DETAILED ACTION
This action is in response to papers filed on 09/06/2023. Claims 1-10 of Xie et al., 18462388 (09/06/2023) are pending examination on the merits. Claims 1-10 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. Applicant is reminded of the duty of disclosure as per 37 CFR 1.56 and detailed in MPEP § 2000.
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 1-10 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 comprising preparing a drug for at least one of treatment and prevention of liver fibrosis using any channel blocker (c.f., claim 1), the specification provides none of the indicia listed above particularly as it relates to the prevention of liver fibrosis. There is no description of an actual reduction to practice in preparing any drug(s) for at least one of treatment and prevention of liver fibrosis using a channel blocker, no showing that the invention is ready for patenting, and no description of distinguishing characteristics of a method comprising the preparation a drug for at least one of treatment and prevention of liver fibrosis using a channel blocker. All statements regarding treatment variables, from composition of formulations to route of administration to dosage amounts and frequency lack specificity (c.f., claim 5, wherein “the drug” comprises pharmaceutical excipients, and no further guidance on a selection of appropriate drugs that can be used; c.f., claim 6 wherein a dosage form of the drug “is any medically recognized dosage form…”); these are boilerplate. Claim 5 also recites wherein the drug comprises “pharmaceutical excipients” for example, but no excipients are mentioned in the Specification. Para. [0010] simply states: “In an embodiment, the drug also includes pharmaceutically acceptable excipients.”. There is nothing in the Specification that supports the prevention of liver fibrosis using a channel blocker. Outside of a mouse model of CCl4 induced liver fibrosis, there is no established clinical disease treated and prevented by the claimed method, and no preparation of a drug(s) using a channel blocker per Applicant’s claim 1.
Indeed, the specification also does not provide any of the listed indicia of possession even for the prevention 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 a method comprising preparing a drug for the treatment and prevention of 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 preventing liver fibrosis using the claimed method comprising preparing a drug of any kind for at least one of treatment and prevention of liver fibrosis using any channel blocker. Therefore, the connection between Applicants’ results and the prevention and 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 1-10 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 comprising preparing a drug for at least one of treatment and prevention of liver fibrosis using a channel blocker. Claim 1, for example covers an extremely broad genus of channel blocker, which encompasses hundreds of thousands of compounds. While the Specification discloses only one species (i.e., phenytoin sodium) of channel blocker per Applicant’s claim 3, independent claim 1 covers a vast genus of channel blockers with no guidance in the Specification to enable the full scope of the claim. Moreover, independent claim 1 also recites preparing a drug for at least of one of treatment and prevention of liver fibrosis using a channel block. 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 no one therapy is known to be fully effective in preventing this disorder. Wang et al., Front. Immunol. (2025) discusses throughout their disclosure and in Table 1 different inhibitors and their respective mechanism of action in liver fibrosis. Wang also 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”. No clinical nexus between Applicant’s claimed method and the prevention of liver fibrosis comprising preparing a drug and using a channel blocker has been established.
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
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 a method comprising preparing a drug for the treatment and prevention of 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 preventing liver fibrosis using the claimed method comprising preparing a drug of any kind for at least one of treatment and prevention of liver fibrosis using any channel blocker. Therefore, the connection between Applicants’ results and the prevention and treatment of liver fibrosis using a channel blocker, in view of the claimed method and Specification is at best hypothetical. Applicants have not established any such connection in any of the embodiments.
Therefore, 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.
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 1-10 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.
Regarding claims 1-10, the claims recite “A[n] application method of a channel blocker…”. It is unclear whether this is a method of treatment, a method of making a drug or a method of using a drug. It is unclear whether Applicant intends to claim that the channel blocker is being used to prepare a composition for treating liver fibrosis, or that the channel blocker is being used to prepare another pharmacologic compound altogether. The lack of clarity renders the claims indefinite since the resulting claims do not clearly set forth the metes and bounds of the patent protection desired.
Claim 1, in particular, further recites functional language without any structure: “… preparing a drug for at least one of treatment and prevention of liver fibrosis by a channel blocker…”. There is no actual treatment or administration, and only mere statements of intended use. The claim does not allow for a clear definition of the structure of the claimed method. The “at least one of” is also unclear, and indefinite as the metes and bounds cannot be clearly ascertained.
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 1-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US FDA Dilantin® (Phenytoin Sodium) (“FDA”) (2009).
Applicant is claiming an application method of a channel blocker, comprising: preparing a drug for at least one of treatment and prevention of liver fibrosis, using a channel blocker (c.f., phenytoin sodium in claim 2).
Considering the lack of clarity around the claims, independent claim 1 is interpreted as a method of treatment and prevention of liver fibrosis: the method comprising use of a channel blocker (i.e., phenytoin sodium).
FDA teaches a compound in claim 1 that anticipates the structure of phenytoin sodium. It is used as an antiepileptic drug (page 1).
The Applicant’s limitation “preparing a drug for at least one of treatment and prevention of liver fibrosis” 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 being 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 anticipates the applicants claim. Dependent claims 2-10 are also rejected.
Conclusion
No claims are allowed.
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/C A/Examiner, Art Unit 1622 March 6, 2026
/JAMES H ALSTRUM-ACEVEDO/
Supervisory Patent Examiner, Art Unit 1622