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 .
Response to Amendment
Applicant’s response of 10/23/2025 has been received and entered into the application file. Claims 1 and 43-47 are pending in this application. Claims 2-42 are canceled. New claims 43-47 are added.
Claim Rejections - 35 USC § 103 (necessitated by amendment)
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), 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).
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. 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 10/23/2025 have been fully considered and new rejection is applied as discussed above.
The examiner thanks the Applicants for amending the claims. However, the blending components listed in claim 1 are taught by Kodgule, as well as various coating layers that would prevent the composition from dissolving in an acidic environment such as 0.01 N HCl solution. Therefore, the claims remain rejected.
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN SEUNGJAI KWON whose telephone number is (571)272-7737. The examiner can normally be reached Mon - Fri 8:00 - 5:00.
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/JOHN SEUNGJAI KWON/Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615