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 .
Application and Claims Status
Applicant has not amended any claims, cancelled any claims, or added any new claims. Therefore, claims 1-4 are currently pending, as originally filed.
Priority
Examiner acknowledges that, according to the Filing receipt received 04/05/2024, the instant application 18/557,194 filed 10/25/2023 is a 371 of PCT/JP2022/019936 filed 05/11/2022, which claims foreign priority to Japanese Patent Application No. 2021-082497 filed 05/14/2021.
Acknowledgment is made of applicant's claim for foreign priority. It is noted, however, that applicant has not provided English translations of the certified copies of the Japanese application as required by 35 U.S.C. 119(b) and 37 CFR 1.55. Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e). Failure to provide a certified translation may result in no benefit being accorded for the non-English application. Without the English translations, one cannot ascertain if the instant invention is present in the Japanese application. For this office action, claim rejections were made based on prior art references that were available before the filing date of the applicant’s US patent application of October 25, 2023.
Further, the instant specification does not claim priority to, or incorporate by reference, the corresponding PCT application PCT/JP2022/019936, filed May 11, 2022 so this application was not acknowledged.
Thus, claims 1-4 of the instant application have been awarded the effective filing date of the instant application, 18/557,194, filed 10/25/2023.
Information Disclosure Statement
The information disclosure statement filed on October 25, 2023 does not fully comply with the requirements of 37 CFR 1.98(b) because there is no explanation of relevance for the following documents, whether in the form of a translated abstract or otherwise:
JP-2015-502967-A (Search report says entire text, all drawings)
JP-2019-507733-A (Search report says entire text, all drawings)
CN-105777727-A (Search report says entire text, all drawings)
Since the submission appears to be bona fide, applicant is given ONE (1) MONTH from the date of this notice to supply the above mentioned omissions or corrections in the information disclosure statement. NO EXTENSION OF THIS TIME LIMIT MAY BE GRANTED UNDER EITHER 37 CFR 1.136(a) OR (b). Failure to timely comply with this notice will result in the above mentioned information disclosure statement being placed in the application file with the noncomplying information not being considered. See 37 CFR 1.97(i).
All references have been considered except where marked with a strikethrough. A signed copy of Form 1449 is included with this Office Action.
Specification - Abstract
Applicant is reminded of the proper content of an abstract of the disclosure.
A patent abstract is a concise statement of the technical disclosure of the patent and should include that which is new in the art to which the invention pertains. The abstract should not refer to purported merits or speculative applications of the invention and should not compare the invention with the prior art.
If the patent is of a basic nature, the entire technical disclosure may be new in the art, and the abstract should be directed to the entire disclosure. If the patent is in the nature of an improvement in an old apparatus, process, product, or composition, the abstract should include the technical disclosure of the improvement. The abstract should also mention by way of example any preferred modifications or alternatives.
Where applicable, the abstract should include the following: (1) if a machine or apparatus, its organization and operation; (2) if an article, its method of making; (3) if a chemical compound, its identity and use; (4) if a mixture, its ingredients; (5) if a process, the steps.
Extensive mechanical and design details of an apparatus should not be included in the abstract. The abstract should be in narrative form and generally limited to a single paragraph within the range of 50 to 150 words in length.
See MPEP § 608.01(b) for guidelines for the preparation of patent abstracts.
Applicant is reminded of the proper content of an abstract of the disclosure.
In chemical patent abstracts for compounds or compositions, the general nature of the compound or composition should be given as well as its use, e.g., “The compounds are of the class of alkyl benzene sulfonyl ureas, useful as oral anti-diabetics.” Exemplification of a species could be illustrative of members of the class. For processes, the type of reaction, reagents and process conditions should be stated, generally illustrated by a single example unless variations are necessary.
The abstract of the disclosure is objected to because: it does not describe the use of compounds represented by Formula (I) or provide a general class; and it is not a concise statement. Examiner recommends removing the definitions of each variable of the Markush structure and adding in a description of the general class of compounds and their use. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Specification - Disclosure
The disclosure is objected to because of the following informalities:
Table 1 (pages 79 - 86) shows the corresponding Markush structure I - 1 (page 78) above it. Table 2 (page 87 – 89) shows the corresponding Markush structure I -1 (page 86) above it. Both Markush structures are exactly the same, and in fact, they are labeled the same. It is unclear why they were separated into separate tables if they correspond to the same overall Markush structure. Examiner is concerned that a different Markush structure was intended to be inserted above to represent Table 2. Additionally, in Table 1, compounds A-1, A-5, A-6 list the X5 substituent as 4-CNOEt. The examiner is unaware about the existence of this substituent and wonders if the applicant perhaps means 4-OEtCN or 4-C(=N-OEt). Last, in Table 1, compounds A-97 and A-98 each list two substituents for X3, when only one substituent is possible. Appropriate correction is required.
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.
