Detailed Action
The present office action is in response to the response filed on 03 Jun 2026.
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
Claims 1-20 of the pending application have been examined on the merits.
Priority
Applicants identify the instant application, Serial #: 18/607,228, filed 15 Mar 2024, as claiming priority from Provisional Application #: 63/490,747, filed 16 Mar 2023.
Response to Applicant Election
Acknowledgement is made of the remarks filed 03 Jun 2026.
Applicant’s election without traverse of losmapimod as the compound in the reply filed on 03 Jun 2026 is acknowledged. A search for the elected compound returned prior art.
Examiner notes that the relevant anticipation rejection below is based upon art which was found incidental to the search for the elected species. The additional art found is relevant to the claims addressing species treat Leigh Syndrome with a p38 inhibitor. This is not indicative that the entire scope of the claims has been examined; however, the following art is being applied in an effort to promote compact prosecution of the case.
Claim Warning
Applicant is advised that should claim 12 be found allowable, claim 17 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim Objections
Claims 4 and 12 are objected to because of the following informalities: Claims 4 and 12 repeat the term “talmapimod” as a species of p38 MAPK inhibitor. Applicant may overcome this objection by amending the claims to remove the second instance of talmapimod. Appropriate correction is required.
Claim Rejections - 35 USC § 112(a)
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 1-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a method of treating ECHS1-mediated Leigh syndrome by administering to a patient in need thereof a compound selected from a p38 MAPK inhibitor or a compound from Table 1 of the specification (paragraph [0079]), does not reasonably provide enablement for treating all ECHS1 mediated diseases or conditions or Leigh syndrome not mediated by ECHS1 with all compounds from the chemical inhibitor classes found in claim 1. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
To be enabling, the specification of the patent application must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557, 1561 (Fd. Cir. 1993). Explaining what is meant by "undue experimentation," the Federal Circuit has stated that:
The test is not merely quantitative, since a considerable amount of experimentation is permissible, if it is merely routine, or if the specification in question provides a reasonable amount of guidance with respect to the direction in which experimentation should proceed to enable the determination of how to practice a desired embodiment of the claimed invention. PPG v. Guardian, 75 F.3d 1558, 1564 (Fed. Cir. 1996). As pointed out by the court in In re Angstadt, 537 F.2d 498 at 504 (CCPA 1976), the key word is "undue", not "experimentation".
The factors that may be considered in determining whether a disclosure would require undue experimentation are set forth In re Wands, 8 USPQ2d 1400 (CAFC 1988) at 1404 wherein, citing Ex parte Forman, 230 USPQ 546 (Bd. Apls. 1986) at 547 the court recited eight factors:
the quantity of experimentation necessary,
the amount of direction or guidance provided,
the presence or absence of working examples,
the nature of the invention,
the state of the prior art,
the relative skill of those in the art,
the predictability of the art, and
the breadth of the claims
These factors are always applied against the background understanding that scope of enablement varies inversely with the degree of unpredictability involved. In re Fisher, 57 CCPA 1099, 1108, 427 F.2d 833, 839, 166 USPQ 18, 24 (1970). Keeping that in mind, the Wands factors are relevant to the instant fact situation for the following reasons:
The nature of the invention, state and predictability of the art, and relative skill of those in the art
The invention relates to methods of treating Leigh syndrome or ECHS-1 mediated diseases comprising administering a compound selected from the group consisting of
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The relative skill of those in the art is high, generally that of an M.D. or Ph.D. The artisan using Applicant' s invention would generally be a physician with a M.D. degree and several years of experience.
The factor is outweighed, however, by the unpredictable nature of the art. It is well established that “the scope of enablement varies with the degree of unpredictability of the factors involved” and physiological activity is considered to be an unpredictable factor. See In re Fisher, 166 USPQ 18, at 24 (In cases involving unpredictable factors, such as most chemical reactions and physiological activity, the scope of enablement obviously varies inversely with the degree of unpredictability of the factors involved); Nationwide Chemical Corporation, et. al. v. Wright, et. al., 192 USPQ 95 (one skilled in chemical and biological arts cannot always reasonably predict how different chemical compounds and elements might behave under varying circumstances); Ex parte Sudilovsky 21 USPQ2d 1702 (Applicant' s invention concerns pharmaceutical activity.); In re Wright 27 USPQ2d 1510 (the physiological activity of RNA viruses was sufficiently unpredictable that success in developing specific avian vaccine was uncertain). As illustrative of the state of the art, the examiner cites Sharpe et al. (Cells, 2018, 7: doi:10.3390/cells7060046), hereinafter Sharpe, Masnada et al. (Eur J Paediatr Neurol, 2020, 28:151-158), hereinafter Masnada, and Lake et al. (Ann Neurol, 2016, 79:190-203), hereinafter Lake.
