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
Applicant’s amendment of 24 July 2026, in which claims 36, 44, 56, 58-60 have been amended, and new claims 62, 63 have been added, is acknowledged.
Claims 36, 38-50, 56-63 are pending in the instant application.
Claims 49-50, 56-57 are withdrawn as being drawn to a non-elected invention.
Claims 36, 38-48, 58-63 are being examined on their merits herein.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 24 July 2026 is acknowledged and considered.
Response to arguments of 24 July 2026
In view of Applicant’s amendment of 24 July 2026, the rejection of claims 58-60 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite, is herein withdrawn. Claims 58-60 have been amended to recite the product of claim 36.
In view of Applicant’s amendment of 24 July 2026, the rejection of claims 36, 38-48, 58-61 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, written description/ new matter, is herein withdrawn. Applicant has deleted the recitation “at least 7 days” from the claims.
On 24 July 2026, Applicant has amended independent claims 36, 44 to recite ammonium -containing cationic polymer selected from the group consisting of polymers no. 1-8.
New rejections are made below, based on Applicant’s amendment of 24 July 2026.
In view of Applicant’s amendment of 24 July 2026, the rejection of claims 36, 39-44, 46-48, 58-61 under 35 U.S.C. 102(a)(1) and 102(a)(2) over Li et al. (CN114795989), as evidenced by Munoz-Bonilla, is herein withdrawn. Li teaches antimicrobial compositions comprising polyquaternium-10 as the ammonium-containing cationic polymer, which is no longer within the scope of the instant claims.
In view of Applicant’s amendment of 24 July 2026, the rejection of claims 36, 38-48, 58-61 under 35 U.S.C. 103 over Hollis in view of Stanojevic and Hu, is herein withdrawn. Hollis teaches polymers A, B, D, which are no longer within the scope of the instant claims.
Applicant’s arguments (Remarks of 24 July 2026, pages 14-16) against the rejection of claims 36, 38-48, 58-61 under 35 U.S.C. 103 over Shair and Merianos, in view of Stanojevic et and Hu, have been considered.
Applicant argues (page 15) that the cited references, alone or in combination, do not teach the limitations in the amended claims, namely polymers no. 1-8 in combination with sodium benzoate.
In response, Shair teaches a polyquaternary amine/ quaternary ammonium containing polymer, with an average molecular weight within the range in instant claims 38, 45, made by reacting dimethyl amine with epichlorohydrin, having antimicrobial activity at pH = 7; and prior art Merianos teaches a high molecular weight antimicrobial agent, which is prepared by reacting equimolar proportions of dimethylamine and epichlorohydrin.
Thus, Shair and Merianos refer to ammonium containing polymers made by reacting dimethyl amine with epichlorohydrin; dimethyl amine with epichlorohydrin are the monomers in polymer 2, Table 3, Applicant’s Specification.
Applicant argues that the polymers in Shair and Merianos are distinct from the instantly claimed polymers. Applicant is encouraged to bring evidence showing how said polymers in the prior art are different from the instantly claimed polymers.
Applicant argues (page 16) unexpected results/ synergistic results with the combination of claimed polymers and sodium benzoate.
In response, the examiner had acknowledged (see office action of 08/20/2025) the data in Applicant’s Specification, namely
Table 13, Specification page 43: No reduction in bacterial cell counts (day 2 or day 7) with unpreserved foaming soap at pH 6.5, 7.0, 7.5 or 8.0
Table 14, page 43: No reduction in viable bacterial cell counts by day 7 in sodium benzoate 0.5% or 1% treated foaming hand soap at pH 6.5, 7.0, 7.5 or 8.0
Table 15, page 44: No reduction in viable bacterial cell counts (day 2 or day 7) in foaming hand soap treated with each of polymers 1, 2 (elected species), 3, 4, or 5 (0.0025%) at pH 7.0
Table 17, page 46: No reduction in viable bacterial cell counts (day 7) in foaming hand soap treated with polymer 4 (0.0025%) at pH 6.5, 7.0, or 7.5
Tables 18A-E, pages 47-48: Significant reduction in viable bacterial cell counts (day 7-day 28, different microorganisms) in foaming hand soap treated with combination of each of polymers 1, 2 (elected species), 3, 4, or 5 (0.0025%) and sodium benzoate (1%) at pH 7.0
The examiner had acknowledged synergistic antimicrobial data with elected species (examined) polymer 2 (0.0025%) + sodium benzoate (1%) at pH = 7.0;
as well as synergistic antimicrobial data with each of polymers 1, 3, 4 or 5 (0.0025%) + sodium benzoate (1%) at pH = 7.0.
