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 28 January 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 Rejections not reiterated from previous office actions are hereby withdrawn.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 28 January 2026, it is noted that claims 19 and 26 have been amended, claims 31-35 have been newly added, and claims 29 and 30 have been canceled. Support for the amendment(s) and/or new claim(s) can be found on pg. 44 of the specification. No new matter has been added.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 32 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 32 depends from claim 32. The metes and bounds of the limitation cannot be reasonably determined or understood when dependent from the same claim.
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, 31-35 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, and webmd.com.
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, 30, 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, a patient with elevated GTP values would eventually reach normal values with longer treatment in regards to claims 19 and 26.
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.
Response to Arguments
Applicant's arguments filed 28 January 2026 have been fully considered but they are not persuasive.
Applicant argued that Abidov does not teach the limitations in amended claims 19 and 26 (Remarks, pgs. 6-7).
Applicant’s argument is not found persuasive. Abidov teaches 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, 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).
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 is not caused by a virus, as evidenced by ufhealth.org (pg. 1).
Since Abidov does not specify using their composition and method for treating autoimmune hepatitis or non-viral 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 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 Abidov does not teach or suggest normalization of liver enzymes (Remarks, pgs. 7-8).
Applicant’s argument is not found persuasive. In regards to the normalization of liver enzyme values in amended claims 19 and 26, Abidov’s examples teach lower values after 5 days of therapy for the liver enzymes (Tables 1-3). Therefore, it is obvious to a skilled artisan that considering the decreasing trend of these liver enzyme values over time (Tables 1-3), a patient with elevated liver enzyme values would eventually reach normal values with longer treatment.
The Applicant argues that MetrioPharm (EP ‘325) teaches lupoid hepatitis out of a laundry list of options (Remarks, pg. 10).
Applicant’s argument is not found persuasive. It is well settled that it is a matter of obviousness for one of ordinary skill in the art to select a particular component from among many disclosed by the prior art as long as it is taught that the selection will result in the disclosed effect, even when the possible selections number 1200 or in the thousands. Merck & Co., Inc. v. Biocraft Labs., Inc., 874 F.2d 804, 807 (Fed. Cir. 1989); In re Corkill, 771 F.2d 1496, 1500 (Fed. Cir. 1985).
The Applicant argues that MetrioPharm (EP ‘325) does not provide any examples for treatment of lupoid hepatitis (Remarks, pg. 10).
Applicant’s argument is not found persuasive. 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).
The Applicant argues that the individual references, such as MetrioPharm (EP ‘325), does not teach the entirety of the instant claims (Remarks, pgs. 10-11).
Applicant’s argument is not found persuasive. One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., Inc., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Furthermore, 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.
Conclusion
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/D.A.K./Examiner, Art Unit 1613
/ANDREW S ROSENTHAL/Primary Examiner, Art Unit 1613