Sharpe, cited for evidence, teaches short chain enoyl-CoA hydratase (ECHS1) is responsible for the second step in fatty acid ß-oxidation and that deficiency in ECHS1 occurs early in life and presents as Leigh syndrome or Leigh-like syndrome, which is not typically observed in other fatty acid ß-oxidation disorders (pgs. 4-5). ECHS1 mutations have also been observed to display symptoms of paroxysmal exercise-induced dyskinesia (pg. 5). Mutations in this gene lead to a build-up in toxic metabolites which reduce activity of the pyruvate dehydrogenase complex in most patients and further lead to secondary oxidative phosphorylation pathway defects (pg. 9). The defects in oxidative phosphorylation do not occur in all patients and present differently in those that do have them, leading to uncertainty in the mechanism behind these disorders (pg. 9-10). Sharpe concludes that further research is required to clarify the relationship between ECHS1 deficiencies and oxidative phosphorylation dysfunction to advance diagnosis and treatment of ECHS1 deficiencies (pg. 10). The uncertainty of treatment for all ECHS1 disorders is further evidenced by Masnada, which teaches that only 49 patients have been reported up to the publishing of Masnada in 2020 and defining the clinical spectrum of ECHS1 dysfunction is difficult due to the absence of previous systematic reviews and descriptions of large series of patients (pg. 156, column 1).
The art further describes the unpredictability of treating all Leigh syndrome cases by only applying compounds which have an effect for treating ECHS1 dysfunction. Lake (2016), cited for evidence, teaches that Leigh syndrome, a progressive neurodegenerative disorder, is the most common clinical presentation of mitochondrial disease in children (pg. 190, column 1). Since the first report of the disorder, over 75 disease genes have been identified highlighting the remarkable heterogeneity of the disorder (pg. 190, column 1;and pg. 193, Table 1). Leigh syndrome has significant variation between patients with respect to age of onset, age of death, and symptomatology with onset occurring generally by 2 years of age and death by 3 years (pg. 190, column 2). Lake teaches the most common cause of Leigh syndrome is complex 1 deficiency, which is not related to ECHS1 defects (pg. 192, column 2; and pg. 193, Table 1). There is no effective treatment for Leigh syndrome as a group but that determining the molecular basis of the disease in a patient is important since several genetic and biochemical forms of Leigh syndrome can benefit from therapeutic intervention. 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.
These articles plainly demonstrate that the art of developing treatments for ECHS1-mediated disease and Leigh syndrome is extremely unpredictable, particularly in the case of a single compound or genus of compounds being used to treat all presentations of Leigh syndrome.
The breadth of the claims
Claim(s) 1-20 are very broad in terms of the type of diseases being treated and the types of compounds administered. All ECHS1-mediated diseases and all presentations of Leigh syndrome are treated by a wide variety of compounds.
The amount of direction or guidance provided and the presence or absence of working examples
The specification provides data that shows the effect of the compounds of Table 1 in treating an ECHS1-mediated Leigh syndrome model of fibroblasts (paragraphs [0079] and [0109]-[0119]) and fly larva (paragraphs [0120]-[0122]).
The specification provides no particular direction or guidance for determining the particular administration regimens (e.g., timing, administration routes, etc.) necessary to treat all of the various manifestations of Leigh syndrome or any ECHS1-mediated diseases encompassed by the claims.
The quantity of experimentation necessary
Because of the known unpredictability of the art (as discussed supra) and in the absence of experimental evidence commensurate in scope with the claims, the skilled artisan would not accept that any of the compound classes in claim 1 could be predictably used as a treatment for all ECHS1-mediated diseases or all molecular causes of Leigh syndrome. Genentech Inc. vs. Nova Nordisk states, "[A] patent is not a hunting license. It is not a reward for a search but a compensation for its successful conclusion and 'patent protection' is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable" (42 USPQ 2d 1001, Fed. Circuit 1997).
Accordingly, the instant claims do not comply with the enablement requirement of 35 U.S.C. 112(a), since to practice the claimed invention a person of ordinary skill in the art would have to engage in undue experimentation, with no assurance of success.
