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 February 10, 2026.
Status of Claims
Amendment of claim 10 and cancellation of claim 11 is acknowledged
Claims 10 and 12-23 are currently pending and are the subject of this office action.
Claims 19-23 were withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on June 11, 2025.
Claims 10 and 12-18 are under examination.
Priority
The present application is a 371 of PCT/EP2020/051652 filed on 01/23/2020.
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Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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to Applicant’s arguments have been addressed immediately after the corresponding rejections, or in the section: Withdrawn Rejections and/or Objections, if the rejection was withdrawn.
Rejections - 35 USC § 103 (Modified 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) 10 and 12-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Basara et. al. (US 2016/0058718) and Basara et. al. (US 2015/0342912) in view Hazenkamp et. al. (WO 2014/177530, cited by Applicant).
For claim 10, Basara (‘718) teaches a method for removing (destroying) biofilm, treating chronic wounds and the bacteria that causes those wounds comprising the administration of a composition comprising a sulfonic acid, wherein the sulfonic acid is phenol sulfonic acid and/or guaiacol sulfonic acid (see abstract, [0136], [0159], [0199], see also claims 1-4).
Further, Basara (‘912) teaches similar compositions are effective in removing biofilms composed of the bacteria Pseudomonas aeruginosa (see [0044]).
Basara (‘718) and Basara (‘912) do not teach the presence of ethane sulfonic acid or 1-propane sulfonic acid. However, Hazenkamp teaches that ethane sulfonic acid and 1-propane sulfonic acid are effective antimicrobial and antibacterial agents (see page 1, line 38 through page 2, line 11; page 4, line 29 through page 5, line 14; page 7, line 11 through page 8, line 3). These compounds are effective against different types of bacteria including Pseudomonas aeruginosa (see page 7, lines 26-33).
Finally, Basara (‘718) teaches the following composition (see [0024] through [0028]):
Benzene sulfonic acid 43%
Phenol sulfonic acid 38%
Total sulfonic acid 81%
The total sulfonic acid above (81%) anticipates the instantly claimed range of 70%-90% by weight.
Since Basara (‘718 and ‘912) teaches a method for removing (destroying) biofilm, treating chronic wounds and treating bacterial infections (including Pseudomonas aeruginosa) that cause those wounds, comprising the administration of a composition comprising a sulfonic acid, wherein the sulfonic acid is phenol sulfonic acid and/or guaiacol sulfonic acid, that are effective antimicrobial and antibacterial agents, and effective against Pseudomonas aeruginosa in particular; and since Hazenkamp teaches that ethane sulfonic acid and 1-propane sulfonic acid are effective antimicrobial and antibacterial agents, and against Pseudomonas aeruginosa in particular, before the effective filing date of the claimed invention it would have been prima facie obvious for a person of ordinary skill in the art to substitute one functional equivalence (a sulfonic acid like phenol sulfonic acid and/or guaiacol sulfonic acid) for another (a sulfonic acid like ethane sulfonic acid and/or 1-propane sulfonic acid) with an expectation of success, since the prior art establishes that both function in similar manner (both are effective against Pseudomonas aeruginosa, which is a bacteria present in biofilms wounds and infections).
Further, the skilled in the art will be motivated to replace the sulfonic acids of Basara with either ethane sulfonic acid or 1-propane sulfonic acid as disclosed in claim 1 in a concentration like the one disclosed by Basara (‘718, 81%), which anticipates the instantly claimed range (70-90%).
All this will result in the practice of claim 10 with a reasonable expectation of success.
For claims 12-13, Basara (‘718 and ‘912) teaches the presence of colloidal silica (i.e. Silicon dioxide) thus resulting in the practice of claims 12-13 with a reasonable expectation of success.
For claim 14, Basara (‘718) teaches that the compositions can be in the form of gels (see [0136], [0145] and [0166] for example), thus resulting in the practice of claim 14 with a reasonable expectation of success.
For claims 15-16, Basara (‘718) teaches the following composition (see [0024] through [0028]):
Benzene sulfonic acid 43%
Phenol sulfonic acid 38%
Total sulfonic acid 81%
Water (solvent like DMSO) 14%, and
Colloidal Silica 5%
So, the skilled in the art will be motivated to replace the sulfonic acids of Basara with either ethane sulfonic acid or 1-propane sulfonic acid as disclosed in claim 1, and further replace the solvent DMSO with the solvent water, thus resulting in the practice of claims 15-16 with a reasonable expectation of success.
For claim 17, Basara (‘912) teaches the removal of the composition for up to 15 seconds (see [0026] and claim 5), thus resulting in the practice of claim 17 with a reasonable expectation of success.
For claim 18, Basara (718) teaches the treatment of dermal (cutaneous) ulcers (see [0003], [0199] and [0201]), thus resulting in the practice of claim 18, with a reasonable expectation of success.
Double Patenting (Maintained Rejection).
