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 .
Claims 1-14, submitted on 12 May 2023, represent all claims currently under consideration.
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.
Priority
This application is a continuation in part of 17/352,382, filed 21 June 2021 (now abandoned), which is a continuation of 17/006,985, filed 21 August 2020, and a continuation in part of 16/867,540, filed 5 May 2020. Application 17/006,985 is a continuation in part of 16/867,540, filed 5 May 2020, which is a continuation in part of 16/041,838, filed 23 July 2018, which claims priority to provisional US 62/535,540, filed 21 July 2017.
The effective filing date is 21 July 2017.
Information Disclosure Statement
One Information Disclosure Statement (IDS), submitted on 2 November 2023, is acknowledged and has been considered. The information disclosure statement filed 2 November fails to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609 because there is no English translation provided for the Chinese Office Actions. It has been placed in the application file, but the information referred to therein has not been considered as to the merits. Applicant is advised that the date of any re-submission of any item of information contained in this information disclosure statement or the submission of any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the statement, including all certification requirements for statements under 37 CFR 1.97(e). See MPEP § 609.05(a).
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure. The abstract contains the use of legal phraseology including “said”, and this should not be included in the abstract.
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.
Claim 1 is 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 1 recites the limitation "wherein variable R5 can be selected from…" in Lines 22-32. There is insufficient antecedent basis for this limitation in the claim. The claim lacks antecedent basis because the artisan cannot find the antecedent basis to variable R5 as the claims do not link R5 to the compounds being claimed. Claims 2-14 are similarly rejected as indefinite as they depend upon an indefinite claim without resolving the underlying issue of indefiniteness with respect to variable R5.
Claim 1 is 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. Regarding claim 1, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Claims 2-4 and 6-14 are similarly rejected as dependent upon an indefinite claim without resolving the underlying issue of indefiniteness.
Claim 2 is 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 2 contains the word “including”, which renders the claim indefinite as it is unclear if the limitations which follow “including” are intended to be merely exemplary or are required limitations of the claim.
Claim 5 is 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 5 depends on Claim 1, which recites the limitation "R8 and R9 are optionally bonded together to form a four-, five-, or six-membered heterocyclyl, cycloalkenyl, or cycloalkyl". However,
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have variables R8 and R9 coming together to form a 10 membered heterocyclic group. There is insufficient antecedent basis for this limitation in the claim. Claim 5 depends on Claim 1, which states that variables R8 and R9 are independently selected from the group consisting of heteroalkyl, aryl, heterocyclyl, cycloalkyl, cycloalkenyl, cycloalkynyl, and tetrahydroquinolinyl, or R8 and R9 are bonded together to form a four-, five-, or six-membered heterocycl, cycloalkenyl, or cycloalkyl. Claim 1 does not state that variables R8 and R9 can come together to form a 10-membered heterocyclic group.
Claim 9 is 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 9 recites the limitation "the composition inhibits biosynthesis of staphyloxanthin in the Staphylococcus aureus" in lines 1-2. There is insufficient antecedent basis for “the Staphylococcus aureus” in the claim. Claim 9 depends on Claim 1, which does not mention Staphylococcus aureus, causing there to be no antecedent basis for the limitation of “the Staphyloccocus aureus”. The Examiner suggests removing “the” to overcome this rejection.
Claim Rejections - 35 USC § 112(d)
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.
Claim 5 is 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. Claim 5 claims two compounds
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and
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which have variables R8 and R9 coming together to form a 10 membered heterocyclic group. Claim 5 depends on claim 1 and states that variables R8 and R9 can come together to form a four-, five-, or six-membered heterocycle, cycloalkenyl, or cycloalkyl. These compounds have R8 and R9 coming together to form a 10 membered heterocycle, which is broader than what is claimed in Claim 1. 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.
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.
Claims 1-4 and 6-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 2 of U.S. Patent No. 11,446,280 (Patent Date: 20 September 2022) (‘280).
