DETAILED ACTION
Claims 3-7, 10, 12-13, 16, 21-26, 29, 31-32, 35 and 40 are currently pending in the instant application.
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 .
Election/Restrictions
Applicant's election with traverse of Group I, drawn to claims 3-7, 10, 12-13, 16 and 21 with election of species
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in the reply filed on 11/18/2025 is acknowledged. The traversal is on the ground(s) that multiple groups may be searched and examined together without undue burden. This is not found persuasive because as stated in the original restriction requirement, the application lacks unity of invention and multiple prior art can be applied to the claims as is.
The requirement is still deemed proper and is therefore made FINAL.
Claims 22-26, 29, 31-32, 35 and 40 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 11/18/2025.
In accordance with the MPEP, if upon examination of the elected species, no prior art is found that would anticipate or render obvious the instant invention based on the elected species and the claims drawn to the elected species are allowable, the search of the Markush-type claim will be extended (see MPEP 803.02). If prior art is then found that anticipates or renders obvious the non-elected species, the Markush-type claim will be rejected. It should be noted that the prior art search will not be extended unnecessarily to cover all non-elected species. Should Applicant overcome the rejection by amending the claim, the amended claim will be reexamined. Id. The prior art search will be extended to the extent necessary to determine patentability of the Markush-type claim. Id. In the event prior art is found during reexamination that renders obvious or anticipates the amended Markush-type claim, the claim will be rejected and the action made final. Id.
Applicant's elected species appears allowable over the prior art of record. Therefore, the search of the Markush-type claim has been extended to the non-elected species of
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. As prior art has been found which anticipates the above identified nonelected species, the Markush-type claims are rejected as follows and the subject matter of the claims drawn to nonelected species held withdrawn from consideration. Claims 3-7, 10, 16 and 21 have been examined to the extent that they are readable on the elected embodiment and the above identified nonelected species. Since art was found on the nonelected species, subject matter not embraced by the elected embodiment or the above identified nonelected species is therefore withdrawn from further consideration.
The remaining subject matter of claims 12-13 and 16 that are not drawn to the above elected invention stand withdrawn under 37 CFR 1.142(b) as being non-elected subject matter. The remaining compounds which are not within the elected invention are independent and distinct from the elected invention as they differ in structure and composition. Therefore the compounds, which are withdrawn, have been restricted as the withdrawn subject matter is patentably distinct from the elected subject matter as it differs in structure and element and would require separate search considerations. In addition, a reference, which anticipates one group, would not render obvious the other. Thus all claims containing compounds falling outside the search strategy of the elected compound and structure shown above are heretofore directed to non-elected subject matter and are withdrawn from consideration under 35 U.S.C. § 121 and 37 C.FR. § 1.142(b). A complete reply to the non-final rejection must include cancellation of non-elected claims include cancellation of non-elected claims or other appropriate action (37 CFR 1.144). See MPEP § 821.01.
Applicant is reminded that upon the cancellation of claims to a non-elected invention, the inventorship must be amended in compliance with 37 CFR 1.48(b). If one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. Any amendment of inventorship must be accompanied by a request under 37 CFR 1.48(b) and by the fee required under 37 CFR 1.17(i).
Priority
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Information Disclosure Statement
Applicant's Information Disclosure Statements filed on 04/24/2023, 11/15/2024 and 05/01/2025 have been considered. Applicant's copies of the 1449 are submitted herewith.
Improper Markush Rejection
Claim 3-7, 10 and 21 are rejected on the basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117.
The Markush grouping of compound of formula (Ia)
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is improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons:
It cannot be said that all members of the Markush group have a single structural similarity. Specifically, the species of the Markush group do not share a “single structural similarity” because there are no required structural features in common such that each member of formula I would have at least one structural feature, which feature is essential to the activity/function of the claimed compounds. The variables R1, R1a, R2 and X prevent the core structure from being an art-recognized physical or chemical class.
