DETAILED ACTION
RESPONSE TO AMENDMENT
1. Receipt of Applicants’ amendments and arguments/remarks filed 2/18/2026 is acknowledged.
INFORMATION DISCLOSURE STATEMENT
2. No new Information Statement has been submitted for review.
WITHDRAWN REJECTIONS
3. Rejections not reiterated from previous Office Actions are hereby withdrawn. The following rejections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
MAINTAINED REJECTIONS
Claim Rejections- 35 USC § 103
4. 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 3-7 and 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Kim et al. (US 20080292696) in view of by Huang et al. “Pharmacokinetics, safety and tolerability of pirfenidone and its major metabolite after single and multiple oral doses in healthy Chinese subjects under fed conditions” and Vaya et al. (US 20060018933).
Kim et al. (US 20080292696) disclose enteric sustained-release tablets having a core with drug (paroxetine) that is coated with an enteric polymer (abstract). Kim et al. disclose that when an enteric coating layer is directly coated on a sustained-release tablet core comprising paroxetine, the release behavior of the tablet changes significantly because of the interaction between the tablet core and the enteric coating layer (para 0006). Kim et al. disclose a sustained-release tablet that minimizes the interaction between the sustained-release tablet core and the enteric coating layer and maintains the drug release rate without regard to the residence time in the stomach (para 0008). This is achieved with a proper separation layer introduced between the tablet core and the enteric coating layer offers a solution (para 0008).The separation layers can be either water soluble or water insoluble and include ethyl cellulose (para 0024-0035). The enteric polymer includes methacrylic acid copolymers (para 0031). The enteric layer includes a plasticizer such as triethylcitrate (para 0032). Kim et al. disclose a weight ratio of the coating containing a water-soluble or insoluble polymer and the coating containing an enteric polymer of 1:60 to 1:1 (see Table 1). The drug is contained in an amount of 10 to 99 % by weight based on the total formulation (Table 1, Ex 1, 14.25/203.25).
Kim et al. does not disclose pirfenidone however, Huang et al. disclose pirfenidone with Tmax of 1.8-2.2 hr (see results and discussion). The pirfenidone is in amounts of 200, 400 and 600 mg. With regards treating idiopathic pulmonary fibrosis, it must be noted that the recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In re Schreiber, 128 F.3d 1473, 1477, 44 USPQ2d 1429, 1431 (Fed.Cir. 1997) MPEP § 2111.02.
With regards to claim 4, the structural limitations of claim 1 are taught and claim 4 recites blood concentrations that occur after administration. Since the structural features of the claim are met with the same Tmax, the properties would necessarily follow. Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
Vaya et al. (US 20060018933) (hereinafter Vaya et al.) disclose modified release (e.g., sustained) dosage forms that includes drugs such as paroxetine or pirfenidone (claims 1 and 28 and para 0027).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to substitute the drug in Kim et al. for pirfenidone in the sustained release dosage form. One would have been motivated to do so to achieve the same goal to minimize interaction between the tablet core and enteric coating layer, enabling constant rate or release time without regard to the residence time of drug in the stomach.
RESPONSE TO ARGUMENTS
5. Applicants’ arguments have been fully considered and are not persuasive for the reasons below.
Applicant argues that the instant invention is directed to a pirfenidone formulation for treating idiopathic pulmonary fibrosis having improved safety where it is not substantially released in the stomach but is released in the small intestine. Applicants argue that the instant specification explains that the primary coating containing a water-soluble or insoluble polymer confers advantages not addressed in Kim, including blocking pirfendione from acidic enteric coating materials and prevenient deterioration of pirfenidone stability due to organic solvents. Huang does not teach multi-layer coatings.
Applicants argue that the present application provides experimental evidence demonstrating the multi-coating structure produces a release behavior and pharmacokinetic and safety outcomes that are not predictable form the prior art. Applicant states that a coating formulation delays the time to maximum plasma concentration while maintaining comparable exposure, consistent with release in the small intestine rather than during gastric transit.
In response, the Examiner respectfully submits that the reason or motivation to modify the reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant. See, e.g., In re Kahn, 441 F.3d 977, 987, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006) (motivation question arises in the context of the general problem confronting the inventor rather than the specific problem solved by the invention); Cross Med. Prods., Inc. v. Medtronic Sofamor Danek, Inc., 424 F.3d 1293, 1323, 76 USPQ2d 1662, 1685 (Fed. Cir. 2005) (“One of ordinary skill in the art need not see the identical problem addressed in a prior art reference to be motivated to apply its teachings.”); In re Lintner, 458 F.2d 1013, 173 USPQ 560 (CCPA 1972) (discussed below); In re Dillon, 919 F.2d 688, 16 USPQ2d 1897 (Fed. Cir. 1990), cert. denied, 500 U.S. 904 (1991) (discussed below).
With regards to the unexpected results, it is noted that the claims are not commensurate in scope. The examples teach a specific enteric coating with amounts and there is no evidence of varying beyond these specific formulations. Additionally, Kim recognizes that immediate release paroxetine drugs are known to cause gastrointestinal reactions such as nausea or vomiting (para 0004). Kim et al. disclose considering that an antidepressant has to be taken for a long time, it is important to improve patient compliance by making it convenient to take and reduce adverse gastrointestinal reactions such as nausea and vomiting. To do so, the drug should not be released while residing in the stomach, i.e., it should be released only after it reaches the small intestine. Second, drug release in the small intestine should be performed at a constant rate as originally designed (para 0004). Therefore, Kim et al. recognizes the same advantages. With regards to the Tmax, "[A]n obvious formulation cannot become nonobvious simply by administering it to a patient and claiming the resulting serum concentrations." Santarus, Inc. v. Par Pharm., Inc., 694 F.3d 1344, 1354 (Fed. Cir. 2012 ).
CONCLUSION
6. 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.
CORRESPONDENCE
7. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Danah Al-awadi whose telephone number is (571) 270-7668. The examiner can normally be reached on 9:00 am - 6:00 pm; M-F (EST).
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Robert A. Wax can be reached on (571) 272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DANAH AL-AWADI/ Primary Examiner, Art Unit 1615
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