DETAILED ACTION
This action is in response to papers filed on 06/12/2026. Claims 11-16 of Xie et al., 18462388 (09/06/2023) are pending examination on the merits. Claims 1-10 are cancelled and claims 11-16 are newly added. Claims 11-16 are rejected.
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
This application claims Foreign Priority of CHINA 2023105834920 filed 05/22/2023.
Information Disclosure Statement
No IDS was filed in this application. Applicants are reminded of the duty of disclosure as per 37 CFR 1.56 and detailed in MPEP § 2000.
Withdrawn Rejections
The following rejections have been withdrawn in view of Applicant’s cancellation of claims 1-10:
The rejection of claims 1-10 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 with respect to “… preparing a drug for at least one of treatment and prevention of liver fibrosis...”.
The rejection of claims 1-10 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement.
The rejection of claims 1-10 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.
The rejection of claims 1-10 under 35 U.S.C. 102(a)(1) as being anticipated by US FDA Dilantin® (Phenytoin Sodium) (“FDA”) (2009).
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(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 11-16 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 with respect to “… preparing a drug for at least one of treatment and prevention of liver fibrosis...”. 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.
To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. Under MPEP §2163, possession may be shown in a variety of ways, including:
description of an actual reduction to practice, such as by describing testing of the claimed invention or by showing that the inventor constructed an embodiment or performed a process that met all the limitations of the claim and determined that the invention would work for its intended purpose;
a showing that the invention was “ready for patenting” such as by the disclosure of drawings or structural chemical formulas that show that the invention was complete; and
description of distinguishing identifying characteristics sufficient to show that the applicant was in possession of the claimed invention.
Despite “a strong presumption that an adequate written description of the claimed invention is present when the application is filed,” (In re Wertheim, 541 F.2d 257, 263,191 USPQ 90, 97 (CCPA 1976), nevertheless, even an original claim may lack adequate written description, if an aspect of the claimed invention has not been described with sufficient particularity such that one skilled in the art would recognize that the applicant had possession of the claimed invention. The claimed invention as a whole may not be adequately described if the claims require an essential or critical feature which is not adequately described in the specification and which is not conventional in the art or known to one of ordinary skill in the art. In the present case, for multiple reasons, that “particularity” is absent.
For a method of treating liver fibrosis comprising administering to a subject a therapeutically effective amount of a channel blocker (c.f., claim 11), the specification provides none of the indicia listed above particularly as it relates to the treatment of liver fibrosis with a therapeutically effective amount. There is no description of an actual reduction to practice in preparing any drug(s) for at least one of treatment of liver fibrosis with a therapeutically effective amount of a channel blocker, no showing that the invention is ready for patenting, and no description of distinguishing characteristics of a method of treating liver fibrosis with a therapeutically effective amount of a channel blocker. Claim 12 (“…wherein the therapeutically effective amount is an intraperitoneal injection of a 1 millimole per liter (mM) solution of phenytoin sodium at a dose of 10 milliliters per kilogram (mL/kg) body weight, administered once daily. …”); these are boilerplate. Applicant states that liver fibrosis was indicated by the mental state and eating habits of the mice in the model group: “During the modeling process, the mental state of mice in the model group is gradually deteriorated, the activity is decreased, and the food intake and drinking water are decreased, indicating that the presence of CCl4 can cause liver damage, thus affecting the healthy growth of the mice…” [para. 0058]. There is nothing in the Specification that supports the clinical evidence much less the treatment of liver fibrosis using PHT sodium channel blocker. Outside of a mouse model of CCl4 induced liver fibrosis, there is no established clinical disease treated by the claimed blocker per Applicant’s claims 11-16.
Indeed, the specification also does not provide any of the listed indicia of possession even for the treatment of liver fibrosis using phenytoin (PHT) sodium. The sole experimental data concerns PHT administration in a mouse model with CCl4 induced liver fibrosis. The experimental groups include a model group, a treatment group, a normal control group, and a drug group (Specification, para. [0034]). Neither para. [0036] of the Specification, with the description “(3) Prevention and treatment of PHT sodium”, or throughout the Specification is any written description for the prevention and treatment of liver fibrosis using PHT. Applicant’s Fig. 1 is unclear concerning the differentiation in appearance of the liver in each group. In embodiment two, Applicant describes validating the effect of PHT sodium on liver fibrosis at a cellular level, but no nexus between Applicants’ results and using PHT in a method for the treatment of liver fibrosis is established. No clinical data to support the actual evidence liver fibrosis. Applicant on pages 10-12 of Specification discusses hepatic stellate cells, the inhibition of autophagy and the downregulation of alpha-smooth muscle in hepatocytes. However, none of this points to treating liver fibrosis using the claimed method. Therefore, the connection between Applicants’ results and the treatment of liver fibrosis using a channel blocker, in view of the claimed method and Specification is at best hypothetical. This is insufficient to show that at the time of filing Applicants had possession of the method. The claims are rejected.
