DETAILED ACTION
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 the Application
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/17/2025 has been entered.
Claims 30-49 and 52-56 are pending as of the response filed 12/17/2025. Claims 1-29 and 50-51 are cancelled. Claim 56 is newly added. Applicant’s election of a species of compound as compound 329 is maintained. Claims 47-48 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim. Therefore, claims 30-46, 49 and 52-56, have been examined herein.
Applicant’s submission of a declaration under 37 C.F.R. 1.132 dated 12/17/2025 is acknowledged. Applicant’s declaration indicating unpredictability in the field of antibacterial activity, with respect to the activity of various LpxC inhibitors against different species of gram negative bacterium were found to be persuasive. Applicant’s discussion of the effectiveness of an antibacterial agent being highly dependent on its specific mechanism of action and the unique resistance profiles of different bacterial species was found to be persuasive.
Applicant’s arguments have been fully considered and was found to be partially persuasive. Specifically, Applicant’s discussion indicating that it is not reasonable to expect that a compound (i.e., the instantly elected species of compound) taught by Moser, to be effective against certain strains of gram-negative bacteria, would work against the instantly recited species of gram-negative bacteria (Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, Actinobacillus pleuropneumoniae) in the treatment of bovine or swine respiratory disease, was found to be persuasive.
In consideration of the declaration and Applicant’s arguments, the 35 U.S.C. 103 rejection of record over Moser in view of Shuster is withdrawn. However, it is noted that the surprising results discussed by Applicants is not commensurate in scope with the breadth of the instant claims.
In view of the pending claims, the following objections/rejections are made.
Information Disclosure Statement
The information disclosure statement filed on 12/17/2025 has been considered. The submission is in compliance with the provisions of 37 CFR 1.97.
Claim Objections
Claims 30-31 are objected to because of the following informalities:
In claim 30, all occurrences of the limitation “C3-8-cycloalkyl” is missing an “l” at the end – say definition of M; definition of Y; definition of R1; etc.
In claim 31, the single occurrence of the limitation “C3-8-cycloalkyl” is missing an “l” at the end.
Further, in claim 31, in the definition of the variable RA1 and RA2 together with the N atom to which they are attached can form a saturated or unsaturated heterocyclic ring, in the limitations for optional substitution,
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the limitation “C1-6 alkyl substituted with aryl” is repeated twice. It is suggested that the second occurrence of this limitation be removed from the claim.
Appropriate correction is required.
Claim Rejections - 35 USC § 112 - Written Description
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 30-46, 49 and 52-56 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 30 is drawn to a method of treatment of bovine respiratory disease or swine respiratory disease associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, Actinobacillus pleuropneumoniae, comprising administering to an animal a compound according to formula (I), wherein the variables are as defined in claim 30.
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The genus of compounds according to formula (I) claimed wherein A, L, M, G, Y, X, R1, R2, R3, R4, R5 encompass a highly divergent variety of functional groups, which includes species that do not share both a substantial structural feature and a common function that flows from the substantial feature. The different compounds would be presumed by one of ordinary skill in the art to have different physical properties (e.g. solubility, stability, etc.) that would lead to different activities (e.g. ADME and PK/PD, efficacy, toxicity, etc.). In consideration of the unpredictability in the field of antibacterial therapy, one of ordinary skill in the art would not expect this diverse group of compounds to show adequate antibacterial activity against the specific species of gram-negative bacteria being claimed. Specifically, the specification discloses the MIC50 and MIC90 values of a limited number of species of the compounds according to formula (I), against M. haemolytica, P. multocida, H. somni and A. pleuropneumoniae (Pg. 345, Table 3; Pgs. 336-341, Table C) and in all in vitro and in vivo studies (Pgs. 346-347, Example 6; Example 7). These are not viewed as being reasonably representative of the genus of compounds in its claimed scope because no readily apparent combination of identifying characteristics is provided, other than the disclosure of those specific species as examples of the claimed genus for use in a method of treatment of bovine respiratory disease or swine respiratory disease associated with the recited species of gram-negative bacteria. It is not readily apparent that the genus of compounds according to formula (I) claimed have a structural entity in common, that leads to said antibacterial activity.
The MPEP lists factors that can be used to determine if sufficient evidence of possession has been furnished in the disclosure of the Application. Whether the specification shows that the inventor was in possession of the claimed invention is not a single, simple determination, but rather is a factual determination reached by considering a number of factors. Factors to be considered in determining whether there is sufficient evidence of possession include the level of skill and knowledge in the art, partial structure, physical and/or chemical properties, functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the method of making the claimed invention. Disclosure of any combination of such identifying characteristics that distinguish the claimed invention from other materials and would lead one of skill in the art to the conclusion that the applicant was in possession of the claimed species is sufficient. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. See MPEP 2163 (II) 3 (a) (i).
A chemical genus can be adequately described if the disclosure presents a sufficient number of representative species that encompass the genus. If the genus has substantial variance, the disclosure must describe a sufficient number of species to reflect the variation within that genus. The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice (see i)(A) above), reduction to drawings (see i)(B) above), or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the inventor was in possession of the claimed genus (see i)(C) above). See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. A "representative number of species" means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. See AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1300, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014). The disclosure of only one species encompassed within a genus adequately describes a claim directed to that genus only if the disclosure "indicates that the patentee has invented species sufficient to constitute the gen[us]." See Enzo Biochem, 323 F.3d at 966, 63 USPQ2d at 1615. "A patentee will not be deemed to have invented species sufficient to constitute the genus by virtue of having disclosed a single species when … the evidence indicates ordinary artisans could not predict the operability in the invention of any species other than the one disclosed. See MPEP 2163 (II) 3 (a) (ii).
