DETAILED ACTION
Claims 3-7, 10, 12-13, 16, 22-26, 29, 31-32, 35 and 40-41 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 .
Response to Amendment/Arguments
Applicant’s amendments and arguments filed in a response 06/29/2026 have been fully considered and entered into the application. Applicant has overcome
The 35 U.S.C. 112(b) rejection of claims 3-7, 10 and 21 in view of Applicant’s amendment to claim 3.
The 35 U.S.C. 102(a)(1) rejection of claims 3-6, 10 and 21 in view of Applicant’s amendments.
The 35 U.S.C. 103 rejection of claims 3, 7 and 21 in view of Applicant’s amendments.
Regarding the improper Markush grouping, Applicant argues that a Markush groups is proper if the members (1) share a single structural similarity, OR (2) share a common use. However, 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. As discussed previously, the compound of formula (Ia) lacks single structural similarity. The only common core shared by the compounds of formula (Ia) is an amide (NC=O) functional group yet there are further multiple variables, i.e. R1, R1a, R2 and X, that have multiple definitions that comprise the compound. An amide group is insufficient to define a Markush group as one could not say that all members of the class will behave in the same way in the context of the claimed invention (i.e., it is well known that each member could be substituted one for the other, with the expectation that the same intended result would be achieved) due to the presence of many other variables. As a result, the rejection has been maintained.
Election/Restrictions
Claims 22-26, 29, 31-32, 35 and 40 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 of
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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, and 41 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.
Improper Markush Rejection
Claim 3-7, 10 and 41 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
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 4-5 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claims 4-5 recite that X is SH or in claim 5, the compound of formula (II) has X = SH. However claims 4-5 depend on claim 3 and claim 3 does not recite that X may be -SH. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claim(s) 3-6, 10, and 41 is/are rejected under 35 U.S.C. 103 as being unpatentable over Moser et al (see CA Reg Abstract Doc. No. 150:56532, entered into STN on 12/18/2008 and US PG Pub 2017/0088549). Moser et al teaches compound
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for antibacterial activity. This compound corresponds to a compound of formula (Ia) wherein X is C(=O)-NH-OH, R2 is an alkyl, R1a is H, R1 is optionally substituted aralkyl group. Moser teaches in US PG Pub 2017/0088549 that a method of administering a compound of formula(I) to a subject infected with a gram-negative bacteria selected from Pseudomonas aeruginosa see paragraph [0340]. Thus it would be obvious to select the compound of Moser et al in CA Reg Abstract Doc. No.150:56532 taught to have antibacterial activity to administer to subjects having a gram-negative bacterial infection, including one infected with Pseudomonas aeruginosa. US PG Pub 2017/0088549 teaches that antibacterial agent refers to agents synthesized or modified in the laboratory that have either bactericidal or bacteriostatic activity and an active agent will inhibit the growth of P. aeruginosa (see paragraph [0377].
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655
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