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 .
DETAILED ACTION
Claims 1-48 are pending in the present application.
Priority
The following continuity data is acknowledged in the present application file:
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Information Disclosure Statement
The Information Disclosure Statement(s) filed 02/21/2024 have been acknowledged by the Examiner. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the Examiner.
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 1-9 and 34-48 are 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 1 is directed to a compound having a structure of Formula (I) or pharmaceutically acceptable salt thereof, wherein Rc of Formula (I) is carboxylic acid or its isostere. Present claim 38 is directed to a method of inhibiting the expression of the telomerase reverse transcriptase (TERT) gene or reducing the amount of TERT mRNA or TERT protein in a cell, comprising administering an effective amount of the compound of claim l. Present claim 45 is directed to a method of treating cancer, reducing tumor volume, reducing tumor growth, or increasing survival of a subject in need thereof, comprising administering an effective amount of the compound of claim 1.
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The specification describes the terms in similar terms without further definition.
The specification details exemplary compounds 100-149 in Table 1 on pages 10-22 (see also chemical names for compounds 100-146 in Table 3 on pages 129-131). The specification details the effects of the compound 101 (provided below) on TERT expression in various cell lines in Examples 3-5.
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The person of skill in the art would be able to extrapolate from the exemplary compounds present specification how to use a compound of present formula (I) or a pharmaceutically acceptable salt of a compound of present formula (I) in a method for inhibiting the expression of the telomerase reverse transcriptase (TERT) gene or reducing the amount of TERT mRNA or TERT protein in a cell, or a method of treating cancer, reducing tumor volume, reducing tumor growth, or increasing survival of a subject in need thereof.
There is no general synthetic methods in order to extrapolate the synthesis to include carboxylic acid isosteres for Rc of present formula (I) as this includes constitutional isomers thereof, which may have the same or different chemical formula as well as potentially a different arrangement of atoms.
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 is described by a generic formula, the generic formula is not sufficiently detailed to show that the Applicant was in possession of the full scope of the claimed invention at the time of filing.
Namely, that the definitions 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 claims lack written description and are properly rejected under 35 U.S.C. 112(a).
Present claims 2-9 and 34-48, which are dependent upon claim 1, are similarly rejected.
To overcome this rejection, Applicant may delete the phrase “or its isosteres” the definition of Rc from claim 1
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, 21 and 32-33 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 claim 1, the phrase "e.g., methyl" 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).
Claims 9, 21 and 32-33 are rejected because they refer to “Compound 100, 101, 102, 103, 104, 105, 106, 107, 108, 109, 110, 111, 112, 113, 114, 115, 116, 117, 118, 119, 120, 121, 122, 123, 124, 125, 126, 127, 128, 129, 130, 131, 132, 133, 134, 135, 136, 137, 138, 139, 140, 141, 142, 143, 144, 145, 146, 147, 148, and 149” of the instant specification. A claim should particularly point out and distinctly claim the subject matter which the applicant regards as his invention and, under modern claim practice, stand alone to define the invention.
MPEP 2173.05(s) states
“Where possible, claims are to be complete in themselves. Incorporation by reference to a specific figure or table “is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant' s convenience.” Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993).
Reference characters corresponding to elements recited in the detailed description and the drawings may be used in conjunction with the recitation of the same element or group of elements in the claims. Generally, the presence or absence of such reference characters does not affect the scope of a claim.
Applicant may amend the claims to include specific compound names or structures depicted via drawings to overcome this rejection.
Allowable Subject Matter
Claims 10-20 and 22-31 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
The closest prior art is from Stevenson, Paul J. "Aza-annulation of enaminones with itaconic anhydride: kinetic preference for exocyclic enamide products." Journal of the Chemical Society, Perkin Transactions 1 20 (1998): 3437-3442.
Stevenson discloses compound 23, 5-Benzoyl-1,2,3,4-tetrahydro-6-methyl-2-oxo-1-(phenylmethyl)-3-pyridineacetic acid, which is similar to a compound having a structure of Formula (I) where,
Ra is H
Rb and Rb’ are H
Rc is carboxylic acid
Rd is aryl; specifically phenyl
Re is aryl; specifically phenyl
However the compounds of Stevenson require several modifications to arrive at the compound of present formula (I) which are not taught or suggested by Stevenson, namely changing the central pyridine moiety to match the identity and connectivity of the piperidine ring and removal of the oxo groups on the central ring as well as the carbon radical between the central ring and Re.
Any case of obviousness would be based on a series of modifications improperly aided by hindsight bias rather than aided by the prior art.
Conclusion
Claims 1-9, 21 and 32-48 are rejected.
Claims 10-20 and 22-31 are objected to.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to QUINCY A MCKOY whose telephone number is (703)756-4598. The examiner can normally be reached Monday - Thursday 8:00 - 6:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joseph McKane can be reached at 5712720699. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/QUINCY A. MCKOY/
Patent Examiner, Art Unit 1626
/JOSEPH K MCKANE/Supervisory Patent Examiner, Art Unit 1626