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 10 and 12-18 stand rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 12,208,072. Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘072 patent and the instant application recite the same method, the only difference if that the US patent recites methane sulfonic acid instead of ethane sulfonic acid. The difference between these two compounds is just one methylene (-CH2-) group.
MPEP 2144.09 II states:
Compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or 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). See also In re May, 574 F.2d 1082, 197 USPQ 601(CCPA 1978) (stereoisomers prima facie obvious); Aventis Pharma Deutschland v. Lupin Ltd., 499 F.3d 1293, 84 USPQ2d 1197 (Fed. Cir. 2007) (5(S) stereoisomer of ramipril obvious over prior art mixture of stereoisomers of ramipril.).
In the instant case, compounds differing by one -CH2- group will be expected to be very similar properties, thus resulting in the practice of instant claims with a reasonable expectation of success
2) Claims 10 and 12-18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 13-25 of copending Application No. 18/958,024 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the only difference that the copending application recites methane sulfonic acid instead of ethane sulfonic acid. The difference between these two compounds is just one methylene (-CH2-) group.
MPEP 2144.09 II states:
Compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or 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). See also In re May, 574 F.2d 1082, 197 USPQ 601(CCPA 1978) (stereoisomers prima facie obvious); Aventis Pharma Deutschland v. Lupin Ltd., 499 F.3d 1293, 84 USPQ2d 1197 (Fed. Cir. 2007) (5(S) stereoisomer of ramipril obvious over prior art mixture of stereoisomers of ramipril.).
In the instant case, compounds differing by one -CH2- group will be expected to be very similar properties, thus resulting in the practice of instant claims with a reasonable expectation of success
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Applicant’s arguments related to the above rejection
Applicant's arguments have been fully considered but are not persuasive.
Since a new rejection necessitated by amendment was issued (see above), it is the Examiner’s belief that most of the arguments presented by Applicant have been considered/answered in the rejection itself, so only those arguments not addressed in the rejection are being considered below:
Applicant argues that:
As a first matter, none of the cited prior art discloses a composition having 70-90% by weight of ethanesulfonic acid or 1-propanesulfonic acid for removing biofilm or necrotic tissues from a skin lesion. Basara '718 and Basara '912 teach the use of phenolsulfonic acid and/or guaiacolsulfonic acid for treating biofilm and chronic wounds. These are different compounds from the ethanesulfonic acid or 1-propanesulfonic acid as claimed.
Hazenkamp discloses the use of non-aromatic sulfonic acids, including ethanesulfonic acid and 1-propanesulfonic acid, with antimicrobial activity. However, Hazenkamp's ready-to-use formulations contain only "0.01 to 5.0 wt.-%, preferably 0.1 to 5.0 wt.-%, more preferably 0.1 to 3.5 wt.-%, of the sulfonic acid.". Even Hazenkamp's concentrate formulations, which must be diluted prior to use, have preferred ranges of only 0.5 to 50 wt.% or 1.0 to 35 wt.% sulfonic acid. The claimed concentration of 70-90% by weight is substantially higher than Hazenkamp's teachings and well above all of Hazenkamp's preferred ranges.
Furthermore, Hazenkamp is directed to cleaning and disinfecting inanimate surfaces, not wound treatment. Hazenkamp does not teach or suggest that ethanesulfonic acid or 1-propanesulfonic acid is suitable for wound cleaning or wound treatment. In contrast, amended claim 10, relates to a medical method for treating skin lesions comprising administering a composition to the skin lesion.
Examiner’s response:
First, even though ethanesulfonic acid or 1-propanesulfonic acid and phenolsulfonic acid or guaiacolsulfonic acid are different compounds, they are all sulfonic acids, but more important, they are all effective against Pseudomonas aeruginosa, the bacteria that causes biofilm resistance in wounds and infections. So even though Hazenkamp discloses that ethanesulfonic acid and 1-propanesulfonic acid are effective in disinfecting inanimate surfaces, the fact remains that ethanesulfonic acid and 1-propanesulfonic acid are effective against Pseudomonas aeruginosa, like phenolsulfonic acid or guaiacolsulfonic acid. So, the skilled in the art will expect that ethanesulfonic acid and 1-propanesulfonic acid will still be effective against Pseudomonas aeruginosa in any environment, including a skin lesion.
Second, the fact that Hazenkamp discloses that the formulations contain only 0.1 to 5.0 wt. % of ethanesulfonic acid and 1-propanesulfonic acid is completely irrelevant, since Hazenkamp teaches formulation for disinfecting inanimate surfaces, not wounds or skin lesion. The skilled in the art will look at the sulfonic acid concentrations of Basara (‘718), not the sulfonic concentrations of Hazenkamp, since Basara (‘718) is the one that teaches formulations for treating wounds and skin lesions
Correspondence
No claims are allowed.
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.
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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
February 11, 2026.