. A specific example in the prior art which is within a claimed range anticipates the range (see MPEP § 2131.03).
The 40 mg/day is within the range of 30-50 mg/day recited in claim 9 and the 1.7 mg/h is within the 1-10 mg/h recited in claim 9. A specific example in the prior art which is within a claimed range anticipates the range (see MPEP § 2131.03).
Hwang (see, e.g., abstract and §s 1-2.1), discloses that fexuprazan: i) exhibits rapid and prolonged gastric acid suppression; and ii) belong to P-CAB class of drugs, which are emerging treatments gastric acid-related disorders including but not limited, peptic ulcer, gastritis, gastric cramp, gastro-oesophageal reflux disease (GERD) and Crohn's disease.
Although Hwang is not explicit in disclosing injection as a route of administration, the claimed invention would have been obvious over Hwang. This is because at the time of the instant invention, it was known in the art that a compound of Formula 1 or a pharmaceutically acceptable salt thereof, can be administered by injection. For example, Kim discloses that a pharmaceutical composition comprising a compound of Formula 1 or a pharmaceutically acceptable salt thereof (see ¶s 0013-0014, 0029), may be administered orally, or administered parenterally, including intravenous, intramuscular, intraperitoneal, subcutaneous and transdermal routes of administration (see ¶ 0031). The pharmaceutical composition can be formulated in forms such as tablets, granules and injection solutions (see ¶ 0033). Regarding dosing, Kim (see ¶ 0032), states:
The pharmaceutical composition may be administered in a therapeutically effective amount, for example, in an effective amount ranging about 0.001 mg/kg to about 100 mg/kg per day. The dosage may vary depending on formulation method, administration method, patient's age, body weight, sexually transmitted infection, diet, administration time, administration route, excretion rate or susceptibility. Emphasis added.
An average human weighing 60 kg would require an amount ranging from 0.06 mg/day to 600 mg/day, which encompasses the dosages administered to human patients in the Hwang disclosure and the claimed invention.
Similar to Hwang (see discussions above), Kim (see abstract, ¶s 0013-0014, 0029, 0064 and claims 1, 5), relates to use of a pharmaceutical composition comprising a compound of Formula 1 or a pharmaceutically acceptable salt thereof, for prevent and treating GI injury due to gastric acid-related disorders or Helicobacter pylori (H. pylori) infection.
Accordingly, at the time of the instant invention, one skilled in the art would have envisaged a method of administering an injection composition comprising a gastric acid suppressor (e.g., fexuprazan), to a subject in need thereof, in the disclosures of Hwang and Kim. A person skilled in the art would have had a reasonable expectation that the administration of the injection composition to the subject (e.g., a subject in need of a prevention from GI disease or bleeding, and unable to take the fexuprazan by oral administration), would, for example, prevent the GI disease or bleeding.
Obviousness requires only a reasonable expectation of success, not complete confidence in a given outcome; "at least some degree of predictability" is all that is required. M.P.E.P. § 2143.02.
The prior art can be modified or combined to reject claims as prima facie obvious as long as there is a reasonable expectation of success. See In re Merck & Co., Inc., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986) (see MPEP § 2143.02).
Therefore, claims 2 and 9-13 are obvious over Hwang and Kim.
MPEP 2143(e) states: The rationale to support a conclusion that the claim would have been obvious is that “a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that product [was] not of innovation but of ordinary skill and common sense.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103(a). From the teachings of the reference, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Thus, the claims fail to patentably distinguish over the state of the art as represented by the cited references.
Claims 2, 6-8, 10-12 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Hwang of record (IAP&T, 2020) in view of: 1) Kim (U.S. Pub. No. 20190031609); and 2) Hamada of record (J, Gastroenterol, 2019).
Independent claim 2 is drawn to a method for preventing or treating GI disease in a subject in need thereof, comprising administering by injecting 10-30 mg/day of a compound of Formula 1 or a pharmaceutically acceptable salt thereof, to the subject.
Similar to claim 2, independent claim 6 is directed to a method for treating bleeding in a subject in need thereof, with 70-90 mg/day or 30-50 mg twice/day of the compound of Formula 1 or a pharmaceutically acceptable salt thereof.
Regarding claims 2, 6-8, 10-12 and 14, Hwang (see abstract and § 2.1), teaches a method comprising orally administering to healthy human subjects:
i) 20 mg/day of fexuprazan (addressing claim 2); and
ii) 80 mg/day of fexuprazan (see addressing claim 6).
