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 1-3 were originally filed June 18, 2025.
Claims 1-3 were amended in the amendment received October 5, 2025.
The amendment received January 23, 2026 amended claims 1-3 and added new claims 4-6.
Claims 1-6 are currently pending.
Claims 1, 2, and 4-6 are currently under consideration.
Please note: additional amendments and/or adding additional new claims may require a new Restriction and/or Species Requirement.
Election/Restrictions
Applicant elected, without traverse, Group III (claims 1-3) in the reply filed on October 5, 2025.
Applicant elected, without traverse, administering a medicament comprising exogenous apoH to a patient thereby preventing and/or treating fatty liver disease, injectable form, recombinant apoH, and MetALD as the species in the reply filed on October 5, 2025.
Claim 3 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.
Please note: claim 3 is withdrawn because applicant did not elect an excipient as a species.
Please note: injectable form, recombinant apoH, and MetALD are not present in the claims and are, therefore, not required for any rejection of record. It is also respectfully noted that recombinant apoH is not structurally different from apoH.
Priority
The present application is a CON of PCT/CN2023/090101 filed April 23, 2023 which claims foreign priority to China 202310420781.9 filed April 19, 2023.
Withdrawn Objections
The objection to the abstract of the disclosure is withdrawn in view of the amendment received January 23, 2026.
The objection to the title of the invention is withdrawn in view of the amendment received January 23, 2026.
The objection to the disclosure is withdrawn in view of the amendment received January 23, 2026.
The objection to claim 1 regarding “in prevention” should read “in the prevention” (see lines 1-2) is withdrawn in view of the amendment received January 23, 2026.
The objection to claim 1 regarding “fatty live disease” should read “fatty liver disease” (see line 4) is withdrawn in view of the amendment received January 23, 2026.
Claim Interpretation
Apolipoprotein H (apoH) is also known in the art as b2-glycoprotein 1.
Fatty liver disease is a family of diseases including, but not limited to, metabolic dysfunction associated steatohepatitis (MASH), metabolic dysfunction associated steatotic liver disease (MASLD), nonalcoholic steatohepatitis (NASH), nonalcoholic fatty liver disease (NAFLD), metabolic and alcoholic associated liver disease (MetALD), etc. Various name changes have occurred as fatty liver disease has been studied.
Withdrawn Rejections
Claim Rejections - 35 USC § 112
The rejection of claims 1 and 2 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 regarding “use” claims is withdrawn in view of the amendment received January 23, 2026.
The rejection of claims 1 and 2 under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter (i.e. “use” claims) is withdrawn in view of the amendment received January 23, 2026.
New Rejections Necessitated by Amendment
Claim Rejections – 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 2, and 4-6 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a new matter rejection.
Support in the originally filed specification was not found for “therapeutically effective amount”.
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.
Claims 1, 2, and 4-6 are 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. One of skill in the art would not be able to determine the scope of the presently claimed method. For example, the preamble requires preventing and/or treating fatty liver disease while the body of the claim only refers to “a patient”. While the preamble may “breath life” into the claim, a nexus between the preamble and the patient is required (e.g. a patient with fatty liver disease, etc.).
Claim 5 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. One of skill in the art would not be able to determine the scope of the presently claimed method. For example, it is unclear if there is a nexus between the patient and the function.
Claim 6 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. One of skill in the art would not be able to determine the scope of the presently claimed method. For example, it is unclear if there is a nexus between the patient and the function.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 4 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 4 is dependent on independent claim 1. Independent claim 1 requires the administration of apoH. Claim 4 simply refers to a function of apoH (i.e. regulates lipid metabolism in the liver of the patient). Therefore, claim 4 fails to further limit independent claim 1 because claim 4 does not alter the reagents utilized or any method steps. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim 5 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 5 is dependent on independent claim 1. Independent claim 1 requires the administration of apoH. Claim 5 simply refers to a function of apoH (i.e. reduces the degree of hepatic steatosis). Therefore, claim 5 fails to further limit independent claim 1 because claim 5 does not alter the reagents utilized or any method steps. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim 6 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 6 is dependent on independent claim 1. Independent claim 1 requires the administration of apoH. Claim 6 simply refers to a function of apoH (i.e. alleviates inflammatory injury and reverses fibrosis). Therefore, claim 6 fails to further limit independent claim 1 because claim 6 does not alter the reagents utilized or any method steps. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Maintained and/or Modified* Rejections
*wherein the modification is due to amendment
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 2 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 2 depends on independent claim 1. Independent claim 1 requires a single administering step of administering a medicament comprising exogenous apoH to a patient. Dependent claim 2 simply refers to the function of the administration step (i.e. increases a level of apoH in liver). Therefore, dependent claim 2 fails to further limit independent claim 1 because dependent claim 2 does not alter the method step or the reagent utilized. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Arguments and Response
Applicants’ arguments directed to the rejection under 35 USC 112(d) (failure to further limit), for claim 2 were considered but are not persuasive for the following reasons.