Claim 1 of ‘280 is directed to a compound having one of the following formulae:
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, which has variable R1 as having A as double bond, X as C, and either R3 or R4 as OH; Z as S, variable R6 and R7 as O, and variables R8 and R9 coming together to form a 5-membered heterocycle;
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which has variable R1 as having A as double bond, X as C, and either R3 or R4 as -OC(O)R11 with R11 as methyl; Z as S, variable R6 and R7 as O, and variables R8 and R9 coming together to form a 5-membered heterocycle;
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which has variable R1 as having A as double bond, X as C, and either R3 or R4 as -OC(O)R11 with R11 as methyl; Z as S, variable R6 and R7 as O, and variables R8 and R9 coming together to form a 5-membered heterocycle;
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which has variable R1 as having A as double bond, X as C, and either R3 or R4 as -OC(O)R11 with R11 as methyl; Z as S, variable R6 and R7 as O, and variables R8 and R9 coming together to form a 5-membered heterocycle; and
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which has variable R1 as having A as double bond, X as C, and either R3 or R4 as phenyl; Z as S, variable R6 and R7 as O, and variables R8 and R9 coming together to form a 5-membered heterocycle;. Each of these compounds meets the limitations of compounds of examined Formula (II). Reference Claim 2 claims a composition comprising a compound of reference Claim 1, such as the species
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and a pharmaceutically acceptable carrier, thus anticipating “an antiseptic composition for pre-surgical and post-surgical skin disinfection” as this is intended use language, and because the intended use of the claimed invention does not result in a structural difference between the claimed invention and the prior art (See MPEP § 2112.02 (II)), the prior art is capable of performing limitation of “for pre-surgical and post-surgical skin disinfection”.
The claims of Reference Application ‘280 and those at issue at not identical but are not patentably distinct because ’280 claims compositions comprising compounds which meet the limitations of the compounds which are claimed in the examined application, and are useful for the treatment of bacterial infections, particularly Staphylococcal infections. These compounds inherently possess the properties of examined Claims 7-10 and 14. As these compounds are known to possess antibacterial properties, it would be obvious to modify the composition of the known antibacterial compound with a second antiseptic agent, including those specifically claimed in examined Claims 3 and 4. "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). Thus, the artisan would be motivated to combine the known antibacterial agent with a second antiseptic agent as they are useful for the same purpose. Regarding the language “for pre-surgical and post-surgical skin disinfection”, this is intended use language, and as the intended use of the claimed invention does not result in a structural difference between the claimed invention and the prior art (See MPEP § 2112.02 (II)), the prior art is capable of performing the limitation of “for pre-surgical and post-surgical skin disinfection”.
Claims 1-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 12-13, and 15-17 of U.S. Patent No. 11,052,078 (Patent Date: 6 July 2021) (‘078).
Claim 1 of ‘078 is directed to a method of treating and/or preventing microbial infections in a subject comprising administering to the subject a composition comprising one or more compounds of Formula (II):
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wherein all variables are identical to those described in the examined application. Reference Claim 2 claims the method of reference claim 1 wherein the composition is administered to reduce a virulence of bacteria causing the microbial infection and/or related disease or conditions in said subject. Reference Claim 3 claims the method of reference claim 1 wherein the compositions further comprise one or more pharmaceutical carrier. Reference Claim 4 claims the method of reference claim 1 wherein the one or more compounds are anti-virulent agents for bacteria. Reference Claim 5 claims the method of reference claim 4 wherein the one or more compounds include
