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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 05/15/2026, has been entered.
Status of the Claims
Claims 1-3, 6-7, 12-13 and 17 are pending.
Applicants’ arguments, filed on 04/06/2026, have been fully considered. Rejections and/or objections not reiterated from previous Office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set of rejections and/or objections presently being applied to the instant application.
Applicants’ amendments filed on 04/06/2026, have been fully considered. Applicants have amended claim 1. Applicants have cancelled claims 4-5, 14-15 and 18. Therefore, claims 1-3, 6-7, 12-13 and 17 are the subject of the Office action below.
Maintained Rejections:
Claim Rejections - 35 USC § 112-Maintained
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.
The rejection of claims 1-3, 6-7, 12-13 and 17 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is maintained for the reasons of record set forth in the previous Office action, of which said reasons are herein reiterated. Claims 2-3, 6-7, 12-13 and 17 depend from the rejected claim 1 and are, therefore, also rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, for the reasons set forth below.
As per MPEP 2173.02, “[d]uring prosecution, applicant has an opportunity and a duty to amend ambiguous claims to clearly and precisely define the metes and bounds of the claimed invention. The claim places the public on notice of the scope of the patentee’s right to exclude (emphasis added). See, e.g., Johnson & Johnston Assoc. Inc. v. R.E. Serv. Co., 285 F.3d 1046, 1052, 62 USPQ2d 1225, 1228 (Fed. Cir. 2002) (en banc).”
If the language of the claim is such that a person of ordinary skill in the art could not interpret the metes and bounds of the claim so as to understand how to avoid infringement, a rejection of the claim under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph, is appropriate (emphasis added). See Morton Int’l, Inc. v. Cardinal Chem. Co., 5 F.3d 1464, 1470, 28 USPQ2d 1190, 1195 (Fed. Cir. 1993).
Claim 1 recites the limitation “wherein the antimicrobial quaternary ammonium compound-anionic surfactant complex is soluble in an aqueous solution at a pH of 9 or less”, however, a person skilled in the art cannot reasonably determine the meets and bounds of the of the composition that the Applicants are claiming.
This is because, it is not clear from either the specification or the common teachings in the art how these limitations further limit the claim. For example, it is not clear if the recited functional limitation, is limiting to a particular quaternary ammonium compound(s), the anionic surfactant(s), or an unnamed excipient(s).
The specification does not teach or provide a nexus between the functional result that Applicants claim to achieve by the claimed composition with any particular component of the formulation or the manner in which it is made. There is no description as to the pharmaceutical approach that makes these results possible (i.e., what cause “wherein the antimicrobial quaternary ammonium compound-anionic surfactant complex is soluble in an aqueous solution at a pH of 9 or less”), nor do Applicants teach any quaternary ammonium compound(s), anionic surfactant(s) and diluent(s) or chemical approaches to avoid. Furthermore, it is unclear to one skilled in the art as to, for example:
a) what composition of claim 1, would exhibit “wherein the antimicrobial quaternary ammonium compound-anionic surfactant complex is soluble in an aqueous solution at a pH of 9 or less”; and
b) what composition of claim 1, would not exhibit “wherein the antimicrobial quaternary ammonium compound-anionic surfactant complex is soluble in an aqueous solution at a pH of 9 or less”.
Thus, a person of ordinary skill in the art would not be able to draw a clear boundary between what is and is not covered by the claims.
Accordingly, for the purpose of examination, any antimicrobial composition comprising a quaternary ammonium compound of claim 1 and an anionic surfactant of claim 1, is included in the interpretation of “wherein the antimicrobial quaternary ammonium compound-anionic surfactant complex is soluble in an aqueous solution at a pH of 9 or less”, recited in instant claim 1. It is recommended that Applicants amend claim 1 to either delete the recited functional limitations or recite specific composition(s) that performs the recited functional limitations, in order to overcome the rejection. Appropriate correction is required.
This lack of clarity makes it impossible to ascertain with reasonable precision when that claim is infringed and when it is not. Lacking such clarity, the skilled artisan would not be reasonably apprised of the metes and bounds of the subject matter for which Applicants seek patent protection. Rather, a subjective interpretation of the claimed language would be required. However, as such is deemed inconsistent with the tenor and express language of 35 U.S.C. § 112, second paragraph, the claims are deemed properly rejected. Appropriate correction is required.
