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
Claims 1-9 and 14-17 are pending in the instant application.
Claims 10-13 have been canceled.
Priority
Acknowledgement is made of Applicant’s claim for foreign priority based on the EP22382445.9 application filed in the European Union on May 9th, 2022.
Information Disclosure Statement
The Information Disclosure Statement received December 12th, 2024 has been fully considered by the examiner, except where marked with a strikethrough.
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.
Drawings
Acknowledgement is made of the drawings received November 1st, 2024. These drawings are acceptable.
Claim Objections
Claims 1-2 are objected to because of the following informalities:
Claims 1-2 do not end in a period. Per MPEP 608.01(m), “Each claim begins with a capital letter and ends with a period.”
Appropriate correction is required.
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 1-7, 9, and 14-17 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 compound of formula (I) in which R1 is defined as hydrogen, halogen, (C1-C4)alkyloxycarbonly, C1alkylcarbonyl, phenylcarbonyl, or -CONH-(CH2)n-Ph wherein n is 1, R2 is defined as hydrogen or halogen, R3 is defined as hydrogen, halogen, (C1-C2)alkyl, C1alkyloxycarbonyl, or pyridinyl, pyrimidinyl, or phenyl wherein the pyridinyl, pyrimidinyl, or phenyl is optionally substituted with one or two groups selected from halogen, (C1-C4)alkyl, (C1-C4)alkyloxy, trifluoromethyloxy, di((C1-C2)alkyl)amino, benzyl, C3cycloalkyl, or a 5 to 6 membered saturated heterocylic ring optionally substituted with C3alkyl, or wherein phenyl optionally forms a 6 membered ring with a divalent group of formula -O-(CH2)2-O- whereby the oxygen atoms of said divalent group are connected to two adjacent atoms of the phenyl group, R4 is defined as hydrogen, and R6 is defined as hydrogen does not reasonably provide enablement for compound of formula (I) in which R1, R2, R3, R4, or R6 are otherwise defined. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
Pursuant to In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988), one considers the following factors to determine whether undue experimentation is required: (1) The breadth of the claims, (2) The nature of the invention, (3) The state of the prior art, (4) The level of one of ordinary skill, (5) The level of predictability in the art, (6) The amount of direction provided by the inventor, (7) The existence of working examples and (8) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
Nature of the invention:
The invention is drawn to a compound of formula (I) or a pharmaceutically acceptable salt thereof.
Breadth of the invention:
The scope of the invention is very broad, as it is drawn to any compounds of the formula:
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This includes any of the myriad of compounds resulting from the combinations of the variables R1-R6 as defined at Claim 1. Further, the breadth of moieties that satisfy the definition of variable R3 results in the possibility of a number of distinct compounds with polycyclic and fused ring systems that are not obvious variants of each other.
State of the prior art and predictability in the art:
The invention is directed toward medicine and is therefore physiological in nature. It is well established that “the scope of enablement varies inversely with the degree of unpredictability of the factors involved,” and physiological activity is generally considered to be an unpredictable factor. 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 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.
Level of ordinary skill in the art:
An ordinary artisan in the area of drug development would have experience in synthesizing chemical compounds for particular activities. The synthesis of new drug candidates, while complex, is routine in the art. The process of finding new drugs that have in vitro activity against a particular biological target (i.e., receptor, enzyme, etc.) is well known. Additionally, while high throughput screening assays can be employed, developing a therapeutic method, as claimed, prior to synthesizing and testing compounds is generally not well-known or routine, given the complexity of certain biological systems.
The amount of direction provided and working examples:
The compound core depicted with specific substituents represents a narrow subgenus for which applicant has provided sufficient guidance to make and use; however, this disclosure is not sufficient to allow extrapolation of the limited examples to enable the scope of the compounds instantly claimed. Applicant has provided no working examples of any compounds, compositions, or pharmaceutically acceptable salts in which the variables R1, R2, R3, R4, and R6 were not defined as mentioned above in the instant application.
Within the specification, “specific operative embodiments or examples of the invention must be set forth. Examples and description should be of sufficient scope as to justify the scope of the claims.” Markush claims must be provided with support in the disclosure for each member of the Markush group. Where the constitution and formula of a chemical compound is stated only as a probability or speculation, the disclosure is not sufficient to support claims identifying the compound by such composition or formula. See MPEP 608.01(p).
MPEP § 2164.01 (a) states, “A conclusion of lack of enablement means that, based on the evidence 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 that Applicant is not enabled for making these compounds.
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 14-17 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.
In both Claims 14 and 17, the recitation of the limitation “A method of treating a subject … at risk of suffering from a viral infection” renders the claim indefinite. A person having ordinary skill in the art would not be able to reasonably ascertain, based on the instant disclosure, the metes and bounds of a subject that meets the limitation of being “at risk of suffering from a viral infection by coronavirus”. Further, the outcome of treatment is indefinite, as the limitation “at risk of suffering from a viral infection by coronavirus” implies the subject is not infected by coronavirus.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claims 15-16 recite the limitation “wherein R1, R2, R3, R4, R5, and R6 are as defined in any one of claims 1 to 8” in which Claim 1 recites broader definitions of these variables, and Claims 2 to 8 narrow this limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 17 recites the limitation "a composition as defined in claim 9" in the last two lines of the claim. There is insufficient antecedent basis for this limitation in the claim, as Claim 9 is drawn to a compound.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 9 and 14 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claims 9 and 14 are drawn to a compound of formula (I) as defined in Claim 1. Claims 9 and 14 improperly expands the scope of Claim 1 first to include a compound of formula (I2), which is excluded by the proviso of Claim 1. Further, the scope of Claim 9 is improperly expanded with the limitation “and one or more pharmaceutically acceptable diluent or carrier”, which is not supported at instant Claim 1.
Applicant can overcome this rejection by amending the claim to read “A composition comprising a compound of formula (I) as defined in claim 1 or a pharmaceutically acceptable salt thereof and one or more pharmaceutically acceptable diluent or carrier.”
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
(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.
Claim 9 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Herrero et. al. (“Versatile synthesis of chiral 2-substituted-5-oxo-1,2,3,4-tetrahydro-5H-1,4-benzodiazepines as novel scaffolds for peptidomimetic building”, Tetrahedron, 2003; cited on Applicant’s Information Disclosure Statement received December 12th, 2024; hereinafter referred to as Herrero).
At Page 4494, Herrero teaches compounds of the formula 6b:
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At the second column of Table 2, Herrero teaches the 2S isomer of this compound defining R1 as indole and R2 as cyano. This is a compound of formula (I2) as recited at instant Claim 1. Additionally, at Page 4494, under 4.1.1., Herrero teaches the synthetic procedure for producing this compound, which includes washing a solution thereof with H2O, thereby reading on the limitation of a compound of formula (I2) and a pharmaceutically acceptable diluent or carrier.
Allowable Subject Matter
Claim 8 is 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.
Conclusion
Claims 1-7, 9, and 14-17 are rejected.
Claim 8 is objected to.
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL JOHN BURKETT whose telephone number is (703)756-5390. The examiner can normally be reached Monday - Friday.
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/D.J.B./ Examiner, Art Unit 1624 /BRENDA L COLEMAN/ Primary Examiner, Art Unit 1624
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