Claim Objections
Claim 1 is objected to because of the following informalities: the term “represents” is used repeatedly when defining claim limitations when this term should instead be replaced with “is”, as in, for example, “L1 is a single bond, an oxygen atom, or a sulfur atom.” Appropriate correction is required.
Claim 1 is objected to because of the following informalities: the term “wherein” should be used before listing all the limitations of Formula (I) – that is, before defining “Ar”. Appropriate correction is required.
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 1-4 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.
Claim 1 is rejected to because the intended use of the compound of Formula (I) is as a pharmaceutical. Thus the “salt” should be limited to “a pharmaceutically acceptable salt thereof” to exclude salts that are not useful for the instant utility (such as toxic salts). Furthermore, the language “a salt of the compound” is improper and unclear. Appropriate Markush language requires alternative and singular claiming, such as, “or a pharmaceutically acceptable salt thereof.”
Claim 1 is objected to because it includes the limitation “substituted” for its description of Ar, L1, L2, X1, X2, X3, X4, R1, R2a, R2b, and Y (e.g. “Ar represents a substituted or unsubstituted C6 to C10 aryl group”). The limitation “substituted” (and thus ‘substituents’) are defined explicitly in the specification and examples are given (page 5 – 11). However, the definitions and examples of substituents concludes (page 11, l 11-12) with “In addition, in these “substituents”, any hydrogen atom in the substituent may be substituted with a group having a different structure.” This provision in the specification renders the metes and bounds of the claims unclear at each occurrence throughout the claims because it is unclear what the applicant means by this statement and no examples are provided. One skilled in the art could not say which substituents are included by this additional language in the specification and therefore the metes and bounds of the invention are unclear. Examiner suggests amending the claim to recite specific substituents which are supported by the specification.
The scope of claims 2-4 are ambiguous because the term “pest control agent” of Claim 2, “insecticidal or acaricidal agent” of Claim 3, and “ectoparasite control or repellent agent” of Claim 4 contain hybrid scope i.e. for claim 3, both a composition containing an insecticidal or acaricidal effective amount and the process of producing an insecticidal or acaricidal effect. It is recommended that the claims are amended to one category of invention. In the instance of claim 3, as an example, applicant is required to either elect a composition comprising an insecticidal or acaricidal effective amount of an elected compound or a process of producing an insecticidal or acaricidal effect using an effective amount of an elected compound.
Claims 2-4 also each recite “at least one selected from the group consisting of the compound according to Claim 1 and a salt of the compound.” The limitation “at least” is regarded as indefinite because it provides no upper limit to number of possible compounds in any of the agents. Accordingly, one skilled in the art cannot ascertain the metes and bound of the invention because the number of possible compounds is unclear.
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.
Scope of Enablement – Compounds
Claims 1-4 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 the following:
A compound represented by Formula (I), as recited in Claim 1
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or a pest control agent comprising a compound having a structure represented by Formula (I), as recited in claim 2, or an insecticidal or acaricidal agent comprising a compound having a structure of Formula (I), as recited in claim 3, or an ectoparasite control or repellent agent comprising a compound having a
wherein L1 is a single bond, O;
wherein L2 is a single bond;
wherein Ar is unsubstituted or substituted C6 aryl groups only;
wherein X1 is CN, unsubstituted thiocarbamoyl (C=S)NH2 only;
wherein X2 is H only;
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wherein X3 is C1 to C3 alkyl, C1 to C3 haloalkyl, CH2OMe;
wherein R1 is H, C1 to C3 alkyl, CH2cPr,
wherein R2a and R2b are C1 to C3 alkyl, combined with each other to form either
-(CH2)5- or -(CH2)2-, as in Compound No. A-94, A-95, A-96, A-111, A-112, A-113;
wherein Y is : EtSCH2CH2, EtSO2CH2CH2, EtS(=O)CH2CH2, 3-EtSCH2-Py-2-yl, 3-F-Py-2-yl, (4-F-Ph)-C(=N-OEt), (4-F-Ph)-C(=N-OMe), (4-F-Ph)-C(=O), (4-F-Ph)-CH(OH), (4-F-Ph)CH2, (Py-2-yl)CH2, iPrSCH2, nPrSCH2, MeSCH2, EtSCH2, EtS(=O)CH2, EtSO2CH2, (5-Me-1,2,4-oxadiazol-3-yl)CH2, and
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does not reasonably provide enablement for elements that are outside the scope of the enabling elements listed above. 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 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:
1- the quantity of experimentation necessary,
2- the amount of direction or guidance provided,
3- the presence or absence of working examples,
4- the nature of the invention,
5- the state of the prior art,
6- the relative skill of those in the art,
7- the predictability of the art, and
8- 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:
The nature of the invention relates to compounds represented by Formula (I) in claim 1. Such compounds are useful as pest control agents. This invention is also directed to pest control, insecticidal, acaricidal, ectoparasite control, and repellent agents comprising said compounds.
