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 .
Current Status of 19/444,750
Claims 14-25 have been examined on the merits.
The claims filed 05/31/2026 were used in this Office Action.
Priority
This Application is a continuation of 17/429,732, which is a national stage entry of PCT/IB2020/051296, filed 2/17/2020, and also claims foreign priority to KR10-2019-0018801, filed 02/18/2019.
Application 17/429,732 also has another continuation (19/444,911).
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Certified copies of the priority documents have been received in Application No.17429732.
Therefore, the effective filing date for the instant claims is the international filing date of 02/18/2019.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 01/09/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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.
Claim(s) 14-21 and 25 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by HK (“Study to Confirm the Safety and Efficacy of CJ-12420 in Patients With Erosive Esophagitis”, HK inno.N Corporation, ClinicalTrials.gov ID NCT03006874, 09/12/2017), as evidenced by HA (Ha et al., “Differences in clinical characteristics between patients with non-erosive reflux disease and erosive esophagitis in Korea”, J Korean Med Sci. 2010 Sep),
HK anticipates using CJ-12420, also called Tegoprazan, once daily in human patients to treat erosive esophagitis (Study Plan on page 6, under “Other Names”).
Chemical properties are inherent to their compounds. See MPEP 2112 (II). Products of identical chemical composition can not have mutually exclusive properties. A chemical composition, tegoprazan, and its properties, Maintaining gastric pH at a value greater than 4, are inseparable. See MPEP 2112.01 (II). This anticipates claim 14.
HK also discloses the outcome for the study is cumulative healing rate of erosive esophagitis at 8-week (Outcome Measures on page 7).
HK anticipates treatment lasts 4-8 weeks (Outcome Measures on page 7). This anticipates claims 15-18.
HK anticipates that subjects are included in the study if they have been endoscopically confirmed to have erosive esophagitis (Criteria on page 4). This anticipates claims 20- 21.
HA is relied upon for the beneficial teaching that Gastroesophageal reflux disease (GERD) can be divided into two groups, erosive esophagitis and non-erosive reflux disease (NERD) (abstract). Erosive esophagitis is a type of Gastroesophageal reflux disease. This anticipates claim 19.
HK anticipates using a tegoprazan tablet (Detailed Description on page 1). This is a unit dosage form for oral administration (claim 25).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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.
Claim(s) 14-25 are rejected under 35 U.S.C. 103 as being unpatentable over HK (“Study to Confirm the Safety and Efficacy of CJ-12420 in Patients With Erosive Esophagitis”, HK inno.N Corporation, ClinicalTrials.gov ID NCT03006874, 09/12/2017), as evidenced by HA (Ha et al., “Differences in clinical characteristics between patients with non-erosive reflux disease and erosive esophagitis in Korea”, J Korean Med Sci. 2010 Sep), and in view of ARMSTRONG (Armstrong, D, “Review article: gastric pH -- the most relevant predictor of benefit in reflux disease?.” Alimentary pharmacology & therapeutics, 2004).
HK teaches that using CJ-12420, also called Tegoprazan, once daily in human patients to treat erosive esophagitis (Study Plan on page 6, under “Other Names”). This teach claim 14.
HK also teaches the outcome for the study is cumulative healing rate of erosive esophagitis at 8-week (Outcome Measures on page 7).
HK teaches treatment lasts 4-8 weeks (Outcome Measures on page 7). This teaches claims 15-18.
HK teaches that subjects are included in the study if they have been endoscopically confirmed to have erosive esophagitis (Criteria on page 4). This teaches claims 20- 21.
HA is relied upon for the beneficial teaching that Gastroesophageal reflux disease (GERD) can be divided into two groups, erosive esophagitis and non-erosive reflux disease (NERD) (abstract). Erosive esophagitis is a type of Gastroesophageal reflux disease. This teaches claim 19.
HK teaches using a tegoprazan tablet (Detailed Description on page 1). This is a unit dosage form for oral administration (claim 25).
