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 .
Priority
The application was filed 22 April 2021 and is the national stage entry for PCT/IB2019/001148 filed 25 October 2019. The Applicant claims priority to provisional application 62/751,260 filed 26 October 2018. Therefore, the effective filing date of the application is 26 October 2018.
Examiner’s Note
The Applicant's amendments and arguments filed 17 July 2026 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Rejections not reiterated from previous office actions are hereby withdrawn.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. In the Applicant’s response, filed 17 July 2026, it is noted that claims 19, 26, 31-33, and 35 have been amended, claim 36 has been newly added, and no claims have been canceled. Support for the amendment and new claim can be found on pg. 4 of the instant specification. No new matter has been added.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim(s) 19, 23-28, 31-36 is/are rejected under 35 U.S.C. 103 as being unpatentable over Abidov et al. (US 6,489,326 B1) and MetrioPharm Ag (EP 3,511,325 A1), as evidenced by ufhealth.org, emedicine.medscape.com, webmd.com, Marzinke (Laboratory diagnosis of liver disease, Contemporary Practice in Clinical Chemistry, 2020), and mayoclinic.org.
Abidov et al. teach a method of treating a human patient with Tamerit (entire teaching, Example 1), which is ADPS dihydrate (evidenced by the Applicant’s specification, pg. 9). The method includes injecting the patient daily (Examples), or alternatively through the form of tablets for peroral administration (col. 3, lns. 48-49), with Tamerit in a single dose of 300 mg in 2 mL of distilled water for 5 days (col. 3, lns. 55-66), addressing claims 23-25, 27, 28, 32-35. Distilled water is interpreted as an acceptable excipient, partially addressing claims 19, 26, and 31. ADPS has anti-inflammatory and immunomodulatory properties (abs). Abidov provides examples where treatments using ADPS dihydrate leads to lower levels of Aspartate transaminase, Alanine transaminase, and gamma-glutamyl transferase (Tables 1-3). Normal levels of Alanine transaminase are “about 7-56 U/L” (evidenced by webmd.com, pg. 2) and Aspartate transaminase are 0-35 U/L (emedicine.medscape.com, pg. 1). Patients in Abodiv’s teaching experienced a reduction in transaminase levels, where in one patient, Aspartate transaminase went from 35.5 to 28.6 (Table 2) and in another patient, Alanine transaminase went from 80.1 to 57.5 (Table 3), addressing the limitation in claim 19. In regards to a normal level of gamma-glutamyl transferase, Abidov’s examples teach lower values after 5 days of therapy. Therefore, it is obvious to a skilled artisan that considering the decreasing trend of GTP values over time (Tables 1 and 2), a patient with elevated GTP values would eventually reach normal values with longer treatment in regards to claims 19, 26, and 31. A skilled artisan would have been easily led to continue the treatment until normal or appropriate levels of ALT, AST, and GTP are reached.
Abidov et al. do not specifically teach a method of treating autoimmune hepatitis or non-viral hepatitis in claims 19, 26, and 31.
EP ‘325 teaches a method of using solubilized ADPS or salt to treat immunodeficient conditions or those with an overshooting immune reaction (entire teaching; abs; para. 84) through oral administration (claim 12). Conditions with an overshooting immune reaction include lupoid hepatitis (para. 130), which is also known as autoimmune hepatitis and considered non-viral, as evidenced by ufhealth.org (pg. 1).
Since Abidov does not specify using their composition and method for treating autoimmune hepatitis in claims 19, 26, and 31, one of ordinary skill in the art would have been motivated to use the teaching from EP ‘325. Since EP ‘325 teaches that ADPS may be used to treat autoimmune hepatitis, which is non-viral, and Abidov teaches that ADPS has immunomodulatory properties, one of ordinary skill in the art would have been motivated to combine the teachings with a reasonable expectation of success.
In regards to new claim 36, toxic hepatitis, which is interpreted to include drug and alcoholic-induced hepatitis (evidenced by mayoclinic.org), is often characterized by elevated liver (ALT, AST, GGT) values (evidenced by Marzinke, pg. 1). Since Abidov and EP’325 teach a method of using ADPS to treat different conditions, such as lupoid hepatitis, to lower liver levels, it is obvious to a skilled artisan that the method may treat alcohol and drug-induced hepatitis through lowering of elevated liver levels.
Response to Arguments
Applicant's arguments filed 17 July 2026 have been fully considered but they are not persuasive.
