Ate 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 .
Priority
This application is a 371 of PCT/EP2022/061994 05/04/2022. Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. EP 21172027.1, filed on 05/04/2021.
Status of Claims
Claims 1-15 are rejected to and under examination.
Allowable Subject Matter
No claims are allowed
Claim Rejections - 35 USC § 112
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 1-9, and 11-15 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.
The metes and bounds of claims 1-9, and 11-15 are rendered uncertain by the phrase “preferably” in claim 1, because it is not clear what the Applicant is claiming as a required limitation of the claim. A preference of a limitation to be present or not does not lend weight to the scope of a claim.
The metes and bounds of claim 11 are rendered uncertain by the phrase “A compound as defined in claim 1…for use as a medicament” because it is not clear whether Applicant is claiming the compound as a product while merely describing its use, or is intending to claim a method of using the compound to treat a disease in a subject in need thereof, as there are no active method steps recited in the claim.
The metes and bounds of claim 13 are rendered uncertain by the phrase “A compound as defined in claim 1…for use in the amelioration, prevention, and/or disease….” because it is not clear whether Applicant is claiming the compound as a product while merely describing its use, or is intending to claim a method of using the compound to treat a disease in a subject in need thereof, as there are no active method steps recited in the claim.
The metes and bounds of claim 14 are rendered uncertain by the phrase “The compound for use of claim 13, wherein the disease caused by or related to…” because it is not clear whether Applicant is claiming the compound as a product while merely describing its use, or is intending to claim a method of using the compound to treat a disease in a subject in need thereof, as there are no active method steps recited in the claim.
The metes and bounds of claim 15 are rendered uncertain by the phrase “The compound for use of claim 13, wherein the disease caused by or related to…” because it is not clear whether Applicant is claiming the compound as a product while merely describing its use, or is intending to claim a method of using the compound to treat a disease in a subject in need thereof, as there are no active method steps recited in the claim.
Attempts to claim a process without setting forth any steps involved in the process generally raises an issue of indefiniteness under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. For example, a claim which read: "[a] process for using monoclonal antibodies of claim 4 to isolate and purify human fibroblast interferon" was held to be indefinite because it merely recites a use without any active, positive steps delimiting how this use is actually practiced. Ex parte Erlich, 3 USPQ2d 1011 (Bd. Pat. App. & Inter. 1986).
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 Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 11, 13, 14, and 15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter. The recitations of “A compound for use as…” and “A compound for use in…” fails to particularly point out subject matter that falls within the four statutory categories, which include processes, machines, manufactures, and compositions of matter, because it merely describes the application of compound without a recitation of active steps in the claim. It is not definite as to whether the applicant intends to claim the compound as a composition of matter, or the use of the compound as a process, such as in a method of treatment.
It is appropriate to reject a claim that recites a use but fails to recite steps under 35 U.S.C. 101 and 35 U.S.C. 112(b) if the facts support both rejections. For failure to recite a claim within one of the statutory classes under 35 U.S.C. 101, the appropriate form paragraph is 7.05.01. For indefiniteness under 35 U.S.C. 112(b), the appropriate form paragraph is 7.34.01. (MPEP 2173.05(q))In an effort to advance prosecution, the examiner is examining these claims to the extent that the claims are drawn to methods of treating a disease by administering the claimed compound to a subject in need thereof.
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 1-15 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 certain species of the compounds of claim 1, including example compounds 1, 2, 4, 5, 7, 10, 12, 17, 23, 26, 27, 40, 41-44, 50, 56, 72, 74, 77, 98, 99, 100-102, wherein H NMR characterization and synthesis steps have been provided by the Applicant, and a method of treating ALS by administering the Example 1 compound to a subject in need thereof, does not reasonably provide enablement for the full scope of compounds claimed, and treating or preventing the full scope of disease states as currently claimed by administering all of the presently claimed compounds of 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 practice the invention commensurate in scope with these claims.
Enablement is considered in view of the Wands factors (MPEP 2164.01(A)). These include: nature of the invention, breadth of the claims, guidance of the specification, the existence of working examples, state of the art predictability of the art and the amount of experimentation necessary. All of the Wands factors have been considered with regard to the instant claims, with the most relevant factors discussed below.
Nature of the Invention: The nature of the invention is complex in that the compound, as claimed, includes a broad range of species, wherein the Applicant only teaches how to make select species and provides H NMR data for examples 1, 2, 4, 5, 7, 10, 12, 17, 23, 26, 27, 40, 41-44, 50, 56, 72, 74, 77, 98, 99, 100-102. The Applicant also claims treating or preventing the full scope of disease states as currently claimed by administering all of the presently claimed compounds of claim 1. However, the efficacy of all of the claimed compounds in the context of the claimed method is not demonstrated. The Applicant only provides disclosure for treating ALS using the compound set forth in Example 1 of Table 1, and prevention, as claimed, is undeterminable and not a guaranteed outcome. The Applicant has not provided sufficient disclosure in light of what was well known to one skilled in the art, as of the Applicant’s effective filing date, commensurate with the scope of the claimed invention.
