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 .
DETAILED ACTION
This office action is in response to Applicant’s reply filed on March 31, 2026.
Status of Claims
Cancellation of claim 7 and amendment of claims 1 and 24 is acknowledged.
Claims 1-6, 9-10, 12-15, 18 and 21-24 are currently pending and are the subject of this office action.
The following species is under examination: monalazone disodium:
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Claims 12, 15 and 24 are withdrawn, since they do not encompass the above examined species.
NOTE: claim 24 introduces a new species since the word “consisting of” now requires that the compound of formula (I) be the only active ingredient in the composition.
Claims 1-6, 9-10, 13-14, 18 and 21-23 are presently under examination.
Priority
The present application claims priority to provisional application No. 63/226,998 filed on 07/29/2021.
Rejections and/or Objections and Response to Arguments
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated (Maintained Rejections and/or Objections) or newly applied (New Rejections and/or Objections, Necessitated by Amendment or New Rejections and/or Objections not Necessitated by Amendment). They constitute the complete set presently being applied to the instant application.
Responses to Applicant’s arguments have been addressed immediately after the corresponding rejections, or in the section: Withdrawn Rejections and/or Objections, if the rejection was withdrawn.
Claim Rejections - 35 USC § 103 (New Rejection Necessitated by Amendment).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-6, 9-10, 13-14, 18 and 21-23 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Schneider et. al. (US 7,465,829, cited in prior office action) in view of Eggers et. al. (US 6,461,624), Popp et. al (US 2006/0264505) and in view of Romano (EP 3058945, cited in previous office action).
For claims 1-2, 5 and 13, Schneider teaches (see column 9 line 65 through column 10, line 25) a method of treating a bacterial infection (a skin condition, see instant specification paragraphs [0007] and [0035]-[0036]) in a human patient comprising administering a composition comprising a compound of formula III:
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, wherein R1 is COOH or COOM, X is Chlorine, and M is sodium (see column 3, lines 45-65) as the sole active ingredient, to the skin of the human patient, in the form of a soap. Although Schneider does not explicitly teach that the administration is topical, it is implicit since the administration of soap to the skin is always topical.
The above structure anticipates the structural limitations of Formula (I) in instant claim 1 and Formula (II) in instant claim 13:
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Schneider does not teach that the composition is in the form of a cream, an emulsion, a lotion, an ointment, a paste or a tape. However, the above formulations are well known in the pharmaceutical art, and in dermatology for the topical treatment of bacterial infections. For example:
Eggers teaches pharmaceutical compositions for the topical treatment of skin conditions, in particular bacterial infections, wherein the composition can be in the form of a cream, a lotion or a soap (see for example abstract, claims 1 and 10).
Popp also teaches dermatological compositions for the treatment of bacterial infections comprising the topical administration of compositions in the form of a lotion, cream, ointment, paste, or soap among other dosage forms (see abstract, [0003], [0138] and [0171]).
Finally, Romano teaches methods of treating patients suffering from skin conditions including antibacterial infections, comprising the administration of a dosage of a composition comprising Chloramine-T (sodium N-Chloro-4-toluensulfonamide, a halo aromatic sulfonamide):
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(See abstract on page 1, [0019], [0060], [0075]-[0077] and claims 1 and 10-12). The above compound is structurally and biologically very similar to the claimed compounds (see Formula (I) and (II) above), except for the presence of a methyl group instead of a carboxylate group at the R3 position of the instantly claimed Formula (I) and (II) compounds. Romano further teaches that the compositions can be in the form of lotion, emulsion, cream, and patch (see [0035]).
Before the effective filing date of the invention, it would have been prima facie obvious for the skilled in the art to treat a skin condition like a bacterial infection comprising the topical administration of a compound of instant Formula (I) or Formula (II) as the only active ingredient, as taught by Schneider. The skilled in the art will be also motivated to substitute the soap formulation of Schneider with either a lotion, cream, ointment, paste or patch formulation, since the prior art teaches that all these types of formulations are equivalent when it comes to the topical treatment of bacterial infections. The skilled in the art will be further motivated by the fact that Romano teaches that very similar compounds were already effective in treating bacterial infections when administered in the form of lotion, emulsion, cream, and patch, thus resulting in the practice of claims 1-2, 5 and 13 with a reasonable expectation of success.
Schneider teaches all the limitation of claim 3, except for the soap comprising a buffering agent, a surfactant or a solvent. However, these are common excipients in most skin formulations like creams, ointments, paste, patch, etc. For example, Romano teaches the presence of water (a solvent) (see [0020] and [0021]), surfactants (see [0042]), and buffers (see claim 14), thus resulting in the practice of claim 3 with a reasonable expectation of success.
