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 Claims and Claim Numbering
The amendments to the claims filed January 17, 2023 are acknowledged and entered.
NOTE : The applicants are reminded that the claims were renumbered under Rule 1.126. There were two claims 4, thus claim 4 (the second occurrence) and 5-8 have been renumbered to claims 5-9.
Claim 5 is canceled. Claims 1-4 and 6-9 are pending.
Specification
The specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any of the errors of which applicant may become aware of in the specification.
Priority
This application is a CON of PCT/US2021/041569, filed July 14, 2021, which claims the benefit of 63/054,515, filed July 21, 2020.
Information Disclosure Statement
Acknowledgement is made of the Information Disclosure Statements filed on January 17, 2023 and February 7, 2023. All references have been considered except where marked with a strikethrough.
Election/Restriction
Applicant's election with traverse of Group II, presently renumbered claims 6-8 in the reply filed on August 25, 2025, and election of species corresponding to LIP-1 (pictured below for convenience) in the Supplemental Response to Restriction Requirement filed December 15, 2025 are acknowledged. The traversal is on the ground(s) that the instant claims are essentially the same as those of the parent PCT application (PCT/US2021/41569). Unity of invention was found in the parent PCT application, and all of the claims in the parent PCT application were searched and examined. This is not found persuasive because it does not point out any errors in the requirement for restriction. Moreover, in the present case the proper analysis is whether the inventions are independent or distinct. Restriction is proper for the reasons set forth in the restriction requirement.
The requirement is still deemed proper and is therefore made FINAL.
Claim 1-4 and 9 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on August 25, 2025 .
Elected Species
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Applicant states that elected claims 5 and 7 (presently renumbered claims 6 and 8) read on this species (page 1 of Supplemental Response to Restriction Requirement filed December 15, 2025).
The guidelines in MPEP § 803.02 provide that upon examination if prior art is found for the elected species, the examination will be limited to the elected species. See MPEP § 803.02.
The elected species was found in the prior art and therefore the search was limited to the elected species.
Claim 5 (presently renumbered claim 6) does not require that the claimed ferroptosis inhibitor possess any particular structure.
Claims 6-7 (presently renumbered claims 7-8) require a compound of Formula (I) or Formula (II); however, the elected species is not a compound of Formula (I) or Formula (II). The elected species would require that variables X and Y of Formulae (I) or (II) are CH; however, if X and Y are CH then the other groups of the elected species do not fall within the scope of either generic Formulae.
Accordingly, renumbered claim 6 reads on the elected species.
Renumbered claims 7-8 (in full) and renumbered claim 6 (in part, other than the elected species) are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species.
Claim Objections
The claims are objected to because of the following informalities:
The instant claims contain two claims numbered “4” which confuses the record. One claim 4 is canceled and the other depends from claim 1 and recites wherein the inhibitor has the structure of formula (II). The claims should be numbered sequentially.
Claim 6 recites “a carrier therefor” and should instead recite “a carrier thereof” Appropriate correction is required.
Claim Rejections - 35 USC § 112a
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 6 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 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.
The claims require a “ferroptosis inhibitor”. The claims do not require that the ferroptosis inhibitor possess any particular conserved structure, or other distinguishing feature. Thus, the claims are drawn to a genus of compounds that is defined by novelty.
To satisfy the written-description requirement, the specification must describe every element of the claimed invention in sufficient detail so that one of ordinary skill in the art would recognize that the inventor possessed the claimed invention at the time of filing. Vas-Cath, 935 F.3d at 1563; see also Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572 [41 USPQ2d 1961] (Fed. Cir. 1997) (patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude that “the inventor invented the claimed invention”); In re Gosteli, 872 F.2d 1008, 1012 [10 USPQ2d 1614] (Fed. Cir. 1989) (“the description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed”). Thus, an applicant complies with the written-description requirement “by describing the invention, with all its claimed limitations, not that which makes it obvious,” and by using “such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention.” Lockwood, 107 F.3d at 1572.
According to the MPEP §2163 I. A. “the issue of a lack of adequate written description may arise even for an original claim when 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.” The MPEP states in §2163 II 3 ii) “The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice (see i)(A), above), reduction to drawings (see i)(B), above), or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus (see i)(C), above). See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.”
According to the MPEP §2163.02 Standard for Determining Compliance With the Written Description Requirement,
“The courts have described the essential question to be addressed in a description requirement issue in a variety of ways. An objective standard for determining compliance with the written description requirement is, “does the description clearly allow persons of ordinary skill in the art to recognize that he or she invented what is claimed". In re Gosteli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989). Under Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Fed. Cir. 1991), to satisfy the written description requirement, an applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention, and that the invention, in that context, is whatever is now claimed. The test for sufficiency of support in a parent application is whether the disclosure of the application relied upon “reasonably conveys to the artisan that the inventor had possession at that time of the later claimed subject matter". Ralston Purina Co. v. Far-Mar-Co., Inc., 772 F.2d 1570, 1575, 227 USPQ 177, 179 (Fed. Cir. 1985) (quoting In re Kaslow, 707 F.2d 1366, 1375, 217 USPQ 1089, 1096 (Fed. Cir. 1983)).”
