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
Formal Matters
Claims 1-15 are pending and under examination.
Priority
This application is a national stage entry of PCT/JP2021/021064 filed on 6/2/2021, which claims priority from JP2020-097174 filed on 6/3/2020.
Abstract Objection
The abstract is objected to for the word “novel”. The abstract should avoid speculative language and comparisons with the prior art. Novel implies the compounds are novel over the prior art. See MPEP 608.01(b) I B. Appropriate correction is required.
Claim Objection
Claims 4-12 and 14-15 are objected to for being dependent on multiply dependent claims. For the purpose of compact prosecution, the examiner will read claims 4-12 as being dependent on claim 1 and claims 14-15 as being dependent on claim 12.
Claim 6 is objected to for “[Formula 4]” since these groups are “[Formula 3]” in the compound found in claim 1. Thus, for consistency, applicant should call these [Formula 3] as in claim 1.
Claims 8, 10, and 11 are objected to for “selected from…. and…” which needs to be “selected from….or….” since it is not in the form of “selected from the group consisting of….and…” where using and is appropriate. Applicant may either change the “and” to “or”, or alternatively use “selected from the group consisting of ….and….” language.
Appropriate corrections are 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 1-15 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.
Claims 1 and 6 are indefinite as it is unclear where the attachment point to the compound is for each of these groups.
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since in organic chemistry an open ended line ( - ) can represent a CH3 group. Thus, it is unclear if each of the lines that ends without a mentioned group is a CH3 group or if this is meant to be the attachment point to the compounds of formula I or II. If applicant means these lines to be the attachment points to the compound, they can represent those with an asterisk (*) at the open end of the line or a squiggle through the open line while indicating it represents the bond to the compound. For the purpose of compact prosecution, the line will be read as the attachment point to the compound.
Claims 1-5 and 7-15 are rejected for being dependent on indefinite claims.
Claim 3 is indefinite as “at least one group of an alkyl group and a halogen atom” makes it unclear if applicant wants at least one group that has both an alkyl group and a halogen atom (as in a halogen substituted alkyl) or if applicant means at least one group that is either an alkyl or a halogen. For the purpose of compact prosecution, the examiner will read the claim as it is at least one of an alkyl group or a halogen atom.
Claims 4-15 are rejected as being dependent on indefinite claims.
Claim 4 is indefinite as “at least one group of an alkyl group having 1 to 6 carbon atoms and a halogen atom” makes it unclear if applicant wants at least one group that has both an alkyl group having 1 to 6 carbons and a halogen atom (as in a halogen substituted alkyl) or if applicant means at least one group that is either an alkyl having 1 to 6 carbon atoms or a halogen. For the purpose of compact prosecution, the examiner will read the claim as it is at least one of an alkyl group having 1 to 6 carbon atoms or a halogen atom.
Claims 5-15 are rejected as being dependent on indefinite claims.
Claims 10, 11, and 12 recite the limitation "the fungus" without a prior recitation of “a fungus” in these claims or claims on which they depend. Antifungal agent is specific to an agent with antifungal activity and does not give basis for a fungus itself. There is insufficient antecedent basis for this limitation in the claim.
Claims 13-15 are rejected as being dependent on an indefinite claim.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 1-4, 6-7, and 9-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by PubChem (1H-imidazole-2-carbonitrile, compound summary, Create date of 3-27-2005 (available)).
The limitations of anti-fungal agent for a human contains the intended use statements of “antifungal” and “for a human” where antifungal is a property of the compound itself (MPEP 2111.02). There are no addition components in the agent besides the compound. Thus, the compound alone can represent the antifungal agent. Similarly with claim 9 providing that antifungal agent is a medicament, this is toward the intended use and does not add any structural or other compositional features to the compound. Claims 10-15 are related to intended uses of the compound. This compound of PubChem below will effective against such microbes and microbe related diseases as it is a compound encompassed by applicant’s claims.
PubChem teaches 1H-imidazole-2-carbonitrile.
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.
Claims 1-7, 9-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Abramovitch US 4006160.
The limitations of anti-fungal agent for a human contains the intended use statements of “antifungal” and “for a human” where antifungal is a property of the compound itself. There are no addition components in the agent besides the compound. Thus, the compound alone can represent the antifungal agent. Similarly with claim 9 providing that antifungal agent is a medicament, this is toward the intended use and does not add any structural or other compositional features to the compound. Claims 10-15 are related to intended uses of the compound. This compound of Abramovitch below will effective against such microbes and microbe related diseases as it is a compound encompassed by applicant’s claims.
Abramovitch teaches a compound of formula
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. Abramovitch provides the R1 can be hydrogen, alkyl or a sulfonyl, R2 can be a hydrogen, alkyl or aryl group and R3 can be hydrogen, alkyl or an aryl group, or that R2 and R3 can comprise part of an aromatic or heteroaromatic ring (column 2 of Abramovitch). Example 20 and the abstract provides for N-hydroxyimidazole-2-carbonitrile where the OR1 group is hydroxy and the R2 and R3 groups are hydrogen. Thus, Abramovitch anticipates such a compound and also anticipates that one of the R2 or R3 groups can be different (an alkyl or aryl instead of hydrogen). Abramovitch recognizes compounds of its invention for treating skin infections (column 5 and abstract). Thus, antimicrobial activity is recognized. Again, in these agent/composition claims, this is toward the intended use of the agent that can be just the compound.