The 20 mg/day is within the range of 10-30 mg/day recited in claim 2. A specific example in the prior art which is within a claimed range anticipates the range (see MPEP § 2131.03).
The 80 mg/day is within the range of 70-90 mg/day recited in claim 6 (see discussions above). A specific example in the prior art which is within a claimed range anticipates the range (see MPEP § 2131.03).
Hwang (see, e.g., abstract and §s 1-2.1), discloses that fexuprazan: i) exhibits rapid and prolonged gastric acid suppression; and ii) belong to P-CAB class of drugs, which are emerging treatments gastric acid-related disorders including but not limited, peptic ulcer, gastritis, gastric cramp, gastro-oesophageal reflux disease (GERD) and Crohn's disease.
Although Hwang is not explicit in disclosing: a) injection composition and b) treating bleeding, the claimed invention would have been obvious over Hwang. This is because at the time of the instant invention, it was known in the art that:
a) a compound of Formula 1 or a pharmaceutically acceptable salt thereof, can be administered by injection. For example, Kim discloses that a pharmaceutical composition comprising a compound of Formula 1 or a pharmaceutically acceptable salt thereof (see ¶s 0013-0014, 0029), may be administered orally, or administered parenterally, including intravenous, intramuscular, intraperitoneal, subcutaneous and transdermal routes of administration (see ¶ 0031). The pharmaceutical composition can be formulated in forms such as tablets, granules and injection solutions (see ¶ 0033). Regarding dosing, Kim (see ¶ 0032), states:
The pharmaceutical composition may be administered in a therapeutically effective amount, for example, in an effective amount ranging about 0.001 mg/kg to about 100 mg/kg per day. The dosage may vary depending on formulation method, administration method, patient's age, body weight, sexually transmitted infection, diet, administration time, administration route, excretion rate or susceptibility. Emphasis added.
An average human weighing 60 kg would require an amount ranging from 0.06 mg/day to 600 mg/day, which encompasses the dosages administered to human patients in the Hwang disclosure and the claimed invention.
Similar to Hwang (see discussions above), Kim (see abstract, ¶s 0013-0014, 0029, 0064 and claims 1, 5), relates to use of a pharmaceutical composition comprising a compound of Formula 1 or a pharmaceutically acceptable salt thereof, for prevent and treating GI injury due to gastric acid-related disorders or Helicobacter pylori (H. pylori) infection.
b) gastric acid-related disorders can cause bleeding. For example, Hamada discloses that peptic ulcer (see page 123, 1st ¶ on left column) and ESD-induced gastric ulcer (iatrogenic ulcer, see page 122 and reference #3) can cause bleeding. Hamada (see abstract and discussions therein), also discloses that vonoprazan (a drug in the same class as fexuprazan, see § 1 of Hwang), can be used to treat bleeding caused by ulcer.
Accordingly, at the time of the instant invention, one skilled in the art would have envisaged a method treating GI disease or GI bleeding in a subject in need thereof, with an injection composition comprising a gastric acid suppressor (e.g., fexuprazan), in the disclosures of Hwang, Kim and Hamada. A person skilled in the art would have had a reasonable expectation that the administration of the composition to a subject suffering from a gastric acid-related disease (e.g., peptic ulcer) and unable to take oral fexuprazan composition, would treat the ulcer and the bleeding caused by the ulcer.
Obviousness requires only a reasonable expectation of success, not complete confidence in a given outcome; "at least some degree of predictability" is all that is required. M.P.E.P. § 2143.02.
The prior art can be modified or combined to reject claims as prima facie obvious as long as there is a reasonable expectation of success. See In re Merck & Co., Inc., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986) (see MPEP § 2143.02).
Therefore, claims 2, 6-8, 10-12 and 14 are obvious over Hwang, Kim and Hamada.
MPEP 2143(e) states: The rationale to support a conclusion that the claim would have been obvious is that “a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that product [was] not of innovation but of ordinary skill and common sense.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103(a). From the teachings of the reference, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Thus, the claims fail to patentably distinguish over the state of the art as represented by the cited references.
Response to the Applicant’s Arguments
Applicants raised several arguments (see pages 8-13 of Remarks), alleging that the claims of the instant invention are non-obvious over the prior art on the grounds that:
1) the claims have been amended to introduce the limitation of “administering by injection” (see pages 10-12 of Remarks).