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,which has variable R1 as having A as double bond, X as C, and either R3 or R4 as bromine; Z as S, variable R6 and R7 as O, and variables R8 and R9 coming together to form a 6-membered heterocycle; as well as two isomers which are identical to those claimed in the examined application, having bromine in different locations on the phenyl ring. Each of these compounds meets the limitations of compounds of examined Formula (II). Reference Claim 5 also claims the compounds
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and
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, which have variable R1 as having A as double bond, X as C, and either R3 or R4 as bromine or hydrogen; Z as S, variable R6 and R7 as O, and variables R8 and R9 coming together to form a 6-membered heterocycle fused with a phenyl ring, and are identical to compounds of examined Claim 5. Thus, the composition of Reference Claim 5 anticipates “an antiseptic composition for pre-surgical and post-surgical skin disinfection” as this is intended use language, and because the intended use of the claimed invention does not result in a structural difference between the claimed invention and the prior art (See MPEP § 2112.02 (II)), the prior art is capable of performing limitation of “for pre-surgical and post-surgical skin disinfection”. Reference Claim 6 claims the method of reference claim 1 wherein the microbial infection comprises infections of the skin and soft tissue, bone and joint, surgical wound, indwelling devices, lung, and heart valves. Reference Claim 7 claims the method of reference claim 1 wherein the bacterial infections comprise Staphylococcus sp. Infections. Reference Claim 9 claims the method of reference claim 8 wherein the Staphylococcus sp. Comprises Staphylococcus aureus or methicillin-resistant Staphylococcus aureus. Reference Claim 10 claims the method of reference claim 1 wherein the composition inhibits biosynthesis of staphyloxanthin in the Staphylococcus aureus. Reference Claim 12 claims the method of reference claim 1 wherein the subject is a mammal. Reference Claim 13 claims the method of reference claim 1 wherein the subject is human. Reference Claim 15 claims the method of reference claim 1 wherein the composition is administered to the subject through non-oral pathways in one or more forms comprising an aqueous suspension, an oily preparation, a drip, suppository, salve, and/or ointment. Reference Claim 16 claims he method of reference claim 1 wherein the composition is administered subcutaneously, intraperitoneally, intravenously, intramuscularly, intradermally, or topically. Reference Claim 17 claims the method of reference claim 1 wherein the composition increases sensitivity and/or susceptibility of microbes causing said microbial infections and/or related diseases or conditions to oxidation and neutrophil killing.
The claims of Reference Application ‘078 and those at issue at not identical but are not patentably distinct because ’078 claims compositions comprising compounds which meet the limitations of the compounds which are claimed, or are identical to compounds claimed in the examined application, and are useful for the treatment of bacterial infections, particularly Staphylococcal infections. These compounds inherently possess the properties of examined Claims 7-10 and 14. As these compounds are known to possess antibacterial properties, it would be obvious to modify the composition of the known antibacterial compound with a second antiseptic agent, including those specifically claimed in examined Claims 3 and 4. "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). Thus, the artisan would be motivated to combine the known antibacterial agent with a second antiseptic agent as they are useful for the same purpose. Regarding the language “for pre-surgical and post-surgical skin disinfection”, this is intended use language, and as the intended use of the claimed invention does not result in a structural difference between the claimed invention and the prior art (See MPEP § 2112.02 (II)), the prior art is capable of performing the limitation of “for pre-surgical and post-surgical skin disinfection”.
Claims 1-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 6-12 and 14-16 of U.S. Patent No. 11,040,949 (Patent Date: 22 June 2021) (‘949).