The examiner further acknowledged the data in Applicant’s Specification, namely
Tables 16A-E, Specification pages 45-46: Some reduction in bacterial cell counts in foaming hand soap treated with each of polymers 6 (0.005%), 7 (0.005%), 8 (0.09%), or 9 (not claimed, 0.005%) at pH 7.0
Tables 19A-E, pages 49-50: Some reduction in viable bacterial cell counts (day 7, different microorganisms) in foaming hand soap treated with combination of each of polymers 6 (0.005%), 7 (0.005%), 8 (0.09%), or 9 (not claimed, 0.005%) and sodium benzoate (1%) at pH 7.0
The examiner had indicated that it is unclear which data above shows synergistic antimicrobial effect with polymers 6, 7, or 8 and sodium benzoate (1%) at pH = 7.0.
The Declaration under 37 CFR 1.132, signed by Ms. Erika Milczek, Ph.D., co-inventor, submitted on 22 December 2025 (the Second Declaration), has been considered in the office action of 27 January 2026.
Dr. Milcez presented additional data, beyond data in the Specification, in support of
Synergistic antimicrobial effects of combinations of polymers and sodium benzoate
(point 6, Declaration of 12/22/2025); synergistic data (Table B) with
sodium benzoate 1% + polymer 10 which is polyquaternium 10 (Table A)
sodium benzoate 1% + polymer 11 which is polyquaternium 11 (Table A)
sodium benzoate 1% + polymer 12 which is polyquaternium 39 (Table A)
sodium benzoate 1% + polymer 13 which is polyquaternium 51 (Table A)
None of these polymers is within the scope of the instant claims.
at pH 8.5 (point 8, Declaration of 12/22/2025) synergistic data with
sodium benzoate 0.5% or 1% + polymer 4 at pH 6.5, 7.0, 7.5, 8.0, 8.5
sodium benzoate 1% + polymer 1 (or 2, or 6, or 7 or 8) at pH 8.5 (point 9, Declaration)
synergistic data with less than 1% sodium benzoate (point 10, Declaration, Specification)
sodium benzoate at 0.2%, 0.4%, 0.5%, or 0.6% + polymer 4.
Dr. Milczek argues (point 11, Declaration of 12/22/2025) that the data support an overall trend that the combination of claimed polymers and about 1% or less sodium benzoate has synergistic effects at pH 6.5 and above for at least 7 days.
Applicant’s amendment of 24 July 2026 necessitated the following new and modified rejections.
Claim Rejections- 35 USC 112
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.
Claims 36, 38-48, 58-63 are 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.
Claims 36, 38-48, 58-63 recite an ammonium-containing cationic polymer selected from the group consisting of polymers 1-8. It is unclear what “the group consisting of polymers no. 1-8” means. There is no definition of the polymers 1-8 in the claims, and certainly there is no indication regarding the chemical structure of said polymers. Without identifying the chemical structure, the recitation “polymers 1-8” renders the claims indefinite because the metes and bounds of the present claims cannot be determined and one having ordinary skill in the art would not necessarily be reasonably apprised of the scope of the claims.
It is noted that cationic polymers numbered 1 to 9 are listed in Table 3, Specification; the table contains the common trade name, the monomers used to prepare the polymers, the molecular weight of the polymers as “low”, “medium” or “high”, and, in some instances, the CAS numbers. However, MPEP states that the claims are to be complete in themselves. In this case, the claims are incomplete because they fail to identify polymers 1-8 by their chemical structure. Even if the claims had referenced Table 3 as support for the claims (which is not the case), incorporation by reference to a specific figure or table "is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant’s convenience." Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993) (citations omitted). See MPEP 2173.05(s).