Applicants contend that changing “is used to increase a level of APOH in liver” to “increases a level of APOH in liver” negates the rejection.
Applicants’ arguments are not convincing since the amendment did not alter the claim scope. The amendment did not alter the reagents utilized in independent claim 1 or alter the method step of independent claim 1. Claim 2 is drawn to a function of administering apoH which does not further limit independent claim 1.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 2, and 4-6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zhang et al., 2018, Protective Effects of Reduced Beta 2 Glycoprotein I on Liver Injury in Streptozotocin (STZ)-Diabetic Rats by Activation of AMP-Activated Protein Kinase, Med Sci Monit, 24: 7577-7584.
For present claims 1, 2, and 4-6, Zhang et al. teach administering b 2 glycoprotein I (i.e. apo H) to protect against fatty liver disease (please refer to the entire reference particularly the abstract; Materials and Methods; Results; Figures 1 and 4; Discussion).
Therefore, the teachings of Zhang et al. anticipate the presently claimed method.
Arguments and Response
Applicants’ arguments directed to the rejection under 35 USC 102 (a)(1) as being anticipated by Zhang et al. for claims 1, 2, and 4-6 were considered but are not persuasive for the following reasons.
Applicants contend that Zhang et al. treat diabetic liver injury while the present method is “intended for treating fatty liver diseases such as MASLD and MetALD” (see paragraphs 4, 5, and 34 of the specification). Applicants contend that since Zhang et al. utilized a diabetes model and the present specification utilizes a genetic and diet-induced fatty liver model that Zhang et al. can not be utilized as prior art. Applicants contend that since Zhang et al. focuses on improving glucose metabolism and oxidative stress while the present specification focuses on correcting hepatic lipid metabolism disorders and reducing hepatic fat content that Zhang et al. cannot be utilized as prior art. Applicants contend that Zhang et al. utilizes reduced b2-GPI while the present specification utilizes non-reduced b2-GPI.
Applicants’ arguments are not convincing since the teachings of Zhang et al. anticipate the method of the instant claims.
It is respectfully noted that MASLD and MetALD are not part of the present claims. It is also respectfully noted that limitations from the specification should NOT be read into the claims. See MPEP § 2173.01. The present claims are also NOT drawn to a method of making an animal model. The present claims do NOT require any method steps for analysis either (e.g. determining is the level of apoH is increased in liver, determining if lipid metabolism is regulated in the liver, determining if the degree of hepatic steatosis is reduced, or determining if inflammatory injury is alleviated or fibrosis is reversed). It is also respectfully noted that any determination steps could also be considered metal steps (e.g. doctor looking at lab results, etc.) which would not be provided patentable weight. Non-reduced b2-GPI is not specified in the present claims. ONLY limitations drawn to the reagents utilized, the patient population, and the method steps SPECIFICALLY identified in the CLAIMS will be prosecuted on the merits.
Zhang et al. teach methods of administering b 2 glycoprotein I (i.e. apo H/Rb2GPI) to protect against fatty liver disease and prevented liver injury (please refer to the entire specification particularly Background of abstract; Results of abstract; Conclusions of abstract; Material and Methods particularly Animal model and groups and Liver glycolipid storage; Results; Figures 1, 2, 4; Discussion).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Gries et al., 2009, b2-glycoprotein-1 plasma levels in liver cirrhosis, Clinica Chimica Acta, 403: 257-258.
Liu et al., 2022, Alcohol-dependent downregulation of apolipoprotein H exacerbates fatty liver and gut microbiota dysbiosis in mice, Lipids in Health and Disease, 21: 89 (10 pages).
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.
Future Communications
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMBER D STEELE whose telephone number is (571)272-5538. The examiner can normally be reached M-F 8-5.
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/AMBER D STEELE/Primary Examiner, Art Unit 1658