DETAILED ACTION
Notice of Pre-AIA or AIA Status
The inventor or joint inventor should note that the instant invention, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Claims
Claims 1-15 are pending in the instant invention. According to the Amendments to the Claims, filed July 13, 2026, claims 1-15 were presented for prosecution on the merits.
Status of Priority
This invention is a 35 U.S.C. § 371 National Stage Filing of International Application No. PCT/US2022/079610, filed November 10, 2022, which claims priority under 35 U.S.C. § 119(e) to US Provisional Application No. 63/281,475, filed November 19, 2021.
Although the inventor’s or joint inventor’s claim for the benefit of a prior-filed invention under 35 U.S.C. § 119(e) is acknowledged, the inventor or joint inventor has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. § 119(e) as follows:
The later-filed invention must be an invention for a patent, for an invention which is also disclosed in the prior-filed invention (the provisional invention). The disclosure of the invention in the prior-filed invention and in the later-filed invention must be sufficient to comply with the requirements of 35 U.S.C. § 112(a). {See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994)}.
The specification of the prior-filed invention, US Provisional Application No. 63/281,475, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. § 112(a) for one or more claims of this invention for the following reason: the specification in the instant invention has been amended with respect to the scope of Formula I, which now discloses amended definitions for R1, R2, R3, R4, R5, R6, R7, and X, respectively, and is no longer coextensive with that of US Provisional Application No. 63/281,475.
Consequently, since the specification of US Provisional Application No. 63/281,475 lacks adequate support or enablement for one or more claims of the elected invention of Group I, as defined below in Restrictions / Election of Species, and in the manner provided by 35 U.S.C. § 112(a), the first Office action on the merits of all relevant claims drawn to Group I will be prosecuted according to the earliest effective filing date afforded this invention, which is that of International Application No. PCT/US2022/079610, filed November 10, 2022.
Restrictions / Election of Species
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The inventor’s or joint inventor’s provisional election of the following, without traverse, in the reply filed on July 13, 2026, is acknowledged: a) Group I - claims 1-10; and b) substituted pyridine of Formula I - p. 17, Table 2, compound (12), shown to the right below, and hereafter referred to as 3-((3-(4-(2,6-dimethylpyridin-4-yl)-1H-pyrazol-3-yl)phenoxy)methyl)benzonitrile (lolamycin), where R1 = -CH3; R2 = -CH3; R3 = -H; R4 = -CN; R5 = -H; each R6 = -H; R7 = -H; and X = -O-. Claims 1-10 read on the elected species. Affirmation of this election must be made by the inventor or joint inventor in replying to this Office action.
Similarly, the inventor or joint inventor should further note that the requirement is still deemed proper and is therefore made FINAL.
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Likewise, the inventor or joint inventor should further note that the elected species, shown to the right, was found to be free of the prior art.
Moreover, the inventor or joint inventor should further note that claims 11-15 were withdrawn from further consideration, pursuant to 37 CFR 1.142(b), as being drawn to a nonelected or cancelled invention, there being no allowable generic or linking claim.
Thus, a first Office action and prosecution on the merits of claims 1-10 is contained within.
Specification Objection - Disclosure
The inventor or joint inventor is advised to format the specification according to 37 CFR 1.77(c). Revisions should particularly address bold-type, underline, and/or upper case formatting. Appropriate correction may be required.
Specification Objection - Title
The inventor or joint inventor is reminded of the proper content of the title of the invention.
The title of the invention should be brief, but technically accurate and descriptive and should contain fewer than 500 characters. See 37 CFR 1.72(a) and MPEP § 606.
The title of the invention is not technically accurate and descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed. In the revised title, the examiner suggests additionally identifying the substituted pyridines of the Formula I.
The following title is suggested: SUBSTITUTED PYRIDINES AS GRAM-NEGATIVE SPECIFIC ANTIBIOTICS.
Appropriate correction is required.
Specification Objection - Abstract
The inventor or joint inventor is reminded of the proper content of an abstract of the disclosure.
With regard particularly to chemical patents, for compounds or compositions, the general nature of the compound or composition should be given as well as the use thereof, 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 reactions, reagents and process conditions should be stated, generally illustrated by a single example, unless variations are necessary. See MPEP § 608.01(b), Section B.
The abstract of the disclosure is objected to because it fails to exemplify any members or formulae illustrative of its class. Correction is required. See MPEP § 608.01(b).
The examiner suggests incorporating the structure of Formula I into the abstract, to overcome this objection.