One wishing to practice the instantly claimed invention would thus not recognize the metes and bounds for which Applicant seeks protection.
Appropriate clarification of the claim language is required.
Claim Rejections- 35 USC 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 36, 38-48, 58-63 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Zhang et al. (CN114146012, published 8 March 2022, cited in PTO-892).
Zhang (CN114146012) teaches (Example 4) a shampoo, which is a personal care/cosmetic product, as in instant claims 40, 48, comprising a composition comprising an ammonium-containing cationic polymer polyquaternium-7 (which is polymer no. 8 in Table 3, Applicant’s Specification), which is a quaternary ammonium-containing polymer, as in instant claim 39, and sodium benzoate, wherein the concentration of sodium benzoate in the product is 0.4%, which satisfies the limitations in instant claims 36, 44, 48, 58, 60, 61, and wherein the pH of the product is 6.5, which is within the ranges in instant claims 36, 41, 44, 59, 60, 62, 63. The product further comprises additional antimicrobial chemical EDTA, as in instant claims 42, 43, 46, 47.
Zhang teaches that the composition is antibacterial/antimicrobial, as in the instant claims.
Regarding the limitation “wherein the antimicrobial composition provides antimicrobial activity for 7 days” in claims 36, 44,
“Products of identical chemical composition can not have mutually exclusive properties.” A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). See MPEP 2112.01. The burden is shifted to Applicant to show that the prior art product does not possess the same properties as the instantly claimed product.
As such, an antimicrobial composition of the instant claims is anticipated by Zhang.
Claim Rejections- 35 USC 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis 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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 36, 38-48, 58-63 are rejected under 35 U.S.C. 103 as being unpatentable over Shair et al. (US 4,111,679 of 5 September 1978, cited in PTO-892 of 17 January 2025) and Merianos et al. (US 4,140,798 of 20 February 1979, cited in PTO-892 of 17 January 2025), in view of Stanojevic et al. (Bulgarian Journal of Agricultural Science 2009, 15 (4), 307-311, cited in PTO-892 of 17 January 2025) and Hu (WO 02092143, cited in PTO-892 of 17 January 2025).
Shair et al. (US 4,111,679) teaches (column 1, lines 40-50) a microbiocidal agent of the formula below:
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104
164
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which is a polyquaternary amine/ quaternary ammonium containing polymer, as in instant claim 39, with an average molecular weight within the range in instant claims 38, 45, made by reacting dimethyl amine with epichlorohydrin (column 1, lines 15-20), the same monomer system as in polymer no.2 in Applicant’s Specification.
Shair teaches that the polymer above inhibits or prevents the growth of microorganisms including
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114
294
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that inhabit and proliferate in industrial cooling water systems.
Shair teaches that the polymer above is effective against a broad spectrum of microorganisms (column 2, lines 27-30) at pH = 7 (Table 1, tested against mixed bacteria, Table 2 tested against two pure cultures of bacteria Aerobacter aerogenes and Bacillus subtilis var. mycoides).
Shair compares (Table 1) the antibacterial efficacy in the presence and in the absence of the ammonium-containing cationic polymer.
Shair evaluates the effectiveness of said polymer as antibacterial at pH 7 (Tables 1, 2), which is within the ranges in instant claims 36, 41, 44, 59, 60, 62, 63.
Shair teaches that the application is in industrial aqueous processes and water handling systems/recirculating water systems (column 4, lines 29-30), thus in industrial cleaning and/or industrial and recreational water, as in instant claims 40, 48.
Shair teaches antimicrobial compositions comprising the polymer of the invention, along with conventional adjuvants, solubilizing agents, stabilizers, solvents or other liquid carriers (column 4, lines 56-59).
Merianos (US 4,140,798) teaches (column 1, lines 10-17) a high molecular weight antimicrobial and preservative agent, which is prepared by reacting equimolar proportions of dimethylamine and epichlorohydrin (Example 1), which are the same monomers as in polymer no.2 in Applicant’s Specification; the product of this process is a very potent antimicrobial (column 1, lines 18-21). It is a non-foaming antimicrobial, useful in the control of microorganisms in re-circulating water systems, or for keeping standing waters/swimming pools free of microbes (column 1, lines 19-27).