Response:
Applicants’ arguments have been fully considered but they are not found to be persuasive, because the limitation of “administering by injection” is addressed in the new grounds of rejections set forth above. The Examiner, therefore, applies the same response hereto.
2) A person skilled in the art would not have had a reasonable expectation of success in arriving at the claimed invention because Hwang and Hamada fail to disclose administration of the claimed dosage by injection (see page11 of Remarks).
Response:
Applicants’ arguments have been fully considered but they are not found to be persuasive. This is because Hwang and Hamada combine to disclose oral administration fexuprazan dosage within the claimed dosing limitation (see discussions above). Kim (see discussions above), discloses that fexuprazan can be administered orally or by injection. Furthermore, Kim (see ¶ 0032), states:
The pharmaceutical composition may be administered in a therapeutically effective amount, for example, in an effective amount ranging about 0.001 mg/kg to about 100 mg/kg per day. The dosage may vary depending on formulation method, administration method, patient's age, body weight, sexually transmitted infection, diet, administration time, administration route, excretion rate or susceptibility. Emphasis added.
An average human weighing 60 kg would require an amount ranging from 0.06 mg/day to 600 mg/day, which encompasses the dosages administered to human patients in the Hwang disclosure and the claimed invention.
3) Applicants surprisingly and unexpectedly discovered that the intravenous (IV) administration of fexuprazan at dosages within the claimed dosing limitations was found to be effective in maintaining pH above pH of 6, and treating diseases associated with gastric acid secretion (see page 12 of Remarks).
Response
Regarding the advantageous results alleged by the Applicants for rebutting the obviousness of claimed invention, please note that advantageous results alone are not sufficient for overcoming an obviousness. The results must be unexpected. For the establishment of unexpected results, a few notable principles are well settled. It is Applicants’ burden to explain any proffered data and establish how any results therein should be taken to be unexpected and significant. See MPEP 716.02 (b). The claims must be commensurate in the scope with any evidence of unexpected results. See MPEP 716.02 (d). Further, A DECLARATION UNDER 37 CFR 1.132 must compare the claimed subject matter with the closest prior art in order to be effective to rebut a prima facie case if obviousness. See, MPEP 716.02 (e).
In the instant case, Hwang (see, e.g., abstract, page 1653 and Figures 2-3), discloses that daily oral fexuprazan doses of 20 mg, 40 mg or 80 mg was found to suppress gastric acid secretion and maintain pH above pH of 4 over 24 hours for up to 90.6%. The pH above pH of 6, necessarily encompasses pH above pH of 6. Since Kim discloses that fexuprazan at dosage range encompassing the dosages administered to human patients in the Hwang disclosure and the claimed invention can be administered orally or by injection, it would have been obvious to one skilled in the art that an oral injection of fexuprazan of Hwang would similarly suppress gastric acid suppression, treat diseases associated with gastric acid secretion and maintain pH above pH 4 (e.g., pH above 6).
Therefore, at the time of the instant invention, it would not have been a surprising and an unexpected observation that an injection composition comprising 20 mg/day, 40 mg/day or 80 mg/day of fexuprazan, was found to suppress gastric acid suppression, treat diseases associated with gastric acid secretion and maintain pH above pH 4 (e.g., pH above 6).
For the reasons above and those made of record in the previous Office action, the rejections are maintained.
Non-Statutory Obviousness-Type Double Patenting-Maintained
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The provisional rejection of claims 2 and 6-14 on the ground of nonstatutory double patenting as being unpatentable over claims of U.S. Patent Application No. 18/859,206 (‘206 application), is maintained for the reasons of record set forth in the previous Office action.
Response to Applicants’ Arguments/Remarks
Applicants argue alleging that the instant claims are non-obvious over claims of the ‘206 application because of the amendment of the instant claims to recite the limitation of “administering by injection” (see page 13 of Remarks).
Response
Applicants’ arguments have been fully considered but they are not found to be persuasive, because the claims of the ‘206 application (e.g., claim 1), are directed to a method comprising “administering”. The recited “administering” necessarily encompasses oral administration and/or administering by injection.
For the reasons above, and those made of record in the previous Office action, the rejections are maintained.
Conclusion
No claim is allowable.
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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Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to IBRAHIM D BORI whose telephone number is (571)270-7020. The examiner can normally be reached on Monday through Friday 8:00AM-5:00PM(EST).
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JEFFREY S LUNDGREN can be reached on 571-272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/IBRAHIM D BORI/
Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629
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