This case was filed before Applicants had a clear idea of the structures of their desired compounds, how to make their compounds and how to use them.
Applicants are reminded of what the U.S. Court of Appeals Federal Circuit wrote in University of California v. Eli Lilly and Co. 43 USPQ2d 1398, "In claims involving chemical materials, generic formulae usually indicate with specificity what the generic claims encompass. One skilled in the art can distinguish such a formula from others and can identify many of the species that the claims encompass. Accordingly, such a formula is normally an adequate description of the claimed genus." "A definition by function, as we have previously indicated, does not suffice to define the genus because it is only an indication of what the gene does, rather than what it is.” See Fiers, 984 F.2d at 1169-71, 25 USPQ2d at 1605-06 (discussing Amgen). "It is only a definition of a useful result rather than a definition of what achieves that result." "The description requirement of the patent statute requires a description of an invention, not an indication of a result that one might achieve if one made that invention. See In re Wilder, 736 F.2d 1516, 1521, 222 USPQ 369, 372-73 (Fed. Cir. 1984) (affirming rejection because the specification does "little more than outlin[e] goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate.")".
Therefore, the full breadth of the claim fails to meet the written description provision of 35 U.S.C. §112, first paragraph. Applicant is reminded that Vas-Cath makes clear that the written description provision of 35 U.S.C. §112 is severable from its enablement provision
Claim 6 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 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. When a compound or composition claim is limited by a particular use, enablement of that claim should be evaluated based on that limitation. See In re Vaeck, 947 F.2d 488, 495, 20 USPQ2d 1438, 1444 (Fed. Cir. 1991) (claiming a chimeric gene capable of being expressed in any cyanobacterium and thus defining the claimed gene by its use).
In the present case, the claims are drawn to a composition which has an intended use of “extending lifespan”. Applicants have not demonstrated nor have they alleged there is any correlation between the assays they disclose beginning at page 255 of the specification (Therapeutic Examples) and clinical efficacy against any disease. Case law is clear on this point. In an unpredictable art, such as drug therapy to treat disease, in vitro assays may be used for enablement only if there is a well-established correlation between the assay and clinical efficacy. In the present case Applicant has not provided any evidence to show that the instant method treats any condition and the state of the prior art is not aware that there is any correlation between inhibition ferroptosis and the treatment of any disease. The scope of the alleged utility of “extending lifespan” is unclear as it has not been defined. Moreover, extension of lifespan is the effect of disease treatment generally (e.g. cancer is treated to extend lifespan). The utility itself of the claimed method is simply not enabled. Given the direction provided by Applicant, one skilled in the art could not practice the claimed methods without undue and unreasonable experimentation.
In evaluating the enablement question, several factors are to be considered. Note In re Wands, 8 USPQ2d 1400 and Ex parte Forman, 230 USPQ 546. The factors include: 1) The nature of the invention, 2) the state of the prior art, 3) the predictability or lack thereof in the art, 4) the amount of direction or guidance present, 5) the presence or absence of working examples, 6) the breadth of the claims, and 7) the quantity of experimentation needed. The determination that “undue experimentation” would have been needed to make and use the claimed invention is not a single, simple factual determination. Rather, it is a conclusion reached by weighing all the above noted factual considerations.
The nature of the invention & breadth of claims:
Claim 6 is drawn to a composition for extending lifespan in an organism, comprising an effective amount of a ferroptosis inhibitor, and a carrier therefor.
The nature of the invention is thus a composition which has the intended use of extending lifespan.
The specification does not provide any definition of what is intended by “extending lifespan”. Nor does the specification define “organism”. A person skilled in the art would recognized that extending lifespan is the effect of disease treatment generally (e.g. cancer treatment extends lifespan). Consequently, the scope of the claim is regarded as including disease treatment generally, including in a human organism, wherein the disease is treated by administration of a ferroptosis inhibitor.
The state of the prior art
The state of the prior art is not aware of any single agent which treats all diseases generally. Moreover, the only diseases that a person skilled in the art would recognize as treatable by a composition comprising a ferroptosis inhibitor would be those diseases for which there is an established correlation between inhibition of ferroptosis and treatment of the disease. In the present case, the state of the prior art does not appear to be aware of any correlation.
The Level of One of Ordinary Skill
The level of skill in the art is high. The artisan using the claimed invention would be a person with medical training such as a medical doctor or physician with an MD degree or the equivalent. Predictability in the art
It is noted that the pharmaceutical art is unpredictable, requiring each embodiment to be individually assessed for physiological activity. In re Fisher, 427 F. 2d 833, 166 USPQ 18 (CCPA 1970) indicates that the more unpredictable an area is, the more specific enablement is necessary in order to satisfy the statute. Pharmacological activity in general is a very unpredictable area. Note that in cases involving physiological activity such as the instant case, “the scope of enablement obviously varies inversely with the degree of unpredictability of the factors involved”. See In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970).