The polymer is a polyquaternary amine/ quaternary ammonium containing polymer, as in instant claim 39.
Merianos teaches (Tables 1-4) that the polymer above is effective against two pure cultures of bacteria Aerobacter aerogenes and Pseudomonas aeruginosa.
Merianos compares (Table 1) the antibacterial efficacy in the presence and in the absence of the ammonium-containing cationic polymer.
Merianos evaluates the effectiveness of said polymer as antibacterial in distilled water (Example 2, column 1, lines 58-60) assumed at pH 7, which is within the ranges in instant claims 36, 41, 44, 59, 60, 62, 63.
Merianos teaches that the application is in industrial aqueous processes and water handling systems/recirculating water systems (column 1, lines 19-27), thus in industrial cleaning and/or industrial and recreational water, as in instant claims 40, 48.
Shair and Merianos do not teach antimicrobial compositions comprising the polymers above and less than 1% sodium benzoate, as in the instant claims.
Shair and Merianos do not teach an additional antimicrobial such as sorbic acid, present in the compositions, as in instant claims 42, 43, 46, 47.
Stanojevic et al. (Bulgarian Journal of Agricultural Science 2009, 15 (4), 307-311) teach that sodium benzoate is an antibacterial (MIC values in Table 1, page 309) against a number of bacteria including Bacillus subtilis, Pseudomonas aer.
Hu (WO 02092143 published 21 November 2002) teach antimicrobial compositions comprising a polyquaternium antibacterial agent, as well as sorbic acid (0.15%) as an antibacterial preservative necessary to reduce the concentration of bacteria on the surface of a biomaterial.
It would have been obvious to a person of ordinary skill in the art to combine the teachings of Shair and Merianos, Stanojevic and Hu in an antibacterial/antimicrobial composition.
The person of ordinary skill in the art would have been motivated to add sodium benzoate to a quaternary ammonium containing polymer prepared by reacting dimethyl amine with epichlorohydrin, because Shair and Merianos prepare such polymers and teach that said polymers are bactericidal at pH 7, and Stanojevic teaches that sodium benzoate is antibacterial. Therefore, one of ordinary skill in the art would have reasonably expected that combining sodium benzoate and a quaternary ammonium containing polymer prepared by reacting dimethyl amine with epichlorohydrin, known to be useful for the same purpose, as antibacterial/antimicrobial, will result in a composition having antibacterial properties. At least additive antibacterial effects would have been reasonably expected. See In re Kerkhoven, 205 USPQ 1069 (CCPA 1980).
Further, it would have been obvious to optimize the content of sodium benzoate in the composition to arrive at the instantly claimed ranges. Such an optimization of content of ingredients in the composition, with the aim of achieving maximum antimicrobial effect and best properties with the composition, is considered routine for the skilled artisan.
Furthermore, it would have been obvious to add sorbic acid (Applicant’s elected species of an additional antimicrobial chemical) to such a composition, because Hu teaches that sorbic acid is compatible with polyquaternium antibacterial agents in antimicrobial compositions. Thus, the person of ordinary skill in the art would have added sorbic acid to the composition, with the expectation that the resulting composition retains antimicrobial properties.
Regarding the limitation “wherein the antimicrobial composition provides antimicrobial activity for 7 days” in claims 36, 44,
“Products of identical chemical composition can not have mutually exclusive properties.” A chemical composition and its properties are inseparable. Therefore, if the prior art teaches or renders obvious the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). See MPEP 2112.01. The burden is shifted to Applicant to show that the prior art product does not possess the same properties as the instantly claimed product.
As such, claims 36, 38-48, 58-63 are rejected as prima facie obvious.
Conclusion
Claims 36, 38-48, 58-63 are rejected.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to IRINA NEAGU whose telephone number is (571)270-5908. The examiner can normally be reached Mon-Fri 8-5.
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/IRINA NEAGU/Primary Examiner, Art Unit 1629