Response to the Applicant’s Arguments
Applicant’s arguments filed on 04/06/2026 (see pages 4-9 of Remarks), have been addressed (see Advisory Action mailed on 05/15/2026).
Claim Rejections - 35 USC § 102-Maintained
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
The rejection of claims 1-3, 6-7, 12-13 and 17 under 35 U.S.C. 102(a)(1) as being anticipated by Bratescu of record (U.S. Pub. No. 20040071653), is maintained for the reasons of record set forth in the previous Office action, of which said reasons are herein reiterated.
Independent claim 1 is directed to an antimicrobial composition free of amine oxides, amides and betaines and comprising:
A) from about 1 wt% to about 75 wt% of a quaternary ammonium compound of formula:
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200
400
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, wherein each of R1, R2, R3 and R4, is independently selected from a ≤ C20 alkyl or alkoxy chain length; and X- = an anion; and
B) from about 1 wt% to about 30 wt% of an anionic surfactant having a C6-C18 chain length.
The limitation of “quaternary ammonium compound-anionic surfactant complex”, is a property of an antimicrobial composition comprising a quaternary ammonium compound of claim 1 and an anionic surfactant of claim 1, when the quaternary ammonium compound and an anionic surfactant are combined to form the composition. Accordingly, for the purpose of examination, any antimicrobial composition comprising a quaternary ammonium compound of claim 1 and an anionic surfactant of claim 1, is included in the interpretation of “quaternary ammonium compound-anionic surfactant complex”.
Claim 1 further requires, wherein the quaternary ammonium compound-anionic surfactant complex is soluble in an aqueous solution at a pH of 9 or less. This limitation is a property of an antimicrobial composition comprising a quaternary ammonium compound of claim 1 and an anionic surfactant of claim 1, when the composition is used, i.e., when the composition is, for example added to water and applied to a surface. Accordingly, for the purpose of examination, antimicrobial composition comprising of a quaternary ammonium compound of claim 1 and an anionic surfactant of claim 1, is included in the interpretation of the functional limitation recited in claim 1.
Similar to the Applicants’ invention, Bratescu at ¶ 0001, states:
“The present invention relates to antimicrobial compositions and more specifically to such compositions containing at least one quaternary ammonium antimicrobial compound, at least one anionic surfactant and optionally at least one “bridging Surfactant. Further, the instant invention relates to a method of preparing the antimicrobial compositions and methods of inhibiting growth of microbial organisms by contacting with the antimicrobial compositions”.
The quaternary ammonium compound can be from about 5 to 25 wt% of the composition (see ¶ 0114), which is within the claimed “from about 1 wt% to about 75 wt%”. A specific example in the prior art which is within a claimed range anticipates the range. Please MPEP § 2131.03.
The anionic surfactant can be from about 2 to about 15 wt% of the composition (see ¶ 0114), which is within the claimed “from about 1 wt% to about 30 wt%”. A specific example in the prior art which is within a claimed range anticipates the range. Please MPEP § 2131.03.
Quaternary ammonium compound and anionic surfactant forms complex when combined (see ¶s 0073-0074 and 0102).
Bratescu discloses a generic quaternary ammonium compound of claim 1 (see, e.g., ¶s 0050-0055). Illustrative quaternary ammonium compounds (see ¶s 0120-0121), include dioctyl dimethyl ammonium chloride and n-alkyl (C12-C18) dimethyl benzyl ammonium chloride, which encompasses Applicants’ elected compound (see Remarks filed on 02/10/2025 and Office action mailed on 07/02/2025).
Suitable anionic surfactants include: i) C8-C16 alkyl sulfate (see ¶ 0033); ii) C8-C18 alkyl sulfonate (see ¶ 0034) and iii) alkyl ethoxy sulfate having C8-C16 in the alkyl portion and C1-C30 moles of ethylene oxide (i.e., EO, see ¶ 0035), which encompasses Applicant’s elected anionic surfactant (see Remarks filed on 02/10/2025 and Office action mailed on 07/02/2025). Illustrative anionic surfactants include: i) 2-methyl-1-undecanoic acid (a surfactant having a C12 chain length, see ¶ 0147); ii) sodium lauryl sulfate (a surfactant having a C12 chain length, see column 20, commercial name Stephanol® WA-Extra); and iii) sodium laureth sulfate (3EO, see column 20, commercial name Steol CS-370), which is the Applicants’ elected surfactant (see discussions above).