In terms of the law, MPEP 2107.03 states “evidence of pharmacological or other biological activity of a compound will be relevant to an asserted therapeutic use if there is a reasonable correlation between the activity in question and the asserted utility. Cross v. Iizuka, 753 F.2d 1040, 224 USPQ 739 (Fed. Cir. 1985); In re Jolles, 628 F.2d 1322, 206 USPQ 885 (CCPA 1980); Nelson v. Bowler, 626 F.2d 853, 206 USPQ 881 (CCPA 1980).” If correlation is lacking, it cannot be relied upon, Ex parte Powers, 220 USPQ 924; Rey-Bellet and Spiegelberg v. Engelhardt v. Schindler, 181 USPQ 453; Knapp v. Anderson, 177 USPQ 688. Indeed, the correlation must have been established “at the time the tests were performed”, Hoffman v. Klaus, 9 USPQ2d 1657.
Amount of guidance/working examples
Applicant provides therapeutic examples at pages 276-284 of the specification; however, it is unclear which conditions or diseases these experiments are intended to model. No experimental or other data is provided to show the instant compositions treat any particular condition within the scope of the claims. Moreover, it is presumed that “extending lifespan” of the claimed organism would require a method of identifying that an organism’s lifespan is extended as a result of the claimed composition. However, there is no direction in the record for objectively determining that the claimed ferroptosis inhibitor has the effect of extending the lifespan of an organism (e.g. human) as claimed. The specification does not provide any guidance to one of ordinary skill in the art to extrapolate the in vitro data provided by applicant to the treatment of all types of diseases claimed, and least of all to the many different forms of disease (e.g. all types of cancer) included in the scope of the claim. Applicant has provided no evidence to suggest that their models are indicative of a treatment of all forms of disease within the scope of the claim. As the Supreme Court said in Brenner v. Manson, 148 USPQ at 696: “a patent is not a hunting license. It is not a reward for the search, but compensation for its successful conclusion.” As U.S. Court of Customs and Patent Appeals stated In re Diedrich 138 USPQ at 130, quoting with approval from the decision of the board: “We do not believe that it was the intention of the statutes to require the Patent Office, the courts, or the public to play the sort of guessing game that might be involved if an applicant could satisfy the requirements of the statutes by indicating the usefulness of a claimed compound in terms of possible use so general as to be meaningless and then, after his research or that of his competitors has definitely ascertained an actual use for the compound, adducing evidence intended to show that a particular specific use would have been obvious to men skilled in the particular art to which this use relates.”
The quantity of experimentation needed:
MPEP 2164.01(a) states, "A conclusion of lack of enablement means that, based on theevidence regarding each of the above factors, the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557, 1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993)."
That conclusion is clearly justified here and one skilled in the art could not practice the claimed invention without undue and unreasonable experimentation.
Claim Rejections - 35 USC § 112b
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 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. MPEP § 2173.02(II) states “If the language of the claim is such that a person of ordinary skill in the art could not interpret the ‘metes and bounds’ of the claim so as to understand how to avoid infringement, a rejection of the claim under 35 USC 112(b) or pre-AIA 35 USC 112, second paragraph, is appropriate. See Morton Int’l, Inc. v. Cardinal Chem. Co., 5 F.3d 1464, 1470, 28 USPQ2d 1190, 1195 (Fed. Cir. 1993)”.
The following limitations are indefinite because a person skilled in the art has no way of ascertaining the metes and bounds of the invention and consequently what would constitute infringement of the claimed invention.
The limitation “ferroptosis inhibitor” in claim 6 is indefinite and unclear because it requires no structural or other features to guide a person skilled in the art to identify such a compound. The specification provides no direction (e.g. structural properties, chemical and physical characteristics) for ascertaining the metes and bounds of the limitation. Examiner recommends amending the claim to include Formula (I) and Formula (II).
The limitation “extending lifespan” in claim 6 is indefinite because the specification does not provide any direction for determining what is meant by “extending lifespan”. When and for how long is an organisms life span extended? What is the upper limit? How is a person skilled in the art supposed to know that life span is extended? The metes and bound of “extending lifespan” cannot be 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.
Claim 6 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Conrad et al. (WO2015007730A1)(hereinafter “Conrad”).
Conrad teaches a composition comprising compound N-2 (page 97, Table 1-N; claim 5; compound pictured below for convenience). Compound N-2 corresponds to Applicant’s elected species.
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Conrad teaches all structural limitations of the claimed invention and therefore anticipates the claim.
MPEP 2112 states “SOMETHING WHICH IS OLD DOES NOT BECOME PATENTABLE UPON THE DISCOVERY OF A NEW PROPERTY
[T]he 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 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).”
Conclusion
No claim is allowed.
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January 15, 2025
/K.S.M./Examiner, Art Unit 1624
/BRENDA L COLEMAN/Primary Examiner, Art Unit 1624