DETAILED ACTION
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 05/05/2026 has been entered.
Response to Amendment
Applicant’s response of 05/05/2026 has been received and entered into the application file. Claims 1 and 43-47 are pending in this application.
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.
Claims 1 and 43-47 are rejected under 35 U.S.C. 103 as being unpatentable over ClinicalTrials.gov (NCT03814642, Effect of Tegoprazan on Pharmacodynamics of Clopidogrel in Healthy Male Participants, January 24, 2019), Lee et al. (Randomized phase 3 trial: tegoprazan, a novel potassium competitive acid blocker vs esomeprazole in patients with erosive oesophagitis, Ailment Pharmacol Ther, 2019), Kodgule et al. (US 2014/0329781 A1), and Thakral et al. (Soluplus-Solubilized Citrated Camptothecin – A Potential Drug Delivery Strategy in Colon Cancer, AAPS PharmSciTech, 2012) as further evidenced by Ruddy et al. (US 2010/0260858 A1).
ClinicalTrials discloses that the study aims to evaluate the influence of tegoprazan on the pharmacodynamics of clopidogrel according to CYP2C19 genotypes following co-administration of tegoprazan and clopidogrel in healthy male volunteers (pg 2). One of the groups received clopidogrel and tegoprazan (pg 3).
Lee discloses that currently proton-pump inhibitors (PPIs) are the first-line drug for treating erosive esophagitis. Tegoprazan, unlike PPIs, does not require a chemical transformation into their active form. Nonclinical studies have shown that this compound suppresses gastric acid secretion faster and more potently than esomeprazole groups (pg 865). The results show that tegoprazan was non-inferior to esomeprazole in regards to the healing rate of erosive esophagitis (pg 869, Discussion section).
Kodgule discloses a therapeutically synergistic pharmaceutical dosage form for treatment of cardiovascular disorders, wherein the dosage form comprises a fixed dose combination of metoprolol in extended-release form and one or more antiplatelet agent along with one or more rate controlling excipients (Abstract). Antiplatelet agents include clopidogrel ([0010]). The dosage form exhibits immediate release of antiplatelet agent ([0031]). The extended-release metoprolol component of the dosage form comprises core coated with one or more rate controlling excipients ([0032]). Kodgule discloses that the formulation can be a tablet-in-tablet formulation ([0103]). The tablet-in-tablet formulation may be prepared by compressing metoprolol with one or more rate controlling excipient, to form a core tablet; and compressing one of more anti-platelet agent optionally along with one or more pharmaceutically acceptable excipient onto the said core tablet to form a compressed outer tablet ([0105]). Kodgule discloses the clopidogrel blend can comprise mannitol, microcrystalline cellulose, hydroxypropyl cellulose ([0146]), croscarmellose sodium ([0122]), colloidal silica ([0088]), magnesium sterate ([0087]). Kodgule discloses coating layers comprising Eudragit L30-D55, PEG, ethyl cellulose, and others ([0120]). Likewise, one of ordinary skill in the art would routinely experiment with various coating layers for controlling release of drugs.
Thakral discloses that camptothecin (CPT), a potent antitumor drug, exhibits poor aqueous solubility and rapid conversion from the active form to inactive form at physiological pH. Solid dispersion of CPT in Soluplus, an amphiphilic polymeric solubilizer was prepared and were subsequently coated with Eudragit S100 polymer (methacrylic acid-methyl methacrylate copolymer) for colonic delivery (Abstract). Exposure of coated capsule in 100 mL of 0.01 N HCl, as release medium, at 37 degrees Celsius for 2 hours showed no drug release. Further, no breach of the coating of the capsule was observed indicating perfect enteric coating, which suggests the gastro-resistance of the formulation (page 64). One of ordinary skill in the art would recognize that an enteric coating comprising methacrylic acid-methyl methacrylate copolymer would protect the formulation from dissolving in a similar environment as gastric fluid (such as 0.01 N HCl).
ClinicalTrials disclose a study evaluating co-administration of clopidogrel and tegoprazan. Lee discloses the advantages of tegoprazan. Kodgule discloses that pharmaceutical dosage forms can contain two different compartments characterized by different rates of release. Thakral discloses that an enteric coating will prevent drug release in 0.01 N HCl. Therefore, it would have been obvious to one of ordinary person in the art before the effective filing date of the claimed invention to have combined tegoprazan and clopidogrel in a dosage form taught by Kodgule. This is taking some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
Regarding claim 43, ClinicalTrials discloses dosing 50 mg of Tegoprazan and 75 mg of Clopidogrel (pg 4).
Regarding claims 44-47, one of ordinary skill in the art would routinely experiment with various dosages within a pharmaceutical composition.
Response to Arguments
Applicant’s arguments filed 05/05/2026 have been fully considered but is not persuasive.
On page 3 of remarks, applicant argues that the combination of references does not teach or suggest the instant claims as a whole and that a person of ordinary skill in the art would not be motivated to combine the references. Applicant argues that the Clinical Trial Document describes a plan for a study and is merely forward-looking. However, the research protocol clearly outlines the intervention/treatment – clopidogrel + tegoprazan vs clopidogrel + esomeprazole. A person of ordinary skill in the art could follow the protocol and arrive at the claimed composition. Applicant argues that the Clinical Trial Document does not show results. However, the protocol provides the “how-to”, and the disclosure does not have to show proof of efficacy. One of ordinary skill in the art would realize that this clinical trial combines clopidogrel with a drug (tegoprazan) that has minimal impact on clopidogrel’s antiplatelet effects since tegoprazan is not metabolized by CYP2C19 (unlike how esomeprazole is metabolized by CYP2C19). The same CYP2C19 enzyme is required to activate clopidogrel. A person of ordinary skill in the art would envisage that tegoprazan could be a reasonable alternative based on disclosure of Lee.
On page 4 of remarks, Applicant argues that Kodgule does not rectify the shortcomings of the Clinical Trial Document. Applicant argues that Kodgule’s composition comprises metoprolol, a beta-blocker. Per MPEP 2145 (IV), One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. Kodgule was relied upon to teach that antiplatelet agents are routinely combined with other pharmaceutical agents. Kodgule also discloses coating layers.
On page 5 of remarks, Applicant argues that Kodgule does not disclose overcoming the problems caused by clopidogrel, namely, that clopidogrel has side effects that cause GI disorders such as ulcers and gastrointestinal bleeding. Per MPEP 2145 (II), Mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention. Additionally, Lee discloses that tegoprazan is more advantageous than esomeprazole.
Conclusion
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/JOHN SEUNGJAI KWON/Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615
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