For claim 4, Schneider teaches that the composition can contain between 0.5 to 5 weight percent of the sulfonamide (see column 10, lines 26-33), thus resulting in the practice of claim 4 with a reasonable expectation of success.
Schneider teaches all the limitations of claim 6, except for the skin condition being: eczemas. However, Romano that the compositions can be used to treat eczemas, (see abstract and claims 10-12), thus resulting in the practice of claim 6 with a reasonable expectation of success.
Schneider teaches all the limitations of claims 9-10, except for the composition being administered by contacting the skin with a delivery device. However, Romano teaches that the composition can be in the form of a transdermal patch (a delivery device) (see claim 14), thus resulting in the practice of claims 9-10 with a reasonable expectation of success.
For claim 14, the skilled in the art will envision Monalazone disodium:
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from the compound of formula III disclosed by Schneider:
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wherein R1 is COOH or COOM, X is Chlorine, and M is sodium (see column 3, lines 45-65), thus resulting in the practice of claim 14 with a reasonable expectation of success.
For claim 18, Schneider does not teach that the pH of the composition can be between 6 and 10. However, Popp teaches that the dermatological compositions can have a pH from about 3 to about 11 (see [0018]), which overlaps the instantly claimed range.
MPEP 2144.05 states: In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Even a slight overlap in range establishes a prima facie case of obviousness. In re Peterson, 65 USPQ2d 1379, 1382 (Fed. Cir. 2003).
"A prior art reference that discloses a range encompassing a somewhat narrower claimed range is sufficient to establish a prima facie case of obviousness." In re Peterson, 315 F.3d 1325, 1330, 65 USPQ2d 1379, 1382-83 (Fed. Cir. 2003). >See also In re Harris, 409 F.3d 1339, 74 USPQ2d 1951 (Fed. Cir. 2005).
All this will result in the practice of claim 18 with a reasonable expectation of success.
Schneider teaches all the limitation of claims 21-23 except for the percent weight ranges of aromatic sulfonamide. However, Schneider teaches ranges from 0.1% to about 10%, or 0.5% to 5%, or from 0.75% to 1.5% (see column 10, lines 26-33), which clearly overlap with the instantly claimed ranges.
MPEP 2144.05 states: In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Even a slight overlap in range establishes a prima facie case of obviousness. In re Peterson, 65 USPQ2d 1379, 1382 (Fed. Cir. 2003).
"A prior art reference that discloses a range encompassing a somewhat narrower claimed range is sufficient to establish a prima facie case of obviousness." In re Peterson, 315 F.3d 1325, 1330, 65 USPQ2d 1379, 1382-83 (Fed. Cir. 2003). >See also In re Harris, 409 F.3d 1339, 74 USPQ2d 1951 (Fed. Cir. 2005).
All this will result in the practice of claims 21-23 with a reasonable expectation of success.
Claim Rejections - 35 USC § 103 (New Rejection Necessitated by Amendment).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-6, 9-10, 13-14, 18 and 21-23 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Schneider et. al. (US 2020/0029561, cited in prior office action) in view of Eggers et. al. (US 6,461,624), Popp et. al (US 2006/0264505) and in view of Romano (EP 3058945, cited in previous office action).
For claims 1-2, 5, and 13, Schneider teaches (see [0002], [0004]-[0005], [0007] and [0041]-[0042]) a method of treating a bacterial infection (a skin condition, see instant specification paragraphs [0007] and [0035]-[0036]) in a human patient comprising administering a composition comprising a compound of formula IV:
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, wherein M2 is halogen, alkali metal or an alkali earth metal, X is halogen, and M is an alkaline or alkaline earth metal, desirably M2 is hydrogen, sodium or potassium (see [0077]); as the sole active ingredient, to the skin (i.e. topically) of the human patient (see [0092] and [0095]).
The above structure anticipates the structural limitations of Formula (I) in instant claim 1 and Formula (II) in instant claim 13:
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Schneider teaches that the composition can be in the form of a powder (see [0063]) or a gel (see [0080]). Schneider does not teach that the composition is in the form of a cream, an emulsion, a lotion, an ointment, a paste or a tape. However, the above formulations are well known in the pharmaceutical art, and in dermatology for the topical treatment of bacterial infections. For example:
Eggers teaches pharmaceutical compositions for the topical treatment of skin conditions, in particular bacterial infections, wherein the composition can be in the form of a cream, or a lotion (see for example abstract, claims 1 and 10).
Popp also teaches dermatological compositions for the treatment of bacterial infections comprising the topical administration of compositions in the form of a lotion, cream, ointment or paste, among other dosage forms (see abstract, [0003], [0138] and [0171]).
