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 .
Priority
The present application claims priority to the applications, EP 21174266.3 and PCT/EP2022/062612, with the effective filing dates of 18 May 2021 and 10 May 2022, respectively.
Claim Status
This Office Action is in response to Applicant’s Response to Restriction Requirement filed, 7 April 2024.
Applicant’s election with traverse of Group I (claims 1-8) and
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in the reply filed on 7 April 2026 is acknowledged. The traversal is on the ground(s) that the unity of invention is evidenced by the International Search Report and that the standards that apply to the International Searching Authority also apply to the U.S. Patent Office. Additionally, Applicant argues that the different categories of invention are considered to have unity if the claims are drawn to a product and a process of use. Further, Applicant argues that the Examiner must explain why there is no single general inventive concept and that the Examiner has not produced proper reasons why each group lacks unity with each other group nor considered the special technical feature recited in, and common to, each claim. Additionally, Applicant argues that Groups I-III are closely related such that there is no serious search burden.
However, this is not found persuasive, because Applicant appears to have misunderstood the finding of lack of unity, which was based on a lack of special technical feature. Thus, the Examiner applied the standards for a National Phase (371) application and considered Groups I-III to have a common technical feature, which did not make a contribution over the prior art (JP 2011/148714: Compound IIa-27; of record, see Requirement for Restriction mailed 11 February 2026). Regarding a serious search burden, Applicant applies a different standard to traverse the restriction requirement, which is irrelevant to 371 applications. Accordingly, the requirement is still deemed proper and is therefore made FINAL.
Claim 4 is withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim. Claim 4 recites R5 and R6 form together with the C atom to which they are a bound a C3-C6 cycloalkyl, which does not read on the elected species.
Claims 9-10 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected group (Groups II and III), there being no allowable generic or linking claim.
Claims 1-3 and 5-8 are pending.
Information Disclosure Statement
The Information Disclosure Statements filed on 14 Nov 2023 and 8 Feb 2024, and the references cited therein have been considered, unless indicated otherwise.
The reference, JP 2008/008139, is lined through, because it does not appear to be relevant as it is directed to a storage system for printing. The Examiner notes the reference, JP 2008/088139, which arose in the search, would seem to be relevant.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
1. Claim(s) 1-3 and 5-8 are rejected under 35 U.S.C. 103 as being unpatentable over Mitani (WO 2009/119089, see IDS filed 2/8/2024) in view of Lovering (J. Med. Chem., 2009, 52, 6752-6756) as evidenced by and Chen (J. Agric. Food Chem., 2022, 70, 10090-10099).
Mitani teaches compounds that are agricultural and horticultural fungicides (abstract). Mitani specifically teaches Compound Ib-23, which is
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, which was selected for further testing and was one of a few compounds that showed a control value of 75% or more (page 22, [0065]; [0116]). Additionally, Mitani teaches Compound Ia-61:
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(page 20, [0064]), which incorporates more sp3 character. Further, Mitani teaches that many control agents used in agricultural and horticultural crops are used inefficiently against crop diseases due to emergence of drug-resistant pathogens ([0002]). Mitani also teaches that design of control agents must also take into account phytotoxicity/pollution to plants, toxicity to humans, livestock, and fish, and impact on the environment, which leads to a strong demand for the emergence of a compound that can be safely used with few defects ([0002]). Mitani teaches that the compounds disclosed therein are reliable and can be used safely ([0004]).
Regarding claim 1, Mitani is silent to the elected species:
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.