Claim Rejections - 35 USC § 112(b)
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, 13-14, 18 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, claim 1 is directed to a “method for treating a disease or condition mediated, at least in part, by ECHS1 enzyme in a patient in need thereof, the method comprising administering a therapeutically effective amount of a compound selected from [list of compounds].” However, it is unclear who the compound is being administered to. Claims 2-10 are rejected for failing to cure the deficiencies of claim 1. Applicant may overcome this rejection by amending the claim to clarify who the compound is administered to.
Regarding claim 13, the claim recites the limitation "the compound is administered in a pharmaceutical composition comprising a therapeutically effective amount of the compound the compound" in line 2. There is insufficient antecedent basis for the phrase “the compound.” Applicant may overcome this rejection by amending the claim to have proper antecedent basis to the independent claim.
Regarding claims 7, 14, and 18, the claims recite a method wherein the patient is “further administered a therapeutically effective amount of an additional therapeutic agent.” The phrase “additional therapeutic agent” is very broad in its scope and encompasses any agent which may have therapeutic effect. While the specification provides examples of “additional therapeutic agents” (paragraph [0050]) there is no limiting definition provided. The therapeutic agents of the claim could therefore be anything with some therapeutic effect resulting in an unlimited number of choices. The lack of boundaries regarding what counts as a therapeutic agent results in claims 7, 14, and 18 being indefinite.
Improper Markush Grouping Rejection
Claims 1-2 and 5-10 are rejected on the basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117.
Regarding claims 1 and 5-10, claim 1 is directed to a method for treating a disease or condition mediated by ECHS1 in a patient in need by administering one of a wide variety of compounds. The compounds are selected from:
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The Markush grouping is improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons: The Markush group of claim 1 does not meet the requirement that all members of the group are of the same recognized physical or chemical class. For example, p38 MAPK inhibitors have a different use than deubiquitinase inhibitors. Further, based on the breadth of the structures claimed, the artisan would have no reasonable expectation of success that all compounds claimed would have the same use. Claims 5-10 are rejected for failing to remedy the deficiencies of claim 1.
Regarding claim 2, claim 2 is directed to the method of claim 1 where the compound is selected from:
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The Markush grouping is improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons: The Markush group of claim 2 does not meet the requirement that all members of the group are of the same recognized physical or chemical class. For example, while ralimetinib and losmapimod are p38 MAPK inhibitors, these compounds have a different use than PPY-A which is a Abl kinase inhibitor. Further, based on the breadth of the structures claimed, the artisan would have no reasonable expectation of success that all compounds claimed would have the same use.
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use.
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 (i.e., changing from AIA to pre-AIA ) 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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
The following anticipation rejections below are based upon art which was found incidental to the search for the elected species. The additional art found is relevant to the claims addressing treating Leigh syndrome with a p38 inhibitor. This is not indicative that the entire scope of the claims has been examined; however, the following art is being applied in an effort to promote compact prosecution of the case.
Claim(s) 1, 3, 5-7, 9, 11, and 13-14 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by WO 2023/097328, hereinafter ‘328. ‘328 was published on 01 Jun 2023 after the effective filing date of the instant application. However, ‘328 claims priority to Provisional Application # 63/284,003, filed 29 Nov 2021.
The instant claims are directed to methods of treating ECHS1-meditiated diseases and conditions by administering a variety of compounds (claim 1). In the reply filed 03 Jun 2026 applicant elected losmapimod as the species of compound. The claims further limit the disease or condition to a neurodegenerative disease or condition (claim 5) which is further limited to Leigh syndrome (claims 6, 11, and 17). The claims further limit the type of compound which may be administered (claims 2-4, 11-12, and 17) and include a pharmaceutical composition of the compound and an acceptable excipient (claims 9 and 13). The instant claims also include administration of an additional therapeutic agent (claims 7, 14, and 18) which is further limited to thiamine (claims 8, 15, and 19). Finally, the age of the patient is limited to less than 3 years old (claims 10, 16, and 20).
‘328 teaches a composition for the treatment of a mitochondrial disease which includes at least one agent selected from (+) epicatechin, (-)-epicatechin, ΙΙ-β-hydroxypregnenolone, 11-
hydroxyprogesterone, probucol, glucose, N-acetylcysteine, cysteine bitartrate, and nicotinic acid,
niacin, or niacinamide, in a pharmaceutically acceptable carrier (pg. 35, claim 1). ‘328 further teaches that the composition may include MAPK-modulators or p38 inhibitors (pg. 20, lines 15-20; and pg. 35, claim 9). One of the diseases which may be treated with this composition is identified as Leigh syndrome (pg. 36, claim 12). Therefore, the reference anticipates the instant claims to treating Leigh syndrome with a p38 MAPK inhibitor in a pharmaceutical composition and with an additional agent.