The composition can be formulated in a variety of forms such as solids, liquids, solutions, semi-solids, pastes, powders or gels (see ¶ 0250). In some embodiment, the solution may be prepared by dissolving the solid form in water (see ¶ 0250). Bratescu discloses that the compositions of the present-invention typically are prepared having a pH of between about 2 and about 10 (see ¶ 0249). Bratescu discloses that quaternary ammonium compounds and anionic surfactants form complexes (see ¶ 0102).
The Examiner would like to draw the Applicant’s attention to the following:
A reference disclosure can anticipate a claim even if the reference does not describe "the limitations arranged or combined as in the claim, if a person of skill in the art, reading the reference, would ‘at once envisage’ the claimed arrangement or combination." Kennametal, Inc. v. Ingersoll Cutting Tool Co., 780 F.3d 1376, 1381, 114 USPQ2d 1250, 1254 (Fed. Cir. 2015) (quoting In re Petering, 301 F.2d 676, 681(CCPA 1962)).
In the instant case, the instant invention (e.g., claim 1), is directed to an antimicrobial composition comprising a genus of quaternary ammonium compound in combination with a genus of an anionic surfactant having C6-C18 chain length. Bratescu discloses an antimicrobial composition comprising a genus of quaternary ammonium compound in combination with a genus of an anionic surfactant having C6-C18 chain length (see discussions above).
Regarding the requirement that the composition of instant claim 1 is free of free of amine oxides, amides and betaines, it is noted that the “amine oxides, amides, and betaines”, i.e., “bridging surfactants” are only disclosed in Bratescu as optional ingredients (see discussions above). Furthermore, Tables I-X of Bratescu comprises quaternary ammonium compounds and anionic surfactants combinations excluding the “amine oxides, amides, and betaines”, i.e., “bridging surfactants” disclosed in Bratescu.
For example, Bratescu discloses a composition comprising Stepanol® WA-Extra and QC8 (see Table I).
Stepanol® WA-Extra is the trademark name for sodium lauryl sulfate (see ¶ 0252), i.e., a C12 chain length anionic surfactant.
QC8 is the trademark name for octyltrimethylammonium chloride (see ¶ 0252), i.e., a quaternary ammonium compound in which: 1) R1 = a C8 alkyl; 2) R2 = R3 = R4 = a C1 alkyl; and 3) X- = Cl-.
Therefore, claim 1 is anticipated by Bratescu.
Regarding claims 2-3, Bratescu teaches cetyltrimethylammonium chloride and sodium laureth sulfate (see discussions above).
Regarding claim 6, Bratescu teaches pH of 7.6 (see Table III).
Regarding claim 7, Bratescu discloses thickeners among the non-limiting examples of functional materials (see ¶ 0184).
Regarding claim 12, Bratescu discloses alkyl dimethyl benzyl ammonium chloride (see discussions above).
Regarding claim 13, Bratescu discloses sodium lauryl ether sulfate (see discussions above).
Regarding claim 17, Bratescu discloses a pH of 5.5 (see Table III).
Response to the Applicant’s Arguments
Applicant’s arguments filed on 04/06/2026 (see pages 9-12 of Remarks), have been addressed (see Advisory Action mailed on 05/15/2026).
Non-Statutory Double Patenting Rejection-Maintained
The provisional rejection of claims 1-3, 6-7, 12-13 and 17 on the ground of nonstatutory double patenting as being unpatentable over claims of U.S. Patent Application Nos: 1) 18/052,786; 2) 17/248,254; and 3) 18/051,245, is maintained for the reasons of record set forth in the previous Office action.
The rejection of claims 1-3, 6-7, 12-13 and 17 on the ground of nonstatutory double patenting as being unpatentable over claims of U.S. Patent Nos: 1) 10,426,162; 2) 11,406,103; and 3) 11,540,512, is maintained for the reasons of record set forth in the previous Office action.
Response to the Applicants’ Arguments
Applicant’s arguments filed on 04/06/2026 (see pages 12-13 of Remarks), have been addressed (see Advisory Action mailed on 05/15/2026).
Conclusion
No claim is allowable.
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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.
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Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to IBRAHIM D BORI whose telephone number is (571)270-7020. The examiner can normally be reached on Monday through Friday 8:00AM-5:00PM(EST).
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JEFFREY S LUNDGREN can be reached on 571-272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/IBRAHIM D BORI/
Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629