Lovering teaches that escaping from flatland (i.e. incorporating more saturation) improves clinical compound success (abstract). Lovering teaches that incorporation of more sp3 character (more saturation) into a compound results in higher solubility and lower melting point in a medicinal chemistry context (page 6755, column 1, paragraph 2), as evidenced by Chen. Chen teaches that the same ADME-T principles of medicinal chemistry apply in agricultural chemistry (abstract; page 10090, column 1, paragraph 1; page 10090, column 2, paragraph 1).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention to select Compound Ib-23,
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, with the t-butyl of Compound Ia-61,
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, as taught by Mitani to incorporate more sp3 character as taught by Lovering (as evidenced by Chen), because:
-Mitani teaches compounds that are agricultural and horticultural fungicides,
-Mitani teaches Compound Ib-23, which is
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, which was selected for further testing and was one of a few compounds that showed a control value of 75% or more,
-Mitani teaches Compound Ia-61:
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, which incorporates more sp3 character, as evidenced by Lovering and Chen. Lovering teaches that incorporation of more sp3 character (more saturation) results in higher solubility and lower melting point in a medicinal chemistry context. Chen teaches that the same ADME-T principles of medicinal chemistry apply in agricultural,
-Mitani teaches that many control agents used in agricultural and horticultural crops are used inefficiently against crop diseases due to emergence of drug-resistant pathogens, and
-Mitani teaches that that the compounds disclosed therein are reliable and can be used safely.
-Lovering teaches that escaping from flatland (i.e. incorporating more saturation) improves clinical success,
-Lovering teaches that incorporation of more sp3 character (more saturation) results in higher solubility and lower melting point in a medicinal chemistry context, as evidenced by Chen. Chen teaches that the same ADME-T principles of medicinal chemistry apply in agricultural chemistry, and
-Lovering teaches that three-dimensionality that saturation imparts also results in greater selectivity, resulting in fewer off-target effects and that more highly saturated compounds are more likely to succeed in the transitions from discovery through clinical trials to drugs (page 6755, column 1, paragraph 2).
Thus, an artisan having ordinary skill in the art would have been motivated to make such
a selection to predictably arrive at the elected species,
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. Thus, Mitani in view of Lovering as evidenced by Chen teaches the compound,
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.
Regarding claim 2, Mitani teaches Compound Ib-23:
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([0065]), wherein R5 is methyl.
Regarding claim 3, Mitani teaches Compound Ia-61:
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([0064]), wherein R6 is t-butyl.
Regarding claim 5, Mitani teaches that X is a halogen (Compound Ib-23, [0065]).
Regarding claim 6, Mitani teaches that X is fluorine (Compound Ib-23, [0065]).
Regarding claim 7, Mitani teaches that Y is fluorine (Compound Ib-23, [0065]).
Regarding claim 8, Mitani teaches a composition of
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([0071]).
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.
2. Claim 1-3 and 5-8 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-3, 5-7, and 9 of copending Application No. 18/292,973 in view of Mitani (WO 2009/119089, see IDS filed 2/8/2024) in view of Lovering (J. Med. Chem., 2009, 52, 6752-6756) as evidenced by and Chen (J. Agric. Food Chem., 2022, 70, 10090-10099). This is a provisional nonstatutory double patenting rejection.
U.S. Application No. 18/292,973 recites a compound of Formula (I):
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, wherein R1 is H, R4 is H, R5 is C1-6 alkyl, R6 is C1-6 alkyl, X is fluorine, and Y is fluorine and compositions thereof (claims 1-3, 5-7, and 9 of ‘973).
Regarding claim 1, ‘973 fails to teach the elected species,
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, wherein eastern ring contains an oxygen.
Mitani teaches compounds that are agricultural and horticultural fungicides (abstract). Mitani specifically teaches Compound Ib-23, which is
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, which was selected for further testing and was one of a few compounds that showed a control value of 75% or more (page 22, [0065]; [0116]). Additionally, Mitani teaches Compound Ia-61:
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(page 20, [0064]), which incorporates more sp3 character. Further, Mitani teaches that many control agents used in agricultural and horticultural crops are used inefficiently against crop diseases due to emergence of drug-resistant pathogens ([0002]). Mitani also teaches that design of control agents must also take into account phytotoxicity/pollution to plants, toxicity to humans, livestock, and fish, and impact on the environment, which leads to a strong demand for the emergence of a compound that can be safely used with few defects ([0002]). Mitani teaches that the compounds disclosed therein are reliable and can be used safely ([0004]).
