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 .
Claims 2-7, 12-14, 17 and 19-21 are canceled. Therefore, claims 1, 8-11, 15, 16, 18, 22 and 23 are currently pending in this Application.
Priority
CONTINUING DATA
This application is a 371 of PCT/EP2022/061545 04/29/2022
FOREIGN APPLICATIONS
UNITED KINGDOM GB2106130.4 04/29/2021
Information Disclosure Statement
Applicant’s Information Disclosure Statement, filed on October 27, 2023 has been considered. Please refer to Applicant’s copies of the 1449 submitted herewith.
Compact Prosecution
In the interest of compact prosecution, the examiner attempted to reach out to applicants to suggest Examiner’s Amendments to advance the prosecution of the case.
Claim Objections
Claims 1, 8-11, 15, 16 and 23 are objected to over the following informal issues, appropriate correction is required.
Claim 1, recites X1 and X2 O. The claims do recite “are”. It is suggested Applicants amend the claim as follows: X1 and X2 are O.
Claims 8-11 depend from claim 1 and each claim recites the article “ A “ at the beginning of each claim. In the interest of clarity, it is suggested to amend the claims the article “The” at the beginning of each claim.
Claims 15 and 16 are objected to for missing a period at the end of each claim. Appropriate correction is required
Claim 23 depend from claim 22 and the claim recites “ A method of treatment as claimed in claim 22“. In the interest of clarity, it is suggested to amend the claims as follows: The method of treatment as claimed in claim 22 …
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.
The primary purpose of this requirement of definiteness of claim language is to ensure that the scope of the claims is clear so the public is informed of the boundaries of what constitutes infringement of the patent. A secondary purpose is to provide a clear measure of what applicants regard as the invention so that it can be determined whether the claimed invention meets all the criteria for patentability and whether the specification meets the criteria of 35 U.S.C. 112, first paragraph with respect to the claimed invention.", (see MPEP § 2173).
Claim 23 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 pre-AIA the applicant regards as the invention.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) is considered indefinite, since the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). Note the explanation given by the Board of Patent Appeals and Interferences in Ex parte Wu, 10 USPQ2d 2031, 2033 (Bd. Pat. App. & Inter. 1989), as to where broad language is followed by "such as" and then narrow language. The Board stated that this can render a claim indefinite by raising a question or doubt as to whether the feature introduced by such language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. Note also, for example, the decisions of Ex parte Steigewald, 131 USPQ 74 (Bd. App. 1961); Ex parte Hall, 83 USPQ 38 (Bd. App. 1948); and Ex parte Hasche, 86 USPQ 481 (Bd. App. 1949).
Claim 23 recites the broad recitation “…mitochondrial diseases ..,” and the claim also recites, “( including for example poor growth, loss of muscle coordination, ….” which are the narrower statements of the range/limitation. The terms "including and for example" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Applicants also need to remove the parenthesis.
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 22 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.
Present claim 22 is drawn to a method of treatment or prevention of a disease or condition comprising administering to a patient in need thereof a therapeutically effective amount of the compound according to claim 1.
The present specification provides compounds of formula (I) and compositions thereof as suitable for the treatment of mitochondrial diseases such as cardiovascular diseases, endothelial cell disfunction, neurological disorders, liver disease etc. See pages 26-29.
The person of skill in the art would be able to extrapolate from the exemplary compounds and data present in the specification how to treat a mitochondrial diseases via administration of a compound of formula (I) of the disclosure.
There are no methods provided in order to extrapolate the method for the treatment of any disease, disorder or condition, which includes diseases other than the one recited in claim 23.
The Applicant is reminded of the written description guidelines set out by the USPTO in MPEP 2163:
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.
While the genus of diseases, disorders or conditions of the present invention are described by the specification to comprise mitochondrial diseases the description of treatment for all diseases or conditions is not sufficiently detailed to show that the Applicant was in possession of the full scope of the claimed invention, a method for the treatment of any disease, disorder or condition, at the time of filing.
Namely, that the definitions of proliferative diseases or conditions described above, while not being indefinite, are not sufficiently detailed in order to stand on their own as being adequately described. Therefore, the “representative number of species” standard is used to determine whether the claims are adequately described.
MPEP 2163 goes on to describe what a "representative number of species" is:
What constitutes a "representative number" is an inverse function of the skill and knowledge in the art. Satisfactory disclosure of a "representative number" depends on whether one of skill in the art would recognize that the applicant was in possession of the necessary common attributes or features of the elements possessed by the members of the genus in view of the species disclosed. For inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus. See, e.g., Eli Lilly. Description of a representative number of species does not require the description to be of such specificity that it would provide individual support for each species that the genus embraces. For example, in the molecular biology arts, if an applicant disclosed an amino acid sequence, it would be unnecessary to provide an explicit disclosure of nucleic acid sequences that encoded the amino acid sequence. Since the genetic code is widely known, a disclosure of an amino acid sequence would provide sufficient information such that one would accept that an applicant was in possession of the full genus of nucleic acids encoding a given amino acid sequence, but not necessarily any particular species. Cf. In re Bell, 991 F.2d 781, 785, 26 USPQ2d 1529, 1532 (Fed. Cir. 1993) and In re Baird, 16 F.3d 380, 382, 29 USPQ2d 1550, 1552 (Fed. Cir. 1994). If a representative number of adequately described species are not disclosed for a genus, the claim to that genus must be rejected as lacking adequate written description under 35 U.S.C. 112, para. 1.
The species described in the specification do not cover the entire genus such that it is a representative sample of the genus as the species are close together in structure and only describe an extremely small portion of the claimed genus.
Therefore, the present claim 22 lacks the required written description and is properly rejected under 35 U.S.C. 112(a). It is suggested that Applicants amend the claim by reciting the diseases or disorders in the claim.
Allowable Subject Matter
Claims 1, 8-11, 15, 16, 18, 22 and 23 would also be allowable once the objections or rejections outlined above have been overcome.
The following is a statement of reasons for the indication of allowable subject matter:
The instant invention is drawn to products of Formula I,
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as defined in claim 1. The invention is also directed to a method of using products of Formula I. The products of the instant claims are novel and non-obvious over the prior art. The closest prior art is US Patent No. 12,264,142 which discloses similar products of Formula,
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, and their use in the treatment of mitochondrial diseases. The products of US Patent No. 12,264,142 has a mandatory carbonyl group attached to the tricyclic group which is absent in the instant products. US Patent No. 12,264,142 fail to disclose or suggest the modifications necessary to arrive at Applicant's claimed compounds. None of the published products anticipated, or rendered obvious, the products as described in this application.
Telephone Inquiry
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAMAL A SAEED whose telephone number is (571) 272-0705.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Adam C Milligan can be reached at (571)270-7674. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Kamal A Saeed/
Primary Examiner, Art Unit 1626