Claim 1 of ‘949 claims a composition comprising one or more compounds having Formula (II)
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wherein each variable is as defined in the examined application for compounds of Formula (II). Reference Claim 2 claims the composition of reference claim 1 wherein the composition is administered to reduce a virulence of bacteria causing microbial infections and/or related disease or conditions in a subject. Reference Claim 3 claims the composition of reference claim 1 wherein the composition further comprises one or more pharmaceutically acceptable carrier. Reference Claim 4 claims the composition of reference claim 1 wherein the one or more compounds thereof are anti-virulent agents for bacteria. Reference Claim 6 claims the composition of reference claim 2 wherein the microbial infections are bacterial infections. Reference Claim 7 claims the composition of reference claim 2 wherein the bacterial infections comprise Staphylococcus sp. Infections. Reference Claim 8 claims the composition of reference claim 7 wherein the Staphylococcus sp. Comprises Staphylococcus aureus or methicillin resistant Staphylococcus aureus. Reference Claim 9 claims the composition of reference claim 1 wherein the composition inhibits biosynthesis of staphyloxanthin in the Staphylococcus aureus. Reference Claim 10 claims the composition of reference claim 1 wherein the composition blocks pigment production in Staphylococcus aureus. Reference Claim 11 claims the composition of reference claim 1 wherein the subject is a mammal. Reference Claim 12 claims the composition of reference claim 2 wherein the subject is human. Reference Claim 14 claims the composition of reference claim 1 wherein the composition increases sensitivity and/or susceptibility of microbes causing microbial infections and/or related diseases or conditions to oxidation and neutrophil killing. Reference Claim 15 claims a composition comprising the compound
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, which has variable R1 as having A as double bond, X as C, and either R3 or R4 as bromine; Z as S, variable R6 and R7 as O, and variables R8 and R9 coming together to form a 6-membered heterocycle, meeting the limitations of examined Formula (II) and is an isomer of the compounds of examined Claim 5. Thus, the compositions of the reference application anticipate “an antiseptic composition for pre-surgical and post-surgical skin disinfection” as this is intended use language, and because the intended use of the claimed invention does not result in a structural difference between the claimed invention and the prior art (See MPEP § 2112.02 (II)), the prior art is capable of performing the limitation of “for pre-surgical and post-surgical skin disinfection”. Reference Claim 16 claims a composition comprising a compound selected from several compounds, including compounds claimed in Claim 5 of the examined application such as
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and
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.
The claims of Reference Application ‘949 and those at issue at not identical but are not patentably distinct because ’949 claims compositions comprising compounds which meet the limitations of the compounds which are claimed, or are identical to compounds claimed in the examined application, and are useful for the treatment of bacterial infections, particularly Staphylococcal infections. These compounds inherently possess the properties of examined Claims 7-10 and 14. As these compounds are known to possess antibacterial properties, it would be obvious to modify the composition of the known antibacterial compound with a second antiseptic agent, including those specifically claimed in examined Claims 3 and 4. "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). Thus, the artisan would be motivated to combine the known antibacterial agent with a second antiseptic agent as they are useful for the same purpose. Regarding the language “for pre-surgical and post-surgical skin disinfection”, this is intended use language, and as the intended use of the claimed invention does not result in a structural difference between the claimed invention and the prior art (See MPEP § 2112.02 (II)), the prior art is capable of performing the limitation of “for pre-surgical and post-surgical skin disinfection”.
Claims 1-4 and 6-14 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 6 and-7 of copending Application No. 17/949,184 (Amended Claims of 1 September 2025) (‘184).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 6 of ‘184 claims a composition for reducing virulence of bacteria in a subject by inhibition of staphyloxanthin biosynthesis of bacteria, comprising an effective amount of a compound of Formula (I)
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wherein R1, R2 and R3 are independently or jointly selected from H, I, OH, CN, C1-C4 alkyl, C2-C4 alkenyl, alkynyl, aralkyl, alkaryl, haloalkyl, aryl, heterocycle, cycloalkyl, cycloalkenyl, cycloalkynyl, hydroxylalkyl, aminoalkyl, acylamino, thiol, thioalkyl, alkoxy, alkoxyalkyl, aryloxy, arylalkoxy, acyloxy, carbamoyl, trifluoromethyl, phenoxy, benzyloxy, phosphonic acid, phosphate ester, sulfonic acid, sulfonate ester, sulfonamide, carbamate, alkyltriphenylphosphonium, ketone, ether, ester, and R1 is not methyl at a C2 position or a C4 position in the cyclic group when both R3 and R2 are H, wherein R1-R3 are not jointly H; R3 is not methyl when R1 and R2 are both H, R1 and R2 are not jointly -OMe, wherein the combinations of substituents are selected for the resulting compound to exhibit effectiveness in reducing virulence of bacteria and a pharmaceutically acceptable carrier; these compounds meet the limitations of compounds of examined Formula (II), having variable R1 with A having a double bond, X as C, and R3 and R4 selected from reference Claim 1 R1 and R2 and variable R2 having variable Z as S, variables R6 and R7 as O, and variables R8 and R9 forming a five-membered heterocycle. As these compositions contain compounds which meet the limitations of examined Formula (II), the compositions of the reference application anticipate “an antiseptic composition for pre-surgical and post-surgical skin disinfection” as this is intended use language, and because the intended use of the claimed invention does not result in a structural difference between the claimed invention and the prior art (See MPEP § 2112.02 (II)), the prior art is capable of performing the limitation of “for pre-surgical and post-surgical skin disinfection”. Reference Claim 7 claims the composition of reference claim 6 wherein the bacteria are Staphylococci sp.