Lovering teaches that escaping from flatland (i.e. incorporating more saturation) improves clinical compound success (abstract). Lovering teaches that incorporation of more sp3 character (more saturation) into a compound results in higher solubility and lower melting point in a medicinal chemistry context (page 6755, column 1, paragraph 2), as evidenced by Chen. Chen teaches that the same ADME-T principles of medicinal chemistry apply in agricultural chemistry (abstract; page 10090, column 1, paragraph 1; page 10090, column 2, paragraph 1).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention to select a compound of Formula (I) as taught by ‘973 and Compound Ib-23,
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, with the t-butyl of Compound Ia-61,
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, as taught by Mitani to incorporate more sp3 character as taught by Lovering (as evidenced by Chen), because:
-‘973 recites a compound of Formula (I):
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, wherein R1 is H, R4 is H, R5 is C1-6 alkyl, R6 is C1-6 alkyl, X is fluorine, and Y is fluorine,
-Mitani teaches compounds that are agricultural and horticultural fungicides,
-Mitani teaches Compound Ib-23, which is
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, which was selected for further testing and was one of a few compounds that showed a control value of 75% or more,
-Mitani teaches Compound Ia-61:
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, which incorporates more sp3 character, as evidenced by Lovering and Chen. Lovering teaches that incorporation of more sp3 character (more saturation) results in higher solubility and lower melting point in a medicinal chemistry context. Chen teaches that the same ADME-T principles of medicinal chemistry apply in agricultural,
-Mitani teaches that many control agents used in agricultural and horticultural crops are used inefficiently against crop diseases due to emergence of drug-resistant pathogens, and
-Mitani teaches that that the compounds disclosed therein are reliable and can be used safely.
-Lovering teaches that escaping from flatland (i.e. incorporating more saturation) improves clinical success,
-Lovering teaches that incorporation of more sp3 character (more saturation) results in higher solubility and lower melting point in a medicinal chemistry context, as evidenced by Chen. Chen teaches that the same ADME-T principles of medicinal chemistry apply in agricultural chemistry, and
-Lovering teaches that three-dimensionality that saturation imparts also results in greater selectivity, resulting in fewer off-target effects and that more highly saturated compounds are more likely to succeed in the transitions from discovery through clinical trials to drugs (page 6755, column 1, paragraph 2).
Thus, an artisan having ordinary skill in the art would have been motivated to make such
a selection to predictably arrive at the elected species,
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. Thus, the combination of ‘973, Mitani, and Lovering as evidenced by Chen teaches the compound,
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.
Regarding claim 2, ‘973 teaches R5 is C1-6 alkyl (claims 1-2 of ‘973). Additionally, Mitani teaches Compound Ib-23:
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([0065]), wherein R5 is methyl.
Regarding claim 3, ‘973 teaches R6 is C1-6 alkyl (claims 1 and 3 of ‘973). Additionally, Mitani teaches Compound Ia-61:
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([0064]), wherein R6 is t-butyl.
Regarding claim 5, ‘973 teaches X is a halogen (claims 1 and 5 of ‘973). Additionally, Mitani teaches that X is a halogen (Compound Ib-23, [0065]).
Regarding claim 6, ‘973 teaches X is fluorine (claims 1 and 6 of ‘973). Additionally, Mitani teaches that X is fluorine (Compound Ib-23, [0065]).
Regarding claim 7, ‘973 teaches Y is fluorine (claims 1 and 7 of ‘973). Additionally, Mitani teaches that Y is fluorine (Compound Ib-23, [0065]).
Regarding claim 8, ‘973 teaches a composition of a compound of Formula (I):
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, wherein R1 is H, R4 is H, R5 is C1-6 alkyl, R6 is C1-6 alkyl, X is fluorine, and Y is fluorine (claims 1 and 9 of ‘973). Additionally, Mitani teaches a composition of
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([0071]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Madeline M Dekarske whose telephone number is (571)272-1789. The examiner can normally be reached Monday - Thursday 10am - 4pm.
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, James Alstrum-Acevedo can be reached at 571-272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MADELINE M. DEKARSKE/Examiner, Art Unit 1622
/JAMES H ALSTRUM-ACEVEDO/Supervisory Patent Examiner, Art Unit 1622
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