Finally, Romano teaches methods of treating patients suffering from skin conditions including antibacterial infections, comprising the administration of a dosage of a composition comprising Chloramine-T (sodium N-Chloro-4-toluensulfonamide, a halo aromatic sulfonamide):
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(See abstract on page 1, [0019], [0060], [0075]-[0077] and claims 1 and 10-12). The above compound is structurally and biologically very similar to the claimed compounds (see Formula (I) and (II) above), except for the presence of a methyl group instead of a carboxylate group at the R3 position of the instantly claimed Formula (I) and (II) compounds. Romano further teaches that the compositions can be in the form of lotion, emulsion, cream, and patch (see [0035]).
Before the effective filing date of the invention, it would have been prima facie obvious for the skilled in the art to treat a skin condition like a bacterial infection comprising the topical administration of a compound of instant Formula (I) or Formula (II) as the only active ingredient, as taught by Schneider. The skilled in the art will be also motivated to substitute the formulations of Schneider with either a lotion, cream, ointment, paste or patch formulation, since the prior art teaches that all these types of formulations are equivalent when it comes to the topical treatment of bacterial infections. The skilled in the art will be further motivated by the fact that Romano teaches that very similar compounds were already effective in treating bacterial infections when administered in the form of lotion, emulsion, cream, and patch, thus resulting in the practice of claims 1-2, 5 and 13 with a reasonable expectation of success.
For claim 3 Schneider teaches that the composition comprises surfactants (see [0085]) and buffering agents (see [0084]), thus resulting in the practice of claim 3 with a reasonable expectation of success.
For claims 4, Schneider teaches that the aromatic sulfonamides can comprise from 0.0001 % wt. to 5 % wt. (see [0080]), thus resulting in the practice of claim 3 with a reasonable expectation of success.
Schneider teaches all the limitations of claim 6, except for the skin condition being: eczemas. However, Romano that the compositions can be used to treat eczemas, (see abstract and claims 10-12), thus resulting in the practice of claim 6 with a reasonable expectation of success.
Schneider teaches all the limitations of claims 9-10, except for the composition being administered by contacting the skin with a delivery device. However, Romano teaches that the composition can be in the form of a transdermal patch (a delivery device) (see claim 14), thus resulting in the practice of claims 9-10 with a reasonable expectation of success.
For claim 14, the skilled in the art will envision Monalazone disodium:
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from the compound of formula III disclosed by Schneider:
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, wherein M2 is halogen, alkali metal or an alkali earth metal, X is halogen, and M is an alkaline or alkaline earth metal, desirably M2 is hydrogen, sodium or potassium (see [0077]), thus resulting in the practice of claim 14 with a reasonable expectation of success.
For claim 18, Schneider teaches that the pH of the composition is from 6.5 to 9.0 (see [0082]), thus resulting in the practice of claim 18 with a reasonable expectation of success.
Schneider teaches all the limitation of claims 21-23 except for the percent weight ranges of aromatic sulfonamide. However, Schneider teaches ranges from 0.1% to 5% wt. (see [0080]), which clearly overlap with the instantly claimed ranges.
MPEP 2144.05 states: In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Even a slight overlap in range establishes a prima facie case of obviousness. In re Peterson, 65 USPQ2d 1379, 1382 (Fed. Cir. 2003).
"A prior art reference that discloses a range encompassing a somewhat narrower claimed range is sufficient to establish a prima facie case of obviousness." In re Peterson, 315 F.3d 1325, 1330, 65 USPQ2d 1379, 1382-83 (Fed. Cir. 2003). >See also In re Harris, 409 F.3d 1339, 74 USPQ2d 1951 (Fed. Cir. 2005).
All this will result in the practice of claims 21-23 with a reasonable expectation of success.
Response to Applicant’s arguments related to the above rejections
Since a new rejection was issued (see above), it is the Examiner’s belief that most of the arguments presented by Applicant are no longer applicable or have been considered/answered in the rejection itself.
Double Patenting (Maintained Rejections)
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.
1) Claims 1-6, 9-10, 13-14, 18 and 21-23 stand rejected on the ground of nonstatutory double patenting as being unpatentable over claims 13-14 of U.S. Patent No. 11,439,574. Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘574 patent claims a method of deodorizing and cleaning the skin (a skin condition) with a composition comprising compounds of formula (I) which overlap the instantly claimed structures.
Claim 1-6, 9-10, 13-14, 18 and 21-23 stand provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 17-18 of copending Application No. 17/880,918 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the copending application claims a method of deodorizing the skin (a skin condition) with a composition comprising compounds of formula (II) which anticipates the instantly claimed structures.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
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 extension fee 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 date of this final action.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARCOS L SZNAIDMAN whose telephone number is (571)270-3498. The examiner can normally be reached Flexing M-F 7 AM-7 PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy L. Clark can be reached on 571 272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARCOS L SZNAIDMAN/
Primary Examiner, Art Unit 1628
April 8, 2026.
Prosecution Insights