For example, R2 is recited to be an alkyl, alkenyl, alkynyl, heteroalkyl, cycloalkyl, heterocycloalkyl, alkylcycloalkyl, heteroalkylcycloalkyl, aryl, heteroaryl, aralkyl or heteroaralkyl group, all of which may optionally be substituted, R1 is an optionally substituted cycloalkyl group, an optionally substituted heterocycloalkyl group, an optionally substituted aryl group or an optionally substituted heteroaryl group or an optionally substituted aralkyl group or an optionally substituted heteroaralkyl group; or a group of formula -CH(R6)-C(═O)-NH-R7, or a group of formula -C(Me)2-CH2-C(═O)-NH-R7, or a group of formula -CH(R6)-CH2-C(═O)-NH-R7, or a group of formula -CH(R6)-R8, R1a is hydrogen, or, if R1 is a group of formula -CH(R6)-C(═O)-NH-R7, R1a and R6 together may be a group of formula -(CH2)3- or -(CH2)4- and X is a group of formula -PO(OH)2, -SH, -C(═O)-NH-OH, an optionally substituted triazolyl group, -SR3, -PO(OH)(OR4) or -PO(OR4)(OR5). Within these groups, various definitions for R3, R4, R5, R6, R7 and R8 also exist. Thus, there is no substantial core structure that is shared by all species within Formula (Ia). In fact, Formula (Ia) is drawn to multiple core structures and claims a variety of species that are structurally distinct due to their unique core structures.
In addition, each alternatively usable member of the Markush group does not share a common use. Rather, the specification discloses that the compounds are inhibitors of the Pseudomonas aeruginosa virulence factor LasB. However, there is no common core in the compounds of formula Ia that is known to impart the activity of inhibition of the Pseudomonas aeruginosa virulence factor LasB. It is suggested that applicant amend the claims to contain only proper Markush groupings to compounds sharing a single structural similarity and a common use, wherein the common use shared by the compounds is a result of the structural similarity essential to the function of the compounds.
Cases where the Markush group was held improper include Ex Parte Palmer, 7 USPQ 11, In re Winnek, 73 USPQ 225, In re Ruzicka, 66 USPQ 226, Ex parte Hentrich, 57 USPQ 419, Ex parte Barnard, 135 USPQ 109, Ex parte Reid, 105 USPQ 251, Ex parte Sun and Huggins, 85 USPQ 516, In re Thompson and Tanner, 69 USPQ 148, In re Swenson, 56 USPQ 180, and In re Kingston, 65 USPQ 371. Note In re Milas 71 USPQ 212 in which the structural difference between vitamin A and D was sufficient to uphold the improper Markush rejection. Also see In re Winnek 73 USPQ 225 and In re Ruzicka 66 USPQ 226 in which structural differences were small and yet a similar holding was maintained. All these cases involved compounds in the pharmaceutical art known to be structure-sensitive. Of particular interest is Ex Parte Hozumi, 3 USPQ2d 1059, which reversed an improper Markush rejection “in view of the relatively large proportion of the structure of the compounds in the claimed class which is common to the entire class.” Here, by contrast, the amount in common is none, relative to the entire molecule.
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use.
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 3-7, 10 and 21 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 3 recites a method for treating a subject “susceptible to a bacterial infection”. The Specification fails to define how a subject would be susceptible to having the bacterial infection and a person having ordinary skill in the art would not know if such criteria is defined by age, comorbidities, immune suppression, etc. Thus, the metes and bounds of the claim are unclear as this would seemingly indicate that any breathing organism could potentially be susceptible to a bacterial infection.
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 (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 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 3-6, 10 and 21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Singh et al (see Chem. Abs. AN: 2005:1201316, 2005, p. 1-2, cited in IDS filed 04/24/2023).