Claim Objections
Claim 1 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(a) and/or 35 U.S.C. § 112(b), the existing recitation should be replaced with the following recitation:
A compound of Formula I:
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I
or a pharmaceutically acceptable salt thereof,
wherein:
R1 is H, C1-C6 alkyl, or C3-C6 cycloalkyl;
R2 is H, C1-C6 alkyl, or C3-C6 cycloalkyl;
R3 is H, halo, CN, C1-C6 alkyl, or C3-C6 cycloalkyl;
R4 is H, halo, CN, C1-C6 alkyl, or C3-C6 cycloalkyl;
R5 is H, halo, CN, C1-C6 alkyl, or C3-C6 cycloalkyl;
each R6 is independently H, halo, CN, C1-C6 alkyl, or C3-C6 cycloalkyl;
R7 is H, C1-C6 alkyl, or C3-C6 cycloalkyl;
X is -NH-, -NCH3-, -O-, or -S-; and
each R’ is independently H or C1-C6 alkyl;
wherein any C1-C6 alkyl is optionally substituted with one or more substituents independently selected from the group consisting of F, Cl, Br, I, CN, C(NH)NR’R’, C(NOR’)R’, C(O)R’, C(O)CH2C(O)R’, C(O)C(O)R’, C(O)NR’R’, C(O)NR’OR’, C(O)OR’, C(S)R’, C(S)NR’R’, NR’R’, NR’C(O)R’, NR’C(O)NR’R’, NR’C(O)OR’, NR’C(S)R’, NR’C(S)NR’R’, NR’NR’C(O)R’, NR’NR’C(O)NR’, NR’NR’C(O)OR’, NR’OR’, NR’S(O)2R’, NR’S(O)2NR’R’, N(COR’)C(O)R’, OR’, OCF3, OC(O)R’, OC(O)NR’R’, SR’, S(O)R’, S(O)2R’, S(O)2NR’R’, S(O)2OR’, cycloalkyl, heterocyclyl, aryl, and heteroaryl; and
wherein any C3-C6 cycloalkyl is optionally substituted with one or more substituents independently selected from the group consisting of F, Cl, Br, I, CN, CF3, C1-C6 alkyl, -(CH2)1-2NHC(O)R’, C(NH)NR’R’, C(NOR’)R’, C(O)R’, C(O)CH2C(O)R’, C(O)C(O)R’, C(O)NR’R’, C(O)NR’OR’, C(O)OR’, C(S)R’, C(S)NR’R’, NR’R’, NR’C(O)R’, NR’C(O)NR’R’, NR’C(O)OR’, NR’C(S)R’, NR’C(S)NR’R’, NR’NR’C(O)R’, NR’NR’C(O)NR’, NR’NR’C(O)OR’, NR’OR’, NR’S(O)2R’, NR’S(O)2NR’R’, N(COR’)C(O)R’, OR’, OCF3, -OCH2O-, -OCH2CH2O-, OC(O)R’, OC(O)NR’R’, SR’, S(O)R’, S(O)2R’, S(O)2NR’R’, S(O)2OR’, cycloalkyl, heterocyclyl, aryl, and heteroaryl;
with the provisos that:
(1) if R1 is H and R2 is H, then R3 is not F; and
(2) R3, R4, and R5 are not all H.
Appropriate correction is required. See MPEP § 2173.02.
Claim 2 is objected to because of the following informalities: for clarity and precision, the existing recitation should be replaced with the following recitation:
The compound of claim 1, or a pharmaceutically acceptable salt thereof, wherein X is -O-.
Appropriate correction is required. See MPEP § 2173.02.
Claim 3 is objected to because of the following informalities: for clarity and precision, the existing recitation should be replaced with the following recitation:
The compound of claim 1, or a pharmaceutically acceptable salt thereof, wherein:
R1 is CH3; and
R2 is CH3.
Appropriate correction is required. See MPEP § 2173.02.
Claim 4 is objected to because of the following informalities: for clarity and precision, the existing recitation should be replaced with the following recitation:
The compound of claim 1, or a pharmaceutically acceptable salt thereof, wherein R3 is H, F, CN, or CH2NH2.
Appropriate correction is required. See MPEP § 2173.02.
Claim 5 is objected to because of the following informalities: for clarity and precision, the existing recitation should be replaced with the following recitation:
The compound of claim 1, or a pharmaceutically acceptable salt thereof, wherein:
R4 is H, CN, or CH2NH2; and
R5 is H, CN, or CH2NH2.
Appropriate correction is required. See MPEP § 2173.02.
Claim 6 is objected to because of the following informalities: for brevity, clarity and precision, the existing recitation should be replaced with the following recitation:
The compound of claim 1, or a pharmaceutically acceptable salt thereof, wherein each R6 is independently H, CN, or CH2NH2.
Appropriate correction is required. See MPEP § 2173.02.
Claim 7 is objected to because of the following informalities: for clarity and precision, the existing recitation should be replaced with the following recitation:
The compound of claim 1, or a pharmaceutically acceptable salt thereof, wherein:
(a) one of R3, R4, and R5 is H; or
(b) two of R3, R4, and R5 are H; or
(c) R7 is H.
Appropriate correction is required. See MPEP § 2173.02.
Claim 8 is objected to because of the following informalities: for clarity and precision, the existing recitation should be replaced with the following recitation:
The compound of claim 1, wherein the compound is represented by Formula II:
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II
or a pharmaceutically acceptable salt thereof.
Appropriate correction is required. See MPEP § 2173.02.
Claim 9 is objected to because of the following informalities: for clarity and precision, the existing recitation should be replaced with the following recitation:
The compound of claim 1, wherein the compound is:
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(12),
or a pharmaceutically acceptable salt thereof.