Claims 1-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kimura JPH08225539A (with English translation).
The limitations of anti-fungal agent for a human contains the intended use statements of “antifungal” and “for a human” where antifungal is a property of the compound itself. There are no addition components in the agent besides the compound. Thus, the compound alone can represent the antifungal agent. Similarly with claim 9 providing that antifungal agent is a medicament, this is toward the intended use and does not add any structural or other compositional features to the compound. Claims 10-15 are related to intended uses of the compound. This compound of Kimura below will effective against such microbes and microbe related diseases as it is a compound encompassed by applicant’s claims.
Kimura teaches a compound of formula II (see original patent document) that has the structure of
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where R is a substituted or unsubstituted alkyl or phenyl group and X is a chlorine or bromine atom (paragraphs 6 and 7 of English translation). Paragraph 18 provides for agricultural or horticultural fungicides. Kimura teaches 4 (5) - chloro-2-cyano-5 (4) - (4-methylphenyl) imidazole (examples 1-4) and 4-chloro-2-cyano-1-hydroxy-5- (4-methyl phenyl) imidazole in example 5. Kimura does teach fungicidal activity of its compounds (abstract).
Claims 1-7, 9-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CN107417622A (published on 12-1-2017, with English translation).
CN ‘622 teaches 4(5) -chloro-2-cyano-5 (4) - (4 '-methylphenyl) imidazole (abstract and claim 1 of CN ‘622). See compound of formula 1 in the disclosure of CN ‘622.
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. Background technology of CN ‘622 provides this is an important intermediate in making the fungicide, cyazofamid. However, in a rejection for anticipation where the limitation of the agent is the compound, the teaching of the compound is sufficient.
Claims 1-7, 9-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shroff US20160007593.
Shroff teaches fungicidal compositions that have
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(figure 1 and abstract). Thus, both of these compounds will be present in a composition with cyazofamid. Also, see paragraph 150 (table). The group attached to the sulfonyl group that is attached on the N1 group of the imidazole ring can be construed as a substituted alkyl as it has two CH3 (methyl) groups N-(CH3)2. The major degradate is a compound of applicant’s invention (compound encompassed by the formula). The major degradate anticipates the claimed compound and is found in these fungicidal compositions.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 8 is also rejected under 35 U.S.C. 103 as being unpatentable over Kimura JPH08225539A (with English translation).
This rejection is in place to obviate other species of the claim by the teachings of Kimura.
Kimura teaches the claims as above and antifungal activity of compounds.
Kimura does not teach all the species in claim 8.
Kimura provides for use of chloro and substituted phenyls on the 4 or 5 positions of the imidazole. Kimura provides for various groups including “R is specifically a phenyl group; 2
-, 3- or 4-fluorophenyl group; 2-, 3- or 4-chlorophenyl group; 2-, 3- or 4-bromophenyl group; 2-, 3- or 4-methylphenyl group; 2-, 3- or 4-ethylphenyl group; 2-, 3- or 4-propylphenyl group; 2-, 3- or 4-methoxyphenyl group; 2-, 3- or 4-ethoxyphenyl group; 3,4-Dichlorophenyl group; 3,4-dimethylphenyl group; 3,4-dimethoxyphenyl group; 3-methyl-4-methoxyphenyl group; 3-chloro-4-methylphenyl group; 3-chloro-4-methoxyphenyl group; tert-butyl group; 1,1-dimethylpropyl group and the like.” (paragraphs 8-11). Example 5 provides for a 1-hydroxy version of a compound indicating a hydroxyl group is possible at this position. It is also noted that adding a short carbon chain such as a methyl to a compound with known function and to move constituents around a ring are considered obvious modifications to expect similar functionality (MPEP 2144.09 – close structural similarity between chemical compounds, similar structure/similar properties).
Thus, one of ordinary skill in the art before the time of filing would have used teachings of the prior with obvious modifications of moving constituents to different positions (swapping positions of constituents) on the same ring or adding a methyl group to compounds taught or motivated in the prior art to provide for new compounds having similar activity with a reasonable expectation of success in making new compounds with the activity. In this instance, the activity of Kimura is antifungal or fungicidal activity.
Statutory Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claims 1-8 provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1-8 of copending Application No. 18/000,424 (reference application). This is a provisional statutory double patenting rejection since the claims directed to the same invention have not in fact been patented. Although claims of ‘424 use the preamble of “An antimicrobial agent for a non-human animal” and applicant’s claims here use the preamble of “An antifungal agent for a human”, these are toward the intended use of the agent with an agent comprising a compound. The bodies of the claim with the compounds are identical, and thus, the scope of the claims is the same.
Non-Statutory Double Patenting
The nonstatutory 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 nonstatutory 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 nonstatutory 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 nonstatutory 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.
Claims 1, 9-15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 9-13 of copending Application No. 18/000,424 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because each claim set provides for the same compounds with overlapping fungi, diseases and skin diseases. Using the agent for a skin disease would offer a medicament.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 10-16 and 18-20 of copending Application No. 18/716,681 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because each claim set provides for a same compound with overlapping fungi, diseases and skin diseases. Using the agent for a skin disease would offer a medicament. The compound of ‘681 is a species of the compounds in applicant’s current claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARK V STEVENS whose telephone number is (571)270-7080. The examiner can normally be reached on M-F 9:00 am to 6:00 pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian-Yong Kwon can be reached on (571)272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARK V STEVENS/Primary Examiner, Art Unit 1613