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 .
Status of the Claims
Claims 14, 15, 18-20 and 22-27 are pending. Acknowledgment is made of the amendment of claims 14, 15, 18-20, and 22-24, the cancellation of claims 16, 17, and 21, and the addition of new claims 25-27, filed 06/05/2026.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 06/05/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Withdrawn Objections/Rejections
Applicant’s amendment to the claims, filed 06/05/2026, overcomes the objection to claims 14, 16-19, 21, 23, and 24 for minor informalities. The objection to claims 14, 16-19, 21, 23, and 24 has been withdrawn.
Applicant’s amendment to the claims, filed 06/05/2026, overcomes the rejection of claims 14-24 under 35 U.S.C. 101 for inoperability. The rejection of claims 14-24 has been withdrawn.
Applicant’s amendment to the claims, filed 06/05/2026, overcomes the rejection of claims 14-24 under 35 U.S.C. 112(b) for indefiniteness. The rejection of claims 14-24 has been withdrawn.
Applicant’s amendment to the claims, filed 06/05/2026, overcomes the rejection of claims 14-16, 20, and 22 under 35 U.S.C. 102 as being unpatentable over Shanghai Genomics, Inc. (cited in previous office action). The rejection of claims 14-16, 20, and 22 has been withdrawn.
New/Modified Rejections
Necessitated by Claim Amendment
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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 14, 15, 18-20, 22, and 25-27 are rejected under 35 U.S.C. 103 as being unpatentable over Shanghai Genomics, Inc. (cited in previous office action).
This clinical study teaches a method of treating hepatic fibrosis in chronic viral hepatitis B patients comprising administering two 30 mg capsules of hydronidone, the compound of instant claim 14, three times per day, which is 180 mg per day (Description, Arms and Interventions). The Inclusion Criteria teaches that the method is administered to patients with an ALT less than 5-fold ULN (maximum), and the Exclusion Criteria teaches that the method is not administered to patients with TBiL greater than 3-fold ULN, as in instant claims 14, 20, and 22.
It is taught, in the Description, that treatment is aimed to decrease the hepatic fibrosis Ishak score by more than 1, as in instant claim 16.
Regarding instant claim 15, the prior art is silent regarding causing a reversal of liver fibrosis. However: causing a reversal of liver fibrosis will inevitably flow from the teachings of the prior art (see above rejection), since the same composition (180 mg hydronidone daily) is being administered to the same subjects (a subject with hepatic fibrosis and chronic viral hepatitis B). In other words, products of identical or similar composition cannot exert mutually exclusive properties when administered under the same or similar circumstances. See MPEP 2112 I.
The clinical trial fails to specify that the method is administered to patients with an Ishak score of ≥ 6 or a liver stiffness measurement of ≥ 13 kPa.
However, an Ishak score ≥ 6 and LSM ≥ 13 kPa indicate severe fibrosis, which would indicate that treatment should be performed on such an individual.
Therefore, it would be prima facie obvious to perform a method of treating hepatic fibrosis, wherein the patients have chronic viral hepatitis B, in patients that have severe hepatic fibrosis, indicated by an Ishak score ≥ 6 or LSM ≥ 13 kPa. One would be motivated to use a method of treating hepatic fibrosis in a patient with severe hepatic fibrosis, since this individual would be in the most need for treatment.
One of ordinary skill would have a reasonable expectation of success since the method in the clinical trial is taught to be aimed at decreasing the Ishak score by more than 1, and this method is used for the same purpose as the instant invention.
Applicant’s Arguments:
Applicant states that there would be no reasonable expectation of success treating hepatic fibrosis using the prior art method, since the method does not explicitly state that it can be used to treat a specific Ishak or LSM score. Applicant states that the method produces unexpected results.
Examiner’s Response:
Applicant's arguments filed 06/05/2026 have been fully considered but they are not persuasive. Applicant has not shown that the composition produces unexpected results compared to the prior art. The prior art teaches the same composition and the same administration techniques. Therefore, the prior art composition would produce the same results as the instant application. Additionally, it is unpersuasive that one of ordinary skill in the art would not be motivated to treat severe hepatic fibrosis using a known method. On the contrary, it would likely be the first method one of ordinary skill in the art would test when treating hepatic fibrosis, since it is already known in the art. Merely limiting the patient population using a known method of treating hepatic fibrosis, without changing the method of treatment itself, is not patentably new.
Maintained Rejections
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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 23 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Shanghai Genomics, Inc. (cited above), further in view of Yi (WO 2005047256 A1), cited by Applicant in the IDS.
The clinical study by Shanghai Genomics, Inc. teaches a method of treating hepatic fibrosis in chronic viral hepatitis B patients comprising administering two 30 mg capsules of hydronidone, the compound of instant claim 14, three times per day, which is 180 mg per day. See above rejection.
The clinical study fails to teach the composition of the capsules, as in instant claims 21, 23, and 24.
However, Li et al. teaches, in Example 5, a method of treating liver fibrosis wherein hydronidone is administered and shown to significantly improve the liver function. Li teaches, on page 2 paragraph 2, that chronic viral hepatitis B is the most common cause of liver fibrosis. In Example 6, Li teaches a composition comprising 100-500 mg hydronidone, 1-5 mg magnesium stearate, 1 mg silica, and 5-10 mg lactin (lactose), as in instant claims 21 and 23.
Regarding instant claim 24, the composition of Li differs from the instant composition in the concentrations of lactose monohydrate and hydronidone used. However, MPEP 2144.05 II. A. teaches that “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)”. Therefore, the difference in concentrations does not render the instant composition patentably new and would be considered routine experimentation.
It would be prima facie obvious to use and optimize the composition of Li in the method taught in the clinical study by Shanghai Genomics, Inc., since the composition is taught to be used for the same purpose.
One of ordinary skill would have a reasonable expectation of success in using the components of the pharmaceutical composition in the clinical trial to treat liver fibrosis in patients having chronic hepatitis B, since the composition is taught by Li to treat liver fibrosis and improve liver function.
Applicant’s Arguments:
Applicant states that one would not be motivated to optimize the composition with a reasonable expectation of success in treating this “challenging disease stage”, and that the prior art is silent regarding treating severe hepatic fibrosis.
Examiner’s Response:
Applicant's arguments filed 06/05/2026 have been fully considered but they are not persuasive. It is common in the art to optimize medicinal compositions, particularly when the composition is being used to treat a more severe disease state. As stated above, MPEP 2144.05 II. A. teaches that “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)”. Merely optimizing the concentration of additives in a known composition, in order to use the composition for the same purpose as taught in the prior art, is not patentably new.
Conclusion
Claims 14, 15, 18-20 and 22-27 are rejected.
THIS ACTION IS MADE FINAL. 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.
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/R.M.S./Examiner, Art Unit 1624
/JEFFREY H MURRAY/Supervisory Patent Examiner, Art Unit 1624
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