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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 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 nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-20 is/are rejected under 35 U.S.C. 103 as being obvious over ‘328 further in view of Mellion et al. (Br J Clin Pharmacol, 2021, 87:4661-4672), hereinafter Mellion, Ortigoza-Escobar et al. (Brain, 2016, 139:31-38), hereinafter Ortigoza-Escobar, and Lake et al. (Ann Neurol, 2016, 79:190-203), hereinafter Lake.
‘328 teaches a composition for the treatment of a mitochondrial disease which includes at least one agent selected from (+) epicatechin, (-)-epicatechin, ΙΙ-β-hydroxypregnenolone, 11-hydroxyprogesterone, probucol, glucose, N-acetylcysteine, cysteine bitartrate, and nicotinic acid, niacin, or niacinamide, in a pharmaceutically acceptable carrier (pg. 35, claim 1). ‘328 further teaches that the composition may include MAPK-modulators or p38 inhibitors (pg. 20, lines 15-20; and pg. 35, claim 9). One of the diseases which may be treated with this composition is identified as Leigh syndrome (pg. 36, claim 12). However, ‘328 does not teach losmapimod as the p38 inhibitor, treating with thiamine, or treating a patient less than 3 years old.
Mellion teaches a phase 1 clinical trial using losmapimod to treat FSHD (Abstract). Losmapimod is a selective p38α/ß MAPK inhibitor which is unlikely to have clinically relevant drug-drug interaction with substrates or inhibitors of cytochrome P450, P-clycoprotein, human organic anion transporting polypeptides 1B1 and 1B3, human organic anion transporter 1, or human renal organic cation transporter 2 (pg. 4662, column 1). Mellion further teaches the treatment was well tolerated with no serious adverse events (Abstract).
Ortigoza-Escobar teaches that thiamine supplementation in children with Leigh syndrome restores CSF and intra-cellular thiamine levels and recommends patients presenting with Leigh syndrome be promptly treated with a vitamin cocktail including thiamine and biotin (pg. 37, column 2).
Lake teaches Leigh syndrome is a progressive encephalopathy that represents the most common pediatric presentation of a defined mitochondrial disease (pg. 482, column 1). Leigh syndrome normally occurs by age 2 and frequently ends in death by age 3 years (pg. 482, column 2).
Based on the teachings of ‘328, Mellion, and Lake the person of ordinary skill in the art would select losmapimod out of the possible p38 inhibitors to treat Leigh syndrome, as taught by ‘328 and Mellion, because losmapimod is unlikely to have interactions with cytochrome P450 and as a drug that is well tolerated with no serious adverse events. It would further be obvious to the artisan having ordinary skill in the art to treat Leigh syndrome in a patient less than 3 years old because Leigh syndrome frequently ends in death by age 3, taught by Lake.
Based on the teachings of ‘328, Mellion, and Ortigoza-Escobar, it would be prima facie obvious to one having ordinary skill in the art to combine the composition of (+) epicatechin, (-)-epicatechin, ΙΙ-β-hydroxypregnenolone, 11-hydroxyprogesterone, probucol, glucose, N-acetylcysteine, cysteine bitartrate, and nicotinic acid, niacin, or niacinamide and losmapimod, taught by ‘328 and Mellion, with the composition of thiamine and biotin, taught by Ortigoza-Escobar to create a third composition for the treatment of Leigh syndrome with a reasonable expectation of success. See In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).
A reference is good not only for what it teaches by direct anticipation but also for what one of ordinary skill in the art might reasonably infer from the teachings (In re Opprecht 12 USPQ 2d 1235, 1236 (Fed Cir. 1989); In re Bode 193 USPQ 12 (CCPA) 1976). In light of the foregoing discussion, the examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103. From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. U.S. 2022/0133648 is considered pertinent for teaching methods of treating Leigh syndrome and Leigh-like syndrome. Wang et al. (Oncotarget, 2016, 7:80131-80139) is considered pertinent for teaching treatment of Leigh syndrome by administration of rapamycin.
Conclusion
No claim is allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jonathan D. Mahlum whose telephone number is (703)756-4691. The examiner can normally be reached 8:30 AM - 5:00 PM ET, M-F.
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/J.D.M./Examiner, Art Unit 1625
/Andrew D Kosar/Supervisory Patent Examiner, Art Unit 1625
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