While HK teaches a method of using tegoprazan to treat erosive esophagitis (Study Design), HK does not teach that gastroesophageal reflex disease is non-erosive.
Furthermore, the claimed compound (tegoprazan) is administered to the claimed patient population (Erosive esophagitis, a type of Gastroesophageal reflux disease, as evidenced by HA). Maintaining gastric pH at a value greater than 4 appears to be a property of the compound; thus administration of the compound will necessarily maintain the pH in that manner. Applicants are reminded that the office does not have the facilities and resources to provide the factual evidence needed in order to establish that the product of the prior art does not possess the same material, structural and functional characteristics of the claimed product. In the absence of evidence to the contrary, the burden is on the applicant to prove that the claimed product is different from those taught by the prior art and to establish patentable differences. See In re Best 562F.2d 1252, 195 USPQ 430 (CCPA 1977) and Ex parte Gray 10 USPQ 2d 1922 (PTO Bd. Pat. App. & Int. 1989).
The artisan would have been motivated to administer tegoprazan to a subpopulation of patients with gastroesophageal reflex disease. HA is relied upon for the beneficial teaching that Gastroesophageal reflux disease (GERD) can be divided into two groups, erosive esophagitis and non-erosive reflux disease (NERD) (abstract). It is obvious to administer tegoprazan to any patient with gastroesophageal reflex disease, including a sub-population of either erosive esophagitis or non-erosive reflux disease, because nothing precludes them from the treatment. This teaches claims 22-23.
Chemical properties are inherent to their compounds. See MPEP 2112 (II). Products of identical chemical composition can not have mutually exclusive properties. A chemical composition, tegoprazan, and its properties, inhibiting the recurrence of gastroesophageal reflex disease, are inseparable. See MPEP 2112.01 (II). This teaches claim 24.
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 14-25 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 14-27 of copending Application No. 17/429,732 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claims anticipate the instant claims. The reference claims of 9/8/2025 were used in this rejection.
Reference claim 14 (drawn to maintaining gastric pH at a value greater than 4 in a human by administering tegoprazan once per day in an amount sufficient to effectively inhibit gastroesophageal reflex disease) anticipates instant claim 14 (which is drawn to maintaining gastric pH at a value greater than 4 in a human by administering tegoprazan once per day).
Ref claim 15 anticipates instant claim 15.
Ref claims 16-18 anticipate instant claims 16-18.
Ref claim 19 anticipates instant claim 19.
Ref claim 20 anticipates instant claim 20.
Ref claim 21 anticipates instant claim 21.
Ref claim 22 anticipates instant claim 22.
Ref claim 23 anticipates instant claim 23.
Ref claim 24 anticipates instant claim 24.
Ref claim 25 anticipates instant claim 25.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 14-25 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 14-26 of copending Application No. 19/444,911 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claims anticipate the instant claims. The reference claims of 5/11/2026 were used in this rejection.
Reference claim 14 (drawn to maintaining gastric pH at a value greater than 4 in a human by administering tegoprazan once per day wherein the pharmaceutical composition inhibits gastroesophageal reflex disease) anticipates instant claim 14 (which is drawn to maintaining gastric pH at a value greater than 4 in a human by administering tegoprazan once per day).
Ref claim 15 anticipates instant claim 15.
Ref claims 16-18 anticipate instant claims 16-18.
Ref claim 19 anticipates instant claim 19.
Ref claim 20 anticipates instant claim 20.
Ref claim 21 anticipates instant claim 21.
Ref claim 22 anticipates instant claim 22.
Ref claim 23 anticipates instant claim 23.
Ref claim 24 anticipates instant claim 24.
Ref claim 25 anticipates instant claim 25.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GILLIAN A HUTTER whose telephone number is (571)272-6323. The examiner can normally be reached M-F 7:30-5.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Andrew Kosar can be reached at 571-272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/G.A.H./Examiner, Art Unit 1625 /Andrew D Kosar/Supervisory Patent Examiner, Art Unit 1625
Prosecution Insights