Predictability of the art:
The compounds synthesized in the instant specification appear novel. However, the hypothetical compounds in claim 1 would be unpredictable in terms of one skilled in the art being able to synthesize every possible compound claimed in instant claim 1. 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 a 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 skill in the art:
An ordinary artisan in the area of drug development would have experience in synthesizing and screening chemical compounds for particular activities, such as a medical doctor or chemist. Screening 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 often be employed, developing a therapeutic method, as claimed, is generally not well-known or routine, given the complexity of certain biological systems.
The breadth of the claims:
The scope of the claims involves compounds of Formula (I), shown below.
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Claim 1 is very broad in the number of variables and the options of substituents for each variable. There is an extremely large amount of hypothetical compounds included in claim 1.
The amount of direction provided, the presence or absence of working examples, and the quantity of experimentation necessary:
The specification only provides the synthesis of 5 compounds (page 61 - 77). This includes some intermediates, which are covered by Formula (I) of claim 1. For instance, the synthetic route described by Example 1 (page 61 – 68) actually provides the synthesis of 3 compounds, described in Step 9, Step 10, and Step 11.
Synthesis methods are not taught in the specification to provide for the aforementioned variables to include all of the possible substituents listed in the claims. For example, there are no working examples of a compound of Formula (I) wherein Ar is anything but a substituted phenyl ring. It would be expected that the varying Ar ring sizes (instant application claims substituted or unsubstituted C6 to C10 aryl group) and heteroatoms in the rings (instant application claims substituted or unsubstituted 5- or 6-membered heteroaryl group) would change the reactivity of the compounds, and therefore may require alternate synthesis methods. It would require one skilled in the art, such as a chemist, to perform thousands of reactions to determine which compounds of Formula (I) can be prepared and would likely require synthesis methods other than those provided in the specification. This is undue experimentation given the limited guidance and direction provided by Applicants.
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.
Claims 2-4, which are dependent on claim 1, are also rejected for further requiring and/or reciting elements that are outside the scope of the enabling elements listed above.
Claim Rejections - 35 USC § 103
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.
Claim(s) 1-4 are rejected under 35 U.S.C. 103 as being unpatentable over Liu et al. (see IDS CN-105777727-A), published July 20, 2016..
At page 55, compound 108.1, Liu teaches the following compound, among others, for use as an agricultural fungicide:
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This reads on a compound of Formula (I) as recited in Claim 1, differing only in the definition of R2a, when the variables are defined as follows:
wherein L1 and L2 are single bonds;
wherein Ar is thiophene;
wherein A is N;
wherein X1 is CN;
wherein X2 is H;
wherein X3 is Et;
wherein R1 is H;
wherein R2a is H;
wherein R2b is H;
wherein Y is 4-fluorophenyl.
This compound is different from a compound of Formula (I) as recited in Claim 1 only in its definition of the R2a variable. In the reference application, R2a is defined as hydrogen, whereas in the instant application, R2a is defined as “a substituted or unsubstituted C1 to C6 alkyl group”. While the exact compound of 108.1 is not disclosed by Liu et al., it is generally noted that the substitution of methyl for hydrogen on a known compound is not a patentable modification absent unexpected or unobvious results. In re Lincoln, 126 U.S.P.Q. 477, 53 U.S. P.Q. 40 (C.C.P.A. 1942); In re Druey, 319 F.2d 237, 138 U.S.P.Q. 39 (C.C. P.A. 1963); In re Lohr, 317 F.2d 388, 137 U.S.P.Q. 548 (C.C.P.A. 1963); In re Hoehsema, 399 F.2d 269, 158 U.S.P.Q. 598 (C.C.P.A. 1968); In re Wood, 582 F.2d 638, 199 U.S. P.Q. 137 (C.C.P.A. 1978); In re Hoke, 560 F.2d 436, 195 U.S.P.Q. 148 (C.C.PA.A. 1977); Ex parte Fauque, 121 U.S.P.Q. 425 (P.O.B.A. 1954); Ex parte Henkel, 130 U.S.P.Q. 474, (P.O.B.A. 1960). Given that applicant did not provide unexpected or unobvious results of the invention, it is concluded that the normal desire of scientists or artisans to improve upon what is already generally known would provide the motivation to substitute the “methyl” group to a hydrogen.
Therefore, claims 1-4 would have been practiced with a reasonable expectation of success.
Conclusion
No claims are allowed.
All claims are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LUKE ALAN BORALSKY whose telephone number is (571)272-9746. The examiner can normally be reached Monday - Friday 7:30 am - 5:00 am.
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, Jeffrey H Murray can be reached at 571-272-9023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/L.A.B./Examiner, Art Unit 1624
/JEFFREY H MURRAY/Supervisory Patent Examiner, Art Unit 1624