Appropriate correction is required. See MPEP § 2173.02.
Claim 10 is objected to because of the following informalities: for clarity and precision, the existing recitation should be replaced with the following recitation:
The compound of claim 1, wherein the compound is selected from the group consisting of:
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(3),
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(4),
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(5),
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(6),
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(7),
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(8),
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(9),
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(10),
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(11),
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(12),
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(13),
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(14),
and
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(15),
or a pharmaceutically acceptable salt thereof.
Appropriate correction is required. See MPEP § 2173.02.
Claim Rejections - 35 U.S.C. § 112(b)
The following is a quotation of the second paragraph of 35 U.S.C. § 112:
(b) CONCLUSION. The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or joint inventor regards as the invention.
Claims 1-8 are rejected under 35 U.S.C. § 112(b) as being indefinite for failing to set forth the subject matter which the inventor or joint inventor regards as the invention.
The inventor or joint inventor should note that the phrase, optionally substituted, in claim 1, is a relative phrase which renders the claim indefinite. The phrase, optionally substituted, is not defined by the claim, the specification does not provide an adequate standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the metes and bounds of the invention. The specification, on page 12, uses open language, such as selected from and include, to define the term, substituent, using a boiler plate list of functional groups, such as F, Cl, etc., and further discloses that the substituents themselves may be further substituted; however, neither the specification, nor the claim, explicitly limits the invention to any specifically disclosed or recited embodiments. Consequently, the substituted pyridines of the Formula I have been rendered indefinite by the use of the phrase, optionally substituted.
Moreover, the inventor or joint inventor should further note that [C]laims which depend from indefinite claims are also indefinite. {See Ex parte Cordova, 10 USPQ 2d 1949, 1952 (PTO Bd. App. 1989)}.
The examiner suggests amending the claims, particularly as stated in the section above entitled Claim Objections, to overcome this rejection.
Claim Rejections - 35 U.S.C. § 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.
Claims 1, 4 and 7 are rejected under 35 U.S.C. § 102(a)(1) as being anticipated by Pulici, et al. in US 8,541,575.
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The inventor or joint inventor should note that the instant invention recites a substituted pyridine of the Formula I, shown to the left, where R1 = -H; R2 = -H; R3 = -H; R4 = -halo; R5 = -halo; R6 = -halo; R7 = -H; and X = -NH-, respectively, and/or a pharmaceutical composition thereof, as a gram-negative specific antibiotic.
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Similarly, the inventor or joint inventor should further note that Pulici, et al. (US 8,541,575), as cited on the IDS, teaches a substituted pyridine of the Formula I, shown to the right, where R1 = -H; R2 = -H; R3 = -H; R4 = -F; R5 = -F; at C-2, R6 = -F; at C-4, R6 = -F; at C-5, R6 = -H; at C-6, R6 = -H; R7 = -H; and X = -NH-, respectively, as a protein kinase inhibitor [Example 37, column 188, lines 25-40].
Likewise, the inventor or joint inventor should further note that [T]he discovery of a previously unappreciated property of a prior art compound, or of a scientific explanation for the prior art’s functioning, does not render the old compound patentably new to the discoverer. {See Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999)}.
Next, the inventor or joint inventor should further note that [T]he claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. {See In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977); and In re Crish, 393 F.3d 1253, 1258, 73 USPQ2d 1364, 1368 (Fed. Cir. 2004)}.
Then, the inventor or joint inventor should note that [W]hen the claim recites using an old compound and the use is directed to a result or property of that compound, then the claim is anticipated. {See In re May, 574 F.2d 1082, 1090, 197 USPQ 601, 607 (CCPA 1978); and In re Tomlinson, 363 F.2d 928, 150 USPQ 623 (CCPA 1966)}.
Moreover, the inventor or joint inventor should further note that [P]roducts of identical chemical composition may not have mutually exclusive properties. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties the inventor or joint inventor discloses and/or claims are necessarily present. {See In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990)}.
Finally, the inventor or joint inventor should further note that in the event the determination of the status of the invention as subject to AIA 35 U.S.C. § 102 (or as subject to pre-AIA 35 U.S.C. § 102) is incorrect, any correction of the statutory basis for the instant 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.
Allowable Subject Matter
No claims are allowed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DOUGLAS M. WILLIS, whose telephone number is 571-270-5757. The examiner may normally be reached on Monday thru Thursday from 8:00-6:00 EST. The examiner is also available on alternate Fridays.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Mr. Jeffrey Murray, may be reached on 571-272-9023. The fax phone number for the organization where this invention or proceeding is assigned is 571-273-8300.
Information regarding the status of an invention may be obtained from Patent Center. For more information about Patent Center, see https://www.uspto.gov/patents/apply/patent-center. Should you have questions on access to Patent Center, contact the Patent Electronic Business Center (PEBC) at 866-217-9197 (toll-free) or ebc@uspto.gov.
/DOUGLAS M WILLIS/
Primary Examiner, Art Unit 1624
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