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 .
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 9/8/2025 has been entered.
Current Status of 17/429,732
The rejections of record are maintained below.
Amended and previously presented claims 14-25 have been examined on the merits. New claims 26 and 27 are also examined on the merits.
The claims filed 9/8/2025 were used in this Office Action.
Priority
This Application 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.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Foreign priority is perfected.
Therefore, the effective filing date for the instant claims is the international filing date of 02/18/2019.
Response to Arguments
Applicants’ claim amendments and Remarks of 9/8/2025 are acknowledged and have been considered.
Any rejection and/or objection not specifically addressed or modified below is herein withdrawn.
Applicants have submitted certified copies of priority papers. See updated Priority Section above.
In regard to the 103 rejection, this rejection is maintained. Applicants remarks with Examiner’s reply is summarized below:
Applicants submit that maintaining the pH of greater than 4 for at least 40% of a day appears to be a property of tegoprazan is incorrect. Applicant’s claims are the result of the discovery of an effect of the administration of a pharmaceutical composition (page 5 of remarks).
This is not persuasive.
Even though this is a method claim (not a composition claim), HK teaches the compound (tegoprazan) administered to patients to treat erosive esophagitis (a type of gastroesophageal reflex disease). A chemical composition (tegoprazan) and its properties (maintaining the pH of greater than 4 for at least 40% of a day) are inseparable. “Products of identical chemical composition can not have mutually exclusive properties.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). See MPEP 2112.01 (II).
Additionally, “[T]he 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.” See MPEP 2112.01(I). 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.
Regarding the instant claims, while HK does not explicitly teach maintaining the pH of greater than 4 for at least 40% of a day, it is reasonable to assume that the method of HK would have the same properties since the tegoprazan is administered for the same purpose to the same patient population as that taught by the instant specification and claims. Thus, while the prior art does not explicitly teach these properties, burden is on Applicant to show that the prior art does not have these properties. See MPEP 2112.02.
Applicants submit that this effect was not known whether administration of tegoprazan could maintain gastric pH until examples form the instant application were performed.
This is not persuasive. Whether a compound/chemical’s effect is known at the time of the instant application does not impact patentability. “There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the relevant time, but only that the subject matter is in fact inherent in the prior art reference”. See MPEP 2112.01(II).
Response to Amendment
Claim Rejections - 35 USC § 102- New due to amendment to claim 14
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”). A chemical composition (tegoprazan) and its properties (maintaining the pH of greater than 4 for at least 40% of a day) are inseparable. “Products of identical chemical composition can not have mutually exclusive properties.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). See MPEP 2112.01 (II). This anticipates claim 14.
HK also anticipates 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- MAINTAINED
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) 14-27 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).
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 helps teach claim 14.
HK teaches a dosage of tegoprazan of 50 mg and 100 mg (Participant Group/Arm on page 6). HK teaches that the dosage will be given in three tablets (Detailed Description on page 1). This helps teach claims 26-27.
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 the amount of tegoprazan, and gastroesophageal reflex disease is non-erosive.
The artisan would have been expected to optimize the dosage of tegoprazan in the normal course of dose tailoring for treating specific conditions. HK teaches amounts of tegoprazan of 50 mg and 100 mg (study design) given in 3 tablets (Detailed Description). The dosage of each of the tablets given is calculated to be approximately 16 mg or 33 mg. Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. “The proportions are so close that prima facie one skilled in the art would have expected them to have the same properties.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP 2144.05(I). Neither the specification nor the claims indicate that the amount of claims 26-27 are critical. This teaches claims 26-27.
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 for at least 40% of a day 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.
Conclusion
No claims are allowed.
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/G.A.H./ Examiner, Art Unit 1625 /Andrew D Kosar/Supervisory Patent Examiner, Art Unit 1625