The claims of Reference Application ‘184 and those at issue at not identical but are not patentably distinct because ’184 claims compositions comprising compounds which meet the limitations of the compounds which are claimed and are useful for the treatment of bacterial infections, particularly Staphylococcal infections. These compounds inherently possess the properties of examined Claims 7-10 and 14. As these compounds are known to possess antibacterial properties, it would be obvious to modify the composition of the known antibacterial compound with a second antiseptic agent, including those specifically claimed in examined Claims 3 and 4. "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). Thus, the artisan would be motivated to combine the known antibacterial agent with a second antiseptic agent as they are useful for the same purpose. Regarding the language “for pre-surgical and post-surgical skin disinfection”, this is intended use language, and as the intended use of the claimed invention does not result in a structural difference between the claimed invention and the prior art (See MPEP § 2112.02 (II)), the prior art is capable of performing the limitation of “for pre-surgical and post-surgical skin disinfection”.
Claims 1-4 and 6-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-8, and 10-11 of U.S. Patent No. 10,471,045 (Patent Date: 12 November 2019) (‘045).
Claim 1 of ‘045 is directed to a method of treating and/or preventing microbial infections in a subject comprising administering to the subject an effective amount of a compound of formula (I)
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wherein R1, R2, and R3 are independently or jointly selected from H, F, Cl, Br, I, OH, CN, alkyl, alkenyl, alkynyl, aralkyl, alkaryl, halogenated alkyl, heteroalkyl, aryl, heterocycle, cycloalkyl, cycloalkenyl, cycloalkynyl, hydroxyalkyl, aminoalkyl, amino, alkylamino, arylamino, dialkylamino, alkylarylamino, diarylamino, acylamino, thiol, thioalkyl, alkoxy, alkylthio, alkoxyalkyl, aryloxy, arylalkoxy, acyloxy, nitro, carbamoyl, trifluoromethyl, phenoxy, benzyloxy, phosphonic acid, phosphate ester, sulfonic acid, sulfonate ester, sulfonamide, arylalkyl, carbamate, alkyltriphenylphosphonium, ketone, ether, and ester. These compounds meet the limitations of examined claim 1, having variable R1 with A having a double bond, X as C, and R3 and R4 selected from variables R1 and R2 of the reference application, and variable R2 having variable Z as S, variables R6 and R7 as O, and variables R8 and R9 forming a five-membered heterocycle. Reference Claim 3 claims the method of reference Claim 1 wherein R3 is H or methyl. Reference Claim 4 claims the method of reference claim 1 wherein the compound is represented by several compounds which meet the limitations of the compounds of examined Formula (II), including
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which has variable R1 as having A as double bond, X as C, and either R3 or R4 as H; Z as S, variable R6 and R7 as O, and variables R8 and R9 coming together to form a 5-membered heterocycle;
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which has variable R1 as having A as double bond, X as C, and either R3 or R4 as Cl; Z as S, variable R6 and R7 as O, and variables R8 and R9 coming together to form a 5-membered heterocycle;
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which has variable R1 as having A as double bond, X as C, and R3 and R4 coming together to form a 5 membered heterocycle; Z as S, variable R6 and R7 as O, and variables R8 and R9 coming together to form a 5-membered heterocycle; and
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which has variable R1 as having A as double bond, X as C, and either R3 or R4 as methoxy; Z as S, variable R6 and R7 as O, and variables R8 and R9 coming together to form a 5-membered heterocycle. Reference Claim 5 claims the method of reference Claim 1 wherein the compound is selected from several compounds which meet the limitations of examined Formula (II), including