Breadth of the Claims: The claims are broad in that the claims recite at least 102 species of compounds, as well as a method for amelioration, prevention and/or treatment of a disease caused by or related to delipidation of a neural tissue, preferably by inhibiting the expression and/or activity of the enzyme Carnitin-Palmitoyl-Transferase-1 (CPT-1), by administering to a subject in need thereof, any compound as defined in claim 1, wherein the disease caused by or related to delipidation of a neural tissue is Morbus Alzheimer, Morbus Parkinson, amyotrophic lateral sclerosis (ALS), inflammatory diseases, acute traumatic events such as surgery or injury, AIDS related wasting due to the toxicity of reverse transcriptase inhibitors, mitochondrial myopathies, senescence and ageing, neuronal ischemia, a polyglutamine disease, dystonia, Leber's heredity optic neuropathy (LHON), schizophrenia, stroke, myodegenerative disorders, Mitochondrial Encephalomyopathy Lactic Acidosis and Strokelike Episodes (MELAS), Myoclonic Epilepsy associated with Ragged-Red Fibers (MERRF), Neuropathy, Ataxia, and Retinitis Pigmentosa (NARP), Progressive External Ophthalmoplegia (PEO), Leigh's disease, Kearns-Sayres Syndromes, muscular dystrophy, myotonic distrophy, chronic fatigue syndrome, Friedreich's Ataxia; developmental delay in cognitive, motor, language, executive function or social skills; epilepsy, peripheral neuropathy, optic neuropathy, autonomic neuropathy, neurogenic bowel dysfunction, sensorineural deafness, neurogenic bladder dysfunction, migraine; renal tubular acidosis, hepatic failure, lactic acidemia, parodontosis, Duchenne muscular dystrophy, Becker's muscular dystrophy, McArdle's disease, abnormities of the testosterone synthesis and/or hypoparathyroidism.
The complex nature of the subject matter of this invention is greatly exacerbated by the breadth of the claims.
Guidance of the Specification and Existence of Working Examples: The specification shows H NMR data and synthesis steps for the select species examples 1, 2, 4, 5, 7, 10, 12, 17, 23, 26, 27, 40, 41-44, 50, 56, 72, 74, 77, 98, 99, 100-102, and shows experimental data using the compound of Example 1 in Table 1, in SOD1 G93A mice which is known in the art to be a mouse model for human ALS research.
However, no working examples are given for the full scope of compounds in claim 1, or treating or preventing the full scope of diseases currently claimed, using the full scope of compounds as claimed in claim 1.
While it is noted that the applicant has shown synthesis steps and H NMR data for select species of compound, as well as some data for activity in treating ALS in a relevant mouse model with the compound of Example 1 in Table 1, the applicant is not enabled for the full scope of compounds in claim 1, or prevention of the full scope of diseases in currently claimed, using the full scope of compounds as claimed in claim 1.
Predictability and State of the Art: The state of the art at the time the invention was made was unpredictable and underdeveloped. It is known in the art that prevention of a disease such as ALS is undeterminable and not guaranteed, as development of ALS is highly dependent on multiple unpredictable or unpreventable factors including individual genetic disposition, demographic, environmental exposures, etc.
It is also known that small changes in chemical structure of a compound can lead to unpredictable changes in biological activity, as taught by (Roy, Kunal, and Arkaprava Banerjee. Activity Cliffs. SpringerBriefs in Molecular Science, Cham, Springer Nature Switzerland, 2025. Accessed 13 Feb. 2026).
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The Applicant’s enabled Example 1 compound is shown below on the left, followed by Example 64 and Example 77, which are species of the Applicant’s claim 1.
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The alterations in Example 64 and Example 77 when compared to the representative Example 1 result in overall change in geometry and electronic profile of the compound, resulting in undue experimentation for one skilled in the art to be able to practice the claimed method using the full scope of compounds in claim 1.
Amount of Experimentation Necessary: The quantity of experimentation necessary to carry out the claimed invention is high, as the skilled artisan could not rely on the prior art or instant specification to teach how to prevent the full scope of diseases by administering to a subject in need thereof the full scope of compounds as claimed.
In order to carry out the claimed invention, one of ordinary skill in the art would have to
discover synthesis steps for all of the claimed compounds and confirm through H NMR data, as well as determine prevention, as claimed, requiring one to administer all of the compounds in claim 1 as regular, prophylactic dosing over the course of a long enough period of time under conditions where it would be certain that all of the diseases claimed would develop, which would be an impossible experimental setup due to the duration and the lack of a true control group. One skilled in the art would need to determine treatment, as claimed, for all of the diseases claimed using the full scope of compounds in claim 1.
In view of the breadth of the claims and the lack of guidance provided by the specification as well as the unpredictability of the art, the skilled artisan would have required an undue amount of experimentation to make and/or use the claimed invention. Therefore, claims 13 and 14 are not considered to be fully enabled by the instant specification.
Double Patenting Rejection
The non-statutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A non-statutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on non-statutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a non-statutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
(Of Note: The following double patenting rejections are PROVISIONAL)
Claims 1-12 are provisionally rejected on the ground of non-statutory double patenting as being unpatentable over the following claims of Co-pending Application No. 18/570,866: 12, and 14 (for present claims 1-12).
Although the claims are not identical, they are not patentably distinct from one another because the claims of the co-pending application are drawn to the same compound of the instant application. The co-pending claims 12 and 14 are all drawn to the same compound, formula (I) and formulations thereof. A notable limitation in the co-pending that is not in that of the Applicant includes a method of using the compound of formula (I) to treat sepsis. The co-pending application including this method of using a compound of formula (I) anticipates the instant Applicant’s compound of formula (I), without this method.
It would have been prima facie obvious to one skilled in the art to arrive at the Applicant’s instant claims, in view of the claims of co-pending application 18/570,866. This is a provisional non-statutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
/OROD MOTEVALLI/Examiner, Art Unit 1628
/JARED BARSKY/Primary Examiner, Art Unit 1628