Singh teaches compounds such as
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as being screened for biological activity on different species of bacteria and found to be sufficiently active. Singh does not explicitly name the bacteria P. aeruginosa. According to Cambridge dictionary, the term “susceptible” is defined as liable to be influence or harmed by a particular thing. Thus by administering a compound to a subject, the same subject could also be susceptible (i.e. liable to be influenced) to a bacterial infection including one caused by P. aeruginosa. The compound of Singh corresponds to a compound of Formula (Ia) wherein R1 is an optionally substituted phenyl group, R1a is H, R2 is alkyl, and X is -SH.
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.
Claims 3, 7 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Singh et al (see Chem. Abs. AN: 2005:1201316, 2005, p. 1-2, cited in IDS filed on 04/24/2023) as applied to claim 3 above, and further in view of Hancock (Drug Resistance Updates, 2000, Vol. 3, p. 247-255, cited in IDS filed on 04/23/2023).
Singh teaches the limitations of claim 3 as discussed in the above 102(a)(1) rejection. Regarding claim 7, varying the length of the alkyl chain from 1 to 4 carbon atoms would lead to compounds that are considered homologues. A homologue is defined as a series of compounds differing from each other by a repeating unit. However, it has long been established that this type of difference --- varying the size of a chain --- constitutes a form of homology, and is a fact of very close structural similarity, rendering the homolog obvious. According to MPEP 2144.09, Section II, compounds which are homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977). Adjacent homologues are considered to be obvious absent unexpected results. See In re Henze, 85 USPQ 261, 263. Ex parte Nathan, 121 USPQ 349 found the insertion of a C2H4 link obvious. In all of these cases, the variation was found to be obvious on the basis of close structural similarity; no secondary teaching was employed. As was stated directly in THE GENERAL TIRE & RUBBER COMPANY v. JEFFERSON CHEMICAL COMPANY, INC., 182 USPQ 70 (1974): “If any structural change is obvious to one skilled in the art, a substitution of the next higher homolog would seem to be.” Note also In re Jones, 21 USPQ2d 1942, which states at 1943 “Particular types or categories of structural similarity without more, have, in past cases, given rise to prima facie obviousness”; one of those listed is “adjacent homologues and structural isomers”. Similar is In re Schechter and LaForge, 98 USPQ 144, 150, which states “a novel useful chemical compound which is homologous or isomeric with compounds of the prior art is unpatentable unless it possesses some unobvious or unexpected beneficial property not possessed by the prior art compounds.” Note also In re Deuel 34 USPQ2d 1210, 1214 which states, “Structural relationships may provide the requisite motivation or suggestion to modify known compounds to obtain new compounds. For example, a prior art compound may suggest its homologs because homologs often have similar properties and therefore chemists of ordinary skill would ordinarily contemplate making them to try to obtain compounds with improved properties.”
In the absence of unexpected results, one skilled in the art would expect that the instant claims which are directed to compounds that are homologues to the compounds of Singh is prima facie. One skilled in the art would be motivated to synthesize structurally similar compounds with the expectation that they would have similar properties and utilities. The explicit teaching of Singh together with the enabled examples would have motivated one skilled in the art to synthesize compounds with the expectation that they would have similar biological activity on different species of bacteria.
Regarding claim 21, specifically for the limitations of “treating a subject suffering from”, the limitations of claims 3 are taught by Singh as discussed in above 102(a)(1) rejection. Hancock teaches that P. aeruginosa is a major cause of infections in Western society and a major cause of opportunistic nosocomial infections and dominant cause of chronic lung infections (see p. 247). Thus, one of ordinary skill in the art would be motivated to test the compound of Hancock in the treatment of P. aeruginosa bacteria as the compounds of Singh are taught to have sufficient biological activity on different species of bacteria since P. aeruginosa is a major cause of infections.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAREN CHENG whose telephone number is (703)756-4699. The examiner can normally be reached M-F, 9AM-6PM PST.
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/KAREN CHENG/Primary Examiner, Art Unit 1623
/ADAM C MILLIGAN/Supervisory Patent Examiner, Art Unit 1623