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 .
Information Disclosure Statement
The information disclosure statement (IDS) dated May 7, 2026 was in compliance with the provisions of 37 CFR 1.97 and 1.98. Accordingly, the IDS document was considered and signed copies of the 1449 forms are attached.
Response to Remarks and Amendments
Applicant’s response filed June 29, 2026 has been entered and is considered herein. Any rejection not reiterated herein is withdrawn.
With regard to the rejection of claims 22-23 and 27-29 under 35 USC 112(b), the rejection is withdrawn in view of the claim amendment to remove all “notably” and “in particular” clauses from the claims.
With regard to the rejection of claims 18 and 27-29 under 35 USC 112(a), the rejection is withdrawn in view of the claim amendment to cancel claim 18 and amend claims 27-29 to depend from claim 17.
With regard to the rejection of claims 17-25, 27-30 and 33-36 under 35 USC 102 as being anticipated by Le Cann et al., Applicants traverse the rejection on several grounds, each of which was considered but was not found persuasive to overcome the rejection. Applicant contends that Le Cann fails to disclose each and every element of the claims, citing the Federal Circuit Perricone v. Medicis Pharm. Corp. case for supposed similarities which preclude the instant finding of anticipation. In the Perricone case, the claims required topical application for skin sunburn, while the art did not suggest the application of the same lotion to skin sunburn. In the Federal Circuit case, the rejection was based on what would happen if the composition were applied to skin sunburn, but neglected the fact that the art did not actually teach that application. Although Applicant contends that the fact pattern in the present instance is similar, the examiner disagrees since the Le Cann reference actually does teach the administration of the same compound to a subject (i.e. mouse) model of disease. Accordingly, the fact pattern is distinct from the case law cited by Applicants because it is not based on a hypothetical administration, but rather on the administration of a known compound for treating hepatitis, which reads on the claimed invention. Further, with respect to the traversal of the rejection over claim 30, which requires an in vitro method of ferroptosis inhibition, it is noted that the only active step required by the claim is adding the compound to a biological material. There is no limitation on the biological material, such that the argument regarding FADD-deficient Jurkat cells previously contacted with TNF-a is not persuasive. The elected species was applied to a biological material, and no ferroptosis occurred, which is necessarily the outcome of applying the same compound to an anticipatory material (i.e. any biological material as claimed).
Accordingly, for at least the foregoing reasons as well as those described in the original rejection, the rejection is still deemed to be proper and is maintained herein
Election/Restrictions
In accordance with the MPEP, if upon examination of the elected species, no prior art is found that would anticipate or render obvious the instant invention based on the elected species and the claims drawn to the elected species are allowable, the search of the Markush-type claim will be extended (see MPEP 803.02). If prior art is then found that anticipates or renders obvious the non-elected species, the Markush-type claim will be rejected. It should be noted that the prior art search will not be extended unnecessarily to cover all non-elected species. Should Applicant overcome the rejection by amending the claim, the amended claim will be reexamined. Id. The prior art search will be extended to the extent necessary to determine patentability of the Markush-type claim. Id. In the event prior art is found during reexamination that renders obvious or anticipates the amended Markush-type claim, the claim will be rejected and the action made final. Id.
As indicated above, the Examiner searched the claimed invention based on the elected species, wherein: the elected species was not found to be allowable over the prior art. Thus the scope of the search and examination was not expanded beyond the elected species of sibriline. Since the elected species remains rejected by the prior art, the scope of the search and examination remains the same as that previously indicated.
Status of Claims
Currently, claims 17 and 19-38 are pending in the instant application. Claims 26 and 31-32 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a non-elected invention and/or species. Claims 17, 19-25, 27-30 and 33-38 read on an elected species and therefore remain under consideration in the instant application to the extent that they read on the elected embodiment.
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.
Claim 38 is 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a new matter rejection.
In particular, the amendment which inserts the limitation “wherein the disorder associate with ferroptosis is not an immune-dependent hepatitis" is not supported by the originally filed disclosure. Regarding an amendment to insert a proviso or negative limitation, MPEP 2173.05(i) provides the following guidance: Any negative limitation or exclusionary proviso must have basis in the original disclosure. If alternative elements are positively recited in the specification, they may be explicitly excluded in the claims. See In re Johnson, 558 F.2d 1008, 1019, 194 USPQ 187, 196 (CCPA 1977) (“[the] specification, having described the whole, necessarily described the part remaining.”). See also Ex parte Grasselli, 231 USPQ 393 (Bd. App. 1983), aff’d mem., 738 F.2d 453 (Fed. Cir. 1984). The mere absence of a positive recitation is not basis for an exclusion [emphasis added].
Claims which change the scope relative to the originally filed claims may lack written description, see In re Ruschig, 371 F.2d 990, 154 USPQ 118 (CCPA) 1967) which supports that the original disclosure of a large genus did not support a later filed claim to a previously unnamed single species. Furthermore, Purdue Pharma L.P. v. Faulding Inc., 230 F.3d 1320, 1326, 56 USPQ2d 1481, 1486 (Fed. Cir.2000) notes that with respect to In re Ruschig, that “Ruschig makes clear that one cannot disclose a forest in the original application, and then later pick a tree out of the forest and say “here is my invention”. In order to satisfy the written description requirement, the blazemarks directing the skilled artisan to that tree must be in the originally filed disclosure.”
In this situation, the claimed method excludes hepatitis treatment where the hepatitis is dependent upon the immune system. The specification as filed does disclose “chronic infections such as hepatitis,” but the inserted claim language is broader than this disclosure. For example, autoimmune hepatitis also depends upon the immune system but is not a chronic infection as disclosed. There is also hepatitis dependent upon an acute infection, such as Hepatitis A, which is typically resolved quickly and thus not covered by the disclosed “chronic infection” language. As such, the application as originally filed contains no positive recitation of the entirety of the scope of “immune-dependent hepatitis,” and therefore no support for the inclusion of the exclusionary proviso.
Claim Rejections - 35 USC § 102
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 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 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.
Claim(s) 17, 19-25, 27-30 and 33-37 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Le Cann et al.
The prior art teaches the instantly elected species sibriline (Sib) as an inhibitor of necroptosis, which inhibits necroptotic cell death in human or mouse cells while not protecting from caspase-dependent apoptosis (see Abstract). The reference goes on to teach that Sib is a RIPK1 inhibitor and was administered to mice and found to have a therapeutic effect against concanavalin A-induced hepatitis. With respect to instant claim 30, the prior art teaches an in vitro method involving the addition of Sib to FADD-deficient Jurkat cells, which reads on the claimed biological material (p. 3052), where the addition is taught to decrease cell death.
Notably, any effect of the claimed administration (e.g. inhibiting ferroptosis or treating/preventing a disease associated therewith) would necessarily occur upon administration of an anticipatory compound to an anticipatory patient population. Finally, since the prior art teaches the administration of sibriline to mice, the anticipatory compound necessarily has the claimed effect recited in the instant claims, including for the treatment of hepatitis. Further, since the instant claims recite prevention of diseases, it is noted that the patient to which the compound is administered need not actually have the disease recited in the claims in order for the administration to be anticipatory. Accordingly, since the art teaches each required limitation of the instant claims, the claims are anticipated.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Alicia L. Otton whose telephone number is (571)270-7683. The examiner can normally be reached on Monday - Thursday, 8:00-6:00.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Mr. Fereydoun Sajjadi can be reached on 571-272-3311. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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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/ALICIA L OTTON/Primary Examiner, Art Unit 1699
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