The Applicant argues that Abidov et al. do not teach that the AST and ALT levels reach normal levels compared to before administration of ADPS in claims 19, 26, and 31 (Remarks, pgs. 7-8).
Applicant’s argument is not found persuasive. Abidov provides examples where treatments using ADPS dihydrate leads to lower levels of Aspartate transaminase, Alanine transaminase, and gamma-glutamyl transferase (Tables 1-3). Normal levels of Alanine transaminase are “about 7-56 U/L” (evidenced by webmd.com, pg. 2) and Aspartate transaminase are 0-35 U/L (emedicine.medscape.com, pg. 1). Patients in Abodiv’s teaching experienced a reduction in transaminase levels, where in one patient, Aspartate transaminase went from 35.5 to 28.6 (Table 2) and in another patient, Alanine transaminase went from 80.1 to 57.5 (Table 3), addressing the limitation in claim 19. In regards to a normal level of gamma-glutamyl transferase, Abidov’s examples teach lower values after 5 days of therapy. Therefore, it is obvious to a skilled artisan that considering the decreasing trend of GTP values over time (Tables 1 and 2), a patient with elevated GTP values would eventually reach normal values with longer treatment in regards to claims 19, 26, and 31. A skilled artisan would have been easily led to continue the treatment until normal or appropriate levels of ALT, AST, and GTP are reached.
The Applicant argues that Abidov et al. do not teach a method of treating a disease selected from non-viral hepatitis, drug-induced hepatitis, alcoholic hepatitis, and autoimmune hepatitis in claims 19 and 26, or non-viral hepatitis, drug-induced hepatitis, and alcoholic hepatitis in claim 31 (Remarks, pg. 9).
Applicant’s argument is not found persuasive. As recited above, Abidov does not specifically teach a method of treating autoimmune hepatitis or non-viral hepatitis in claims 19, 26, and 31.
However, EP ‘325 teaches a method of using solubilized ADPS or salt to treat immunodeficient conditions or those with an overshooting immune reaction (entire teaching; abs; para. 84) through oral administration (claim 12). Conditions with an overshooting immune reaction include lupoid hepatitis (para. 130), which is also known as autoimmune hepatitis and considered non-viral, as evidenced by ufhealth.org (pg. 1).
Since Abidov does not specify using their composition and method for treating autoimmune hepatitis in claims 19, 26, and 31, one of ordinary skill in the art would have been motivated to use the teaching from EP ‘325. Since EP ‘325 teaches that ADPS may be used to treat autoimmune hepatitis, which is non-viral, and Abidov teaches that ADPS has immunomodulatory properties, one of ordinary skill in the art would have been motivated to combine the teachings with a reasonable expectation of success.
The Applicant argues that MetrioPharm (‘325) does not provide any data regarding ALT, AST, or GTP levels (Remarks, pgs. 9-10).
Applicant’s argument is not found persuasive. As recited above, EP ‘325 teaches a method of using solubilized ADPS or salt to treat immunodeficient conditions or those with an overshooting immune reaction (entire teaching; abs; para. 84) through oral administration (claim 12). Conditions with an overshooting immune reaction include lupoid hepatitis (para. 130), which is also known as autoimmune hepatitis and considered non-viral, as evidenced by ufhealth.org (pg. 1). Therefore, it is obvious to a skilled artisan that MetrioPharm’s teaching can be interpreted as capable of treating lupoid hepatitis using ADPS.
The Applicant argues unpredictability of immune-mediated diseases (Remarks, pgs. 10-11).
Applicant’s argument is not found persuasive. As recited above, MetrioPharm’s teaching provides a method of using solubilized ADPS to treat several different immunodeficient conditions, one of which is lupoid hepatitis. A skilled artisan would easily interpret MetrioPharm’s teaching as a method of successfully treating lupoid hepatitis. Art is art, not only for what it expressly teaches, but also for what it would reasonably suggest to the skilled artisan, including alternative or non-preferred embodiments (see MPEP § 2123). Furthermore, Abidov’s teaching demonstrates lowering of liver levels, wherein abnormal liver levels are symptoms of autoimmune hepatitis, alcoholic hepatitis, etc. Therefore, a method for treating different types of hepatitis using ADPS to normalize liver levels is not considered predictable in view of the recited teachings.
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.
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/D.A.K./Examiner, Art Unit 1613
/ANDREW S ROSENTHAL/Primary Examiner, Art Unit 1613
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