In the instant case, there is no evidence Applicants had possession of the full genus of compounds according to formula (I) recited in the method claims at the time of filing, because the specification does not conclusively demonstrate the structure-activity relationship of the claimed vast array of compounds, towards their antibacterial activity with respect to all four gram-negative bacteria being claimed. The instant specification does not describe enough species of compounds having said antibacterial activity within the scope of the claimed invention. Thus, the written description requirement for the claimed genus of antibacterial compounds has not been met.
In response to this rejection, the Applicant can amend the claim(s) to recite only individual species or grouping of species that share a substantial structure as well as a common function that flows from the substantial structural feature, or present a sufficient showing that the species recited in the alternative of the claim(s) in fact share a common function that flows from the substantial structural feature.
Claims 31-46, 49 and 52-56 depend from a rejected base claim and are similarly rejected.
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 30-46 and 49 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 of U.S. Patent No. 11,406,617 B2.
Although the claims at issue are not identical, they are not patentably distinct from each other.
The instant claims are drawn to a method of treatment of bovine respiratory disease or swine respiratory disease comprising administering to an animal a compound according to formula (I) with variables as defined in claim 30.
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The claims of the ‘617 patent are drawn to a method of treatment of bovine respiratory disease or swine respiratory disease comprising administering to an animal a compound of the following formula.
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The compound of the reference patent anticipates the genus of compounds of formula (I) of instant claim 30.
Therefore, instant claims 30-46 and 49 and claims 1-2 of the ‘617 patent are not patentably distinct.
This is a nonstatutory double patenting rejection.
Claims 30-46 and 49 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 and 15 of co-pending Application No 18/721,947.
Although the claims at issue are not identical, they are not patentably distinct from each other.
The instant claims are drawn to a method of treatment of bovine respiratory disease or swine respiratory disease comprising administering to an animal a compound according to formula (I) with variables as defined in claim 30.
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The claims of the reference ‘947 application are drawn to a method of treating a bacterial infection in an animal comprising administering to an animal an injectable composition of a compound of the following formula.
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The compound of the reference ‘947 application anticipates the genus of compounds of formula (I) of instant claim 30. Although the reference ‘947 application does not explicitly teach treating bovine respiratory disease or swine respiratory disease, looking into the specification of the co-pending application for the utility of the injectable pharmaceutical composition, the composition is taught to be useful in treating bovine respiratory disease (BRD) and or swine respiratory disease (SRD) (page 2, lines 15-18). This renders the instant method claims prima facie obvious.
The instant claims 30-46 and 49 and the claims 1-2 and 15 of co-pending Application No 18/721,947 are therefore not patentably distinct.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicants argue on pages 13-16 of the response dated 12/17/2025, that “Based on the varied activity of LpxC inhibitors against a variety of bacteria species and strains, one skilled in the art would have no expectation that the compounds of Formula (I) would be active against Mannheimia haemolytica, Pasteurella multocida, Histophilus somni or Actinobacillus pleuropneumoniae based on the disclosure of Moser that some of those compounds are active against different gram-negative bacteria (e.g. Pseudomonas aeruginosa, Stenotrophomonas, maltophila, Burkholderia cepacia, Alcaligenes xylosoxidans, Acinetobacter, Enterobacteriaceae, Haemophilus, Franciscellaceae (Franciscella tularensis) and Neisseria species)”. Applicants argue “The effectiveness of the compounds of Formula (I) against Mannheimia haemolytica, Pasteurella multocida, Histophilus somni or Actinobacillus pleuropneumoniae, the bacteria that are responsible for BRD, would have been unpredictable and therefore unexpected to one skilled in the art “. Applicants conclude “Applicants believe that the present application is now in condition for allowance”.
Applicant's arguments have been fully considered but they are not fully persuasive.
Applicant’s arguments are partially persuasive as is reflected in the withdrawn rejections. While the examiner appreciates the Applicants discussion of unexpected antibacterial activity of the compounds of formula (I) with respect to the treatment of bovine and swine respiratory disease, the examiner respectfully disagrees a sufficient showing of unexpected results for the following reasons.
As stated in MPEP 716.02(d), “Whether the unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the "objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support." In other words, the showing of unexpected results must be reviewed to see if the results occur over the entire claimed range. In re Clemens, 622 F.2d 1029, 1036, 206 USPQ 289, 296 (CCPA 1980)”. In the instant case, as stated in the 35 U.S.C. 112(a) rejection above, the results of MIC50 and MIC90 values of the compounds tested towards the instantly claimed species of gram-negative bacteria (M. haemolytica, P. multocida, H. somni and A. pleuropneumoniae), shown in Table 3 of the instant specification are limited to a handful of compounds of formula (I). However, the instant claims are considerably broader, encompassing a wide variety of compounds of formula (I) as recited in instant claim 30. In consideration of Applicant’s discussion of unpredictability in the field of antibacterial activity and assuming that the instant compounds exhibit unexpected antibacterial activity against the said bovine or swine respiratory pathogens, the evidence referred to by Applicants is not anywhere near commensurate in scope with the claims.
Therefore, the application is not in condition for allowance.
Conclusion
Claims 30-46, 49 and 52-56 are rejected.
Claims 30-31 are objected to.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PADMAJA S RAO whose telephone number is (571) 272-9918. The examiner can normally be reached 9:00-5:30 pm EDT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kortney L Klinkel can be reached on (571) 270-5239. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/P.S.R./Examiner, Art Unit 1627
/SARAH PIHONAK/Primary Examiner, Art Unit 1627