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which has variable R1 as having A as double bond, X as C, and either R3 or R4 as nitro; Z as S, variable R6 and R7 as O, and variables R8 and R9 coming together to form a 5-membered heterocycle;
PNG
media_image24.png
145
402
media_image24.png
Greyscale
which has variable R1 as having A as double bond, X as C, and either R3 or R4 as fluorine; Z as S, variable R6 and R7 as O, and variables R8 and R9 coming together to form a 5-membered heterocycle; and
PNG
media_image25.png
169
390
media_image25.png
Greyscale
which has variable R1 as having A as double bond, X as C, and both R3 and R4 as methoxy; Z as S, variable R6 and R7 as O, and variables R8 and R9 coming together to form a 5-membered heterocycle. Reference Claim 6 claims the method of reference Claim 1 wherein the compound is represented by several compounds which meet the limitations of examined Formula (II), including
PNG
media_image26.png
210
358
media_image26.png
Greyscale
which has variable R1 as having A as double bond, X as C, and either R3 or R4 as bromine; Z as S, variable R6 and R7 as O, and variables R8 and R9 coming together to form a 5-membered heterocycle;
PNG
media_image27.png
182
397
media_image27.png
Greyscale
which has variable R1 as having A as double bond, X as C, and either R3 or R4 as OH; Z as S, variable R6 and R7 as O, and variables R8 and R9 coming together to form a 5-membered heterocycle; and
PNG
media_image28.png
161
372
media_image28.png
Greyscale
which has variable R1 as having A as double bond, X as C, and either R3 or R4 as -OC(O)R11 with R11 as methyl; Z as S, variable R6 and R7 as O, and variables R8 and R9 coming together to form a 5-membered heterocycle. Reference Claim 7 claims the method of reference Claim 1 wherein the microbial infections comprise staphylococcal infections. Reference Claim 8 claims the method of reference Claim 1 wherein the method reduces production of pigment in Staphylococcus aureus. Reference Claim 10 claims the method of reference Claim 1 wherein said subject is a mammal. Reference Claim 11 claims the method of reference Claim 1 wherein said subject is a human.
The claims of Reference Application ‘045 and those at issue at not identical but are not patentably distinct because ’184 claims methods of treating and/or preventing microbial infections comprising administering compounds which meet the limitations of the compounds which are claimed in the examined application and are useful for the treatment of bacterial infections, particularly Staphylococcal infections. Reference Application ‘045 does not claim that these compounds are in the form of a pharmaceutical composition; however, it would be obvious to one of ordinary skill in the art to formulate the compounds of the reference application into a pharmaceutical composition using standard techniques utilized in the pharmaceutical arts in order to improve the delivery of these compounds to the site of the infection, and to improve patient compliance. These compounds inherently possess the properties of examined Claims 7-10 and 14. As these compounds are known to possess antibacterial properties, it would be obvious to modify the composition of the known antibacterial compound with a second antiseptic agent, including those specifically claimed in examined Claims 3 and 4. "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). Thus, the artisan would be motivated to combine the known antibacterial agent with a second antiseptic agent as they are useful for the same purpose. Regarding the language “for pre-surgical and post-surgical skin disinfection”, this is intended use language, and as the intended use of the claimed invention does not result in a structural difference between the claimed invention and the prior art (See MPEP § 2112.02 (II)), the prior art is capable of performing the limitation of “for pre-surgical and post-surgical skin disinfection”.
Conclusion
Claims 1-14 are rejected.
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/P.M.R./Examiner, Art Unit 1625
/JOHN S KENYON/Primary Patent Examiner, Art Unit 1625