Claims 11-16 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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Under MPEP §2164, in order to satisfy the enablement requirement, a disclosure must enable a person skilled in the art to practice the claimed invention without undue experimentation. The so-called “Wands factors” provide a standard for determining whether a disclosure satisfies the enablement requirement or whether, on the other hand, any experimentation necessary for the practice of the invention is “undue.” In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988). The Wands factors are:
(A) The breadth of the claims;
(B) The nature of the invention;
(C) The state of the prior art;
(D) The level of one of ordinary skill;
(E) The level of predictability in the art;
(F) The amount of direction provided by the inventor;
(G) The existence of working examples; and
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
These claims encompass a method for treating liver fibrosis using phenytoin sodium. This was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The skill level of practitioners of the therapeutic arts is high. The level of predictability is low. The state of the art is such that phenytoin sodium as a therapy to treat liver fibrosis is unknown and instead is known to cause liver injury and hepatoxicity. Sasaki et al., teaches Phenytoin (5,5-diphenylhydantoin, DPH) as an anticonvulsant drug that is widely used for the treatment of epilepsy. A fraction of patients administered DPH will suffer symptoms of drug hypersensitivity, typically characterized by a rash, lymphadenopathy, fever, and if the drug continues to be used, drug-induced liver injury. The prior art teaches that the claimed channel blocker may result in drug-induced liver injury. Applicant has not demonstrated any nexus between phenytoin sodium and the treatment of liver fibrosis.
Wang et al., Front. Immunol. (2025) also discusses throughout their disclosure and in Table 1 different inhibitors and their respective mechanism of action in liver fibrosis. Wang states in the abstract that, for example, “Although TGF-b-targeted therapy has made breakthroughs in basic research and clinical translation, future studies need to focus on multi-target drug design, personalized treatment regimens, and novel delivery systems to accelerate the transition from preclinical research to clinical application, providing innovative therapeutic strategies for liver fibrosis and related liver diseases”. Again, there is no clinical nexus between Applicant’s claimed method and the treatment of liver fibrosis using a single channel blocker.
The sole experimental data concerns PHT administration in a mouse model with CCl4 induced liver fibrosis. The experimental groups include a model group, a treatment group, a normal control group, and a drug group (Specification, para. [0034]). Neither para. [0036] of the Specification, with the description “(3) Prevention and treatment of PHT sodium”, or throughout the Specification is any written description for the prevention and treatment of liver fibrosis using PHT. Applicant’s Fig. 1 is unclear concerning the differentiation in appearance of the liver in each group. In embodiment two, Applicant describes validating the effect of PHT sodium on liver fibrosis at a cellular level, but no nexus between Applicants’ results and a method for treating liver fibrosis using PHT is established. Applicant on pages 10-12 of Specification discusses hepatic stellate cells, the inhibition of autophagy and the downregulation of alpha-smooth muscle in hepatocytes. However, none of this points to the treatment liver fibrosis using the claimed method comprising the administration of phenytoin sodium. Therefore, the connection between Applicants’ results and the treatment of liver fibrosis using phenytoin sodium, in view of the claimed method and Specification is at best hypothetical. Applicants have not established any such connection in any of the embodiments.
In order to practice the full scope of this invention, a skilled artisan would have to conduct several levels of experimentation, starting from the most fundamental proof-of-concept, proceeding through establishing a cellular model, through high-throughput screening, through several levels of animal-model experiments. This amount to invention, not development. It is an undue amount and kind of experimentation.
Claim Rejections - 35 USC § 103
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 non-obviousness.
Claims 11-16 are rejected under 35 U.S.C. 103 as being unpatentable over US FDA Dilantin® (Phenytoin Sodium) (“FDA”) (2009).
Regarding claim 11, FDA teaches phenytoin sodium as an antiepileptic drug (page 1). The Applicant is claiming the administration of phenytoin sodium in a method for treating liver fibrosis.
The Applicant’s limitation is construed to be an intended use of the compound taught by FDA and not an additional method step, and, therefore, this language does not patentably distinguish the recited composition, per se, since the undisclosed use is inherent in the reference composition. In the instant case, the intended use does not create a structural change to the product and is not construed as being an additional method step, thus the intended use is not limiting. “The discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. Ireco Inc., 190. Therefore, the compound taught by FDA meets the structural limitation and is therefore obvious. Dependent claims 12-16 are also rejected.
Applicant’s Arguments/Examiner’s Response
Applicants argue the cancellation of claims 1-10, thus rendering the rejections moot. Applicant further argues that newly added claims 11-16 have overcome the rejections because they have been revised to narrow the scope of the claimed invention and add greater specificity. While Applicants cancellation of claims 1-10 have rendered the previous rejection moot, Applicants newly added claims have not overcome the above rejection. Details of the rejection are described above. No claims are allowed.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. Applicants are 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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/C A/Examiner, Art Unit 1622 September 29, 2026
/JAMES H ALSTRUM-ACEVEDO/Supervisory Patent Examiner, Art Unit 1622
